Meloflex

Meloflex may be available in the countries listed below.

Ingredient matches for Meloflex

Meloxicam

Meloxicam is reported as an ingredient of Meloflex in the following countries:

• Peru

International Drug Name Search

Meloxicam Eg

Meloxicam Eg may be available in the countries listed below.

Ingredient matches for Meloxicam Eg

Meloxicam

Meloxicam is reported as an ingredient of Meloxicam Eg in the following countries:

• Belgium


• Italy


• Luxembourg

International Drug Name Search

Meloxicam Danapha

Meloxicam Danapha may be available in the countries listed below.

Ingredient matches for Meloxicam Danapha

Meloxicam

Meloxicam is reported as an ingredient of Meloxicam Danapha in the following countries:

• Vietnam

International Drug Name Search

Marzine

Marzine may be available in the countries listed below.

Ingredient matches for Marzine

Cyclizine

Cyclizine hydrochloride (a derivative of Cyclizine) is reported as an ingredient of Marzine in the following countries:

• Denmark


• Finland


• Norway


• Taiwan

International Drug Name Search

Mixfard

Mixfard may be available in the countries listed below.

Ingredient matches for Mixfard

Insulin Injection, Soluble

Insulin Injection, Soluble human (a derivative of Insulin Injection, Soluble) is reported as an ingredient of Mixfard in the following countries:

• Ethiopia

International Drug Name Search

Miol

Miol may be available in the countries listed below.

Ingredient matches for Miol

Omeprazole

Omeprazole is reported as an ingredient of Miol in the following countries:

• Spain

International Drug Name Search

Hydroxychloroquine Sulfate

Class: Antimalarials
VA Class: AP101
CAS Number: 747-36-4
Brands: Plaquenil

Introduction

Antimalarial; 4-aminoquinoline derivative.^a

Uses for Hydroxychloroquine Sulfate

Malaria

Prevention (prophylaxis) of malaria caused by Plasmodium malariae, P. ovale, P. vivax, or susceptible strains of P. falciparum.^{105 109} CDC and others recommend chloroquine for prevention of malaria caused by Plasmodium susceptible to 4-aminoquinoline derivatives;^{105 110} hydroxychloroquine is as effective and may be better tolerated¹⁰⁵ and may be used when chloroquine is unavailable.^{105 110}

Treatment of uncomplicated malaria caused by P. malariae, P. ovale, P. vivax, or susceptible strains of P. falciparum.^{109 110}

Active only against the asexual erythrocytic forms of Plasmodium (not exoerythrocytic stages) and cannot prevent delayed primary attacks or relapse of P. ovale or P. vivax malaria or provide a radical cure; primaquine usually also indicated to eradicate hypnozoites and prevent relapse in patients exposed to or being treated for P. ovale or P. vivax malaria.^{105 109}

Detailed recommendations regarding prevention of malaria available from CDC 24 hours a day from the voice information service (877-394-8747), fax information service (888-232-3299), or Internet at .¹⁰⁵

Assistance with diagnosis or treatment of malaria available from CDC Malaria Epidemiology Branch by contacting CDC Malaria Hotline at 770-488-7788 from 8:00 a.m. to 4:30 p.m. Eastern Standard Time or CDC Emergency Operation Center at 770-488-7100 after hours, on weekends, and holidays.¹¹⁸

Rheumatoid Arthritis

Treatment of rheumatoid arthritis in patients whose symptoms progress despite an adequate regimen of nonsteroidal anti-inflammatory agents (NSAIAs).^{103 104 109}

One of several disease-modifying antirheumatic drugs (DMARDs) that can be used when DMARD therapy is appropriate.^{103 104} If used for prolonged periods in treatment of rheumatoid arthritis, the risk of severe and sometimes irreversible toxicity should be considered.¹⁰⁹ (See Cautions.)

Lupus Erythematosus

Treatment of discoid lupus erythematosus and systemic lupus erythematosus.¹⁰⁹ Used as an adjunct to corticosteroids and/or other appropriate therapy.^a

If used for prolonged periods in treatment of lupus erythematosus, the risk of serious and sometimes irreversible toxicity should be considered. (See Cautions.)

Q Fever

Treatment of Q fever endocarditis† caused by Coxiella burnetii; used in conjunction with doxycycline.^{111 112 113}

CDC recommends a 2- to 3-week regimen of doxycycline for treatment of acute Q fever, a 1-year regimen of doxycycline and hydroxychloroquine for treatment of acute Q fever in patients with preexisting valvular heart disease (to prevent progression of acute disease to endocarditis), and a 1.5- to 3-year regimen of doxycycline and hydroxychloroquine for treatment of chronic Q fever.¹¹³

Porphyria Cutanea Tarda and Polymorphous Light Eruptions

Has been used in treatment of porphyria cutanea tarda†.^{115 116 117} (See Patients with Psoriasis or Porphyria under Cautions.)

Has been effective in some cases when used in the treatment of polymorphous light eruptions†.

Hydroxychloroquine Sulfate Dosage and Administration

Administration

Oral Administration

Administer orally.¹⁰⁹

When used in treatment of rheumatoid arthritis, administer with a meal or a glass of milk.¹⁰⁹

Dosage

Available as hydroxychloroquine sulfate; dosage usually expressed as hydroxychloroquine.¹⁰⁹

Each 200 mg of hydroxychloroquine sulfate is equivalent to 155 mg of hydroxychloroquine.¹⁰⁹

Pediatric Patients

Malaria

Prevention of Malaria in Areas Without Chloroquine-resistant Plasmodium

Oral

5 mg/kg (6.5 mg/kg of hydroxychloroquine sulfate) once weekly on the same day each week.^{105 109}

Initiate prophylaxis 1–2 weeks prior to entering a malarious area and continue for 4 weeks after leaving the area.^{105 114} CDC states it may be advisable to initiate prophylaxis 3–4 weeks prior to travel to ensure that the drug or combination of drugs (in individuals receiving other drugs) is well tolerated and to allow ample time if a switch to another antimalarial agent is required.¹⁰⁵

If not initiated prior to entering a malarious area, manufacturer recommends a loading dose of 10 mg/kg (13 mg/kg of hydroxychloroquine sulfate) given in 2 equally divided doses 6 hours apart followed by the usual dosage.¹⁰⁹

Treatment of Uncomplicated Chloroquine-susceptible Malaria

Oral

An initial dose of 10 mg/kg (13 mg/kg of hydroxychloroquine sulfate) followed by 5-mg/kg doses (6.5 mg/kg of hydroxychloroquine sulfate) given at 6, 24, and 48 hours after the initial dose.¹⁰⁹

Adults

Malaria

Prevention of Malaria in Areas Without Chloroquine-resistant Plasmodium

Oral

310 mg (400 mg of hydroxychloroquine sulfate) once weekly on the same day each week.^{105 109}

Initiate prophylaxis 1–2 weeks prior to entering a malarious area and continue for 4 weeks after leaving the area.^{105 114} CDC states it may be advisable to initiate prophylaxis 3–4 weeks prior to travel to ensure that the drug or combination of drugs (in individuals receiving other drugs) is well tolerated and to allow ample time if a switch to another antimalarial agent is required.¹⁰⁵

If not initiated prior to entering a malarious area, the manufacturer recommends a loading dose of 620 mg (800 mg of hydroxychloroquine sulfate) followed by the usual dosage regimen.¹⁰⁹

Treatment of Uncomplicated Chloroquine-susceptible Malaria

Oral

An initial dose of 620 mg (800 mg of hydroxychloroquine sulfate) followed by 310-mg doses (400 mg of hydroxychloroquine sulfate) given 6–8 hours, 24, and 48 hours after the initial dose.¹⁰⁹ This represents a total hydroxychloroquine dose of 1.55 g (2 g of hydroxychloroquine sulfate) in 3 days.¹⁰⁹ Alternatively, adults may receive a single 620-mg dose (800 mg of hydroxychloroquine sulfate).¹⁰⁹

Rheumatoid Arthritis

Oral

Initiate treatment with 310–465 mg (400–600 mg of hydroxychloroquine sulfate) daily.¹⁰⁹ If adverse effects occur, dosage may be temporarily reduced; after 5–10 days, increase dosage gradually until an optimum response occurs without recurrence of adverse effects.¹⁰⁹

A response may not occur until after 4–12 weeks and several months of therapy may be required to attain optimum response.¹⁰⁹ When a good response is obtained, decrease dosage by 50% and continue treatment with a maintenance dosage of 155–310 mg (200–400 mg of hydroxychloroquine sulfate) daily.¹⁰⁹

If relapse occurs after hydroxychloroquine is discontinued, the drug can be reinitiated or continued on an intermittent schedule if there is no evidence of adverse ocular effects.¹⁰⁹

If objective improvement of rheumatoid arthritis (e.g., reduced joint swelling, increased mobility) does not occur within 6 months, hydroxychloroquine should be discontinued.¹⁰⁹

Lupus Erythematosus

Oral

310 mg (400 mg of hydroxychloroquine sulfate) once or twice daily for several weeks or months depending on response of the patient.¹⁰⁹ For prolonged maintenance therapy, 155–310 mg (200–400 mg of hydroxychloroquine sulfate) daily may be adequate.¹⁰⁹

Q Fever†

Acute Q Fever in Patients with Preexisting Valvular Heart Disease†

Oral

CDC recommends 465 mg (600 mg of hydroxychloroquine sulfate) daily in conjunction with oral doxycycline (200 mg daily) for 1 year.¹¹³ Adjust hydroxychloroquine dosage to maintain plasma hydroxychloroquine concentrations at 1 ± 0.2 mcg/mL.¹¹³

