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Trade Names:
Donnatal
- Tablets 0.0194 mg atropine sulfate/0.0065 mg scopolamine hydrobromide/0.1037 mg hyoscyamine sulfate/16.2 mg phenobarbital
- Elixir 0.0194 mg atropine sulfate/0.0065 mg scopolamine hydrobromide/0.1037 mg hyoscyamine sulfate/16.2 mg phenobarbital

Trade Names:
Donnatal Extentabs
- Tablets, extended-release 0.0582 mg atropine sulfate/0.0195 mg scopolamine hydrobromide/0.3111 mg hyoscyamine sulfate/48.6 mg phenobarbital

Mechanism of Action

Pharmacology

Promotes peripheral anticholinergic/antispasmodic action (decreases GI motility); provides mild sedation.

Indications and Usage

Possibly effective for treatment of irritable bowel syndrome and acute enterocolitis. Also may be useful as adjunctive therapy for duodenal ulcer.

Contraindications

Glaucoma; obstructive uropathy; obstructive disease of the GI tract; paralytic ileus; intestinal atony in elderly or debilitated patient; severe ulcerative colitis; toxic megacolon complicating ulcerative colitis; hepatic or renal disease; tachycardia; myocardial ischemia; unstable CV status in acute hemorrhage; myasthenia gravis; acute intermittent porphyrinuria.

Dosage and Administration

PO 1 to 2 tablets 3 to 4 times daily; 1 extended-release tablet every 12 h; 5 to 10 mL elixir 3 to 4 times daily according to condition and severity of symptoms.

PO 0.5 to 5 mL elixir every 4 to 6 h, according to body weight.

Storage/Stability

Store in a cool, dry place.

Drug Interactions

Anticoagulant effects may be decreased.

Additive anticholinergic effects.

Worsened schizophrenic symptoms; decreased haloperidol concentrations.

Decreased antipsychotic effects and increased anticholinergic effects may occur.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Bradycardia; flushing; palpitations; tachycardia.

CNS

CNS stimulation (restlessness, tremor); confusion; dizziness; drowsiness; fever (especially in children); headache; insomnia; mental confusion or excitement (especially in the elderly, even with small doses); nervousness; psychosis; weakness.

Dermatologic

Urticaria and other dermal manifestations of allergic reaction.

EENT

Altered taste perception; blurred vision; cycloplegia; dilated pupils; increased IOP; mydriasis; nasal congestion; photophobia.

GI

bloated feeling; constipation; dysphagia; heartburn; nausea; paralytic ileus; vomiting; xerostomia.

Genitourinary

Impotence; urinary hesitancy and retention.

Miscellaneous

Decreased sweating; severe allergic reactions, including anaphylaxis; suppression of lactation.

Precautions

Pregnancy

Category C .

Lactation

If possible, do not use.

Elderly

May react with agitation, drowsiness, and other untoward manifestations even with small doses.

Special Risk Patients

Used with caution in patients with neuropathy, hepatic or renal disease, hyperthyroidism, coronary artery disease, CHF, arrhythmias, hypertension, or tachycardia. May complicate gastric ulcer treatment.

Addiction potential

May be habit forming; when possible, not given to addiction-prone individual.

Diarrhea

May be symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy and, therefore, may serve as contraindication.

Heat prostration

Can occur in presence of high ambient temperature because of interference with normal sweating.

Potentially hazardous tasks

May produce drowsiness, dizziness, or blurred vision.

Overdosage

Symptoms

Dry mouth, thirst, vomiting, nausea, abdominal distention, CNS stimulation, delirium, drowsiness, restlessness, stupor, fever, seizures, hallucinations, convulsions, coma, “flat” EEG, circulatory failure, tachycardia, weak pulse, hypertension, hypotension, respiratory depression, palpitations, arrhythmias, urinary urgency, blurred vision, dilated pupils, photophobia, rash, dry and hot skin.

Patient Information

• Caution patient to have adequate oral intake.
• Advise patient to include fiber in diet to prevent constipation.
• Caution patient to limit exposure to high ambient temperatures.
• Advise patient that dilated pupils may be experienced.
• Warn patient that product may cause excitability or sedation. Remind patient not to drive or operate heavy machinery if sedation occurs.
• Advise patient to notify health care provider if confusion, disorientation, ataxia, nausea, vomiting, diarrhea, abdominal distention, or elevated body temperature occurs.