PHENOBARBITAL WITH BELLADONNA ALKALOIDS- phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide tablet

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:

Bryant Ranch Prepack

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. - 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; - se

Product summary:

Phenobarbital with Belladonna Alkaloids Tablets are supplied as: White, round, convex tablet debossed with 'PBA' on one side and '7' 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

Authorization status:

unapproved drug other

Summary of Product characteristics

PHENOBARBITAL WITH BELLADONNA ALKALOIDS- PHENOBARBITAL, HYOSCYAMINE
SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE TABLET
BRYANT RANCH PREPACK
_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 WITH BELLADONNA ALKALOIDSTABLETS
RX ONLY
DESCRIPTION
Each Phenobarbital with Belladonna Alkaloids 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
Calcium Stearate, Colloidal Silicon Dioxide, Lactose, Microcrystalline
Cellulose, and
Pregelatinized Starch.
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
patie