Chronic Q Fever†

Oral

CDC recommends 465 mg (600 mg of hydroxychloroquine sulfate) daily in conjunction with oral doxycycline (200 mg daily) for 1.5–3 years.¹¹³

Prescribing Limits

Pediatric Patients

Malaria

Prevention of Malaria in Areas Without Chloroquine-resistant Plasmodium

Oral

Maximum of 310 mg (400 mg of hydroxychloroquine sulfate) daily, regardless of weight.¹⁰⁵

Cautions for Hydroxychloroquine Sulfate

Contraindications

• 
  

  Hypersensitivity to 4-aminoquinoline derivatives.¹⁰⁹

  
  


• 
  

  Retinal or visual field changes attributable to 4-aminoquinoline derivatives or to any other etiology.¹⁰⁹

  
  


• 
  

  Long-term use in children.¹⁰⁹

  
  

Warnings/Precautions

Warnings

Chloroquine-resistant Plasmodium

Hydroxychloroquine is not effective against chloroquine-resistant P. falciparum.^{105 109} For prevention of malaria, use only in individuals traveling to malarious areas where chloroquine-resistant P. falciparum malaria has not been reported.¹⁰⁵

For prevention or treatment of malaria, consider that chloroquine-resistant P. falciparum have been reported in all areas where malaria occurs, except the Dominican Republic, Haiti, Mexico and Central America west of the former Panama Canal zone, Paraguay, northern Argentina, Egypt, most of the Middle East (chloroquine resistance has been reported in Iran, Oman, Saudi Arabia, and Yemen), and most of China (chloroquine resistance has been reported in Hainin and Yunnan provinces).^{105 110 114}

Ocular Effects

Dose-related retinopathy reported, which may progress even after the drug is discontinued.¹⁰⁹ Irreversible retinal damage has occurred in some patients who received long-term or high-dosage 4-aminoquinoline therapy for treatment of discoid and systemic lupus erythematosus or rheumatoid arthritis.¹⁰⁹

Whenever long-term therapy is contemplated, perform initial (base line) and periodic (every 3 months) ophthalmologic examinations, including visual acuity, slit-lamp, funduscopic, and visual field tests.¹⁰⁹

Discontinue drug immediately and closely observe patient for possible progression if there is any indication of abnormalities in visual acuity or visual field, abnormalities in the retinal macular area (such as pigmentary changes or loss of foveal reflex), or if any other visual symptoms (e.g., light flashes and streaks) occur which are not fully explainable by difficulties of accommodation or corneal opacities.¹⁰⁹

Neuromuscular Effects

Skeletal muscle palsies or skeletal muscle myopathy or neuromyopathy reported.¹⁰⁹ May lead to progressive weakness and atrophy of proximal muscle groups and may be associated with mild sensory changes, depression of tendon reflexes, and abnormal nerve conduction.¹⁰⁹

Patients receiving prolonged therapy should be questioned and examined periodically for evidence of muscular weakness; knee and ankle reflexes should be tested.¹⁰⁹

Discontinue hydroxychloroquine if muscular weakness occurs.¹⁰⁹

Patients with Psoriasis or Porphyria

May exacerbate psoriasis and precipitate a severe attack in patients with the disease.¹⁰⁹ Use in psoriasis patients only if potential benefits outweigh risks.¹⁰⁹

May exacerbate porphyria.¹⁰⁹ Use in patients with porphyria only if potential benefits outweigh risks.¹⁰⁹

General Precautions

Dermatologic Effects

Dermatologic reactions may occur; use with caution in patients with tendency for dermatitis.¹⁰⁹

Hematologic Effects

Aplastic anemia, agranulocytosis, leukopenia, thrombocytopenia (hemolysis in patients with G-6-PD deficiency) reported rarely.¹⁰⁹

Periodically monitor CBCs in patients receiving prolonged treatment.¹⁰⁹ Consider discontinuing hydroxychloroquine if any severe blood disorder occurs which is not attributable to the disease being treated.¹⁰⁹

Use with caution in patients with G-6-PD deficiency.¹⁰⁹

Specific Populations

Pregnancy

Category C.^b

Avoid use during pregnancy unless the clinician determines that the benefits of prevention or treatment of malaria outweigh the risks.¹⁰⁹ Chloroquine has been used for prophylaxis and treatment of malaria in pregnant women without evidence of adverse effects on the fetus,^{105 110} and CDC states that the benefits of chloroquine or hydroxychloroquine prophylaxis in pregnant women exposed to malaria outweigh potential risks to the fetus.^{105 110}

Lactation

Distributed into milk.¹⁰² Amount of drug present in human milk does not appear to be harmful to nursing infants, but is insufficient to provide adequate protection against malaria in these infants.¹⁰⁵ When chemoprophylaxis is necessary in such infants, they should receive recommended dosages of the appropriate antimalarial agent(s).¹⁰⁵

Pediatric Use

Pediatric patients are especially sensitive to 4-aminoquinoline derivatives.¹⁰⁹ Fatalities have been reported following accidental ingestion of relatively small doses.¹⁰⁹

Prolonged therapy with hydroxychloroquine is contraindicated in children; safe use of the drug for treatment of juvenile arthritis has not been established.¹⁰⁹

Hepatic Impairment

Hydroxychloroquine may concentrate in the liver;^a use with caution in patients with hepatic disease or alcoholism and in patients receiving other hepatotoxic drugs.¹⁰⁹

Common Adverse Effects

Ocular effects; skeletal muscle myopathy or neuromyopathy; GI effects (anorexia, diarrhea, nausea, abdominal cramps, vomiting); CNS effects (headache, dizziness); dermatologic effects.¹⁰⁹

Hydroxychloroquine Sulfate Pharmacokinetics

Distribution

Extent

Distributed into milk.¹⁰²

Elimination

Metabolism

Partially metabolized; the major metabolites are desethylhydroxychloroquine and desethylchloroquine.¹⁰⁰ Bisdesethylchloroquine, a carboxylic acid derivative, also is formed in small amounts.¹⁰⁰

Elimination Route

Hydroxychloroquine and its metabolites are slowly excreted by the kidneys.¹⁰⁰

Stability

Storage

Oral

Tablets

Room temperature ≤30°C in tight, light-resistant container.¹⁰⁹

Actions and SpectrumActions

• 
  

  A blood schizonticidal agent active against asexual erythrocytic forms of most strains of Plasmodium malariae, P. ovale, P. vivax, and many strains of P. falciparum.^a Not active against preerythrocytic or exoerythrocytic forms of plasmodia.^a Gametocidal for P. malariae and P. vivax, but has no direct activity against the gametocytes of P. falciparum.^a

  
  


• 
  

  Chloroquine-resistant P. falciparum also are resistant to hydroxychloroquine¹⁰⁹ and may be cross-resistant to pyrimethamine or quinine.^a

  
  


• 
  

  Has anti-inflammatory activity; mechanism(s) of action in the treatment of rheumatoid arthritis and lupus erythematosus has not been determined.^a

  
  

Advice to Patients

• 
  

  Importance of keeping hydroxychloroquine out of reach of children since they are especially sensitive to 4-aminoquinoline derivatives.¹⁰⁹

  
  


• 
  

  Necessity of taking protective measures to reduce contact with mosquitoes (protective clothing, insect repellents, mosquito nets, remaining in air-conditioned or well-screened areas).^{105 110}

  
  


• 
  

  Possibility of contracting malaria during travel, regardless of prophylactic regimen used.^{105 110}

  
  


• 
  

  Importance of seeking medical attention as soon as possible if febrile illness develops during or after return from a malaria-endemic area and of informing clinician of possible malaria exposure.^{105 110}

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.

  
  


• 
  

  Importance of women informing clinician if they are or plan to become pregnant or plan to breast-feed.¹⁰⁹

  
  


• 
  

  Importance of advising patients of other important precautionary information. (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Hydroxychloroquine Sulfate

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets, film-coated	155 mg (of hydroxychloroquine)*	Plaquenil	Sanofi-Synthelabo

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Hydroxychloroquine Sulfate 200MG Tablets (WATSON LABS): 60/$35.99 or 180/$88.99

Plaquenil 200MG Tablets (SANOFI-AVENTIS U.S.): 60/$204.33 or 180/$587.44

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions August 2005. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

Only references cited for selected revisions after 1984 are available electronically.

100. McChesney EW. Animal toxicity and pharmacokinetics of hydroxychloroquine sulfate. Am J Med. 1983; 75(Suppl. 1A):11-8. [IDIS 174380] [PubMed 6408923]

101. Janssen NM, Genta MS. The effects of immunosuppressive and anti-inflammatory medications on fertility, pregnancy, and lactation. Arch Inter Med. 2000; 160:610-9.

102. American Academy of Pediatrics Committee on Drugs. Transfer of drugs and other chemicals into human milk. Pediatrics. 1989; 84:924-36. [IDIS 260411] [PubMed 2677964]

103. American College of Rheumatology Subcommittee on Rheumatoid Arthritis Guidelines. Guidelines for the management of rheumatoid arthritis: 2002 update. Arthritis Rheum. 2002; 46:328-46. [IDIS 476480] [PubMed 11840435]

104. Anon. Drugs for rheumatoid arthritis. Med Lett Drugs Ther. 2000; 42:57-64. [PubMed 10887424]

105. Centers for Disease Control and Prevention. Health information for international travel, 2003–2004. Atlanta, GA: US Department of Health and Human Services; 2003:13-39,99-116,136,138,175-7,227,231-5,240-2,249-50. Updates available from CDC website ().

