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Ergotamine, Belladonna Alkaloids, and Phenobarbital (Systemic)


VA CLASSIFICATION
Primary: CN105
Secondary: AU900

Commonly used brand name(s): Bellergal; Bellergal Spacetabs; Bellergal-S.

Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).



Category:


Vascular headache prophylactic—

menopausal symptoms suppressant—

Indications

Accepted

Headache, vascular (prophylaxis)—Ergotamine, belladonna alkaloids, and phenobarbital combination is used in the prevention of vascular (migraine or cluster) headaches {01} {02} {03}.

Menopausal symptoms (treatment)—Ergotamine, belladonna alkaloids, and phenobarbital combination is indicated to ameliorate symptoms such as hot flushes, sweating, restlessness, and insomnia in menopausal women {01} {02}. It is usually used for women who are unable to take estrogens {04}. However, unlike estrogen replacement therapy, the ergotamine, belladonna, and phenobarbital combination does not protect against postmenopausal osteoporosis {04}.

—The ergotamine, belladonna alkaloids, and phenobarbital combination has also been used for its autonomic effects in the treatment of various cardiovascular, gastrointestinal, and genitourinary disorders {01} {02}. However, it generally has been replaced by more specific agents for these uses {05}.


Pharmacology/Pharmacokinetics

Ergotamine—See Vascular Headache Suppressants, Ergot derivative–containing (Systemic).

Belladonna alkaloids—See Anticholinergics/Antispasmodics (Systemic).

Phenobarbital—See Barbiturates (Systemic) .


Precautions to Consider

Ergotamine—See Vascular Headache Suppressants, Ergot derivative–containing (Systemic).

Belladonna alkaloids—SeeAnticholinergics/Antispasmodics (Systemic).

Phenobarbital—See Barbiturates (Systemic) .


Side/Adverse Effects
Ergotamine—See Vascular Headache Suppressants, Ergot derivative–containing (Systemic).
Belladonna alkaloids—See Anticholinergics/Antispasmodics (Systemic).
Phenobarbital—See Barbiturates (Systemic) .



Overdose
For specific information on the agents used in the management of ergotamine, belladonna alkaloids, and phenobarbital overdose, see:


Benzodiazepines (Systemic) monograph;


Charcoal, Activated (Oral-Local) monograph;


Ipecac (Oral-Local) monograph;


Neostigmine in Antimyasthenics (Systemic) monograph;


Physostigmine (Systemic) monograph;


Nitroprusside (Systemic) monograph; and/or


Nitroglycerin in Nitrates (Systemic) monograph.
For more information on the management of overdose or unintentional ingestion, contact a Poison Control Center (see Poison Control Listing ).

Treatment of overdose


Additional treatment for overdose of ergotamine may involve {06}:
In general—Discontinuation of therapy, followed (in acute intoxications) by treatment of convulsions (if they occur); monitoring vital signs; monitoring cardiac rhythm (if vital signs are abnormal or the patient has a history of cardiovascular disease); supportive measures required to maintain pulmonary ventilation and correct hypotension; and measures to reduce additional absorption of orally ingested ergotamine, if an acute overdose had been ingested within the past 4 hours; and (in both acute and chronic intoxications) measures to ascertain the presence and/or extent of ischemia and to maintain adequate circulation. If no indication of vasospasm or ischemia is present 6 hours or longer following ingestion of an acute overdose, the patient should be informed about typical signs and symptoms, and instructed to seek medical attention immediately if they occur on a delayed basis.

To decrease absorption of ergotamine—May include inducing emesis with ipecac. Alternatively, the stomach may be emptied via gastric lavage, provided that pharyngeal and laryngeal reflexes are present and the patient is conscious. If the patient is unconscious, gastric lavage should be performed only after intubation with a cuffed endotracheal tube has been performed. Activated charcoal in water or a saline cathartic, may then be introduced and left in the stomach.

To enhance elimination—There is no evidence that forced diuresis accelerates elimination of ergotamine, although ergotamine is dialyzable.

Specific treatment—

For convulsions: Use of a benzodiazepine such as intravenous diazepam or lorazepam is recommended. The fact that intravenous benzodiazepines may cause circulatory depression when administered intravenously must be kept in mind.

For hypotension (in acute intoxication, may occur following initial hypertension): Mild to moderate hypotension may respond to positioning the patient in the Trendelenburg position and/or administering intravenous fluids. Volume expanders may be administered if necessary. Vasopressors may be considered if hypotension is very severe, keeping in mind the hazards of administering such substances in the presence of ergot derivative–induced peripheral vasoconstriction.

