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
Documents
Package Inserts
Prenolol-PI- Proposed - clean.pdf
Approved: June 6, 2022