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 dermal manifestations; and decreased sweating. Acquired hypersensitivity to barbituates consists chiefly in allergic reactions that occur especially in persons who tend to have asthma, urticaria, angioedema and similar conditions. Hypersensitivity reactions in this category include localized swelling, particularly of the eyelids, cheeks, or lips, and erythematous dermatitis. Rarely, exfoliative dermatitis (e.g. Stevens-Johnson syndrome and toxic epidermal necrolysis) may be caused by phenobarbital and can prove fatal. The skin eruption may be associated with fever, delirium, and marked degenerative changes in the liver and other parenchymatous organs. In few cases, megaloblastic anemia has been associated 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 produce exctextent in some patients, rather than sedative effect. In patients habituated to barbiturates, abrupt withdrawal may produce delirium or convulsions.

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION.

Carcinogenesis, mutagenesis:. Long-term studies in animals have not been performed to evaluate carcinogenic potential.

CONTRAINDICATIONS SECTION.

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(R) 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 exctextent.

DESCRIPTION SECTION.

Description:. Each Donnatal Extentabs(R) tablet contains: Phenobarbital, USP (3/4 gr.) 48.6 mgHyoscyamine Sulfate, USP 0.3111 mgAtropine Sulfate, USP 0.0582 mgScopolamine Hydrobromide, USP .0.0195 mg Each Donnatal Extentabs(R) tablet contains the equivalent of three Donnatal(R) 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: and Yellow 10 Aluminum Lake, FD and Blue Aluminum Lake, Hydroxypropyl Methylcellulose, Polydextrose, Polyethylene Glycol, Titanium Dioxide, and Triacetin. The printing ink contains Titanium Dioxide.

DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND ADMINISTRATION:. The dosage of Donnatal Extentabs(R) should be adjusted to the needs of the individual patient to assure symptomatic control with 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.

HOW SUPPLIED SECTION.

HOW SUPPLIED:. Donnatal Extentabs(R) Tablets are supplied as: film coated green, round, compressed tablets printed P421 in black ink. Bottles of 100 tabletsBottles of 500 tablets Store at 20-25C (68-77F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in well-closed, light-resistant container as defined in the USP using child-resistant closure. Also available: Donnatal(R) Tablets in bottles of 100 and 1000 tablets and Donnatal(R) Elixir in fl oz bottles and pint bottles.

INDICATIONS & USAGE SECTION.

INDICATIONS. Based on 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 DUODENAL ULCER, DECREASE THE RATE OF RECURRENCES OR PREVENT COMPLICATIONS.

MECHANISM OF ACTION SECTION.

ACTIONS:. This drug combination provides natural belladonna alkaloids in specific, fixed ratio combined with phenobarbital to provide peripheral anticholinergic/antispasmodic action and mild sedation.

NURSING MOTHERS SECTION.

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(R) is administered to nursing mother.

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 gastric lavage, emetics, and activated charcoal. If indicated, parenteral cholinergic agents such as physostigmine or bethanechol chloride should be added.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

NDC 66213-421-10 100 Tablets Donnatal Extentabs(R)Each Extentabs tablet contains:Phenbarbital, USP . . 48.6 mgHyoscyamine Sulfate, USP . . . 0.3111 mgAtropine Sulfate, USP . . . 0.0582 mgScopolamine Hydrobromide, USP . . . . 0.0195 mgRX only Usual Adult Usage:See accompanying product literature for complete information. U421-10-3 PBM Pharmaceuticals, Inc.Charlottesville, VA 22902Exp. Date:Control No: Store at 20-25C (68-77F) [See USP Controlled Room Temperature].Dispense in well closed, light resistant container as defined in the USP using child-resistant closure.. Label for 100 tab bottle.

PRECAUTIONS SECTION.

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 delay in gastric emptying (antral stasis) which would complicate the management of gastric ulcer. Theoretically, with overdosage, curare-like action may occur.

PREGNANCY SECTION.

Pregnancy Category C:. Animal reproduction studies have not been conducted with Donnatal Extentabs(R). It is not known whether Donnatal Extentabs(R) can cause fetal harm when administered to pregnant woman or can affect reproduction capacity. Donnatal Extentabs(R) should be given to pregnant woman only if clearly needed.

SPL PATIENT PACKAGE INSERT SECTION.

Patient Insert. DONNATAL EXTENTABS(R)Rx Only Rev. 06/07.

SPL UNCLASSIFIED SECTION.

Manufactured For:PBM Pharmaceuticals, Inc.Gordonsville, VA 22942 Manufactured By: West-ward Pharmaceutical Corp.Eatontown, NJ 07724 Revised June 2007.

WARNINGS SECTION.

WARNINGS:. In the presence of 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(R) 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 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 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.