Valsatens® Film Coated Tablet

Composition:

Each Film Coated Tablet contains; Active Ingredients: Valsartan 40 or 80 mg .

Indications And Usage:

Hypertension: Valsartan is indicated for the treatment of hypertension. It may be used alone or in combination with other anti-hypertensive agents. Heart Failure: Valsartan is indicated for the treatment of heart failure (NYHA class II-IV). Post-Myocardial Infarction: Valsatens is indicated to reduce cardiovascular mortality.

Contraindications:

Valsartan is contraindicated in patients who are hypersensitive to any component of this product.

Dosage & Administration:

Hypertension :The recommended starting dose of Valsartan is 80 mg or 160 mg once daily when used as monotherapy in patients who are not volume-depleted. Patients requiring greater reductions may be started at the higher dose. Valsartan may be used over a dose range of 80 mg to 320 mg daily,administered once a dayThe antihypertensive effect is substantially present within 2 weeks and maximal reduction is generally attained after 4 weeks. 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 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. Post-Myocardial Infarction: Valsartan may be initiated as early as 12 hours after a myocardial infarction.The recommended starting dose of Valsartan is 20 mg twice daily. Patients may be uptitrated within 7 days to 40 mg twice daily, with subsequent titrations to a target maintenance dose of 160 mg twice daily, as tolerated by the patient. If symptomatic hypotension or renal dysfunction occurs, consideration should be given to a dosage reduction. Valsartan may be given with other standard post-myocardial infarction treatment, including thrombolytics, aspirin, beta-blockers, and statins. Warnings: Fetal/Neonatal Morbidity and Mortality. Drugs that act directly on the renin-angiotensin system can cause fetal and neonatal morbidity and death when administered to pregnant women. When pregnancy is detected , Valsartan should be discontinued as soon as possible Hypotension: In patients with an activated renin-angiotensin system, such as volume- and/or salt-depleted patients receiving high doses of diuretics, symptomatic hypotension may occur. This condition should be corrected prior to administration of Valsartan, or the treatment should start under close medical supervision.Caution should be taken when initiating therapy in patients with heart failure or post-myocardial infarction patients. Patients with heart failure or post-myocardial infarction patients given Valsartan commonly have some reduction in blood pressure, but discontinuation of therapy because of continuing symptomatic hypotension is not necessary when dosing instructions are followed.

Drug Interactions:

No clinically significant pharmacokinetic interactions were observed when valsartan was co-administered with amlodipine, atenolol, cimetidine, digoxin, furosemide, glyburide, hydrochlorothiazide, or indomethacin. The valsartan-atenolol combination was more antihypertensive than either component, but it did not lower the heart rate more than atenolol alone. Co-administration of valsartan and warfarin did not change the pharmacokinetics of valsartan or the time-course of the anticoagulant properties of warfarin. Nursing Mothers: It is not known whether valsartan is excreted in human milk ، a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Precautions:

General Impaired Hepatic Function: As the majority of valsartan is eliminated in the bile, patients with mild-to-moderate hepatic impairment, including patients with biliary obstructive disorders, showed lower valsartan clearance (higher AUCs). Impaired Renal Function: As a consequence of inhibiting the renin-angiotensin-aldosterone system,changes in renal function may be anticipated in susceptible individuals. In patients with severe heart failure whose renal function may depend on the activity of the renin-angiotensin-aldosterone system, treatment with angiotensin-converting enzyme inhibitors and angiotensin receptor antagonists has been associated with oliguria and/or progressive azotemia and (rarely) with acute renal failure and/or death. Similar outcomes have been reported with Valsartan. Some patients with heart failure who have developed increases in blood urea nitrogen, serum creatinine, and potassium. These effects are usually minor and transient, and they are more likely to occur in patients with pre-existing renal impairment. Dosage reduction and/or discontinuation of the diuretic and/or Valsartan may be required.

Storage:

Store below 30°C in a dry place. Keep out of reach of children.

Pregnancy & Lactation:

Warning : Use In Pregnancy When used in pregnancy,.drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus. When pregnancy is detected, Valsatens should be discontinued as soon as. possible.

Adverse Effects:

It may include hypotension ,headache, dizziness, upper respiratory tract infection, cough, diarrhea, rhinitis,sinusitis, nausea, pharyngitis, edema, and arthralgia , allergic reaction and asthenia ,palpitations, pruritus and rash, constipation, dry mouth, dyspepsia, and flatulence, back pain, muscle cramps, and myalgia,anxiety, insomnia, paresthesia, and somnolence, dyspnea, vertigo, mpotence. Other reported events seenless frequently in clinical trials included chest pain, syncope, anorexia, vomiting, and angioedema.

Package:

Valsatens 40 Film Coated Tablet is available as Film Coated Tablet packed in a carton box containing 1,2,3 Al/PVC strips each of 10 Film Coated Tablet with enclosed leaflet. Valsatens 80 Film Coated Tablet is available as Film Coated Tablet packed in a carton box containing 1,2,3 Al/PVC strips each of 10 Film Coated Tablet with enclosed leaflet.

Dose: