GLYCOPYRROLATE injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Hikma Pharmaceuticals USA Inc.

INN (International Name):

GLYCOPYRROLATE

Composition:

GLYCOPYRROLATE 0.2 mg in 1 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Glycopyrrolate Injection, USP 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, USP 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. 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 ulcer patients, because

Product summary:

Glycopyrrolate Injection, USP, 0.2 mg/mL, is available in: 1 mL single dose vials packaged in 25s                     (NDC 0143-9587-25) 2 mL single dose vials packaged in 25s                     (NDC 0143-9586-25) 5 mL multiple dose vials packaged in 25s                (NDC 0143-9585-25) 20 mL multiple dose vials in 10s                                  (NDC 0143-9584-10) Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Manufactured by: HIKMA FARMACÊUTICA (PORTUGAL), S.A. Estrada do Rio da Mó, 8, 8A e 8B – Fervença – 2705-906 Terrugem SNT, PORTUGAL Distributed by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 NOVAPLUS is a registered trademark of Vizient, Inc. NOVAPLUS® Revised: December 2020 PIN366-NOV/5

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

GLYCOPYRROLATE- GLYCOPYRROLATE INJECTION
HIKMA PHARMACEUTICALS USA INC.
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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:
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, USP 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).
19
28
3
10
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
anticho