What is valsartan, and how does it work (mechanism of action)?
WARNING [update 10/15/2019]: Today, the U.S. Food and Drug Administration posted a warning letter to Torrent Pharmaceuticals in Ahmedabad, Gujarat, India. Torrent manufactures losartan potassium tablets and has been one subject of an ongoing global investigation into nitrosamine impurities in angiotensin II receptor blockers (ARBs) such as valsartan, losartan and irbesartan.
The warning letter outlines several manufacturing violations at Torrent’s Taluka-Kadi, Indrad, Gujarat facility, including failure to follow written procedures for production and process control and failure to adequately investigate batch discrepancies. Failure to correct these violations may result in further action by the agency. The warning letter is another result of the agency’s ongoing investigation.
FDA reminds patients taking recalled ARBs to continue taking their current medicine until their pharmacist provides a replacement or their doctor prescribes a different medication that treats the same condition.
What is valsartan, and how does it work (mechanism of action)?
Valsartan is an oral medication that is used to treat high blood pressure and congestive heart failure. It belongs to a class of drugs called angiotensin receptor blockers (ARBs) which also includes irbesartan (Avapro), losartan (Cozaar), and candesartan (Atacand). Angiotensin, formed in the blood by the action of angiotensin converting enzyme (ACE), is a powerful chemical that attaches to angiotensin receptors found in many tissues but primarily on smooth muscle cells of blood vessels. Angiotensin's attachment to the receptors causes the blood vessels to narrow (vasoconstrict) which leads to an increase in blood pressure (hypertension). Valsartan blocks the angiotensin receptor. By blocking the action of angiotensin, valsartan dilates blood vessels and reduces blood pressure. Valsartan was approved by the FDA in December 1996.
What are the uses for valsartan?
Valsartan is used to treat high blood pressure and heart failure. It also is prescribed after heart attacks since valsartan may reduce deaths in patients who developed congestive heart failure after a heart attack. Valsartan also may reduce hospitalizations in patients with congestive heart failure.
What are the side effects of valsartan?
Valsartan is generally well-tolerated. The most common side effects are:
Other important side effects are:
- hyperkalemia,
- impotence,
- reduced renal function, and
- allergic reactions.
Rhabdomyolysis (inflammation and destruction of muscle) and angioedema (swelling of soft tissues including those of the throat and larynx) are rare but serious side effects of valsartan.
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What is the dosage for valsartan?
The usual dose of valsartan for adults with high blood pressure is 80 to 160 mg once daily. The maximum dose is 320 mg daily. Maximum blood pressure reduction occurs within 4 weeks. For congestive heart failure, the usual dose is 40 mg twice daily. The doses may be increased to 80-160 mg twice daily. The initial dose after a heart attack is 20 mg twice daily. The dose may be increased to 160 mg twice daily if tolerated without side effects.
Which drugs or supplements interact with valsartan?
Combining valsartan with potassium-sparing diuretics (for example., spironolactone (Aldactone), triamterene, amiloride), potassium supplements, or salt substitutes containing potassium may lead to hyperkalemia (elevated potassium in the blood) and in heart failure patients, it increases serum creatinine, a blood test used for monitoring function of the kidneys.
Combining valsartan or other ARBs with nonsteroidal anti-inflammatory drugs (NSAIDs) in patients who are elderly, fluid-depleted (including those on diuretic therapy), or with poor kidney function may result in reduced kidney function, including kidney failure. These effects are usually reversible. There have been reports that aspirin and other NSAIDs such as ibuprofen (Advil, Children's Advil/Motrin, Medipren, Motrin, Nuprin, PediaCare Fever, etc.), indomethacin (Indocin, Indocin-SR), and naproxen (Anaprox, Naprelan, Naprosyn, Aleve) may reduce the effects of ARBs.
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Is valsartan safe to take if I’m pregnant or breastfeeding?
When used in the second or third trimester of pregnancy , valsartan and similar drugs can cause injury and even death to the fetus. Valsartan should not be used during pregnancy. When pregnancy is detected, valsartan should be stopped as soon as possible.
It is not known whether valsartan is secreted into human milk. Valsartan is secreted into the milk of rats.
What else should I know about valsartan?
Preparations, storage, generic and prescription information about valsartan
- Valsartan is available as Tablets: 40, 80, 160 and 320 mg. Tablets are scored and can be split.
- Capsules should be stored at room temperature, 15-30 C (59-86 F).
- Valsartan is available in generic form. You need a prescription for Vasartan.