For peripheral vasospasm or ischemia: Warmth should be applied to ischemic extremities, taking care to avoid excessive heat. If necessary, a vasodilator may be administered, keeping in mind the risk of administering vasodilators in the presence of hypotension. Severe ischemia may require intravenous or intra-arterial nitroprusside; severe coronary ischemia or vasospasm may require intravenous nitroglycerin. Less severe cases may respond to oral vasodilators. Prazosin and captopril have been reported effective in a few patients.

Careful nursing measures designed to prevent tissue damage should be instituted. Anticoagulant therapy may be warranted if ischemia is present, especially if the patient is unconscious; some emergency care physicians recommend low-dose heparin for ergot-induced vasospasm, even when arterial thrombosis has not been documented. Severe ischemia or gangrene unresponsive to treatment may require vascular surgery, catheter dilation, or even amputation.

Monitoring—May include monitoring vital signs; monitoring cardiac rhythm (if vital signs are abnormal or the patient has a history of cardiovascular disease).

Supportive care—May include maintaining pulmonary ventilation. Mucus secretions may be removed via pharyngeal and tracheal suction. Oxygen may be administered if necessary, keeping in mind that further respiratory depression and hypercapnia may occur in the presence of hypoventilation hypoxia unless respiration is assisted. Very severe cases may require endotracheal intubation and tracheostomy, with or without assisted respiration.



Additional treatment for overdose of belladonna alkaloids may involve {06}:
Specific treatment—Use of physostigmine or neostigmine is recommended to reverse severe anticholinergic symptoms.



Additional treatment of overdose of phenobarbital may involve {06}:
To enhance elimination—May include inducing forced diuresis if renal function is normal, which may help to eliminate the barbiturate. Alkalinization of the urine increases renal excretion of some barbiturates.

Instituting hemodialysis or hemoperfusion in severe barbiturate poisoning or if the patient is anuric or in shock. However, hemodialysis or hemoperfusion is not recommended as a routine procedure.

Specific treatment—May include administering chest physiotherapy. Use of antibiotics if pneumonia is suspected. Appropriate cultures should be taken to determine therapy. Also, appropriate care should be taken to prevent hypostatic pneumonia, decubiti, aspiration, and other complications that may occur with altered states of consciousness.



Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Ergotamine, Belladonna Alkaloids, and Phenobarbital (Systemic).

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Before using this medication
»   Conditions affecting use, especially:
Allergies to ergotamine, belladonna alkaloids, or barbiturates

Pregnancy—Use is not recommended because of ergotamine's oxytocic activity; also, belladonna alkaloids and barbiturates cross placenta; phenobarbital may cause fetal abnormalities and neonatal hemorrhage





Breast-feeding—Ergot alkaloids inhibit lactation; also, they are distributed into breast milk and may cause ergotism in the infant; belladonna alkaloids may also inhibit lactation; phenobarbital is distributed into breast milk and may cause CNS depression in the infant





Use in children—Increased susceptibility to toxic effects of belladonna alkaloids; increased response to belladonna alkaloids in children with spastic paralysis or brain damage; also, risk of paradoxical phenobarbital-induced excitement in hypersensitive children






Use in the elderly—Increased risk of hypothermia and other adverse effects associated with peripheral vasoconstriction; also, increased susceptibility to mental and other toxic effects of anticholinergics and barbiturates; danger of precipitating undiagnosed glaucoma; possible memory impairment
Other medications, especially other anticholinergics, antacids, anticoagulants, antidiarrheals, carbamazepine, CNS depressants, corticosteroids or corticotropin, estrogen- and progestin-containing oral contraceptives, other ergot alkaloids, ketoconazole, monoamine oxidase (MAO) inhibitors, potassium chloride, and other vasoconstrictors (including those present in local anesthetic solutions)
Other medical problems, especially angina pectoris, coronary artery disease, gastrointestinal obstructive disease, glaucoma, hepatic function impairment, hypertension, severe infection, peripheral vascular disease, pruritus, renal function impairment, urinary retention, and recent or contemplated angioplasty or vascular surgery

Proper use of this medication
» Importance of not using more medication than the amount prescribed; risk of ergotism with overdosage; habit-forming potential

Proper administration of extended-release tablets: Swallowing whole without crushing, breaking, or chewing

» Proper dosing
Missed dose: Not taking missed dose at all; not doubling doses

» Proper storage

Precautions while using this medication
» Checking with physician before discontinuing medication after prolonged use; gradual dosage reduction may be necessary to avoid the possibility of withdrawal symptoms

