PHENYLEPHRINE INJECTION BP 10MG/ML

Active substance: PHENYLEPHRINE HYDROCHLORIDE

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726-3981-APIL

FOR THE INFORMATION OF THE MEDICAL PROFESSION.

PHENYLEPHRINE INJECTION BP 10 mg per ml
Phenylephrine Injection BP is a sterile solution of Phenylephrine Hydrochloride Ph Eur, in purified water.
Phenylephrine is a sympathomimetic agent with mainly direct effects on adrenergic receptors. It has predominantly
alpha-adrenergic activity and is without significant stimulating effects on the central nervous system at usual doses. After
injection, it produces peripheral vasoconstriction and an increase in arterial pressure. It also produces reflex bradycardia.
Indications
Phenylephrine Injection is used to treat hypotensive states, for example circulatory failure during spinal anaesthesia, or
drug induced hypotension.
Contraindications, Warnings, etc
Phenylephrine Injection is contraindicated in the presence of severe hypertension and hyperthyroidism. It should not be given
to patients being treated with monoamine oxidase inhibitors, nor within two weeks of stopping such treatment. Extreme caution
is required in patients with pre-existing cardiovascular disease, such as ischaemic heart disease, arrhythmias and occlusive
vascular disease. Anginal pain may be precipitated in patients with angina pectoris. Care is also required in patients with diabetes
mellitus or closed angle glaucoma.

Patient Information Leaflet
WHAT YOU SHOULD KNOW ABOUT PHENYLEPHRINE INJECTION BP
This leaflet provides a summary of the information available on your medicine. If you have any questions or are not sure
about anything, ask your doctor or pharmacist.
The name of your medicine is Phenylephrine Injection BP. Its active ingredient is phenylephrine hydrochloride.
Each 1 ml ampoule contains 10 mg of Phenylephrine Hydrochloride Ph Eur in purified water, with sodium hydroxide and/or
hydrochloric acid as pH adjusters.
Phenylephrine belongs to a group of medicines called anti-hypotensive drugs.
Product licence holder: Waymade Plc (Trading as Sovereign Medical), Sovereign House, Miles Gray Road, Basildon, Essex
SS14 3FR, England
Manufacturer responsible for release: Waymade Plc, Sovereign House, Miles Gray Road, Basildon, Essex SS14 3FR, England
What is your medicine used for?
Phenylephrine Injection is used to relieve low blood pressure which, for example, may occur during an operation or after
an injury.

Interactions
Phenylephrine may interact with cyclopropane, halothane and other halogenated inhalational anaesthetics to induce ventricular
fibrillation. There may be an increased risk of arrhythmias with concomitant use of cardiac glycosides, quinidine and tricyclic
antidepressants. Phenylephrine, by increasing the blood pressure, may reverse the effect of many antihypertensives. Interactions
of phenylephrine with alpha receptor agonists/antagonists and beta receptor blocking drugs may be complex.

Before you are given your medicine:
Are you pregnant or planning to become pregnant, or are you breast feeding?
Do you suffer from diabetes?
Do you suffer from an overactive thyroid?
Do you suffer from glaucoma?
Do you suffer from heart disease, angina, or high blood pressure?

Use in Pregnancy and Lactation
The safety of phenylephrine during pregnancy and lactation has not been established. Administration in late pregnancy or
labour may cause foetal hypoxia and bradycardia. Excretion of phenylephrine in breast milk appears to be minimal.

Are you taking any of the following medicines:
antidepressants (either currently or within the last 14 days)?
tablets for heart problems or high blood pressure?
any other medication prescribed by a doctor?

Dosage and Administration
Adults:
By subcutaneous or intramuscular injection: 2 to 5 mg, with further doses of 1 to 10 mg if necessary, according to response.

If the answer to any of these questions is “yes”, please tell your doctor.

By slow intravenous injection: 100 to 500 micrograms as a 0.1% solution, repeated as necessary after at least 15 minutes.
By intravenous infusion: 10 mg in 500 ml of glucose 5% or sodium chloride 0.9% infused initially at a rate of up to
180 micrograms per minute. This should be reduced to 30 - 60 micrograms per minute according to response.

