(belladonna alkaoids, phenobarbital)
Each Donnatal Extentabs® (belladonna alkaloids, phenobarbital) tablet contains:
Phenobarbital, USP (3/4 gr.) ................................ 48.6 mg
Hyoscyamine Sulfate, USP ................................... 0.3111 mg
Atropine Sulfate, USP ............................................ 0.0582 mg
Scopolamine Hydrobromide, USP ...................... 0.0195 mg
Each Donnatal Extentabs® (belladonna alkaloids, phenobarbital) 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.
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.
DOSAGE AND ADMINISTRATION
The dosage of Donnatal Extentabs® (belladonna alkaloids, phenobarbital) should be adjusted to the needs of the individual patient to assure symptomatic control with a minimum of adverse reactions. The usual dose is one tablet every twelve (12) hours. If indicated, one tablet every eight (8) hours may be given.
Donnatal Extentabs® (belladonna alkaloids, phenobarbital) Tablets are supplied as: film coated green, round, compressed tablets printed "P421" in black ink.
- Bottles of 100 tablets
- Bottles of 500 tablets
Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture.
Dispense in a well-closed, light-resistant container as defined in the USP using a child-resistant closure.
Also available: Donnatal® Tablets in bottles of 100 and 1000 tablets and Donnatal® Elixir in 4 fl oz bottles and 1 pint bottles.
PBM Pharmaceuticals, Inc. Gordonsville, VA 22942. FDA Rev date: n/a
Adverse reactions may include xerostomia; urinary hesitancy and retention; blurred vision; tachycardia; palpitation; mydriasis; cycloplegia; increased ocular tension; loss of taste sense; headache; nervousness; drowsiness; weakness; dizziness: insomnia; nausea; vomiting; impotence; suppression of lactation; constipation; bloated feeling; musculoskeletal pain; severe allergic reaction or drug idiosyncrasies, including anaphylaxis, urticaria and other dermal manifestations; and decreased sweating. Elderly patients may react with symptoms of excitement, agitation, drowsiness, and other untoward manifestations to even small doses of the drug.
No information provided.
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® (belladonna alkaloids, phenobarbital) 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.
Use with caution in patients with: autonomic neuropathy, hepatic or renal disease, hyperthyroidism, coronary heart disease, congestive heart failure, cardiac arrhythmias, tachycardia, and hypertension.
Theoretically, with overdosage, a curare-like action may occur.
Carcinogenesis, mutagenesis: Long-term studies in animals have not been performed to evaluate c arcinogenic potential.
Pregnancy Category C: Animal reproduction studies have not been conducted with Donnatal Extentabs® (belladonna alkaloids, phenobarbital) . It is not known whether Donnatal Extentabs® (belladonna alkaloids, phenobarbital) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Donnatal Extentabs® (belladonna alkaloids, phenobarbital) should be given to a pregnant woman only if clearly needed.
Nursing mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Donnatal Extentabs® (belladonna alkaloids, phenobarbital) is administered to a nursing mother.
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.
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® (belladonna alkaloids, phenobarbital) 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.
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