DEXACURE Tablet Ref.[115635] Active ingredients: Dexamethasone

Source: Registered Drug Product Database (NG)  Revision Year: 2022  Publisher: Unicure Pharmaceutical Ltd, Ikofa Village, Lagos - Benin Expressway, Ikofa, Ijebu - Ode, Email: unicurepharms@163.com

4.1. Therapeutic indications

Indicated in a wide variety of disorders amenable to Glucocorticoid therapy, as well as an adjunct in the control of cerebral oedema.

4.2. Posology and method of administration

Posology

In general, glucocorticoid dosage depends on the severity of the condition and response of the patient. Under certain circumstances, for instance in stress and changed clinical picture, extra dosage adjustments may be necessary. If no favourable response is noted within a couple of days, glucocorticoid therapy should be discontinued. Adults Usually, daily oral dosages of 0.5-10 mg are sufficient. In some patients higher dosages may be temporarily required to control the disease. Once the disease is under control the dosage should be reduced or tapered off to the lowest suitable level under continuous monitoring and observation of the patient. (See Section 4.4) For a short DEXACURE Dexamethasone suppression test, 1mg Dexamethasone is given at 11 p.m. and plasma cortisol measured the next morning. Patients who do not show a decrease in cortisol can be exposed to a longer test: 500 micrograms DEXACURE Dexamethasone is given at 6 hourly intervals for 48 hours followed by 2 mg every 6 hours for a further 48 hours. 24 hour-urine collections are made before, during and at the end of the test for determination of 17-hydroxycorticosteroids. Paediatric population 0.01-0.1mg/kg of body weight daily. Dosage of glucocorticoids should be adjusted on the basis of the individual patient's response.

4.9. Overdose

It is difficult to define an excessive dose of a corticosteroid as the therapeutic dose will vary according to indication and patient requirements. Exaggeration of corticosteroid related adverse effects may occur.

Treatment should be asymptomatic and supportive as necessary.

6.3. Shelf life

36 months.

6.4. Special precautions for storage

Store below 25°C in a dry place. Protect from light.

6.5. Nature and contents of container

Child-resistant blister pack: 10 Tablets/ Pack X 10 packs/ Small Pack X 10 small packs/ Shrink film X 20 shrink film/ Carton.

6.6. Special precautions for disposal and other handling

No special requirements for disposal.

© 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.