SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Ephedrine Hydrochloride Injection    30 mg in    1 ml

2.    QUALITATIVE AND QUANTITATIVE COMPOSITION

Ephedrine Hydrochloride BP 3% w/v.

3.    PHARMACEUTICAL FORM

Injection

4.    CLINICAL PARTICULARS

4.1.    Therapeutic Indications

To reduce hypotension during spinal anaesthesia

4.2.    Posology and Method of Administration

Adults and the elderly

Up to 30 mg in increments of 3 - 7.5 mg.

After the development of hypotension, by slow intravenous administration. Children

0.5 - 0.75 mg / kg body weight or 17 - 25 mg / M body surface.

After the development of hypotension, by slow intravenous administration.

Patients receiving treatment with monoamine oxidase inhibitors (or within 2 weeks of their withdrawal). Coronary thrombosis, diabetes mellitus, ischaemic heart disease, hypotension, thyrotoxicosis, closed angle glaucoma or, in the case of elderly patients prostatic hypertrophy.

4.4. Special Warnings and Special Precautions for Use

None stated.

4.5. Interaction with other Medicinal Products and other Forms of Interaction

See under 4.3 above.

4.6. Pregnancy and Lactation

There is no, or inadequate evidence of safety of the drug in human pregnancy, but it has been in use for many years without apparent ill consequence. if drug therapy during pregnancy is needed the use of this drug is acceptable.

4.7. Effects on Ability to Drive and Use Machines

None known.

4.8. Undesirable Effects

The following side effects have been reported:

Giddiness, headache, nausea, vomiting, sweating, thirst, arryhthmias, tachycardia, precordial pain, palpitations, difficulty in micturition, muscular weakness, tremors, anxiety, restlessness and insomnia. In the case of patients with prostatic hypertrophy the retention of urine may become acute.

Symptoms as in 4.8, paranoid psychosis, delusions and hallucinations may occur.

Treatment In severe overdosage Diazepam may be required to control CNS stimulation and severe hypertension will require specific therapy.

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic Properties

Ephedrine is a sympathomimetic agent with direct and indirect effects on adrenergic receptors.

It has alpha and beta- adrenergic activity and has pronounced stimulating effects on the central nervous system.

It causes bronchodilation, relaxes the bladder wall, contracts the sphincter muscles, but relaxes the detruser muscles.

It has stimulant action on the respiratory centre.

5.2. Pharmacokinetic Properties

Ephedrine accumulates in the liver, lungs, kidneys, spleen and brain. It is largely excreted unchanged in the urine together with small amounts of metabolites.

It has a plasma half-life reportedly between 3 and 6 hours depending on the urinary pH; elimination is enhanced and half-life accordingly shorter in acid urine.

5.3. Pre-clinical Safety Data

None stated.

6.

6.1.    List of Excipients

Water for Injections BP

6.2.    Incompatibilities

Incompatible with anionic salts.

6.3.    Shelf-Life

36 months.

6.4.    Special Precautions for Storage

Do not store above 25° C.

Keep in outer carton.

6.5.    Nature and Content of Container

1 ml in type 1 colourless neutral glass ampoules. Fusion sealed. Packed into cartons of 10 ampoules.

6.6.    Instructions for Use, Handling and Disposal

None applicable.

7. MARKETING AUTHORISATION HOLDER

Macarthys Laboratories Ltd T/A Martindale Pharmaceuticals Bampton Road,

Harold Hill,

Romford,

RM3 8UG

8. MARKETING AUTHORISATION NUMBER(S)

PL 1883/6131R

9. DATE OF FIRST AUTHORISATION / RENEWAL OF AUTHORISATION

First authorised: 21^st May 1990 Last renewal:    21^st March 1996

10. DATE OF (PARTIAL) REVISION OF THE TEXT

July 2002