DONNATAL- phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide tablet

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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)

זמין מ:

Mckesson Rxpak Inc

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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 mega-colon; myasthenia gravis; hiatal hernia

leaflet_short:

Donnatal® Tablets are supplied as: White, D-shaped tablets debossed “D” on one side and “Donnatal” on the other side. Bottles of 100 tablets. Bottles of 1000 tablets. AVOID FREEZING 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. Use safety closures when dispensing this product unless otherwise directed by a physician or requested by purchaser. Also available: Donnatal Extentabs® Tablets, the only extended release formulation, in bottles of 100 and 500 tablets. Donnatal® Elixir, a purple colored, grape flavored liquid, in 4 fl oz (118 mL) and 1 pint (473 mL) bottles.

מצב אישור:

unapproved drug other

מאפייני מוצר

DONNATAL- PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE,
SCOPOLAMINE
HYDROBROMIDE TABLET
MCKESSON RXPAK INC
_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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DONNATAL TABLETS
DES CRIPTION
Each Donnatal® 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: Anhydrous Lactose, Calcium Stearate, Colloidal
Silicon Dioxide, Corn Starch, and Microcrystalline Cellulose.
INACTIVE INGREDIENTS
Anhydrous Lactose, Calcium Stearate, Colloidal Silicon Dioxide, Corn
Starch, and Microcrystalline
Cellulose
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 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.
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