Friday, 30 March 2012

Senna S


Generic Name: docusate and senna (DOK yoo sate and SEN a)

Brand Names: Doc-Q-Lax, Doculax, Dok Plus, Gentlax S, Peri-Colace, Senna Plus, Senna S, Sennalax-S, Senokot S, SenoSol-SS


What is Senna S (docusate and senna)?

Docusate is a stool softener. It makes bowel movements softer and easier to pass.


Senna is a laxative. It stimulates muscle movement in the intestines.


The combination of docusate and senna is used to treat occasional constipation.


Docusate and senna may also be used for other purposes not listed in this medication guide.


What is the most important information I should know about Senna S (docusate and senna)?


Use this medication as directed on the label, or as your doctor has prescribed. Do not use the medication in larger amounts or for longer than recommended.


You should not use this medication if you are allergic to docusate and senna, or if you are also taking mineral oil.

Ask a doctor or pharmacist before using docusate and senna if you have nausea, vomiting, stomach pain, a sudden change in bowel habits, or an intestinal disorder (such as Crohn's disease or ulcerative colitis).


Do not use this medication without your doctor's advice if you are pregnant or breast-feeding. Do not take this medication for longer than 7 days in a row. Call your doctor if your constipation does not improve or if it gets worse. Stop taking this docusate and senna and call your doctor at once if you have rectal bleeding, severe stomach pain, nausea and vomiting, or if you do not have a bowel movement. Do not use any other over-the-counter laxatives or other stool softener without first asking your doctor or pharmacist.

What should I discuss with my healthcare provider before using Senna S (docusate and senna)?


You should not use this medication if you are allergic to docusate and senna, or if you are also taking mineral oil.

Ask a doctor or pharmacist about using docusate and senna if you have:



  • nausea or vomiting;




  • stomach pain;




  • a sudden change in bowel habits that lasts for 2 weeks or longer; or




  • if you have an intestinal disorder such as Crohn's disease or ulcerative colitis.




Do not use this medication without your doctor's advice if you are pregnant. It is not known whether docusate and senna passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Ask a doctor before giving this medication to a child younger than 2 years old.

How should I use Senna S (docusate and senna)?


Use this medication exactly as directed on the label, or as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended.


Take this medication with a full glass of water.

It may be best to take this medication at night or at bedtime. Docusate and senna should cause you to have a bowel movement within 6 to 12 hours.


Do not take this medication for longer than 7 days in a row, unless your doctor tells you to. Call your doctor if your constipation does not improve or if it gets worse after taking docusate and senna. Store docusate and senna at room temperature away from moisture and heat.

What happens if I miss a dose?


Since docusate and senna is taken as needed, you are not likely to be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.


What happens if I overdose?


Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include nausea, vomiting, stomach pain, or diarrhea.


What should I avoid while using Senna S (docusate and senna)?


Do not use any other over-the-counter laxatives or other stool softener without first asking your doctor or pharmacist. Docusate or senna may be contained in other medicines available over the counter. If you take certain products together you may accidentally take too much of a certain medicine. Read the label of any other medicine you are using to see if it contains docusate or senna.

Senna S (docusate and senna) side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using docusate and senna and call your doctor at once if you have a serious side effect such as:

  • rectal bleeding;




  • severe stomach pain, nausea, vomiting; or




  • no bowel movement.



Less serious side effects may include:



  • gas, bloating;




  • diarrhea; or




  • mild nausea.



This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.


What other drugs will affect Senna S (docusate and senna)?


There may be other drugs that can interact with docusate and senna. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.



More Senna S resources


  • Senna S Side Effects (in more detail)
  • Senna S Use in Pregnancy & Breastfeeding
  • Drug Images
  • Senna S Drug Interactions
  • Senna S Support Group
  • 1 Review for Senna S - Add your own review/rating


  • Senna Plus MedFacts Consumer Leaflet (Wolters Kluwer)



Compare Senna S with other medications


  • Constipation, Acute


Where can I get more information?


  • Your pharmacist can provide more information about docusate and senna.

See also: Senna S side effects (in more detail)


Wednesday, 28 March 2012

Pilocarpine Gel


Pronunciation: pye-loe-KAR-peen
Generic Name: Pilocarpine
Brand Name: Pilopine HS


Pilocarpine Gel is used for:

Treating certain types of glaucoma (increased pressure in the eye) alone or in combination with other medicines. It may also be used for other conditions as determined by your doctor.


Pilocarpine Gel is a direct-acting miotic. It works by lowering the fluid pressure inside the eyeball by increasing fluid drainage from the eyeball. It also causes the pupils to constrict or get smaller (miosis).


Do NOT use Pilocarpine Gel if:


  • you are allergic to any ingredient in Pilocarpine Gel

  • you have a certain type of glaucoma (eg, pupillary block glaucoma), eye inflammation, or a severe eye infection

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



Before using Pilocarpine Gel:


Some medical conditions may interact with Pilocarpine Gel. 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 a detached retina, an eye infection, asthma, or chronic obstructive pulmonary disease

  • if you have had a heart attack

Some MEDICINES MAY INTERACT with Pilocarpine Gel. However, no specific interactions with Pilocarpine Gel are known at this time.


Ask your health care provider if Pilocarpine Gel 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 Pilocarpine Gel:


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


  • Pilocarpine Gel is only for the eye. Do not get it in your nose or mouth.

  • Pilocarpine Gel may be used around the eye or in the eye. To use Pilocarpine Gel in the eye, first, wash your hands. Using your index finger, pull the lower eyelid away from your eye to form a pouch. Squeeze a thin strip of ointment into the pouch. After using Pilocarpine Gel, gently close your eyes for 1 to 2 minutes. Wash your hands to remove any medicine that may be on them. Wipe the applicator tip with a clean, dry tissue.

  • To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including the eye. Keep the container tightly closed.

  • If you miss a dose of Pilocarpine Gel, use 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 use 2 doses at once.

Ask your health care provider any questions you may have about how to use Pilocarpine Gel.



Important safety information:


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

  • Pilocarpine Gel may cause harm if it is swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Pilocarpine Gel while you are pregnant. It is not known if Pilocarpine Gel is found in breast milk. If you are or will be breast-feeding while you use Pilocarpine Gel, check with your doctor. Discuss any possible risks to your baby.


Possible side effects of Pilocarpine Gel:


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:



Blurred vision; change in vision; eye irritation; eyelid twitching; headache at the temples or around the eyes; increased tearing; nearsightedness; redness or swelling of the eye; temporary stinging or burning.



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); detachment of the retina; poor vision at night.



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 asthma; blurred vision; diarrhea; fainting; increased saliva; increased sweating; irregular heartbeat; low blood pressure; nausea; slow pulse; tremor; vomiting.


