Country: United States
Language: English
Source: NLM (National Library of Medicine)
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)
Ingenus Pharmaceuticals, LLC
ORAL
PRESCRIPTION DRUG
- 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.
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 Manufactured for: Ingenus Pharmaceuticals, LLC Orlando, FL 32839-6408 Revised: 05/2021 LF-122302-01 MPL-095
unapproved drug other
PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE AND SCOPOLAMINE HYDROBROMIDE - PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE AND SCOPOLAMINE HYDROBROMIDE TABLET INGENUS PHARMACEUTICALS, LLC _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._ ---------- PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE AND SCOPOLAMINE HYDROBROMIDE TABLETS RX ONLY REVISED: 05/21 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 PRE Read the complete document