Caripran Capsule

Caripran Capsule is used for: Schizophrenia, manic or mixed episodes associated with bipolar I disorder, depressive episodes associated with bipolar I disorder (bipolar depression)

Adults Schizophrenia Treatment of schizophrenia Starting dose: 1.5 mg daily Recommended Dose: 1.5 mg to 6 mg daily Bipolar Mania Acute treatment of manic or mixed episodes associated with bipolar I disorder in adults Starting dose: 1.5 mg daily Recommended Dose: 3 mg to 6 mg daily Schizophrenia and Bipolar Mania: Dosages above 6 mg daily do not confer significant benefit but increase the risk of dose-related adverse reactions Bipolar Depression Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) Starting dose: 1.5 mg daily Recommended Dose: 1.5 mg or 3 mg daily Bipolar Depression: The maximum recommended daily dosage is 3 mg

Renal impairment Mild-to-moderate (CrCl >30 mL/min): No dosage adjustment required Severe (CrCl <30 mL/min): Not recommended; safety and efficacy has not been established

Take orally with or without food

History of hypersensitivity to cariprazine

Increased mortality in elderly patients with dementia-related psychosis Elderly patients with dementia-related psychosis treatment with antipsychotic drugs are at an increased risk of death Not approved for treatment of patients with dementia-related psychosis Suicidal thoughts and behaviors Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies Closely monitor all antidepressant-treated patients for clinical worsening, and for the emergence of suicidal thoughts and behaviors Safety and effectiveness of cariprazine has not been established in pediatric patients Cerebrovascular Adverse Reactions in Elderly Patients with Dementia Related Psychosis: Increased incidence of cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack) Neuroleptic Malignant Syndrome: Manage with immediate discontinuation and close monitoring Tardive Dyskinesia: Discontinue if appropriate Late-Occurring Adverse Reactions: Because of Cariprazine’s long halflife, monitor for adverse reactions and patient response for several weeks after starting Cariprazine and with each dosage change Metabolic Changes: Monitor for hyperglycemia/diabetes mellitus, dyslipidemia and weight gain Leukopenia, Neutropenia, and Agranulocytosis: Perform complete blood counts (CBC) in patients with pre-existing low white blood cell counts (WBC) or history of leukopenia or neutropenia. Consider discontinuing Cariprazine if a clinically significant decline in WBC occurs in absence of other causative factors Orthostatic Hypotension: Monitor heart rate and blood pressure and warn patients with known cardiovascular or cerebrovascular disease, and risk of dehydration or syncope Seizures: Use cautiously in patients with a history of seizures or with conditions that lower the seizure threshold Potential for Cognitive and Motor Impairment: Use caution when operating machinery Monitoring Parameters Monitor for hyperpyrexia, muscle rigidity, delirium, and autonomic instability; other signs include increased CPK, myoglobinuria (rhabdomyolysis), and acute renal failure Monitor for hyperglycemia/diabetes mellitus, dyslipidemia and weight gain Perform complete blood counts (CBC) in patients with pre-existing low white blood cell counts (WBC) or history of leukopenia or neutropenia Monitor heart rate and blood pressure and warn patients with known cardiovascular or cerebrovascular disease, and risk of dehydration or syncope

Pregnancy Neonates exposed to antipsychotic drugs during third trimester of pregnancy are at risk for extrapyramidal symptoms or withdrawal symptoms after delivery; these complications vary in severity, with some being self-limited and others requiring ICU support and prolonged hospitalization Animal data Administration in pregnant rats during organogenesis at doses 0.2 to 3.5 times maximum recommended human dose caused fetal developmental toxicity at all doses, including reduced body weight, decreased male anogenital distance, and skeletal malformations of bent limb bones, scapula, and humerus Decreased postnatal survival, birth weight, and post-weaning body weight was also observed Lactation Unknown if distributed in human breast milk Present in rat milk Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition

