Valsts: Amerikas Savienotās Valstis
Valoda: angļu
Klimata pārmaiņas: NLM (National Library of Medicine)
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)
PBM Pharmaceuticals Inc.
Phenobarbital
Phenobarbital 16.2 mg in 5 mL
ORAL
PRESCRIPTION DRUG
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
unapproved drug other
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._ ---------- DONNATAL ELIXIR MINT 16 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. 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; severe ulcerative colitis especially if complicated by toxic megacolon; myasthenia gravis; hi Izlasiet visu dokumentu