BOXED WARNING SECTION.
INDICATIONSANDUSAGE: Based on a review of this drug by the National Academy ofSciences-National Research Council and/or other information,FDA has classified the following indications as possiblyeffective: For use as adjunctive therapy in the treatment of irritablebowel syndrome (irritable colon, spastic colon, mucouscolitis) and acute enterocolitis. May also be useful as adjunctive therapy in the treatment ofduodenal ulcer. IT HAS NOT BEEN SHOWN CONCLUSIVELYWHETHER ANTICHOLINERGIC/ANTISPASMODIC DRUGSAID IN THE HEALING OF DUODENAL ULCER, DECREASETHE RATE OF RECURRENCES OR PREVENT COMPLICATIONS.
ADVERSE REACTIONS SECTION.
ADVERSE REACTIONS: Adverse reactions may include xerostomia, urinary hesitancy andretention; 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; bloatedfeeling; musculoskeletal pain; severe allergic reaction or drugidiosyncrasies, including anaphylaxis, urticaria and other dermalmanifestations; and decreased sweating. Elderly patients mayreact with symptoms of excitement, agitation, drowsiness, and otheruntoward manifestations to even small doses of the drug.Phenobarbital may produce excitement in some patients, ratherthan a sedative effect. In patients habituated to barbiturates, abruptwithdrawal may produce delirium or convulsions.
DOSAGE & ADMINISTRATION SECTION.
DOSAGE AND ADMINISTRATION: The dosage of belladonna alkaloids with phenobarbital tabletsshould be adjusted to the needs of the individual patient to assuresymptomatic control with a minimum of adverse effects. Adults: One or two tablets three or four times a day according tocondition and severity of symptoms.
HOW SUPPLIED SECTION.
HOW SUPPLIED: Belladonna Alkaloids with Phenobarbital Tabletsare supplied as; White, round, scored, compressed tablets imprintedWest-ward 140. Bottles of 20 tablets. Store at 20 25 C (68- 77F) [See USP Controlled RoomTemperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USPusing a child-resistant closure.
DESCRIPTION: Each Tablet contains: Atropine Sulfate, USP..........................0.0194 mg Hyoscyamine Sulfate, USP.................0.1037 mg Scopolamine Hydrobromide, USP.....0.0065 mg Phenobarbital, USP..................................16.2 mg Inactive ingredients: Anhydrous Lactose, Calcium Stearate,Colloidal Silicon Dioxide, Corn Starch, and MicrocrystallineCellulose.
OVERDOSAGE: The signs and symptoms of overdose are headache, nausea, vomiting,blurred vision, dilated pupils, hot and dry skin, dizziness, dryness ofthe mouth, difficulty in swallowing, CNS stimulation. Treatmentshould consist of gastric lavage, emetics and activated charcoal. Ifindicated, parenteral cholinergic agents such as physostigmine or bethanechol chloride, should be added.
PRECAUTIONS: Use with caution in patients with: autonomic neuropathy, hepatic orrenal disease, hyperthyroidism, coronary heart disease, congestiveheart failure, cardiac arrhythmias, tachycardia, and hypertension. Belladonna alkaloids may produce a delay in gastric emptying(antral stasis) which would complicate the management of gastriculcer. Theoretically, with overdosage, a curare-like action may occur. Carcinogenesis, mutagenesis. Long-term studies in animals havenot been performed to evaluate carcinogenic potential. PregnancyCategoryC. Animal reproduction studies have not beenconducted with belladonna alkaloids with phenobarbital tablets. It isnot known whether belladonna alkaloids with phenobarbital tabletscan cause fetal harm when administered to a pregnant woman orcan affect reproduction capacity. Belladonna alkaloids with phenobarbitaltablets should be given to a pregnant woman only if clearlyneeded. Nursing mothers. It is not know whether this drug is excreted inhuman milk. Because many drugs are excreted in human milk, caution should be exercised when belladonna alkaloids with phenobarbitaltablets are administered to a nursing mother.
CLINICAL PHARMACOLOGY SECTION.
CLINICAL PHARMACOLOGY: This drug combination provides natural belladonna alkaloids in aspecific, fixed ratio combined with phenobarbital to provideperipheral anticholinergic/antispasmodic action and mild sedation.
CONTRAINDICATIONS: Glaucoma, obstructive uropathy (for example, bladder neckobstruction due to prostatic hypertrophy); obstructive disease of thegastrointestinal tract (as in achalasia, pyloroduodenal stenosis,etc.); paralytic ileus, intestinal atony of the elderly or debilitatedpatient; unstable cardiovascular status in acute hemorrhage; severeulcerative colitis especially if complicated by toxic magacolon;myasthenia gravis; hiatal hernia associated with reflux esophagitis. Belladonna alkaloids with phenobarbital tablets are contraindicatedin patients with known hypersensitivity to any of the ingredients.Phenobarbital is contraindicated in acute intermittent porphyria andin those patients in whom phenobarbital produces restlessness and/or excitement.
WARNINGS: In the presence of a high environmental temperature, heat prostrationcan occur with belladonna alkaloids (fever and heatstroke due todecreased sweating). Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. Inthis instance treatment with this drug would be inappropriate andpossibly harmful. Belladonna alkaloids with phenobarbital tablets may producedrowsiness or blurred vision. The patient should be warned, shouldthese 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, andnecessitate larger doses of the anticoagulant for optimal effect. When the phenobarbital is discontinued, the dose of the anticoagulantmay have to be decreased. Phenobarbital may be habit forming and should not be administeredto individuals known to be addiction prone or to those with a historyof physical and/or psychological dependence upon drugs. Since barbiturates are metabolized in the liver, they should be usedwith caution and initial doses should be small in patients withhepatic dysfunction.