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

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Method Pharmaceuticals, LLC

INN (국제 이름):

PHENOBARBITAL

구성:

PHENOBARBITAL 16.2 mg in 5 mL

처방전 유형:

PRESCRIPTION DRUG

승인 상태:

unapproved drug other

제품 특성 요약

ME-PB-HYOS- PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE AND
SCOPOLAMINE
HYDROBROMIDE ELIXIR
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 ELIXIR
Me-PB-Hyos Elixir
Rx only
Rev. 04/2014
DESCRIPTION:
Me-PB-Hyos Elixir - Grape:
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, FD&C Blue #2, FD&C Red #40, Artificial Grape Flavor,
Glycerin, Purified Water,
Saccharin Sodium, Sorbitol, Sucrose.
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