Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate and Scopolamine Hydrobromide Tablets Rx Only Revised: 02/20

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PHENOBARBITAL (UNII: YQE403BP4D) (PHENOBARBITAL - UNII:YQE403BP4D), HYOSCYAMINE SULFATE (UNII: F2R8V82B84) (HYOSCYAMINE - UNII:PX44XO846X), ATROPINE SULFATE (UNII: 03J5ZE7KA5) (ATROPINE - UNII:7C0697DR9I), SCOPOLAMINE HYDROBROMIDE (UNII: 451IFR0GXB) (SCOPOLAMINE - UNII:DL48G20X8X)

Available from:

Prasco Laboratories

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate and Scopolamine Hydrobromide Tablets are supplied as: white, D-shaped, flat faced beveled edge tablets embossed "D" on one side and debossed "Donnatal" on the other side. Store 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. DEA EXEMPT PRODUCT Distributed by: Prasco Laboratories Mason, OH 45040 Revised: 02/20

Authorization status:

unapproved drug other

Summary of Product characteristics

PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE AND
SCOPOLAMINE HYDROBROMIDE - PHENOBARBITAL, HYOSCYAMINE SULFATE,
ATROPINE SULFATE AND
SCOPOLAMINE HYDROBROMIDE TABLET
PRASCO LABORATORIES
_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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PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE AND SCOPOLAMINE
HYDROBROMIDE TABLETS
RX ONLY
REVISED: 02/20
DESCRIPTION
PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE AND SCOPOLAMINE
HYDROBROMIDE TABLETS
Each Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate and
Scopolamine Hydrobromide 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.
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.
CONTRAINDIC