PHENYLALPHA SOLUTION FOR INJECTION 50MCG/ML [SIN15896P]

Product Info

PHENYLALPHA SOLUTION FOR INJECTION 50MCG/ML

[SIN15896P]

4.1 Therapeutic indications
Treatment of hypotension during general anaesthesia and locoregional anaesthesia, whether spinal or epidural, and whether for surgical or obstetric procedures.
Preventive treatment of hypotension during spinal anaesthesia for surgical or obstetric procedures.

4.2 Posology and method of administration
Posology
Intravenous bolus injection
Normal dose is 50 to 100 micrograms, which can be repeated until the desired effect is attained. The doses may be increased in the case of severe hypotension, but must not exceed a bolus of 100 micrograms.

Continuous infusion
Initial dose is 25 to 50 micrograms/min. Doses can be increased up to 100 micrograms/min or reduced in order to maintain systolic blood pressure close to its reference value.
Doses between 25 and 100 micrograms/min have been considered effective in maintaining maternal blood pressure.

Renal impairment
Lower doses of PHENYLALPHA® may be needed in patients with impaired renal function.

Hepatic Impairment
Higher doses of PHENYLALPHA® may be needed in patients with cirrhosis of the liver.

Older people:
Treatment of the elderly should be carried out with care.

Paediatric population
The safety and efficacy of phenylephrine in children have not been established. No data are available.

Method of administration
Parenteral administration. Intravenous bolus injection or intravenous infusion.
PHENYLALPHA® 50 micrograms/ml, solution for injection should only be administered by healthcare professionals with appropriate training and relevant experience.

4.3 Contraindications
PHENYLALPHA® should not be used:

• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information;

• in combination with non-selective monoamine oxidase inhibitors (MAOs) (or within 2 weeks of their withdrawal) due to risk of paroxysmal hypertension and possibly fatal hyperthermia (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information);

• in patients with severe hypertension or peripheral vascular disease due to the risk of ischemic gangrene or vascular thrombosis;

• in patients with severe hyperthyroidism.