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Aripiprazole (Aripiprazole)

Trade Name : Aripiprazole

Atlantic Biologicals Corps

TABLET

Strength 5 mg/1

ARIPIPRAZOLE Atypical Antipsychotic [EPC]

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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 Corps. It is available in strength of 5 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
  • Warnings and Precautions, Pathological Gambling and Other Compulsive Behaviors (5.7) u00a0u00a0u00a0u00a0u00a0u00a0u00a0 08/2016 Warnings and Precautions, Falls (5.9)u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 02/2017
  • 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
  • Antidepressants increased the risk of suicidal n- 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
  • 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 n
  • WARNINGS: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDAL THOUGHTSu00a0u00a0and BEHAVIOURS 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. Aripiprazole 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)
  • Aripiprazole is indicated for the treatment of: u2022Schizophrenia n
  • Additional pediatric use information is approved for Otsuka America Pharmaceutical, Inc.u2019s ABILIFYu00ae (aripiprazole) product. However, due to Otsuka America Pharmaceutical, Inc.u2019s marketing exclusivity rights, this drug product is not labeled with that information.
  • Aripiprazole is an atypical antipsychotic indicated as oral formulations for the: u2022Schizophrenia (14.1)
  • u2022Oral formulations: Administer once daily without regard to meals (2) u2022Known CYP2D6 poor metabolizers: Half of the usual dose (2.7)
  • Aripiprazole Tablets, USPu00a0are available as described in Table 2.n n n n n
  • Array
  • Tablets: 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg (3)
  • Aripiprazole is contraindicated in patients with a history of a hypersensitivity reaction to aripiprazole. Reactions have ranged from pruritus/urticaria to anaphylaxis n
  • Known hypersensitivity to aripiprazole (4)
  • No data
  • Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis:
  • Neuroleptic Malignant Syndrome:
  • Tardive Dyskinesia:
  • Metabolic Changes:
  • u00a0Pathological Gambling and Other Compulsive Behaviors:n- Array
  • 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: u2022Increased Mortality in Elderly Patients with Dementia-Related Psychosisu2022Cerebrovascular Adverse Events, Including Strokeu2022Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adultsu2022Neuroleptic Malignant Syndrome (NMS)u2022Tardive Dyskinesiau2022Metabolic ChangesPathological Gambling and Other Compulsive Behaviorsu2022Orthostatic HypotensionFallsu2022Leukopenia, Neutropenia, and Agranulocytosisu2022Seizures/Convulsionsu2022Potential for Cognitive and Motor Impairmentu2022Body Temperature Regulationu2022Suicideu2022DysphagiaThe 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,u00a0another indication, Dementia of the Alzheimeru2019s type, Parkinsonu2019s disease, and alcoholism, and who had approximately 7619 patient-years of exposure to oral aripiprazole and 749 patients with exposure to aripiprazole injection. 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 schizophreniau00a0or 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 tablets 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 ABILIFYu00ae (aripiprazole) product. However, due to Otsuka America Pharmaceutical, Inc.u2019s marketing exclusivity rights, this drug product is not labeled with that information.n
  • Commonly observed adverse reactions (incidence u22655% and at least twice that for placebo) were (6.1): n
  • To report SUSPECTED ADVERSE REACTIONS, contact Trigen Laboratories, LLC at 888-9-TRIGEN (888-987-4436) or FDA at 1-800-FDA-1088 or
  • Given the primary CNS effects of aripiprazole, caution should be used when aripiprazole is taken in combination with other centrally-acting drugs or alcohol.n Due to its alpha adrenergic antagonism, aripiprazole has the potential to enhance the effect of certain antihypertensive agents.
  • Dosage adjustment due to drug interactions (7.1):n
  • u2022: May cause extrapyramidal and/or withdrawal symptoms in neonates with third trimester exposure (8.1) u2022: Discontinue drug or nursing, taking into consideration importance of drug to the mother (8.3) n n
  • 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 CHClNO and its molecular weight is 448.38. The chemical structure is:
