Diovan 80 mg/1
valsartan · TABLET · Novartis Pharmaceuticals Corporation
Diovan (valsartan) is a prescription tablet taken by mouth to treat high blood pressure and heart failure by relaxing blood vessels and reducing the workload on the heart. It belongs to a class of medications called angiotensin 2 receptor blockers.
Key Facts
- Brand Name
- Diovan
- Generic Name
- valsartan
- NDC Code (Product)
0078-1245- Manufacturer
- Novartis Pharmaceuticals Corporation
- Strength
- 80 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- NDA021283
- Drug Class
- Angiotensin 2 Receptor Blocker [EPC]
- Marketing Start
- 07/01/2001
Recall History
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.
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.
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 Diovan is an angiotensin II receptor blocker (ARB) indicated for: Hypertension , to lower blood pressure in adults and children 1 year and older. 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), to reduce hospitalization for heart failure in adults ( 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 in adults ( 1.3 ) 1.1 Hypertension Diovan ® is indicated for the treatment of hypertension, to lower blood pressure in adults and pediatric patients one year 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 Diovan. Control…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION *As tolerated by patient Indication Starting Dose Dose Range* Hypertension Adults ( 2.2 ) 80 mg to 160 mg once daily 80 mg to 320 mg once daily 1 to 16 years ( 2.3 ) 1 mg/kg once daily Up to 40 mg daily 1 mg/kg to 4 mg/kg once daily Up to 160 mg daily Heart Failure ( 2.4 ) 40 mg twice daily 40 mg to 160 mg twice daily Post-Myocardial Infarction ( 2.5 ) 20 mg twice daily 20 mg to 160 mg twice daily 2.1 Important Dosage and Preparation Information Diovan 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 [see Clinical Pharmacology (12.3)] . Use of the oral suspension is recommended: in pediatric patients aged 1 to 5 years in patients >5 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 Diovan. 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 Or…
Contraindications
4 CONTRAINDICATIONS Do not use in patients with known hypersensitivity to any component. Do not coadminister aliskiren with Diovan in patients with diabetes [see Drug Interactions (7.3)] . Known hypersensitivity to any component. Do not coadminister aliskiren with Diovan 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 ) Non-Steroidal Anti-Inflammatory Drug (NSAID) use may lead to increased risk of renal impairment and loss of antihypertensive effect ( 7.2 ) Dual inhibition of the Renin-Angiotensin System (RAS): 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,…
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 Novartis Pharmaceuticals Corporation at 1-888-669-6682 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 Diovan has been evaluated for safety in more than 4000 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. The over…
Frequently Asked Questions
What is Diovan used for?
Diovan (valsartan) is a prescription tablet taken by mouth to treat high blood pressure and heart failure by relaxing blood vessels and reducing the workload on the heart. It belongs to a class of medications called angiotensin 2 receptor blockers.
Is Diovan a controlled substance?
Diovan is not classified as a controlled substance by the DEA.
What is the generic name for Diovan?
The generic name for Diovan is valsartan. There are 11 other brand versions of valsartan.
What is the NDC code for Diovan 80 mg/1?
The NDC (National Drug Code) for Diovan 80 mg/1 is 0078-1245, listed by Novartis Pharmaceuticals Corporation.
Other Valsartan Brands
See all →- Valsartan160 mg/172578-133
- 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
- Valsartan and Hydrochlorothiazide25 mg/165162-849
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)