DONNATAL- phenobarbital elixir elixir

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

Phenobarbital (UNII: YQE403BP4D) (Phenobarbital - UNII:YQE403BP4D), Hyoscyamine sulfate (UNII: F2R8V82B84) (Hyoscyamine - UNII:PX44XO846X), Scopolamine hydrobromide (UNII: 451IFR0GXB) (Scopolamine - UNII:DL48G20X8X), Atropine sulfate (UNII: 03J5ZE7KA5) (Atropine - UNII:7C0697DR9I)

Pieejams no:

PBM Pharmaceuticals Inc.

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

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; hiatal hernia

Autorizācija statuss:

unapproved drug other

Produkta apraksts

DONNATAL - PHENOBARBITAL ELIXIR ELIXIR
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 ELIXIR MINT 4 OZ
DESCRIPTION
DONNATAL® ELIXIR - MINT: Each 5 mL (teaspoonful) of elixir (alcohol
not more than 23.8%) 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:
Ethyl Alcohol, Glycerin, Purified Water, Saccharin Sodium, Sorbitol,
Sucrose, Natural Mint Flavor, FD
&C Yellow #5, FD & C Blue #1 and FD&C Red #40.
DESCRIPTION
DONNATAL® ELIXIR - MINT: Each 5 mL (teaspoonful) of elixir (alcohol
not more than 23.8%) 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:
Ethyl Alcohol, Glycerin, Purified Water, Saccharin Sodium, Sorbitol,
Sucrose, Natural Mint Flavor, FD
&C Yellow #5, FD & C Blue #1 and FD&C Red #40.
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