106. Clark P, Casas E, Tugwell P et al. Hydroxychloroquine compared with placebo in rheumatoid arthritis: a randomized controlled trial. Ann Intern Med. 1993; 119:1067-71. [IDIS 322560] [PubMed 8239224]

107. Harris ED Jr. Hydroxychloroquine is safe and probably useful in rheumatoid arthritis. Ann Intern Med. 1993; 119:1146-7. [IDIS 322565] [PubMed 8239236]

108. Makin AJ, Wendon J, Fitt S. Fulminant hepatic failure secondary to hydroxychloroquine. Gut. 1994; 35:569-70. [IDIS 330037] [PubMed 8175002]

109. Sanofi-Synthelabo. Plaquenil (hydroxychloroquine sulfate) prescribing information. New York, NY; 2002 Apr.

110. Anon. Drugs for parasitic infections. Med Lett Drugs Ther. Aug 2004. From the Medical Letter website (). Accessed 2005 Feb 2.

111. Raoult D, Houpikian P, Dupont HT et al. Treatment of Q fever endocarditis: comparison of 2 regimens containing doxycycline and ofloxacin or hydrochloroquine. Arch Intern Med. 1999; 159:167-73. [IDIS 418047] [PubMed 9927100]

112. Lupoglazoff JM, Brouqui P, Magnier S et al. Q fever tricuspid valve endocarditis. Arch Dis Child. 1997; 77:448-9. [IDIS 398559] [PubMed 9487972]

113. Centers for Disease Control and Prevention. Q fever—California, Georgia, Pennsylvania, and Tennessee, 2000-2001. MMWR Morb Mortal Wkly Rep. 2002; 51:924-5. [PubMed 12403408]

114. Anon. Advice for travelers. Med Lett Drugs Ther. 2004; 2:33-40.

115. Bruce AJ, Ahmed I. Childhood-onset porphyria cutanea tarda: successful therapy with low-dose hydroxychloroquine (Plaquenil). J Am Acad Dermatol. 1998; 38(5 pt 2):810-3. [IDIS 406218] [PubMed 9591792]

116. Wallace DJ. The use of chloroquine and hydroxychloroquine for non-infectious conditions other than rheumatoid arthritis or lupus: a critical review. Lupus. 1996; 5(Suppl 1):S59-64.

117. Petersen CS, Thomsen K. High-dose hydroxychloroquine treatment of porphyria cutanea tarda. J Am Acad Dermatol. 1992; 26:614-9. [PubMed 1597548]

118. Centers for Disease Control and Prevention. CDC treatment guidelines: Treatment of malaria (guidelines for clinicians). 2004 Jun 28. From the CDC website: (). Accessed 2004 Oct 25.

a. AHFS Drug Information 2004. McEvoy GK, ed. hydroxychloroquine Sulfate. Bethesda, MD: American Society of Health-System Pharmacists; 2004:827-8.

b. Briggs GG, Freeman RK, Yaffe SJ. Drugs in pregnancy and lactation. 6th ed. Philadelphia; PA: Lippincott Wiliams & Wilkins; 2002:671-4.

More Hydroxychloroquine Sulfate resources

• Hydroxychloroquine Sulfate Side Effects (in more detail)
• Hydroxychloroquine Sulfate Dosage
• Hydroxychloroquine Sulfate Use in Pregnancy & Breastfeeding
• Drug Images
• Hydroxychloroquine Sulfate Drug Interactions
• Hydroxychloroquine Sulfate Support Group
• 50 Reviews for Hydroxychloroquine Sulfate - Add your own review/rating

• hydroxychloroquine Concise Consumer Information (Cerner Multum)


• hydroxychloroquine Advanced Consumer (Micromedex) - Includes Dosage Information


• Hydroxychloroquine MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Hydroxychloroquine Sulfate with other medications

• Dermatomyositis
• Lyme Disease, Arthritis
• Malaria
• Malaria Prevention
• Rheumatoid Arthritis
• Sjogren's Syndrome
• Systemic Lupus Erythematosus
• Undifferentiated Connective Tissue Disease

Antivenin Polyvalent

Generic Name: antivenin (CROTALIDAE) POLYVALENT (Injection route)

an-tee-VEN-in (kroe-TAL-i-dee) pol-ee-VAY-lent

Commonly used brand name(s)

In the U.S.

• Antivenin Polyvalent

Available Dosage Forms:

• Kit

Therapeutic Class: Antivenom

Uses For Antivenin Polyvalent

Pit viper antivenin belongs to a group of medicines known as immunizing agents. It is used to treat the bites of certain poisonous snakes called pit vipers (crotalids), which are native to Central, North, and South America. Pit vipers include rattlesnakes, such as the Eastern and the Western diamond rattlesnakes; copperheads and cottonmouth moccasins, including those of Korea and Japan; the fer-de-lance and similar species; the tropical rattler (Cascabel) and similar species; the Cantil; and the bushmaster of Central and South America.

Pit viper antivenin is to be used only by or under the supervision of a doctor.

Before Using Antivenin Polyvalent

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies show that children tolerate pit viper antivenin better than do adults. However, children usually have more severe reactions to snakebite poisoning because of the greater amount of poison per body weight. Therefore, children may need larger doses of pit viper antivenin than do adults.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of pit viper antivenin in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of Antivenin Polyvalent

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Make certain your health care professional knows if you are on any special diet, such as a low-sodium or low-sugar diet.

Antivenin Polyvalent Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Difficulty in breathing or swallowing


• hives


• itching, especially of feet or hands


• reddening of skin, especially around ears


• swelling of eyes, face, or inside of nose


• unusual tiredness or weakness (sudden and severe)

For up to 24 days after you have received pit viper antivenin, you may develop symptoms of a side effect called serum sickness. The severity of the symptoms and the length of the sickness depend on the amount of pit viper antivenin you were given and how long the treatment lasted. During the 24 days after treatment with pit viper antivenin, check with your doctor if you notice any of the following side effects:

• Fever


• joint pain


• rash and itching


• swollen lymph glands

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

Acyclovir Suspension

Pronunciation: ay-SYE-kloe-vir
Generic Name: Acyclovir
Brand Name: Zovirax

Acyclovir Suspension is used for:

Treating shingles or chickenpox, or treating or suppressing genital herpes. It may also be used for other conditions as determined by your doctor.

Acyclovir Suspension is an antiviral. It works by preventing the herpes virus from reproducing. Acyclovir does not eliminate the virus and is not a cure. It does not prevent transmission of the virus to others.

Do NOT use Acyclovir Suspension if:

• you are allergic to any ingredient in Acyclovir Suspension or to valacyclovir

Contact your doctor or health care provider right away if any of these apply to you.

Before using Acyclovir Suspension:

Some medical conditions may interact with Acyclovir Suspension. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have kidney problems or a weakened immune system


• if you are receiving hemodialysis

Some MEDICINES MAY INTERACT with Acyclovir Suspension. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Medicines that may harm the kidney (eg, aminoglycoside antibiotics [eg, gentamicin], amphotericin B, cyclosporine, nonsteroidal anti-inflammatory drugs [NSAIDs] [eg, ibuprofen], tacrolimus, vancomycin) because the risk of kidney side effects may be increased. Ask your doctor if you are unsure if any of your medicines might harm the kidney

This may not be a complete list of all interactions that may occur. Ask your health care provider if Acyclovir Suspension may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Acyclovir Suspension:

Use Acyclovir Suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Acyclovir Suspension by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• Shake well before each use.


• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.


• Drinking extra fluids while you are taking Acyclovir Suspension is recommended. Check with your doctor for instructions.


• Start therapy with Acyclovir Suspension at the earliest sign or symptom of chickenpox, shingles, or genital herpes (pain, burning, blisters).


• If treating an acute outbreak, continue using Acyclovir Suspension for the full course of treatment even if you feel better in a few days.


• If you miss a dose of Acyclovir Suspension, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Acyclovir Suspension.

Important safety information:

• Acyclovir Suspension may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Acyclovir Suspension with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Acyclovir Suspension may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Acyclovir Suspension. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• Acyclovir Suspension is not a cure for genital herpes and will not prevent the virus from spreading. Avoid sexual intercourse when sores are present to prevent infecting your partner. You can also be contagious and spread the herpes virus but not have any signs or symptoms at all. This is called asymptomatic viral shedding.


• Lab tests, including kidney function, may be performed while you use Acyclovir Suspension. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Acyclovir Suspension with caution in the ELDERLY; they may be more sensitive to its effects, especially confusion, drowsiness, or hallucinations.


• Acyclovir Suspension should be used with extreme caution in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Acyclovir Suspension while you are pregnant. Acyclovir Suspension is found in breast milk. If you are or will be breast-feeding while you use Acyclovir Suspension, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Acyclovir Suspension:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; dizziness; drowsiness; general body discomfort; headache; muscle weakness; nausea; stomach upset; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); aggressive behavior; blood in the urine; confusion; decreased consciousness; decreased urination; easy bruising or bleeding; fever; hallucinations; hoarseness; lower back pain; mania; mental or mood changes; red, swollen, or blistered skin; seizures; swelling of the hands or feet; vision changes; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include agitation; loss of consciousness; seizures; tiredness.

Proper storage of Acyclovir Suspension:

Store Acyclovir Suspension at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Acyclovir Suspension out of the reach of children and away from pets.

General information:

• If you have any questions about Acyclovir Suspension, please talk with your doctor, pharmacist, or other health care provider.


• Acyclovir Suspension is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Acyclovir Suspension. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Acyclovir resources

• Acyclovir Use in Pregnancy & Breastfeeding
• Drug Images
• Acyclovir Drug Interactions
• Acyclovir Support Group
• 26 Reviews for Acyclovir - Add your own review/rating

Compare Acyclovir with other medications

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• Herpes Simplex, Suppression
• Herpes Zoster
• Varicella-Zoster

Busipron-Egis

Busipron-Egis may be available in the countries listed below.

