Trospium Chloride (4 brand names, 3 dosage forms, 1 route)
Available dosage forms: TABLET, CAPSULE, EXTENDED RELEASE, CAPSULE.
Routes of administration: ORAL.
Brand Names
- COBENFY
- SANCTURA
- SANCTURA XR
- TROSPIUM CHLORIDE
Indications and Usage
COBENFY is indicated for the treatment of schizophrenia in adults.
Contraindications
COBENFY is contraindicated in patients with: •urinary retention [see Warnings and Precautions (5.1)]. •moderate (Child-Pugh Class B) or severe (Child-Pugh Class C) hepatic impairment [see Warnings and Precautions (5.2)]. •gastric retention [see Warnings and Precautions (5.4)]. •history of hypersensitivity to COBENFY or trospium chloride. Angioedema has been reported with COBENFY and trospium chloride [see Warnings and Precautions (5.5)]. •untreated narrow-angle glaucoma [see Warnings and Precautions (5.6)].
Adverse Reactions
The following clinically significant adverse reactions are described elsewhere in the labeling: •Risk of Urinary Retention [see Warnings and Precautions (5.1)] •Risk of Use in Patients with Hepatic Impairment [see Warnings and Precautions (5.2)] •Risk of Use in Patients with Biliary Disease [see Warnings and Precautions (5.3)] •Decreased Gastrointestinal Motility [see Warnings and Precautions (5.4)] •Risk of Angioedema [see Warnings and Precautions (5.5)] •Risk of Use in Patients with Narrow-angle Glaucoma [see Warnings and Precautions (5.6)] •Increases in Heart Rate [see Warnings and Precautions (5.7)] •Anticholinergic Adverse Reactions in Patients with Renal Impairment [see Warnings and Precautions (5.8)] •Central Nervous System Effects [see Warnings and Precautions (5.9)]
Mechanism of Action
The mechanism of action of xanomeline in the treatment of schizophrenia is unclear; however, its efficacy is thought to be due to its agonist activity at M1 and M4 muscarinic acetylcholine receptors in the central nervous system. Trospium chloride is a muscarinic antagonist. Trospium chloride antagonizes the muscarinic receptors primarily in the peripheral tissues.
Overdosage
Overdose of COBENFY may produce cholinergic, anticholinergic or a combination of cholinergic and anticholinergic signs and symptoms: •Cholinergic Signs and Symptoms: seizures, vomiting, diarrhea, abdominal pain, hyperhidrosis, salivary hypersecretion, and hypotension possibly preceded by hypertension. •Anticholinergic Signs and Symptoms (geriatric patients may be more susceptible): delirium, agitation, garbled speech, dizziness, hypertension, tachycardia, dry mouth and eyes, ileus, blurred vision, and urinary retention. Consider calling the Poison Help Line 1-800-222-1222 or a medical toxicologist for specific treatment recommendations.