Aripen Tablet

Aripen Tablet is used for: Major depressive disorder, Schizophrenia, Acute manic episodes of bipolar disorder, Agitation, Irritability in autism

Adult: Oral Schizophrenia Initial: 10-15 mg once daily. Maintenance: 15 mg once daily. Max: 30 mg once daily without regard to food. Dose increment should not be made before 2 weeks, the time needed to achieve steady state. Bipolar Mania Indicated for maintenance monotherapy treatment of bipolar I disorder in adults Indicated for acute and maintenance treatment of manic or mixed episodes associated with bipolar I disorder, either as monotherapy or as an adjunct to lithium or valproate Monotherapy: 15 mg/day PO initially; may be increased gradually; not to exceed 30 mg/day Adjunct to lithium or valproate: 10-15 mg/day PO initially; recommended daily dose is 15 mg/day; may be gradually increased; not to exceed 30 mg/day Continue stabilization dose for up to 6 weeks; treatment >6 weeks not studied Major Depressive Disorder 2-5 mg/day PO initially; increased weekly PRN by <5 mg/day to a dose range of 2-15 mg/day

Schizophrenia 13-17 years: 2 mg/day PO initially; increased to 5 mg/day after 2 days; increased to recommended dosage of 10 mg/day after additional 2 days; may subsequently be increased by 5 mg/day; maintenance: 10-30 mg/day Bipolar Mania Acute manic or mixed episodes, either as monotherapy or as an adjunct to lithium or valproate 10-17 years: 2 mg/day PO initially; increased to 5 mg/day after 2 days; increased to recommended dosage of 10 mg/day after additional 2 days; may subsequently be increased by 5 mg/day; maintenance: 10-30 mg/day Autism Indicated for irritability associated with autistic disorder <6 years: Safety and efficacy not established 6-17 years: 2 mg/day PO initially; increase gradually at > 1-week intervals to target dosage of 5 mg/day; may gradually be further increase PRN to 10 mg/day or higher; not to exceed 15 mg/day Tourette's Disorder Indicated for treatment of Tourette's disorder <6 years: Safety and efficacy not established 6-18 years (<50 kg) Initiate at 2 mg/day PO with a target dose of 5 mg/day after 2 days The dose can be increased to 10 mg/day in patients who do not achieve optimal control of tics Dosage adjustments should occur gradually at intervals of no less than 1 week 6-18 years (>50 kg) Initiate at 2 mg/day PO for 2 days, and then increase to 5 mg/day for 5 days, with a target dose of 10 mg/day on day 8 The dose can be increased up to 20 mg/day for patients who do not achieve optimal control of tics Dosage adjustments should occur gradually in increments of 5 mg/day at intervals of no less than 1 week

No dosage adjustment for Aripiprazole is required on the basis of a patient’s renal function (mild to severe renal impairment, glomerular filtration rate between 15 and 90 mL/minute).

Oral Administration Oral solution can be substituted for tablets on a mg-per-mg basis up to the 25 mg dose level; patient receiving 30 mg tablets should receive 25 mg of solution Tablet May take with or without food Swallow tablet whole; do not divide, crush, or chew ODT Dosing for orally disintegrating tablets (ODT) is the same as for the oral tablets May take with or without food Do not open the blister until ready to take the ODT Remove 1 ODT by opening the package and peeling back the foil on the blister to expose the tablet Do not push the tablet through the foil because this could damage the tablet Immediately upon opening the blister, using dry hands, remove the tablet and place the entire ODT on tongue Tablet disintegration occurs rapidly in saliva; recommended to take without liquid, however, if needed, it can be taken with liquid Do not attempt to split the tablet

Hypersensitivity. Lactation. Children <18 yr.

