DBL™ Dexamethasone Sodium Phosphate

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

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

Available from:

Pfizer New Zealand Limited

INN (International Name):

Dexamethasone sodium phosphate 4.37 mg/mL (= 4 mg dexamethasone phosphate)

Dosage:

4 mg/mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Dexamethasone sodium phosphate 4.37 mg/mL equivalent to 4 mg dexamethasone phosphate Excipient: Disodium edetate Hydrochloric acid Sodium citrate Sodium hydroxide Sodium sulfite Water for injection

Units in package:

Vial, glass, single dose, Type 1, amber 2mL, 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, 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. hould 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: Vial, glass, single dose, Type 1, amber 2mL - 5 dose units - 24 months from date of manufacture stored at or below 25°C - Vial, glass, single dose, Type 1, amber 2mL - 10 dose units - 24 months from date of manufacture stored at or below 25°C

Authorization date:

2011-09-30

Summary of Product characteristics

Version: pfddexai11122
Supersedes: pfddexai10322
Page 1 of 18
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
DBL
TM
Dexamethasone Sodium Phosphate Injection 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.
The 4 mg/1 mL ampoule formulation contains sodium citrate and
creatinine. No preservatives
or antioxidants are present.
The 8 mg/2 mL vial formulation contains sodium citrate, disodium
edetate and sodium sulfite
(as an antioxidant).
EXCIPIENT(S) WITH KNOWN EFFECT
Vial (8 mg/2 mL)
Sodium sulfite
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Dexamethasone phosphate (as sodium) is a white or slightly yellow,
very hygroscopic,
crystalline powder. It is odourless or has a slight odour of alcohol.
Dexamethasone phosphate
(as sodium) is soluble 1 in 2 of water, slightly soluble in alcohol,
practically insoluble in
chloroform and ether, and very slightly soluble in dioxane.
DBL Dexamethasone Sodium Phosphate Injection is a clear colourless
solution, free from
visible particulate matter.
The pH of the solutions is adjusted using sodium hydroxide and/or
hydrochloric acid.
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;
Version: pfddexai11122
Supersedes: pfddexai10322
Page 2 of 18
•
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 insu