DIDRALIN Tablet Ref.[107882] Active ingredients: Hydrochlorothiazide

Source: Υπουργείο Υγείας (CY)  Revision Year: 2021  Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

4.1. Therapeutic indications

Didralin contains hydrochlorothiazide, which is a thiazide diuretic and antihypertensive.

Didralin is indicated, either alone or with other antihypertensives, in patients with hypertension, oedema associated with congestive heart failure and with renal and hepatic disorders (e.g. hepatic cirrhosis). It is also indicated for the treatment of oedema accompanying the premenstrual syndrome, the prevention of water retention associated with corticosteroids and oestrogens, the treatment of diabetes insipidus and the prevention of renal calculus formation in patients with hypercalciuria.

4.2. Posology and method of administration

Method of administration

For oral administration.

Posology

Dosage should be determined on an individual basis and the lowest dosage necessary to achieve the desired result should be used.

Adults

For oedema: The usual dose is 25 to 100 mg daily given as a single dose or in two divided doses. Many patients respond to intermittent therapy; for example every other day or 3 to 5 days a week. Intermittent therapy is less likely to produce excessive diuretic response with resulting undesirable electrolyte imbalance. The maximum recommended daily dose is 100 mg.

In oedema accompanying with premenstrual tension: 25 to 50 mg once or twice daily form the first morning of symptoms until the onset of menses.

For control of hypertension: Usual starting dose is 25 mg daily as a single dose. Dosage should be adjusted according to patients response but it should not exceed 50 mg daily.

Thiazides may add to the action of other antihypertensive agents and it may be necessary to reduce the dosage of such agents so as to prevent an excessive drop in blood pressure.

Elderly

Particular caution is needed in the elderly because of their susceptibility to electrolyte imbalance. Dosage should be carefully adjusted according to the renal function and clinical response.

Paediatric population

The dosage is determined according to body weight. A suggested initial dose for children is 2.5 mg per Kg body weight daily in 2 divided doses. Although the drug is administered to children less than 2 years old another pharmaceutical form (like liquid preparations) are suitable for this group of patients so as to administer the exact dose.

4.9. Overdose

Symptoms

The most common sign and symptoms observed are those caused by electrolyte depletion (hypokalaemia, hypochloraemia, hyponatraemia) and dehydration resulting from excessive diuresis. If digitalis has also been administered hypokalaemia may accentuate cardiac arrhythmias.

Treatment

In the event of overdosage symptomatic and supportive measures should be employed. If ingestion is recent, emesis should be induced or gastric lavage performed. Dehydration, electrolyte imbalance, hepatic coma and hypotension should be corrected by established methods.

6.3. Shelf life

5 years.

6.4. Special precautions for storage

Store below 25°C, in the original package.

6.5. Nature and contents of container

Aluminium/PVC blister packs containing 30, 50 or 100 tablets.

Securitainers containing 1000 tablets.

Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

No special requirements for disposal.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.