Regulatory Information
AGUETTANT ASIA PACIFIC PTE. LTD.
AGUETTANT ASIA PACIFIC PTE. LTD.
Therapeutic
Prescription Only
Formulation Information
INJECTION, SOLUTION
**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.
INTRAVENOUS
Medical Information
**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.
**4.3 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.
C01CA06
phenylephrine
Manufacturer Information
AGUETTANT ASIA PACIFIC PTE. LTD.
Laboratoire Aguettant
Active Ingredients
Documents
Package Inserts
PHENYLEPHRINE PI_Approved.pdf
Approved: March 3, 2022