Valsartan

Valsartan tablets are 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 Valsartan tablets are indicated for the treatment of hypertension, to lowe …

• Indication Starting Dose Dose Range * Hypertension Adult 80-160 mg once daily 80-320 mg once daily 1-16 years 1 mg/kg once daily Up to 40 mg daily 1-4 mg/kg once daily Up to 160 mg daily Heart Failure 40 mg twice daily 40-160 mg twice daily Post-Myocardial Infarction 20 mg twice daily 20-160 mg twice daily * As tolerated by patient 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 [see Clinical Pharmacology ]
• 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 valsartan
• 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 bottle containing 8 valsartan 80 mg tablets and shake for a minimum of 2 minutes. • Allow the suspension to stand for a minimum of 1 hour. • After the standing time, shake the suspension for a minimum of 1 additional minute. • Add 80 mL of Ora-Sweet SF ® * oral sweetening vehicle to the bottle and shake the suspension for at least 10 seconds to disperse the ingredients. …

40 mg are scored yellow, capsule-shaped, biconvex, film-coated tablets debossed with “341” and bisect between 3 and 41 on one side, and “HH” on the other side. 80 mg are brown, capsule-shaped, biconvex, film-coated tablets debossed with “342” on one side and “HH” on the other side. …

• Advise the patient to read the FDA-approved patient labeling (Patient Information)
• Pregnancy : Advise female patients of childbearing age about the consequences of exposure to valsartan during pregnancy
• Discuss treatment options with women planning to become pregnant
• Ask patients to report pregnancies to their healthcare provider as soon as possible [see Warnings and Precautions , Use in Specific Populations ]
• Lactation: Advise women not to breastfeed during treatment with valsartan [see Use in Specific Populations ]. …

• Do not use in patients with known hypersensitivity to any component
• Do not coadminister aliskiren with valsartan in patients with diabetes [ see Drug Interactions ]
• Known hypersensitivity to any component
• Do not coadminister aliskiren with valsartan in patients with diabetes

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, tr …

Observe for signs and symptoms of hypotension ( 5.2 ) Monitor renal function and potassium in susceptible patients ( 5.3 , 5.4 ) 5.1 Fetal Toxicity Valsartan can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. …

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 Solco Healthcare US, LLC at 1-866-257-2597 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …

IN SPECIFIC POPULATIONS Lactation: Breastfeeding is not recommended ( 8. 2) Pediatrics : Use of valsartan tablets is not recommended in children less than 1 year of age ( 6.1 , 8.4 , 13.2 ) 8.1 Pregnancy Risk Summary Valsartan can cause fetal harm when administered to a pregnant woman. …

Limited data are available related to overdosage in humans. The most likely manifestations of overdosage would be hypotension and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. Depressed level of consciousness, circulatory collapse and shock have been reported. If symptomatic hypotension should occur, institute supportive treatment. Valsartan is not removed from the plasma by hemodialysis. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.