Prescription Drug Information: Aripiprazole (Page 12 of 12)

14.6 Agitation Associated with Schizophrenia or Bipolar Mania

The efficacy of intramuscular aripiprazole for injection for the treatment of agitation was established in three short-term (24-hour), placebo-controlled trials in agitated inpatients from two diagnostic groups: schizophrenia and bipolar I disorder (manic or mixed episodes, with or without psychotic features). Each of the trials included a single active comparator treatment arm of either haloperidol injection (schizophrenia studies) or lorazepam injection (bipolar mania study). Patients could receive up to three injections during the 24-hour treatment periods; however, patients could not receive the second injection until after the initial 2-hour period when the primary efficacy measure was assessed. Patients enrolled in the trials needed to be: (1) judged by the clinical investigators as clinically agitated and clinically appropriate candidates for treatment with intramuscular medication, and (2) exhibiting a level of agitation that met or exceeded a threshold score of ≥15 on the five items comprising the Positive and Negative Syndrome Scale (PANSS) Excited Component (i.e., poor impulse control, tension, hostility, uncooperativeness, and excitement items) with at least two individual item scores ≥4 using a 1 to 7 scoring system (1 = absent, 4 = moderate, 7 = extreme). In the studies, the mean baseline PANSS Excited Component score was 19, with scores ranging from 15 to 34 (out of a maximum score of 35), thus suggesting predominantly moderate levels of agitation with some patients experiencing mild or severe levels of agitation. The primary efficacy measure used for assessing agitation signs and symptoms in these trials was the change from baseline in the PANSS Excited Component at 2 hours post-injection. A key secondary measure was the Clinical Global Impression of Improvement (CGI-I) Scale. The results of the trials follow:

In a placebo-controlled trial in agitated inpatients predominantly meeting DSM-IV criteria for schizophrenia (n=350), four fixed aripiprazole injection doses of 1 mg, 5.25 mg, 9.75 mg, and 15 mg were evaluated. At 2 hours post-injection, the 5.25 mg, 9.75 mg, and 15 mg doses were statistically superior to placebo in the PANSS Excited Component (Study 1 in Table 31) and on the CGI-I Scale.

In a second placebo-controlled trial in agitated inpatients predominantly meeting DSM-IV criteria for schizophrenia (n=445), one fixed aripiprazole injection dose of 9.75 mg was evaluated. At 2 hours post-injection, aripiprazole for injection was statistically superior to placebo in the PANSS Excited Component (Study 2 in Table 31) and on the CGI-I Scale.

In a placebo-controlled trial in agitated inpatients meeting DSM-IV criteria for bipolar I disorder (manic or mixed) (n=291), two fixed aripiprazole injection doses of 9.75 mg and 15 mg were evaluated. At 2 hours post-injection, both doses were statistically superior to placebo in the PANSS Excited Component (Study 3 in Table 31).

Examination of population subsets (age, race, and gender) did not reveal any differential responsiveness on the basis of these subgroupings.

Table 31: Agitation Associated with Schizophrenia or Bipolar Mania Studies

SD: standard deviation; SE: standard error; LS Mean: least-squares mean; CI: unadjusted confidence interval.

a Difference (drug minus placebo) in least-squares mean change from baseline.

* Doses statistically significantly superior to placebo.

Study Number Treatment Group Primary Efficacy Measure: PANSS Excited Component
Mean Baseline Score (SD) LS Mean Change from Baseline (SE) Placebo- subtracted difference a (95%CI)
Agitation Associated with Schizophrenia
Study 1 Aripiprazole (1 mg) * Aripiprazole (5.25 mg) * Aripiprazole (9.75 mg) * Aripiprazole (15 mg) * Placebo 19.16 (3.26) 19.41 (3.31) 19.42 (2.80) 19.34 (2.38) 19.18 (2.95) -4.47 (0.72) -5.65 (0.68) -6.69 (0.72) -5.72 (0.72) -3.28 (0.70) -1.19 (-2.96, -0.59) -2.37 (-4.10, -0.63) -3.40 (-5.18, -1.62) -2.44 (-4.21, -0.68) —
Study 2 Aripiprazole (9.75 mg) * Placebo 18.82 (2.67) 18.74 (2.71) -7.27 (0.59) -4.78 (0.69) -2.48 (-3.77, -1.19) —
Agitation Associated with Bipolar Mania
Study 3 Aripiprazole (9.75 mg) * Aripiprazole (15 mg) * Placebo 18.77 (2.45) 18.29 (2.49) 17.95 (2.63) -8.74 (0.57) -8.67 (0.57) -5.76 (0.58) -2.99 (-4.53, -1.44) -2.91 (-4.44, -1.38) —

