Last month, the us food and drug administration fda approved novartis valturna aliskiren and valsartan, which combines in a single pill valsartan, the active ingredient in diovan, the topselling branded high blood pressure medicine and aliskiren, the active ingredient in tekturna the only approved direct renin inhibitor dri. Valsartan, losartan and other blood pressure medication. Valsartan is marketed under the trademark diovan and when used in combination with amlodipine, under the trademark exforge. Valsartan api dmfs us drug master file dmf details.
Valsartan, blood pressure reduction, and creactive. Valsartan is used when a group of medicines called angiotensin converting enzyme ace inhibitors a medication to treat heart failure cannot be used or it may. The valsartan antihypertensive longterm use evaluation. Data sources include ibm watson micromedex updated 4 may 2020, cerner multum updated 4 may 2020. Valsartan is generally welltolerated with a sideeffect profile superior. It belongs to the bcs class iii drug classified as low permeability and high solubility drug. By blocking the action of angiotensin, valsartan dilates blood vessels and reduces blood pressure. Valsartan is indicated for the treatment of hypertension, to lower blood pressure. Pharmacokinetics of multiple doses of valsartan in.
In drugclassspecific subgroup analyses, valsartan tended to. It is a lipophilic drug and possesses moderate onset of action than other drugs of the same category. This is the first nonvalsartan drug product the agency has found to. Manufacturers issued the recalls after finding carcinogens in the blood pressure medication.
When pregnancy is detected, discontinue diovan as soon as possible. Overview of clinical use and side effect profile of valsartan in chinese hypertensive patients qifang huang, yan li, jiguang wangcentre for epidemiological studies and clinical trials, the shanghai institute of hypertension, ruijin hospital, shanghai jiaotong university school of medicine, shanghai, peoples republic of chinaabstract. Diovan valsartan drug medicine information newsmedical. The angiotensin ii receptor blocker arb family of drugs unique in.
Valsartan, when administered as an oral solution, is primarily recovered in feces about 83% of dose and urine about % of dose. Food and drug administration approved a new generic of diovan valsartan. Valsartan is a moderately priced drug used to treat high blood pressure. Valsartan oral tablet is available as the brandname drug diovan. Ranitidine cancer lawsuits move forward in florida after. Food and drug administration fda announced the recall of more than 600 lots of generic valsartan. Eighteen patients with chronic stable heart failure and left ventricular ejection fractions. Other medications in the valsartan drug class include irbesartan avapro. Fda updates and press announcements on angiotensin ii receptor blocker arb recalls valsartan, losartan, and irbesartan. Almost 60 million prescriptions were written for losartan drugs in 2016 and 14 million for valsartan or a drug that includes it. This drug is also used to treat patients with heart failure and patients who have had a heart attack. Diovan valsartan dose, indications, adverse effects.
Overview of clinical use and side effect profile of. Dafiro, exforge, amlodipinevalsartan product profile bciq. Voluntary recalls of the drug by sanofi and other companies have also taken place. Valsartan drug manufacturers face thousands of lawsuits following nationwide recalls. Valsartan is a widely used blood pressure medication that comes in dosages of 80. Ranitidine is not the first drug to contain a nitrosamine impurity. Review side effects, drug interactions, warnings and precautions, and pregnancy safety information prior to taking this medication. Valsartan is also used in adults to treat heart failure, and to lower the risk of death after a heart attack valsartan may also be used for purposes not listed in this medication guide. List of drug master files dmf of valsartan active pharmaceutical ingredient api submitted to the u. The valsartan antihypertensive longterm use evaluation value trial was designed to test the theory in hypertensive patients determined to be at high cardiovascular risk that, for the same level of blood pressure bp control, valsartan would reduce cardiac morbidity and mortality more so than amlodipine.
Additive hypotension may occur when used concurrently with fentanyl, other antihypertensives, nitrates, acute ingestion of alcohol,orquinidine. Use caution during aerobic exercise and other forms of therapeutic exercise in patients recovering from myocardial infarction. Valsartan is an angiotensin ii antagonist which was launched overseas more than 10 years ago, but was not marketed in australia. Valsartan selectively and competitively blocks the binding of angiotensin ii to the at1 subtype receptor in vascular smooth muscle and the adrenal gland, preventing at iimediated vasoconstriction, aldosterone synthesis and secretion, and renal reabsorption of sodium. All generic drug interactions for valsartan oral lists will include brand and generic names. Three different companies have recalled heart medications containing the active ingredient valsartan over concerns the drugs may be tainted by a cancercausing substance, going back at least the last four years, according to the u. Antihypertensive effects may bepby concurrent use of nonsteroidal antiin. Valsartan, tablet, 40 mg1, oral, torrent pharmaceuticals limited, 20150105, not applicable, us us. See full prescribing information for complete boxed warning.