Proper storage of Pilocarpine Gel:

Store Pilocarpine Gel between 36 and 80 degrees F (2 and 27 degrees C). Store away from heat, moisture, and light. Do not freeze. Do not store in the bathroom. Keep Pilocarpine Gel out of the reach of children and away from pets.


General information:


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

  • Pilocarpine Gel 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 Pilocarpine Gel. 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 Pilocarpine resources


  • Pilocarpine Use in Pregnancy & Breastfeeding
  • Pilocarpine Drug Interactions
  • Pilocarpine Support Group
  • 0 Reviews for Pilocarpine - Add your own review/rating


Compare Pilocarpine with other medications


  • Glaucoma
  • Intraocular Hypertension

Ethionamide


Class: Antituberculosis Agents
VA Class: AM500
CAS Number: 536-33-4
Brands: Trecator

Introduction

Antituberculosis agent; synthetic isonicotinic acid derivative.127


Uses for Ethionamide


Tuberculosis


Treatment of active (clinical) tuberculosis (TB) in conjunction with other antituberculosis agents.106 107 127


Second-line agent used in treatment of drug-resistant TB caused by Mycobacterium tuberculosis known or presumed to be susceptible to ethionamide when isoniazid and/or rifampin cannot be used because of resistance and/or intolerance.106 107


For initial treatment of active TB caused by drug-susceptible M. tuberculosis, recommended multiple-drug regimens consist of an initial intensive phase (2 months) and a continuation phase (4 or 7 months).106 Although the usual duration of treatment for drug-susceptible pulmonary and extrapulmonary TB (except disseminated infections and TB meningitis) is 6–9 months,106 107 ATS, CDC, and IDSA state that completion of treatment is determined more accurately by the total number of doses and should not be based solely on the duration of therapy.106 A longer duration of treatment (e.g., 12–24 months) usually is necessary for infections caused by drug-resistant M. tuberculosis.106 107


Patients with treatment failure or drug-resistant M. tuberculosis, including multidrug-resistant (MDR) TB (resistant to both isoniazid and rifampin) or extensively drug-resistant (XDR) TB (resistant to both isoniazid and rifampin and also resistant to a fluoroquinolone and at least one parenteral second-line antimycobacterial such as capreomycin, kanamycin, or amikacin), should be referred to or managed in consultation with experts in the treatment of TB as identified by local or state health departments or CDC.106 127


Mycobacterium avium Complex (MAC) Infections


Has been used as an alternative agent in multiple-drug regimens used for treatment of M. avium complex (MAC) infections.113 Evidence of clinical efficacy not available;113 not included in current ATS, CDC, NIH, or IDSA recommendations for treatment of MAC infections, including macrolide-resistant MAC.113 e f


Treatment of MAC infections is complicated and should be directed by clinicians familiar with mycobacterial diseases; consultation with a specialist is particularly important when the patient cannot tolerate first-line drugs or when the infection has not responded to prior therapy or is caused by macrolide-resistant MAC.113


Leprosy


Has been used for treatment of multibacillary leprosy in conjunction with other antimycobacterials.104 105


Previously recommended as an alternative agent for use in multiple-drug regimens in leprosy patients who would not accept or could not tolerate clofazimine,104 105 but WHO no longer recommends use of ethionamide for leprosy because severe hepatotoxicity has been reported.116 123


Ethionamide Dosage and Administration


Administration


Oral Administration


Administer orally.127


May be administered without regard to meals,127 but should be given at the time of day that the patient finds most suitable to avoid or minimize GI intolerance, which usually is at mealtimes.127


Administered as a single daily dose (usually at bedtime or with the main meal).106 127 a If GI effects occur, give in divided doses with meals.106 127 a


Since severity of adverse GI effects may diminish as treatment proceeds, patients should be encouraged to persevere with ethionamide treatment if GI effects occur.127


Concomitant use of pyridoxine (vitamin B6) is recommended to prevent or relieve neurotoxic effects.127


Dosage


Should not be used alone for treatment of TB; must be given in conjunction with other antituberculosis agents.106 107 127


Data not available to date to support use of ethionamide in intermittent (e.g., 1–3 times weekly) multiple-drug TB regimens.106


Pediatric Patients


Tuberculosis

Treatment of Active (Clinical) Tuberculosis

Oral

Children <15 years of age or weighing ≤40 kg: 15–20 mg/kg daily (up to 1 g daily) given in 2 or 3 divided doses recommended by ATS, CDC, IDSA, and AAP.106 107 Manufacturer states that optimum dosage has not been established, but that dosages of 10–20 mg/kg daily given in 2 or 3 divided doses or 15 mg/kg daily as a single dose have been recommended.127


Adolescents ≥15 years of age: 15–20 mg/kg daily (up to 1 g daily) recommended by ATS, CDC, and IDSA.106 Usual dosage is 500–750 mg daily as a single dose or in 2 divided doses.106


Adults


Tuberculosis

Treatment of Active (Clinical) Tuberculosis

Oral

15–20 mg/kg daily (up to 1 g daily) recommended by ATS, CDC, and IDSA.106 Usual dosage is 500–750 mg daily as a single dose or 2 divided doses.106


Manufacturer states that it may be beneficial to initiate therapy using a dosage of 250 mg daily and then gradually titrate to optimal dosage (up to 1 g daily) as tolerated by the patient.127 A regimen consisting of ethionamide 250 mg daily for 1–2 days, followed by 250 mg twice daily for 1–2 days with a subsequent increase to 1 g daily in 3 or 4 divided doses, has been used.127 The minimum effective dosage has not been identified; use highest tolerated dosage (usually 0.5–1 g daily).127


Prescribing Limits


Pediatric Patients


Tuberculosis

Treatment of Active (Clinical) Tuberculosis

Oral

Maximum 1 g daily.106 107


Adults


Tuberculosis

Treatment of Active (Clinical) Tuberculosis

Oral

Maximum 1 g daily.106 127


Special Populations


Renal Impairment


Some experts suggest a dosage of 250–500 mg daily for treatment of TB in patients with Clcr <30 mL/minute or undergoing hemodialysis.106


Cautions for Ethionamide


Contraindications



  • Known hypersensitivity to ethionamide or any ingredient in the formulation.127




  • Severe hepatic impairment.127



Warnings/Precautions


General Precautions


Hepatic Effects

Hepatitis (with or without jaundice) reported.127 Transient increases in serum bilirubin, AST, and ALT have occurred.127


Determine serum AST and ALT concentrations at baseline and at monthly intervals.106 127 If AST or ALT concentrations become elevated, temporarily discontinue ethionamide and concomitant antituberculosis drugs until laboratory abnormalities resolve.127 Reintroduce ethionamide and concomitant antituberculosis drugs sequentially to determine which drug(s) are responsible for hepatotoxicity.127


Diabetes Mellitus

Measure blood glucose at baseline and periodically during therapy.127


Use caution in diabetic patients;127 must be particularly alert for episodes of hypoglycemia.127


