Product Data
Composition:
Each 1 mL ampoule contains 50 mg cyclizine lactate. The active ingredient :cyclizine The inactive ingredient :Lactic acid
Indications And Usage:
Emetrex® is indicated for the prevention and treatment of nausea and vomiting including:- • Motion sickness when the oral route cannot be used. • Nausea and vomiting caused by narcotic analgesics and by general anaesthetics in the post-operative period. • Vomiting associated with radiotherapy especially for breast cancer since cyclizine does not elevate prolactin levels. • Emetrex® injection, by the intravenous route, is also indicated pre-operatively in patients undergoing emergency surgery in order to reduce the hazard of regurgitation and aspiration of gastric contents during induction of general anaesthesia. Emetrex® may be of value in relieving vomiting and attacks of vertigo associated with Meniere's disease and other forms of vestibular disturbance when the oral route cannot be used.
Contraindications:
Emetrex® should not be given to individuals with known hypersensitivity to cyclizine.
Adverse Reactions:
Blood and lymphatic system disorders: Agranulocytosis Cardiac disorders: Tachycardia Eye disorders: Blurred vision, oculogyric crisis Gastrointestinal system disorders: Dryness of the mouth, nose and throat, constipation General disorders and administration site conditions Asthenia: Injection site reactions including vein tracking, erythema, pain, thrombophlebitis and blisters. A sensation of heaviness, chills and pruritus have been reported rarely. Anaphylaxis has been recorded following intravenous administration of cyclizine co-administered with propanidid in the same syringe. Hepatobiliary disorders: Hepatic dysfunction, hypersensitivity hepatitis, cholestatic jaundice and cholestatic hepatitis have occurred in association with cyclizine. Immune system disorders: Hypersensitivity reactions, including anaphylaxis have occurred. Musculoskeletal and connective tissue disorders: Twitching, muscle spasms Nervous system disorders: Effects on the central nervous system have been reported with cyclizine these include somnolence, headache, dystonia, dyskinesia, extrapyramidal motor disturbances, tremor, convulsions, dizziness, decreased consciousness, transient speech disorders, paraesthesia and generalised chorea. There have been rare case reports of patients experiencing depressed levels of consciousness/loss of consciousness. The use of cyclizine has been associated with cases of transient paralysis following administration of the intravenous formulation of the medicine. The onset of paralysis is usually within minutes of administration, affects the limbs, and fully resolves within hours of discontinuation of the medicine. Psychiatric disorders: Disorientation, restlessness or agitation, nervousness, insomnia and auditory and visual hallucinations have been reported, particularly when dosage recommendations have been exceeded. Renal and urinary disorders: Urinary retention Respiratory, thoracic and mediastinal disorders: Bronchospasm, apnoea Skin and subcutaneous tissue disorders: Urticaria, pruritus, drug rash, angioedema, allergic skin reactions, fixed drug eruption Vascular disorders: Hypertension, hypotension
Dosage & Administration:
Route of Administration: intramuscularly or intravenously Adults 50 mg intramuscularly or intravenously up to three times daily. When used intravenously, Emetrex® should be injected slowly into the bloodstream, with only minimal withdrawal of blood into the syringe. For the prevention of postoperative nausea and vomiting, administer the first dose by slow intravenous injection 20 minutes before the anticipated end of surgery Cyclizine given intravenously, in half the recommended dose, increases the lower oesophageal sphincter tone and thereby reduces the hazard of regurgitation and aspiration of gastric contents if given to patients, undergoing emergency surgery, before induction of general anaesthesia Use in the Elderly: There have been no specific studies of Emetrex® in the elderly. Experience has indicated that normal adult dosage is appropriate.
Drug Interactions:
Emetrex® may have additive effects with alcohol and other central nervous system depressants e.g. hypnotics, tranquillisers, anaesthetics. Emetrex® enhances the soporific effect of pethidine. Because of its anticholinergic activity, cyclizine may enhance the side-effects of other anticholinergic drugs.
How Supplied:
Box of 2 ampoules
Precautions:
Not used in children As with other anticholinergic agents, Emetrex® may precipitate incipient glaucoma and it should be used with caution and appropriate monitoring in patients with glaucoma, obstructive disease of the gastrointestinal tract, hepatic disease, epilepsy and in males with possible prostatic hypertrophy. Emetrex® injection, may have a hypotensive effect. Cyclizine should be used with caution in patients with severe heart failure. In such patients, cyclizine may cause a fall in cardiac output associated with increases in heart rate, mean arterial pressure and pulmonary wedge pressure. Cyclizine should be avoided in porphyria.There have been reports of abuse of cyclizine, either oral or intravenous, for its euphoric or hallucinatory effects. The concomitant misuse of Emetrex® with large amounts of alcohol is particularly dangerous, since the antiemetic effect of cyclizine may increase the toxicity of alcohol . There have been isolated case reports of transient paralysis occurring in patients using intravenous cyclizine. Two of the patients mentioned in these reports had an underlying neuromuscular disorder. Thus intravenous cyclizine should be used with caution in all patients in general, and in patients with underlying neuromuscular disorders in particular.effects on ability to drive and use machines: Studies designed to detect drowsiness did not reveal sedation in healthy adults who took a single oral therapeutic dose (50 mg) of cyclizine, sedation of short duration was reported by subjects receiving intravenous cyclizine. Patients should not drive or operate machinery until they have determined their own response. Although there are no data available, patients should be cautioned that Emetrex® may have additive effects with alcohol and other central nervous system depressants, e.g. hypnotics and tranquillisers
Pregnancy & Lactation:
