VASEBOS 80

POSOLOGY AND METHOD OF ADMINISTRATION

Method of administration: By oral, with or without meal.

Posology

Hypertension: The recommended starting dose: 80 mg once daily. This dose may be increase to 160 mg once daily, if necessary.

Heart failure:

The recommended dose: 40 mg twice daily.

Uptitrate to 80 mg and 160 mg twice daily or to the highest dose tolerated by the patient.

The maximum daily dose administered in clinical trials is 320 mg in divided doses.

Post-Myocardial Infarction: Treatment may be initiated as early as 12 hours after a myocardial infarction.

After the recommended starting dose is 20 mg twice daily, this dose should be titrated to 40 mg, 80 mg, and 160 mg twice daily in the following weeks.

If symptomatic hypotension or renal dysfunction occurs, consider dosage reduction.

Patients with renal impairment and hepatic impairment: No dose adjustment is necessary for patients with renal impairment and hepatic impairment not due to biliary tract or nephrolithiasis, but usually a low starting dose of 40 mg once daily is recommended.

Children and adolescents below the age of 18 years: Safety and effectiveness have not been established.

CONTRAINDICATIONS

Hypersensitivity to any of the excipients.
Pregnancy.

WARNINGS AND PRECAUTIONS

For patients with hyperkalemia and/or fluid loss.

Precaution with patients with renal artery stenosis, renal impairment.

Particular care should be taken when administering Valsartan to patients with biliary obstruction.

No dose adjustment is necessary for patients with hepatic impairment, but should be caution in severe (creatinine clearance < 10 ml/min).

Patients with heart failure or post-myocardial infarction patients should be cautioned when initiating valsartan.

In patients with heart failure, caution when combined use of an angiotensin-converting enzyme inhibitors, a beta-blocker, and valsartan.

SHELF-LIFE: 36 months from the manufacturing date. Do not use after the expiry date.

Box of 02 blisters x 14 film-coated tablets.