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Aripiprazole tablets, USP 2 mg are yellow, round, uncoated tablets with scattered specks, debossed with “2″ on one side and “16″ on other side.

Bottles of 30 NDC 13668-216-30

Bottles of 90 NDC 13668-216-90

Bottles of 100 NDC 13668-216-01

Bottles of 500 NDC 13668-216-05

Bottles of 6250 NDC 13668-216-69

100 Unit dose Tablets NDC 13668-216-74

Aripiprazole tablets, USP 5 mg are white to off-white, round, uncoated tablets, debossed with “5″ on one side and “17″ on other side.

Bottles of 30 NDC 13668-217-30

Bottles of 90 NDC 13668-217-90

Bottles of 100 NDC 13668-217-01

Bottles of 500 NDC 13668-217-05

Bottles of 6250 NDC 13668-217-69

100 Unit dose Tablets NDC 13668-217-74

Aripiprazole tablets, USP 10 mg are white to off-white, round, uncoated tablets, debossed with “10″ on one side and “18″ on other side.

Bottles of 30 NDC 13668-218-30

Bottles of 90 NDC 13668-218-90

Bottles of 100 NDC 13668-218-01

Bottles of 500 NDC 13668-218-05

Bottles of 7000 NDC 13668-218-52

100 Unit dose Tablets NDC 13668-218-74

Aripiprazole tablets, USP 15 mg are white to off-white, round, uncoated tablets, debossed with “15″ on one side and “19″ on other side.

Bottles of 30 NDC 13668-219-30

Bottles of 90 NDC 13668-219-90

Bottles of 100 NDC 13668-219-01

Bottles of 500 NDC 13668-219-05

Bottles of 5000 NDC 13668-219-51

100 Unit dose Tablets NDC 13668-219-74

Aripiprazole tablets, USP 20 mg are white to off-white, round, uncoated tablets, debossed with “20″ on both sides.

Bottles of 30 NDC 13668-220-30

Bottles of 90 NDC 13668-220-90

Bottles of 100 NDC 13668-220-01

Bottles of 500 NDC 13668-220-05

Bottles of 3400 NDC 13668-220-68

100 Unit dose Tablets NDC 13668-220-74

Aripiprazole tablets, USP 30 mg are white to off-white, round, uncoated tablets, debossed with “30″ on one side and “21″ on other side.

Bottles of 30 NDC 13668-221-30

Bottles of 90 NDC 13668-221-90

Bottles of 100 NDC 13668-221-01

Bottles of 500 NDC 13668-221-05

Bottles of 2500 NDC 13668-221-31

100 Unit dose Tablets NDC 13668-221-74

16.2 Storage

Tablets

Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling ( Medication Guide).

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 patient’s prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient’s presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring and possibly changes in the medication [see Warnings and Precautions ( 5.3) ] .

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 “Antidepressant Medicines, Depression and other Serious Mental Illness, and Suicidal Thoughts or Actions” 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 [see Warnings and Precautions ( 5.7)].

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 [see Warnings and Precautions ( 5.11) ] .

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 [see Drug Interactions ( 7) ] .

Heat Exposure and Dehydration

Patients should be advised regarding appropriate care in avoiding overheating and dehydration [see Warnings and Precautions ( 5.12) ] .

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 [see Use in Specific Populations ( 8.1) ].

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Manufactured by:

TORRENT PHARMACEUTICALS LTD., INDIA.

