ROBINUL injection

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

West-Ward Pharmaceuticals Corp.

ИНН (Международная Имя):

GLYCOPYRROLATE

состав:

GLYCOPYRROLATE 0.2 mg in 1 mL

Администрация маршрут:

INTRAMUSCULAR

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

ROBINUL 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, ROBINUL 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. 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 of the longer duration

Обзор продуктов:

ROBINUL (glycopyrrolate) Injection, 0.2 mg/mL, is available in:     1 mL single dose vials packaged in 25s (NDC 0641-6104-25)     2 mL single dose vials packaged in 25s (NDC 0641-6105-25)     5 mL multiple dose vials packaged in 25s (NDC 0641-6106-25)     20 mL multiple dose vials in 10s (NDC 0641-6107-10) Store at controlled room temperature, between 20 °C and 25 °C (68 °F and 77 ° F). To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. For Product Inquiry call 1-877-845-0689. Manufactured by: WEST-WARD A HIKMA COMPANY Eatontown, NJ 07724 USA Revised June 2017 462-185-06

Статус Авторизация:

New Drug Application

Характеристики продукта

ROBINUL- ROBINUL INJECTION
WEST-WARD PHARMACEUTICALS CORP.
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ROBINUL INJECTION
(GLYCOPYRROLATE INJECTION, USP)
RX ONLY
NOT FOR USE IN NEONATES
CONTAINS BENZYL ALCOHOL
DESCRIPTION
ROBINUL (glycopyrrolate) Injection 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:
C
H BrNO MW 398.33
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. ROBINUL
(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.
19
28
3
19
28
3
10
Glycopyrrolate antagonizes muscarinic symptoms (e.g., bronchorrhea,
bronchospasm, bradycardia, and
intestinal hypermotility) induced