Ingredient matches for Busipron-Egis

Buspirone

Buspirone hydrochloride (a derivative of Buspirone) is reported as an ingredient of Busipron-Egis in the following countries:

• Czech Republic

International Drug Name Search

Syntocin

Syntocin may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Syntocin

Oxytocin

Oxytocin is reported as an ingredient of Syntocin in the following countries:

• Australia


• Bangladesh

International Drug Name Search

Methyldopa and Hydrochlorothiazide

Ingredient matches for Methyldopa and Hydrochlorothiazide

Hydrochlorothiazide

Hydrochlorothiazide is reported as an ingredient of Methyldopa and Hydrochlorothiazide in the following countries:

• United States

Methyldopa

Methyldopa is reported as an ingredient of Methyldopa and Hydrochlorothiazide in the following countries:

• United States

International Drug Name Search

Melleril

Melleril may be available in the countries listed below.

Ingredient matches for Melleril

Thioridazine

Thioridazine is reported as an ingredient of Melleril in the following countries:

• Japan

Thioridazine hydrochloride (a derivative of Thioridazine) is reported as an ingredient of Melleril in the following countries:

• Bangladesh


• Brazil


• Ethiopia


• Germany


• Indonesia

International Drug Name Search

Petnidan

Petnidan may be available in the countries listed below.

Ingredient matches for Petnidan

Ethosuximide

Ethosuximide is reported as an ingredient of Petnidan in the following countries:

• Germany


• Hungary


• Luxembourg


• Slovakia


• Slovenia

International Drug Name Search

Muxen

Muxen may be available in the countries listed below.

Ingredient matches for Muxen

Ambroxol

Ambroxol hydrochloride (a derivative of Ambroxol) is reported as an ingredient of Muxen in the following countries:

• Venezuela

International Drug Name Search

Simply Sleep

Pronunciation: DYE-fen-HYE-dra-meen
Generic Name: Diphenhydramine
Brand Name: Examples include Nytol and Simply Sleep

Simply Sleep is used for:

Treating occasional sleeplessness and reducing difficulty falling asleep.

Simply Sleep is an antihistamine. It works by depressing the central nervous system (brain) to produce drowsiness.

Do NOT use Simply Sleep if:

• you are allergic to any ingredient in Simply Sleep or to other similar medicines


• you are taking sodium oxybate (GHB)


• you are breast-feeding

Contact your doctor or health care provider right away if any of these apply to you.

Before using Simply Sleep:

Some medical conditions may interact with Simply Sleep. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have asthma, chronic obstructive pulmonary disease (COPD), chronic bronchitis, emphysema, lung disease, shortness of breath, or sleep apnea


• if you have blockage of the stomach, intestine, or urinary tract; difficulty urinating; diabetes; ulcers; enlargement of the prostate; glaucoma; heart disease; high blood pressure; the blood disease porphyria; or thyroid disease

Some MEDICINES MAY INTERACT with Simply Sleep. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Sodium oxybate (GHB) because an increase in sleep duration and a decrease in the ability to breathe are likely to occur

This may not be a complete list of all interactions that may occur. Ask your health care provider if Simply Sleep may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Simply Sleep:

Use Simply Sleep as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Simply Sleep by mouth with or without food.


• Use Simply Sleep exactly as directed on the package, unless instructed differently by your doctor.


• Take at least 30 minutes before bedtime to help fall asleep.


• If you miss a dose of Simply Sleep and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Simply Sleep.

Important safety information:

• Simply Sleep may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Simply Sleep with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Simply Sleep; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Simply Sleep may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.


• Do not become overheated in hot weather or while you are being active; heatstroke may occur.


• Simply Sleep may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Simply Sleep. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• Simply Sleep has diphenhydramine in it. Before you start any new medicine, check the label to see if it has diphenhydramine in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• If sleeplessness persists for more than 2 weeks, contact your health care provider.


• Use Simply Sleep with caution in the ELDERLY; they may be more sensitive to its effects, especially dizziness, sedation, and lightheadedness upon standing.


• Simply Sleep should not be used in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Simply Sleep while you are pregnant. Simply Sleep is found in breast milk. Do not breast-feed while taking Simply Sleep.

Possible side effects of Simply Sleep:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; drowsiness; dry mouth, throat, and nose; thickening of mucus in nose or throat.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); convulsions; decreased alertness; excitability; fast heartbeat; hallucinations; tightness or pounding in the chest; tremor; wheezing.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Simply Sleep side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include coma; excitement; hallucinations; loss of consciousness; muscle twitching; seizures; tremor; weakness.

Proper storage of Simply Sleep:

Store Simply Sleep at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), or according to directions on the package label. Store in the original package or container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Simply Sleep out of the reach of children and away from pets.

General information:

• If you have any questions about Simply Sleep, please talk with your doctor, pharmacist, or other health care provider.


• Simply Sleep is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Simply Sleep. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Simply Sleep resources

• Simply Sleep Side Effects (in more detail)
• Simply Sleep Use in Pregnancy & Breastfeeding
• Simply Sleep Drug Interactions
• Simply Sleep Support Group
• 6 Reviews for Simply Sleep - Add your own review/rating

• Benadryl Consumer Overview


• Children's Allergy Prescribing Information (FDA)


• Diphen Advanced Consumer (Micromedex) - Includes Dosage Information


• Diphenhydramine Prescribing Information (FDA)


• Diphenhydramine Hydrochloride Monograph (AHFS DI)


• Diphenoxylate Hydrochloride Monograph (AHFS DI)

Compare Simply Sleep with other medications

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Methotrexat Wyeth

Methotrexat Wyeth may be available in the countries listed below.

Ingredient matches for Methotrexat Wyeth

Methotrexate

Methotrexate sodium salt (a derivative of Methotrexate) is reported as an ingredient of Methotrexat Wyeth in the following countries:

• Switzerland

International Drug Name Search

Methotrexate Orion

Methotrexate Orion may be available in the countries listed below.

Ingredient matches for Methotrexate Orion

Methotrexate

Methotrexate is reported as an ingredient of Methotrexate Orion in the following countries:

• Sweden

International Drug Name Search

Minims Rose Bengal

Minims Rose Bengal may be available in the countries listed below.

Ingredient matches for Minims Rose Bengal

Rose Bengal (131I) Sodium

Rose Bengal (131I) Sodium is reported as an ingredient of Minims Rose Bengal in the following countries:

• Ireland

International Drug Name Search

Ambroxol Edigen

Ambroxol Edigen may be available in the countries listed below.

Ingredient matches for Ambroxol Edigen

Ambroxol

Ambroxol hydrochloride (a derivative of Ambroxol) is reported as an ingredient of Ambroxol Edigen in the following countries:

• Spain

International Drug Name Search

Molgramostime

Molgramostime may be available in the countries listed below.

Ingredient matches for Molgramostime

Molgramostim

Molgramostime (DCF) is also known as Molgramostim (Rec.INN)

International Drug Name Search

Glossary

DCF	Dénomination Commune Française
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)

Click for further information on drug naming conventions and International Nonproprietary Names.

Sobulaline

Sobulaline may be available in the countries listed below.

Ingredient matches for Sobulaline

Difenidol

Difenidol hydrochloride (a derivative of Difenidol) is reported as an ingredient of Sobulaline in the following countries:

• Japan

International Drug Name Search

Meloxicam Orion

Meloxicam Orion may be available in the countries listed below.

Ingredient matches for Meloxicam Orion

Meloxicam

Meloxicam is reported as an ingredient of Meloxicam Orion in the following countries:

• Finland

International Drug Name Search

Natura Fenac

Natura Fenac may be available in the countries listed below.

Ingredient matches for Natura Fenac

Diclofenac

Diclofenac sodium salt (a derivative of Diclofenac) is reported as an ingredient of Natura Fenac in the following countries:

• Argentina

International Drug Name Search

Nyogel 0.1% Eye Gel

Nyogel 0.1% eye gel

Timolol

Read all of this leaflet carefully before you start using this medicine.

• Keep this leaflet. You may need to read it again.


• If you have any further questions, ask your doctor or pharmacist.


• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.


• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

• 1. What Nyogel is and what it is used for


• 2. Before you use Nyogel


• 3. How to use Nyogel


• 4. Possible side effects


• 5. How to store Nyogel


• 6. Further information

What Nyogel Is And What It Is Used For

Nyogel contains the active substance timolol. Timolol belongs to a group of medicines called beta-blockers which help to reduce pressure inside the eye.

Nyogel is used to treat conditions where there is an increased pressure in the eye.

Before You Use Nyogel

Do not use Nyogel

• if you are allergic (hypersensitive) to timolol, to any other beta-blocker medicine or any of the other ingredients of Nyogel. If you think you may be allergic, do not use this medicine and talk to your doctor.


• if you have any heart problems such as severe heart failure, irregular pulse or slow pulse.


• if you have or have had asthma or any other breathing disorder.


• if you have symptoms such as runny nose, sneezing, itching of the nose, eyes, throat or roof of the mouth.


• if you have an eye disorder known as corneal dystrophy.


• if you have numb or cold toes and fingers (Raynaud’s syndrome).


• if you have angina (pain and tightness around the chest).


• if you have untreated phaeochromocytoma (high blood pressure due to a tumour near the kidneys).


• if you have low blood pressure.


• if you are taking a medicine containing floctafenine or sultopride.
  Floctafenine is used to treat pain and swelling. Sultopride is used to treat mental problems.

