EAST WEST PHARMA KH NO 54 BELDI SOLAHAPUR HARIDWAR ROAD ROORKE HARDIWAR 247667
Aripiprazole Lauroxil 5mg/10mg/15mg/20mg/30mg tablets,
List of Related Indications:
List Of Drugs:
- Aripiprazole Lauroxil - @-Aristada (Oct 2015) (2003) -Antipsychotic agent- Quinolinone derivative
Indication Type Description:
Dosages/ Overdosage Etc
Interaction with Food
Pregnancy and lactation
Drugs that induce CYP3A4 (eg carbamazepine), could cause an increase in aripiprazole clearance and lower blood levels Inhibitors of CYP3A4 ( eg ketoconazole ) or CYP2D6 ( eg quinidine , fluoxetine or paroxetine ) can inhibit aripiprazole elimination and cause increased blood levels.
Increased CNS depression with ethanol
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
ARISTADA® safely and effectively. See full prescribing information for ARISTADA®. ARISTADA® (aripiprazole lauroxil) extended-release injectable suspension, for intramuscular use
Initial U.S. Approval: 2015
WARNING: RELINCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-ATED PSYCHOSIS
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.
• ARISTADA is not approved for the treatment of patients with dementia-related psychosis.
RECENT MAJOR CHANGES
Dosage and Administration 06/2017
Warnings and Precautions, Falls 02/2017
Warnings and Precautions, Pathological Gambling and Other Compulsive Behaviors 07/2016
INDICATIONS AND USAGE
ARISTADA is an atypical antipsychotic indicated for the treatment of schizophrenia
DOSAGE AND ADMINISTRATION
• To be administered by intramuscular injection in the deltoid (441 mg dose only) or gluteal (441 mg, 662 mg, 882 mg or 1064 mg) muscle by a healthcare professional
• For patients naïve to aripiprazole, establish tolerability with oral aripiprazole prior to initiating treatment with ARISTADA
• In conjunction with the first ARISTADA injection, administer treatment with oral aripiprazole for 21 consecutive days for 441 mg, 662 mg, 882 mg, and 1064 mg
• ARISTADA can be initiated at a dose of 441 mg, 662 mg or 882 mg administered monthly, 882 mg dose every 6 weeks, or 1064 mg dose every 2 months
• Dosing regimen adjustments may be required for missed doses
• Dose adjustments are required for 1) known CYP2D6 poor metabolizers and 2) for patients taking CYP3A4 inhibitors, CYP2D6 inhibitors, or CYP3A4 inducers for more than 2 weeks
DOSAGE FORMS AND STRENGTHS
For extended-release injectable suspension: 441 mg, 662 mg, 882 mg or 1064 mg single-use pre-filled syringe
Headache, insomnia, somnolence, dyspepsia
, constipation, pain, nausea, vomiting,
abdominal pain,dry mouth,
Contraindicated in patients with known hypersensitivity to the product.
Ariprazole should be used with caution in patients with known cardiovascular diseases(history of myocardial infarction or ischemic heart disease, heart failure or conduction abnormalities), cerbrovascular diseases,or conditions , which predispose patients to hypotension (dehydration hypovalemia, and treatment with antihypertensive medications),
Alzheimers disease, and dementia.
Patients should be cautioned about operating hazardous machinery, including automobiles when taking aripiprazole
Patients with known CV diseases or conditions which would predispose patients to hypotension.
Alzheimers disease and dementia
Dosages/ Overdosage Etc:
Date of Approval 2003
The recommended staring and target dose for aripiprazole is 10 or 15 mg/day administered on a once a day schedule without regard to meals.
Dosage increases should not be made before 2 weeks, the time needed to acheive steady state
At least 1 or 2 weeks and sometimes up to 4 weeks may pass before aripiprazole reaches its full efect.
PATIENT COUNSELING INFORMATION
Advise patients to read FDA-approved patient labeling (Medication Guide).
