PINDOLOL Tablet Ref.[8379] Active ingredients: Pindolol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2014  Publisher: Generics [UK] Limited, T/A Mylan, Station Close, Potters Bar, Hertfordshire, EN6 1TL

Therapeutic indications

Essential hypertension: For reduction of blood pressure in essential hypertension. Onset of action of Pindolol is usually rapid, most patients showing a response within the first one to two weeks of treatment. However, maximum response may take several weeks to develop.

Prophylactic treatment of angina pectoris: Prophylactic treatment with Pindolol reduces the frequency and severity of anginal attacks and increases work capacity.

Posology and method of administration

Posology

Adults

Hypertension

Initially one 5 mg tablet two or three times a day. According to the response of the patient the dose may be increased at weekly intervals to a maximum of 45 mg given in divided doses twice or three times daily.

Once daily dosage schedule

Further work shows that many patients respond to a once daily dosage regime. Initially 15 mg (3 tablets) should be taken once a day with breakfast and adjusted according to individual response up to a maximum of 45 mg (9 tablets). Most patients respond to a once daily dose of between 15-30 mg (3-6 tablets).

Patients not responding after three to four weeks at this dosage level rarely benefit from further elevations in dosage. Addition of Pindolol to existing diuretic therapy increases the hypotensive effect and combination with other antihypertensives enables reduction in dosage of these agents.

Angina Pectoris

Usually 2.5 mg or 5 mg of Pindolol up to three times a day according to response.

Elderly patients

No evidence exists that elderly patients require different dosages or show different side-effects from younger patients.

Paediatric population

Experience with pindolol in children is limited. Pindolol tablets are therefore not recommended for use in children.

Method of administration

For oral administration only.

Overdose

Management

Treat by elimination of any unabsorbed drug and general supportive measures. Marked bradycardia as a result of overdosage or idiosyncrasy should be treated with atropine sulphate 1 to 2 mg intravenously. If necessary, isoprenaline hydrochloride can be administered by a slow intravenous injection under constant supervision, beginning with 25 μg (5 μg/min) until the desired effect is achieved. A cardiac pacemaker may be required; i.v. glucagon (5 to 10 mg) has been reported to overcome some of the features of serious overdosage and may be useful.

Shelf life

3 years.

Special precautions for storage

Store below 25°C. Store in the original package in order to protect from light.

Nature and contents of container

Polypropylene containers with polyethylene caps (with optional use of polyethylene ullage filler) and PVC/aluminium foil blister packs containing 5, 7, 10, 14, 15, 20, 21, 25, 28, 30, 56, 60, 84, 90, 100, 112, 120, 168, 180, 250, 500 and 1000 tablets.

Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements for disposal.

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