Aripiprazole (Aripiprazole)

Trade Name : Aripiprazole

Ajanta Pharma Limited

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 Ajanta Pharma Limited. 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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Warnings and Precautions, Falls ()u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a008/2019

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 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 n- aged 65 and older .
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 n n
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.(n- Arrayn- )
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.u00a0(n- Arrayn- )

Aripiprazole Oral Tablets are indicated for the treatment of:
Additional pediatric use information 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 information.n- Array
Aripiprazole is an atypical antipsychotic. The oral formulations are indicated for:

Schizophrenia ()

No data

Oral formulations: Administer once daily without regard to meals ()
Known CYP2D6 poor metabolizers: Half of the usual dose ()

Aripiprazole tablets, USPu00a0are available as described in Table 3.

Tablets: 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg ()

Aripiprazole 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 ()

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: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. u00a0 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,u00a0other indications, 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 schizophrenia,u00a0or 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. u00a0 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 ABILIFY (aripiprazole) product. However, due to Otsuka America Pharmaceutical, Inc.u2019s marketing exclusivity rights, this drug product is not labeled with that information.
To report SUSPECTED ADVERSE REACTIONS, contact Ajanta Pharma USA Inc. at 855-664-7744 or FDA at 1-800-FDA-1088 n- Array

Adult patients with schizophrenia: akathisia
Pediatric patients (13 to 17 years) with schizophrenia: extrapyramidal disorder, somnolence, and tremor

Dosage adjustment due to drug interactions ():

Additional pediatric use information 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 information.

Pregnancy:

No data

MedDRA terminology has been used to classify the adverse reactions.

Aripiprazole is an atypical antipsychotic drug that is available as aripiprazole tablets, USP. Aripiprazole USP is 7-[4-[4-(2,3-dichlorophenyl)-1- piperazinyl]butoxy]-3,4-dihydrocarbostyril. Theu00a0empirical formula is CHClNO and its molecular weight is 448.38. The chemical structure is:n n
Aripiprazole tablets, USPu00a0are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include lactose monohydrate, magnesium stearate, microcrystalline cellulose, corn starch, hydroxypropyl cellulose and low-substituted hydroxypropyl cellulose. The 5 mg tablet also contains ferric oxide yellow. The 10 mg tablet, 15 mg tablet, 20 mg tablet, and 30 mg tablet also contains ferric oxide red.n Aripiprazole tablets meets USP Dissolution Test 2.

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 ABILIFY (aripiprazole) product. However, due to Otsuka America Pharmaceutical, Inc.u2019s marketing exclusivity rights, this drug product is not labeled with that information.

No data

Advise the patient to read the FDA-approved patient labeling 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
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
Interference with Cognitive and Motor Performance
u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0
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 .
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
Heat Exposure and Dehydration
Array
Patients should be advised regarding appropriate care in avoiding overheating and dehydration .
Pregnancy
Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with aripiprazole. Advise patients that aripiprazole may cause extrapyramidal and/or withdrawal symptoms (agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder) in a neonate. Advise patients that there is a pregnancy registry that monitors pregnancy outcomes in women exposed to aripiprazole during pregnancy n
Marketed by:
Ajanta Pharma USA Inc.
Bridgewater, NJ 08807.
Made in India.
ABILIFY is a trademark of Otsuka Pharmaceutical Company.

Aripiprazole (aru201di pipu2019ra zole)n n
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?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?
It is not known if aripiprazole is safe or effective in children:
Do not take aripiprazole tablets if you
Before taking aripiprazole, tell your healthcare provider about all your medical conditions, including if you n- have or had:
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 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?
What should I avoid while taking aripiprazole?
What are the possible side effects of aripiprazole?
Aripiprazole may cause serious side effects, including:
Call your healthcare provider if you have any of these symptoms of high blood sugar while receiving aripiprazole:
The most common side effectsu00a0of aripiprazole in adults include:
The most common side effectsu00a0of aripiprazole in children include:
These 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.
How should I store aripiprazole tablets?
Aripiprazole tablets comes in a child-resistant package.n
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 aripiprazoleu00a0for a condition for which it was not prescribed. Do not give aripiprazoleu00a0to 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 that was written for healthcare professionals.
For more information about aripiprazole tablets, call . n n
Active ingredient:
Inactive ingredients:n n- Arrayn- Additional pediatric use information 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 information.n
Marketed by:
Ajanta Pharma USA Inc.n
Made in India.n ABILIFY is a trademark of Otsuka Pharmaceutical Company.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Revised: 4/2020

30 Tablets NDC 27241-051-03 Aripiprazole Tablets, USP 2 mg n Dispense the enclosed Medication Guide to each patient. Rx only n n

30 Tablets NDC 27241-052-03 Aripiprazole Tablets, USP 5 mgu00a0n Dispense the enclosed Medication Guide to each patient. Rx only n n

30 Tablets NDC 27241-053-03
AripiprazoleTablets, USP
10 mg
PHARMACIST:
Rx onlyn u00a0n n

30 Tablets NDC 27241-054-03
Aripiprazole Tablets, USP
15 mg
PHARMACIST:
Rx onlyn u00a0n n

30 Tablets NDC 27241-055-03
AripiprazoleTablets, USP
20 mg
PHARMACIST:
Rx onlyn u00a0n n

30 Tablets NDC 27241-056-03
AripiprazoleTablets, USP
30 mg
PHARMACIST:
Rx onlyn u00a0n n

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Aripiprazole (Aripiprazole)

Trade Name : Aripiprazole

TABLET

Delivery Process

Product information is meant for

Disclaimer

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

Packaging and Delivery

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Aripiprazole (Aripiprazole)

Trade Name : Aripiprazole

TABLET

Delivery Process

Product information is meant for

Disclaimer

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

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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Browse from other international pharmaceuticals

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