ROBINUL Tablet Ref.[50367] Active ingredients: Glycopyrronium

Source: FDA, National Drug Code (US)  Revision Year: 2022 

12.1. Mechanism of Action

Glycopyrrolate, an anticholinergic (antimuscarinic) agent, inhibits the action of acetylcholine on parietal cells in the stomach and decreases the volume and acidity of gastric secretions.

12.2. Pharmacodynamics

No formal pharmacodynamic studies have been conducted with ROBINUL and ROBINUL FORTE.

12.3. Pharmacokinetics

Patients with Renal Impairment

In the published literature, glycopyrrolate 4 mcg/kg was administered intravenously (ROBINUL and ROBINUL FORTE are not recommended for intravenous use) in uremic patients undergoing renal transplantation surgery. The mean AUC (10.6 mcgยทh/L) and 24-hour urinary excretion (7%) for glycopyrrolate were significantly different from normal healthy adult subjects undergoing general surgery (3.7 mcgยทh/L, and 65%, respectively) [see Use in Specific Populations (8.6)].

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Reproduction studies in rats resulted in diminished rates of conception in a dose-related manner. Studies in dogs suggest that diminished rates of conception may be due to diminished seminal secretion, which is evident at high doses of glycopyrrolate.

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