Aripiprazole (Aripiprazole)

Trade Name : ARIPIPRAZOLE

Accord Healthcare, Inc.

TABLET

Strength 2 mg/1

ARIPIPRAZOLE Atypical Antipsychotic [EPC]

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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 Accord Healthcare, Inc.. It is available in strength of 2 mg/1 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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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
  • 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 n n .n n n
  • 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 n n n .ntttttttn n n
  • 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 prescribern n n .ntttttttn n n
  • 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
  • n 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 n n n
  • 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 n n n
  • Warnings and Precautions, Pathological Gambling and Other Compulsive Behaviors (n n n )u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a008/2016n nn
  • Warnings and Precautions, Falls (n n n )u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a002/2017n nn
  • Aripiprazole tablets are indicated for the treatment of:
  • Additional pediatric use information is approved for Otsuka America Pharmaceutical, Inc.u2019s ABILIFYn n n (aripiprazole) product. However, due to Otsuka America Pharmaceutical, Inc.u2019s marketing exclusivity rights, this drug product is not labeled with that information.n n n
  • Aripiprazole is an atypical antipsychotic. The oral formulations are indicated for:
  • Schizophrenia n n n n
  • No data
  • Oral formulations: Administer once daily without regard to meals n n n n
  • Known CYP2D6 poor metabolizers: Half of the usual dose n n n n
  • Aripiprazole tablets, USP are available as described in n n n n
  • Tablets: 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg n n n n
  • Aripiprazole tablets are contraindicated in patients with a history of a hypersensitivity reaction to aripiprazole. Reactions have ranged from pruritus/urticaria to anaphylaxis n n n n
  • Known hypersensitivity to aripiprazole n n n n
  • 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.
  • 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.
  • 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.
  • Aripiprazole has been evaluated for safety in 13,543 adult patients who participated in multiple-dose, clinical trials in schizophrenia, other indications, Dementia of the Alzheimeru2019s type, Parkinsonu2019s disease, and alcoholism, and who had approximately 7619 patient-years of exposure to oral aripiprazole. A total of 3390 patients were treated with oral aripiprazole for at least 180 days and 1933 patients treated with oral aripiprazole had at least 1 year of exposure.
  • Aripiprazole has been evaluated for safety in 1,686 patients (6 to 18 years) who participated in multiple-dose, clinical trials in schizophrenia, 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.
  • 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.
  • Additional pediatric use information is approved for Otsuka America Pharmaceutical, Inc.u2019s ABILIFYn n n (aripiprazole) product. However, due to Otsuka America Pharmaceutical, Inc.u2019s marketing exclusivity rights, this drug product is not labeled with that information.n n n
  • Commonly observed adverse reactions (incidence u22655% and at least twice that for placebo) were n n n : n n n
  • To report SUSPECTED ADVERSE REACTIONS, contact Accord Healthcare Inc. at 1-866-941-7875 or n n n or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.n n n
  • Adult patients with schizophrenia: akathisia
  • Pediatric patients (13 to 17 years) with schizophrenia: extrapyramidal disorder, somnolence, and tremor
  • Dosage adjustment due to drug interactions n n n n
  • Additional pediatric use information is approved for Otsuka America Pharmaceutical, Inc.u2019s ABILIFYn n n (aripiprazole) product. However, due to Otsuka America Pharmaceutical, Inc.u2019s marketing exclusivity rights, this drug product is not labeled with that information.n n n
  • Pregnancy:n- (8.1)
  • Nursing Mothers:n- (8.3)
  • No data
  • MedDRA terminology has been used to classify the adverse reactions.
