Land: Storbritannien
Språk: engelska
Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)
Phenylephrine hydrochloride
Advanz Pharma
Phenylephrine hydrochloride
10mg/1ml
Solution for injection
Intramuscular; Subcutaneous; Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: ; GTIN: 5060337260039
FOR THE INFORMATION OF THE MEDICAL PROFESSION. PHENYLEPHRINE 10 MG/ML INJECTION Phenylephrine hydrochloride Phenylephrine Injection is a sterile solution of Phenylephrine Hydrochloride 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 indicated in adults and children 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. 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. 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 atrop Läs hela dokumentet
OBJECT 1 PHENYLEPHRINE INJECTION BP 10 MG/ML Summary of Product Characteristics Updated 19-Sep-2016 | Concordia International - formerly AMCo 1. Name of the medicinal product Phenylephrine 10 mg/ml Injection 2. Qualitative and quantitative composition Each 1 ml ampoule contains 10 mg of the active ingredient phenylephrine hydrochloride. Excipients with known effect: Sodium hydroxide solution (q.s.- quantity per ml) For the full list of excipients, see section 6.1. 3. Pharmaceutical form A clear, colourless sterile solution 4. Clinical particulars 4.1 Therapeutic indications Phenylephrine Injection is indicated in adults and children for the treatment of hypotensive states e.g. circulatory failure, during spinal anaesthesia or drug induced hypotension. 4.2 Posology and method of administration Posology _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. _Paediatric population_ 100 mcg/kg body weight subcutaneously or intramuscularly. _Elderly _ There is no need for dosage reduction in the elderly. Method of administration For subcutaneous, intramuscular, slow intravenous injection or intravenous infusion. 4.3 Contraindications Hypersensitivity to phenylephrine or to any of the excipients listed in section 6.1. Patients taking monoamine oxidase inhibitors, or within 14 days of ceasing such treatment. Severe hypertension and hyperthyroidism. 4.4 Special warnings and precautions for use Great care should be exercised in administering Phenylephrine Injection to patients with pre-existing cardiovascular disease such as ischa Läs hela dokumentet