valsartan 80 mg/1
valsartan · TABLET · A-S Medication Solutions
valsartan is a tablet containing valsartan at 80 mg/1, taken oral. Manufactured by A-S Medication Solutions.
Key Facts
- Brand Name
- valsartan
- Generic Name
- valsartan
- NDC Code (Product)
50090-5190- Manufacturer
- A-S Medication Solutions
- Strength
- 80 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA203536
- Drug Class
- Angiotensin 2 Receptor Blocker [EPC]
- Marketing Start
- 01/05/2015
Recall History
Mylan Laboratories Limited, (Nashik FDF)
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Novartis Pharmaceuticals Corp.
Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves.
Mylan Laboratories Limited, (Nashik FDF)
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
AVKARE Inc.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Teva Pharmaceuticals USA
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Teva Pharmaceuticals USA
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Mylan Laboratories Limited, (Nashik FDF)
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Aidapak Services, LLC
Labeling: Label Mixup: VALSARTAN, Tablet, 80 mg may have potentially been mislabeled as one of the following drugs: TEMAZEPAM, Capsule, 7.5 mg, NDC 00378311001, Pedigree: AD49418_1, EXP: 5/17/2014; VALSARTAN, Tablet, 320 mg, NDC 00078036034, Pedigree: AD65475_7, EXP: 5/28/2014; ISOSORBIDE MONONITRATE, Tablet, 20 mg, NDC 62175010701, Pedigree: AD67989_10, EXP: 5/28/2014; CHOLECALCIFEROL, Tablet
Torrent Pharma Inc.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Prinston Pharmaceutical Inc
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Valsartan tablets are an angiotensin II receptor blocker (ARB) indicated for: Hypertension ,to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions ( 1.1 ) Heart failure (NYHA class II-IV); valsartan tablets significantly reduced hospitalization for heart failure ( 1.2 ) Post-myocardial infarction ; for the reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction ( 1.3 ) 1.1 Hypertension Valsartan tablets are indicated for the treatment of hypertension, to lower blood pressure in adults and pediatric patients six years of age and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which valsartan principally belongs. There are no controlled trials in hypertensive patients demonstrating risk reduction with valsartan tablets. Contr…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Indication Starting Dose Dose Range * Adult Hypertension ( 2.2 ) 80 or 160 mg once daily 80-320 mg once daily 6-16 years ( 2.3 ) 1mg/kg once daily (up to 40 mg total) 1-4mg/kg once daily (up to 160 mg total) Heart Failure ( 2.4 ) 40 mg twice daily 40-160 mg twice daily Post-Myocardial Infarction ( 2.5 ) 20 mg twice daily 20-160 mg twice daily * As tolerated by patient 2.1 Important Dosage and Preparation Information Valsartan tablets and oral suspension are not substitutable on a milligram-per-milligram basis. Do not combine two dosage forms to achieve the total dose. The systemic exposure to valsartan (AUC) is 60% higher with the suspension compared to tablets [ S ee Clinical Pharmacology (12.3) ] . Use of the oral suspension is recommended: in patients ≥ 6 years of age who cannot swallow tablets and in pediatric patients for whom the calculated dose (mg/kg) does not correspond to the available tablet strengths of valsartan tablets When switching between suspension and tablets, the dose of valsartan may need to be adjusted. Preparation of Suspension (for 160 mL of a 4 mg/mL suspension) Add 80 mL of Ora-Plus ® * oral suspending vehicle to an amber glass …
Contraindications
4 CONTRAINDICATIONS Do not use in patients with known hypersensitivity to any component. Do not coadminister aliskiren with valsartan tablets in patients with diabetes [See Drug Interactions (7.3) ]. Known hypersensitivity to any component. Do not coadminister aliskiren with valsartan tablets in patients with diabetes ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Potassium-sparing diuretics, potassium supplements or salt substitutes may lead to increases in serum potassium, and in heart failure patients, increases in serum creatinine ( 7.1 ) NSAID use may lead to increased risk of renal impairment and loss of antihypertensive effect ( 7.2 ) Dual inhibition of the renin-angiotensin system : Increased risk of renal impairment, hypotension, and hyperkalemia ( 7.3 ) Lithium : Increases in serum lithium level and lithium toxicity ( 7.4 ) 7.1 Agents Increasing Serum Potassium Concomitant use of valsartan with other agents that block the renin-angiotensin system, potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), potassium supplements, salt substitutes containing potassium or other drugs that may increase potassium levels (e.g., heparin) may lead to increases in serum potassium and in heart failure patients to increases in serum creatinine. If co-medication is considered necessary, monitoring of serum potassium is advisable. 7.2 Non-Steroidal Anti-Inflammatory Agents Including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors) In patients who are elderly, volume-depleted (including those on diuret…
Adverse Reactions
6 ADVERSE REACTIONS Hypertension: Most common adverse reactions are headache, dizziness, viral infection, fatigue and abdominal pain ( 6.1 ) Heart Failure :Most common adverse reactions are dizziness, hypotension, diarrhea, arthralgia, back pain, fatigue and hyperkalemia ( 6.1 ) Post-Myocardial Infarction : Most common adverse reactions which caused patients to discontinue therapy are hypotension, cough and increased blood creatinine ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact RK Pharma Inc at 1-844-757-4276 (1-844-RKPHARMA) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Adult Hypertension Valsartan tablets have been evaluated for safety in more than 4,000 patients, including over 400 treated for over 6 months, and more than 160 for over 1 year. Adverse reactions have generally been mild and transient in nature and have only infrequently required discontinuation of therapy. T…
Frequently Asked Questions
What is valsartan used for?
valsartan contains valsartan. It is a tablet taken oral. Consult your doctor for specific uses.
Is valsartan a controlled substance?
valsartan is not classified as a controlled substance by the DEA.
What is the generic name for valsartan?
The generic name for valsartan is valsartan. There are 12 other brand versions of valsartan.
What is the NDC code for valsartan 80 mg/1?
The NDC (National Drug Code) for valsartan 80 mg/1 is 50090-5190, listed by A-S Medication Solutions.
Other Valsartan Brands
See all →- Valsartan160 mg/172578-133
- Diovan80 mg/10078-1245
- Valsartan160 mg/133342-064
- Valsartan160 mg/142291-858
- Valsartan and Hydrochlorothiazide12.5 mg/142291-968
- Valsartan320 mg/146708-047
- Valsartan and Hydrochlorothiazide12.5 mg/146708-454
- Valsartan80 mg/150090-2424
- Valsartan and Hydrochlorothiazide25 mg/151655-243
- Valsartan160 mg/151655-456
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)