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RX ITEM-Aripiprazole 2mg Tab 30 by Amneal Pharma

NDC No.65162-0896-03 UPC/GTIN No. MPN 89603 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,ReVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scopWant to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

RX ITEM-Aripiprazole 2mg Tab 30 by Amneal Pharma

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NDC No.65162-0896-03 UPC/GTIN No. MPN 89603 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scope of practice can order this RX item. Rx Item No.Rx617084 Aripiprazole 2mg Tab 30 by Amneal Pharma, Item No.617084 NDC No. 65162089603 UPC No. Other Name Abilify Therapeutic Class Atypical Antipsychotics Item Class Non Controlled Rx. Case Qnty: 144 Atypica

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HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ABILIFY safely and effectively. See full prescribing information for ABILIFY. ABILIFY � (aripiprazole) Tablets ABILIFY DISCMELT � (aripiprazole) Orally Disintegrating Tablets ABILIFY � (aripiprazole) Oral Solution ABILIFY � (aripiprazole) Injection FOR INTRAMUSCULAR USE ONLY Initial U.S. Approval: 2002 WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDAL THOUGHTS AND BEHAVIORS WITH ANTIDEPRESSANT DRUGS See full prescribing information for complete boxed warning. � Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. ABILIFY is not approved for the treatment of patients with dementia-related psychosis. (5.1) � Increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants. Monitor for worsening and emergence of suicidal thoughts and behaviors. (5.3) -------------------------------INDICATIONS AND USAGE-------------------------------- ABILIFY is an atypical antipsychotic. The oral formulations are indicated for: � Schizophrenia (14.1) � Acute Treatment of Manic and Mixed Episodes associated with Bipolar I (14.2) � Adjunctive Treatment of Major Depressive Disorder (14.3) � Irritability Associated with Autistic Disorder (14.4) � Treatment of Tourette's disorder (14.5) The injection is indicated for: � Agitation associated with schizophrenia or bipolar mania (14.6) ----------------------------DOSAGE AND ADMINISTRATION------------------------------ Initial Dose Recommended Dose Maximum Dose Schizophrenia � adults (2.1) 10-15 mg/day 10-15 mg/day 30 mg/day Schizophrenia � adolescents (2.1) 2 mg/day 10 mg/day 30 mg/day Bipolar mania � adults: monotherapy (2.2) 15 mg/day 15 mg/day 30 mg/day Bipolar mania � adults: adjunct to lithium or valproate (2.2) 10-15 mg/day 15 mg/day 30 mg/day Bipolar mania � pediatric patients: monotherapy or as an adjunct to lithium or valproate (2.2) 2 mg/day 10 mg/day 30 mg/day Major Depressive Disorder � Adults adjunct to antidepressants (2.3) 2-5 mg/day 5-10 mg/day 15 mg/day Irritability associated with autistic disorder � pediatric patients (2.4) 2 mg/day 5-10 mg/day 15 mg/day Tourette's disorder � (2.5) Patients <50 kg 2 mg/day 5 mg/day 10 mg/day Patients ?50 kg 2 mg/day 10 mg/day 20 mg/day Agitation associated with schizophrenia or bipolar mania � adults (2.6) 9.75 mg/1.3 mL injected IM 30 mg/day injected IM � Oral formulations: Administer once daily without regard to meals (2) � IM injection: Wait at least 2 hours between doses. Maximum daily dose 30 mg (2.5) � Known CYP2D6 poor metabolizers: Half of the usual dose (2.7) ----------------------------DOSAGE FORMS AND STRENGTHS-------------------------- � Tablets: 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg (3) � Orally Disintegrating Tablets: 10 mg and 15 mg (3) � Oral Solution: 1 mg/mL (3) � Injection: 9.75 mg/1.3 mL single-dose vial (3) ----------------------------------CONTRAINDICATIONS--------------------------------- Known hypersensitivity to ABILIFY (4) ---------------------------- WARNINGS AND PRECAUTIONS------------------------------ - � Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis: Related Psychosis: Increased incidence of cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack, including fatalities) (5.2) � Neuroleptic Malignant Syndrome: Manage with immediate discontinuation and close monitoring (5.4) � Tardive Dyskinesia: Discontinue if clinically appropriate (5.5) � Metabolic Changes: Atypical antipsychotic drugs have been associated with metabolic changes that include hyperglycemia/diabetes mellitus, dyslipidemia, and body weight gain (5.6) o Hyperglycemia/Diabetes Mellitus: Monitor glucose regularly in patients with and at risk for diabetes (5.6) o Dyslipidemia: Undesirable alterations in lipid levels have been observed in patients treated with atypical antipsychotics (5.6) o Weight Gain: Weight gain has been observed with atypical antipsychotic use. Monitor weight (5.6) � Orthostatic Hypotension: Monitor heart rate and blood pressure and warn patients with known cardiovascular or cerebrovascular disease, and risk of dehydration or syncope (5.7) � Leukopenia, Neutropenia, and Agranulocytosis: have been reported with antipsychotics including ABILIFY. 