Coadministration with a strong CYP3A4 inhibitor increases the exposures of cariprazine and its major active metabolite, didesmethylcariprazine (DDCAR), compared to use of cariprazine alone Effect of CYP3A4 inducers on the exposure of cariprazine has not been evaluated, and net effect is unclear Contraindicated (24) amisulpride bosentan carbamazepine dabrafenib dexamethasone efavirenz enzalutamide eslicarbazepine acetate etravirine fosphenytoin lumacaftor/ivacaftor mitotane nafcillin nevirapine oxcarbazepine pentobarbital phenobarbital phenytoin primidone rifabutin rifampin rifapentine St John's Wort thalidomide

Side effects of Cariprazine : >10% (Schizophrenia) Extrapyramidal symptoms, all (24-33%) Parkinsonism (13-18%) Headache (9-18%) Akathisia (9-14%) Insomnia (11-13%) Bipolar mania Extrapyramidal symptoms, all (41-45%) Extrapyramidal symptoms, excluding akathisia/restlessness (26-29%) Parkinsonism (21-26%) Akathisia (20-21%) Headache (13-14%) Nausea (11-13%) Constipation (6-11%) Bipolar depression Extrapyramidal symptoms, all (10-19%) 1-10% Decreased appetite (>1%) Schizophrenia Constipation (6-10%) Somnolence (5-10%) Nausea (5-8%) Abdominal pain (3-7%) Restlessness (4-6%) Anxiety (3-6%) Toothache (3-6%) Hypertension (2-7%) Dyspepsia (4-5%) Vomiting (4-5%) Dizziness (3-5%) Agitation (3-5%) Diarrhea (1-5%) Pain in extremity (2-4%) Cough (1-4%) Tachycardia (2-3%) Increased weight (2-3%) Decreased appetite (1-3%) Dry mouth (1-3%) Fatigue (1-3%) Increased CPK (1-3%) Musculoskeletal stiffness (<3%) Back pain (1-3%) Dystonia (2%) Tachycardia (1-2%) Arthralgia (1-2%) Hepatic enzyme increased (1-2%) Nasopharyngitis (1-2%) Urinary tract infections (1-2%) Rash (1-2%) Bipolar mania Vomiting (8-10%) Insomnia (8-9%) Dyspepsia (7-9%) Somnolence (7-8%) Abdominal pain (6-8%) Restlessness (7%) Dizziness (6-7%) Diarrhea (5-6%) Hypertension (4-5%) Fatigue (4-5%) Dystonia (3-5%) Blurred vision (4%) Decreased appetite (3-4%) Toothache (3-4%) Pain in extremity (2-4%) Pyrexia (1-4%) Weight increased (2-3%) Increased CPK (2-3%) Dry mouth (2-3%) Oropharyngeal pain (1-3%) Back pain (1-3%) Hepatic enzymes increased (1-3%) Musculoskeletal stiffness (2%) Tachycardia (1-2%) Bipolar depression Insomnia (7-10%) Akathisia (6-10%) Nausea (7%) Somnolence (6-7%) Restlessness (2-7%) Extrapyramidal symptoms, excluding akathisia/restlessness (4-6%) Dizziness (3-4%) Fatigue (3-4%) Parkinsonism (3-4%) Increased appetite (3%) Increased weight (2%) Musculoskeletal stiffness (<1%) <1% Gastroesophageal reflux disease (0.1-1%) Gastritis (0.1-1%) Suicide attempts (0.1-1%) Suicide ideation (0.1-1%) Hyponatremia (0.1-1%) Pollakiuria (0.1-1%) Hyperhidrosis (0.1-1%) Rhabdomyolysis (0.1%) Ischemic stroke (0.1%) Completed suicide (0.1%) Hepatitis (0.1%) Bipolar disorder Tardive dyskinesia (<1%) Dystonia (<1%)

Precise mechanism by which cariprazine works for schizophrenia or bipolar disorder is unknown Efficacy could be mediated through a combination of partial agonist activity at central dopamine (D2) and serotonin 5-HT1A receptors Forms 2 major metabolites, desmethyl cariprazine (DCAR) and didesmethyl cariprazine (DDCAR), that have in vitro receptor binding profiles similar to the parent drug

Caripran 1.5 mg Capsule manufactured by Incepta Pharmaceuticals Ltd.. Its generic name is Cariprazine. Caripran is availble in Bangladesh. Farmaco BD drug index information on Caripran Capsule is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.