Valsartan STELLA 40 mg

Rx

Indications:

• Hypertension.
• Heart failure.
• Following myocardial infarction.

Dosage:

• In hypertension: Initial dose of 80 mg once daily. This may be increased, if necessary, to 160 mg once daily, although doses of up to 320 mg once daily have been used. A lower initial dose of 40 mg once daily may be used in elderly patients over 75 years, and in those with intravascular volume depletion; similar dosage reductions have been suggested in hepatic or renal impairment.
• In heart failure: Initial dose of 40 mg twice daily. The dose should be increased, as tolerated, to 160 mg twice daily.
• Following myocardial infarction: Valsartan may be started as early as 12 hours after the infarction in clinically stable patients, in an initial dose of 20 mg twice daily; the dose may be doubled at intervals over the next few weeks up to 160 mg twice daily if tolerated.
• In mild to moderate hepatic impairment, the total daily dose should not exceed 80 mg.
• No dose adjustment is required in patients with creatinine clearance > 10 ml/min and in elderly patients.

Usage:
Valsartan STELLA 40 mg is taken orally, independently of a meal and should be administered with water.

• Known hypersensitivity to any ingredient in the formulation.
• Severe hepatic impairment, biliary cirrhosis and cholestasis.
• Second and third trimesters of pregnancy.
• The concomitant use of valsartan with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment.

Common:

• Dizziness, postural dizziness,
• Hypotension, orthostatic hypotension,
• Renal failure and impairment.

• Hyperkalaemia: Concomitant use with potassium supplements, potassium-sparing diuretics, salt substitutes containing potassium, or other agents that may increase potassium levels (heparin, etc.) is not recommended.
• Dual blockade of the renin-angiotensin-aldosterone system (RAAS): There is evidence that the concomitant use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure). ACE-inhibitors and angiotensin II receptor blockers should not be used concomitantly in patients with diabetic nephropathy.
• Sodium and/or volume depleted patients: In severely sodium-depleted and/or volume-depleted patients, such as those receiving high doses of diuretics, symptomatic hypotension may occur in rare cases after initiation of therapy with valsartan. For those patients whose diuretic dose cannot be reduced in order to correct their sodium and/or volume depletion a starting dose of 40 mg is recommended.
• Renal artery stenosis: Since other drugs that affect the renin-angiotensin-aldosterone system may increase blood urea and serum creatinine in patients with bilateral or unilateral renal artery stenosis, monitoring is recommended as a safety measure.
• Hepatic impairment: Based on pharmacokinetic data which demonstrate significantly increased plasma concentrations of valsartan in mild to moderately hepatically impaired patients, a lower dose is recommended in patients with hypertension.
• Renal function impairment: As a consequence of inhibiting the renin-angiotensin-aldosterone system, increases of blood urea and serum creatinine and changes in renal function including renal failure (very rarely) have been reported particularly in patients with pre-existing renal dysfunction or those with severe cardiac insufficiency.
• Serum potassium should be monitored in renally impaired or elderly patients if they are also taking potassium supplement.
• Post-myocardial infarction: As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function may be anticipated in susceptible individuals. Evaluation of patients with post-myocardial infarction should always include assessment of renal function.
• Valsartan STELLA 40 mg contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
• Pregnancy: When pregnancy is detected, valsartan should be discontinued as soon as possible.
• Lactation: A decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
• When driving vehicles or operating machines, it should be recognised that occasionally dizziness or weariness may occur during treatment with any antihypertensive agent.