Take special care with Nyogel

Tell your doctor before using Nyogel if you have:

• cardiac failure (a heart disorder)


• sick sinus syndrome (a persistent slow heartbeat causing weakness and tiredness)


• excessive acidity of the blood (a disorder called metabolic acidosis causing rapid breathing, confusion and tiredness)


• an overactive thyroid gland


• a low level of sugar in the blood. If you have diabetes, you should check your blood sugar level more frequently at the beginning of treatment.

If you have any allergies, you may be more likely to have an allergic reaction while using Nyogel. Your doctor will regularly examine your eye pressure and eye.

Children

Nyogel is not recommended for use in children below 12 years.

Elderly patients

No dosage adjustment is necessary.

Using other medicines

If you need to apply other medicinal products to your eyes at the same time as Nyogel, wait at least 5 minutes between applying each product and always apply Nyogel last.

Follow your doctor’s instructions carefully when changing treatment from another product used to decrease eye pressure.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

This is especially important if you are taking:

• MAO inhibitors, which are used to treat depression (e.g. moclobemide)


• medicines used for widening the pupil (e.g. epinephrine)


• medicines used to treat heart problems (e.g. amiodarone, disopyramide, quinidine, lidocain i.v.)


• medicines used to treat high blood pressure (e.g. nifedipine, verapamil, diltiazem)


• medicines used to treat diabetes (e.g. insulin)


• anaesthetics


• medicines used to treat ulcers in your stomach or intestine (e.g. cimetidine)


• contrast liquids which are used for radiological examination

Pregnancy

Tell your doctor if you are pregnant or planning to become pregnant. Do not use Nyogel during pregnancy, unless your doctor considers it necessary.

Breast-feeding

Breast-feeding is not recommended while you are using Nyogel.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Nyogel may cause disturbances of vision including blurred and double vision, drooping eyelids as well as dizziness or tiredness. If this happens to you, do not drive or use any tools or machines.

Important information about some of the ingredients of Nyogel

This medicine contains benzalkonium chloride, which may discolour soft contact lenses and cause eye irritation. Do not use Nyogel if you wear contact lenses.

How To Use Nyogel

Always use Nyogel exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Do not stop using Nyogel without asking your doctor, as your symptoms may get worse.

Nyogel is for use in the eyes (ocular use) only. Do not swallow.

The usual dose is one drop of Nyogel in the affected eye(s) once a day, preferably in the morning. Follow your doctor’s instructions carefully. Do not exceed the recommended dose.

Instructions for proper use of Nyogel

• 1. Wash your hands.


• 2. Tilt your head back.


• 3. Pull the lower eyelid down with a finger. With the other hand hold the bottle with the dropper pointing downwards.


• 4. Gently squeeze the bottle so that one drop falls into the eye. To avoid contamination, do not allow the eye or anything else to touch the tip of the dropper.


• 5. After applying the drop, close your eyelid and press the inside corner of your eye for 3 minutes with your fingertip. This prevents the drop running into your throat through the tear duct and more Nyogel will remain in the eye.


• 6. If necessary repeat steps 2 to 5 with your other eye.


• 7. Close the bottle after use. Do not wipe or rinse off dropper.

If you use more Nyogel than you should

If you use too many drops or accidentally swallow Nyogel, contact your doctor immediately as you may need medical attention. If you need to see a doctor or go to the hospital, take the pack with you.

If you forget to use Nyogel

Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible Side Effects

Like all medicines, Nyogel can cause side effects, although not everybody gets them. Although Nyogel is a local eye treatment, you may experience side effects in other parts of your body.

Some effects could be serious:

• eye pain and abnormal sensitivity of the eye


• slow or irregular heart beat; low blood pressure; heart disorder which can cause breathlessness or swelling of the ankles; fainting; stroke; heart attack; chest pain


• difficulty breathing with wheezing or coughing


• depression; worsening of signs and symptoms of myasthenia gravis (a neurological disorder causing muscle weakness)


• lupus erythematosus (a condition which causes swelling and reddening of the skin with fever and joint pain)


• severe allergic reaction, including breathing difficulties and swelling mainly of the face and throat


• low blood sugar

If you experience any of these, tell your doctor straight away.

Further side effects which have been reported include:

• irritation of the eye such as itching, red and swollen eyes or eyelids; disturbance of vision including blurred and double vision; drooping eyelids; dry eyes


• palpitations; cold hands and feet; leg pain and weakness brought on by walking


• tiredness; headache; weakness


• allergic reactions which may cause local or widespread skin reddening including itchy rash, hair loss and worsening of existing psoriasis


• dizziness; difficulty sleeping; nightmares; memory loss; tingling or numbness


• nausea; vomiting; diarrhoea; indigestion; stomach pain; dry mouth


• decreased sexual desire; impotence; painful erection of the penis

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How To Store Nyogel

Keep out of the reach and sight of children.

Do not use Nyogel after the expiry date which is stated on the carton and the bottle. The expiry date refers to the last day of that month.

Keep the bottle in the outer carton. After first opening store bottle upside down in the outer carton.

Do not use Nyogel for longer than 4 weeks after opening the bottle.

Do not store above 25°C.

Do not freeze.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further Information

What Nyogel contains

The active substance is timolol. 1 g of Nyogel contains 1.37 mg timolol maleate, corresponding to 1 mg timolol (0.1%).

The other ingredients are benzalkonium chloride, sorbitol, polyvinyl alcohol, carbomer 974 P, sodium acetate trihydrate, lysine monohydrate, water for injection.

What Nyogel looks like and contents of the pack

Nyogel is a colourless, odourless gel, free of visible particulate matter.

Nyogel is available in bottles containing 5 g.

The following pack sizes are available: cartons containing 1 or 3 bottles of 5 g. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley

Surrey

GU16 7SR

Manufacturer

EXCELVISION

Rue De La Lombardiere

F-07104 Annonay

France

This medicinal product is authorised in the Member States of the EEA under the following names:

Belgium: Nyogel

Denmark: Timosan Depot

Finland: Timosan

France: Nyogel

Greece: Nyogel

Iceland: Timosan Depot

Ireland: Nyogel

Italy: Nyogel

Netherlands: Nyogel

Portugal: Nyogel

Spain: Timogel

United Kingdom: Nyogel

This leaflet was last approved in 11/2008

Meloxicam Farmoz

Meloxicam Farmoz may be available in the countries listed below.

Ingredient matches for Meloxicam Farmoz

Meloxicam

Meloxicam is reported as an ingredient of Meloxicam Farmoz in the following countries:

• Portugal

International Drug Name Search

Meloksikam Merck

Meloksikam Merck may be available in the countries listed below.

Ingredient matches for Meloksikam Merck

Meloxicam

Meloxicam is reported as an ingredient of Meloksikam Merck in the following countries:

• Slovenia

International Drug Name Search

Zolpidem Helvepharm

Zolpidem Helvepharm may be available in the countries listed below.

Ingredient matches for Zolpidem Helvepharm

Zolpidem

Zolpidem tartrate (a derivative of Zolpidem) is reported as an ingredient of Zolpidem Helvepharm in the following countries:

• Switzerland

International Drug Name Search

Helmiflu

Helmiflu may be available in the countries listed below.

Ingredient matches for Helmiflu

Flubendazole

Flubendazole is reported as an ingredient of Helmiflu in the following countries:

• Colombia

International Drug Name Search

Magnesium Citrate

In the US, Magnesium Citrate (magnesium citrate systemic) is a member of the drug class laxatives and is used to treat Constipation.

US matches:

• Magnesium Citrate Solution


• Magnesium citrate


• Magnesium Citrate Liquid

Scheme

USP

ATC (Anatomical Therapeutic Chemical Classification)

A06AD19,A12CC04,B05CB03

CAS registry number (Chemical Abstracts Service)

0003344-18-1

Chemical Formula

C12-H10-Mg3-O14

Molecular Weight

451

Therapeutic Categories

Mineral supplement

Laxative, osmotically acting

Salt solution

Chemical Names

2-Hydroxy-1,-2,3-propanetricarboxylic acid magnesium salt (2:3)

Citric acid, magnesium salt (2:3)

Magnesium citrate (3:2)

Trimagnesium dicitrate (IUPAC)

Foreign Names

• Magnesii citras (Latin)
• Magnesiumcitrat (German)
• Magnésium citrate (French)
• Magnesio, citrato de (Spanish)

Generic Names

• EINECS 222.093-9 (IS)
• Trimagnesium dicitrat (IS)
• Magnesii citras anhydricus (PH: Ph. Eur. 6)
• Magnesium Citrate (PH: USP 32)
• Magnesium Citrate, Anhydrous (PH: Ph. Eur. 6, BP 2010)

Brand Names

• Citramag
  Sanochemia, United Kingdom



• Citrodan
  Odan, Canada



• Epimag
  Eipico, Oman



• Evac-Q-Mag
  Savage, United States



• Magcorol
  Horii Yakuhin, Japan



• Magcorol P
  Horii Yakuhin, Japan



• Magne (Magnesium Citrate and Pyridoxine)
  Sanofi-Aventis, Slovakia



• Magnegon (Magnesium Citrate and Magnesium Lactate)
  Nycomed Pharma, Switzerland



• Magnesium Diasporal
  Med, Turkey; Protina, Austria



• Magnesium-Diasporal
  Doetsch Grether, Switzerland; Protina, Germany



• Magnesol
  Krka, Slovenia



• Magnevie B6 (Magnesium Citrate and Pyridoxine)
  Sanofi-Aventis, France



• Oromag (Magnesium Citrate and Magnesium Lactate)
  Theramex, Tunisia; Théramex, Monaco



• Tectol
  Sawai Seiyaku, Japan

International Drug Name Search

Glossary

IUPAC	International Union of Pure and Applied Chemistry
IS	Inofficial Synonym
PH	Pharmacopoeia Name
USP	Pharmacopoeia of the United States

Click for further information on drug naming conventions and International Nonproprietary Names.

