Valsartan STELLA 80 mg

Rx

Indications

• Management of hypertension,
• To reduce mortality in patients with left ventricular dysfunction following myocardial infarction,
• Management of heart failure.

Dosage

Adults

• Hypertension
  The recommended starting dose of valsartan is 80 mg once daily. The antihypertensive effect is substantially present within 2 weeks, and maximal effects are attained within 4 weeks. In some patients whose blood pressure is not adequately controlled, the dose can be increased to 160 mg once daily and to a maximum of 320 mg.
• Recent myocardial infarction
  In clinically stable patients, therapy may be initiated as early as 12 hours after a myocardial infarction.
  After an initial dose of 20 mg twice daily, valsartan should be titrated to 40 mg, 80 mg, and 160 mg twice daily over the next few weeks.
  The target maximum dose is 160 mg twice daily. In general, it is recommended that patients achieve a dose level of 80 mg twice daily by two weeks after treatment initiation and that the target maximum dose, 160 mg twice daily, be achieved by three months, based on the patient’s tolerability. If symptomatic hypotension or renal dysfunction occurs, consideration should be given to a dose reduction.
  Valsartan may be used in patients treated with other post-myocardial infarction therapies, e.g. thrombolytics, acetylsalicylic acid, beta blockers, statins and diuretics. The combination with ACE inhibitors is not recommended.
• Heart failure
  The recommended starting dose of valsartan is 40 mg twice daily. Uptitration to 80 mg and 160 mg twice daily should be done at intervals of at least two weeks to the highest dose, as tolerated by the patient. Consideration should be given to reducing the dose of concomitant diuretics. The maximum daily dose administered in clinical trials is 320 mg in divided doses.
  Valsartan may be administered with other heart failure therapies. However, the triple combination of an ACE inhibitor, a beta blocker and valsartan is not recommended.
• Patients with renal impairment
  No dose adjustment is required for these patients with a creatinine clearance ≥ 10 ml/min.
  In patients with a creatinine clearance < 10 ml/min: Valsartan should be used with cautions.

Elderly

• No dose adjustment is required.

Paediatric

• Hypertension
  Children and adolescents 6 to 18 years of age: The initial dose is 40 mg once daily for children weighing below 35 kg and 80 mg once daily for those weighing 35 kg or more. The dose should be adjusted based on blood pressure response.
  For maximum doses:
  18 – 35 kg: Maximum 80 mg
  35 – 80 kg: Maximum 160 mg
  80 – 160 kg: Maximum 320 mg
  Children less than 6 years of age: Safety and efficacy of valsartan in children aged 1 to 6 years have not been established.
  Valsartan is not recommended for the treatment of heart failure or recent myocardial infarction in children and adolescents below the age of 18 years due to the lack of data on safety and efficacy.
• Renal impairment
  Valsartan is not recommended in these patients with a creatinine clearance < 30 ml/min.
  No dose adjustment is required for these patients with a creatinine clearance > 30 ml/min.
  Renal function and serum potassium should be closely monitored.
• Diabetes mellitus
  Concomitant use of valsartan with aliskiren is contraindicated in patients with diabetes mellitus.
• Hepatic impairment
  Valsartan should be used with caution in patients with hepatic impairment.
  In patients with mild to moderate hepatic impairment without cholestasis, the dose of valsartan should not exceed 80 mg.
  Valsartan is contraindicated in patients with severe hepatic impairment, billiary cirrhosis and cholestasis.
• Renal impairment
  Creatinine clearance < 30 ml/min and undergoing dialysis: Valsartan is not recommended.
  Creatinine clearance > 30 ml/min: No dose adjustment is required.
  Renal function and serum potassium should be closely monitored.
• Recent myocardial infarction
  Valsartan is not recommended due to the lack of data on safety and efficacy.

Usage

Valsartan STELLA 80 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 angiotensin receptor antagonists (ARBS) – including valsartan or of angiotensin-converting-enzyme inhibitors with aliskiren in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m²).

• Dizziness, postural dizziness.
• Hypotension, orthostatic hypotension.

• 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. Monitoring of potassium should be undertaken as appropriate.
• Impaired renal function: There is currently no experience on the safe use in patients with a creatinine clearance < 10 ml/min and patients undergoing dialysis, therefore valsartan should be used with caution in these patients. No dose adjustment is required for adult patients with a creatinine clearance > 10 ml/min.
  The concomitant use of ARBs – including valsartan – or of ACEIs with aliskiren is contraindicated in patients with renal impairment (GFR < 60 ml/min/1.73m²).
• Hepatic impairment: In patients with mild to moderate hepatic impairment without cholestasis, valsartan should be used with caution.
• 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. Sodium and/or volume depletion should be corrected before starting treatment with valsartan, for example by reducing the diuretic dose.
• In patients with bilateral renal artery stenosis or stenosis to a solitary kidney, the safe use of valsartan has not been established. However, other agents that affect the renin-angiotensin system may increase blood urea and serum creatinine in patients with unilateral renal artery stenosis, therefore monitoring of renal function is recommended when patients are treated with valsartan.
• Patients with primary hyperaldosteronism should not be treated with valsartan as their renin-angiotensin system is not activated.
• As with all other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or hypertrophic obstructive cardiomyopathy.
• Caution should be observed when initiating therapy in post-myocardial infarction/heart failure patients. Evaluation of post-myocardial infarction/heart failure patients should always include assessment of renal function. Use of valsartan in post-myocardial infarction/heart failure patients commonly results in some reduction in blood pressure, but discontinuation of therapy because of continuing symptomatic hypotension is not usually necessary provided dosing instructions are followed.
• Angioedema, including swelling of the larynx and glottis, causing airway obstruction and/or swelling of the face, lips, pharynx, and/or tongue has been reported in patients treated with valsartan; some of these patients previously experienced angioedema with other drugs including ACE inhibitors. Valsartan should be immediately discontinued in patients who develop angioedema, and valsartan should not be re-administered.
• Hypotension, syncope, stroke, hyperkalaemia, and changes in renal function (including acute renal failure) have been reported in susceptible individuals, especially if combining medicinal products that affect this system.
• In patients whose renal function may depend on the activity of the renin-angiotensin system (e.g patients with severe congestive heart failure), treatment with angiotensin converting enzyme inhibitors has been associated with oliguria and/or progressive azotaemia and in rare cases with acute renal failure and/or death. As valsartan is an angiotensin II antagonist, it cannot be excluded that the use of valsartan may be associated with impairment of the renal function.
• Valsartan STELLA 80 mg contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
• When pregnancy is detected, valsartan should be discontinued as soon as possible. Because of the potential for adverse effects on the nursing infant, 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 taken into account that occasionally dizziness or weariness may occur when taking valsartan.