Aripiprazole (Aripiprazole)

Trade Name : Aripiprazole

ATLANTIC BIOLOGICALS CORP.

SOLUTION

Strength 1 mg/mL

ARIPIPRAZOLE Atypical Antipsychotic [EPC]

Delivery Process

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Aripiprazole (Aripiprazole) which is also known as Aripiprazole and Manufactured by ATLANTIC BIOLOGICALS CORP.. It is available in strength of 1 mg/mL per ml. Read more

Aripiprazole (Aripiprazole) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Warnings and Precautions, Pathological Gambling and Other Compulsive Behaviorsu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 08/2016Warnings and Precautions, Fallsu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 02/2017
  • WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDAL THOUGHTS AND BEHAVIORS WITH ANTIDEPRESSANT DRUGSn
  • Arrayn- Array
  • Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Aripiprazole is not approved for the treatment of patients with dementia-related psychosis. n
  • 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. n
  • Aripiprazole oral solution is indicated for the treatment of:
  • Additional pediatric use information in patients ages 6 to 18 years is approved for Otsuka America Pharmaceutical, Inc.u2019s ABILIFY (aripiprazole) product. However, due to Otsuka America Pharmaceutical, Inc.u2019s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
  • Aripiprazole is an atypical antipsychotic. The oral formulation is indicated for:
  • Schizophrenia n
  • Acute Treatment of Manic and Mixed Episodes associated with Bipolar I n
  • No data
  • Oral formulation: Administer once daily without regard to meals n
  • Known CYP2D6 poor metabolizers: Half of the usual dose n
  • Aripiprazole oral solution (1 mg/mL) is a clear, colorless to light-yellow solution, supplied in child-resistant bottles along with a calibrated oral dosing cup.
  • Oral Solution: 1 mg/mL n
  • Aripiprazole oral solution is contraindicated in patients with a history of a hypersensitivity reaction to aripiprazole. Reactions have ranged from pruritus/urticaria to anaphylaxis .
  • Known hypersensitivity to aripiprazole oral solutionu00a0n
  • No data
  • Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis:
  • Neuroleptic Malignant Syndrome:
  • Tardive Dyskinesia:
  • Metabolic Changes:
  • Pathological Gambling and Other Compulsive Behaviors:
  • Orthostatic Hypotension:
  • Leukopenia, Neutropenia, and Agranulocytosis:
  • Seizures/Convulsions:
  • Potential for Cognitive and Motor Impairment:
  • Suicide:
  • Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.n The following adverse reactions are discussed in more detail in other sections of the labeling:
  • The most common adverse reactions in adult patients in clinical trials (u226510%) were nausea, vomiting, constipation, headache, dizziness, akathisia, anxiety, insomnia, and restlessness.n The most common adverse reactions in the pediatric clinical trials (u226510%) were somnolence, headache, vomiting, extrapyramidal disorder, fatigue, increased appetite, insomnia, nausea, nasopharyngitis, and weight increased.n Aripiprazole has been evaluated for safety in 13,543 adult patients who participated in multiple-dose, clinical trials in schizophrenia, bipolar disorder, another indication, Dementia of the Alzheimeru2019s type, Parkinsonu2019s disease, and alcoholism, and who had approximately 7,619 patient-years of exposure to oral aripiprazole. A total of 3,390 patients were treated with oral aripiprazole for at least 180 days and 1,933 patients treated with oral aripiprazole had at least 1 year of exposure.n Aripiprazole has been evaluated for safety in 1,686 patients (6 to 18 years) who participated in multiple-dose, clinical trials in schizophrenia, or bipolar mania, or other indications and who had approximately 1,342 patient-years of exposure to oral aripiprazole. A total of 959 pediatric patients were treated with oral aripiprazole for at least 180 days and 556 pediatric patients treated with oral aripiprazole had at least 1 year of exposure.n The conditions and duration of treatment with aripiprazole included (in overlapping categories) double-blind, comparative and noncomparative open-label studies, inpatient and outpatient studies, fixed- and flexible-dose studies, and short- and longer-term exposure.n n
  • Additional pediatric use information in patients ages 6 to 18 years is approved for Otsuka America Pharmaceutical, Inc.u2019s ABILIFY (aripiprazole) product. However, due to Otsuka America Pharmaceutical, Inc.u2019s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
  • Commonly observed adverse reactions (incidence u22655% and at least twice that for placebo) were :
  • To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA,u00a0Inc.u00a0at 1-866-850-2876 or FDA at 1-800-FDA-1088 or n
  • 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
  • Dosage adjustment due to drug interactions :
  • Additional pediatric use information in patients ages 6 to 18 years is approved for Otsuka America Pharmaceutical, Inc.u2019s ABILIFY (aripiprazole) product. However, due to Otsuka America Pharmaceutical, Inc.u2019s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
  • Pregnancy:
  • Nursing Mothers:
  • No data
  • MedDRA terminology has been used to classify the adverse reactions.
  • Aripiprazole is a psychotropic drug that is available as aripiprazole oral solution. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The molecular formula is CHClNOand its molecular weight is 448.38. The chemical structure is:
  • Array
  • Aripiprazole oral solution is a clear, colorless to light-yellow solution available in a concentration of 1 mg/mL. The inactive ingredients for this solution include edetate disodium, fructose, glycerin, hydrochloric acid, methylparaben, propylene glycol, propylparaben, purified water, sodium hydroxide pelletsu00a0and sucrose. The oral solution is flavored with orange flavor which containing benzylu00a0alcohol and propylene glycol.
  • No data
  • No data
  • Efficacy of the oral formulations of aripiprazole was established in the following adequate and well-controlled trials:
  • No data
  • No data
  • Aripiprazole Oral Solutionn- (ar'' i pip' ra zole)n- Array
  • 1.n- Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatmentn- 2n- Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions.n- 3n- How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?
  • Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you:
  • What else do I need to know about antidepressant medicines?
  • What is aripiprazole oral solution?
  • It is not known if aripiprazole oral solution is safe or effective in children:
  • Do not take aripiprazole oral solution if youn- Before taking aripiprazole oral solution, tell your healthcare provider about all your medical conditions, including if you have or had:
  • Tell your healthcare provider about all the medicines that you taken- Array
  • What should I avoid while taking aripiprazole oral solution?
  • What are the possible side effects of aripiprazole oral solution?n- Array
  • Arrayn- Call your healthcare provider if you have any of these symptoms of high blood sugar while receiving aripiprazole oral solution
  • If you or your family members notice that you are having unusual urges or behaviors, talk to your healthcare provider.
  • The most common side effects of aripiprazole oral solution in adults include:
  • The most common side effects of aripiprazole oral solution in children include:
  • These are not all the possible side effects of aripiprazole oral solution.n Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.n n
  • Keep aripiprazole oral solution and all medicines out of the reach of children.n- Arrayn- Arrayn- aripiprazole oral solution? n- Array
  • Inactive ingredients:
  • Additional pediatric use information in patients ages 6 to 18 years is approved for Otsuka America Pharmaceutical, Inc.u2019s ABILIFY (aripiprazole) product. However, due to Otsuka America Pharmaceutical, Inc.u2019s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
  • For more information, call Aurobindo Pharma USA,u00a0Inc. at 1-866-850-2876.
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • Dispense with Medication Guide available at: n
  • DISTRIBUTED BY:
  • ATLANTIC BIOLOGICALS CORP.
  • 20101 NE 16TH PLACEu00a0
  • MIAMI, FL 33179
  • NDC 17856-0110-01n n n n
  • PHARMACIST: Dispense the Medication Guide providedu00a0separately to each patient.
  • Arrayn- Array

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