Nervous System and Ophthalmic Effects

Psychotic disturbances (including mental depression), drowsiness, dizziness, restlessness, headache, and postural hypotension reported.127


Peripheral neuritis, diplopia, optic neuritis, blurred vision, and a pellagra-like syndrome reported rarely.127


Perform ophthalmic evaluations (including ophthalmoscopy) at baseline and periodically during therapy.127


Manufacturer recommends concomitant use of pyridoxine (vitamin B6) to prevent or relieve neurotoxic effects.127


Hypothyroidism

Hypothyroidism (with or without goiter) reported.127


Monitor thyroid function.127


Some experts recommend determining thyroid-stimulating hormone (TSH) concentrations at baseline and at monthly intervals.106


Precautions Related to Treatment of Tuberculosis

Should not be used alone for treatment of TB; must be given in conjunction with other antituberculosis agents.106 107 127


Clinical specimens for microscopic examination and mycobacterial cultures and in vitro susceptibility testing should be obtained prior to initiation of antituberculosis therapy and periodically during treatment to monitor therapeutic response.106 127 The antituberculosis regimen should be modified as needed.106 Patients with positive cultures after 4 months of treatment should be considered to have failed treatment (usually as the result of noncompliance or drug-resistant TB).106


If ethionamide is added as a new drug to a regimen in patients experiencing treatment failure who have proven or suspected drug-resistant TB, at least 2 (preferably 3) new drugs known or expected to be active against the resistant strain should be added at the same time.106


Compliance with the full course of antituberculosis therapy and all drugs included in the multiple-drug regimen is critical.106 Missed doses increase the risk of treatment failure and increase the risk that M. tuberculosis will develop resistance to the antituberculosis regimen.106


To ensure compliance, ATS, CDC, IDSA, and AAP recommend that directly observed (supervised) therapy (DOT) be used for treatment of active (clinical) TB whenever possible, especially when intermittent regimens are used, when the patient is immunocompromised or infected with HIV, or when drug-resistant M. tuberculosis is involved.106 107


Specific Populations


Pregnancy

Category C.127


ATS, CDC, and IDSA state that ethionamide should not be used in pregnant women.106


Lactation

Not known whether ethionamide is distributed into milk.127 Use with caution and only when benefits outweigh risks; carefully observe breast-fed infants for adverse effects.127


Pediatric Use

Limited data are available.127


Manufacturer states the drug should not be used in children <12 years of age except when TB is known to be resistant to first-line therapy and systemic dissemination of the disease or other life-threatening complications of TB are judged to be imminent.127


Hepatic Impairment

Use caution in patients with hepatic disease;106 contraindicated in those with severe hepatic impairment.127


Renal Impairment

Dosage reduction advised.106 (See Renal Impairment under Dosage and Administration.)


Common Adverse Effects


Nausea, vomiting, diarrhea, abdominal pain, excessive salivation, metallic taste, stomatitis, anorexia, weight loss.127


Interactions for Ethionamide


Specific Drugs















Drug



Interaction



Comments



Alcohol



Psychotic reaction reported127



Avoid excessive alcohol ingestion127



Cycloserine



Possible increased risk of adverse effects; seizures reported127



Use concomitantly with caution127



Isoniazid



Increased isoniazid concentrations127



Use concomitantly with caution127


Ethionamide Pharmacokinetics


Absorption


Bioavailability


Essentially completely absorbed following oral administration; does not undergo any appreciable first-pass metabolism.127 Peak plasma concentrations attained within about 1 hour.127


Peak plasma concentrations are higher and attained more quickly with ethionamide film-coated tablets (Trecator) than with the previously available sugar-coated tablets (Trecator-SC); AUC is similar for both preparations.128


Distribution


Extent


Studies using sugar-coated tablets (Trecator-SC; no longer commercially available in the US) indicate ethionamide is rapidly and widely distributed into body tissues and fluids and concentrations in plasma and various organs are approximately equal.127 Although studies have not been performed to date with ethionamide film-coated tablets (Trecator), distribution of the drug is expected to be the same as that reported with the sugar-coated tablets.127


CSF concentrations may be equal to concurrent plasma concentrations.106


Crosses placenta.106


Not known whether ethionamide is distributed into milk.127


Plasma Protein Binding


30%.127


Elimination


Metabolism


Metabolized to active and inactive metabolites in the liver.127


Elimination Route


Less than 1% of an oral dose is excreted in urine127 as active drug and metabolites;a the remainder is excreted in urine as inactive metabolites.a


Only low concentrations removed by hemodialysis.106 129


Half-life


1.9–3 hours.127 129 a


Stability


Storage


Oral


Tablets

20–25°C in a tight container.127


Actions and SpectrumActions



  • Bactericidal or bacteriostatic in action.127 b d




  • Appears to inhibit peptide synthesis in susceptible organisms.127 Like isoniazid, ethionamide inhibits mycolic acid synthesis in susceptible organisms.d May form covalent adducts with nicotinamide adenine dinucleotide (NAD).d




  • A highly specific agent; active only against Mycobacterium.a Active against M. tuberculosis,a b d M. bovis,a M. kansasii,113 a and M. malmoense.113 Some strains of M. avium complex (MAC) may be susceptible,a b c but high concentrations may be required.c Also active against M. leprae.a d




  • Natural and acquired resistance to ethionamide demonstrated in vitro and in vivo in strains of M. tuberculosis.a




  • Cross-resistance may occur between ethionamide and isoniazid or thiosemicarbazones such as thiacetazone (drugs not commercially available in the US).127 No evidence of cross-resistance between ethionamide and aminosalicylic acid, cycloserine, or streptomycin.127



Advice to Patients



  • Advise patients that poor compliance with antituberculosis regimens can result in treatment failure and development of drug-resistant TB, which can be life-threatening and lead to other serious health risks.106 127




  • Importance of completing full course of therapy; importance of not missing any doses.127




  • Importance of informing clinicians of any change in visual acuity (with or without eye pain).127




  • Importance of avoiding excessive alcohol consumption.127




  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.127




  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.127




  • Importance of informing patients of other important precautionary information.127 (See Cautions.)



Preparations


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













Ethionamide

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Oral



Tablets, film-coated



250 mg



Trecator (with povidone)



Wyeth



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 February 2008. 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



100. Drucker D, Eggo MC, Salit IE et al. Ethionamide-induced goitrous hypothyroidism. Ann Intern Med. 1984; 100:837-9. [IDIS 186246] [PubMed 6721300]



101. Gupta DK. Acceptability of thioamides. I. Ethionamide. J Postgrad Med. 1977; 23:175-80. [PubMed 615264]



102. Moulding T, Fraser R. Hypothyroidism related to ethionamide. Am Rev Respir Dis. 1970; 101:90-4. [PubMed 5410078]



103. Schless JM, Allison RF, Inglis RM et al. The use of ethionamide in combined drug regimens in the re-treatment of isoniazid resistant pulmonary tuberculosis. Am Rev Respir Dis. 1965; 91:728-37. [PubMed 14280946]



104. Report of a WHO Study Group. Chemotherapy of leprosy for control programmes. Technical Report Series No. 675. Geneva: World Health Organization; 1982:3-33.



