Composition: Acetylsalicylic acid (as DL-lysine acetylsalicylate) 900mg and anhydrous metoclopramide (as hydrochloride) 10mg.
Presentation: Sachets containing powder for oral solution.
Storage and stability: Store at or below 25C.
Action: Analgesic and antiemetic.
Indications: Treatment of migraine-associated symptoms, such as headache, nausea and vomiting.
Contraindications: Patients with active, chronic or recurrent gastric or duodenal ulcers; history of hypersensitivity to salicylates or to any component of the product; congenital or acquired bleeding disorders; obstruction, haemorrhage or perforation of the gastrointestinal tract; known or suspected phaeochromocytoma.
Dosage and administration: Adults (20 years and over) and elderly, one sachet should be taken at the first warning of a migraine attack. A second sachet may be taken two hours later if symptoms have not resolved. Do not exceed three sachets in a 24 hour period. Powder must be completely dissolved in water before taking.
Young adults (under 20 years) and children, not recommended.
Pregnancy and lactation, Migramax is contraindicated in the third trimester of pregnancy. During the first and second trimester it should only be used if benefits outweigh the risks. Not recommended during lactation as acetylsalicylic acid and metoclopramide are excreted in breast milk.
Overdosage: Toxic reactions are mainly ascribable to aspirin. Moderate overdose symptoms include tinnitus, feeling of reduced hearing, headaches, dizziness and nausea. Severe overdose symptoms include fever, hyperventilation, ketosis, respiratory alkalosis, metabolic acidosis, coma, cardiovascular collapse, respiratory insufficiency, and marked hypoglycaemia. Overdosage should be treated with gastric lavage and control of acid-base balance. Forced alkaline diuresis may be used; haemodialysis or peritoneal dialysis may also be required.
Precautions: If vomiting persists the patient should be reassessed to exclude possibility of underlying disorder. Migramax should be avoided in patients at risk of developing sensitivity reactions, which includes individuals with asthma or rhinitis, a history of atopy or nasal polyps, and patients sensitive to other salicylates or NSAIDs. Use with caution in patients with significant renal or hepatic impairment, gout, menorrhagia, epilepsy or history of gastroduodenal ulcer or gastrointestinal haemorrhage. Care should be taken in patients using intra-uterine contraceptive devices and in patients who have a high alcohol intake. Metoclopromide may induce an acute hypertensive response in patients with phaeochromocytoma.
Drug interactions, side effects, etc: As for other salicylates and metoclopramide. See SPC.
Net price: Six sachets £7, 20 sachets £23.33.
Supplier: Elan Pharma Ltd, Elan House, Avenue One, Letchworth, Herts SG6 2HU. Tel 01462 707237, fax 01462 707282.
Legal class: POM.