GLYCOPYRROLATE injection

Country: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

Solco Healthcare US, LLC

প্রশাসন রুট:

INTRAMUSCULAR

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

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 ulcer

পণ্য সারাংশ:

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 20o C and 25o C (68o F and 77o 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

অনুমোদন অবস্থা:

Abbreviated New Drug Application

তথ্য লিফলেট

Solco Healthcare US, LLC
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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 20oC and 25oC (68oF and
77oF).
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: 3/2019
Document Id: 3707f06a-6cba-4f5c-86ab-fb95bc2a933c
34391-3
Set id: 3707f06a-6cba-4f5c-86ab-fb95bc2a933c
Version: 1
Effective Time: 20190315
Solco Healthcare US, LLC

পণ্য বৈশিষ্ট্য

GLYCOPYRROLATE- GLYCOPYRROLATE INJECTION
SOLCO HEALTHCARE US, 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 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 across lipid
membranes,