105. Jacobson RR. Treatment. In: Hastings RC, ed. Leprosy. New York: Churchill Livingstone; 1985:193-222.



106. Centers for Disease Control and Prevention. Treatment of tuberculosis, American Thoracic Society, CDC, and Infectious Diseases Society of America. MMWR Recomm Rep. 2003; 52(RR-11):1-77.



107. American Academy of Pediatrics. 2006 Red Book: Report of the Committee on Infectious Diseases. 27th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2006.



110. Donald PR, Seifart HI. Cerebrospinal fluid concentrations of ethionamide in children with tuberculous meningitis. J Pediatr. 1989; 115:483-6. [IDIS 259454] [PubMed 2769511]



113. Griffith DE, Aksamit T, Brown-Elliott BA et al. An official ATS/IDSA statement: diagnosis, treatment, and prevention of nontuberculous mycobacterial diseases. Am J Respir Crit Care Med. 2007; 175:367-416. [PubMed 17277290]



114. Reviewers’ comments (personal observations) on the Antituberculosis Agents General Statement 8:16.04.



115. Wyeth. Trecator-SC (ethionamide) sugar-coated tablets prescribing information. Philadelphia, PA; 2002 Mar 14.



116. WHO Expert Committee on Leprosy. Seventh Report. WHO Technical Report Series No. 874. Geneva: World Health Organization; 1998:1-43.



117. Whitty CJ, Lockwood DN. Leprosy—new perspectives on an old disease. J Infect. 1999; 38:2-5. [IDIS 424615] [PubMed 10090496]



118. Jacobson RR, Krahenbuhl JL. Leprosy. Lancet. 1999; 353:655-60. [IDIS 421539] [PubMed 10030346]



119. MacDougall AC, Ulrich MI. Mycobacterial Disease: Leprosy. In: Fitzpatrick TB, Eisen AZ, Wolff K et al, eds. Dermatology in General Medicine, 4th ed. New York, NY: McGraw -Hill Inc; 1993:2395-2410.



120. Panda S. Let’s learn some clinical facts on leprosy - before it is eradicated. Bull on Drug Health Information (India). 1998; 5:5-12.



121. Anon. Choice of antibacterial drugs. Med Lett Treat Guid. 2004; 2:18-26.



122. Anon. Essential drugs. WHO Model Formulary. Antibacterials. Antileprosy Drugs. WHO Drug Information. 1997; 11:253.



123. WHO Study Group on Chemotherapy of Leprosy. Seventh Report. WHO Technical Report Series No. 847. Geneva: World Health Organization; 1994:1-24.



124. WHO. Action Programme for the elimination of leprosy (LEP). From WHO Website () 1999 Sept 23.



125. WHO. Reports on individual drugs. Simplified treatment for leprosy. WHO Drug Information. 1997; 11:131.



126. Single-lesion multicentre trial group. Efficacy of single-dose multidrug therapy for the treatment of single-lesion paucibacillary leprosy. Indian J Leprosy. 1997; 69:121-9.



127. Wyeth. Trecator (ethionamide) tablets prescribing information. Philadelphia, PA; 2006 Sept.



128. Tucker HR. Dear healthcare provider letter regarding reformulation of Trecator-SC (ethionamide sugar-coated tablets). Philadelphia, PA: Wyeth Pharmaceuticals; 2005 Mar 10.



129. Malone RS, Fish DN, Spiegel DM et al. The effect of hemodialysis on cycloserine, ethionamide, para-aminosalicylate, and clofazimine. Chest. 1999; 116:984-90. [IDIS 437367] [PubMed 10531163]



a. AHFS Drug Information 2007. McEvoy GK, ed. Ethionamide. American Society of Health-System Pharmacists; 2007:552-4.



b. Heifets LB, Lindholm-Levy JP, Flory M. Comparison of bacteristatic and bactericidal activity of isoniazid and ethionamide against Mycobacterium avium and Mycobacterium tuberculosis. Am Rev Respir Dis. 1991; 143:268-70. [PubMed 1899326]



c. Rastogi N, Bauriaud RM, Bourgoin A et al. French multicenter study involving eight test sites for radiometric determination of activities of 10 antimicrobial agents against Mycobacterium avium complex. Antimicrob Agents Chemother. 1995; 39:638-44. [PubMed 7793865]



d. Wang F, Langley R, Gulten G et al. Mechanism of thioamide drug action against tuberculosis and leprosy. J Exp Med. 2007; 204:73-8. [PubMed 17227913]



e. Centers for Disease Control and Prevention. Treating opportunistic infections among HIV-infected adults and adolescents: recommendations from CDC, the National Institutes of Health, and the HIV Medicine Association/Infectious Diseases Society of America. MMWR Recomm Rep. 2004; 53(RR-15):1-112.



f. Centers for Disease Control and Prevention. Treating opportunistic infections among HIV-exposed and infected children: recommendations from CDC, the National Institutes of Health, and the Infectious Diseases Society of America. MMWR Recomm Rep. 2004; 53(RR-14):1-92.



More Ethionamide resources


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


  • Ethionamide Professional Patient Advice (Wolters Kluwer)

  • Ethionamide MedFacts Consumer Leaflet (Wolters Kluwer)

  • ethionamide Concise Consumer Information (Cerner Multum)

  • ethionamide Advanced Consumer (Micromedex) - Includes Dosage Information

  • Trecator Prescribing Information (FDA)



Compare Ethionamide with other medications


  • Tuberculosis, Active

Sunday, 25 March 2012

Ultra NatalCare


Pronunciation: pree-NATE-al VYE-ta-mins
Generic Name: Prenatal Multivitamins and Minerals with Docusate, Iron, and Folic Acid
Brand Name: Examples include Atabex EC and Ultra NatalCare


Ultra NatalCare is used for:

Treating or preventing a lack of vitamins or minerals before, during, and after pregnancy and while breast-feeding. It may be also be used for other conditions as determined by your doctor.


Ultra NatalCare is a vitamin, mineral, folic acid, and stool softener combination. It works by providing extra vitamins, minerals, and folic acid to the body. The stool softener helps to decrease constipation that may occur with iron products.


