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Tenofovir

 
Drug Info: Tenofovir, PMPA

Brand names: Viread®

Chemical formula:



Tenofovir, PMPA tablets

What are tenofovir tablets?

TENOFOVIR, PMPA (Viread™) is a drug used to treat human immunodeficiency virus (HIV) infection. Tenofovir is an antiviral drug called a nucleotide reverse transcriptase inhibitor. Tenofovir may reduce the amount of HIV in the blood and increase the number of CD4 cells (T-cells) in the blood. Tenofovir is used in combination with other drugs to treat the HIV virus. Tenofovir will not cure or prevent HIV infection or AIDS. You may still develop other infections or conditions associated with HIV. Generic tenofovir capsules are not yet available.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:
• bone disease or osteoporosis
• kidney disease or a history of kidney disease
• liver disease
• an unusual or allergic reaction to tenofovir, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I take this medicine?

Take tenofovir tablets by mouth. You may take this medicine with or without food. Follow the directions on the prescription label. Take your doses at regular intervals. Do not take your medicine more often than directed.

To help to make sure that your anti-HIV therapy works as well as possible, be very careful to take all of your medicine exactly as prescribed. Do not stop taking except on your prescriber's advice.

Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What drug(s) may interact with tenofovir?

amphotericin B
• antiviral agents (such as acyclovir, cidofovir, foscarnet, ganciclovir, valacyclovir, valganciclovir)
cyclosporine
didanosine, ddI
hydroxyurea
• lopinavir
probenecid
tacrolimus

Tell your prescriber or health care professional about all other medicines you are taking, including nonprescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

What should I watch for while taking tenofovir?

Visit your prescriber or health care professional for regular checks on your progress. Discuss any new symptoms with your prescriber or health care professional.

Tenofovir will not cure HIV and you can still get other illnesses or complications associated with your disease. Taking tenofovir does not reduce the risk of passing HIV infection to others through sexual or blood contact. It is best to avoid sexual contact so that you do not spread the disease to others. For any sexual contact, use a condom. Be careful about cuts, abrasions, and other possible sources of blood contact. Never share a needle or syringe with anyone.

What side effects may I notice from taking tenofovir?

Side effects that you should report to your prescriber or health care professional as soon as possible:
• breathing difficulties or shortness of breath
• changes in body appearance (weight gain around waist and/or face)
• dizziness
• muscle aches, pains, or weakness
• passing out or fainting
• severe vomiting or diarrhea
• slow or irregular heartbeat
• symptoms of high blood sugar: dizziness, dry mouth, flushed dry-skin, fruit-like breath odor, loss of appetite, nausea, stomach ache, unusual thirst, frequent passing of urine
• unusual stomach pain or discomfort
• unusual weakness, fatigue or discomfort

Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):
• diarrhea
• gas
• headache
• loss of appetite
• nausea, vomiting
• stomach pain
• tiredness

Where can I keep my medicine?

Keep out of the reach of children in a container that small children cannot open.

Store at room temperature between 15—25 degrees C (59—77 degrees F). Protect from light and moisture. Throw away any unused medicine after the expiration date.

Last updated: 7/1/2002

Important Disclaimer: The drug information provided here is for educational purposes only. It is intended to supplement, not substitute for, the diagnosis, treatment and advice of a medical professional. This drug information does not cover all possible uses, precautions, side effects and interactions. It should not be construed to indicate that this or any drug is safe for you. Consult your medical professional for guidance before using any prescription or over the counter drugs.

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Wikipedia: Tenofovir
Top
Tenofovir
and tenofovir disoproxil fumarate
Systematic (IUPAC) name
({[(2R)-1-(6-amino-9H-purin-9-yl)propan-2-yl]oxy}methyl)phosphonic acid
Identifiers
CAS number 147127-20-6
ATC code J05AF07
PubChem 464205
DrugBank APRD01248
Chemical data
Formula C9H14N5O4P 
Mol. mass 287.213 g/mol
Pharmacokinetic data
Bioavailability 25%
Protein binding < 1%
Metabolism  ?
Half life 17 hours
Excretion Renal
Therapeutic considerations
Pregnancy cat.

B (U.S.)

Legal status

℞-only (U.S.), POM (UK)

Routes Oral
 Yes check.svgY(what is this?)  (verify)

Tenofovir disoproxil fumarate (TDF or PMPA[1]), marketed by Gilead Sciences under the trade name Viread, belongs to a class of antiretroviral drugs known as nucleotide analogue reverse transcriptase inhibitors (nRTIs), which block reverse transcriptase, an enzyme crucial to viral production in HIV-infected people.

Contents

Drug forms

Tenofovir disoproxil fumarate is a prodrug form of Tenofovir. Tenofovir is also available in a fixed-dose combination with emtricitabine in a product with the brand name Truvada for once-a-day dosing. (Emtricitabine is marketed as a single-compound product called Emtriva, also by Gilead.) Atripla, a fixed-dose triple combination of tenofovir, emtricitabine and efavirenz, was approved by the FDA on 12 July 2006 and is now available, providing a single daily dose for the treatment of HIV.

History

Tenofovir was discovered through a collaborative research effort between Antonín Holý at the Institute of Organic Chemistry and Biochemistry, Academy of Sciences of the Czech Republic (IOCB) in Prague, and Erik DeClercq, Rega Institute for Medical Research, Catholic University of Leuven, Belgium. Analagous to adenosine.

Tenofovir was approved by the U.S. Food and Drug Administration (FDA) on October 26, 2001 for the treatment of HIV, and on August 11, 2008 for the treatment of chronic hepatitis B[2][3].

Indications

Tenofovir is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults. This indication is based on analyses of plasma HIV-1 RNA levels and CD4 cell counts in controlled studies of tenofovir in treatment-naïve and treatment-experienced adults. There are no study results demonstrating the effect of tenofovir on the clinical progression of HIV. It also has activity against wild-type and lamivudine-resistant HBV.

Adverse effects and drug interactions

The most common side effects associated with tenofovir include nausea, vomiting, diarrhea, and asthenia. Less frequent side effects include hepatotoxicity, abdominal pain, and flatulence.[4] Tenofovir has also been implicated in causing renal toxicity, particularly at elevated concentrations.[5]

Tenofovir can cause acute renal failure, Fanconi syndrome, proteinuria, tubular necrosis. These side effects are due to accumulation of drug in proximal tubule. Tenofovir can interact with didanosine by increasing didanosine's concentration. It also decreases the concentration of Atazanavir sulfate.

HIV risk reduction

A 2006 trial by Family Health International gave either Viread or a placebo to 936 high-risk women in Cameroon, Ghana and Nigeria. While the results show signs that the Viread group contracted HIV at a reduced rate, the researchers cautioned against drawing conclusions from the study because the sample size was so small.[6] [7]

External links

References

  1. ^ Emau P, Jiang Y, Agy MB, et al. (2006). "Post-exposure prophylaxis for SIV revisited: Animal model for HIV infection". AIDS Res Ther 3: 29. doi:10.1186/1742-6405-3-29. 
  2. ^ FDA letter of approval (regarding treatment of hepatitis B)
  3. ^ FDA Clears Viread for Hepatitis B
  4. ^ USPDI. Thompson. 2005. pp. 2741–2. 
  5. ^ "Viread Prescribing Guidelines" (PDF). U.S. Food and Drug Administration. March 2006. http://www.fda.gov/cder/foi/label/2006/021356s016lbl.pdf. Retrieved 2007-02-12. 
  6. ^ "Tenofovir Use Safe for Uninfected, West African Women at Risk of HIV Infection". Family Health International. 2006-08-17. http://www.fhi.org/en/AboutFHI/Media/Releases/TenofovirSafe081706.htm. Retrieved 2007-06-01. 
  7. ^ "Additional Studies Needed to Assess Effectiveness of Tenofovir for Prevention". Family Health International. http://www.fhi.org/en/RH/Pubs/Briefs/HIVprevTrials/fhitdfstudy.htm. Retrieved 2007-06-01. 

 
 
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Emtricitabine; Tenofovir
Efavirenz; Emtricitabine; Tenofovir
Tenofovir, PMPA tablets

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