ROBINUL Solution for injection Ref.[50366] Active ingredients: Glycopyrronium

Source: FDA, National Drug Code (US)  Revision Year: 2017 

Product 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 C19H28BrNO3 and the molecular weight is 398.33.

Its structural formula is as follows:

C19H28BrNO3 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 (log10 P= -1.52) at ambient room temperature (24°C).

How Supplied

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)

Manufactured by: WEST-WARD, A HIKMA COMPANY, Eatontown, NJ 07724 USA

Drugs

Drug Countries
ROBINUL Austria, Estonia, Finland, New Zealand, Romania, United States, South Africa

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