Do NOT use Ultra NatalCare if:


  • you are allergic to any ingredient in Ultra NatalCare

  • you have high levels of iron in your blood, hemochromatosis (a disorder of iron metabolism), or Wilson disease (a disorder of copper metabolism)

  • you have nausea, vomiting, or stomach pain from an unknown cause; appendicitis; or a history of bowel blockage

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



Before using Ultra NatalCare:


Some medical conditions may interact with Ultra NatalCare. 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 a bowel disorder (eg, colitis, Crohn disease, diverticulitis), certain blood disorders (eg, hemolytic, megaloblastic or pernicious anemia, porphyria cutanea tarda, thalassemia), kidney stones, or peptic ulcer

  • if you have had multiple blood transfusions

  • if you have stomach pain, nausea, or vomiting

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


  • Acitretin and fluorouracil because their actions and side effects may be increased by Ultra NatalCare.

  • Hydantoins (eg, phenytoin), mycophenolate, or penicillamine because their effectiveness may be decreased by Ultra NatalCare.

  • Oral anticoagulants (eg, warfarin) because their side effects, including risk of bleeding, may be increased by Ultra NatalCare.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Ultra NatalCare 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 Ultra NatalCare:


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


  • Take Ultra NatalCare by mouth with food.

  • Take Ultra NatalCare with a full glass of water.

  • Swallow whole. Do not break, crush, or chew before swallowing.

  • Avoid taking Ultra NatalCare with dairy products as they may interfere with the absorption of the iron in Ultra NatalCare.

  • If you also take bisphosphonates (eg, etidronate), quinolones (eg, ciprofloxacin), tetracyclines (eg, doxycycline), or thyroid hormones (eg, levothyroxine), do not take them within 2 hours before or 2 hours after taking Ultra NatalCare. Check with your doctor if you have questions.

  • If you also take antacids, cephalosporins (eg, cephalexin), methyldopa, or levodopa, do not take them within 3 hours before or 3 hours after taking Ultra NatalCare. Check with your doctor if you have questions.

  • If you also take eltrombopag, do not take it within 4 hours before or 4 hours after taking Ultra NatalCare. Check with your doctor if you have questions.

  • If you miss a dose of Ultra NatalCare, 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 Ultra NatalCare.



Important safety information:


  • While you are taking Ultra NatalCare you may notice darkening of stools. This is normal.

  • Ultra NatalCare has iron in it. Iron overdose is a leading cause of fatal poisoning in children younger than 6 years of age. In case of an overdose, call a doctor or poison control center right away.

  • Ultra NatalCare contains a stool softener. Do not take any other laxative or stool softener products without first checking with your doctor or pharmacist.

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


Possible side effects of Ultra NatalCare:


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:



Constipation; diarrhea; nausea; 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); black, tarry stools; stomach pain or cramping.



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: Ultra NatalCare 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 diarrhea; headache; lack of feeling alert; loss of balance; nausea; vomiting.


Proper storage of Ultra NatalCare:

Store Ultra NatalCare at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Ultra NatalCare out of the reach of children and away from pets.


General information:


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

  • Ultra NatalCare 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 Ultra NatalCare. 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 Ultra NatalCare resources


  • Ultra NatalCare Side Effects (in more detail)
  • Ultra NatalCare Use in Pregnancy & Breastfeeding
  • Drug Images
  • Ultra NatalCare Drug Interactions
  • Ultra NatalCare Support Group
  • 0 Reviews for Ultra NatalCare - Add your own review/rating


  • Advance Care Plus Concise Consumer Information (Cerner Multum)

  • CitraNatal Assure Prescribing Information (FDA)

  • CitraNatal Harmony Prescribing Information (FDA)

  • Concept DHA Prescribing Information (FDA)

  • Docosavit Prescribing Information (FDA)

  • Folcal DHA Prescribing Information (FDA)

  • Folcaps Care One Prescribing Information (FDA)

  • Gesticare DHA Prescribing Information (FDA)

  • Inatal Advance Prescribing Information (FDA)

  • Inatal Ultra Prescribing Information (FDA)

  • Multi-Nate DHA Prescribing Information (FDA)

  • Multi-Nate DHA Extra Prescribing Information (FDA)

  • Multifol Plus Concise Consumer Information (Cerner Multum)

  • Natelle One Prescribing Information (FDA)

  • Paire OB Plus DHA Prescribing Information (FDA)

  • PreNexa Prescribing Information (FDA)

  • PreferaOB Prescribing Information (FDA)

  • Prenatal Plus Prescribing Information (FDA)

  • Prenatal Plus Iron Prescribing Information (FDA)

  • Prenate Elite tablets

  • Prenate Elite Prescribing Information (FDA)

  • Prenate Essential Prescribing Information (FDA)

  • PrimaCare ONE capsules

  • Renate DHA Prescribing Information (FDA)

  • Se-Natal 19 Prescribing Information (FDA)

  • Tandem DHA Prescribing Information (FDA)

  • Tandem OB Prescribing Information (FDA)

  • TriAdvance Prescribing Information (FDA)

  • Triveen-PRx RNF Prescribing Information (FDA)

  • UltimateCare ONE NF Prescribing Information (FDA)

  • Vinate AZ Prescribing Information (FDA)

  • Zatean-CH Prescribing Information (FDA)



Compare Ultra NatalCare with other medications


  • Vitamin/Mineral Supplementation during Pregnancy/Lactation

Friday, 23 March 2012

TCP Antiseptic Liquid





1. Name Of The Medicinal Product



TCP Liquid Antiseptic


2. Qualitative And Quantitative Composition



Active ingredients: TCP Liquid Antiseptic is an aqueous solution of Phenol 0.175% w/v and halogenated phenols 0.68% w/v.



3. Pharmaceutical Form



Aqueous liquid antiseptic.



4. Clinical Particulars



4.1 Therapeutic Indications



Symptomatic relief of sore throats including those associated with colds and influenza. Common mouth ulcers, cuts, grazes, bites, stings, boils, spots and pimples.



4.2 Posology And Method Of Administration



Adults, children and the elderly.



Symptomatic relief of sore throats including those associated with colds and flu.



Gargle twice a day with TCP diluted with 5 parts water. Do not swallow.



Common mouth ulcers.



Dab undiluted onto affected areas three times a day. If symptoms persist for more than 14 days, consult your doctor or dentist.



Cuts, grazes, bites and stings.



Dilute with an equal quantity of water and apply freely. In emergencies may be used undiluted.



Boils, spots and pimples.



Dab undiluted every 4 hours. Do not cover.



4.3 Contraindications



Hypersensitivity to any of the active ingredients



4.4 Special Warnings And Precautions For Use



Seek medical advice if symptoms persist for more than a few days.



Keep out of the reach and sight of children.



4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction



None known.



4.6 Pregnancy And Lactation



There is no experience of the use of the product in pregnancy and lactation, but the product has been widely used for many years with no adverse effects.



4.7 Effects On Ability To Drive And Use Machines



None known.



4.8 Undesirable Effects



Use in allergic skin conditions should be avoided.



4.9 Overdose



Serious adverse events are unlikely to result from overdosage of this product.



