For the treatment of hypotensive states, e.g. circulatory failure, during spinal anesthesia or drug induced
hypotension.

For subcutaneous, intramuscular or slow intravenous injection or by intravenous infusion.
Whenever solution and container permit, parenteral drug products should be inspected visually
for particulate matter and discolouration prior to administration.

Adults
Phenylephrine injection may be administered subcutaneously or intramuscularly in a dosage of 2
to 5 mg with further doses of 1 to 10 mg if necessary according to response, or in a dose of 0.1 to
0.5 mg by slow intravenous injection as a 0.1% solution, repeated as necessary after at least 15
minutes.
Alternatively, 10 mg in 500 ml of glucose 5% injection or sodium chloride 0.9% injection may be
infused intravenously, initially at a rate of up to 0.18 mg per minute, reduced according to
response to 0.03 – 0.06 mg per minute.

Children

0.1 mg/kg bodyweight subcutaneously or intramuscularly.

Elderly
There is no need for dosage reduction in the elderly.

Great care should be exercised in administering Phenylephrine Injection to patients with preexisting
cardiovascular disease such as ischaemic heart disease, arrhythmias, occlusive vascular
disease including arteriosclerosis, hypertension or aneurysms. Angina pain may be precipitated in
patients with angina pectoris.
Care is also required when given to patients with diabetes mellitus or closed-angle glaucoma.
Keep all medicines out of the reach of children.

Phenylephrine may interact with cyclopropane and halothane and other halogenated inhalational
anaesthetics, to induce ventricular fibrillation.
An increased risk of arrhythmias may also occur if phenylephrine injection is given to patients
receiving cardiac glycosides, quinidine or tricyclic antidepressants.
Phenylephrine may increase blood pressure and consequently reverse the action of many
antihypertensive agents.
Interactions of phenylephrine with alpha and beta receptor blocking drugs may be complex.
Drugs which have an effect on α1- adrenoreceptors could potentiate (such as ganisetron or
clonidine) or inhibit (such as doxazosin or buspirone) the vasopressive action of phenylephrine.
Caution should be applied when administering atomoxetine concurrently, as there is potential for
synergistic pharmacological effects.
Severe hypertension may occur following the use of phenylephrine and atropine or other
antimuscarinics.
The pressor effects of phenylephrine may be slightly reduced by lithium carbonate.
The effects of phenylephrine may be potentiated by the use of monoamine oxidase inhibitors or
reversible inhibitors of monoamine oxidase.

The safety of phenylephrine during pregnancy and lactation has not been established. Due to the
vasoconstrictive properties of phenylephrine, the product should be used with caution in patients
with a history of pre-eclampsia. Administration of phenylephrine in late pregnancy or labour may
cause foetal hypoxia and bradycardia.
Excretion of phenylephrine in breast milk appears to be minimal.

No adverse effects known

Immune system disorders
Hypersensitivity
Metabolism and nutrition disorders
Metabolic disorders
Psychiatric disorders
Nervousness, insomnia
Nervous system disorders
Headache, cerebral haemorrhage, paraesthesia
Eye disorders
Mydriasis, angle-closure glaucoma
Cardiac disorders
Pulmonary oedema, bradycardia, tachycardia, arrhythmia, angina pectoris, palpitations, cardiac
arrest
Vascular disorders
Hypotension, dizziness, syncope, flushing
Respiratory, thoracic and mediastinal disorders
Dyspnoea
Gastrointestinal disorders
Vomiting, salivary hypersecretion
Renal and urinary disorders
Dysuria, urinary retention
General disorders and administration site conditions
Extravasation, infusion site necrosis, hyperhidrosis
Investigations
Increased blood pressure, abnormal blood glucose
Phenylephrine is without significant stimulating effects on the central nervous system at usual
doses.

To report any side effect(s):
Saudi Arabia:
The National Pharmacovigilance and Drug Safety Centre (NPC)
Fax: +966-11-205-7662
Call NPC at +966-11-2038222, Exts: 2317-2356-2353-2354-2334-2340.
Toll free phone: 8002490000
E-mail: npc.drug@sfda.gov.sa
Website: www.sfda.gov.sa/npc
Other GCC States:
Please contact the relevant competent authority.

Symptoms of overdosage include headache, vomiting, hypertension and reflex bradycardia and
other cardiac arrhythmias. In severe cases confusion, hallucinations and seizures may occur.
Treatment should consist of symptomatic and supportive measures. The hypertensive effects may
be treated with an alpha-adrenoceptor blocking drug, such as phentolamine, 5 to 60 mg IV over
10-30 minutes, repeated as necessary

Pharmacotherapeutic group: Adrenergic and dopaminergic agents.
ATC code: C01C A06
Phenylephrine hydrochloride 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 increased arterial pressure. It also causes reflex bradycardia.

When injected subcutaneously or intramuscularly, phenylephrine takes 10 to 15 minutes to act.
Subcutaneous and intramuscular injections are effective for up to about one and up to two hours
respectively. Intravenous injections are effective for up to about 20 minutes. Phenylephrine is
metabolized in the liver by monoamine oxidase. The metabolites, their route and rate of excretion
have not been identified.

Phenylephrine has been used to induce cardiac myocyte hypertrophy in cultures of rat neonatal
myocytes at doses of 100 μM and 10 μM. To the best of our knowledge there have been no human
studies associating therapeutic phenylephrine use with the development of cardiac myocyte
hypertrophy.

Sodium chloride 3.5 mg
Sodium citrate dihydrated 4 mg
Citric acid monohydrate 1 mg
Sodium meta bisulfite 2 mg
HCl/NaOH for pH adjustment
Water for injection QS 1ml

Phenylephrine Injection has been stated to be incompatible with alkalis, ferric salts, phenytoin
sodium and oxidizing agents.

Keep the vials in the outer carton in order to protect from light.
Store below 30°C.
Do not use if the vial is leaking or solution cloudy.
Discard unused portion.

Carton boxes with 10 vials containing 1 ml Solution for injection, or concentrate solution to be
diluted for injection or infusion.

For single use only. If only part used, discard the remaining solution.
Do not use if bottle is leaking, solution cloudy, or contains particles.
Any unused product or waste material should be disposed of in accordance with local requirements
Phenylephrine PSI Injection 10mg/ml must be diluted before administration as an intravenous bolus or
continuous intravenous infusion to achieve the desired concentration:
Bolus: Dilute with normal saline or 5% dextrose in water.
Continuous infusion: Dilute with normal saline or 5% dextrose in water.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to
administration. Do not use if the solution is colored or cloudy, or if it contains particulate matter. The
diluted solution should not be held for more than 4 hours at room temperature or for more than 24 hours
under refrigerated conditions. Discard any unused portion.

During Phenylephrine PSI Injection 10mg/ml administration:
Correct intravascular volume depletion.
Correct acidosis. Acidosis may reduce the effectiveness of phenylephrine