  • Aripiprazole is a psychotropic drug that is available as aripiprazole tablets, USP. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is Cn n n Hn n n Cln n n Nn n n On n n and its molecular weight is 448.38. The chemical structure is:n nn
  • Aripiprazole tablets, USP are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, maize starch and microcrystalline cellulose. Colorants include ferric oxide red (10 mg and 30 mg), ferric oxide yellow (2 mg and 15 mg), and FD&C Blue No. 2 aluminum lake (2 mg and 5 mg).
  • No data
  • No data
  • Efficacy of the oral formulations of aripiprazole was established in the following adequate and well-controlled trials:
  • Additional pediatric use information is approved for Otsuka America Pharmaceutical, Inc.u2019s ABILIFYn n n (aripiprazole) product. However, due to Otsuka America Pharmaceutical, Inc.u2019s marketing exclusivity rights, this drug product is not labeled with that information.n n n
  • No data
  • See n n n n
  • Discuss the following issues with patients prescribed aripiprazole:
  • Clinical Worsening of Depression and Suicide Risk
  • Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down. Families and caregivers of patients should be advised to look for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt. Such symptoms should be reported to the patientu2019s prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patientu2019s presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior n n n n .n nn
  • Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with aripiprazole and should counsel them in its appropriate use. A patient Medication Guide including information about u201cAntidepressant Medicines, Depression and other Serious Mental Illness, and Suicidal Thoughts or Actionsu201d is available for aripiprazole. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. It should be noted that aripiprazole is not approved as a single agent for treatment of depression and has not been evaluated in pediatric major depressive disorder.
  • Pathological Gambling and Other Compulsive Behaviors
  • Advise patients and their caregivers of the possibility that they may experience compulsive urges to shop, intense urges to gamble, compulsive sexual urges, binge eating and/or other compulsive urges and the inability to control these urges while taking aripiprazole. In some cases, but not all, the urges were reported to have stopped when the dose was reduced or stopped n n n .n nn
  • Interference with Cognitive and Motor Performance
  • Because aripiprazole may have the potential to impair judgment, thinking, or motor skills, patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that aripiprazole therapy does not affect them adversely n n n .n nn
  • Nursing
  • Advise patients that breastfeeding is not recommended with aripiprazole treatment because of the potential for serious adverse reactions in a nursing infant n n n .n nn
  • Concomitant Medication
  • Patients should be advised to inform their physicians if they are taking, or plan to take, any prescription or over-the-counter drugs, since there is a potential for interactions n n n .n nn
  • Heat Exposure and Dehydration
  • Patients should be advised regarding appropriate care in avoiding overheating and dehydration n n n .n nn
  • ABILIFYn n n is a trademark of Otsuka Pharmaceutical Company.n nn
  • Manufactured For:
  • Manufactured By:
  • 51 1878 0 712890
  • Issued March 2017
  • u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0MEDICATION GUIDE
  • u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0Aripiprazole Tablets
  • What is the most important information I should know about aripiprazole tablets?
  • (For other side effects, also see u201cWhat are the possible side effects of aripiprazole tablets?u201d).
  • Serious side effects may happen when you take aripiprazole tablets, including:
  • 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 are aripiprazole tablets?
  • Aripiprazole tablets
  • It is not known if aripiprazole is safe or effective in children:
  • Do not take aripiprazole tablets if you
  • Before taking aripiprazole tablets, tell your healthcare provider
  • Tell your healthcare provider about all the medicines that you take,
