ROBINUL- glycopyrrolate tablet ROBINUL FORTE- glycopyrrolate tablet

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

GLYCOPYRROLATE (UNII: V92SO9WP2I) (GLYCOPYRRONIUM - UNII:A14FB57V1D)

Доступна з:

Shionogi Inc.

ІПН (Міжнародна Ім'я):

GLYCOPYRROLATE

Склад:

GLYCOPYRROLATE 1 mg

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

For use as adjunctive therapy in the treatment of peptic ulcer. 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; toxic megacolon complicating ulcerative colitis; myasthenia gravis. Robinul (glycopyrrolate) tablets are contraindicated in those patients with a hypersensitivity to glycopyrrolate.

Огляд продуктів:

Robinul® (glycopyrrolate, 1 mg) tablets in bottles of 100 (NDC 59630-200-10). Robinul® Forte (glycopyrrolate, 2 mg) tablets in bottles of 100 (NDC 59630-205-10). Store at controlled room temperature, 20°C to 25°C (68°F to 77°F); excursions permitted to   15°-30°C (59°-86°F)[see USP Controlled Room Temperature]. Keep out of reach of children. Dispense in tight container Rx only Manufactured by: MIKART, INC. Atlanta, GA 30318 Manufactured for: Shionogi Inc. Florham Park, NJ 07932 ROB-PI-3 Rev. 12/11 Printed in USA

Статус Авторизація:

New Drug Application

Характеристики продукта

ROBINUL- GLYCOPYRROLATE TABLET
ROBINUL FORTE- GLYCOPYRROLATE TABLET
SHIONOGI INC.
----------
ROBINUL AND ROBINUL FORTE
DESCRIPTION
Robinul
and Robinul
Forte tablets contain the synthetic anticholinergic, glycopyrrolate.
Glycopyrrolate is a quaternary ammonium compound with the following
chemical name: 3-
[(cyclopentylhydroxyphenylacetyl)oxy]-1, 1-dimethylpyrrolidinium
bromide.
ROBINUL tablets are scored, compressed white tablets engraved HPC 200.
Each tablet contains:
Glycopyrrolate, USP
............................................................................................................
1 mg
ROBINUL FORTE tablets are scored, compressed white tablets engraved
HORIZON 205. Each
tablet contains:
Glycopyrrolate,
USP..............................................................................................................
2 mg
INACTIVE INGREDIENTS: Dibasic Calcium Phosphate, Lactose, Magnesium
Stearate, Povidone, Sodium
Starch Glycolate
ACTIONS
Glycopyrrolate, like other anticholinergic (antimuscarinic) agents,
inhibits the action of
acetylcholine on structures innervated by postganglionic cholinergic
nerves and on smooth muscles that
respond to acetylcholine but lack cholinergic innervation. These
peripheral cholinergic receptors are
present in the autonomic effector cells of smooth muscle, cardiac
muscle, the sino-atrial node, the
atrioventricular node, exocrine glands, and, to a limited degree, in
the autonomic ganglia. Thus, it
diminishes the volume and free acidity of gastric secretions and
controls excessive pharyngeal,
tracheal, and bronchial secretions.
Glycopyrrolate antagonizes muscarinic symptoms (e.g., bronchorrhea,
bronchospasm, bradycardia, and
intestinal hypermotility) induced by cholinergic drugs such as the
anticholinesterases.
The highly polar quaternary ammonium group of glycopyrrolate limits
its passage across
lipid membranes, such as the blood-brain barrier, in contrast to
atropine sulfate and
scopolamine hydrobromide, which are non-polar tertiary amines which
penetrate lipid barriers e