GLYCOPYRROLATE injection

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

A-S Medication Solutions

관리 경로:

INTRAMUSCULAR

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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 injection or any of its inactive ingredients. In addition, in the management of pe

제품 요약:

Product: 50090-4513 NDC: 50090-4513-0 1 mL in a VIAL

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

GLYCOPYRROLATE- GLYCOPYRROLATE INJECTION
A-S MEDICATION SOLUTIONS
----------
GLYCOPYRROLATE INJECTION, USP
RX ONLY
NOT FOR USE IN NEONATES
CONTAINS BENZYL ALCOHOL
DESCRIPTION
Glycopyrrolate injection, USP 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:
C
H
BrNO MW 398.33
Glycopyrrolate, USP 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, USP is a clear, colorless, sterile liquid;
pH 2.0 to 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).
19
28
3
19
28
3
10
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