INDICATIONS FOR DONNATAL EXTENTABS
Based on a review of this drug by the National Academy of Sciences - National Research Council and/or other information, FDA has classified the following indications as possibly effective: For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis.
Only Donnatal Extentabs provide gradual dissolution over 12 hours, distinctively longer than immediate release tablets.
Each Donnatal Extentabs tablet contains the equivalent of three Donnatal tablets. Extentabs are designed to release the ingredients gradually to provide effects for up to twelve (12) hours.
In addition, each tablet contains the following inactive ingredients: Anhydrous Lactose, Calcium Sulfate Granular, Colloidal Silicon Dioxide, Dibasic Calcium Phosphate, Lactose Monohydrate, Magnesium Stearate, and Stearic Acid. Film Coating and Polishing Solution contains: D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, Hydroxypropyl Methylcellulose, Polydextrose, Polyethylene Glycol, Titanium Dioxide, and Triacetin. The printing ink contains Titanium Dioxide.
ACTIONS: This drug combination provides natural belladonna alkaloids in a specific, fixed ratio combined with phenobarbital to provide peripheral anticholinergic/antispasmodic action and mild sedation.
INDICATIONS
Based on a review of this drug by the National Academy of Sciences - National Research Council and/or other information, FDA has classified the following indications as possibly effective:
For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis.
May also be useful as adjunctive therapy in the treatment of duodenal ulcer. IT HAS NOT BEEN SHOWN CONCLUSIVELY WHETHER ANTICHOLINERGIC/ANTISPASMODIC DRUGS AID IN THE HEALING OF A DUODENAL ULCER, DECREASE THE RATE OF RECURRENCES OR PREVENT COMPLICATIONS.
CONTRAINDICATIONS: Glaucoma, obstructive uropathy (for example, bladder neck obstruction due to prostatic hypertrophy) obstructive disease of the gastrointestinal tract (as in achalasia, pyloroduodenal stenosis, etc.) paralytic ileus, intestinal atony of the elderly or debilitated patient unstable cardiovascular status in acute hemorrhage severe ulcerative colitis especially if complicated by toxic megacolon myasthenia gravis hiatal hernia associated with reflux esophagitis.
Donnatal Extentabs is contraindicated in patients with known hypersensitivity to any of the ingredients. Phenobarbital is contraindicated,in acute intermittent porphyria and in those patients in whom phenobarbital produces restlessness and/or excitement.
WARNINGS: In the presence of a high environmental temperature, heat prostration can occur with belladonna alkaloids (fever and heatstroke due to decreased sweating).
Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance treatment with this drug would be inappropriate and possibly harmful.
Donnatal Extentabs may produce drowsiness or blurred vision. The patient should be warned, should these occur, not to engage in activities requiring mental alertness, such as operating a motor vehicle or other machinery, and not to perform hazardous work.
Phenobarbital may decrease the effect of anticoagulants and necessitate larger doses of the anticoagulant for optimal effect. When phenobarbital is discontinued, the dose of the anticoagulant may have to be decreased.
Phenobarbital may be habit forming and should not be administered to individuals known to be addiction prone or to those with a history of physical and/or psychological dependence upon drugs.
Since barbiturates are metabolized in the liver, they should be used with caution and initial doses should be small in patients with hepatic dysfunction.
PRECAUTIONS: Use with caution in patients with: autonomic neuropathy, hepatic or renal disease, hyperthyroidism, coronary heart disease, congestive heart failure, cardiac arrhythmias, tachycardia, and hypertension.
Belladonna alkaloids may produce a delay in gastric emptying (antral stasis) which would complicate the management of gastric ulcer.
Theoretically, with overdosage, a curare-like action may occur.
OVERDOSAGE: The signs and symptoms of overdose are headache, nausea, vomiting, blurred vision, dilated pupils, hot and dry skin, dizziness, dryness of the mouth, difficulty in swallowing, and CNS stimulation. Treatment should consist of gastric lavage, emetics, and activated charcoal. If indicated, parenteral cholinergic agents such as physostigmine or bethanechol chloride should be added.
