GLYRX-PF

The following pharmacokinetic information and conclusions were obtained from published studies that used nonspecific assay methods.

DistributionThe mean volume of distribution of glycopyrrolate was estimated to be 0.42 ± 0.22 L/kg.

Elimination

MetabolismThe in vivo metabolism of glycopyrrolate in humans has not been studied.

ExcretionThe mean clearance and mean t 1/2 values were reported to be 0.54 ± 0.14 L/kg/hr and 0.83 ± 0.27 hr, respectively post IV administration. After IV administration...

The following adverse reactions were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Adverse reactions to anticholinergics include xerostomia (dry mouth); urinary hesitancy and retention; blurred vision and photophobia due to mydriasis (dilation of the pupil); cycloplegia; increa...

GLYRX ® -PF is contraindicated in:

• patients with known hypersensitivity to glycopyrrolate or any of its inactive ingredients.
• peptic ulcer patients with the following concurrent conditions: glaucoma; obstructive uropathy (for example, bladder neck obstruction due to prostatic hypertrophy); obstructive disease of the gastrointestinal tract (as in achalasia, pyloroduodenal stenosis, etc.); paral...

• Precipitation of Acute Glaucoma : Glycopyrrolate may cause mydriasis and increase intraocular pressure in patients with glaucoma. Advise patients with glaucoma to promptly seek medical care if they experience symptoms of acute angle closure glaucoma. ( 5.1 )
• Drowsiness or Blurred Vision : May cause drowsiness or blurred vision. Advise patients not to drive or perform hazardous work until resolved. ( 5.2 )
• Heat Prostration : Advise patients to avoid exertion and high environmental temperatu...

7 DRUG INTERACTIONS The concurrent use of GLYRX ® -PF with other anticholinergics or medications with anticholinergic activity, such as phenothiazines, antiparkinson drugs, or tricyclic antidepressants, may intensify the antimuscarinic effects and result in an increase in anticholinergic side effects. Concomitant administration of GLYRX ® -PF and potassium chloride in a wax matrix may increase the...