ADVERSE REACTIONS SECTION.

ADVERSE REACTIONS. 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 dermalmanifestations; and decreased sweating. Acquired hypersensitivity to barbituates consists chiefly in allergic reactionsthat occur especially in persons who tend to have asthma, urticaria, angiodema and similar conditions. Hypersensitivityreactions in this category include localized swelling, particularly of the eyelids, cheeks, or lips, and erythematousdermatitis. Rarely, exfoliative dermatitis (e.g. Stevens-Johnson syndrome and toxic epidermal necrolysis) may becaused by phenobarbital and can prove fatal. The skin eruption may be associated with fever, delirium, and markeddegenerative changes in the liver and other parenchymatous organs. In few cases, megaloblastic anemia has beenassociated with the chronic use of phenobarbital. Elderly patients may react with symptoms of exctextent, agitation,drowsiness, and other untoward manifestations to even small doses of the drug. Phenobarbital may produceexctextent in some patients, rather than sedative effect. In patients habituated to barbiturates, abrupt withdrawalmay produce delirium or convulsions.

CLINICAL PHARMACOLOGY SECTION.

CLINICAL PHARMACOLOGY. This drug combination provides natural belladonna alkaloids in specific, fixed ratio combined with phenobarbital toprovide peripheral anticholinergic/antispasmodic action and mild sedation.

CONTRAINDICATIONS SECTION.

CONTRAINDICATIONS. Glaucoma, obstructive uropathy (for example, bladder neck obstruction due to prostatic hypertrophy); obstructivedisease of the gastrointestinal tract (as in achalasia, pyloroduodenal stenosis, etc.); paralytic ileus, intestinal atony ofthe elderly or debilitated patient; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitisespecially if complicated by toxic mega-colon; myasthenia gravis; hiatal hernia associated with reflux esophagitis.Donnatal(R) is contraindicated in patients with known hypersensitivity to any of the ingredients. Phenobarbital iscontraindicated in acute intermittent porphyria and in those patients in whom phenobarbital produces restlessnessand/or exctextent.

DESCRIPTION SECTION.

Description. Each Donnatal(R) Tablet contains:Phenobarbital, USP....................................... 16.2 mgHyoscyamine Sulfate, USP...................... 0.1037 mgAtropine Sulfate, USP ...............................0.0194 mgScopolamine Hydrobromide, USP ...........0.0065 mgINACTIVE INGREDIENTS: Anhydrous Lactose, Calcium Stearate, ColloidalSilicon Dioxide, Corn Starch, and Microcrystalline Cellulose.

DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND ADMINISTRATION. The dosage of Donnatal(R) should be adjusted to the needs of the dividual patient to assure symptomatic control with aminimum of adverse effects.Donnatal(R) Tablets. Adults: One or two Donnatal(R) tablets three or four times day according to condition and severityof symptoms.

HOW SUPPLIED SECTION.

How Supplied. Donnatal(R) Tablets are supplied as: White, D-shaped tablets debossed D on one side and Donnatal on the otherside.Bottles of 100 tablets.Bottles of 1000 tablets.AVOID FREEZINGStore at 20-25C (68-77F) [See USP Controlled Room Temperature].Protect from light and moisture.Dispense in tight, light-resistant container as defined in the USP using child-resistant closure. Use safety closureswhen dispensing this product unless otherwise directed by physician or requested by purchaser.Also available: Donnatal Extentabs(R) Tablets, the only extended release formulation, in bottles of 100 and 500 tablets.Donnatal(R) Elixir, purple colored, grape flavored liquid, in fl oz (118 mL) and pint (473 mL) bottles.

INDICATIONS & USAGE SECTION.

INDICATIONS AND USAGE. Based on review of this drug by the National Academy of Sciences-National Research Council and/or otherinformation, 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 SHOWNCONCLUSIVELY WHETHER ANTICHOLINERGIC/ANTISPASMODIC DRUGS AID IN THE HEALING OF ADUODENAL ULCER, DECREASE THE RATE OF RECURRENCES OR PREVENT COMPLICATIONS.

OVERDOSAGE SECTION.

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 gastriclavage, emetics, and activated charcoal. If indicated, parenteral cholinergic agents such as physostigmine orbethanechol chloride, should be used.

PRECAUTIONS SECTION.

PRECAUTIONS. Use with caution in patients with: autonomic neuropathy, hepatic or renal disease, hyperthyroidism, coronary heartdisease, congestive heart failure, cardiac arrhythmias, tachycardia, and hypertension.Belladonna alkaloids may produce delay in gastric emptying (antral stasis) which would complicate the managementof gastric ulcer.Do not rely on the use of the drug in the presence of complication of biliary tract disease.Theoretically, with overdosage, curare-like action may occur.

PREGNANCY SECTION.

PREGNANCY. PREGNANCY CATEGORY CAnimal reproduction studies have not been conducted with Donnatal(R). It is not known whether Donnatal(R) can causefetal harm when administered to pregnant woman or can affect reproduction capacity. Donnatal(R) should be given toa pregnant woman only if clearly needed.

WARNINGS SECTION.

WARNINGS. In the presence of high environmental temperature, heat prostration can occur with belladonna alkaloids (fever andheatstroke due to decreased sweating).Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy orcolostomy. In this instance, treatment with this drug would be inappropriate and possibly harmful.Donnatal(R) may produce drowsiness or blurred vision. The patient should be warned, should these occur, not toengage in activities requiring mental alertness, such as operating motor vehicle or other machinery, and not toperform hazardous work.Phenobarbital may decrease the effect of anticoagulants, and necessitate larger doses of the anticoagulant for optimaleffect. When the 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 tothose with 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 inpatients with hepatic dysfunction.