Dexamethasone phosphate

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Dexamethasone sodium phosphate 4.37 mg/mL equivalent to dexamethasone phosphate 4 mg/mL

Available from:

Max Health Limited

INN (International Name):

Dexamethasone sodium phosphate 4.37 mg/mL (equivalent to dexamethasone phosphate 4 mg/mL)

Dosage:

4 mg/mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Dexamethasone sodium phosphate 4.37 mg/mL equivalent to dexamethasone phosphate 4 mg/mL Excipient: Disodium edetate Nitrogen Propylene glycol Sodium hydroxide Water for injection

Units in package:

Ampoule, 5 x 2ml Type I, colourless, neutral glass, 5 dose units

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Sanofi Chimie

Therapeutic indications:

Dexamethasone has predominantly glucocorticoid activity and therefore is not a complete replacement therapy in cases of adrenocortical insufficiency. Dexamethasone should be supplemented with salt and/or a mineralocorticoid. When so supplemented, dexamethasone is indicated in: · Acute adrenocortical insufficiency - Addison's disease, bilateral adrenalectomy; · Relative adrenocortical insufficiency - Prolonged administration of adrenocortical steroids can produce dormancy of the adrenal cortex. The reduced secretory capacity gives rise to a state of relative adrenocortical insufficiency which persists for a varying length of time after therapy is discontinued. Should a patient be subjected to sudden stress during this period of reduced secretion (for up to two years after therapy has ceased) the steroid output may not be adequate. Steroid therapy should therefore be reinstituted to help cope with stress such as that associated with surgery, trauma, burns, or severe infections where specific antibiotic therapy is available; · Primary and secondary adrenocortical insufficiency.

Product summary:

Package - Contents - Shelf Life: Ampoule, 2ml Type I, colourless, neutral glass - 5 dose units - 24 months from date of manufacture stored at or below 25°C protect from light. Do not freeze. - Ampoule, 2ml Type I, colourless, neutral glass - 10 dose units - 24 months from date of manufacture stored at or below 25°C protect from light. Do not freeze. - Ampoule, 1ml Type I, colourless, neutral glass - 10 dose units - 24 months from date of manufacture stored at or below 25°C protect from light. Do not freeze.

Authorization date:

2013-05-16

Summary of Product characteristics

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NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Dexamethasone phosphate 4 mg/mL Solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each millilitre of solution contains dexamethasone sodium phosphate
equivalent to 4 mg of
dexamethasone phosphate.
EXCIPIENT(S) WITH KNOWN EFFECT
Each ml contains 20 mg of propylene glycol – see section 4.4.
Each ml contains a maximum of 0.42 mg of sodium – see section 4.4.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear and colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
REPLACEMENT THERAPY - ADRENOCORTICAL INSUFFICIENCY
Dexamethasone has predominantly glucocorticoid activity and therefore
is not a complete
replacement therapy in cases of adrenocortical insufficiency.
Dexamethasone should be
supplemented with salt and/or a mineralocorticoid, such as
deoxycorticosterone. When so
supplemented, dexamethasone is indicated in:
•
Acute adrenocortical insufficiency - Addison’s disease, bilateral
adrenalectomy;
•
Relative adrenocortical insufficiency - Prolonged administration of
adrenocortical steroids
can produce dormancy of the adrenal cortex. The reduced secretory
capacity gives rise to a
state of relative adrenocortical insufficiency which persists for a
varying length of time after
therapy is discontinued. Should a patient be subjected to sudden
stress during this period of
reduced secretion (for up to two years after therapy has ceased) the
steroid output may not be
adequate. Steroid therapy should therefore be reinstituted to help
cope with stress such as
that associated with surgery, trauma, burns, or severe infections
where specific antibiotic
therapy is available;
•
Primary and secondary adrenocortical insufficiency.
DISEASE THERAPY
Dexamethasone is indicated for therapy of the following diseases:
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COLLAGEN DISEASES:
Systemic lupus erythematosus, polyarteritis nodosa, dermatomyositis,
giant cell arteritis, adjunctive therapy for short-term administration
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