Ephedrine Hydrochloride Injection 30mg in 1ml

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

EPHEDRINE HYDROCHLORIDE

Available from:

Martindale Pharmaceuticals Limited Bampton Road, Harold Hill, Romford Essex, RM3 8UG, United Kingdom

ATC code:

R03CA02

INN (International Name):

EPHEDRINE HYDROCHLORIDE 30 mg/ml

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

EPHEDRINE HYDROCHLORIDE 30 mg/ml

Prescription type:

POM

Therapeutic area:

DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES

Authorization status:

Withdrawn

Authorization date:

2007-07-09

Patient Information leaflet

100MM MEASUREMENT VERIFICATION BAR
WHAT IS IN THIS LEAFLET:
1.
What Ephedrine Injection is and what it is used for
2.
What you need to know before you are given Ephedrine
Injection
3.
How Ephedrine Injection is given
4.
Possible side effects
5.
How to store Ephedrine Injection
6.
Contents of the pack and other information
1. WHAT EPHEDRINE INJECTION IS AND WHAT IT IS USED
FOR
Ephedrine belongs to a group of medicines called
sympathomimetics. Sympathomimetic drugs affect the part of
your nervous system that works automatically.
Ephedrine Injection is used to relieve low blood pressure during
spinal or epidural anaesthesia. It raises blood pressure by
temporarily reducing the blood supply to small blood vessels.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN
EPHEDRINE INJECTION
You should not be given Ephedrine Injection if:
• you are allergic to ephedrine hydrochloride or to any of the
other ingredients in this medicine, (listed in section 6).
• you are taking another indirect sympathomimetic agent such
as phenylpropanolamine, phenylephrine, pseudoephedrine
(medicines used to RELIEVE BLOCKED NOSE) or methylphenidate
(medicine used to TREAT “ATTENTION DEFICIT HYPERACTIVITY
DISORDER (ADHD)”)
• you are taking an alpha sympathomimetic agent (medicines
used to TREAT LOW BLOOD PRESSURE)
• you are taking or have taken in the last 14 days a non-selective
monoamine oxidase inhibitor (medicines used to
TREAT DEPRESSION)
WARNINGS AND PRECAUTIONS
Talk to your doctor before using Ephedrine Injection if:
• you suffer from diabetes
• you suffer from heart disease or any other heart conditions,
including angina;
• you suffer from weakness in a blood vessel wall leading to a
bulge developing (aneurysm);
• you have high blood pressure;
• you have a narrowing and/or blockage of blood vessels
(occlusive vascular disorders)
• you have an overactive thyroid gland (hyperthyroidism);
• you know or suspect that you suffer from glaucoma (increased
pressure in your eyes) or prostatic hypertrophy (enlarged
prostate g

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ephedrine Hydrochloride 30 mg per 1 ml Solution for Injection
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ephedrine Hydrochloride 3% w/v.
Each ml of Solution for Injection contains 30 mg ephedrine
hydrochloride.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Clear, colourless solution for Injection
pH = 5.00 – 7.00
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Reversal of hypotension from spinal or epidural anaesthesia.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and the elderly _
Up to 30 mg in increments of 3 - 7.5 mg.
After the development of hypotension, by slow intravenous
administration.
_Paediatric Population _
_ _
0.5 - 0.75 mg / kg body weight or 17 - 25 mg / m
2
body surface.
After the development of hypotension, by slow intravenous
administration.
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
Warnings
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 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 glaucoma or prostatic hypertrophy.
Ephedrine should be avoided or used with caution in patients
undergoing
anaesthesia with cyclopropane, halothane, or other halogenated
a