Recommended Oral Dosage of Glycopyrrolate
For patients aged 3-16 years with neurologic conditions and chronic severe drooling, the recommended oral dosage of glycopyrrolate is to initiate at 0.02 mg/kg three times daily and titrate in increments of 0.02 mg/kg every 5-7 days based on therapeutic response and adverse reactions, with a maximum recommended dosage of 0.1 mg/kg three times daily (not exceeding 1.5-3 mg per dose based on weight). 1
Dosing Guidelines for Pediatric Patients
- Glycopyrrolate oral solution should be initiated at 0.02 mg/kg orally three times daily 1
- Dose should be titrated in increments of 0.02 mg/kg every 5-7 days based on therapeutic response and adverse reactions 1
- Maximum recommended dosage is 0.1 mg/kg three times daily, not to exceed 1.5-3 mg per dose based on weight 1
- Medication should be administered at least one hour before or two hours after meals, as high-fat food reduces bioavailability 1
- An accurate measuring device should be used for administration 1
Weight-Based Dosing Schedule
The FDA-approved weight-based dosing schedule for glycopyrrolate oral solution is as follows:
| Weight | Dose Level 1 (~0.02 mg/kg) | Dose Level 2 (~0.04 mg/kg) | Dose Level 3 (~0.06 mg/kg) | Dose Level 4 (~0.08 mg/kg) | Dose Level 5 (~0.1 mg/kg) |
|---|---|---|---|---|---|
| 13-17 kg | 0.3 mg (1.5 mL) | 0.6 mg (3 mL) | 0.9 mg (4.5 mL) | 1.2 mg (6 mL) | 1.5 mg (7.5 mL) |
| 18-22 kg | 0.4 mg (2 mL) | 0.8 mg (4 mL) | 1.2 mg (6 mL) | 1.6 mg (8 mL) | 2.0 mg (10 mL) |
| 23-27 kg | 0.5 mg (2.5 mL) | 1.0 mg (5 mL) | 1.5 mg (7.5 mL) | 2.0 mg (10 mL) | 2.5 mg (12.5 mL) |
| 28-32 kg | 0.6 mg (3 mL) | 1.2 mg (6 mL) | 1.8 mg (9 mL) | 2.4 mg (12 mL) | 3.0 mg (15 mL) |
| 33-37 kg | 0.7 mg (3.5 mL) | 1.4 mg (7 mL) | 2.1 mg (10.5 mL) | 2.8 mg (14 mL) | 3.0 mg (15 mL) |
| 38-42 kg | 0.8 mg (4 mL) | 1.6 mg (8 mL) | 2.4 mg (12 mL) | 3.0 mg (15 mL) | 3.0 mg (15 mL) |
| 43-47 kg | 0.9 mg (4.5 mL) | 1.8 mg (9 mL) | 2.7 mg (13.5 mL) | 3.0 mg (15 mL) | 3.0 mg (15 mL) |
| ≥48 kg | 1.0 mg (5 mL) | 2.0 mg (10 mL) | 3.0 mg (15 mL) | 3.0 mg (15 mL) | 3.0 mg (15 mL) |
Dosing for Other Indications
For diarrhea management in palliative care:
- Consider glycopyrrolate 0.2-0.4 mg IV every 4 hours as needed 2
For anticholinergic premedication in anesthesia:
- Intravenous atropine and glycopyrrolate are acceptable anticholinergic medications to prevent bradycardia, arrhythmia, or occasional ECT-induced cardiac asystole 2
Efficacy and Clinical Response
- In clinical trials, 75% of patients receiving glycopyrrolate oral solution showed at least a 3-point reduction in drooling scores compared to 11% in the placebo group 1
- The effective dose range can vary widely from 0.01 to 0.82 mg/kg per day, highlighting the importance of individualized titration 3
Safety Considerations and Adverse Effects
- The most common adverse reactions (≥30%) are dry mouth, vomiting, constipation, flushing, and nasal congestion 1
- Constipation is a common dose-limiting adverse reaction which sometimes leads to glycopyrrolate discontinuation 1
- Assess patients for constipation, particularly within 4-5 days of initial dosing or after a dose increase 1
- Use with caution in patients with renal impairment as elimination is severely impaired in these patients 1
Contraindications
Glycopyrrolate oral solution is contraindicated in:
- Patients with medical conditions that preclude anticholinergic therapy (e.g., glaucoma, paralytic ileus, unstable cardiovascular status in acute hemorrhage, severe ulcerative colitis, toxic megacolon, myasthenia gravis) 1
- Patients taking solid oral dosage forms of potassium chloride 1
Drug Interactions
- Digoxin tablets: Use with glycopyrrolate can increase digoxin serum levels 1
- Amantadine: Effects of glycopyrrolate may be increased with concomitant administration 1
- Atenolol or metformin: Glycopyrrolate may increase serum levels of these medications 1
- Haloperidol or levodopa: Glycopyrrolate may decrease serum levels of these medications 1
Special Populations
- Safety and effectiveness have not been established in patients less than 3 years of age 1
- Systemic exposure to glycopyrronium is similar between adult and pediatric patients when administered topically 4
- Elderly patients may require dose adjustments, though specific pharmacokinetics have not been characterized in this population 1