Phenylephrine may interact with some drugs used as general anaesthetics, but your doctor will be fully prepared to deal
with this should it occur.
How will the medicine be given?
As phenylephrine is given by injection, the doctor will administer it to you.

Elderly: No special dosage reduction necessary.

Adults: The dose depends on the way it is given, e.g. if injected into a muscle or just under the skin, the usual dose is
2 to 5 mg. If injected directly into a vein, this is carried out slowly using a more dilute solution of up to 10 mg.

Children: 100 micrograms per kilogram of body weight subcutaneously or intramuscularly.

Children: The usual dose is 100 micrograms per kilogram of body weight, injected into a muscle or just under the skin.

Adverse Effects
Adverse effects reported with Phenylephrine Injection include headache, vomiting, sweating, hypersalivation, difficulty in micturition,
urinary retention, mydriasis, dyspnoea, transient tingling and coolness of the skin, a temporary sensation of fullness in the head
and disturbances of glucose metabolism. Cerebral haemorrhage and pulmonary oedema have occasionally been reported.
Other effects include reflex bradycardia or tachycardia, other cardiac arrhythmias, anginal pain, cardiac arrest, and hypotension
with dizziness, fainting and flushing.

After receiving your medicine
As well as benefits, all medicines may sometimes have effects you do not want.
Side effects which may occur with phenylephrine include tingling and coolness of the skin, sweating, an increase in saliva,
a feeling of fullness in the head and changes in blood sugar levels. Sometimes a drop in blood pressure may occur with
dizziness, fainting and flushing. The injection itself may occasionally lead to skin reactions in some people.

Extravasation of the injection may occasionally cause local tissue necrosis.

As described earlier in this leaflet, Phenylephrine Injection is used to raise the blood pressure, when necessary, but this in
itself may cause other effects such as headaches and sickness. These are usually short-lived, but may lead to more serious
problems such as fluid on the lungs and/or bleeding in the brain. Fortunately, these effects are rare and can be treated.

Treatment of Overdosage
Symptoms of overdosage include headache, vomiting, hypertension and reflex bradycardia. Treatment should consist of
symptomatic and supportive measures. Hypertensive effects may be treated with an alpha-blocker such as phentolamine,
5 to 60 mg given intravenously over 10 to 30 minutes, repeated as necessary.

Phenylephrine Injection may also cause changes in heart rate and rhythm, anginal pain, heart block (rare), difficulty in
passing urine, and shortness of breath.

Drug Interactions
Phenylephrine may interact with halothane and other halogenated inhalational anaesthetics leading to ventricular fibrillation.
An increased risk of arrhythmias may also occur in patients taking cardiac glycosides, quinidine or tricyclic antidepressants.
Phenylephrine will reverse the action of anti-hypertensive agents.
Additional Information
Phenylephrine acts within 10 to 15 minutes following subcutaneous or intramuscular injection. Subcutaneous injections are
effective for up to around 1 hour and intramuscular injections for up to around 2 hours. Intravenous injections are effective
for up to around 20 minutes. Phenylephrine is metabolised in the liver by monoamine oxidase.
PL 6464/0902
Further information is available on request.
Sovereign Medical, Sovereign House, Miles Gray Road, Basildon, Essex, SS14 3FR, England.
Leaflet prepared April 2009.

Your pupils may become bigger, which could give you symptoms such as blurred vision.
If you any experience any of these effects, or any other unexpected symptoms after your injection, you should tell your doctor.
Storage
Phenylephrine Injection will be stored either in a refrigerator or at room temperature (2°C - 25°C), protected from light, until
it is given to you. The doctor or nurse will check that the expiry date on the label has not passed before you are given the
injection.
This leaflet does not contain the complete information about your medicine. If you have any questions or are not sure about
anything, ask your doctor who has access to additional information.
The manufacturer of this product is not able to discuss the treatment your doctor has prescribed for you.
Leaflet prepared: April 2009

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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.

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