Melocox

Melocox may be available in the countries listed below.

Ingredient matches for Melocox

Meloxicam

Meloxicam is reported as an ingredient of Melocox in the following countries:

• Greece

International Drug Name Search

Meted

In the US, Meted (salicylic acid/sulfur topical) is a member of the drug class miscellaneous topical agents and is used to treat Acne and Dandruff.

US matches:

• Meted Shampoo

Ingredient matches for Meted

Aspirin

Acetylsalicylic Acid is reported as an ingredient of Meted in the following countries:

• Ireland

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Thyroid

Class: Thyroid Agents
ATC Class: H03AA05
VA Class: HS851
CAS Number: 8028-36-2
Brands: Armour Thyroid, Nature-Throid, Westhroid

Introduction

Natural thyroid agent; cleaned, dried, and powdered thyroid gland (obtained from domesticated animals) containing tetraiodothyronine (thyroxine, T₄) and triiodothyronine (liothyronine, T₃).^{a b c d h}

Uses for Thyroid

Hypothyroidism

Replacement or supplemental therapy in congenital or acquired hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis.^{a b c} Specific indications include primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) hypothyroidism.^{a b c}

Not considered drug of choice for replacement therapy^{a c d e} because of potential problems (e.g., variability in T₄:T₃ ratio, fluctuating and often elevated T₃ concentrations).^{a c m} Levothyroxine is considered drug of choice for replacement therapy.^{a c d e i m}

For the treatment of congenital hypothyroidism (cretinism),^{a b c} levothyroxine is considered drug of choice.^{a c}

Pituitary TSH Suppression

Treatment or prevention of various types of euthyroid goiters, including thyroid nodules, subacute or chronic lymphocytic thyroiditis (Hashimoto’s thyroiditis), and multinodular goiter.^{a b c}

Adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.^{b c}

Efficacy of TSH suppression for benign nodular disease remains controversial.^{p q r}

Diagnosis of Thyroid Disorders

Used diagnostically in suppression tests to differentiate suspected mild hyperthyroidism or thyroid gland autonomy.^{b c} Use with caution in patients in whom there is a strong suspicion of thyroid gland autonomy because exogenous hormone effects will be additive to endogenous source.^b

Thyrotoxicosis

Has been used in combination with antithyroid agents for the treatment of thyrotoxicosis to prevent goitrogenesis and hypothyroidism.^{a c}

May occasionally be useful to prevent antithyroid agent-induced hypothyroidism in the management of thyrotoxicosis during pregnancy; however, combination therapy generally considered unnecessary because it may increase the requirement for antithyroid agents and, therefore, the risk of fetal hypothyroidism.^{a c}

Other Uses

See Unlabeled Uses under Cautions.

Thyroid Dosage and Administration

General

• 
  

  Initially, monitor response to therapy about every 6–8 weeks.^{e m} Once normalization of thyroid function and serum TSH concentrations has been achieved, patients may be evaluated less frequently (i.e., every 6–12 months).^{e m} However, if dosage is changed, measure serum TSH concentrations after 8–12 weeks.^m

  
  


• 
  

  Commercially available natural thyroid preparations have different T₄:T₃ ratios and fluctuating T₃ concentrations.^{a c m} Do not switch from one manufacturer's natural thyroid preparation to another manufacturer's preparation unless under the direction and supervision of a clinician.^a

  
  


• 
  

  Natural and synthetic thyroid agent preparations are not necessarily directly comparable; however, the following equivalencies have been suggested based on clinical response:^c

  
  

Equivalencies of Thyroid Preparations Based on Clinical Responsec

Thyroid Agent	Approximate Equivalent Dosage
Levothyroxine Sodium	100 mcg or less
Liothyronine Sodium	25 mcg
Liotrix (Levothyroxine Sodium/Liothyronine Sodium)	50 mcg/12.5 mcg (Thyrolar)
Thyroglobulin	65 mg
Thyroid	60–65 mg (1 grain)

Administration

Oral Administration

Administer orally, usually as a single daily dose before breakfast.^{a b c}

Dosage

Each 65 mg of thyroid contains approximately 38 and 9 mcg of measurable levothyroxine and T₃, respectively.^{a b} Each 60–65 mg of thyroid is approximately clinically equivalent to 100 mcg or less of levothyroxine sodium or to 25 mcg of liothyronine sodium.^{a c d} (See General under Dosage and Administration.)

Adjust dosage carefully according to clinical and laboratory response to treatment. ^{a b c} Avoid undertreatment or overtreatment.^{b c} (See Therapy Monitoring under Cautions.)

Initiate dosage at a lower level in geriatric patients, in patients with functional or ECG evidence of cardiovascular disease, and in patients with severe, long-standing hypothyroidism or other endocrinopathies.^{a b c}

Pediatric Patients

Hypothyroidism

Oral

Initiate therapy at full replacement dosages as soon as possible after diagnosis of hypothyroidism to prevent deleterious effects on intellectual and physical growth and development.^{a b c o} The following dosages have been recommended:

Dosage for Management of Hypothyroidism in Pediatric Patientsb

Age	Daily Dosage
0–6 months	15–30 mg or 4.8–6 mg/kg
6–12 months	30–45 mg or 3.6–4.8 mg/kg
1–5 years	45–60 mg or 3–3.6 mg/kg
6–12 years	60–90 mg or 2.4–3 mg/kg
>12 years	>90 mg or 1.2–1.8 mg/kg

When transient hypothyroidism is suspected, therapy may be temporarily discontinued when the child is >3 years of age to reassess the condition.^{b o} (See Pediatric Use under Cautions.)

Adults

Hypothyroidism

Oral

Usual initial dosage is 15–30 mg daily.^{b d} May increase dosage in increments of 15 mg at intervals of 2–3 weeks.^b

For management of long-standing myxedema, usual initial dosage is 15 mg daily.^b

Usual maintenance dosage is 60–120 mg daily.^b Failure to respond adequately to oral dosages of 180 mg daily suggests presence of malabsorption or patient noncompliance.^b

Pituitary TSH Suppression

Thyroid Cancer

Oral

Administration of dosages higher than those used for replacement therapy usually is required to suppress TSH concentrations to low or undetectable concentrations.^b

Special Populations

Patients with Cardiovascular Disease

Hypothyroidism

Initiate therapy at lower dosages than those recommended in patients without cardiovascular disease.^{b c}

Usual initial dosage is 15–30 mg daily.^b If angina appears or if cardiovascular disease is aggravated, reduce dosage or temporarily withhold therapy and then cautiously restart therapy at a lower dosage.^{b c}

Geriatric Patients

Hypothyroidism

Initiate therapy at lower dosages than those recommended in younger patients.^{b c}

Usual initial dosage is 15–30 mg daily.^b If cardiovascular disease is aggravated, reduce dosage or temporarily withhold therapy and then cautiously restart therapy at a lower dosage.^{b c}

Cautions for Thyroid

Contraindications

• 
  

  Untreated thyrotoxicosis.^{b c}

  
  


• 
  

  AMI uncomplicated by hypothyroidism.^c

  
  


• 
  

  Uncorrected adrenal insufficiency.^{b c}

  
  


• 
  

  Known hypersensitivity to any ingredient in the formulation.^{b c} (See Sensitivity Reactions under Cautions.)

  
  

Warnings/Precautions

Warnings

Unlabeled Uses

Should not be used for the treatment of obesity or for weight loss either alone or with other therapeutic agents.^{b c m} In euthyroid patients, doses within the range of daily hormonal requirements are ineffective for weight reduction.^{b c} Larger doses may produce serious or life-threatening toxicity, particularly when given in conjunction with sympathomimetic amines (e.g., anorectic agents).^{b c}

Should not be used in the treatment of male or female infertility unless this condition is associated with hypothyroidism.^{b c m}

Sensitivity Reactions

Hypersensitivity to thyroid hormone not known to occur;^b however, concern for allergic reactions to animal proteins exists.ⁱ Hypersensitivity reactions to inactive ingredients of thyroid hormone products have been reported and include urticaria, pruritus, rash, flushing, angioedema, abdominal pain, nausea, vomiting, diarrhea, fever, arthralgia, serum sickness, and wheezing.^c

May rarely cause GI intolerance in patients highly sensitive to pork or corn.^c

Major Toxicities

Effects on Bone Mineral Density

Potential for excessive doses to result in hypermetabolic state^b and decreased bone mineral density.^{c n} Use lowest dose necessary to achieve desired clinical and biochemical response.ⁿ

General Precautions

Therapy Monitoring

Thyroid agents have a narrow therapeutic index.^c Avoid undertreatment or overtreatment, that may result in adverse effects on growth and development in pediatric patients, cardiovascular function, bone metabolism, reproductive function, cognitive function, emotional state, GI function, and glucose and lipid metabolism.^c

Periodically perform appropriate laboratory tests (e.g., serum TSH, total or free T₄, total T₃) and clinical evaluations to monitor adequacy of therapy.^{b c i m}

Preexisting Cardiovascular Disease

Use with extreme caution.^{b c} (See Patients with Cardiovascular Disease under Dosage and Administration.) Patients with CHD should be monitored closely during surgical procedures due to increased risk of arrhythmias.^c

Associated Endocrine Disorders

Hypopituitarism, adrenal insufficiency, and other endocrine disorders such as diabetes mellitus and diabetes insipidus are characterized by signs and symptoms that may be diminished in severity or obscured by hypothyroidism.^c Thyroid agents may aggravate the intensity of previously obscured symptoms in patients with endocrine disorders, and appropriate adjustment of therapy for these concomitant disorders may be required.^{b c}

