Ephedrine Hydrochloride Injection (Max Health)
Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Summary of Product characteristics
(SPC)
15-09-2021
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Active ingredient:
Ephedrine hydrochloride 30 mg/mL
Available from:
Max Health Limited
INN (International Name):
Ephedrine hydrochloride 30 mg/mL
Dosage:
30 mg/mL
Pharmaceutical form:
Solution for injection
Composition:
Active: Ephedrine hydrochloride 30 mg/mL Excipient: Water for injection
Units in package:
Ampoule, glass, Type I with a one-point cut 1mL, 10 dose units
Class:
Class B2 Controlled Drug
Prescription type:
Class B2 Controlled Drug
Manufactured by:
Siegfried PharmaChemikalien Minden GmbH
Therapeutic indications:
Indicated in the treatment of hypotension secondary to spinal anaesthesia in adults.
Product summary:
Package - Contents - Shelf Life: Ampoule, glass, Type I with a one-point cut 1mL - 10 dose units - 36 months from date of manufacture stored at or below 25°C protect from light
Authorization date:
2011-06-08
Summary of Product characteristics
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
Ephedrine Hydrochloride Injection 30mg/ml, solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Ephedrine hydrochloride 30mg/ml
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Clear, colourless solution for Injection
pH = 5.00 – 7.000
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ephedrine Hydrochloride Injection is indicated in the treatment of
hypotension secondary to
spinal anaesthesia.
4.2
DOSE AND METHOD OF ADMINISTRATION
Ephedrine Hydrochloride Injection is administered by the intravenous
route.
_Adults and Elderly _
Ephedrine hydrochloride should be administered in the lowest effective
dose.
A 3 mg/mL solution should be given as a slow intravenous injection of
3 to 7.5 mg (maximum
10 mg), repeated as needed every 3 - 4 minutes to a maximum of 30 mg.
A lack of efficacy after 30 mg should lead to reconsideration of the
choice of therapeutic agent.
_Children _
Ephedrine hydrochloride injection is not approved for use in this
patient population.
4.3
CONTRAINDICATIONS
Hypersensitivity to Ephedrine hydrochloride or to any of the
excipients listed in section 6.1.
•
In combination with other indirect sympathomimetic agents such as
phenylpropanolamine,
phenylephrine, pseudoephedrine and methylphenidate.
•
In combination with alpha sympathomimetic agents.
•
In combination with non-selective Monoamine Oxidase Inhibitors (MAOI)
or within 14 days
of their withdrawal.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Ephedrine should be used with caution in patients who may be
particularly susceptible to their
effects, particularly those with hyperthyroidism. Great care is also
needed in patients with
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cardiovascular disease such as ischaemic heart disease, arrhythmia or
tachycardia, occlusive
vascular disorders including arteriosclerosis, hypertension, or
aneurysms. Angina pain may
be precipitated in patients with angina pectoris.
Care is also required when Ephedrine is given to patients with
diabetes mellitus, closed-angle
gl
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