GLYCOPYRROLATE - glycopyrrolate injection, solution

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Piramal Critical Care Limited

Antoreitti:

INTRAMUSCULAR

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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 pe

Tuoteyhteenveto:

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 71361-001-01 25 single dose vials in a carton:        NDC 71361-001-25 0.2 mg/mL, 2 mL vial Single dose vial:                                NDC 71361-002-01 25 single dose vials in a carton:        NDC 71361-002-25 0.2 mg/mL, 5 mL vial Multiple dose vial:                              NDC 71361-003-01 25 multiple dose vials in a carton:     NDC 71361-003-25 0.2 mg/mL, 20 mL vial Multiple dose vial:                              NDC 71361-004-01 10 multiple dose vials in a carton:     NDC 71361-004-10 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 Inc. at 1-800-414-1901, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Manufactured by: Gland Pharma Limited Survey No. 143 – 148, 150 - 151, Near Gandimaisamma cross road, D P Pally, Quthubullapur Mandal, Ranga Reddy District, Dundigal (post), Hyderabad 500043, Telangana, India.   Distributed by: Piramal Critical Care Inc. 3950 Schelden Circle Bethlehem, PA 18017, USA Product of India Issued: 07/2018

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

GLYCOPYRROLATE - GLYCOPYRROLATE INJECTION, SOLUTION
PIRAMAL CRITICAL CARE LIMITED
----------
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 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
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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