[ Controlled Medicine ]
Treatment of migraine attacks and related types of vascular headache.
Cafergot tablets contain 1 mg ergotamine tartrate and 100 mg caffeine.
Circular, flat, bevelled edge tablet of speckled yellowish/whitish colour,
scored and coded "XU on one side.
Acute attacks of migraine (classical migraine) and related types of vascular
DOSAGE AND ADMINISTRATION
Cafergot should be given at the first symptoms of an attack.
The first time Cafergot is taken, an initial dose of 2 Cafergot tablets
orally is recommended. If relief is not obtained within half an hour, a
further tablet should be administered; this may be repeated at half-hourly
intervals, but the maximum daily dose indicated below should not be
For subsequent attacks the initial dose may be increased to 3 tablets,
depending on the total dose required in previous attacks. If pain persists,
of 1 tablet may be taken at half-hourly intervals up to the maximum dose
The following restriction must be observed:
If supplementary antimigraine medication is required, the use of any
ergotamine-containing preparations, intranasal or parenteral
dihydroergotamine or sumatriptan or other 5HT1-receptor agonists must be
avoided (see section "CONTRAINDICATIONS").
Maximum dose per attack or per day
Adults: 6 mg ergotamine tartrate = 6 tablets.
Maximum weekly dose
Adults: 10 mg ergotamine tartrate = 10 tablets
Known hypersensitivity to ergot alkaloids, caffeine, or any other components
of the formulations (see section "EXCIPIENTS").
Pregnancy and breast-feeding (see section "PREGNANCY AND LACTATION")
Impaired peripheral circulation,
obliterative vascular disease, coronary heart disease, inadequately
controlled hypertension, septic conditions, shock.
Severe renal or hepatic impairment.
Concomitant treatment with macrolide antibiotics, HIV protease or reverse
transcriptase inhibitors, azole antifungals (see section "INTERACTIONS").
Concomitant treatment with vasoconstrictor agents (including ergot
alkaloids, sumatriptan and other 5HT1 receptor agonists) (see section
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Cafergot is only indicated for the treatment of acute migraine attacks and
not for prevention.
Continued daily use of Cafergot or it's use in excess of the recommended
doses must be avoided since it may cause vasospasm.
If contrary to recommendations (see section "SPECIAL WARNINGS AND
PRECAUTIONS FOR USE") ergotaminecontaining drugs including Cafergot are used
excessively over years, they may
induce fibrotic changes, in particular of the pleura and the retroperitoneum.
There have also been rare reports of fibrotic changes of the cardiac valves.
Patients who are being treated with Cafergot should be informed of the
maximum doses allowed and of the first symptoms of overdosage: paresthesia
(e.g. numbness, tingling) in the fingers and toes, non-migraine-related
nausea and vomiting, and symptoms of myocardial ischaemia (e.g. precordial
pain). If symptoms such as tingling in the fingers or toes occur, the drug
should be discontinued at once and the physician consulted.
Patients with mild to moderate hepatic impairment, especially cholestatic
patients should be appropriately monitored.
The occurrence of drug-induced headaches has been reported during prolonged
and uninterrupted treatment with Cafergot.
Rare cases of a solitary rectal or anal ulcer have occurred from abuse of
ergotamine-containing suppositories, usually at higher than recommended
doses or with continuous use at the recommended dose for many years.
The concomitant use of cytochrome P450 3A (CYP3A) inhibitors such as
macrolide antibiotics (e.g. troleandomycin, erythromycin, clarithromycin),
HIV protease or reverse transcriptase inhibitors (e.g. ritonavir, indinavir,
nelfinavir, delavirdine or azole antifungals (e.g. ketoconazole,
itraconazole, voriconazole) and Cafergot must be avoided (see section
"CONTRAINDICATIONS"), since this can result in an elevated exposure to
ergotamine and ergot toxicity (vasospasm and ischemia of the extremities and
other tissues). Ergot alkaloids have also been shown to be inhibitors of
CYP3A. No pharmacokinetic interactions involving other cytochrome P450
isoenzymes are known.
A few cases of vasospastic reactions have been reported among patients
treated concomitantly with ergotamine-containing preparations and
Concurrent use of vasoconstrictor agents including preparations containing
ergot alkaloids, sumatriptan and other 5HT1 receptor agonists, and nicotine
(e.g. heavy smoking) must be avoided since this may result in enhanced
vasoconstriction (see "CONTRAINDICATIONS")