Manufactured for:

TORRENT PHARMA INC., Basking Ridge, NJ 07920.

8076134 Revised September 2019

MEDICATION GUIDE Aripiprazole (AR-i-PIP-ra-zole) Tablets, USP
What is the most important information I should know about aripiprazole tablets? (For other side effects, also see “What are the possible side effects of aripiprazole tablets?”). Serious side effects may happen when you take aripiprazole tablets, including: ● Increased risk of death in elderly patients with dementia-related psychosis: Medicines like aripiprazole tablets can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). Aripiprazole tablets are not approved for the treatment of patients with dementia-related psychosis. ● Risk of suicidal thoughts or actions: Antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions: 1. Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment. 2. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions. 3. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member? ● Pay 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. ● Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings. ● Keep 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: ● thoughts about suicide or dying ● attempts to commit suicide ● new or worse depression ● new or worse anxiety ● feeling very agitated or restless ● panic attacks ● trouble sleeping (insomnia) ● new or worse irritability ● acting aggressive, being angry, or violent ● acting on dangerous impulses ● an extreme increase in activity and talking (mania) ● other unusual changes in behavior or mood What else do I need to know about antidepressant medicines? Never stop an antidepressant medicine without first talking to a healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms. ● Antidepressants are medicines used to treat depression and other illnesses. 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. ● Antidepressant medicines have other side effects. Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member. ● Antidepressant medicines can interact with other medicines. 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. ● Not all antidepressant medicines prescribed for children are FDA approved for use in children. Talk to your child’s healthcare provider for more information.
What are aripiprazole tablets? Aripiprazole Oral tablets , are prescription medicine used to treat: Ο Schizophrenia Ο manic or mixed episodes that happen with bipolar I disorder Ο major depressive disorder (MDD) when aripiprazole tablets are used with antidepressant medicines Ο irritability associated with autistic disorder Ο Tourette’s disorder It is not known if aripiprazole tablets are safe or effective in children: ● under 13 years of age with schizophrenia ● under 10 years of age with bipolar I disorder ● under 6 years of age with irritability associated with autistic disorder ● under 6 years of age with Tourette’s disorder
Do not take aripiprazole tablets if you are allergic to aripiprazole or any of the ingredients in aripiprazole tablets. See the end of this Medication Guide for a complete list of ingredients in aripiprazole tablets.
Before taking aripiprazole tablets, tell your healthcare provider about all your medical conditions, including if you have or had: ● diabetes or high blood sugar in you or your family; your healthcare provider should check your blood sugar before you start aripiprazole tablets and also during therapy. ● seizures (convulsions). ● low or high blood pressure. ● heart problems or stroke. ● pregnancy or plans to become pregnant. It is not known if aripiprazole tablets will harm your unborn baby. o If you become pregnant while receiving aripiprazole, talk to your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1-866-961-2388 or go to http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/ breast-feeding or plans to breast-feed. Aripiprazole passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you receive aripiprazole tablets. ● low white blood cell count. Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. 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 tablets work. 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? ● Take aripiprazole tablets exactly as your healthcare provider tells you to take them. Do not change the dose or stop taking aripiprazole tablets yourself. ● Aripiprazole tablets can be taken with or without food. ● Aripiprazole tablets should be swallowed whole. ● If you miss a dose of aripiprazole tablets, 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 tablets at the same time. ● If you take too many aripiprazole tablets, 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 tablets? ● Do not drive, operate heavy machinery, or do other dangerous activities until you know how aripiprazole tablets affect you. Aripiprazole tablets may make you drowsy. ● Avoid getting over-heated or dehydrated. Ο Do not over-exercise. Ο In hot weather, stay inside in a cool place if possible. Ο Stay out of the sun. Do not wear too much or heavy clothing. Ο Drink plenty of water.
What are the possible side effects of aripiprazole tablets? Aripiprazole may cause serious side effects, including: See “What is the most important information I should know about aripiprazole tablets?” Stroke in elderly people (cerebrovascular problems) that can lead to death Neuroleptic malignant syndrome (NMS). 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. ● Uncontrolled body movements (tardive dyskinesia). 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. ● Problems with your metabolism such as: ▪ High blood sugar (hyperglycemia) and diabetes. Increases in blood sugar can happen in some people who take aripiprazole tablets. 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 tablets and during your treatment. Call your healthcare provider if you have any of these symptoms of high blood sugar while receiving aripiprazole tablets: ► feel very thirsty ► need to urinate more than usual ► feel very hungry ► feel weak or tired ► feel sick to your stomach ► feel confused, or your breath smells fruity Ο Increased fat levels (cholesterol and triglycerides) in your blood. Ο Weight gain. You and your healthcare provider should check your weight regularly. ● Unusual urges. Some people taking aripiprazole tablets 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. ● Orthostatic hypotension (decreased blood pressure). Lightheadedness or fainting may happen when rising too quickly from a sitting or lying position. ● Falls. Aripiprazole may make you sleepy or dizzy, may cause a decrease in your blood pressure when changing position and can slow your thinking and motor skills which may lead to falls that can cause fractures or other injuries. ● Low white blood cell count Seizures (convulsions) Problems with control of your body temperature especially when you exercise a lot or are in an area that is very hot. It is important for you to drink water to avoid dehydration. See “What should I avoid while taking aripiprazole tablets?” ● Difficulty swallowing that can cause food or liquid to get into your lungs. The most common side effects of aripiprazole tablets in adults include: ● Nausea ● vomiting ● constipation ● headache ● blurred vision ● upper respiratory illness ● dizziness ● anxiety ● insomnia ● restlessness ● inner sense of restlessness/need to move (akathisia) The most common side effects of aripiprazole tablets in children include: ● feeling sleepy ● headache ● vomiting ● fatigue ● increased or decreased appetite ● increased saliva or drooling ● insomnia ● nausea ● stuffy nose ● weight gain ● uncontrolled movement such as restlessness, tremor ● muscle stiffness 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? ● Store aripiprazole tablets at 20° to 25° C (68° to 77° F); excursions permitted to 15° to 30° C (59° to 86° F) 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 tablets for a condition for which it was not prescribed. Do not give aripiprazole tablets 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: aripiprazole, USP Inactive ingredients: Tablets: colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, magnesium stearate, mannitol and microcrystalline cellulose. Additionally, 2 mg tablets contain ferric oxide yellow. For more information about aripiprazole tablets call 1-800-912-9561 This Medication Guide has been approved by the U.S. Food and Drug Administration. Image Manufactured by: TORRENT PHARMACEUTICALS LTD., INDIA. Manufactured For: TORRENT PHARMA INC., Basking Ridge, NJ 07920. 8076135 Revised: September 2019

