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General MedicationsORALHigh Alert

Glycopyrrolate Oral Solution

GLYCOPYRROLATE

Standard Dose
2 DOSAGE AND ADMINISTRATION Glycopyrrolate oral solution must be measured and administered with an accurate measuring device [see Patient Counseling Information (17) ]. Initiate dosing at 0.02 mg/kg orally three times daily and titrate in increments of 0.02 mg/kg every 5 to 7 days based on therapeutic response and adverse reactions. The maximum recommended dosage is 0.1 mg/kg three times daily not to exceed 1.5 to 3 mg per dose based upon weight. For greater detail, see Table 1. During the four-week titration period, dosing can be increased with the recommended dose titration schedule while ensuring that the anticholinergic adverse events are tolerable. Prior to each increase in dose, review the tolerability of the current dose level with the patient's caregiver. Glycopyrrolate oral solution should be dosed at least one hour before or two hours after meals. The presence of high fat food reduces the oral bioavailability of Glycopyrrolate oral solution if taken shortly after a meal [see Clinical Pharmacology (12.3) ]. Table 1: Recommended Dose Titration Schedule (each dose to be given three times daily) Weight Dose Level 1 Dose Level 2 Dose Level 3 Dose Level 4 Dose Level 5 kg lbs (⁓0.02 mg/kg) (⁓0.04 mg/kg) (⁓0.06 mg/kg) (⁓0.08 mg/kg) (⁓0.1 mg/kg) 13-17 27-38 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 39-49 0.4 mg 2 mL 0.8 mg 4 mL 1.2 mg 6 mL 1.6 mg 8 mL 2 mg 10 mL 23-27 50-60 0.5 mg 2.5 mL 1 mg 5 mL 1.5mg 7.5 mL 2 mg 10mL 2.5 mg 12.5mL 28-32 61-71 0.6 mg 3 mL 1.2 mg 6 mL 1.8 mg 9 mL 2.4 mg 12 mL 3 mg 15 mL 33-37 72-82 0.7 mg 3.5 mL 1.4 mg 7 mL 2.1 mg 10.5 mL 2.8 mg 14 mL 3 mg 15 mL 38-42 83-93 0.8 mg 4 mL 1.6 mg 8 mL 2.4 mg 12 mL 3 mg 15 mL 3 mg 15 mL 43-47 94-104 0.9 mg 4.5 mL 1.8 mg 9 mL 2.7 mg 13.5 mL 3 mg 15 mL 3 mg 15 mL ≥48 ≥105 1 mg 5 mL 2 mg 10 mL 3 mg 15 mL 3 mg 15 mL 3 mg 15 mL Initiate dosing at 0.02 mg/kg three times daily and titrate in increments of 0.02 mg/kg every 5 to 7 days, based on therapeutic response and adverse reactions. (2) Maximum recommended dose is 0.1 mg/kg three times daily, not to exceed 1.5 to 3 mg per dose based upon weight. (2) Administer at least one hour before or two hours after meals. (2)
Max Dose
See official label
Primary Use
1 INDICATIONS AND USAGE Glycopyrrolate 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).
Summary

Indications and usage 1 INDICATIONS AND USAGE Glycopyrrolate 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).

Glycopyrrolate oral solution is an anticholinergic indicated to reduce chronic severe drooling in patients aged 3 to 16 years with neurologic conditions associated with problem drooling (e.g., cerebral palsy). (1) Dosage and administration 2 DOSAGE AND ADMINISTRATION Glycopyrrolate oral solution must be measured and administered with an accurate measuring device [see Patient Counseling Information (17) ].

