Land: Bandaríkin
Tungumál: enska
Heimild: NLM (National Library of Medicine)
GLYCOPYRROLATE (UNII: V92SO9WP2I) (GLYCOPYRRONIUM - UNII:A14FB57V1D)
Solco Healthcare US, LLC
INTRAMUSCULAR
PRESCRIPTION DRUG
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
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
Abbreviated New Drug Application
Solco Healthcare US, LLC ---------- 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 Lestu allt skjalið
GLYCOPYRROLATE- GLYCOPYRROLATE INJECTION SOLCO HEALTHCARE US, LLC ---------- 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, Lestu allt skjalið