Accidental ingestion: If a quantity (over 30ml) of neat TCP is swallowed accidentally, drink 0.5 to 1 litre of water immediately. If discomfort persists, seek medical advice.



5. Pharmacological Properties



5.1 Pharmacodynamic Properties



Halogenated phenols act on all pathogenic micro-organisms similarly and to approximately the same degree - i.e. they are non-specific, their activity is not appreciably reduced by the presence of relatively large amounts of non-living organic matter, their relatively simple chemical constitution means that their use is not liable to encourage the emergence of strains of micro-organisms adapted to resist their action.



5.2 Pharmacokinetic Properties



TCP Liquid Antiseptic is for topical use only. Significant absorption from this topical dosage form is considered unlikely.



5.3 Preclinical Safety Data



None stated.



6. Pharmaceutical Particulars



6.1 List Of Excipients



Other ingredients: glycerol, concentrated phosphoric acid, quinoline yellow (E104) and purified water.



6.2 Incompatibilities



None known.



6.3 Shelf Life



36 months.



6.4 Special Precautions For Storage



None.



6.5 Nature And Contents Of Container



TCP Liquid Antiseptic is stored in amber flint glass bottles of 50ml, 100ml and 200ml capacity, with white wadless polypropylene tamper-evident caps, or 500ml amber flint glass bottles with white wadless polypropylene caps.



6.6 Special Precautions For Disposal And Other Handling



None stated.



7. Marketing Authorisation Holder



Chefaro UK Ltd,



4th Floor, Hamilton House,



Mabledon Place, Bloomsbury,



LONDON, WC1H 9BB



United Kingdom



8. Marketing Authorisation Number(S)



PL 02855/0021



9. Date Of First Authorisation/Renewal Of The Authorisation



16th November 2004



10. Date Of Revision Of The Text



14th November 2010



LEGAL CATEGORY


GSL




Friday, 16 March 2012

griseofulvin


gris-ee-oh-FUL-vin


Commonly used brand name(s)

In the U.S.


  • Fulvicin P/G

  • Fulvicin-U/F

  • Grifulvin V

  • Gris-PEG

Available Dosage Forms:


  • Tablet

  • Capsule

  • Suspension

Therapeutic Class: Antifungal


Uses For griseofulvin


Griseofulvin belongs to the group of medicines called antifungals. It is used to treat fungus infections of the body, feet, groin and thighs, scalp, skin, fingernails, and toenails. griseofulvin may be taken alone or used along with medicines that are applied to the skin for fungus infections.


Use of griseofulvin for prevention of fungus infection have not been established.


griseofulvin is available only with your doctor's prescription.


Before Using griseofulvin


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 griseofulvin, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to griseofulvin 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


Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of griseofulvin in children. However, safety and efficacy have not been established in children up to 2 years of age.


Geriatric


No information is available on the relationship of age to the effects of griseofulvin in geriatric patients.


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. When you are taking griseofulvin, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using griseofulvin with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Desogestrel

  • Dienogest

  • Drospirenone

  • Estradiol Cypionate

  • Estradiol Valerate

  • Ethinyl Estradiol

  • Ethynodiol Diacetate

  • Etonogestrel

  • Levonorgestrel

  • Medroxyprogesterone Acetate

  • Mestranol

  • Norelgestromin

  • Norethindrone

  • Norgestimate

  • Norgestrel

  • Phenobarbital

  • Warfarin

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using griseofulvin with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use griseofulvin, or give you special instructions about the use of food, alcohol, or tobacco.


  • Ethanol

Other Medical Problems


The presence of other medical problems may affect the use of griseofulvin. Make sure you tell your doctor if you have any other medical problems, especially:


  • Actinomycosis (bacterial infection) or

  • Blastomycosis (Gilchrist’s disease) or

  • Candidiasis (yeast infection) or

  • Histoplasmosis (Darling’s disease) or

  • Other infections (e.g., bacteria) or

  • Sporotrichosis (Rose gardener's disease) or

  • Tinea versicolor (Tinea flava)—Griseofulvin will not work in patients with these conditions.

  • Liver failure or

  • Porphyria (enzyme problem)—Should not be used in patients with these conditions.

  • Lupus erythematosus or lupus-like diseases—Use with caution. May make this condition worse.

Proper Use of griseofulvin


Keep using griseofulvin for the full treatment time, even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon.


Keep yourself clean to help control infection and prevent reinfection.


Griseofulvin is absorbed best when it is taken with a high fat meal, such as a cheeseburger, whole milk, or ice cream. Tell your doctor if you are on a low-fat diet.


Griseofulvin is best taken with or after meals, especially fatty ones (e.g., whole milk or ice cream). This lessens possible stomach upset and helps to clear up the infection by helping your body absorb the medicine better. However, if you are on a low-fat diet, check with your doctor.


For patients taking the oral liquid:


  • Use a specially marked measuring spoon or other device to measure each dose accurately. The average household teaspoon may not hold the right amount of liquid.

You may swallow the tablets whole or sprinkle the crushed tablets in one tablespoonful of applesauce. Swallow it immediately without chewing.


Dosing


The dose of griseofulvin 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 griseofulvin. 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.


  • For oral dosage forms (microsize capsules, tablets, or suspension):
    • Treatment of fungus infections of the feet and nails:
      • Adults and teenagers—500 milligrams (mg) every 12 hours.

      • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 5 milligrams (mg) per kilogram (kg) (2.3 mg per pound) of body weight every 12 hours, or 10 milligrams (mg) per kilogram (kg) (4.6 mg per pound) of body weight once a day.


    • Treatment of fungus infections of the scalp, skin, and groin:
      • Adults and teenagers—250 milligrams (mg) every 12 hours or 500 mg once a day.

      • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 5 milligrams (mg) per kilogram (kg) (2.3 mg per pound) of body weight every 12 hours, or 10 milligrams (mg) per kilogram (kg) (4.6 mg per pound) of body weight once a day.



  • For oral dosage form (ultramicrosize tablets):
    • Treatment of fungus infections:
      • Adults—375 milligrams (mg) per day, taken as a single dose or divided in small doses. Some patients may need 750 mg divided in small doses.

      • Children 3 years of age and older weighing over 60 pounds—Dose is based on body weight and must be determined by your doctor. The usual dose is 187.5 to 375 mg per day.

      • Children 3 years of age and older weighing 35 to 60 pounds—Dose is based on body weight and must be determined by your doctor. The usual dose is 125 to 187.5 mg per day.

      • Children up to 2 years of age—Use and dose must be determined by your doctor.



Missed Dose


If you miss a dose of griseofulvin, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.


Storage


Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


Ask your healthcare professional how you should dispose of any medicine you do not use.


Precautions While Using griseofulvin


It is very important that your doctor should check the progress of you or your child at regular visits to make sure that griseofulvin is working properly and to check for unwanted effects.


