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  • DONNATAL® (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide) ElixirRx OnlyRevised: 08/2016

    DONNATAL- phenobarbital, hyoscyamine sulfate, atropine sulfate and scopolamine hydrobromide elixir 
    Concordia Pharmaceuticals Inc.

    Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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    DONNATAL® (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide) Elixir
    Rx Only
    Revised: 08/2016

    DESCRIPTION

    Donnatal® Elixir - Grape

    Each 5 mL (teaspoonful) of elixir (alcohol not more than 23.8%) 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

    Purified Water, Glycerin, Sorbitol, Ethyl Alcohol, Sucrose, Saccharin Sodium, Artificial and Natural Grape Flavor, FD&C Red #3, and FD&C Blue #1.

    Donnatal® Elixir - Mint

    Each 5 mL (teaspoonful) of elixir (alcohol not more than 23.8%) 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

    Purified Water, Glycerin, Sorbitol, Ethyl Alcohol, Sucrose, Saccharin Sodium, Natural Mint Flavor, FD&C Yellow #5, and FD&C Blue #1.

    CLINICAL PHARMACOLOGY

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

    INDICATIONS AND USAGE

    Based on a review of this drug by the National Academy of Sciences-National Research Council and/or other information, FDA has classified the indications as follows: "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.


    Final classification of the less-than-effective indications requires further investigation.


    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.

    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;
    • 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.

    WARNINGS

    Donnatal® Elixir can cause fetal harm when administered to a pregnant woman. Animal reproduction studies have not been conducted with Donnatal® Elixir. 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 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® Elixir 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:

    • autonomic neuropathy
    • hepatic or renal disease
    • hyperthyroidism
    • coronary heart disease
    • congestive heart failure
    • cardiac arrhythmias
    • tachycardia
    • hypertension

    Belladonna alkaloids may produce a delay in gastric emptying (antral stasis) which would complicate the management of gastric ulcer.

    Do not rely on the use of the drug in the presence of complication of biliary tract disease.

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

    Donnatal® Elixir – Mint contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

    Information for Patients

    Donnatal® Elixir 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.

    Drug Interactions

    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.

    Carcinogenesis, Mutagenesis, Impairment of Fertility

    Long-term studies in animals have not been performed to evaluate carcinogenic potential.

    Pregnancy

    Pregnancy Category D

    Animal reproduction studies have not been conducted with Donnatal® Elixir. 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 WARNINGS).

    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® Elixir is 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.

    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 barbiturates 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 a few cases, megaloblastic anemia has been associated with the chronic use of phenobarbital.

    Phenobarbital may produce excitement in some patients, rather than a sedative effect.

    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 addiction prone or to those with a history of physical and/or psychological dependence upon drugs (see WARNINGS).

    Dependence

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

    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 used.

    DOSAGE AND ADMINISTRATION

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

    Donnatal® Elixir. Adults: One or two teaspoonfuls of elixir three or four times a day according to conditions and severity of symptoms.

    Pediatric patients: may be dosed every 4 to 6 hours. Use a pediatric dosing device or oral syringe to measure the dose.

    Starting Dosage
    Body weight Every 4 hours Every 6 hours
    10 lb. (4.5 kg) 0.5 mL 0.75 mL
    20 lb. (9.1 kg) 1 mL 1.5 mL
    30 lb. (13.6 kg) 1.5 mL 2 mL
    50 lb. (22.7 kg) 2.5 mL 3.75 mL
    75 lb. (34 kg) 3.75 mL 5 mL
    100 lb. (45.4 kg) 5 mL 7.5 mL

    HOW SUPPLIED

    Donnatal® Elixir - Grape is a purple colored, grape flavored liquid.

    • 4 fl oz (118 mL) bottles- NDC 59212-423-04.
    • 1 Pint (473 mL) bottles- NDC 59212-423-16.

    Donnatal® Elixir - Mint is a green colored, mint flavored liquid.

    • 4 fl oz (118 mL) bottles- NDC 59212-422-04.
    • 1 Pint (473 mL) bottles- NDC 59212-422-16.

    Avoid Freezing

    Store Donnatal® Elixir at 20º- 25ºC (68º - 77ºF) [see USP Controlled Room Temperature]. Protect from light and moisture.

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

    Manufactured For:
    Concordia Pharmaceuticals Inc.
    St. Michael, Barbados BB11005
    www.donnatal.com

    Manufactured By:
    IriSys, LLC
    San Diego, CA 92121


    Revised: 5_08/2016

    PRODUCT PHOTO

    NOTE: These photos can be used only for identification by shape, color, and imprint. They do not depict actual or relative size.

    The product samples shown here have been supplied by the manufacturer and reproduced in full color by PDR as a quick-reference identification aid. While every effort has been made to assure accurate reproduction, please remember that any visual identification should be considered preliminary. In cases of poisoning or suspected over dosage, the drug's identity should be verified by chemical analysis.

    Image from Drug Label Content