Asprito Tablets (Generic Aripiprazole Tablets)

1. Asprito Tablets (Generic Aripiprazole Tablets) © The Swiss Pharmacy

2. Asprito Tablets (Generic Aripiprazole Tablets) Asprito (Generic Aripiprazole Tablets) is used for the treatment of schizophrenia including maintenance of clinical improvement during continuation therapy. Asprito tablets monotherapy is indicated for acute and maintenance treatment of manic and mixed episodes with Bipolar I Disorder with or without psychotic features. Asprito is indicated as an adjunctive therapy to either lithium or valproate for the acute treatment of manic and mixed episodes associated with Bipolar I Disorder with or without psychotic features. © The Swiss Pharmacy

3. Asprito Tablets (Generic Aripiprazole Tablets) Asprito Tablets are manufactured by Intas Pharmaceuticals Limited, India in the strengths of 2 mg, 10 mg, 15 mg, 20 mg and 30 mg. © The Swiss Pharmacy

4. Asprito Tablets (Generic Aripiprazole Tablets) Chemical Structure © The Swiss Pharmacy

5. Asprito Tablets (Generic Aripiprazole Tablets) The active ingredient contained in Asprito tablets is Aripiprazole . Each Asprito tablet contains 2 mg, 10 mg, 15 mg, 20 mg or 30 mg of Aripiprazole. © The Swiss Pharmacy

6. Asprito Tablets (Generic Aripiprazole Tablets) Uses of Asprito 2mg, 10mg, 15mg, 20mg and 30mg Tablets: Asprito tablets contain the active substance Aripiprazole and belong to a group of medicines called antipsychotics. Asprito (Generic Aripiprazole Tablets) is used alone or together with other medicines to treat mental conditions such as bipolar I disorder (manic-depressive illness), major depressive disorder, and schizophrenia. This medicine is also used in children to treat irritability associated with autistic disorder and Tourette syndrome. Aripiprazole works in the brain to change how certain chemicals affect patients. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9495_Aripiprazole-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9495_Aripiprazole-Tablets.html © The Swiss Pharmacy

7. Asprito Tablets (Generic Aripiprazole Tablets) Recommended Adult Dosage For most adult patients, the starting dose of Asprito Tablets (Generic Aripiprazole Tablets) to treat Schizophrenia is 10 or 15 mg/day administered on a once-a-day schedule without regard to meals. Doses in the range of 10 to 30 mg/day have been effective in clinical trials. Daily dosage may be adjusted on the basis of individual clinical status within the range of 10 mg to 30 mg daily. Dosage increases should not be made before 2 weeks, the time needed to achieve steady state. Asprito Tablets URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9495_Aripiprazole-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9495_Aripiprazole-Tablets.html © The Swiss Pharmacy

8. Asprito Tablets (Generic Aripiprazole Tablets) Recommended Adult Dosage The recommended starting dose for Asprito for acute treatment of Bipolar Disorder in adults as well as target dose is 15mg as monotherapy or as adjunctive therapy with lithium or valproate given once a day, without regard to meals. The dose can be increased to 30mg/day based on clinical response. Maintenance of efficacy in Bipolar I disorder was demonstrated in a trial involving patients who had been symptomatically stable on Aripiprazole tablets (15 mg/day or 30 mg/day, as monotherapy) for at least 6 consecutive weeks. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9495_Aripiprazole-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9495_Aripiprazole-Tablets.html © The Swiss Pharmacy

9. Asprito Tablets (Generic Aripiprazole Tablets) Contraindications ➔Asprito tablets are contraindicated in patients with a known hypersensitivity to Aripiprazole or any component of the tablet. Reactions have ranged from pruritus / urticaria to anaphylaxis. © The Swiss Pharmacy

10. Asprito Tablets (Generic Aripiprazole Tablets) Storage Instructions Asprito Tablets (Generic Aripiprazole Tablets) have to be stored at controlled room temperature i.e. from 20°C to 25°C (68°F to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F). Keep this as well as all other medicines away from children and pets. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9495_Aripiprazole-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9495_Aripiprazole-Tablets.html © The Swiss Pharmacy

11. Asprito Tablets (Generic Aripiprazole Tablets) Warnings Elderly patients with dementia treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. 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. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9495_Aripiprazole-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9495_Aripiprazole-Tablets.html © The Swiss Pharmacy

12. Asprito Tablets (Generic Aripiprazole Tablets) Warnings 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 Asprito (Aripiprazole tablets). 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 Asprito tablets should be considered at the first sign of a clinically significant decline in WBC in the absence of other causative factors. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9495_Aripiprazole-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9495_Aripiprazole-Tablets.html © The Swiss Pharmacy

13. Asprito Tablets (Generic Aripiprazole Tablets) Warnings 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. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9495_Aripiprazole-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9495_Aripiprazole-Tablets.html © The Swiss Pharmacy

