Glycopyrronium Bromide

Introduction: Glycopyrronium Bromide oral solution is indicated to reduce chronic severe drooling in patients aged 3 to 16 years with neurologic conditions associated with problem drooling (e.g., cerebral palsy).

How it works: Glycopyrrolate is a competitive inhibitor of acetylcholine receptors that are located on certain peripheral tissues, including salivary glands. Glycopyrrolate indirectly reduces the rate of salivation by preventing the stimulation of these receptors.

Important Information: Dose at least one hour before or two hours after meals. High-fat food reduces oral bioavailability.

• Chronic severe drooling: in patients aged 3-16 years with neurologic conditions (e.g., cerebral palsy)

Anticholinergics (antimuscarinics)/ Anti-spasmodics

Anticholinergic Agent

Glycopyrrolate is a competitive inhibitor of acetylcholine receptors that are located on certain peripheral tissues, including salivary glands. Glycopyrrolate indirectly reduces the rate of salivation by preventing the stimulation of these receptors. Glycopyrrolate inhibits the action of acetylcholine on salivary glands thereby reducing the extent of salivation.

Glycopyrronium Bromide inhibits acetylcholine receptors to reduce salivary gland stimulation, thereby decreasing salivation.

Initial Dose:

• 0.02 mg/kg orally three times daily
• Titrate in increments of 0.02 mg/kg every 5-7 days
• Maximum: 0.1 mg/kg three times daily (not to exceed 1.5-3 mg per dose)

Administration:

• At least one hour before or two hours after meals
• Use accurate measuring device

* Use as directed by the registered physician

Oral solution. Use accurate measuring device. Take at least 1 hour before or 2 hours after meals.

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and follow your regular schedule.

Common Side Effects:

• Abdominal distention
• Abdominal pain
• Chapped lips, dry tongue
• Constipation
• Headache
• Nasal congestion
• Dry skin
• Restlessness, agitation
• Upper respiratory tract infection
• Urinary tract infection

Precautions:

• Constipation is a common dose-limiting reaction - monitor within 4-5 days of initial dosing or after dose increase
• Heat prostration can occur in high ambient temperatures - avoid exposure to hot environments
• May cause drowsiness or blurred vision - avoid driving or operating machinery

Contraindications:

• Glaucoma
• Paralytic ileus
• Unstable cardiovascular status in acute hemorrhage
• Severe ulcerative colitis
• Toxic megacolon
• Myasthenia gravis
• Patients taking solid oral dosage forms of potassium chloride

Drug Interactions:

• Digoxin: May increase serum digoxin levels
• Amantadine: May increase glycopyrrolate effects
• Atenolol or metformin: May increase serum levels
• Haloperidol or levodopa: May decrease serum levels

Food Interactions:

• High-fat food reduces oral bioavailability - take 1 hour before or 2 hours after meals

Use in Pregnancy: No adequate data in pregnant women. Use only if potential benefit justifies potential risk to the fetus.

Use in Lactation: No data on presence of glycopyrrolate or its metabolites in human milk. Use with caution.

Pediatric Use: Efficacy and safety established in patients 3-16 years. Not studied in patients under 3 years.

Geriatric Use: Clinical studies did not include subjects aged 65 and over.

Renal Impairment: Glycopyrrolate is largely renally eliminated - use with caution in renal impairment.

Hepatic Impairment: No specific restrictions. Use with caution.

Overdose: Glycopyrrolate is a quaternary amine which does not easily cross the BBB - symptoms are peripheral. Maintain open airway, provide ventilation, manage hyperthermia, coma or seizures. Neostigmine may be administered.

Storage: Keep below 30°C, away from light and moisture. Keep out of reach of children.

Glycopyrronium Bromide Oral Solution