GLYCOPYRROLATE injection

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Medical Purchasing Solutions, LLC

Calea de administrare:

INTRAMUSCULAR

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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

Rezumat produs:

Glycopyrrolate injection, 0.2 mg/mL, is clear and colorless solution, essentially free of visible foreign matter and available in: 1 mL single dose vials (NDC 43547-543-01) packaged in 25s (NDC 43547-543-25) 2 mL single dose vials (NDC 43547-544-01) packaged in 25s (NDC 43547-544-25) Store at controlled room temperature, between 20 o C and 25 o C (68 o F and 77 o F). To report SUSPECTED ADVERSE REACTIONS, contact Solco Healthcare US, LLC at 1-866-257-2597, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. For Product Inquiry call Solco Healthcare US, LLC at 1-866-257-2597. Manufactured for: Solco Healthcare US, LLC Somerset, NJ 08873, USA Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xunqiao, Linhai, Zhejiang 317024, China Revised: 12/2018 26697-01

Statutul autorizaţiei:

Abbreviated New Drug Application

Prospect

Medical Purchasing Solutions, LLC
----------
HOW SUPPLIED
Glycopyrrolate injection, 0.2 mg/mL, is clear and colorless solution,
essentially free of visible foreign
matter and available in:
1 mL single dose vials (NDC 43547-543-01) packaged in 25s (NDC
43547-543-25)
2 mL single dose vials (NDC 43547-544-01) packaged in 25s (NDC
43547-544-25)
Store at controlled room temperature, between 20 oC and 25 oC (68 oF
and 77 oF).
To report SUSPECTED ADVERSE REACTIONS, contact Solco Healthcare US,
LLC at 1-866-257-
2597, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
For Product Inquiry call Solco Healthcare US, LLC at 1-866-257-2597.
Manufactured for:
Solco Healthcare US, LLC
Somerset, NJ 08873, USA
Manufactured by:
Zhejiang Huahai Pharmaceutical Co., Ltd.
Xunqiao, Linhai, Zhejiang 317024, China
Revised: 12/2018
26697-01
Revised: 5/2023
Document Id: fad2cfd6-08a1-a491-e053-6394a90a5043
34391-3
Set id: a2a2a03f-21cc-5fec-e053-2995a90a84cb
Version: 2
Effective Time: 20230503
Medical Purchasing Solutions, LLC

Caracteristicilor produsului

GLYCOPYRROLATE- GLYCOPYRROLATE INJECTION
MEDICAL PURCHASING SOLUTIONS, LLC
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GLYCOPYRROLATE INJECTION, USP, R ONLY
DESCRIPTION
Glycopyrrolate injection is a synthetic anticholinergic agent. Each 1
mL contains:
Glycopyrrolate, USP 0.2 mg
Water for Injection, USP q.s.
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
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
X
19
28
3
10
o
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