Structured Monograph

Clinical summary

Indications and usage 1 INDICATIONS AND USAGE Glycopyrrolate 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). Glycopyrrolate oral solution is an anticholinergic indicated to reduce chronic severe drooling in patients aged 3 to 16 years with neurologic conditions associated with problem drooling (e.g., cerebral palsy). (1) Dosage and administration 2 DOSAGE AND ADMINISTRATION Glycopyrrolate oral solution must be measured and administered with an accurate measuring device [see Patient Counseling Information (17) ]. Initiate dosing at 0.02 mg/kg orally three times daily and titrate in increments of 0.02 mg/kg every 5 to 7 days based on therapeutic response and adverse reactions. The maximum recommended dosage is 0.1 mg/kg three times daily not to exceed 1.5 to 3 mg per dose based upon weight. For greater detail, see Table 1. During the four-week titration period, dosing can be increased with the recommended dose titration schedule while ensuring that the anticholinergic adverse events are tolerable. Prior to each increase in dose, review the tolerability of the current dose level with the patient's caregiver. Glycopyrrolate oral solution should be dosed at least one hour before or two hours after meals. The presence of high fat food reduces the oral bioavailability of Glycopyrrolate oral solution if taken shortly after a meal [see Clinical Pharmacology (12.3) ]. Table 1: Recommended Dose Titration Schedule (each dose to be given three times daily) Weight Dose Level 1 Dose Level 2 Dose Level 3 Dose Level 4 Dose Level 5 kg lbs (⁓0.02 mg/kg) (⁓0.04 mg/kg) (⁓0.06 mg/kg) (⁓0.08 mg/kg) (⁓0.1 mg/kg) 13-17 27-38 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 39-49 0.4 mg 2 mL 0.8 mg 4 mL 1.2 mg 6 mL 1.6 mg 8 mL 2 mg 10 mL 23-27 50-60 0.5 mg 2.5 mL 1 mg 5 mL 1.5mg 7.5 mL 2 mg 10mL 2.5 mg 12.5mL 28-32 61-71 0.6 mg 3 mL 1.2 mg 6 mL 1.8 mg 9 mL 2.4 mg 12 mL 3 mg 15 mL 33-37 72-82 0.7 mg 3.5 mL 1.4 mg 7 mL 2.1 mg 10.5 mL 2.8 mg 14 mL 3 mg 15 mL 38-42 83-93 0.8 mg 4 mL 1.6 mg 8 mL 2.4 mg 12 mL 3 mg 15 mL 3 mg 15 mL 43-47 94-104 0.9 mg 4.5 mL 1.8 mg 9 mL 2.7 mg 13.5 mL 3 mg 15 mL 3 mg 15 mL ≥48 ≥105 1 mg 5 mL 2 mg 10 mL 3 mg 15 mL 3 mg 15 mL 3 mg 15 mL Initiate dosing at 0.02 mg/kg three times daily and titrate in increments of 0.02 mg/kg every 5 to 7 days, based on therapeutic response and adverse reactions. (2) Maximum recommended dose is 0.1 mg/kg three times daily, not to exceed 1.5 to 3 mg per dose based upon weight. (2) Administer at least one hour before or two hours after meals. (2) Warnings and cautions 5 WARNINGS AND PRECAUTIONS Constipation or intestinal pseudo-obstruction: May present as abdominal distention, pain, nausea, or vomiting. Assess patients for constipation, particularly within 4 to 5 days of initial dosing or after a dose increase. (5.1) Incomplete mechanical intestinal obstruction: May present as diarrhea. If obstruction is suspected, discontinue Glycopyrrolate oral solution and evaluate. (5.2) High ambient temperature: To reduce the risk of heat prostration, avoid high temperatures. (5.3) 5.1 Constipation or Intestinal Pseudo-obstruction Constipation is a common dose-limiting adverse reaction which sometimes leads to glycopyrrolate discontinuation [see Adverse Reactions (6.1) ]. Assess patients for constipation, particularly within 4 to 5 days of initial dosing or after a dose increase. Intestinal pseudo-obstruction has been reported and may present as abdominal distention, pain, nausea or vomiting. 5.2 Incomplete Mechanical Intestinal Obstruction Diarrhea may be an early symptom of incomplete mechanical intestinal obstruction, especially in patients with ileostomy or colostomy. If incomplete mechanical intestinal obstruction is suspected, discontinue treatment with Glycopyrrolate oral solution and evaluate for intestinal obstruction. 5.3 High Ambient Temperatures In the presence of high ambient temperature, heat prostration (fever and heat stroke due to decreased sweating) can occur with the use of anticholinergic drugs such as Glycopyrrolate oral solution. Advise patients/ caregivers to avoid exposure of the patient to hot or very warm environmental temperatures. 5.4 Operating Machinery or an Automobile Glycopyrrolate oral solution may produce drowsiness or blurred vision. As appropriate for a given age, warn the patient not to engage in activities requiring mental alertness such as operating a motor vehicle or other machinery, or performing hazardous work while taking Glycopyrrolate oral solution. 5.5 Anticholinergic Drug Effects Use Glycopyrrolate oral solution with caution in patients with conditions that are exacerbated by anticholinergic drug effects including: Autonomic neuropathy Renal disease Ulcerative colitis – Large doses may suppress intestinal motility to the point of producing a paralytic ileus and for this reason may precipitate or

Monitoring

  • • 5 WARNINGS AND PRECAUTIONS Constipation or intestinal pseudo-obstruction: May present as abdominal distention, pain, nausea, or vomiting.
  • • Assess patients for constipation, particularly within 4 to 5 days of initial dosing or after a dose increase.
  • • (5.1) Incomplete mechanical intestinal obstruction: May present as diarrhea.
  • • If obstruction is suspected, discontinue Glycopyrrolate oral solution and evaluate.

Interaction Notes

  • • 7 DRUG INTERACTIONS Drugs Affected by Reduced GI Transit Time Glycopyrrolate reduces GI transit time, which may result in altered release of certain drugs when formulated in delayed- or controlled-release dosage forms.
  • • The passage of potassium chloride tablets through the GI tract may be arrested or delayed with coadministration of glycopyrrolate.
  • • Solid dosage forms of potassium chloride are contraindicated [see Contraindications (4) ].
  • • Digoxin administered as slow dissolution oral tablets may have increased serum levels and enhanced action when administered with glycopyrrolate.