DONNATAL- phenobarbital elixir elixir

Donnatal by

Drug Labeling and Warnings

Donnatal by is a Prescription medication manufactured, distributed, or labeled by AvKARE, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

DESCRIPTION

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

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 AvKARE, Inc. at 1-855-361-3993 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: 42291-244-04
• 1 Pint (473 mL) bottles- NDC: 42291-244-16

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

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:

AvKARE, Inc.

Pulaski, TN 38478

Mfg. Rev. 10/17

AV Rev. 09/19 (P)

Principal Display Panel - Donnatal Elixir - Grape, 4 oz

NDC: 42291-244-04 4 FL OZ

Donnatal ®

(Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide)

Elixir grape flavored

Each 5 mL (1 teaspoonful) contains:

Phenobarbital, USP.............................. 16.2 mg

Hyoscyamine Sulfate, USP............... 0.1037 mg

Atropine Sulfate, USP...................... 0.0194 mg

Scopolamine Hydrobromide, USP.... 0.0065 mg

Alcohol not more than 23.8%

DO NOT USE IF TAMPER-EVIDENT SEAL UNDER CAP IS BROKEN OR MISSING.

Rx only

Warnings: Keep this and all drugs out of reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

Avoid freezing.

Protect from light and moisture.

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

Concordia Pharmaceuticals

Dosage and Administration: See accompanying prescribing information.

Manufactured For:

AvKARE, Inc.

Pulaski, TN 38478

Mfg. Rev. 12/16 AV 01/19 (P)

INGREDIENTS AND APPEARANCE

DONNATAL 
phenobarbital elixir elixir

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 42291-244
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
ATROPINE SULFATE (UNII: 03J5ZE7KA5) (ATROPINE - UNII:7C0697DR9I)	ATROPINE SULFATE	0.0194 mg  in 5 mL
SCOPOLAMINE HYDROBROMIDE (UNII: 451IFR0GXB) (SCOPOLAMINE - UNII:DL48G20X8X)	SCOPOLAMINE HYDROBROMIDE	0.0065 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	1981 mg  in 5 mL
ALCOHOL (UNII: 3K9958V90M)	407 mg  in 5 mL
WATER (UNII: 059QF0KO0R)	2119 mg  in 5 mL
SORBITOL (UNII: 506T60A25R)	895 mg  in 5 mL
SUCROSE (UNII: C151H8M554)	289 mg  in 5 mL
SACCHARIN SODIUM (UNII: SB8ZUX40TY)	28.9 mg  in 5 mL
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)

Product Characteristics
Color	purple	Score
Shape		Size
Flavor	GRAPE (Artificial and Natural Grape)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42291-244-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/04/2014
2	NDC: 42291-244-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/04/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/13/2014

Labeler - AvKARE, Inc (796560394)