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 ABILIFY should be considered at the first sign of a clinically significant decline in WBC in the absence of other causative factors (5.8) � Seizures/Convulsions: Use cautiously in patients with a history of seizures or with conditions that lower the seizure threshold (5.9) � Potential for Cognitive and Motor Impairment: Use caution when operating machinery (5.10) � Suicide: The possibility of a suicide attempt is inherent in schizophrenia and bipolar disorder. Closely supervise high-risk patients (5.12) --------------------------------ADVERSE REACTIONS----------------------------------- Commonly observed adverse reactions (incidence ? 5% and at least twice that for placebo) were (6.1): � Adult patients with schizophrenia: akathisia � Pediatric patients (13 to 17 years) with schizophrenia: extrapyramidal disorder, somnolence, and tremor � Adult patients (monotherapy) with bipolar mania: akathisia, sedation, restlessness, tremor, and extrapyramidal disorder � Adult patients (adjunctive therapy with lithium or valproate) with bipolar mania: akathisia, insomnia, and extrapyramidal disorder � Pediatric patients (10 to 17 years) with bipolar mania: somnolence, extrapyramidal disorder, fatigue, nausea, akathisia, blurred vision, salivary hypersecretion, and dizziness � Adult patients with major depressive disorder (adjunctive treatment to antidepressant therapy): akathisia, restlessness, insomnia, constipation, fatigue, and blurred vision � Pediatric patients (6 to 17 years) with autistic disorder: sedation, fatigue, vomiting, somnolence, tremor, pyrexia, drooling, decreased appetite, salivary hypersecretion, extrapyramidal disorder, and lethargy � Pediatric patients (6 to 18 years) with Tourette's disorder: sedation, somnolence, nausea, headache, nasopharyngitis, fatigue, increased appetite � Adult patients with agitation associated with schizophrenia or bipolar mania: nausea To report SUSPECTED ADVERSE REACTIONS, contact Bristol-Myers Squibb at 1-800-721-5072 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. -----------------------------------DRUG INTERACTIONS-------------------------------- Dosage adjustment due to drug interactions (7.1): Factors Dosage Adjustments for ABILIFY Known CYP2D6 Poor Metabolizers Administer half of usual dose Known CYP2D6 Poor Metabolizers and strong CYP3A4 inhibitors Administer a quarter of usual dose Strong CYP2D6 or CYP3A4 inhibitors Administer half of usual dose Strong CYP2D6 and CYP3A4 inhibitors Administer a quarter of usual dose Strong CYP3A4 inducers Double usual dose over 1 to 2 weeks -------------------USE IN SPECIFIC POPULATIONS------------------------- � Pregnancy: May cause extrapyramidal and/or withdrawal symptoms in neonates with third trimester exposure (8.1) � Nursing Mothers: Discontinue drug or nursing, taking into consideration importance of drug to the mother (8.3) See 17 for PATIENT COUNSELING INFORMATION and Medication Guide. Revised: 01/2016 FULL PRESCRIB ING INFORMATION: CONTENTS* WARNING: INCREASED MO RTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDAL THOUGHTS AND BEHAVIORS WITH ANTIDEPRESSANT DRUGS 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2.1 Schizophrenia 2.2 Bipolar I Disorder 2.3 Adjunctive Treatment of Major Depressive Disorder 2.4 Irritability Associated with Autistic Disorder 2.5 Tourette's Disorder 2.6 Agitation Associated with Schizophrenia or Bipolar Mania (Intramuscular Injection) 2.7 Dosage Adjustments for Cytochrome P450 Considerations 2.8 Dosing of Oral Solution 2.9 Dosing of Orally Disintegrating Tablets 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Increased Mortality in Elderly Patients with Dementia-Related Psychosis 5.2 Cerebrovascular Adverse Events, Including Stroke 5.3 Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults 5.4 Neuroleptic Malignant Syndrome (NMS) 5.5 Tardive Dyskinesia 5.6 Metabolic Changes 5.7 Orthostatic Hypotension 5.8 Leukopenia, Neutropenia, and Agranulocytosis 5.9 Seizures/Convulsions 5.10 Potential for Cognitive