Valsartan angiotan or diovan is an angiotensin ii receptor antagonist more commonly called an arb, or angiotensin receptor blocker, with particularly high affinity for the type i at 1 angiotensin receptor. Overall, valsartan had similar blood pressurelowering efficacy as the other classes of antihypertensive drugs or olmesartan, for systolic as well as diastolic blood pressure p. Sacubitrilvalsartan was also more effective than enalapril in slowing disease progression by decreasing the risk of worsening heart failure requiring hospitalization or emergency admission and. There have been so many types of valsartan recalled this year that the fda has created a website listing just for them. Sacubitrilvalsartan, sold under the brand name entresto among others, is a combination drug for use in heart failure. The recovery is mainly as unchanged drug, with only about 20% of dose recovered as metabolites. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and heart attacks myocardial infarctions, or mi control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management. On day 7 of each dosing period, serial blood samples were obtained over 12 h for. The % release of valsartan from the valsartan epo solid dispersion microparticles in phosphate buffer ph 6. Pharmacological and pharmaceutical profile of valsartan. Valsartan is an angiotensin ii receptor blocker arb that treats high blood pressure and heart failure. It consists of the neprilysin inhibitor sacubitril and the angiotensin receptor blocker valsartan.
Valsartan is an orally active antihypertensive drug developed in the 1990s and is a selective angiotensin ii receptor blocker arb 1 which relaxes the blood vessels and thus reduces blood pressure. It is recommended for use as a replacement for an ace inhibitor or an angiotensin receptor blocker in people with heart failure with reduced ejection fraction. Learn about drug interactions between atorvastatin oral and valsartan oral and use the rxlist drug interaction checker to check drug combinations. Search list of recalled angiotensin ii receptor blockers arbs including valsartan, losartan and irbesartan. High levels of the chemical were discovered in batches of several valsartan blood pressure medications that prompted a voluntary fda recall in july 2018. Food and drug administration the voluntary recalls were prompted by the discovery that valsartan produced in a particular chinese facility contained a probable. Consumers affected by the recalled drug are now filing lawsuits against valsartan. This consumer medicine information cmi is intended for. These medications may interact and cause very harmful effects. Valsartan is sometimes given together with other blood pressure medications.
Capitals indicate lifethreatening, underlines indicate most frequent. Ucb and novartis extended to 2014 a codistribution agreement for cardiovascular drug provas valsartan in germany. Valsartan is an orally active nonpeptide triazolederived antagonist of angiotensin at ii with antihypertensive properties. Valsartan, sold under the trade name diovan among others, is a medication used to treat high. Like other members of the class, such as candesartan and losartan, valsartan lowers blood pressure by acting at the angiotensin type i receptor.
Find out which specific blood pressure medications are affected by the recall. Valsartan is used to treat high blood pressure hypertension in adults and children who are at least 6 years old. Indicated for the treatment of heart failure nyha class iiiv to reduce the risk of hospitalization for heart failure in patients unable to swallow valsartan tablets. Strong cyp3a4 inhibitors, including ketoconazole, itraconazole, and ritonavirmayqlevels. Data sources include ibm watson micromedex updated 4 may 2020, cerner multum updated 4 may 2020, wolters kluwer updated. Valsartan medical definition merriamwebster medical. The drug is a very good target for the generic industries. The 104 additional lots include 26 lots of amlodipine and valsartan tablets, 51 lots of valsartan tablets and 27 lots of valsartan and hydrochlorothiazide tablets. Valsartan c24h29n5o3 cid 60846 structure, chemical names, physical and chemical. Drug name active ingredients strength dosage formroute marketing status rld te code application no. Valsartan diovan is an arb drug prescribed for the treatment of high blood pressure and congestive heart failure. The positive effect of valsartan 80 mg versus placebo on aer was statistically significant 95% confidence interval ci for end pointbaseline ratio.
There was significant heterogeneity across trials for diastolic blood pressure p. Implement aerobic exercise and cardiac conditioning programs to augment drug therapy and maintain or improve cardiovascular pump function in patients with heart failure and other cardiac conditions. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. The latest is american health packagings 160 mg valsartan. Request pdf pharmacological and pharmaceutical profile of valsartan.
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