14. Asprito Tablets (Generic Aripiprazole Tablets) Driving And Using Machines Dizziness and vision problems may occur during treatment with Asprito (Aripiprazole tablets). Avoid driving vehicles or operating heavy machines while taking this medication as it can cause dizziness and blurred vision. This should be considered in cases where full alertness is required, e.g. when driving a car or handling machines. Do not drive a car or operate machinery until you know how this medication affects you. you should know that alcohol can add to the drowsiness caused by this medication. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9495_Aripiprazole-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9495_Aripiprazole-Tablets.html © The Swiss Pharmacy

15. Asprito Tablets (Generic Aripiprazole Tablets) Possible Side Effects Most common Aripiprazole tablets (Asprito) side effects in adult patients during clinical trials with an incidence rate of greater than or equal to 10% include were nausea, vomiting, constipation, headache, dizziness, akathisia, anxiety, insomnia, and restlessness. Most common Aripiprazole tablets (Asprito) side effects in pediatric patients during clinical trials with an incidence rate of greater than or equal to 10% include somnolence, headache, vomiting, extrapyramidal disorder, fatigue, increased appetite, insomnia, nausea, nasopharyngitis, and weight increased. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9495_Aripiprazole-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9495_Aripiprazole-Tablets.html © The Swiss Pharmacy

16. Asprito Tablets (Generic Aripiprazole Tablets) Possible Side Effects Less common Aripiprazole tablets (Asprito) side effects in adult patients during clinical trials with an incidence rate of greater than or equal to 2% and more than placebo: Blurred Vision, Nausea, Constipation, Vomiting, Dyspepsia, Dry Mouth, Toothache, Abdominal Discomfort, Stomach Discomfort, Fatigue, Pain, Musculoskeletal Stiffness, Pain in Extremity, Myalgia, Muscle Spasms, Headache, Dizziness, Akathisia, Sedation, Extrapyramidal Disorder, Tremor, Somnolence, Agitation, Insomnia, Anxiety, Restlessness, Pharyngolaryngeal Pain and Cough. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9495_Aripiprazole-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9495_Aripiprazole-Tablets.html © The Swiss Pharmacy

17. Asprito Tablets (Generic Aripiprazole Tablets) Overdosage Common adverse reactions (reported in at least 5% of all overdose cases) reported with oral Aripiprazole (Asprito tablets) overdosage (alone or in combination with other substances) include vomiting, somnolence, and tremor. Other clinically important signs and symptoms observed in one or more patients with aripiprazole overdoses (alone or with other substances) include acidosis, aggression, aspartate aminotransferase increased, atrial fibrillation, bradycardia, coma, confusional state, convulsion, blood creatine phosphokinase increased, depressed level of consciousness, hypertension, hypokalemia, hypotension, lethargy, loss of consciousness, QRS complex prolonged, QT prolonged, pneumonia aspiration, respiratory arrest, status epilepticus, and tachycardia. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9495_Aripiprazole-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9495_Aripiprazole-Tablets.html © The Swiss Pharmacy

18. Asprito Tablets (Generic Aripiprazole Tablets) Treatment of Asprito Overdosage No specific information is available on the treatment of overdose with Aripiprazole (Asprito tablets). An electrocardiogram should be obtained in case of overdosage and if QT interval prolongation is present, cardiac monitoring should be instituted. Otherwise, management of overdose should concentrate on supportive therapy, maintaining an adequate airway, oxygenation and ventilation, and management of symptoms. Close medical supervision and monitoring must continue until the patient recovers. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9495_Aripiprazole-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9495_Aripiprazole-Tablets.html © The Swiss Pharmacy

19. Asprito Tablets (Generic Aripiprazole Tablets) Asprito Tablets During Pregnancy Aripiprazole (Asprito tablets) has been classified by the US FDA as Pregnancy Category C. Neonates exposed to antipsychotic medicines including Aripiprazole tablets (Asprito) during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms. Adequate and well controlled studies with Aripiprazole tablets have not been conducted in pregnant women. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9495_Aripiprazole-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9495_Aripiprazole-Tablets.html © The Swiss Pharmacy

20. Asprito Tablets (Generic Aripiprazole Tablets) Asprito Tablets During Pregnancy Oral and intravenous Aripiprazole administration during organogenesis in rats and/or rabbits at doses higher than the maximum recommended human dose (MRHD) produced fetal death, decreased fetal weight, undescended testicles, delayed skeletal ossification, skeletal abnormalities, and diaphragmatic hernia. Oral and intravenous Aripiprazole administration during the pre- and post-natal period in rats at doses higher than the maximum recommended human dose (MRHD) produced prolonged gestation, stillbirths, decreased pup weight, and decreased pup survival. Asprito can be administered during pregnancy only if the potential benefit justifies the potential risk to the fetus. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9495_Aripiprazole-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9495_Aripiprazole-Tablets.html © The Swiss Pharmacy

21. Asprito Tablets (Generic Aripiprazole Tablets) Asprito Tablets Asprito Tablets (Aripiprazole Tablets) are manufactured by Intas Pharmaceuticals Limited, India. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9495_Aripiprazole-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9495_Aripiprazole-Tablets.html © The Swiss Pharmacy