Aripiprazole (Aripiprazole)

Trade Name : Aripiprazole

Macleods Pharmaceuticals Limited

TABLET

Strength 2 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 Macleods Pharmaceuticals 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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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 )u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 08/2019
  • WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDAL THOUGHTS AND BEHAVIORS WITH ANTIDEPRESSANT DRUGSn n
  • See full prescribing information for complete boxed warning.
  • Aripiprazole oral tablets are indicated for the treatment of: u2022u00a0Schizophrenia n
  • 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
  • Aripiprazole is an atypical antipsychotic. The oral formulations are indicated for: u2022u00a0Schizophrenia ()
  • 2
  • 2.7
  • Aripiprazole tablets, USP are available as described in Table 3.n n
  • u00a0
  • u2022u00a0Tablets: 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 n
  • u2022u00a0Known hypersensitivity to aripiprazole ()
  • u2022u00a0 Increased incidence of cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack, including fatalities) () u2022u00a0 Manage with immediate discontinuation and close monitoring () u2022u00a0 Discontinue if clinically appropriate () u2022u00a0 Atypical antipsychotic drugs have been associated with metabolic changes that include hyperglycemia/diabetes mellitus, dyslipidemia, and body weight gain () u00a0u00a0u00a0u00a0u00a0 ou00a0 Monitor glucose regularly in patients with and at risk for diabetes () u00a0u00a0u00a0u00a0u00a0 o Undesirable alterations in lipid levels have been observed in patients treated with atypical antipsychotics ()u00a0 u00a0u00a0u00a0u00a0u00a0u00a0ou00a0 Weight gain has been observed with atypical antipsychotic use. Monitor weight () u2022u00a0 Consider dose reduction or discontinuation () u2022u00a0 Monitor heart rate and blood pressure and warn patients with known cardiovascular or cerebrovascular disease, and risk of dehydration or syncope () u2022u00a0 have been reported with antipsychotics including aripiprazole. 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 aripiprazole should be considered at the first sign of a clinically significant decline in WBC in the absence of other causative factors () u2022u00a0 Use cautiously in patients with a history of seizures or with conditions that lower the seizure threshold () u2022 Use caution when operating machinery () u2022u00a0 The possibility of a suicide attempt is inherent in schizophrenia. Closely supervise high-risk patients ()
  • 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: u2022u00a0Increased Mu2022u00a0ortality in Elderly Patients with Dementia-Related Psychosis Cerebrovascular Adverse Events, Including Stroke u2022u00a0Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults u2022u00a0Neuroleptic Malignant Syndrome (NMS) n u2022u00a0Tardive Dyskinesia n u2022u00a0Metabolic Changes u2022u00a0Pathological Gambling and Other Compulsive Behaviors n u2022u00a0Orthostatic Hypotension n n Falls u2022u00a0Leukopenia, Neutropenia, and Agranulocytosis u2022u00a0Seizures/Convulsions n u2022u00a0Potential for Cognitive and Motor Impairment u2022u00a0Body Temperature Regulation n u2022u00a0Suicide n u2022u00a0Dysphagia n u00a0
  • 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 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, 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 ABILIFY (aripiprazole) product. However, due to Otsuka America Pharmaceutical, Inc.u2019s marketing exclusivity rights, this drug product is not labeled with that information.
  • Commonly observed adverse reactions (incidence u22655% and at least twice that for placebo) were ():
  • To report SUSPECTED ADVERSE REACTIONS, contact Macleods Pharma USA, Inc., at 1-888-943-3210 or 1-855-926-3384 oru00a0FDA at 1-800-FDA-1088 or
  • Dosage adjustment due to drug interactions ():n n
  • u2022u00a0 May cause extrapyramidal and/or withdrawal symptoms in neonates with third trimester 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.
  • u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0n
  • No data
  • MedDRA terminology has been used to classify the adverse reactions.
  • Aripiprazole, USP is an atypical antipsychotic drugu00a0that is available as Aripiprazole tablets, USP. Aripiprazole, USP is 7-[4-[4-(2,3-dichlorophenyl)-1piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is CHCNO and its molecular weight is 448.38. The chemical structure is:
  • Aripiprazole tablets, USP are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake.
  • No data
  • No data
