EPHEDRINE HYDROCHLORIDE INJECTION 30MG IN 1 ML

Active substance: EPHEDRINE HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩

Transcript
3. How Ephedrine Injection is given

Ephedrine Hydrochloride 30mg in 1ml Solution for Injection
Ephedrine Hydrochloride

(Referred to as Ephedrine Injection in this leaflet)
Read all of this leaflet carefully before you are given
this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor
or nurse.
• If any of the side effects get serious, or if you notice any
side effects not listed in this leaflet, please tell your
doctor or nurse.

In this leaflet:
1. What Ephedrine Injection is and what it is used for
2. Before Ephedrine Injection is given
3. How Ephedrine Injection is given
4. Possible side effects
5. How to store Ephedrine Injection
6. Further information
This leaflet contains a summary of the information available
for this medicine. You should ask your doctor or pharmacist if
you are unsure about any aspect of this medicine.

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 anaesthesia. It raises blood pressure by
temporarily reducing the blood supply to small blood
vessels.

2. Before you are given Ephedrine Injection
You should not be given Ephedrine Injection if:
• you are allergic (hypersensitive) to ephedrine or to any of
the other ingredients in this medicine, listed in section 6
of this leaflet
• you suffer from an overactive thyroid gland which can cause
increased appetite, weight loss or sweating
• you suffer from prostate gland enlargement
• you suffer from any heart disease
• you suffer from increased pressure in the eye (glaucoma)
• you suffer from diabetes
• you suffer from blood clots
• you suffer from high blood pressure
• you are taking monoamine oxidase inhibitors or MAOIs
(see Taking other medicines).
If any of the above applies to you, please tell your doctor.
Taking other medicines
Please tell your doctor or nurse if you are taking, or have
recently taken, any other medicine including medicines
obtained without prescription.
Other medicines which may interact with Ephedrine Injection
are:
• a type of anti-depressant known as monoamine oxidase
inhibitors (MAOIs). Tell your doctor or nurse even if you
have stopped taking them in the past 2 weeks.
Pregnancy and breast-feeding
Tell your doctor if you are pregnant, trying to become
pregnant or breast-feeding before you are given this
medicine.
Driving and using machines
Ephedrine Injection is not thought to have any effect on
driving or using machines however if you feel at all unwell
you should consult your doctor before you begin driving or
using machines again.
Continued overleaf

5. How to Store Ephedrine Injection

This medicine is an injection and will be given to you by your
doctor. Your doctor will determine the dose you require.

Package leaflet: information for the user

Keep out of the reach and sight of children.

Adults and the elderly:
The usual starting dose is 3-7.5mg given slowly into a vein.
Your dose may be repeated until the maximum amount of
medicine (30mg) is given.
Children:
Your child will be given a slow injection into the vein of
either 0.5-0.75mg per kg of body weight or 17-25mg per
square metre of body surface.
If you think you have been given too much Ephedrine
Injection
This medicine is given to you by your doctor so it is unlikely
you will receive too much. Your doctor has information on
how to recognise and treat an overdose. If you are concerned
about your treatment, please talk to your doctor.
If you have any further questions on the use of this product,
ask your doctor or nurse.

4. Possible side effects
Like all medicines Ephedrine Injection can cause side effects,
although not everybody gets them.
Possible side effects include:
• a light headed or dizzy feeling (giddiness)
• headache
• feeling worried
• restlessness
• problems sleeping
• feeling sick or being sick
• thirst
• sweating
• muscular weakness or shaking
• fast or irregular heartbeat
• heightened sense of your heart beating (palpitations)
• pain over the heart
• difficulty in passing urine.

You should not be given this medicine if it has passed the
expiry date shown on the ampoule label and carton after EXP.
This refers to the last day of that month. Your doctor or nurse
will check this.
Do not store above 25°C. Keep in the outer carton in order to
protect from light. This medicine will only be used for your
treatment. Your doctor will dispose of any left over medicine.

6. Further Information
What Ephedrine Injection contains
The active ingredient is Ephedrine Hydrochloride 3%w/v.
Each 1ml ampoule contains 30mg ephedrine hydrochloride.
The other ingredient is water for injections.
What Ephedrine Injection looks like and contents of the
pack
This medicine is a clear, colourless solution for injection
supplied to your doctor or pharmacist in a pack of 10 clear
glass ampoules, each containing 1ml of medicine.
Marketing Authorisation Holder:
Martindale Pharmaceuticals Ltd. Bampton Road, Romford,
RM3 8UG, United Kingdom.
Manufacturer:
Macarthys Laboratories Ltd trading as Martindale
Pharmaceuticals, Bampton Road, Romford, RM3 8UG,
United Kingdom.
Product Licence No.: PL 01883/6131
Date of revision: August 2012

If you are given too much of this medicine you may:
• see or hear things that aren’t there (hallucinations)
• believe in things that aren’t true (delusions)
• notice changes in your personality or the way you
feel/think.
If any of these side effects get serious, or you notice any
other side effects not listed in this leaflet, please tell your
doctor or pharmacist.

D0226500000

TECHNICAL PRESCRIBING INFORMATION
D0226500000

Pharmaco-dynamics:

Ephedrine Hydrochloride 30mg in 1ml Solution for Injection
Ephedrine Hydrochloride
Indications:

Pregnancy:

To reduce hypotension during spinal anaesthesia

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.

Dose

Adults and the elderly
Up to 30 mg in increments of 3 - 7.5 mg.
By slow intravenous administration, after development of
hypotension.
Children
0.5 - 0.75 mg / kg body weight or 17 - 25 mg / M2 body surface.
By slow intravenous administration, after development of
hypotension.

Contra-indications:

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

Warnings:
None stated.

Interactions:

Patients receiving treatment with monoamine oxidase
inhibitors (or within 2 weeks of their withdrawal).

Side effects:
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.

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.

Pharmaco-kinetics:
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.
Incompatibilities:

Overdose:
Symptoms
Giddiness, headache, nausea, vomiting, sweating, thirst,
arryhthmias, tachycardia, precordial pain, palpitations,
difficulty in micturition, muscular weakness, tremors,
anxiety, restlessness and insomnia, 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.
Continued overleaf

None.

Shelf life:
36 months unopened. Do not store above 25°C. Keep in outer
carton. This is a potent drug, which should be stored carefully.
Do not administer if there are visible signs of deterioration.
This product is for single use only. If only part of the solution is
used the remainder should be discarded.

Authorisation holder:

Martindale Pharmaceuticals
Bampton Road, Romford, RM3 8UG England
Authorisation numbers: PL1883/6131R
Last revised: August 2012


Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web4)