  • u00a0Aripiprazole Tablets, USP u00a0are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include corn starch, hydroxypropyl cellulose, lactose monohydrate, crospovidone, colloidal silicon dioxide, magnesium stearate and microcrystalline cellulose. Colorants include ferric oxide (yellow or red).
  • No data
  • No data
  • Efficacy of the oral formulations of aripiprazole was established in the following adequate and well-controlled trials: u2022Four short-term trials and one maintenance trial in adult patients and one short-term trial in adolescents (ages 13 to 17) with schizophrenia u2022u00a0u00a0 One maintenance monotherapy trial in adult patients with bipolar I disorder (14.2).n
  • Additional pediatric use information is approved for Otsuka America Pharmaceutical, Inc.'s ABILIFYu00ae (aripiprazole) product. However, due to Otsuka America Pharmaceutical, Inc.'s marketing exclusivity rights, this drug product is not labeled with that information.n
  • Product: 17856-0680
  • NDC: 17856-0680-1 100 TABLET in a BOTTLE
  • See Medication Guide
  • Discuss the following issues with patients prescribed aripiprazole:n
  • Aripiprazole (AR-i-PIP-ra-zole ) Tablets, USP
  • What is the most important information I should know about aripiprazole?
  • (For other side effects, also see u201cWhat are the possible side effects of aripiprazole?u201d).
  • Serious side effects may happen when you take aripiprazole, including:
  • u2022u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Medicines like aripiprazole can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). Aripiprazole is not approved for the treatment of patients with dementia-related psychosis. u2022 Antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions:
  • 1n
  • 2. These include people who have (or have a family history of)bipolar illness or u00a0suicidal thoughts or actions.
  • 3.n
  • u2022Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed. u2022Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings. u2022Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.
  • 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:
  • u2022thoughts about suicide or dying u2022attempts to commit suicide u2022new or worse depression u2022new or worse anxiety u2022feeling very agitated or restless u2022panic attacks u2022trouble sleeping (insomnia) u2022new or worse irritability u2022acting aggressive, being angry, or violent u2022acting on dangerous impulses u2022an extreme increase in activity and talking (mania) u2022other unusual changes in behavior or mood
  • What else do I need to know about antidepressant medicines?
  • u2022 Stopping an antidepressant medicine suddenly can cause other symptoms. u2022. It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants. u2022 Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member. u2022. Know all of the medicines that you or your family member takes. Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider. u2022 Talk to your childu2019s healthcare provider for more information.
  • What is aripiprazole?
  • Aripiprazole is a prescription medicine used to treat:
  • u2022schizophrenia
  • It is not known if aripiprazole is safe or effective in children:n n- Do not take aripiprazole if you
  • Before taking aripiprazole, tell your healthcare provider about all your medical conditions, including if you have or had:
  • u2022diabetes or high blood sugar in you or your family; your healthcare provider should check your blood sugar before you start aripiprazole and also during therapy. u2022seizures (convulsions). u2022low or high blood pressure. u2022heart problems or stroke. u2022pregnancy or plans to become pregnant. It is not known if aripiprazole will harm your unborn baby. u2022breast-feeding or plans to breast-feed. Aripiprazole can pass into your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you receive aripiprazole. u2022low white blood cell count.
  • Tell your healthcare provider about all the medicines that you take
  • Aripiprazole and other medicines may affect each other causing possible serious side effects. Aripiprazole 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 with your other medicines. Do not start or stop any medicines while taking aripiprazole without talking to your healthcare provider first. Know the medicines you n u00a0 list of your medicines to show your healthcare provider and pharmacist when you get a new medicine.
  • How should I take aripiprazole?
