Label: DONNATAL- phenobarbital elixir elixir
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Updated December 3, 2013
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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
Ethyl Alcohol, Glycerin, Purified Water, Saccharin Sodium, Sorbitol, Sucrose, Natural Mint Flavor, FD &C Yellow #5, FD & C Blue #1 and FD&C Red #40.
- CLINICAL PHARMACOLOGY
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 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 A DUODENAL ULCER, DECREASE THE RATE OF RECURRENCES OR PREVENT COMPLICATIONS.
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® Elixir 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 excitement.
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.
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 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.
CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY: Long-term studies in animals have not been performed to evaluate carcinogenic potential.
PREGNANCY CATEGORY C
Animal reproduction studies have not been conducted with Donnatal® Elixir. It is not known whether Donnatal®
Elixir can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Donnatal® Elixir should be given to a pregnant woman only if clearly needed.
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.
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. Elderly patients may react with symptoms of excitement, agitation, drowsiness, and other untoward manifestations to even small doses of the drug. Phenobarbital may produce excitement in some patients, rather than a sedative effect. In patients habituated to barbiturates, abrupt withdrawal may produce delirium or convulsions.
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.
Body weight q4h q6h
10 lb. (4.5 kg) 0.5 mL 0.75 mL
20 lb. (9.1 kg) 1.0 mL 1.5 mL
30 lb. (13.6 kg) 1.5 mL 2.0 mL
50 lb. (22.7 kg) ½ tsp ¾ tsp
75 lb. (34 kg) ¾ tsp 1 tsp
100 lb. (45.4 kg) 1 tsp 1½ tsp
Donnatal® Elixir - Grape is a purple colored, grape flavored liquid.
4 fl oz (118 mL) bottles NDC 66213-423-04.
1 Pint (473 mL) bottles NDC 66213-423-16.
Donnatal® Elixir - Mint is a green colored, mint flavored liquid.
4 fl oz (118 mL) bottles NDC 66213-422-04.
1 Pint (473 mL) bottles NDC 66213-422-16.
Store Donnatal® Elixir at 20° - 25°C (68° - 77°F) [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. Use safety closures when dispensing this product unless otherwise directed by a physician or requested by purchaser.
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
phenobarbital elixir elixir
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66213-422 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Phenobarbital (UNII: YQE403BP4D) (Phenobarbital - UNII:YQE403BP4D) Phenobarbital 16.2 mg in 5 mL Hyoscyamine sulfate (UNII: F2R8V82B84) (Hyoscyamine - UNII:PX44XO846X) Hyoscyamine sulfate 0.1037 mg in 5 mL Scopolamine hydrobromide (UNII: 451IFR0GXB) (Scopolamine - UNII:DL48G20X8X) Scopolamine hydrobromide 0.0065 mg in 5 mL Atropine sulfate (UNII: 03J5ZE7KA5) (Atropine - UNII:7C0697DR9I) Atropine sulfate 0.0194 mg in 5 mL Inactive Ingredients Ingredient Name Strength Glycerin (UNII: PDC6A3C0OX) 2.007 g in 5 mL alcohol (UNII: 3K9958V90M) .4158 g in 5 mL water (UNII: 059QF0KO0R) 2.1432 g in 5 mL sucrose (UNII: C151H8M554) .2925 g in 5 mL sorbitol (UNII: 506T60A25R) .9068 g in 5 mL saccharin sodium (UNII: SB8ZUX40TY) .02925 g in 5 mL FD&C Blue No. 1 (UNII: H3R47K3TBD) FD&C Red No. 3 (UNII: PN2ZH5LOQY) MINT (UNII: FV98Z8GITP) .041 g in 5 mL Product Characteristics Color green Score Shape Size Flavor MINT (Natural Mint) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66213-422-16 470 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 07/01/2011 Labeler - PBM Pharmaceuticals Inc. (785470050) Registrant - IriSys, Inc. (959205568) Establishment Name Address ID/FEI Business Operations IriSys, Inc. 959205568 manufacture(66213-422)