Dementia-related Psychosis Not approved for dementia-related psychosis; patients with dementia-related psychosis who are treated with antipsychotic drugs are at increased risk of death, as shown in short-term controlled trials; deaths reported in trials appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature Suicidal thoughts and behaviors Aripiprazole PO and injection only Antidepressants increase the risk of suicidal thinking and behavior in children, adolescents, and young adults (<24 years) taking antidepressants for major depressive disorders and other psychiatric illnesses, as shown in short-term studies; monitor for worsening and emergence of suicidal thoughts and behaviors Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis: Increased incidence of cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack, including fatalities) • Neuroleptic Malignant Syndrome: Manage with immediate discontinuation and close monitoring • Tardive Dyskinesia: Discontinue if clinically appropriate • Metabolic Changes: Atypical antipsychotic drugs have been associated with metabolic changes that include hyperglycemia/diabetes mellitus, dyslipidemia, and body weight gain o Hyperglycemia/Diabetes Mellitus: Monitor glucose regularly in patients with and at risk for diabetes o Dyslipidemia: Undesirable alterations in lipid levels have been observed in patients treated with atypical antipsychotics o Weight Gain: Weight gain has been observed with atypical antipsychotic use. • Pathological Gambling and Other Compulsive Behaviors: Consider dose reduction or discontinuation • Orthostatic Hypotension: Monitor heart rate and blood pressure and warn patients with known cardiovascular or cerebrovascular disease, and risk of dehydration or syncope • Leukopenia, Neutropenia, and Agranulocytosis: have been reported with antipsychotics including Aripiprazole. Patients with a history of a clinically significant low white blood cell count (WBC) or a drug-induced leukopenia/neutropenia should have their complete blood count (CBC) monitored frequently during the first few months of therapy and discontinuation of Aripiprazole should be considered at the first sign of a clinically significant decline in WBC in the absence of other causative factors • Seizures/Convulsions: 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 • Suicide: The possibility of a suicide attempt is inherent in schizophrenia and bipolar disorder. Closely supervise high-risk patients Monitoring Parameters Monitor for worsening and emergence of suicidal thoughts and behaviors. Monitor heart rate and blood pressure and warn patients with known cardiovascular or cerebrovascular disease, and risk of dehydration or syncope. Monitor for orthostatic hypotension. Continue monitoring WBC count until recovery. Monitor glucose regularly in patients with and at risk for diabetes. Monitor weight.

Pregnancy Neonates exposed to antipsychotic drugs during third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery; limited published data on aripiprazole use in pregnant women are not sufficient to inform any drug-associated risks for birth defects or miscarriage; no teratogenicity observed in animal reproductive studies with intramuscular administration of drug Extrapyramidal and/or withdrawal symptoms, including agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder reported in neonates exposed to antipsychotic drugs during the third trimester of pregnancy; symptoms have varied in severity; monitor neonates for extrapyramidal and/or withdrawal symptoms and manage symptoms appropriately; some neonates recover within hours or days without specific treatment; others required prolonged hospitalization Lactation Aripiprazole is present in human breast milk; there are reports of poor weight gain in breastfed infants exposed to aripiprazole and reports of inadequate milk supply in lactating women taking aripiprazole; development and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant from treatment or from underlying maternal condition

Drugs that induce CYP3A4 (e.g. carbamazepine) could cause an increase in aripiprazole clearance and lower blood levels. Inhibitors of CYP3A4 (e.g. ketoconazole) or CYP2D6 (e.g. quinidine, fluoxetine or paroxetine) can inhibit aripiprazole elimination and cause increased blood levels. Increased CNS depression with ethanol. Antihypertensives: Due to its alpha adrenergic antagonism, aripiprazole may potentiate the effects of certain antihypertensive agents; Benzodiazepines: Orthostatic hypotension and the intensity of sedation was greater with the combination of oral aripiprazole and lorazepam as compared to that observed with aripiprazole alone; Contraindicated (5) amisulpride cisapride dronedarone mavorixafor thioridazine

Side effects of Aripiprazole : >10% Weight gain (8-30%),Headache (27%),Agitation (19%),Insomnia (18%),Anxiety (17%),Nausea and vomiting (11-15%),Akathisia (10-13%),Lightheadedness (11%),Constipation (10-11%) 1-10% Dizziness (10%),Dyspepsia (9%),Somnolence (5-8%),Fatigue (6%),Restlessness (6%),Tremor (6%),Dry mouth/xerostomia (5%) ,Extrapyramidal disorder (5%),Orthostatic hypotension (1-5%),Musculoskeletal stiffness (4%),Abdominal discomfort (3%),Blurred vision (3%),Cough (3%),Pain (3%),Myalgia (2%),Rash,Rhinitis <1% Altered mental status,Autonomic instability,Dysphagia,Hyperpyrexia,Muscle rigidity,Neuroleptic malignant syndrome (NMS),Seizure,Tardive dyskinesia

Aripiprazole acts as a partial agonist at D2 and 5-HT1A receptors and as an antagonist at 5-HT2A receptors.

Aripen 10mg Tablet manufactured by Opsonin Pharma Limited. Its generic name is Aripiprazole. Aripen is availble in Bangladesh. Farmaco BD drug index information on Aripen Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.