PROPANTHELINE BROMIDE tablet, film coated

Country: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

PROPANTHELINE BROMIDE (UNII: UX9Z118X9F) (PROPANTHELINE - UNII:1306V2B0Q8)

থেকে পাওয়া:

West-Ward Pharmaceuticals Corp.

INN (International Name):

PROPANTHELINE BROMIDE

রচনা:

PROPANTHELINE BROMIDE 15 mg

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

Propantheline bromide is effective as adjunctive therapy in the treatment of peptic ulcer. Propantheline is contraindicated in patients with:

পণ্য সারাংশ:

Propantheline Bromide Tablets USP 15 mg tablets are supplied as white, film-coated tablets imprinted in black ink with product identification “54 303.” NDC 0054-4721-25: Bottles of 100 Tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in tight, light-resistant container as defined in the USP/NF. Distr. by: West-Ward Pharmaceuticals Corp. Eatontown, NJ 07724 4071101//07 Revised March 2016

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

PROPANTHELINE BROMIDE- PROPANTHELINE BROMIDE TABLET, FILM COATED
WEST-WARD PHARMACEUTICALS CORP.
----------
PROPANTHELINE BROMIDE TABLETS USP
RX ONLY
DESCRIPTION
Each tablet for oral administration contains:
Propantheline bromide
USP.................................................. 15 mg
Propantheline bromide, a synthetic quaternary ammonium compound,
occurs as white or nearly white
crystals. It is odorless and has a bitter taste, and is very soluble
in water and chloroform; practically
insoluble in ether, acetone and ethyl acetate. It is designated
chemically as (2-Hydroxyethyl)
diisopropylmethyl-ammonium bromide xanthene-9-carboxylate.
The structural formula is:
INACTIVE INGREDIENTS
Each tablet contains corn starch, hydrogenated vegetable oil, lactose
monohydrate and magnesium
stearate. In addition to the ingredients listed above, each tablet
contains Opacode Black (monogramming
ink), Opadry Clear and Opadry White. Opacode Black contains ammonium
hydroxide, black iron oxide,
isopropyl alcohol, n-butyl alcohol, propylene glycol and shellac
glaze. Opadry Clear contains
hypromellose and polyethylene glycol. Opadry White contains
hypromellose, polyetheylene glycol,
polysorbate 80 and titanium dioxide.
CLINICAL PHARMACOLOGY
Propantheline bromide inhibits gastrointestinal motility and
diminishes gastric acid secretion. The drug
also inhibits the action of acetylcholine at the postganglionic nerve
endings of the parasympathetic
nervous system.
Propantheline bromide is extensively metabolized in man primarily by
hydrolysis to the inactive
materials xanthene-9-carboxylic acid and (2-hydroxyethyl)
diisopropylmethylammonium bromide. In a
bioavailability study, peak plasma concentrations of propantheline
were achieved in about one hour,
following a single oral dose.
The plasma elimination half-life of propantheline is about 1.6 hours.
Approximately 70% of the dose is
excreted in the urine, mostly as metabolites. The urinary excretion of
propantheline is about 3% after
oral tablet administration.
INDICATIONS AND USAGE
Prop