DEXAMED Tablet Ref.[28236] Active ingredients: Dexamethasone

General considerations: dosage must be individualized on the basis of the disease and the response of the patient. In order to minimize side effects, the lowest possible dosage adequate to control the disease process should be used.

Posology

The initial dosage varies from 0.5 mg to 9 mg a day depending on the disease being treated. In more severe diseases, doses higher than 9 mg may be required. The initial dosage should be maintained or adjusted until the patient’s response is satisfactory. Both the dose in the evening which is useful in alleviating morning stiffness and the divided dosage regimen are associated with greater suppression of the hypothalamo – pituitary-adrenal axis. If satisfactory clinical response does not occur after a reasonable period of time, discontinue Dexamed tablets and transfer the patient to other therapy.

After a favourable initial response, the proper maintenance dosage should be determined by decreasing the initial dosage in small amounts to the lowest preferably not exceed 1.5mg dexamethasone daily.

Patients should be monitored for signs that might require dosage adjustment including changes in clinical status resulting from remissions or exacerbation of surgery infection, trauma. During stress it may be necessary to increase dosage temporarily.

To avoid hypoadrenalism and/or a relapse of the underlying disease it may be necessary to withdraw the drug gradually.

The following equivalents facilitate changing to Dexamed from other glucocorticoids.

Milligram for milligram dexamethasone is approximately equivalent to betamethasone 4 to 6 times more potent than methylprednisolone and triamcinolone, 6 to 8 times more potent than prednisone and prednisolone, 25 to 30 times more potent than hydrocortisone and about 35 times more potent than cortisone.

In acute, self-limiting allergic disorders or acute exacerbations of chronic allergic disorders the following dosage schedule combining parenteral and oral therapy is suggested.

First day: Dexamed injection, 4 mg or 8 mg (1ml or 2 ml) intramuscularly
Second day: Two 500mcg Dexamed tablets twice a day
Third day: Two 500mcg Dexamed tablets twice a day
Fourth day: One 500mcg Dexamed tablets twice a day
Fifth day: One 500mcg Dexamed tablet twice a day
Sixth day: One 500mcg Dexamed tablet
Seventh day: One 500mcg Dexamed tablet
Eighth day: reassessment day

This schedule is designed to ensure adequate therapy during acute episodes while minimizing the risk of overdosage in chronic cases.

Dexamethasone suppression tests:

1. Tests for Cushing’s syndrome: 2 mg is given orally at 11 p.m., then blood is drawn for plasma cortisol determination at 8 a.m. the following morning.

For greater accuracy, 500 mcg is given orally every 6 hours for 48 hours. Plasma cortisol is measured at 8 a.m. on the third morning. Twenty-four hour urine collections are made for determination of 17-hydroxycorticosteroid excretion.

2. Test to distinguish Cushing’s syndrome caused by pituitary ACTH excess from the syndrome induced by other causes: 2 mg is given orally every 6 hours for 48 hours. Plasma cortisol is measured at 8 a.m. on the morning following the last dose. Twenty-four- hour urine collections are made for determination of 17-hydroxycorticosteroid excretion.

Paediatric population

Dosage should be limited to a single dose on alternate days to lessen retardation of growth and minimize suppression of hypothalamo-pituitary-adrenal axis.

Elderly

Treatment of elderly patients, particularly if long term, should be planned bearing in mind the more serious consequences of the common side effects of corticosteroids in old age, especially osteoporosis, diabetes, hypertension, hypokalaemia, susceptibility to infection and thinning of the skin. Close clinical supervision is required to avoid life-threatening reactions.

Method of administration

Dexamed tablets are for oral administration only.

Definition of overdose is difficult as therapeutic dose varies widely according to indication and patient response. In overdose it would be anticipated that corticosteroid adverse effects would be severe and greater. Symptomatic and supportive treatment is recommended. Treat anaphylaxis with adrenaline and positive pressure ventilation.

60 months.

Store below 25°C.

Dexamed 0.5mg: Packs of 100 tablets.

Dexamed 1.5mg: Packs of 50 and 100 tablets.

For oral administration only.