GLYCOPYRROLATE tablet

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

AvKARE

INN (nume internaţional):

GLYCOPYRROLATE

Compoziție:

GLYCOPYRROLATE 1 mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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.

Rezumat produs:

Glycopyrrolate tablets 1 mg are bisected, compressed white, round tablets debossed “EP” above the bisect and “139” below the bisect on one side of the tablet, and plain on the other side. Available in bottles of 90 (NDC 42291-303-90) Glycopyrrolate tablets 2 mg are bisected, compressed white, round tablets debossed “EP” above the bisect and “140” below the bisect on one side of the tablet, and plain on the other side. Available in bottles of 90 (NDC 42291-304-90) Store at Controlled Room Temperature 20° - 25°C (68° - 77°F). Dispense in a tight, light-resistant container as defined in the USP, using a child-resistant closure. Rx only Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Mfg. Rev. 08/16 AV Rev. 11/18 (P)

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

GLYCOPYRROLATE- GLYCOPYRROLATE TABLET
AVKARE
----------
GLYCOPYRROLATE TABLETS, USP
RX ONLY
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
emprical formula is C
H
BrNO
, its molecular weight is 398.33, and its structural
formula is:
Each 1 mg tablet contains: Glycopyrrolate USP, 1 mg
Each 2 mg tablet contains: Glycopyrrolate USP, 2 mg
Inactive ingredients:
Dibasic Calcium Phosphate, Lactose, Magnesium Stearate, Povidone, and
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
19
28
3
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
For use as adjunctive therapy in the treatment of peptic ulcer.
CONTRAINDICATIONS
Glaucoma; obstructive uropathy (for example, bladder neck obstruction
due to prostatic
hypertrophy); obstructive disease of the gastrointestinal tract (as in
achalasia,
pyloroduodenal steno