  • u2022Take aripiprazole exactly as your healthcare provider tells you to take it. Do not change the dose or stop taking aripiprazole yourself. u2022Aripiprazole can be taken with or without food. u2022Aripiprazole tablets should be swallowed whole. u2022If you miss a dose of aripiprazole, take the missed dose as soon as you remember. If it is almost time for the next dose, just skip the missed dose and take your next dose at the regular time. Do not take two doses of aripiprazole at the same time. u2022If you take too much aripiprazole, call your healthcare provider or poison control center at 1-800-222-1222 right away, or go to the nearest hospital emergency room.
  • What should I avoid while taking aripiprazole?
  • u2022Do not drive, operate heavy machinery, or do other dangerous activities until you know how aripiprazole affects you. Aripiprazole may make you drowsy. u2022Avoid getting over-heated or dehydrated. oDo not over-exercise. oIn hot weather, stay inside in a cool place if possible. oStay out of the sun. Do not wear too much or heavy clothing. oDrink plenty of water.
  • What are the possible side effects of aripiprazole?
  • Aripiprazole may cause serious side effects, including:
  • u2022u2022u2022 Tell your healthcare provider right away if you have some or all of the following symptoms: high fever, stiff muscles, confusion, sweating, changes in pulse, heart rate, and blood pressure. These may be symptoms of a rare and serious condition that can lead to death. Call your healthcare provider right away if you have any of these symptoms. u2022 Aripiprazole may cause movements that you cannot control in your face, tongue, or other body parts. Tardive dyskinesia may not go away, even if you stop receiving aripiprazole. Tardive dyskinesia may also start after you stop receiving aripiprazole. u2022u2022 Increases in blood sugar can happen in some people who take aripiprazole. Extremely high blood sugar can lead to coma or death. If you have diabetes or risk factors for diabetes (such as being overweight or a family history of diabetes), your healthcare provider should check your blood sugar before you start aripiprazole and during your treatment.
  • Call your healthcare provider if you have any of these symptoms of high blood sugar while taking aripiprazole:
  • u2022u2022 You and your healthcare provider should check your weight regularly. u2022u00a0u00a0 Some people taking aripiprazole have had unusual urges, such as gambling, binge eating or eating that you cannot control (compulsive), compulsive shopping and sexual urges. If you or your family members notice that you are having unusual urges or behaviors, talk to your healthcare provider.n u2022 Lightheadedness or fainting when rising too quickly from a sitting or lying position. u2022 See u201cWhat should I avoid while receiving aripiprazole?u201d u2022n
  • The most common side effectsu00a0of aripiprazole in adults include:
  • The most common side effectsu00a0of aripiprazole in children include:n
  • u00a0These are not all the possible side effects of aripiprazole.
  • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or Trigen Laboratories, LLC at 888-9-TRIGEN (888-987-4436).
  • How should I store aripiprazole?
  • u2022Store aripiprazole at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F); excursions permitted to 15-30u00b0C (59-86u00b0F) [See USP Controlled Room Temperature]. Keep aripiprazole and all medicines out of the reach of children.
  • General information about the safe and effective use of aripiprazole
  • 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 condition. It may harm them. You can ask your healthcare provider or pharmacist for information about aripiprazole that was written for healthcare professionals. For more information about aripiprazole call Trigen Laboratories, LLC at 888-9-TRIGEN (888-987-4436).
  • What are the ingredients in aripiprazole tablets?
  • Active ingredient:
  • Inactive ingredients:n- Additional pediatric use information is approved for Otsuka America Pharmaceutical, Inc.u2019s ABILIFYu00ae (aripiprazole) product. However, due to Otsuka America Pharmaceutical, Inc.u2019s marketing exclusivity rights, this drug product is not labeled with that information.
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • ABILIFYu00ae is a trademark of Otsuka Pharmaceutical Company. Made in India.
  • Manufactured for: Trigen Laboratories, LLC Bridgewater, NJ 08807
  • www.trigenlab.comn n
  • Issued: 03/2017
  • No data

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