  • Efficacy of the oral formulations of aripiprazole was established in the following adequate and well-controlled trials: u2022u00a0Four short-term trials and one maintenance trial in adult patients and one short-term trial in adolescents (ages 13 to 17) with schizophrenia n
  • 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
  • Adults
  • In the four positive trials for aripiprazole, four primary measures were used for assessing psychiatric signs and symptoms. Efficacy was evaluated using the total score on the Positive and Negative Syndrome Scale (PANSS). The PANSS is a 30 item scale that measures positive symptoms of schizophrenia (7 items), negative symptoms of schizophrenia (7 items), and general psychopathology (16 items), each rated on a scale of 1 (absent) to 7 (extreme); total PANSS scores range from 30 to 210. The Clinical Global Impression (CGI) assessment reflects the impression of a skilled observer, fully familiar with the manifestations of schizophrenia, about the overall clinical state of the patient. In a 4-week trial (n=414) comparing two fixed doses of aripiprazole (15 or 30 mg/day) to placebo, both doses of aripiprazole were superior to placebo in the PANSS total score (Study 1 in Table 26), PANSS positive subscale, and CGI-severity score. In addition, the 15 mg dose was superior to placebo in the PANSS negative subscale. In a 4-week trial (n=404) comparing two fixed doses of aripiprazole (20 or 30 mg/day) to placebo, both doses of aripiprazole were superior to placebo in the PANSS total score (Study 2 in Table 26), PANSS positive subscale, PANSS negative subscale, and CGI-severity score. In a 6-week trial (n=420) comparing three fixed doses of aripiprazole (10, 15, or 20 mg/day) to placebo, all three doses of aripiprazole were superior to placebo in the PANSS total score (Study 3 in Table 26), PANSS positive subscale, and the PANSS negative subscale. In a 6-week trial (n=367) comparing three fixed doses of aripiprazole (2, 5, or 10 mg/day) to placebo, the 10 mg dose of aripiprazole was superior to placebo in the PANSS total score (Study 4 in Table 26), the primary outcome measure of the study. The 2 and 5 mg doses did not demonstrate superiority to placebo on the primary outcome measure. u00a0
  • Thus, the efficacy of 10, 15, 20, and 30 mg daily doses was established in two studies for each dose. Among these doses, there was no evidence that the higher dose groups offered any advantage over the lowest dose group of these studies. An examination of population subgroups did not reveal any clear evidence of differential responsiveness on the basis of age, gender, or race. u00a0
  • A longer-term trial enrolled 310 inpatients or outpatients meeting DSM-IV criteria for schizophrenia who were, by history, symptomatically stable on other antipsychotic medications for periods of 3 months or longer. These patients were discontinued from their antipsychotic medications and randomized to aripiprazole 15 mg/day or placebo for up to 26 weeks of observation for relapse. Relapse during the double-blind phase was defined as CGI-Improvement score of u22655 (minimally worse), scores u22655 (moderately severe) on the hostility or uncooperativeness items of the PANSS, or u226520% increase in the PANSS total score. Patients receiving aripiprazole 15 mg/day experienced a significantly longer time to relapse over the subsequent 26 weeks compared to those receiving placebo (Study 5 in Figure 6). u00a0
  • Pediatric Patients
  • Table 26: Schizophrenia Studiesn
  • Figure 6: Kaplan-Meier Estimation of Cumulative Proportion of Patients with Relapse (Schizophrenia Study 5)n n
  • Additional pediatric use information is approved for Otsuka America Pharmaceutical, Inc.'s ABILIFY (aripiprazole) product. However, due to Otsuka America Pharmaceutical, Inc.'s 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:n- Clinical Worsening of Depression and Suicide Riskn- [seeu00a0Warnings and Precautions ()].n- Pathological Gambling and Other Compulsive Behaviorsn- compulsiven- [see Warnings and Precautions ()].n
  • 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 adverselyn
  • Concomitant Medicationn- [see Drug Interactions ()].n n- Heat Exposure and Dehydrationn- [see Warnings and Precautions ()].n- Pregnancyn- [see Use in Specific Populations ()].
  • Manufactured for:n n Plainsboro, NJ 08536
  • Manufactured by:n n Baddi, Himachal Pradesh, Indian n
  • u00ae
  • Rx only Aripiprazole Tablets, USP 2 mg NDC: 33342-122-07 30's Tablets
  • Rx only Aripiprazole Tablets, USPu00a05 mg NDC:33342-123-07 30's Tablets
  • Rx only Aripiprazole Tablets, USPu00a010 mg NDC:33342-124-07 30's Tablets
  • Rx only Aripiprazole Tablets, USPu00a015 mg NDC: 30's Tablets
  • Rx only Aripiprazole Tablets, USPu00a020 mg NDC: 30's Tablets
  • Rx only Aripiprazole Tablets, USP 30 mg NDC: 30's Tablets

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