In patients with secondary or tertiary hypothyroidism, consider possibility of additional hypothalamic/pituitary hormone deficiencies and treat if diagnosed.ⁿ

Chronic autoimmune thyroiditis may occur in association with other autoimmune disorders (e.g., adrenal insufficiency, pernicious anemia, type 1 diabetes mellitus).^{e f}

Patients with concomitant adrenal insufficiency should be treated with replacement corticosteroids prior to initiation of thyroid agents.^c Failure to do so may precipitate an acute adrenal crisis due to increased metabolic clearance of corticosteroids when the thyroid agent is initiated.^c

Patients with diabetes mellitus may require increased dosages of antidiabetic agents when treated with thyroid agents.^b

Specific Populations

Pregnancy

Category A.^{b h}

During pregnancy in hypothyroid patients, serum free T₄ levels may decrease and serum TSH levels increase to values outside the normal range.^{f n} Elevations in serum TSH may occur at 4 weeks' gestation;ⁿ monitor TSH levels during each trimester (or every 6 weeks) and adjust thyroid dosage accordingly.^{d e m} Reduce dosage to pre-pregnancy level immediately after delivery, since postpartum TSH concentrations are similar to preconception levels;ⁿ measure serum TSH concentrations 6–8 weeks postpartum.^m

Lactation

Although thyroid hormones are minimally distributed into human milk, exercise caution when administering to a nursing woman.^{b c n} However, adequate replacement dosages generally are needed to maintain normal lactation.ⁿ

Pediatric Use

The goal of treatment in pediatric patients with hypothyroidism is to achieve and maintain normal intellectual and physical growth and development.^c Initiate therapy immediately upon diagnosis.^{b c} Maintain therapy for life, unless transient hypothyroidism is suspected.^{b c}

Neonates with suspected hypothyroidism should receive thyroid agent therapy pending results of confirmative tests.^c If a positive diagnosis cannot be made on the basis of laboratory findings but there is a strong clinical suspicion of congenital hypothyroidism, initiate replacement therapy to achieve euthyroidism until the child is 1–2 years of age.^c During the first 2 weeks of therapy, closely monitor infants for cardiac overload, arrhythmias, and aspiration resulting from avid suckling.^c Evaluate infant’s clinical response to therapy about 6 weeks after initiation of thyroid agent therapy and at least at 6 and 12 months of age and yearly thereafter.^c

When transient hypothyroidism is suspected, temporarily discontinue therapy for 2–8 weeks to reassess the condition when the child is >3 years of age.^{b o} If the diagnosis of permanent hypothyroidism is confirmed, reinstitute full replacement therapy.^o However, if serum concentrations of free T₄ and TSH are normal, discontinue thyroid agent therapy and monitor carefully;^{b o} repeat thyroid function tests if manifestations of hypothyroidism develop.^o

In pediatric patients with transient severe hypothyroidism, reduce replacement dosage by half for 30 days.^o If, after 30 days, serum TSH >20 mU/L, consider the hypothyroidism permanent and reinstitute full replacement therapy.^o However, if serum free TSH has not increased, temporarily discontinue thyroid agent therapy for another 30 days, then repeat serum free T₄ and TSH measurements.^o Reinstitute or discontinue replacement therapy based on laboratory findings.^o

Monitor patients closely to avoid undertreatment or overtreatment.^c Undertreatment may result in impaired intellectual development, poor school performance (due to impaired concentration and slowed mentation), and reduced adult height.^c Overtreatment may result in craniosynostosis in infants and accelerate aging of bones, resulting in premature epiphyseal closure and compromised adult stature.^{b c}

Treated children may manifest a period of catch-up growth, which may be adequate in some cases to achieve normal adult height.^c In children with severe or long-standing hypothyroidism, catch-up growth may not be adequate to achieve normal adult height.^c

Pseudotumor cerebri and slipped capital femoral epiphysis have been reported in children receiving thyroid agents.^c

Geriatric Use

Because of the increased risk of cardiovascular disease among geriatric patients, thyroid therapy should not be initiated at the full replacement dose.^{b c m} (See Geriatric Patients under Dosage and Administration.)

Common Adverse Effects

Adverse reactions result from overdosage and resemble manifestations of hyperthyroidism,^{a b c} including fatigue, weight loss, increased appetite, heat intolerance, fever, excessive sweating, headache, hyperactivity, nervousness, anxiety, irritability, emotional lability, insomnia, tremor, muscle weakness, palpitations, tachycardia, arrhythmias, increased heart rate and BP, heart failure, angina, AMI, cardiac arrest, diarrhea, vomiting, abdominal cramps, elevations in liver function tests, hair loss, flushing, decreased bone mineral density, menstrual irregularities, and impaired fertility.^c

Interactions for Thyroid

Drugs Affecting Hepatic Microsomal Enzymes

Potential increased metabolism of thyroid hormone with drugs that induce hepatic microsomal enzymes, resulting in increased thyroid agent dosage requirements.^c

Drugs That May Decrease T₄ 5'-Deiodinase Activity

Inhibitors of T₄ 5’-deiodinase decrease peripheral conversion of T₄ to T₃, resulting in decreased T₃ concentrations.^{c s} However, serum T₄ concentrations usually remain within normal range, but may occasionally be slightly increased.^{c n}

Specific Drugs and Foods

Drug	Interaction	Comments
Amiodarone	Decreased metabolism of T4 to T3c
Anticoagulants, oral (e.g., coumarins)	Potentiation of anticoagulant activityb c	Carefully monitor PT and adjust anticoagulant dosage accordingly when thyroid agent therapy is initiatedb c
Antidepressants (tricyclics, tetracyclics, SSRIs)	Increased risk of cardiac arrhythmias and CNS stimulation when levothyroxine is used with tricyclics or tetracyclicsc Faster onset of action of tricyclics following concomitant use with levothyroxinec Sertraline may increase levothyroxine requirementsc
Antidiabetic agents (biguanides, meglitinides, sulfonylureas, thiazolidinediones, insulin)	Thyroid agents may cause increased antidiabetic agent or insulin requirementsb c	Carefully monitor diabetic control, especially when thyroid therapy is initiated, changed, or discontinuedb c
β-Adrenergic blocking agents (e.g., propranolol hydrochloride dosages >160 mg daily)	Decreased metabolism of T4 to T3c Impaired antihypertensive effects when hypothyroid patient is converted to euthyroid statec
Bile acid sequestrants (e.g., cholestyramine, colestipol)	Impaired thyroid agent absorptionb c	Administer thyroid agents ≥4 hours apart from these agentsb c
Carbamazepine	Potential increased metabolism of thyroid agentc	May require thyroid agent dosage increasec
Cardiac glycosides	Decreased serum digitalis glycoside concentrations in patients with hyperthyroidism or in patients with hypothyroidism in whom a euthyroid state has been achieved; potential for reduced therapeutic effects of digitalis glycosides with thyroid usec	May need to increase dosage of digitalis glycoside when hypothyroidism has been correctedd n
Corticosteroids (e.g., dexamethasone at dosages ≥4 mg daily)	Decreased metabolism of T4 to T3.c Short-term administration of large doses of corticosteroids may decrease serum T3 concentrations by 30% with minimal change in serum T4 levelsc
Estrogen or estrogen-containing oral contraceptives	Possible decreased free T4 concentrationsb	Patients without a functioning thyroid gland may require thyroid dosage increaseb
Ferrous sulfate	Delayed or impaired thyroid absorptionc	Administer thyroid agents ≥4 hours apart from this agentc
Food with large amounts of fiber (e.g., cotton seed meal, infant soybean formula, soybean flour, walnuts)	Decreased levothyroxine absorptionn
Furosemide (at IV dosages >80 mg)	Concomitant use with levothyroxine produces transient increases in serum free T4 concentrations; continued administration results in a decrease in serum T4 and normal free T4 and TSH concentrations, and therefore, patients are clinically euthyroidc
GI drugs (e.g., antacids [aluminum hydroxide, magnesium hydroxide, calcium carbonate], simethicone, sucralfate)	Delayed or impaired thyroid agent absorptionc	Administer thyroid agents ≥4 hours apart from these agents
Growth hormones (e.g., somatropin)	Excessive use of thyroid agents with growth hormones may accelerate epiphyseal closure; however, untreated hypothyroidism may interfere with growth response to growth hormonec
Heparin	Concomitant use with levothyroxine produces transient increases in serum free T4 concentrations; continued administration results in a decrease in serum T4 and normal free T4 and TSH concentrations, and therefore, patients are clinically euthyroidc
Hydantoins (e.g., phenytoin)	Potential increased metabolism of thyroid agentc Reduced levothyroxine serum protein bindingc Concomitant use with levothyroxine produces transient increases in serum free T4 concentrations; continued administration results in a decrease in serum T4 and normal free T4 and TSH concentrations, and therefore, patients are clinically euthyroidc	May require thyroid dosage increasec
Ketamine	Risk of marked hypertension and tachycardiac	Use with cautionc
NSAIAs (e.g., fenamates, phenylbutazone)	Concomitant use with levothyroxine produces transient increases in serum free T4 concentrations; continued administration results in a decrease in serum T4 and normal free T4 and TSH concentrations, and therefore, patients are clinically euthyroidc
Phenobarbital	Potential increased metabolism of thyroid agentc	May require thyroid agent dosage increasec
Radiographic agents	Reduced uptake of 123I, 131I, and 99mTcc
Rifampin	Potential increased metabolism of thyroid agentc	May require thyroid agent dosage increasec
Salicylates (dosages >2 g daily)	Inhibit binding of T4 and T3 to TBG and transthyretin; initially increases serum free T4 followed by return to normal concentrations with sustained therapeutic serum salicylate concentrations, although total T4 concentrations may decrease by as much as 30%c
Sodium polystyrene sulfonate	Delayed or impaired thyroid absorptionc	Administer thyroid agents ≥4 hours apart from this agentc
Sympathomimetic agents	Potentiation of sympathomimetic effects; increased risk of coronary insufficiency in patients with CHDc	Observe patient carefully when sympathomimetic agent is administeredc
Xanthine derivatives (e.g., theophylline)	Clearance of xanthine derivatives may be decreased in hypothyroid patients but returns to normal when the euthyroid state is achievedc

Drugs Affecting Thyroid Function or Thyroid Function Tests

Various drugs or concomitant medical conditions (e.g., pregnancy, infectious hepatitis) may adversely affect thyroid function (e.g., alter endogenous thyroid hormone secretion, reduce TSH secretion) resulting in hypothyroidism or hyperthyroidism or interfere with laboratory tests used to assess thyroid function.^{b c} Consult specialized references for information.

