Yes

Ergot Derivative

Management and treatment of menopausal disorders, GI disorders and recurrent throbbing headache

X

Hypersensitivity to belladonna alkaloids, phenobarbital, ergotamine, or any component; dopamine therapy; hypertension; glaucoma; pregnancy; coronary heart disease and peripheral vascular disease; impaired hepatic or renal function; sepsis; history of manifest or latent porphyria

Total weekly dosage of ergotamine should not exceed 10 mg. May be habit-forming. Use with caution in patients with bronchial asthma or obstructive uropathy. Caution should be used with prolonged use.

>10%:

Cardiovascular: Peripheral vascular effects (numbness and tingling of fingers and toes)

Central nervous system: Drowsiness, dizziness,

Dermatologic: Dry skin

Gastrointestinal: Constipation, dry mouth and throat, diarrhea, nausea, vomiting

Respiratory: Dry nose

Miscellaneous: Decreased diaphoresis

1% to 10%:

Cardiovascular: Precordial distress and pain, transient tachycardia or bradycardia

Dermatologic: Photosensitivity

Endocrine & metabolic: Decreased flow of breast milk

Gastrointestinal: Difficulty in swallowing

Neuromuscular & skeletal: Muscle pains in the extremities, weakness in the legs

<1% (Limited to important or life-threatening symptoms): Orthostatic hypotension, ventricular fibrillation, tachycardia, palpitations, confusion, headache, loss of memory, drowsiness, skin rash, increased intraocular pain, blurred vision

CNS depressants

Oral: 1 tablet each morning and evening

No information available to require special precautions

>10% of patients experience dry mouth

Take as directed; do not take more than recommended dose. Maintain adequate nutritional and fluid intake (2-3 L/day of fluids unless instructed to restrict fluid intake) to prevent constipation. May cause drowsiness or dizziness (use caution when driving or engaging in tasks that require alertness until response to drug is known); dry throat or mouth (frequent mouth care or sucking on lozenges may help); dry nose (use humidifier); photosensitivity (use sunblock, wear protective clothing and eyewear, and avoid direct sunlight); nausea or vomiting (small frequent meals, frequent mouth care, sucking lozenges, or chewing gum may help); dry skin (mild skin lotion may help); or orthostatic hypotension (use caution when rising from sitting or lying position or climbing stairs). Report any signs of numbness in extremities (fingers and toes), unusual leg pain or cyanosis of extremities; difficulty swallowing; persistent muscle pain or weakness; pain in eye or vision changes; or chest pain, rapid heartbeat, or palpitations. Pregnancy/breast-feeding precautions: Inform prescriber if you are pregnant and do not get pregnant during or for 1 month following therapy. Consult prescriber for instruction on appropriate contraceptive measures. This drug may cause severe fetal defects. Do not breast-feed.

May cause drowsiness

Tablet, sustained release: l-alkaloids of belladonna 0.2 mg, phenobarbital 40 mg, and ergotamine tartrate 0.6 mg