ergotamine + caffeine


A. Menarini


Zuellig Pharma
Concise Prescribing Info
Ergotamine tartrate 1 mg, caffeine 100 mg
Acute migraine attack (classical migraine) & related types of vascular headache.
Dosage/Direction for Use
Adult Initially 2 tab at 1st symptomatic attack, may be repeated up to max daily dose at ½-hrly intervals if pain persists w/in ½ hr. Subsequent attacks: Initial dose may be increased to 3 tab. Additional 1 tab may be given up to max dose at ½-hrly intervals if pain persists. Max: 6 tab daily & 10 tab wkly.
May be taken with or without food.
Hypersensitivity to ergot alkaloids & caffeine. Impaired peripheral circulation, obliterative vascular disease, CHD, inadequately controlled HTN, sepsis, shock, temporal arteritis, hemiplegic or basilar migraine. Concomitant use w/ macrolides, HIV protease or reverse transcriptase inhibitors, azole antifungals, vasoconstrictor agents eg, ergot alkaloids, sumatriptan & other 5HT1-receptor agonists. Severe renal or hepatic impairment. Pregnancy & lactation.
Special Precautions
Not for preventive measures. Discontinue use if symptoms of paresthesia, pain or vasoconstriction, non-migraine related nausea & vomiting & myocardial ischaemia occurs. Ergotism including severe peripheral blood vasoconstriction symptoms. Avoid use in excess of the recommended doses. Long-term or excessive use. Concomitant use w/ dopaminergic ergot alkaloids, α & indirect sympathomimetics, crizotinib, idelalisib or enoxacin. May affect ability to drive & use machines. Mild to moderate hepatic failure especially cholestatic patients. Not to be used during pregnancy. Not recommended in patients <12 yr or >65 yr.
Adverse Reactions
Dizziness; non-migraine related nausea & vomiting, abdominal pain.
Drug Interactions
Elevated exposure & ergot toxicity w/ CYP3A4 inhibitors eg, macrolides, HIV protease or reverse transcriptase inhibitors, azole antifungals. Vasospastic reactions w/ propranolol. Enhanced vasoconstriction w/ ergot alkaloids-containing prep, sumatriptan, other 5HT1-receptor agonists, nicotine. Increased plasma exposure to caffeine w/ fluoroquinolones, mexiletine, fluvoxamine, OCs. Increased exposure to ergotamine w/ moderate to weak CYP3A4 inhibitors. Serotonin syndrome w/ serotonin reuptake inhibitors (eg, amitriptyline), SSRIs (eg, sertraline). Reduced pharmacological activity w/ CYP3A4 inducers. Risk of HTN, coronary artery vasoconstriction w/ triptans, phenylpropanolamine, dopaminergic ergot alkaloids, α- & indirect sympathomimetics. Ergotism w/ macrolides, protease & reverse transcriptase inhibitors, voriconazole, quinupristin-dalfopristin, stiripentol, diltiazem, triclabendazole, β-blockers. Increased plasma caffeine conc w/ enoxacin, ciprofloxacin, norfloxacin, mexiletine.
MIMS Class
Antimigraine Preparations
ATC Classification
N02CA52 - ergotamine, combinations excl. psycholeptics ; Belongs to the class of ergot alkaloids preparations. Used to relieve migraine.
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