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Author: Admin | 2025-04-28
(Solution)Maximum 25 mcg (contents of one single-dose vial) twice daily.Glycopyrrolate/Formoterol Fixed CombinationOral Inhalation (Aerosol)Maximum 18 mcg of glycopyrrolate and 9.6 mcg of formoterol fumarate twice daily.Glycopyrrolate/Indacaterol Fixed CombinationOral Inhalation (Powder)Maximum 15.6 mcg of glycopyrrolate and 27.5 mcg of indacaterol (contents of one capsule) twice daily.Peptic Ulcer DiseaseOral (Tablets)Maximum 8 mg daily. IV or IMMaximum 4 doses daily. Special PopulationsHepatic ImpairmentIM or IV: Manufacturer makes no dosage recommendations.Oral (solution or tablets): Manufacturers make no dosage recommendations. Oral inhalation (powder or solution): No dosage adjustment needed for hepatic impairment. Renal ImpairmentIM or IV: Dosage reduction may be necessary. (See Renal Impairment under Cautions.)Oral inhalation (powder or solution): No dosage adjustment needed in patients with mild to moderate renal impairment. (See Renal Impairment under Cautions.)Geriatric PatientsIM or IV: Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.Oral inhalation (powder or solution): No dosage adjustment needed. Cautions for Glycopyrrolate (Systemic, Oral Inhalation)ContraindicationsOral, IM, IV, and Oral Inhalation:Known hypersensitivity to glycopyrrolate or any ingredient in the formulation. Oral Therapy and Prolonged Parenteral Therapy (e.g., for Treatment of Peptic Ulcer)Angle-closure glaucoma. Obstructive uropathy (e.g., bladder neck obstruction secondary to prostatic hypertrophy). Obstructive GI disease (e.g., pyloroduodenal stenosis, achalasia). Paralytic ileus. Intestinal atony (especially in geriatric and debilitated patients). Severe ulcerative colitis. Toxic megacolon complicating ulcerative colitis. Acute hemorrhage when cardiovascular status is unstable. Myasthenia gravis (unless used to reduce adverse muscarinic effects of an anticholinesterase agent such as neostigmine).Oral solution: Concomitant use of solid dosage forms of potassium chloride.Oral InhalationGlycopyrrolate/indacaterol and glycopyrrolate/formoterol fixed combinations: Patients with asthma without concomitant use of a long-term asthma controller therapy. Warnings/PrecautionsWarningsOverdosageAvoid overdosage. Potential risk of curariform neuromuscular blockade resulting in muscle weakness or paralysis with overdosage. Thermoregulatory EffectsPresence of fever, exposure to high environmental temperatures, and/or physical exertion may result in heat prostration due to decreased sweating, particularly in children and geriatric patients. CNS EffectsRisk of drowsiness. Performance of activities requiring mental alertness (e.g., operating machinery, driving a motor vehicle) may be impaired. Intestinal ObstructionExtreme caution in patients with diarrhea (especially in those with ileostomy or colostomy) because diarrhea may be an early sign of intestinal obstruction. Oral solution: Monitor for constipation, especially during first 4–5 days of therapy or after a dosage increase. Intestinal pseudo-obstruction reported; may present as abdominal distension, pain, nausea, or vomiting.Major ToxicitiesCardiovascular EffectsCaution in cardiac arrhythmias (including tachyarrhythmia), CHF, or CAD since antimuscarinics block vagal inhibition of the SA nodal pacemaker. Investigate cause of tachycardia before administering glycopyrrolate injection, since an increase in heart rate may occur.GI DisordersExtreme caution in known or suspected GI infections because of decreased GI motility and retention of causative organism and/or toxins.Extreme caution in mild to moderate ulcerative colitis;
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