GLYCOPYRROLATE solution

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

Somerset Therapeutics, LLC

प्रशासन का मार्ग:

INTRAMUSCULAR

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

In Anesthesia: Glycopyrrolate Injection is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation. When indicated, Glycopyrrolate Injection may be used intraoperatively to counteract surgically or drug - induced or vagal reflexes associated arrhythmias. Glycopyrrolate protects against the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing muscle relaxants. In Peptic Ulcer: For use in adults as adjunctive therapy for the treatment of peptic ulcer when rapid anticholinergic effect is desired or when oral medication is not tolerated. Known hypersensitivity to glycopyrrolate or any of its inactive ingredients. In addition, in the management of peptic u

उत्पाद समीक्षा:

Glycopyrrolate Injection, 0.2 mg/mL, is available as: 4 mg/20 mL (0.2 mg/mL) Multiple-dose Vials packaged in 10s (NDC 70069-616 -10)    Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Trademarks are the property of their respective owners. To report SUSPECTED ADVERSE REACTIONS, contact Somerset Therapeutics, LLC at 1-800-417-9175 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024 Made in India Code No.:KR/DRUGS/KTK/28/289/97 ST- GLY/P/00 Revised: February, 2022

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

GLYCOPYRROLATE - GLYCOPYRROLATE SOLUTION
SOMERSET THERAPEUTICS, LLC
----------
GLYCOPYRROLATE INJECTION, USP
RX ONLY
NOT FOR USE IN NEONATES
CONTAINS BENZYL ALCOHOL
DESCRIPTION
Glycopyrrolate Injection is a synthetic anticholinergic agent.
Each 1 mL contains:
Glycopyrrolate, USP 0.2 mg
Water for Injection, USP q.s.
Benzyl Alcohol, NF 0.9 % (preservative)
pH adjusted, when necessary, with hydrochloric acid and/or sodium
hydroxide.
For Intramuscular (IM) or Intravenous (IV) administration.
Glycopyrrolate is a quaternary ammonium salt with the following
chemical name:
3[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethyl pyrrolidinium
bromide. The
molecular formula is C
H
BrNO and the molecular weight is 398.33.
Its structural formula is as follows:
Glycopyrrolate occurs as a white, odorless crystalline powder. It is
soluble in water and
alcohol, and practically insoluble in chloroform and ether.
Unlike atropine, glycopyrrolate is completely ionized at physiological
pH values.
Glycopyrrolate Injection is a clear, colorless, sterile liquid; pH 2.0
– 3.0. The partition
coefficient of glycopyrrolate in a n-octanol /water system is 0.304
(log
P= -1.52) at
19
28
3
10
ambient room temperature (24°C).
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 sinoatrial 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.