Avoiding antacids and antidiarrheal medication within 1 hour of taking this medication

» Avoiding use of alcohol or other central nervous system (CNS) depressants; alcohol also aggravates headache

» Caution when driving or doing jobs requiring alertness because of possible dizziness, lightheadedness, or drowsiness

Avoiding smoking, since nicotine constricts blood vessels

Avoiding exposure to excessive cold, which may aggravate peripheral vasoconstriction

» Caution during exercise and hot weather; overheating may result in heat stroke

Possible increased sensitivity of eyes to light

Notifying physician if infection develops, since infection may cause increased sensitivity to medication

Possible dryness of mouth, nose, and throat; using sugarless candy or gum, ice or saliva substitute for relief; checking with physician or dentist if dry mouth continues for more than 2 weeks


Side/adverse effects
Signs and symptoms of potential side effects, especially agranulocytosis, allergic reactions, edema, fast or slow heartbeat, gangrene, hepatitis, increased intraocular pressure, cerebral or peripheral ischemia, thrombocytopenia, and coronary or ocular vasospasm


General Dosing Information
Individual sensitivity to the effects of ergotamine varies, and signs of toxicity may occur in some patients even with usual doses. Ergotamine therapy should be withdrawn at the first sign of vasospasm.


Oral Dosage Forms

ERGOTAMINE TARTRATE, BELLADONNA ALKALOIDS, AND PHENOBARBITAL SODIUM TABLETS

Usual adult dose
Vascular headache prophylactic and
Menopausal symptoms suppressant
Oral, 1 tablet in the morning and at noon and 2 tablets at bedtime. In more resistant cases, therapy may begin with 6 tablets per day, the dosage being gradually reduced at weekly intervals to the lowest effective dose. {02}


Note: Geriatric and debilitated patients may react to usual doses of barbiturates with excitement, confusion, or mental depression. Lower doses may be required in these patients.


Usual adult prescribing limits
Not to exceed 33 tablets per week {02}.

Usual pediatric dose
Safety and efficacy have not been established {01}.

Strength(s) usually available
U.S.—
Not commercially available.

Canada—


300 mcg (0.3 mg) of ergotamine tartrate, 100 mcg (0.1 mg) of belladonna alkaloids, and 20 mg of phenobarbital (Rx) [Bellergal (lactose) (tartrazine)]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a well-closed container, unless otherwise specified by manufacturer. Protect from light.

Auxiliary labeling:
   • May cause drowsiness.
   • Avoid alcoholic beverages.


ERGOTAMINE TARTRATE, BELLADONNA ALKALOIDS, AND PHENOBARBITAL SODIUM EXTENDED-RELEASE TABLETS

Usual adult dose
Vascular headache prophylactic and
Menopausal symptoms suppressant
Oral, 1 tablet in the morning and 1 tablet in the evening {01} {02}.


Note: Geriatric and debilitated patients may react to usual doses of barbiturates with excitement, confusion, or mental depression. Lower doses may be required in these patients.


Usual pediatric dose
Safety and efficacy have not been established {01}.

Strength(s) usually available
U.S.—


600 mcg (0.6 mg) of ergotamine tartrate, 200 mcg (0.2 mg) of belladonna alkaloids, and 40 mg of phenobarbital (Rx) [Bellergal-S (scored) (lactose)]

Canada—


600 mcg (0.6 mg) of ergotamine tartrate, 200 mcg (0.2 mg) of belladonna alkaloids, and 40 mg of phenobarbital (Rx) [Bellergal Spacetabs (scored) (lactose) ( tartrazine)]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a well-closed container, unless otherwise specified by manufacturer. Protect from light.

Auxiliary labeling:
   • May cause drowsiness.
   • Avoid alcoholic beverages.
   • Swallow whole.



Revised: 08/30/1994



References
  1. Bellergal-S (Sandoz). In: PDR Physicians' desk reference. 48th ed. 1994. Montvale, NJ: Medical Economics Data Production Company, 1994: 2041-2.
  1. Bellergal and Bellergal Spacetabs (Sandoz). In: Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 29th ed. Ottawa: Canadian Pharmaceutical Association, 1994: 149.
  1. Reviewers' responses to ballot 6/94.
  1. Obstetrics and Gynecology Advisory Panel Meeting, 6/94.
  1. Reviewers' responses to ballot 6/94.
  1. Reviewers' responses to Vascular Headache Supressants, Ergot derivative–Containing (Systemic) monograph, 1992.
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