HYGROTON Tablet Ref.[6661] Active ingredients: Chlortalidone

The dosage of Hygroton/Chlortalidone should be individually titrated to give the lowest effective dose; this is particularly important in the elderly. Hygroton/Chlortalidone should be taken orally, preferably as a single daily dose at breakfast time.

Adults

Hypertension

The recommended starting dose is 25mg/day. This is sufficient to produce the maximum hypotensive effect in most patients. If the decrease in blood pressure proves inadequate with 25mg/day, then the dose can be increased to 50mg/day. If a further reduction in blood pressure is required, additional hypertensive therapy may be added to the dosage regime.

Stable, chronic heart failure (NYHA: functional class II/III)

The recommended starting dose is 25 to 50mg/day, in severe cases it may be increased up to 100 to 200mg/day. The usual maintenance dose is the lowest effective dose, eg 25 to 50mg/day either daily or every other day. If the response proves inadequate, digitalis or an ACE inhibitor, or both, may be added. (See Section 4.4 “Special warnings and precautions for use”).

Oedema of specific origin (see Section 4.1 “Therapeutic indications”)

The lowest effective dose is to be identified by titration and administered over limited periods only. It is recommended that doses should not exceed 50mg/day.

Diabetes insipidus

Initially 100mg twice daily but reducing where possible to a daily maintenance dose of 50mg.

Children

The lowest effective dose should also be used in children. For example, an initial dose of 0.5 to 1mg/kg/48hours and a maximum dose of 1.7mg/kg/48hours have been used.

Elderly patients and patients with renal impairment

The lowest effective dose of Hygroton/Chlortalidone is also recommended for patients with mild renal insufficiency and for elderly patients (see Section 5.2 “Pharmacokinetic properties”).

In elderly patients, the elimination of chlortalidone is slower than in healthy young adults, although absorption is the same. Therefore, a reduction in the recommended adult dosage may be needed. Close medical observation is indicated when treating patients of advanced age with chlortalidone.

Hygroton/Chlortalidone and the thiazide diuretics lose their diuretic effect when the creatinine clearance is <30ml/min.

Signs and symptoms

In poisoning due to an overdosage the following signs and symptoms may occur: dizziness, nausea, somnolence, hypovolaemia, hypotension and electrolyte disturbances associated with cardiac arrhythmias and muscle spasms.

Treatment

There is no specific antidote to Hygroton/Chlortalidone. Gastric lavage, emesis or activated charcoal should be employed to reduce absorption. Blood pressure and fluid and electrolyte balance should be monitored and appropriate corrective measures taken. Intravenous fluid and electrolyte replacement may be indicated.

Five years.

None.

Aluminium/PVC blister packs of 28 tablets.

None.