If your symptoms do not improve, or if they become worse, check with your doctor. You may need to take griseofulvin for several weeks or months before your infection gets better.


Using griseofulvin while you are pregnant may cause serious unwanted effects in your newborn baby. Tell your doctor right away if you think you are pregnant or if you plan to become pregnant while using griseofulvin.


Serious skin reactions can occur with griseofulvin. Stop using griseofulvin and check with your doctor right away if you or your child have blistering, peeling, or loosening of the skin; red skin lesions; severe acne or skin rash; sores or ulcers on the skin; or fever or chills while you are using griseofulvin.


Stop using griseofulvin and check with your doctor right away if you or your child have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem.


Griseofulvin has been shown to cause liver and thyroid tumors in some animals. You and your doctor should discuss the good griseofulvin will do, as well as the risks of taking it.


Birth control pills containing estrogen may not work properly if you take them while you are taking griseofulvin. Unplanned pregnancies may occur. To keep from getting pregnant, use another form of birth control for up to 1 month after your last treatment. Other forms of birth control include condoms, diaphragms, or contraceptive foams or jellies.


Griseofulvin may increase the effects of alcohol. If taken with alcohol it may also cause fast heartbeat, flushing, increased sweating, or redness of the face. If you have these symptoms, do not drink alcoholic beverages while you are taking griseofulvin, unless you have checked first with your doctor.


griseofulvin may cause some people to become dizzy, drowsy, or less alert than they are normally. Make sure you know how you react to griseofulvin before you drive, use machines, or do other things that could be dangerous if you are dizzy or are not alert. If these reactions are especially bothersome, check with your doctor.


Griseofulvin may cause your skin to be more sensitive to sunlight than it is normally. Exposure to sunlight, even for brief periods of time, may cause a skin rash, itching, redness or other discoloration of the skin, or a severe sunburn. When you begin taking griseofulvin:


  • Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.

  • Wear protective clothing, including a hat. Also, wear sunglasses.

  • Apply a sun block product that has a skin protection factor (SPF) of at least 15. Some patients may require a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your doctor.

  • Apply a sun block lipstick that has an SPF of at least 15 to protect your lips.

  • Do not use a sunlamp or tanning bed or booth.

If you have a severe reaction from the sun, check with your doctor.


Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.


griseofulvin 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
  • Blistering, peeling, or loosening of the skin

  • chills

  • cough

  • diarrhea

  • fever

  • itching

  • joint or muscle pain

  • red, irritated eyes

  • sore throat

  • sores, ulcers, or white spots in the mouth or on the lips

  • unusual tiredness or weakness

Less common
  • Confusion

  • increased sensitivity of the skin to sunlight

  • skin rash, hives, or itching

  • soreness or irritation of the mouth or tongue

Rare
  • Black, tarry stools

  • chest pain

  • cloudy urine

  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

  • numbness, tingling, pain, or weakness in the hands or feet

  • painful or difficult urination

  • shortness of breath

  • swollen glands

  • unusual bleeding or bruising

  • yellow eyes or skin

Incidence not known
  • Abdominal or stomach pain

  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

  • clay-colored stools

  • dark urine

  • dizziness

  • headache

  • loss of appetite

  • nausea

  • unpleasant breath odor

  • vomiting of blood

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:


More common
  • Hives or welts

  • redness of the skin

Less common
  • Trouble with sleeping

Incidence not known
  • Heartburn

  • pain or discomfort in the chest, upper stomach, or throat

  • sleeplessness

  • unable to sleep

  • white patches in the mouth or throat or on the tongue

  • white patches with diaper rash

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.

See also: griseofulvin side effects (in more detail)



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.


More griseofulvin resources


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


  • griseofulvin Concise Consumer Information (Cerner Multum)

  • Griseofulvin Professional Patient Advice (Wolters Kluwer)

  • Griseofulvin Prescribing Information (FDA)

  • Griseofulvin Monograph (AHFS DI)

  • Griseofulvin Microsize Oral Suspension MedFacts Consumer Leaflet (Wolters Kluwer)

  • Gris-PEG Prescribing Information (FDA)

  • Gris-PEG Ultramicrosize Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

  • Grisactin 250 Concise Consumer Information (Cerner Multum)



Compare griseofulvin with other medications


  • Dermatophytosis
  • Onychomycosis, Fingernail
  • Onychomycosis, Toenail
  • Tinea Barbae
  • Tinea Capitis
  • Tinea Corporis
  • Tinea Cruris
  • Tinea Pedis

abacavir and lamivudine


a-BAK-a-vir SUL-fate, la-MIV-ue-deen


Oral route(Tablet)

Fatal hypersensitivity reactions have been reported with abacavir sulfate; discontinue if hypersensitivity reaction suspected and do not restart. Patients with HLA-B*5701 allele are at high risk for hypersensitivity to abacavir sulfate; screening for allele is recommended prior to initiating or reinitiation of therapy. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with nucleoside analogues alone or in combination with other antiretrovirals. Severe acute exacerbations of hepatitis B have been reported in patients co-infected with HBV and HIV who have discontinued lamivudine; monitor hepatic function upon discontinuation of therapy .



Commonly used brand name(s)

In the U.S.


  • Epzicom

Available Dosage Forms:


  • Tablet

Therapeutic Class: Antiretroviral Agent


Pharmacologic Class: Abacavir


Uses For abacavir and lamivudine


Abacavir and lamivudine combination is used together with other medicines to treat human immunodeficiency virus (HIV) infection. HIV is the virus that causes acquired immune deficiency syndrome (AIDS).


Abacavir and lamivudine combination will not cure or prevent HIV infection or the symptoms of AIDS. abacavir and lamivudine helps keep HIV from reproducing, and appears to slow down the destruction of the immune system. This may help delay the development of serious health problems usually related to AIDS or HIV infection. Abacavir and lamivudine combination will not keep you from spreading HIV to other people. People who receive abacavir and lamivudine may continue to have other problems usually related to AIDS or HIV infection.


abacavir and lamivudine is available only with your doctor's prescription.


Before Using abacavir and lamivudine


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 abacavir and lamivudine, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to abacavir and lamivudine 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


Appropriate studies have not been performed on the relationship of age to the effects of abacavir and lamivudine combination in the pediatric population. Safety and efficacy have not been established.


Geriatric


Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of abacavir and lamivudine in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving abacavir and lamivudine.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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. When you are taking abacavir and lamivudine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using abacavir and lamivudine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Interferon Alfa

  • Ribavirin

  • Zalcitabine

Using abacavir and lamivudine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Methadone

  • Tipranavir

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.


Other Medical Problems


The presence of other medical problems may affect the use of abacavir and lamivudine. Make sure you tell your doctor if you have any other medical problems, especially:


  • Diabetes or

  • Heart disease or

  • Hepatitis B, history of or

  • Hepatitis C, history of or

  • Hyperlipidemia (high cholesterol or fats in the blood) or

  • Hypertension (high blood pressure)—Use with caution. May make these conditions worse.

