DONNATAL EXTENTABS- phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide tablet, film coated, extended

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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)

Доступна з:

PBM Pharmaceuticals, Inc

ІПН (Міжнародна Ім'я):

Phenobarbital

Склад:

Phenobarbital 48.6 mg

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

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 megacolon; myasthenia gravis; hia

Огляд продуктів:

Donnatal Extentabs® Tablets are supplied as: film coated green, round, compressed tablets printed “P421” in black ink. Bottles of 100 tablets Bottles of 500 tablets Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature].  Protect from light and moisture. Dispense in a well-closed, light-resistant container as defined in the USP using a child-resistant closure. Also available: Donnatal® Tablets in bottles of 100 and 1000 tablets and Donnatal® Elixir in 4 fl oz bottles and 1 pint bottles.

Статус Авторизація:

unapproved drug other

Характеристики продукта

DONNATAL EXTENTABS - PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE
SULFATE, SCOPOLAMINE
HYDROBROMIDE TABLET, FILM COATED, EXTENDED RELEASE
PBM PHARMACEUTICALS, 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 EXTENTABS
PATIENT INSERT
DONNATAL EXTENTABS®
Rx Only
Rev. 06/07
DES CRIPTION:
Each Donnatal Extentabs® tablet contains:
Phenobarbital, USP (3/4 gr.) 48.6 mg
Hyoscyamine Sulfate, USP 0.3111 mg
Atropine Sulfate, USP 0.0582 mg
Scopolamine Hydrobromide, USP .0.0195 mg
Each Donnatal Extentabs® tablet contains the equivalent of three
Donnatal® tablets. Extentabs are
designed to release the ingredi¬ents gradually to provide effects for
up to twelve (12) hours.
In addition, each tablet contains the following inactive ingredients:
Anhydrous Lactose, Calcium Sulfate
Granular, Colloidal Silicon Dioxide, Dibasic Calcium Phosphate,
Lactose Monohydrate, Magnesium
Stearate, and Stearic Acid. Film Coating and Polishing Solution
contains: D and C Yellow #10
Aluminum Lake, FD and C Blue #1 Aluminum Lake, Hydroxypropyl
Methylcellulose, Polydextrose,
Polyethylene Glycol, Titanium Dioxide, and Triacetin. The printing ink
contains Titanium Dioxide.
ACTIONS:
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
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