Hyoscyamine, Atropine, Scopolamine, and Phenobarbital

Pronunciation

(hye oh SYE a meen, A troe peen, skoe POL a meen, & fee noe BAR bi tal)

U.S. Brand Names

Donnatal®; Donnatal Extentabs®

Synonyms

Atropine, Hyoscyamine, Scopolamine, and Phenobarbital; Belladonna Alkaloids With Phenobarbital; Phenobarbital, Hyoscyamine, Atropine, and Scopolamine; Scopolamine, Hyoscyamine, Atropine, and Phenobarbital

Generic Available

Yes: Elixir, tablet

Canadian Brand Names

Donnatal®

Use

Adjunct in treatment of irritable bowel syndrome, acute enterocolitis, duodenal ulcer

Pregnancy Risk Factor

Pregnancy Implications

Reproduction studies with this combination have not been done; refer to individual components.

Lactation

Excretion in breast milk unknown/use caution

Contraindications

Hypersensitivity to hyoscyamine, atropine, scopolamine, phenobarbital, or any component of the formulation; narrow-angle glaucoma; tachycardia; GI and GU obstruction; myasthenia gravis; paralytic ileus; intestinal atony; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis; hiatal hernia associated with reflux esophagitis; acute intermittent porphyria

Warnings/Precautions

Use with caution in patients with hepatic or renal disease, hyperthyroidism, cardiovascular disease, CHF, hypertension, autonomic neuropathy. Use caution with diarrhea; may be an early symptom of incomplete intestinal obstruction. May causes sedation or blurred vision, caution must be used in performing tasks which require alertness (eg, operating machinery or driving). Due to the phenobarbital component, a potential for drug dependency exists, abrupt cessation may precipitate withdrawal, including status epilepticus in epileptic patients. Use caution in the elderly, may be more sensitive to adverse reactions.

Adverse Reactions

Frequency not defined.

Cardiovascular: Palpitation, tachycardia

Central nervous system: Dizziness, drowsiness, headache, insomnia, nervousness

Dermatologic: Urticaria

Gastrointestinal: Bloating, constipation, nausea, taste loss, vomiting, xerostomia

Genitourinary: Impotence, urinary hesitancy, urinary retention

Neuromuscular & skeletal: Musculoskeletal pain, weakness

Ocular: Blurred vision, cycloplegia, mydriasis, ocular tension increased

Miscellaneous: Allergic reaction (may be severe), anaphylaxis, lactation suppressed, diaphoresis decreased

Overdosage/Toxicology

Symptoms of overdose include unsteady gait, slurred speech, confusion, hypotension, respiratory collapse, dilated unreactive pupils, hot or flushed skin, diminished bowel sounds, urinary retention. Anticholinergic toxicity is caused by strong binding of the drug to cholinergic receptors. Anticholinesterase inhibitors reduce acetylcholinesterase, the enzyme that breaks down acetylcholine and thereby allows acetylcholine to accumulate and compete for receptor binding with the offending anticholinergic. For anticholinergic overdose with severe life-threatening symptoms, physostigmine 1-2 mg (0.5 mg or 0.02 mg/kg for children) SubQ or I.V., slowly may be given to reverse these effects.

Drug Interactions

Phenobarbital: Substrate (minor) of CYP2C8/9, 2C19, 2E1; Induces CYP1A2 (strong), 2A6 (strong), 2B6 (strong), 2C8/9 (strong), 3A4 (strong)

Increased toxicity: CNS depressants, coumarin anticoagulants, amantadine, antihistamine, phenothiazines, antidiarrheal suspensions, corticosteroids, digitalis, griseofulvin, tetracyclines, anticonvulsants, MAO inhibitors, tricyclic antidepressants

CYP1A2 substrates: Phenobarbital may decrease the levels/effects of CYP1A2 substrates. Example substrates include aminophylline, estrogens, fluvoxamine, mirtazapine, ropinirole, and theophylline.

CYP2A6 substrates: Phenobarbital may decrease the levels/effects of CYP2A6 substrates. Example substrates include ifosfamide and rifampin.

CYP2B6 substrates: Phenobarbital may decrease the levels/effects of CYP2B6 substrates. Example substrates include bupropion, efavirenz, promethazine, selegiline, and sertraline.

CYP2C8/9 substrates: Phenobarbital may decrease the levels/effects of CYP2C8/9 substrates. Example substrates include amiodarone, fluoxetine, glimepiride, glipizide, losartan, nateglinide, phenytoin, pioglitazone, rosiglitazone, sertraline, sulfonamides, warfarin, and zafirlukast.

CYP3A4 substrates: Phenobarbital may decrease the levels/effects of CYP3A4 substrates. Example substrates include benzodiazepines, calcium channel blockers, clarithromycin, cyclosporine, erythromycin, estrogens, mirtazapine, nateglinide, nefazodone, nevirapine, protease inhibitors, tacrolimus, and venlafaxine

Mechanism of Action

A fixed combination of belladonna alkaloids and phenobarbital which provides anticholinergic/antispasmodic action and mild sedation.

Dosage

Oral:

Children: Donnatal® elixir: To be given every 4-6 hours; initial dose based on weight:

4.5 kg: 0.5 mL every 4 hours or 0.75 mL every 6 hours

10 kg: 1 mL every 4 hours or 1.5 mL every 6 hours

14 kg: 1.5 mL every 4 hours or 2 mL every 6 hours

23 kg: 2.5 mL every 4 hours or 3.8 mL every 6 hours

34 kg: 3.8 mL every 4 hours or 5 mL every 6 hours

45 kg: 5 mL every 4 hours or 7.5 mL every 6 hours

Adults:

Donnatal®: 1-2 tablets or 5-10 mL of elixir 3-4 times/day

Donnatal Extentabs®: 1 tablet every 12 hours; may increase to 1 tablet every 8 hours if needed

Administration

Do not crush extended release tablets.

Dietary Considerations

Should be taken 30-60 minutes before meals unless otherwise directed.

Patient Education

See individual components listed in Related Information. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to become pregnant. Consult prescriber if breast-feeding.

Dental Health: Effects on Dental Treatment

Key adverse event(s) related to dental treatment: Xerostomia, dry throat (normal salivary flow resumes upon discontinuation).

Dental Health: Vasoconstrictor/Local Anesthetic Precautions

No information available to require special precautions

Mental Health: Effects on Mental Status

May rarely cause confusion, drowsiness, headache, loss of memory, fatigue, ataxia

Mental Health: Effects on Psychiatric Treatment

Anticholinergic effects are common and may be increased with concurrent psychotropic use

Dosage Forms

Elixir (Donnatal®): Hyoscyamine sulfate 0.1037 mg, atropine sulfate 0.0194 mg, scopolamine hydrobromide 0.0065 mg, and phenobarbital 16.2 mg per 5 mL (120 mL, 480 mL) [contains alcohol 23%; citrus flavor]

Tablet (Donnatal®): Hyoscyamine sulfate 0.1037 mg, atropine sulfate 0.0194 mg, scopolamine hydrobromide 0.0065 mg, and phenobarbital 16.2 mg

Tablet, extended release (Donnatal Extentabs®): Hyoscyamine sulfate 0.3111 mg, atropine sulfate 0.0582 mg, scopolamine hydrobromide 0.0195 mg, and phenobarbital 48.6 mg

International Brand Names

Donnatal® (CA)

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