Some drugs may affect transport of thyroid hormones (T₃, T₄, levothyroxine) by affecting serum thyroxine-binding globulin (TBG) concentrations.^{c n} However, free T₄ concentrations may remain normal and the patient may remain euthyroid.^{c n} Monitor therapy and adjust thyroid dosage as necessary.^c

Drugs Affecting Thyroxine Binding Globulin Concentrations^{b c}

• Drugs That May Increase Serum TBG Concentration


• 
  

  Estrogens, oral (including estrogen-containing oral contraceptives)^{b c}

  
  


• 
  

  Fluorouracil^c

  
  


• 
  

  Methadone^c

  
  


• 
  

  Mitotane^c

  
  


• 
  

  Tamoxifen^c

  
  

• Drugs That May Decrease Serum TBG Concentration


• 
  

  Androgens^c

  
  


• 
  

  Asparaginase^c

  
  


• 
  

  Corticosteroids^c

  
  


• 
  

  Niacin (sustained-release)^c

  
  

Thyroid Pharmacokinetics

Absorption

Bioavailability

Levothyroxine: Variably absorbed from the GI tract (range: 40–80%).^{b c} Extent of absorption is increased in the fasting state and decreased in malabsorption states.^{b c}

Liothyronine: Almost completely absorbed from the GI tract (about 95%).^{b c}

Absorption of hormones contained in natural thyroid agent preparations is similar to that of synthetic hormones.^{b c d} However, commercially available natural thyroid preparations have different T₄:T₃ ratios and fluctuating T₃ concentrations.^{a c m} (See General under Dosage and Administration.)

Onset

Peak therapeutic effects may not be attained for 1–3 weeks.^c

Duration

Therapeutic effects are maintained for 1–3 weeks following discontinuance of therapy.^c

Food

Infant soybean formula may decrease absorption.ⁿ

Distribution

Extent

T₄ is distributed throughout most body tissues and fluids; highest concentrations found in liver and kidneys.^c

Thyroid hormones do not readily cross the placenta;^{b c h} however, some transfer does occur, as evidenced by levels in cord blood of athyrotic fetuses being approximately one-third maternal levels.ⁿ

Thyroid hormones are minimally distributed into breast milk.^{b c}

Plasma Protein Binding

Circulating thyroid hormones are >99% bound to serum proteins, including TBG, thyroxine-binding prealbumin (TBPA), and albumin.^{b c} T₄ is more extensively and firmly bound to TBG and TBPA than T₃.^{b c} Only unbound hormone is metabolically active.^b

Elimination

Metabolism

T₄ and T₃ are metabolized principally in the liver through sequential deiodination.^{c n} Approximately 80% of the daily dose of T₄ is deiodinated to yield equal amounts of T₃ and reverse T₃ (rT₃).ⁿ T₃ and rT₃ are further deiodinated to diiodothyronine.^{c n} Thyroid hormones are also metabolized via conjugation with glucuronides and sulfates and excreted directly into the bile and gut where they undergo enterohepatic recirculation.^{b c}

Elimination Route

Thyroid hormones are primarily eliminated by the kidneys.ⁿ A portion of the conjugated hormone reaches the colon unchanged and is eliminated in the feces.^{c n} Approximately 20% of T₄ is eliminated in the stool.ⁿ Urinary excretion of T₄ decreases with age.ⁿ

Half-life

T₄: Approximately 6–7 days.^c

T₃: Approximately 1–2 days.^c

These plasma half-lives are decreased in patients with hyperthyroidism and increased in those with hypothyroidism.^c

Stability

Storage

Oral

Tablets

Tight containers at 15–30°C.^{a b} Protect from moisture and light.^a

ActionsActions

• 
  

  Thyroid hormones (T₄ and T₃) regulate multiple metabolic processes, including augmentation of cellular respiration and thermogenesis, as well as metabolism of proteins, carbohydrates, and lipids.ⁿ

  
  


• 
  

  Thyroid hormones also play an essential role in normal growth and development and normal maturation of the CNS and bone.^c The protein anabolic effects of thyroid hormones are essential for normal growth and development.^{c n}

  
  


• 
  

  The physiologic actions of thyroid hormones are produced predominantly by T₃, most of which (approximately 80%) is derived from T₄ by deiodination in peripheral tissues.^{a b c}

  
  


• 
  

  T₃ is 4 times more potent than T₄.^b

  
  

Advice to Patients

• 
  

  Importance of understanding the need to continue thyroid agent therapy for life, unless transient hypothyroidism is suspected.^b

  
  


• 
  

  Importance of taking thyroid exactly as prescribed.ⁿ Do not alter regimen or discontinue therapy unless directed by a clinician.ⁿ

  
  


• 
  

  Risk of transient hair loss.^{b c} Importance of immediately informing a clinician if rapid or irregular heartbeat, chest pain, shortness of breath, leg cramps, headache, nervousness, irritability, sleeplessness, tremors, change in appetite, weight gain or loss, vomiting, diarrhea, excessive sweating, heat intolerance, fever, changes in menstrual periods, hives or skin rash, or any other unusual medical event occurs.^{b c e m n}

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and herbal supplements, as well as concomitant illnesses (e.g., cardiovascular disease, diabetes mellitus, clotting disorders, adrenal or pituitary gland problems.)^{b c}

  
  


• 
  

  In patients with diabetes mellitus, importance of monitoring blood and/or urinary glucose levels and immediately reporting any changes to a clinician.^{b c n} In patients receiving concomitant anticoagulant therapy, importance of monitoring clotting status frequently.^{b c}

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.^b Dosage may need to be increased during pregnancy.^e

  
  


• 
  

  Importance of informing physician or dentist of current thyroid hormone therapy prior to any surgery.^c

  
  


• 
  

  Importance of informing patients of other important precautionary information.^b (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Thyroid

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets	15 mg*	Armour Thyroid	Forest
		16.25 mg	Nature-Throid	Western Research
		30 mg*	Armour Thyroid	Forest
		32.5 mg	Nature-Throid	Western Research
			Westhroid	Western Research
		60 mg*	Armour Thyroid	Forest
		65 mg*	Nature-Throid	Western Research
			Westhroid	Western Research
		90 mg*	Armour Thyroid	Forest
		120 mg*	Armour Thyroid	Forest
		130 mg*	Nature-Throid	Western Research
			Westhroid	Western Research
		180 mg*	Armour Thyroid	Forest
		195 mg	Nature-Throid	Western Research
		240 mg	Armour Thyroid	Forest
		300 mg*	Armour Thyroid	Forest

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Armour Thyroid 120MG Tablets (FOREST): 30/$18.99 or 90/$34.97

Armour Thyroid 15MG Tablets (FOREST): 30/$14.99 or 60/$18.97

Armour Thyroid 180MG Tablets (FOREST): 30/$23.99 or 90/$52.97

Armour Thyroid 240MG Tablets (FOREST): 30/$29.99 or 90/$69.97

Armour Thyroid 30MG Tablets (FOREST): 30/$14.99 or 90/$22.97

Armour Thyroid 300MG Tablets (FOREST): 30/$32.99 or 90/$79.97

Armour Thyroid 60MG Tablets (FOREST): 30/$14.99 or 60/$19.98

Armour Thyroid 90MG Tablets (FOREST): 30/$18.99 or 60/$25.98

Nature-Throid 130MG Tablets (RLC LABS): 100/$29.99 or 200/$45.97

Nature-Throid 32.5MG Tablets (RLC LABS): 100/$19.99 or 200/$28.98

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions June 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

a. AHFS Drug Information 2008. McEvoy GK, ed. Thyroid. Bethesda, MD: American Society of Health-System Pharmacists; 2008:3308-9.

b. Forest Pharmaceuticals, Inc. Armour Thyroid (thyroid) tablets prescribing information. St. Louis, MO; 2002 Nov.

c. AHFS Drug Information 2008. McEvoy GK, ed. Thyroid Agents General Statement. Bethesda, MD: American Society of Health-System Pharmacists; 2008:3298-302.

d. Anon. Drugs for hypothyroidism and hyperthyroidism. Treat Guidel Med Lett. 2006; 4:17-24.

e. American Association of Clinical Endocrinologists. Medical guidelines for clinical practice for the evaluation and treatment of hyperthyroidism and hypothyroidism, 2006 amended version. Endocr Pract. 2002; 8:457-69. [PubMed 15260011]

f. American College of Obstetricians and Gynecologists (ACOG) Practice Bulletin. Clinical management guidelines for obstetrician-gynecologists, number 37, August 2002: Thyroid disease in Pregnancy. Obstet Gynecol. 2002; 100:387-96. [PubMed 12166417]

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