ME-PB-HYOS phenobarbital hyoscyamine sulfate atropine and scopolamine hydrobromide tablet

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

PHENOBARBITAL (UNII: YQE403BP4D) (PHENOBARBITAL - UNII:YQE403BP4D)

Commercializzato da:

Method Pharmaceuticals, LLC

INN (Nome Internazionale):

PHENOBARBITAL

Composizione:

PHENOBARBITAL 16.2 mg

Tipo di ricetta:

PRESCRIPTION DRUG

Stato dell'autorizzazione:

unapproved drug other

Scheda tecnica

ME-PB-HYOS- PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE AND
SCOPOLAMINE
HYDROBROMIDE TABLET
METHOD PHARMACEUTICALS, LLC
_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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ME-PB-HYOS TABLETS
Me-PB-Hyos Tablets
Rx Only
Rev. 04/2014
DESCRIPTION
Me-PB-Hyos Tablets: Each Me-PB-Hyos 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:
Starch 1500, Microcrystalline Cellulose, Silicon Dioxide, Anhydrous
Lactose, Magnesium Stearate.
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.
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.
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