Belladonna / Phenobarbital / Ergotamine Tartrate

Pronunciation: Bell-ah-DON-ah/Fee-no-BAR-bih-tahl/ehr-GOT-ah-mean TAR-trate
Class: GI anticholinergic

Trade Names:
Bellamine
- Tablets 0.2 mg levorotatory alkaloids of belladonna/40 mg phenobarbital/0.6 mg ergotamine

Pharmacology

Inhibition of the sympathetic and parasympathetic nervous system by ergotamine and belladonna, respectively, reinforced by the synergistic activity of phenobarbital in dampening the cortical centers.

Indications and Usage

Management of disorders characterized by nervous tension and exaggerated autonomic response; menopausal disorders with hot flushes, sweats, restlessness, and insomnia; CV disorders with palpitation, tachycardia, chest oppression, and vasomotor disturbances; GI disorders with hypermotility, hypersecretion, “nervous stomach,” diarrhea, constipation; interval treatment of recurrent, throbbing headache.

Contraindications

Peripheral vascular disease; coronary heart disease; hypertension; impaired hepatic or renal function; sepsis; pregnancy; breast-feeding mothers; glaucoma; coadministration of ergotamine and dopamine; history of manifest or latent porphyria; patients with history of restlessness and/or excitement with phenobarbital use; hypersensitivity to any component of the product.

Dosage and Administration

Adults

PO 1 tablet in morning and evening.

Do not administer within 24 h of treatment with another 5-HT 1 agonist or other ergot-containing or ergot-type drug (eg, methysergide).

Storage/Stability

Store at controlled room temperature (59° to 86°F).

Drug Interactions

Beta-adrenergic blocking agents

Excessive vasoconstriction may occur.

CNS depressants (eg, alcohol, narcotic analgesics, phenothiazines, tricyclic antidepressants)

Depressant action may be potentiated.

Doxycycline, estrogen, griseofulvin, quinidine

Pharmacologic effects of these agents may be decreased.

Hydantoins (eg, phenytoin)

Effects of hydantoins may be increased or decreased.

Oral anticoagulants (eg, warfarin)

Anticoagulant activity as measured by prothrombin time may be decreased.

Valproic acid

Pharmacologic effects of phenobarbital may be increased.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Palpitations; tachycardia.

CNS

Drowsiness.

EENT

Blurred vision.

GI

Dry mouth; decreased GI motility.

Genitourinary

Urinary retention.

Miscellaneous

Tingling and other paresthesias of the extremities; decreased sweating; flushing.

Precautions

Monitor

Discontinue therapy and notify health care provider immediately if any of the following symptoms occur: numbness, tingling, coldness, or paleness in the fingers or toes; muscle pain in arms or legs; weakness in the legs; chest pain, tightness, or pressure; changes in heart rate; sudden worsening of headache; swelling; or itching.


Pregnancy

Category X .

Lactation

Ergot alkaloids excreted in breast milk.

Children

Safety and efficacy not established.

Special Risk Patients

Use with caution in patients with bronchial asthma or obstructive uropathy.

Drug dependence

Because of presence of phenobarbital, has abuse potential and may cause true addiction.

Overdosage

Symptoms

Symptoms may be attributable to any 1 or more of the 3 active ingredients; which toxic symptoms might predominate in an individual would be impossible to predict.

Patient Information

  • Advise patient to take 1 tablet twice daily (morning and evening) without regard to meals but to take with food if GI upset occurs.
  • Caution patient not to take more than 16 tablets in 1 wk because of the risk of toxic effects developing.
  • Instruct patient to avoid alcoholic beverages and other depressants while taking this medication.
  • Advise patient that drug may impair judgment, thinking, or motor skills or cause drowsiness and to use caution while driving or performing other tasks requiring mental alertness until tolerance is determined.
  • Advise patient to stop taking the drug and notify health care provider if any of the following symptoms occur: numbness, tingling, coldness, or paleness in the fingers or toes; muscle pain in arms or legs; weakness in the legs; chest pain, tightness, or pressure; changes in heart rate; sudden worsening of headache; swelling; or itching.

Copyright © 2009 Wolters Kluwer Health.

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