General: Although signs and symptoms of ergotism rarely develop even
after long-term intermittent use of the orally administered drug, care should
be exercised to remain within the limits of recommended dosage.
Ergotism is manifested by intense arterial vasoconstriction, producing signs
and symptoms of peripheral vascular ischemia. Ergotamine induces vasoconstriction
by a direct action on vascular smooth muscle. In chronic intoxication with ergot
derivatives, headache, intermittent claudication, muscle pains, numbness, coldness
and pallor of the digits may occur. If the condition is allowed to progress
untreated, gangrene can result.
While most cases of ergotism associated with ergotamine treatment result from
frank overdosage, some cases have involved apparent hypersensitivity. There
are few reports of ergotism among patients taking doses within the recommended
limits or for brief periods of time. In rare instances, patients, particularly
those who have used the medication indiscriminately over long periods of time,
may display withdrawal symptoms consisting of rebound headache upon discontinuation
of the drug.
Pregnancy Category X: There are no studies on the placental transfer
or teratogenicity of the combined products of CAFERGOT® (ergotamine tartrate and caffeine) (ergotamine tartrate
and caffeine tablets, USP). Caffeine is known to cross the placenta and has
been shown to be teratogenic in animals. Ergotamine crosses the placenta in
small amounts, although it does not appear to be embryotoxic in this quantity.
However, prolonged vasoconstriction of the uterine vessels and/or increased
myometrial tone leading to reduced myometrial and placental blood flow may have
contributed to fetal growth retardation observed in animals (see CONTRAINDICATIONS).
Nonteratogenic Effects: CAFERGOT® (ergotamine tartrate and caffeine) (ergotamine tartrate and
caffeine tablets, USP) is contraindicated in pregnancy due to the oxytocic effects
of ergotamine (see CONTRAINDICATIONS).
Labor and Delivery: CAFERGOT® (ergotamine tartrate and caffeine
tablets, USP) is contraindicated in labor and delivery due to its oxytocic effect
which is maximal in the third trimester (see CONTRAINDICATIONS).
Nursing Mothers: Ergot drugs are known to inhibit prolactin but there
are no reports of decreased lactation with CAFERGOT® (ergotamine tartrate and caffeine) (ergotamine tartrate
and caffeine tablets, USP). Ergotamine is excreted in breast milk and may cause
symptoms of vomiting, diarrhea, weak pulse and unstable blood pressure in nursing
infants. Because of the potential for serious adverse reactions in nursing infants
from CAFERGOT® (ergotamine tartrate and caffeine tablets, USP), a decision
should be made whether to discontinue nursing or discontinue the drug, taking
into account the importance of the drug to the mother. Pediatric Use: Safety
and effectiveness in pediatric patients have not been established.