Cotempla Xr-odt Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Generic Availability
Mechanism of Action
Cotempla Xr-odt Indications
Indications
Cotempla Xr-odt Dosage and Administration
Adults and Children
Cotempla Xr-odt Contraindications
Contraindications
Cotempla Xr-odt Boxed Warnings
Boxed Warning
Abuse, misuse, and addiction.
Cotempla Xr-odt Warnings/Precautions
Warnings/Precautions
High potential for abuse, misuse, and addiction; assess patient's risk before prescribing. Assess for presence of cardiac disease before initiating. Avoid in known structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other cardiac disease. Pre-existing psychotic disorder. Bipolar disorder. Screen for risk factors in developing a manic episode prior to initiation. Consider discontinuing if psychotic/manic symptoms occur. Peripheral vasculopathy, including Raynaud’s phenomenon; monitor for digital changes. Risk for acute angle closure glaucoma. History of increased IOP or open angle glaucoma; monitor closely. Assess family history and evaluate for tics or Tourette’s syndrome before initiating; monitor for emergence or worsening, and discontinue if clinically appropriate. Monitor BP, HR, growth in children. Reduce dose or discontinue if paradoxical aggravation of symptoms occur. Reevaluate periodically. Pregnancy. Nursing mothers: monitor infants.
Cotempla Xr-odt Pharmacokinetics
Absorption
Median time to maximum plasma concentration: 5 hours after dosing.
Elimination
Renal (90%). Half-life: ~4 hours.
Cotempla Xr-odt Interactions
Interactions
See Contraindications. Concomitant gastric pH modulators (eg, omeprazole, famotidine, sodium bicarbonate): not recommended. May decrease effectiveness of antihypertensive drugs (eg, K+-sparing or thiazide diuretics, CCBs, ACE inhibitors, ARBs, beta blockers, centrally acting alpha-2 receptor agonists); monitor and adjust dose of antihypertensives as needed. Concomitant halogenated anesthetics may increase the risk of sudden BP and HR increase during surgery; avoid use. Concomitant risperidone may increase risk of extrapyramidal symptoms; monitor.
Cotempla Xr-odt Adverse Reactions
Adverse Reactions
Appetite decreased, insomnia, nausea, vomiting, dyspepsia, abdominal pain, weight decreased, anxiety, dizziness, irritability, affect lability, tachycardia, BP increased; priapism, glaucoma, motor/verbal tics.
Cotempla Xr-odt Clinical Trials
See Literature
Cotempla Xr-odt Note
Notes
Cotempla Xr-odt Patient Counseling
See Literature