glycopyrrolate oral solution

glycopyrrolate oral solution

(glye-koe-pye-roe-late) ,

Cuvposa

(trade name)

Classification

Therapeutic: none assigned
Pharmacologic: anticholinergics
Pregnancy Category: C

Indications

Prevention of excessive drooling associated with neurologic conditions in patients 3-16 yr.

Action

Competitively inhibits peripheral cholinergic receptors, including salivary glands.

Therapeutic effects

↓ problem drooling.

Pharmacokinetics

Absorption: Absorption following oral administration is low and variable; absorption is ↓ by a high fat meal.
Distribution: Unknown.
Metabolism and Excretion: Excreted mostly unchanged in urine (65–80%), small amount eliminated as metabolites.
Half-life: 3–3.2 hr.

Time/action profile

ROUTEONSETPEAK†DURATION
POunknown2.6–3.1 hr6–8 hr
†Blood levels.

Contraindications/Precautions

Contraindicated in: Conditions or concurrent drug therapy for which anticholinergic therapy is contraindicated including glaucoma, paralytic ileus, unstable cardiovascular status due to acute hemorrhage, severe ulcerative colitis, toxic megacolon as a complication of ulcerative colitis, myasthenia gravis; Concurrent use of potassium chloride capsules or tablets (passage through GI tract may be delayed).
Use Cautiously in: High ambient temperatures; ↑ risk of heat prostration (fever and heat stroke) due to ↓ sweating); Renal impairment; Autonomic neuropathy ; Ulcerative colitis (↑ doses may ↑ risk of paralytic ileus [“toxic megacolon”] ); Hyperthyroidism ; Coronary heart disease, HF, cardiac tachyarrhythmias, tachycardia, or hypertension ; Hiatal hernia (may aggravate reflux esophagitis); Obstetric: Use in pregnant women only if clearly needed; Lactation: Use cautiously during lactation; Pediatric: Safety and effectiveness not established in children <3 yr.

Adverse Reactions/Side Effects

Central nervous system

  • seizures (life-threatening)
  • headache (most frequent)
  • abnormal behavior
  • agression
  • agitation
  • crying
  • drowsiness
  • irritability
  • moaning
  • mood altertion
  • poor impulse control
  • restlessness

Ear, Eye, Nose, Throat

  • nasal congestion (most frequent)
  • blurred vision
  • nasal dryness
  • nystagmus

Respiratory

  • ↑ viscosity of secretions

Cardiovascular

  • tachycardia

Gastrointestinal

  • incomplete mechanical intestinal obstruction (life-threatening)
  • constipation (most frequent)
  • dry mouth (most frequent)
  • vomiting (most frequent)
  • abdominal discomfort
  • abdominal distention
  • abnormal taste
  • chapped lips
  • diarrhea
  • flatulence
  • intestinal pseudo-obstruction

Genitourinary

  • urinary retention (most frequent)

Dermatologic

  • flushing (most frequent)
  • dry skin
  • pallor
  • pruritus
  • rash

Fluid and Electrolyte

  • dehydration

Interactions

Drug-Drug interaction

May ↑ levels of digoxin, atenolol, or metformin levels; consider dose reductions or other changes in therapy.Effects may be ↑ by amantadine ; consider ↓ dose of glycoypyrrolate.May ↓ levels of haloperidol or levodopa ; ↑ glycopyrrolate dose may be required.

Route/Dosage

Oral (Children 3–16 yr) 0.02 mg/kg three times daily initially; titrate in increments of 0.02 mg/kg every 5-7 days (not to exceed 0.1 mg/kg three times daily or 1.5-3 mg per dose ).

Availability

Oral solutioncherry: 1 mg/5 mL

Nursing implications

Nursing assessment

  • Assess for constipation (abdominal distension, pain, nausea, vomiting), especially within 4–5 days of initial dose or after dose ↑.

Potential Nursing Diagnoses

Risk for constipation (Adverse Reactions)
Risk for imbalanced body temperature (Adverse Reactions)

Implementation

  • Oral: Administer at least 1 hr before or 2 hrs after meals.

Patient/Family Teaching

  • Instruct patient or parent to take glycopyrrolate as directed. Use an accurate measuring device (dosing cup) for correct dosing and administer with an oral syringe to ensure dose is taken. Dosing is started low and titrated slowly over several wk; do not ↑ dose without consulting health care professional. Advise patient/parent to read Patient and Caregiver Information prior to starting therapy and with each Rx refill.
  • May cause drowsiness or blurred vision. Caution patient to avoid driving or other activities requiring alertness until response to medication is known.
  • If constipation, diarrhea, signs of urinary retention (inability to urinate, dry diapers or undergarments, irritability, crying), or signs of hypersensitivity (rash, hives, allergic reaction) occur, stop administering glycopyrrolate and notify health care professional.
  • May cause ↓ sweating; avoid overheating. Avoid exposure to hot or very warm environments and notify health care professional immediately if signs of heatstroke (hot, red skin; ↓ alertness or unconsciousness, fast, weak pulse; fast, shallow breathing; ↑ temperature.
  • Advise patient to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

Evaluation/Desired Outcomes

  • ↓ in chronic, severe drooling.
References in periodicals archive ?
Randomized phase III evaluation of the efficacy and safety of a novel glycopyrrolate oral solution for the management of chronic severe drooling in children with cerebral palsy or other neurologic conditions.
A multicenter, open-label, 24-week study assessing the safety and efficacy of glycopyrrolate oral solution for the management of pathologic drooling in pediatric patients with cerebral palsy and other neurologic conditions.
a Shionogi company, today announced that it has submitted a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for glycopyrrolate oral solution to treat chronic, moderate-to-severe drooling in pediatric patients.
Ed Schutter, President and Chief Operating Officer of Sciele Pharma, said, "We are pleased to announce the filing of this NDA for glycopyrrolate oral solution, which represents further diversification of our pediatric product portfolio.