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HSA Approval

PRENOLOL 50 TABLET 50 mg

SIN10277P

PRENOLOL 50 TABLET 50 mg

PRENOLOL 50 TABLET 50 mg

October 14, 1998

POLYMEDIC TRADING ENTERPRISE PTE LTD

POLYMEDIC TRADING ENTERPRISE PTE LTD

Regulatory Information

POLYMEDIC TRADING ENTERPRISE PTE LTD

POLYMEDIC TRADING ENTERPRISE PTE LTD

Therapeutic

Prescription Only

Formulation Information

TABLET, FILM COATED

**DOSAGE AND ADMINISTRATION** **Adults** **Hypertension** Most patients respond to 50–100 mg daily given orally as a single daily dose. The effect will be fully established after one to two weeks. A further reduction in blood pressure may be achieved by combining “Prenolol” with other antihypertensive agents. **Angina** Most patients with angina pectoris will respond to 100 mg daily given orally as a single dose or as 50 mg given twice a day. It is unlikely that additional benefit will be gained by increasing the dose. **Elderly** Dosage requirement may be reduced, especially in patients with impaired renal function. **Children** There is no paediatric experience with “Prenolol” and for this reason it is not recommended for use in children. **Renal Failure** Since “Prenolol” is excreted via the kidneys dosage should be reduced in cases of severe impairment of renal function. No significant accumulation of “Prenolol” occurs in patients who have a creatinine clearance greater than 35 ml/min/1.73 m2 (normal range is 100–150 ml/min/1.73 m2). For patients with a creatinine clearange of 15–35 ml/min/1.73 m2 (equivalent to serum creatinine of 300–600 mcmol/litre) the oral dose should be 50 mg daily. For patients with a creatinine clearance of <15 ml/min/1.73 m2 (equivalent to serum creatinine of >600 mcmol/litre) the oral dose should be 25 mg daily or 50 mg on alternate days. Patients on haemodialysis should be given 50 mg orally after each dialysis : this should be done under hospital supervision as marked falls in blood pressure can occur.

ORAL

Medical Information

**INDICATIONS** 1. Hypertension 2. Angina pectoris 3. Cardiac arrhythmias 4. Myocardial infarction. Early and late intervention.

**CONTRA-INDICATIONS** “Prenolol” as with other beta-blockers, should not be used in patients with any of the following : known hypersensitivity to the substance ; bradycardia ; cardiogenic shock ; hypotension ; metabolic acidosis ; severe peripheral arterial circulatory disturbances ; second or third degree heart block ; sick sinus syndrome ; untreated phaeochromocytoma ; uncontrolled heart failure.

C07AB03

atenolol

Manufacturer Information

POLYMEDIC TRADING ENTERPRISE PTE LTD

BERLIN PHARMACEUTICAL INDUSTRY CO LTD

Active Ingredients

ATENOLOL

50 mg

Atenolol

Documents

Package Inserts

Prenolol-PI- Proposed - clean.pdf

Approved: June 6, 2022

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