TRANDATE Film-coated tablet Ref.[7719] Active ingredients: Labetalol

Trandate tablets should be taken orally with food.

Adults

Hypertension

Treatment should start with 100mg twice daily. In patients already being treated with antihypertensives and in those of low body weight this may be sufficient to control blood pressure. In others, increases in dose of 100mg twice daily should be made at fortnightly intervals. Many patients' blood pressure is controlled by 200mg twice daily and up to 800mg daily may be given as a twice daily regimen. In severe, refractory hypertension, daily doses up to 2400mg have been given. Such doses should be divided into a three or four times a day regimen.

Elderly

In elderly patients, an initial dose of 50mg twice daily is recommended. This has provided satisfactory control in some cases.

In the hypertension of pregnancy

The initial dose of 100mg twice daily may be increased, if necessary, at weekly intervals by 100mg twice daily. During the second and third trimester, the severity of the hypertension may require further dose titration to a three times daily regimen, ranging from 100mg tds to 400mg tds. A total daily dose of 2400mg should not be exceeded. Hospital in-patients with severe hypertension, particularly of pregnancy, may have daily increases in dosage.

General

If rapid reduction of blood pressure is necessary, see the SPC for Trandate Injection. If long-term control of hypertension following the use of Trandate Injection is required, oral therapy with Trandate tablets should start with 100mg twice daily. Additive hypotensive effects may be expected if Trandate tablets are administered together with other antihypertensives e.g. diuretics, methyldopa etc. When transferring patients from such agents, Trandate tablets should be introduced with a dosage of 100mg twice daily and the previous therapy gradually decreased. Abrupt withdrawal of clonidine or beta-blocking agents is undesirable.

Angina co-existing with hypertension

In patients with angina pectoris co-existing with hypertension, the dose of Trandate will be that required to control the hypertension.

Children

Safety and efficacy in children have not been established

Symptoms of overdosage are bradycardia, hypotension, bronchospasm and acute cardiac insufficiency.

After ingestion of an overdose or in case of hypersensitivity, the patient should be kept under close supervision and be treated in an intensive-care ward. Absorption of any drug material still present in the gastro-intestinal tract can be prevented by gastric lavage, administration of activated charcoal and a laxative. Artificial respiration may be required. Bradycardia or extensive vagal reactions should be treated by administering atropine or methylatropine.

Hypotension and shock should be treated with plasma/plasma substitutes and, if necessary, catecholamines. The beta-blocking effect can be counteracted by slow intravenous administration of isoprenaline hydrochloride, starting with a dose of approximately 5mcg/min, or dobutamine, starting with a dose of approximately 2.5mcg/min, until the required effect has been obtained. If this does not produce the desired effect, intravenous administration of 8-10mg glucagon may be considered. If required the injection should be repeated within one hour, to be followed, if necessary, by an iv infusion of glucagon at 1-3mg/hour. Administration of calcium ions, or the use of a cardiac pacemaker, may also be considered.

Oliguric renal failure has been reported after massive overdosage of labetalol orally. In one case, the use of dopamine to increase the blood pressure may have aggravated the renal failure.

Labetalol does have membrane stabilising activity which may have clinical significance in overdosage.

Haemodialysis removes less than 1% labetalol hydrochloride from the circulation.

60 months.

No special storage conditions are necessary.

Calendar blister pack containing 56 tablets; composed of hard tempered aluminium foil and opaque PVC blister.

None.