GLYCOPYRROLATE tablet

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Par Pharmaceutical, Inc.

INN (Rahvusvaheline Nimetus):

GLYCOPYRROLATE

Koostis:

GLYCOPYRROLATE 1 mg

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

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. Glycopyrrolate tablets are contraindicated in those patients with a hypersensitivity to glycopyrrolate.

Toote kokkuvõte:

Glycopyrrolate tablets 1 mg are bisected, compressed white, round tablets debossed “K” above the bisect and “400” below the bisect on one side of the tablet, and plain on the other side. Available in bottles of 100 (NDC 49884-065-01). Glycopyrrolate tablets 2 mg are bisected, compressed white, round tablets debossed “K” above the bisect and “401” below the bisect on one side of the tablet, and plain on the other side. Available in bottles of 100 (NDC 49884-066-01). Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Dispense in tight container. Rx only * Dopram® is a registered trademark of Baxter Healthcare Corporation. Manufactured by: Par Pharmaceutical Companies, Inc. Spring Valley, NY 10977 Rev: 07/2010 OS065-01-1-02

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

GLYCOPYRROLATE- GLYCOPYRROLATE TABLET
PAR PHARMACEUTICAL, INC.
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GLYCOPYRROLATE
DESCRIPTION
Glycopyrrolate tablets contain the synthetic anticholinergic
glycopyrrolate. Glycopyrrolate is a
quaternary ammonium compound with the following chemical name:
3-[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethylpyrrolidinium
bromide. Its empirical formula is
C
H BrNO , its molecular weight is 398.33, and its structural formula
is:
Each 1 mg tablet contains: Glycopyrrolate, USP 1mg
Each 2 mg tablet contains: Glycopyrrolate, USP 2mg
Inactive Ingredients: Dibasic Calcium Phosphate, Lactose, Magnesium
Stearate, Povidone, Sodium
Starch Glycolate
CLINICAL PHARMACOLOGY
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 easily.
INDICATIONS AND USAGE
For use as adjunctive therapy in the treatment of peptic ulcer.
CONTRAINDICATIONS
Glaucoma; obstructive uropathy (for example, bladder neck obstruction
due to prostatic hypertrophy);
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28
3
obstructive disease of the gastrointestinal tract (as in achalasia,
pyloro