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. In some cases, but not all, the urges were reported to have stopped when the dose was reduced or stopped
Neuroleptic Malignant Syndrome Counsel patients about a potentially fatal adverse reaction referred to as NMS that has been reported in association with administration of antipsychotic drugs. Advise patients to contact a healthcare provider or report to the emergency room if they experience signs or symptoms of NMS
Tardive Dyskinesia Advise patients that abnormal involuntary movements have been associated with administration of antipsychotic drugs. Counsel patients to notify their healthcare provider if they notice any movements which they cannot control in their face, tongue, or other body part
Metabolic Changes (Hyperglycemia and Diabetes Mellitus, Dyslipidemia, and Weight Gain) Educate patients about the risk of metabolic changes, how to recognize symptoms of hyperglycemia and diabetes mellitus, and the need for specific monitoring, including blood glucose, lipids, and weight
Orthostatic Hypotension- Educate patients about the risk of orthostatic hypotension (symptoms include feeling dizzy or lightheaded upon standing), particularly at the time of initiating treatment, re-initiating treatment, or increasing the dose
Falls- Advise patients and their caregivers of the possibility that they may experience somnolence, postural hypotension, or motor and sensory instability, which may lead to the risk of falls, particularly in patients with diseases, conditions, or medications that could exacerbate these effects
Leukopenia/ Neutropenia- Advise patients with a pre-existing low WBC count or a history of drug-induced leucopenia/neutropenia that they should have their CBC monitored while receiving ARISTADA
Interference with Cognitive and Motor Performance- Because ARISTADA may have the potential to impair judgment, thinking or motor skills, instruct patients to be cautious about operating hazardous machinery, including automobiles, until they are reasonably certain that ARISTADA therapy does not affect them adversely
Heat Exposure and Dehydration - Advise patients regarding appropriate care in avoiding overheating and dehydration
Concomitant Medication - Advise patients 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
Pregnancy - Advise patients that ARISTADA may cause extrapyramidal and/or withdrawal symptoms in a neonate and to notify their healthcare provider with a known or suspected pregnancy.
Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ARISTADA during pregnancy
Manufactured and marketed by:
Alkermes, Inc. 852 Winter Street Waltham, MA 02451-1420 ©2016 Alkermes, Inc. All rights reserved. ALKERMES® is a registered trademark of Alkermes, Inc. and ARISTADA® is a registered trademark used by Alkermes, Inc. under license. Printed in U.S.A. Rev: June 2017
The mechanism of action of aripiprazole is mediated through a combination of partial agonist activity at D2 and 5-HT14 receptors and antagonist activity at 5-HT24 receptors. Its activity is primarily due to the parent drug aripiprazole, and to a lesser extent, dehydro-aripiprazole ,which has been shown to have affinities for D2 receptors similar to the parent drug and represents 40% of the parent drug exposure in plasma.
Ariprazole is well tolerated with peak plasma concentrations occuring within 3 to 5 hours. The steady-state volume of distribution of aripiprazole following intervenous administration is high (404 L or 4.9 L/kg), including extravascular distribution.
At steady therapeutic concentrations, aripiprazole and its major metabolite are greater than 90% bound to the mean elimination half-lives are about 75 hours and 94 hours for ariprazole and dehydro-aripiprazole , respy.
Steady-state concentrations are attained within 14 days of dosing for both active moieties
Interaction with Food:
Can be administered without regard to meals.
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
1.Pregnancy Teratogenic Effects: Pregnancy Category C
There are no adequate and well-controlled studies of BROVANA Inhalation Solution in pregnant women.
Because animal reproduction studies are not always predictive of human response, BROVANA Inhalation Solution should be used during pregnancy, only if the potential benefit justifies the potential risk to the fetus.
2. Labor and Delivery There are no human studies that have investigated the effects of BROVANA Inhalation Solution on preterm labor or labor at term. Because beta-agonists may potentially interfere with uterine contractility, BROVANA Inhalation Solution should be used during labor and delivery only if the potential benefit justifies the potential risk.
3. Nursing Mothers . It is not known whether arformoterol is excreted in human milk.
Because many drugs are excreted in human milk, caution should be exercised when BROVANA Inhalation Solution is administered to a nursing woman.
4.Pediatric- Use BROVANA Inhalation Solution is approved for use in the long-term maintenance treatment of bronchoconstriction associated with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema. This disease does not occur in children.
The safety and efficacy of BROVANA Inhalation Solution in pediatric patients have not been established.
5. Geriatric Use- Of the 873 patients who received BROVANA Inhalation Solution in two placebocontrolled clinical studies in adults with COPD, 391 (45%) were 65 years of age or older while 96 (11%) were 75 years of age or older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects.
6. Hepatic Impairment BROVANA Inhalation Solution should be used cautiously in patients with hepatic impairment due to increased systemic exposure in these patients
7. Renal Impairment- The systemic exposure to arformoterol was similar to renally impaired patients compared with demographically matched healthy control subjects
OVERDOSAGE The expected signs and symptoms associated with overdosage of BROVANA (arformoterol tartrate) Inhalation Solution are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of any of the signs and symptoms