and Motor Impairment 5.11 Body Temperature Regulation 5.12 Suicide 5.13 Dysphagia 6 ADVERSE REACTIONS 6.1 Clinical Trials Experience 6.2 Postmarketing Experience 7 DRUG INTERACTIONS 7.1 Drugs Having Clinically Important Interactions with ABILIFY 7.2 Drugs Having No Clinically Important Interactions with ABILIFY 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.2 Labor and Delivery 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 8.6 CYP2D6 Poor Metabolizers 8.7 Hepatic and Renal Impairment 8.8 Other Specific Populations 9 DRUG ABUSE AND DEPENDENCE 9.1 Controlled Substance 9.2 Abuse 9.3 Dependence 10 OVERDOSAGE 10.1 Human Experience 10.2 Management of Overdosage 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 12.2 Pharmacodynamics 12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 13.2 Animal Toxicology and/or Pharmacology 14 CLINICAL STUDIES 14.1 Schizophrenia 14.2 Bipolar Disorder 14.3 Adjunctive Treatment of Major Depressive Disorder 14.4 Irritability Associated with Autistic Disorder 14.5 Tourette's Disorder 14.6 Agitation Associated with Schizophrenia or Bipolar Mania 16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied 16.2 Storage 17 PATIENT COUNSELING INFORMATION * Sections or subsections omitted from the full prescribing information are not listed. FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE ABILIFY Oral Tablets, Orally-Disintegrating Tablets, and Oral Solution are indicated for the treatment of: � Schizophrenia [see CLINICAL STUDIES (14.1)] � Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder [see CLINICAL STUDIES (14.2)] � Adjunctive Treatment of Major Depressive Disorder [see CLINICAL STUDIES (14.3)] � Irritability Associated with Autistic Disorder [see CLINICAL STUDIES (14.4)] � Treatment of Tourette's Disorder [see CLINICAL STUDIES (14.5)] WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDAL THOUGHTS AND BEHAVIORS WITH ANTIDEPRESSANT DRUGS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. ABILIFY is not approved for the treatment of patients with dementia-related psychosis [see WARNINGS AND PRECAUTIONS (5.1)] . Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older [see WARNINGS AND PRECAUTIONS (5.3)] . In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber [see WARNINGS AND PRECAUTIONS (5.3)] . ABILIFY Injection is indicated for the treatment of: � Agitation associated with schizophrenia or bipolar mania [see CLINICAL STUDIES (14.6)] 2 DOSAGE AND ADMINISTRATION 2.1 Schizophrenia Adults The recommended starting and target dose for ABILIFY is 10 or 15 mg/day administered on a once-a-day schedule without regard to meals. ABILIFY has been systematically evaluated and shown to be effective in a dose range of 10 to 30 mg/day, when administered as the tablet formulation; however, doses higher than 10 or 15 mg/day were not more effective than 10 or 15 mg/day. Dosage increases should generally not be made before 2 weeks, the time needed to achieve steady-state [see CLINICAL STUDIES (14.1)]. Maintenance Treatment: Maintenance of efficacy in schizophrenia was demonstrated in a trial involving patients with schizophrenia who had been symptomatically stable on other antipsychotic medications for periods of 3 months or longer. These patients were discontinued from those medications and randomized to either ABILIFY 15 mg/day or placebo, and observed for relapse [see CLINICAL STUDIES (14.1)] . Patients should be periodically reassessed to determine the continued need for maintenance treatment. Adolescents The recommended target dose of ABILIFY is 10 mg/day. Aripiprazole was studied in adolescent patients 13 to 17 years of age with schizophrenia at daily doses of 10 mg and 30 mg. The starting daily dose of the tablet formulation in these patients was 2 mg, which was titrated to 5 mg after 2 days and to the target dose of 10 mg after 2 additional days. Subsequent dose increases should be administered in 5 mg increments. The 30 mg/day dose was not shown to be more efficacious than the 10 mg/day dose. ABILIFY can be administered without regard to meals [see CLINICAL STUDIES (14.1)] . Patients should be periodically reassessed to determine the need for maintenance treatment. ABILIFY � (aripiprazole) ABILIFY � (aripiprazole) 2


NDC No.65162-0896-03 UPC/GTIN No. MPN 89603 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Re
Aripiprazole 2mg Tab 30 by Amneal Pharma
NDC No.65162-0896-03 UPC/GTIN No. MPN 89603 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Re

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