  • Aripiprazole tablets and other medicines may affect each other causing possible serious side effects. Aripiprazole tablets may affect the way other medicines work, and other medicines may affect how aripiprazole works.
  • Your healthcare provider can tell you if it is safe to take aripiprazole tablets with your other medicines. Do not start or stop any medicines while taking aripiprazole tablets without talking to your healthcare provider first. Know the medicines you take. Keep a list of your medicines to show your healthcare provider and pharmacist when you get a new medicine.
  • How should I take aripiprazole tablets?
  • What should I avoid while taking aripiprazole tablets?
  • What are the possible side effects of aripiprazole tablets?
  • Aripiprazole tablets may cause serious side effects, including:
  • Call your healthcare provider if you have any of these symptoms of high blood sugar while receiving aripiprazole tablets:
  • u00a0u00a0u00a0u00a0u25bafeel very thirstyn n n u00a0u00a0u00a0u00a0u25baneed to urinate more than usualnttttt n n n u00a0u00a0u00a0u00a0u25bafeel very hungrynttttt n n n u00a0u00a0u00a0u00a0u25bafeel weak or tirednttttt n n n u00a0u00a0u00a0u00a0u25bafeel sick to your stomachnttttt n n n u00a0u00a0u00a0u00a0u25bafeel confused, or your breath smells fruityn nn
  • The most common side effects of aripiprazole tablets in adults include:
  • The most common side effects of aripiprazole tablets in children include:
  • These are not all the possible side effects of aripiprazole tablets.
  • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • How should I store aripiprazole tablets?
  • Keep aripiprazole tablets and all medicines out of the reach of children.
  • General information about the safe and effective use of aripiprazole tablets
  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use aripiprazole for a condition for which it was not prescribed. Do not give aripiprazole to other people, even if they have the same symptoms you have. It may harm them.
  • You can ask your healthcare provider or pharmacist for information about aripiprazole tablets that was written for healthcare professionals.
  • What are the ingredients in aripiprazole tablets?
  • Active ingredient:
  • Inactive ingredients:
  • Additional pediatric use information is approved for Otsuka America Pharmaceutical, Inc.u2019s ABILIFYn n n (aripiprazole) product. However, due to Otsuka America Pharmaceutical, Inc.u2019s marketing exclusivity rights, this drug product is not labeled with that information.n n n
  • For more information about aripiprazole tablets, visit www.accordhealthcare.us or call Accord Healthcare Inc. at 1-866-941-7875.
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • ABILIFYn n n is a trademark of Otsuka Pharmaceutical Company.n nn
  • Manufactured For:
  • Manufactured By:
  • 51 1878 0 712890
  • Issued March 2017
  • n NDC 16729-n n n -10n n nn
  • Aripiprazole Tablets, USP
  • 2 mg-30 Tablets
  • PHARMACIST:
  • Rx Only
  • n NDC 16729-n n n -46n n nn
  • Aripiprazole Tablets, USP
  • 2 mg-100 (10 x 10) Unit-dose Tablets
  • PHARMACIST:
  • Rx Only
  • n NDC 16729-n n n -10n n nn
  • Aripiprazole Tablets, USP
  • 5 mg-30 Tablets
  • PHARMACIST:
  • Rx Only
  • n NDC 16729-n n n -46n n nn
  • Aripiprazole Tablets, USP
  • 5 mg-100 (10 x 10) Unit-dose Tablets
  • PHARMACIST:
  • Rx Only
  • n NDC 16729-n n n -10n n nn
  • Aripiprazole Tablets, USP
  • 10 mg-30 Tablets
  • PHARMACIST:
  • Rx Only
  • n NDC 16729-n n n -46n n nn
  • Aripiprazole Tablets, USP
  • 10 mg-100 (10 x 10) Unit-dose Tablets
  • PHARMACIST:
  • Rx Only
  • n NDC 16729-n n n -10n n nn
  • Aripiprazole Tablets, USP
  • 15 mg-30 Tablets
  • PHARMACIST:
  • Rx Only
  • n NDC 16729-n n n -46n n nn
  • Aripiprazole Tablets, USP
  • 15 mg-100 (10 x 10) Unit-dose Tablets
  • PHARMACIST:
  • Rx Only
  • n NDC 16729-n n n -10n n nn
  • Aripiprazole Tablets, USP
  • 20 mg-30 Tablets
  • PHARMACIST:
  • Rx Only
  • n NDC 16729-n n n -46n n nn
  • Aripiprazole Tablets, USP
  • 20 mg-100 (10 x 10) Unit-dose Tablets
  • PHARMACIST:
  • Rx Only
  • n NDC 16729-n n n -10n n nn
  • Aripiprazole Tablets, USP
  • 30 mg-30 Tablets
  • PHARMACIST:
  • Rx Only
  • n NDC 16729-n n n -46n n nn
  • Aripiprazole Tablets, USP
  • 30 mg-100 (10 x 10) Unit-dose Tablets
  • PHARMACIST:
  • Rx Only

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