  • Genetic condition (e.g., gene variation called HLA-B*5701)—This condition may increase the risk for serious and life-threatening side effects.

  • Kidney disease, severe or

  • Liver disease—Should not be used in patients with these conditions.

Proper Use of abacavir and lamivudine


Take abacavir and lamivudine exactly as directed by your doctor. Do not take it more often, and do not take it for a longer time than your doctor ordered. Also, do not start or stop taking abacavir and lamivudine without checking first with your doctor.


abacavir and lamivudine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.


When your supply of abacavir and lamivudine runs low, get more from your pharmacy or from your doctor. The amount of virus in your blood may increase if the medicine is stopped, even for a short time. The virus may develop resistance to abacavir and lamivudine and be harder to treat.


abacavir and lamivudine will be given together with other medicines for HIV infection. Take all of the medicines your doctor gives you at the right time of day. These medicines work best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. If you need help in planning the best times to take your medicines, check with your doctor.


Abacavir and lamivudine combination contains a fixed amount of each medicine in the tablet.


abacavir and lamivudine can be taken with or without food.


Dosing


The dose of abacavir and lamivudine 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 abacavir and lamivudine. 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.


  • For oral dosage form (tablets):
    • For HIV infection:
      • Adults—600 milligrams (mg) of abacavir and 300 mg of lamivudine (equal to one tablet) once a day.

      • Children—Use and dose must be determined by your doctor.



Missed Dose


If you miss a dose of abacavir and lamivudine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.


Storage


Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


Ask your healthcare professional how you should dispose of any medicine you do not use.


Precautions While Using abacavir and lamivudine


It is very important that your doctor check your progress at regular visits to make sure abacavir and lamivudine is working properly. Blood tests may be needed to check for unwanted effects.


abacavir and lamivudine may cause a severe allergic reaction in some patients. This reaction usually occurs within 6 weeks after the medicine is started, but may occur at any time. If untreated, it can lead to severe low blood pressure and even death. Stop taking abacavir and lamivudine and check with your doctor immediately if you notice sudden fever, skin rash, diarrhea, nausea, stomach pain, vomiting, or a feeling of unusual tiredness or illness, cough, shortness of breath, or sore throat.


When you begin taking abacavir and lamivudine, you will be given a warning card which describes symptoms of severe allergic reactions that may be caused by abacavir and lamivudine combination. The warning card also provides information about how to treat these allergic reactions. For your safety, you should carry the warning card with you at all times.


If you must stop using abacavir because of an allergic reaction, you should never use the medicine again. Return the unused medicine to your doctor or pharmacist. A worse reaction, possibly even death, can occur if you use the medicine again. Tell your doctor right away if you have ever taken abacavir, especially if you have experienced an allergic reaction to it in the past.


Two rare but serious reactions to abacavir and lamivudine are lactic acidosis (too much acid in the blood) and liver toxicity, which includes an enlarged liver. These are more common if you are female, very overweight (obese), or have been taking anti-HIV medicines for a long time. Call your doctor right away if you have more than one of these symptoms: abdominal or stomach discomfort or cramping; dark urine; decreased appetite; diarrhea; general feeling of discomfort; light-colored stools; muscle cramping or pain; nausea; unusual tiredness or weakness; trouble breathing; vomiting; or yellow eyes or skin.


When you start taking HIV medicines, your immune system may get stronger. If you have certain infections that are hidden in your body, such as pneumonia or tuberculosis, you may notice new symptoms when your body tries to fight them. If this occurs, tell your doctor right away.


You should not breastfeed if you have HIV or AIDS, because you may give the infection to your baby through your breast milk.


abacavir and lamivudine will not keep you from giving HIV to your partner during sex. Make sure you understand and practice safe sex such as using latex condoms, even if your partner also has HIV. Do not share needles, toothbrushes, and razor blades with anyone.


abacavir and lamivudine may cause you to have excess body fat. Tell your doctor if you notice changes in your body shape, such as an increased amount of fat in the upper back and neck, or around the chest and stomach area; or a loss of fat from the legs, arms, and face.


abacavir and lamivudine may increase your risk of having a heart attack. This is more likely to occur if you already have heart disease, high blood pressure, high cholesterol or fats in the blood, or if you smoke.


Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.


abacavir and lamivudine 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
  • Hypersensitivity reaction, including abdominal or stomach pain; cough; diarrhea; fever; headache; nausea; numbness or tingling of the face, feet, or hands; pain in the joints; pain in the muscles; shortness of breath; skin rash; sore throat; swelling of the feet or lower legs; unusual feeling of discomfort or illness; unusual tiredness or weakness; or vomiting

Incidence not known
  • Blistering, peeling, or loosening of the skin

  • bloating

  • burning, numbness, tingling, or painful sensations

  • chest pain

  • chills

  • constipation

  • convulsions

  • dark urine

  • decreased appetite

  • diarrhea

  • difficulty with swallowing

  • dizziness

  • fast heartbeat

  • fast, shallow breathing

  • feeling of fullness

  • general feeling of discomfort

  • hives or welts

  • indigestion

  • itching

  • light-colored stools

  • loss of appetite

  • loss of bladder control

  • muscle cramping

  • muscle spasm or jerking of all extremities

  • pains in the stomach, side, or abdomen, possibly radiating to the back

  • pale skin

  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

  • red, irritated eyes

  • redness of the skin

  • red skin lesions, often with a purple center

  • sleepiness

  • sores, ulcers, or white spots on the lips or in the mouth

  • sudden loss of consciousness

  • swollen, painful, or tender lymph glands in the neck, armpit, or groin

  • tightness in the chest

  • troubled breathing with exertion

  • unsteadiness or awkwardness

  • unusual bleeding or bruising

  • upper right abdominal or stomach pain

  • weakness in the arms, hands, legs, or feet

  • wheezing

  • yellow eyes and skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:


More common
  • Abnormal dreams

  • burning feeling in the chest or stomach

  • fear

  • feeling of constant movement of self or surroundings

  • lightheadedness

  • nervousness

  • sensation of spinning

  • severe and throbbing headache

  • sleeplessness

  • stomach upset

  • tenderness in the stomach area

  • trouble with sleeping

  • unable to sleep

Incidence not known
  • Abnormal breathing sounds

  • blurred vision

  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

  • dry mouth

  • flushed, dry skin

  • fruit-like breath odor

  • gaining weight around your neck, upper back, breast, face, or waist

  • hair loss

  • increased hunger

  • increased thirst

  • increased urination

  • muscle weakness

  • sweating

  • swelling or inflammation of the mouth

  • thinning of the hair

  • unexplained weight loss

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.

See also: abacavir and lamivudine side effects (in more detail)



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