Diovan (valsartan) tablets
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – June and December 2011, February and August 2012
- Do not use in patients with known hypersensitivity to any component
WARNINGS AND PRECAUTIONS
Impaired Renal Function
- Changes in renal function including acute renal failure can be caused by drugs that inhibit the renin-angiotensin system and by diuretics…
- Some patients with heart failure have developed increases in potassium…
- The table shows adverse reactions in double-blind short-term heart failure trials, including the first 4 months of the Valsartan Heart Failure Trial, with an incidence of at least 2% that were more frequent in valsartan-treated patients than in placebo-treated patients…
- Discontinuations due to renal dysfunction occurred in 1.1% of valsartan-treated patients and 0.8% of captopril-treated patients.
- Hypersensitivity: There are rare reports of angioedema. Some of these patients previously experienced angioedema with other drugs including ACE inhibitors. Diovan should not be re-administered to patients who have had angioedema.
- Renal: renal failure
USE IN SPECIFIC POPULATIONS
- Safety and effectiveness of Diovan in patients with severe renal impairment (CrCl ≤ 30mL/min) have not been established. No dose adjustment is required in patients with mild (CrCl 60-90 mL/min) or moderate (CrCl 30-60) renal impairment.
- No dose adjustment is necessary for patients with mild-to-moderate liver disease. No dosing recommendations can be provided for patients with severe liver disease.
PATIENT COUNSELING INFORMATION
Tell your doctor about all your medical conditions including whether you:
- have ever had a reaction called angioedema, to another blood pressure medicine. Angioedema causes swelling of the face, lips, tongue and/or throat, and may cause difficulty breathing.
- potassium supplements. Your doctor may check the amount of potassium in your blood periodically
- a salt substitute. Your doctor may check the amount of potassium in your blood periodically
- certain antibiotics (rifamycin group), a drug used to protect against transplant rejection (cyclosporin) or an antiretroviral drug used to treat HIV/AIDS infection (ritonavir). These drugs may increase the effect of valsartan.
Clinical Studies Experience, Pediatric Hypertension
- Headache and hyperkalemia were the most common adverse events suspected to be study drug-related in older children (6 to 17 years old) and younger children (6 months to 5 years old), respectively. Hyperkalemia was mainly observed in children with underlying renal disease.
- Diovan is not recommended for pediatric patients under 6 years of age
- Concomitant use of valsartan with other agents that block the renin-angiotensin system, potassium sparing diuretics (e.g. spironolactone, triamterene, amiloride), potassium supplements, or salt substitutes containing potassium may lead to increases in serum potassium and in heart failure patients to increases in serum creatinine.
USE IN SPECIFIC POPULATIONS
- In children and adolescents with hypertension where underlying renal abnormalities may be more common, renal function and serum potassium should be closely monitored as clinically indicated.
- No data are available in pediatric patients either undergoing dialysis or with a glomerular filtration rate <30 mL/min/1.73 m2.
- There is limited clinical experience with Diovan in pediatric patients with mild to moderate hepatic impairment.
PATIENT PACKAGE INSERT
High Blood Pressure (Hypertension)
- Medicines that lower your blood pressure lower your chance of having a stroke or heart attack
Non-Steroidal Anti-Inflammatory Agents including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors)
- In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, co-administration of NSAIDs, including selective COX-2 inhibitors with angiotensin II receptor antagonists, including valsartan, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving valsartan and NSAID therapy.
- The antihypertensive effect of angiotensin II receptor antagonists, including valsartan may be attenuated by NSAIDs including selective COX-2 inhibitors.
What should I tell my doctor before taking Diovan
- Nonsteroidal anti-inflammatory drugs (like ibuprofen or naproxen)