GLYCOPYRROLATE injection, solution

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Medical Purchasing Solutions, LLC

Uygulama yolu:

INTRAMUSCULAR

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

In Anesthesia 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. 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

Ürün özeti:

Glycopyrrolate Injection, USP, 0.2 mg/mL , is a clear colorless solution, and supplied as single and multiple dose vials available in following strengths and package sizes: 0.2 mg/mL, 1 mL vial Single dose vial: NDC 66794-202-02 25 single dose vials in a carton: NDC 66794-202-42 0.2 mg/mL, 2 mL vial Single dose vial: NDC 66794-203-02 25 single dose vials in a carton: NDC 66794-203-42 0.2 mg/mL, 5 mL vial Multiple dose vial: NDC 66794-204-02 25 multiple dose vials in a carton: NDC 66794-204-42 0.2 mg/mL, 20 mL vial Multiple dose vial: NDC 66794-205-02 10 multiple dose vials in a carton: NDC 66794-205-41 Store at controlled room temperature, between 20°C and 25°C (68°F and 77°F). To report SUSPECTED ADVERSE REACTIONS, contact Piramal Critical Care at 1-800-414-1901, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Manufactured for: Piramal Critical Care Bethlehem, PA 18017, USA Product of India Issued: 07/2018

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

GLYCOPYRROLATE- GLYCOPYRROLATE INJECTION, SOLUTION
MEDICAL PURCHASING SOLUTIONS, LLC
----------
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.
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
19
28
3
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).
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.
The highly polar quaternary ammon