Donnatal Tablets

h3>DESCRIPTION

Donnatal® Tablets

Each Donnatal® Tablet contains:

Phenobarbital, USP.............................................16.2 mg
Hyoscyamine Sulfate, USP...............................0.1037 mg
Atropine Sulfate, USP......................................0.0194 mg
Scopolamine Hydrobromide, USP.....................0.0065 mg

Inactive Ingredients

Dibasic Calcium Phosphate Dihydrate, Compressible Sugar, Microcrystalline Cellulose, Sodium Starch Glycolate, Stearic Acid, Silicon Dioxide Colloidal, Magnesium Stearate.

INDICATIONS

DOSAGE AND ADMINISTRATION

The dosage of Donnatal® Tablets should be adjusted to the needs of the individual patient to assure symptomatic control with a minimum of adverse effects.

Donnatal® Tablets - Adults: One or two Donnatal® Tablets three or four times a day according to condition and severity of symptoms.

HOW SUPPLIED

Donnatal® Tabletsare supplied as: white, D-shaped, flat faced beveled edge tablets debossed “D” on one side and “Donnatal” on the other side.

Bottles of 100 tablets-NDC59212-425-10.
Bottles of 1000 tablets-NDC59212-425-11.
Bottles of 4 tablets-NDC59212-425-04.

Store at 20°-25°C (68°-77°F) [SeeUSP Controlled Room Temperature]. Protect from light and moisture.

Dispense in a tight, light-resistant container as defined in the USP using a childresistant closure.

Manufactured For: Concordia Pharmaceuticals Inc., St. Michael, Barbados BB11005. Manufactured By: IriSys, LLC, San Diego, CA 92121. Revised: March 2015

SIDE EFFECTS

Adverse reactions may includexerostomia; urinary hesitancy and retention; blurred vision;tachycardia; palpitation;mydriasis; cycloplegia; increasedoculartension; loss of tastesense; headache; nervousness; drowsiness; weakness; dizziness; insomnia; nausea; vomiting;impotence; suppression of lactation; constipation; bloated feeling; musculoskeletal pain; severe allergic reaction or drug idiosyncrasies, includinganaphylaxis,urticaria, and otherdermalmanifestations; and decreased sweating.

Acquiredhypersensitivity to barbiturates consists chiefly in allergic reactions that occur especially in persons who tend to haveasthma, urticaria,angioedema, and similar conditions. Hypersensitivity reactions in this category include localized swelling, particularly of the eyelids, cheeks, or lips, and erythematousdermatitis. Rarely, exfoliative dermatitis (e.g.Stevens-Johnson syndromeandtoxic 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 a few cases, megaloblasticanemiahas been associated with the chronic use of phenobarbital.

Phenobarbital may produce excitement in some patients, rather than asedativeeffect.

To report SUSPECTED ADVERSE REACTIONS, contact Concordia Pharmaceuticals Inc. at 1-877-370-1142 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug Abuse And Dependence

Abuse

Phenobarbital may be habit forming and should not be administered to individuals known to be addictionproneor to those with a history of physical and/ or psychological dependence upon drugs (see警告).

Dependence

In patients habituated to barbiturates, abrupt withdrawal may produce delirium or convulsions.

DRUG INTERACTIONS

Phenobarbital may decrease the effect of anticoagulants, and necessitate larger doses of theanticoagulantfor optimal effect. When the phenobarbital is discontinued, the dose of the anticoagulant may have to be decreased.

警告

Donnatal® Tablets can cause fetal harm when administered to a pregnant woman. Animal reproduction studies have not been conducted with Donnatal® Tablets. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

In the presence of a high environmental temperature, heat prostration can occur withbelladonnaalkaloids (fever and heatstroke 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® Tablets 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 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 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

General

Use with caution in patients with:

• autonomicneuropathy
• hepatic or renal disease
• hyperthyroidism
• coronaryheart disease
• congestive heart failure
• cardiac arrhythmias
• tachycardia
• hypertension

Belladonna alkaloids may produce a delay ingastricemptying (antralstasis) which would complicate the management of gastric ulcer.

Do not rely on the use of the drug in the presence ofcomplicationofbiliarytract disease.

Theoretically, with overdosage, a curare-like action may occur.

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Long-term studies in animals have not been performed to evaluatecarcinogenicpotential.

Pregnancy

Pregnancy Category D

动物繁殖研究尚未conducted with Donnatal® Tablets. There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks (see警告).

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® Tablets are administered to a nursing woman.

Geriatric Use

Elderly patients may react with symptoms of excitement, agitation, drowsiness, and other untoward manifestations to even small doses of the drug.

OVERDOSE

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, andactivated charcoal. If indicated,parenteralcholinergic agents such as physostigmine or bethanechol chloride should be used.

CONTRAINDICATIONS

• glaucoma;
• obstructive uropathy (for example,bladderneck obstruction due to prostatichypertrophy);
• obstructive disease of thegastrointestinal tract(as inachalasia, pyloroduodenalstenosis, etc.);
• paralytic ileus, intestinal atony of the elderly or debilitated patient;
• unstablecardiovascularstatus in acutehemorrhage;
• severeulcerative colitisespecially if complicated by toxic megacolon;
• myasthenia gravis;
• hiatalhernia associated withrefluxesophagitis;
• in patients with known hypersensitivity to any of the ingredients.

Phenobarbital is contraindicated in acute intermittentporphyriaand in those patients in whom phenobarbital produces restlessness and/or excitement.

CLINICAL PHARMACOLOGY

This drug combination provides natural belladonna alkaloids in a specific, fixed ratio combined with phenobarbital to provide peripheralanticholinergic/antispasmodicaction and mild sedation.

PATIENT INFORMATION

Donnatal® Tablets 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.