Phenylephrine Sintetica 10 mg/ml

/ CTS

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 100 to 500 micrograms 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 180 micrograms per minute, reduced according to response to 30-60 micrograms per minute.
Children:
100 micrograms/kg bodyweight subcutaneously or intramuscularly.
Elderly:
There is no need for dosage reduction in the elderly.

For the treatment of hypotensive states, e.g. septic shock, circulatory failure, during spinal anaesthesia or drug‐induced hypotension.

Hypersensitivity to phenylephrine or to any of the excipients.
Patients taking monoamine oxidase inhibitors, or within 14 days of ceasing such treatment.
Severe hypertension and hyperthyroidism.

Great care should be exercised in administering Phenylephrine Injection to patients with pre-existing cardiovascular disease such as ischaemic heart disease, arrhythmias, occlusive vascular disease including arteriosclerosis, hypertension or aneurysms. Anginal 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.

See prescribing information for full details.

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 can 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.
The most common maternal adverse reactions reported in published studies of phenylephrine use during neuraxial anesthesia during Cesarean delivery include nausea and vomiting, bradycardia, reactive hypertension, and transient arrhythmias. Phenylephrine, when administered during labor or delivery, does not appear to alter either neonatal Apgar scores or umbilical artery blood-gas status.
Excretion of phenylephrine in breast milk appears to be minimal.

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 i.v. over 10-30 minutes, repeated as necessary.

Store below 25°C. Do not refrigerate or freeze. This product is only for a single use.