DRUG: aripiprazole

GENERIC: aripiprazole

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 70518-2536-0

COLOR: white

SHAPE: ROUND

SCORE: No score

SIZE: 5 mm

IMPRINT: 5;17

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • ARIPIPRAZOLE 5mg in 1

INACTIVE INGREDIENT(S):

  • CELLULOSE, MICROCRYSTALLINE
  • MAGNESIUM STEARATE
  • MANNITOL
  • CROSPOVIDONE, UNSPECIFIED
  • HYDROXYPROPYL CELLULOSE (1600000 WAMW)
  • SILICON DIOXIDE
Remedy_Label
(click image for full-size original)
ARIPIPRAZOLE aripiprazole tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70518-2536(NDC:13668-217)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARIPIPRAZOLE (ARIPIPRAZOLE) ARIPIPRAZOLE 5 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
CROSPOVIDONE, UNSPECIFIED
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
MAGNESIUM STEARATE
MANNITOL
SILICON DIOXIDE
Product Characteristics
Color white (white to off-white) Score no score
Shape ROUND Size 5mm
Flavor Imprint Code 5;17
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70518-2536-0 30 TABLET in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201519 01/10/2020
Labeler — REMEDYREPACK INC. (829572556)

Revised: 01/2020 REMEDYREPACK INC.

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