Dexmethsone

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Dexamethasone 4mg

Available from:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (International Name):

Dexamethasone 4 mg

Dosage:

4 mg

Pharmaceutical form:

Tablet

Composition:

Active: Dexamethasone 4mg Excipient: Lactose monohydrate Magnesium stearate Maize starch Povidone

Units in package:

Bottle, White, opaque, HDPE bottle with screw closure and induction seal liner, 30 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Pharmacia & Upjohn Company LLC

Therapeutic indications:

Dexamethasone is indicated for replacement therapy in secondary adrenal insufficiency arising from insufficient corticotrophin secretion. It is not indicated for primary adrenal insufficiency states, such as Addisons disease or after adrenalectomy. In such cases hydrocortisone and fludrocortisone in combination is more appropriate. Dexamethasone is also indicated for allergic disorders such as bronchial asthma and allergic skin reactions, blood disorders such as leukaemia, thrombocytopoenia and haemolytic anaemias, selected collagen and rheumatic disorders (only rarely in rheumatoid arthritis), gastrointestinal disorders such as inflammatory bowel disease, connective tissue disorders such as arteritis, systemic lupus erythematosus (but not scleroderma), some skin diseases such as pemphigus, oedema, some eye disorders, certain neoplastic disorders such as cerebral neoplasm, secondary hypercalcaemia, and acute leukaemia in children. It may also be used to prevent neonatal respiratory distress syndrome and in the diagnosis of Cushing's syndrome. Dexamethasone is indicated in the treatment of coronavirus disease 2019 (COVID-19) in adult and adolescent patients (aged 12 years and older with body weight at least 40 kg) who require supplemental oxygen therapy.

Product summary:

Package - Contents - Shelf Life: Bottle, White, opaque, HDPE bottle with screw closure and induction seal liner - 30 tablets - 36 months from date of manufacture stored at or below 30°C protect from light

Authorization date:

2009-07-07

Summary of Product characteristics

DEXMETHSONE dexamethasone 0.5 mg & 4 mg - data sheet
Page 1 of 10
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
DEXMETHSONE dexamethasone 0.5 mg tablet.
DEXMETHSONE dexamethasone 4 mg tablet.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains either dexamethasone 0.5 mg or 4 mg.
Excipients with known effect: lactose monohydrate and wheat starch
(0.5 mg tablet only). For
the list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
0.5 mg:
Round, slightly biconvex white tablets plain on one side and 'DS/0.5'
with
breakline on the other side.
4 mg:
Round, white tablets plain on one side and 'DS/4' with breakline on
the other
side.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Dexamethasone is indicated for replacement therapy in secondary
adrenal insufficiency
arising from insufficient corticotrophin secretion. It is not
indicated for primary adrenal
insufficiency states, such as Addison’s disease or after
adrenalectomy. In such cases
hydrocortisone and fludrocortisone in combination is more appropriate.
Dexamethasone is also indicated for allergic disorders such as
bronchial asthma and
allergic skin reactions, blood disorders such as leukaemia,
thrombocytopoenia and
haemolytic anaemias, selected collagen and rheumatic disorders (only
rarely in
rheumatoid arthritis), gastrointestinal disorders such as inflammatory
bowel disease,
connective tissue disorders such as arteritis, systemic lupus
erythematosus (but not
scleroderma), some skin diseases such as pemphigus, oedema, some eye
disorders,
certain neoplastic disorders such as cerebral neoplasm, secondary
hypercalcaemia,
and acute leukaemia in children. It may also be used to prevent
neonatal respiratory
distress syndrome and in the diagnosis of Cushing's syndrome.
Dexamethasone is indicated in the treatment of coronavirus disease
2019 (COVID-19) in
adult and adolescent patients (aged 12 years and older with body
weight at least 40 kg) who
require supplemental oxygen therapy.
4.2 DOSE AND METHOD OF ADMINISTRATION
The dose of dexamethasone varies ac