GLYCOPYRROLATE tablet

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Alembic Labs LLC

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

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.

Proizvod sažetak:

Glycopyrrolate Tablets USP, 1 mg are white, round tablets with debossing of “OL” above bisect and “305” below bisect on one side and plain on the other side. They are supplied as follows: Bottles of 100 Tablets     (NDC 15955-305-01) Glycopyrrolate Tablets USP, 2 mg are white, round tablets with debossing of “OL” above bisect and “318” below bisect on one side and plain on the other side. They are supplied as follows: Bottles of 100 Tablets     (NDC 15955-318-01) Store at 20˚to 25˚C (68˚to 77˚F) [See USP Controlled Room Temperature].  Dispense in a tight container as defined in the USP. Keep this and all drugs out of the reach of children.  Rx only   Manufactured By: Appco Pharma LLC Piscataway, NJ 08854 Manufactured For: Alembic Labs LLC West Caldwell, NJ 07006 Rev. 12/2020

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

GLYCOPYRROLATE - GLYCOPYRROLATE TABLET
ALEMBIC LABS LLC
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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.
GLYCOPYRROLATE TABLETS 1 MG are white, round-shape, flat face bevel
edge, scored, with “OL” above
bisect and “305” below bisect. Each tablet contains:
Glycopyrrolate, USP..........................1 mg
GLYCOPYRROLATE TABLETS 2 MG are white, round-shape, flat face bevel
edge, scored, with “OL” above
bisect and “318” below bisect. Each tablet contains:
Glycopyrrolate, USP..........................2 mg
INACTIVE INGREDIENTS: Copovidone, Dibasic Calcium Phosphate, Lactose
Anhydrous, Magnesium
Stearate, 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 adjunctiv