drugs effects

 Overview
It is not known if Aripiprazole Orally Disintegrating Tablets can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Aripiprazole Orally Disintegrating Tablets while you are pregnant. Using Aripiprazole Orally Disintegrating Tablets during the third trimester may result in uncontrolled muscle movements or withdrawal symptoms in the newborn. Discuss any questions or concerns with your doctor. It is not known if Aripiprazole Orally Disintegrating Tablets are found in breast milk. Do not breast-feed while taking Aripiprazole Orally Disintegrating Tablets.

Aripiprazole Pregnancy Warnings

According to 1 case report, exposure to aripiprazole (10 mg/day initially then increased to 15 mg/day over 2 weeks) at week 29 of gestation until 6 days prior to delivery did not result in adverse peri- or post- natal effects.

Aripiprazole has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of developmental toxicity, including possible teratogenic effects. There are no controlled data in human pregnancy. Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder in these neonates. These complications have varied in severity; while in some cases symptoms have been self-limited, in other cases neonates have required intensive care unit support and prolonged hospitalization. Aripiprazole should only be given during pregnancy if the potential benefits outweigh the potential risks.

Aripiprazole Breastfeeding Warnings

There are no data on the excretion of aripiprazole into human milk. The manufacturer recommends that women receiving aripiprazole should not breast-feed.

 Adults
Dose Selection: The recommended starting and target dose for ABILIFY is 10 mg/day or 15 mg/day administered on a once-a-day schedule without regard to meals. ABILIFY has been systematically evaluated and shown to be effective in a dose range of 10 mg/day to 30 mg/day, when administered as the tablet formulation; however, doses higher than 10 mg/day or 15 mg/day were not more effective than 10 mg/day or 15 mg/day. Dosage increases should generally not be made before 2 weeks, the time needed to achieve steady-state [see CLINICAL STUDIES (14.1)].
Maintenance Treatment: Maintenance of efficacy in schizophrenia was demonstrated in a trial involving patients with schizophrenia who had been symptomatically stable on other antipsychotic medications for periods of 3 months or longer. These patients were discontinued from those medications and randomized to either ABILIFY 15 mg/day or placebo, and observed for relapse [see CLINICAL STUDIES (14.1)]. Patients should be periodically reassessed to determine the continued need for maintenance treatment.
Adolescents
Dose Selection: The recommended target dose of ABILIFY is 10 mg/day. Aripiprazole was studied in adolescent patients 13 to 17 years of age with schizophrenia at daily doses of 10 mg and 30 mg. The starting daily dose of the tablet formulation in these patients was 2 mg, which was titrated to 5 mg after 2 days and to the target dose of 10 mg after 2 additional days. Subsequent dose increases should be administered in 5 mg increments. The 30 mg/day dose was not shown to be more efficacious than the 10 mg/day dose. ABILIFY can be administered without regard to meals [see CLINICAL STUDIES (14.1)].
Maintenance Treatment: The efficacy of ABILIFY for the maintenance treatment of schizophrenia in the adolescent population has not been evaluated. While there is no body of evidence available to answer the question of how long the adolescent patient treated with ABILIFY should be maintained on the drug, maintenance efficacy can be extrapolated from adult data along with comparisons of aripiprazole pharmacokinetic parameters in adult and pediatric patients. Thus, it is generally recommended that responding patients be continued beyond the acute response, but at the lowest dose needed to maintain remission. Patients should be periodically reassessed to determine the need for maintenance treatment.
Switching from Other Antipsychotics
There are no systematically collected data to specifically address switching patients with schizophrenia from other antipsychotics to ABILIFY or concerning concomitant administration with other antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized.
Bipolar I Disorder

Acute Treatment of Manic and Mixed Episodes
​Adults: The recommended starting dose in adults is 15 mg given once daily as monotherapy and 10 mg to 15 mg given once daily as adjunctive therapy with lithium or valproate. ABILIFY can be given without regard to meals. The recommended target dose of ABILIFY is 15 mg/day, as monotherapy or as adjunctive therapy with lithium or valproate. The dose may be increased to 30 mg/day based on clinical response. The safety of doses above 30 mg/day has not been evaluated in clinical trials.
Pediatrics: The recommended starting dose in pediatric patients (10 to 17 years) as monotherapy is 2 mg/day, with titration to 5 mg/day after 2 days, and a target dose of 10 mg/day after 2 additional days. Recommended dosing as adjunctive therapy to lithium or valproate is the same. Subsequent dose increases, if needed, should be administered in 5 mg/day increments. ABILIFY can be given without regard to meals [see CLINICAL STUDIES (14.2)].
Maintenance Treatment
​The recommended dose for maintenance treatment, whether as monotherapy or as adjunctive therapy, is the same dose needed to stabilize patients during acute treatment, both for adult and pediatric patients. Patients should be periodically reassessed to determine the continued need for maintenance treatment [see CLINICAL STUDIES (14.2)].
Adjunctive Treatment of Major Depressive Disorder

Adults
Dose Selection: The recommended starting dose for ABILIFY as adjunctive treatment for patients already taking an antidepressant is 2 mg/day to 5 mg/day. The efficacy of ABILIFY as an adjunctive therapy for major depressive disorder was established within a dose range of 2 mg/day to 15 mg/day. Dose adjustments of up to 5 mg/day should occur gradually, at intervals of no less than 1 week [see CLINICAL STUDIES (14.3)].
Maintenance Treatment: The efficacy of ABILIFY for the adjunctive maintenance treatment of major depressive disorder has not been evaluated. While there is no body of evidence available to answer the question of how long the patient treated with ABILIFY should be maintained, patients should be periodically reassessed to determine the continued need for maintenance treatment.
Irritability Associated with Autistic Disorder

Pediatric Patients
Dose Selection: The efficacy of aripiprazole has been established in the treatment of pediatric patients 6 to 17 years of age with irritability associated with autistic disorder at doses of 5 mg/day to 15 mg/day. The dosage of ABILIFY should be individualized according to tolerability and response.
Dosing should be initiated at 2 mg/day. The dose should be increased to 5 mg/day, with subsequent increases to 10 mg/day or 15 mg/day if needed. Dose adjustments of up to 5 mg/day should occur gradually, at intervals of no less than 1 week [see CLINICAL STUDIES (14.4)].
Maintenance Treatment: The efficacy of ABILIFY for the maintenance treatment of irritability associated with autistic disorder has not been evaluated. While there is no body of evidence available to answer the question of how long the patient treated with ABILIFY should be maintained, patients should be periodically reassessed to determine the continued need for maintenance treatment.

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Abilify Solution:
 Abnormal dreams; blurred vision; constipation; dizziness; drowsiness; headache; increased appetite (in children); increased saliva production; lightheadedness; nausea; sore throat (in children); stomach upset; tiredness; trouble sleeping; vomiting; weight gain.

Seek medical attention right away if any of these SEVERE side effects occur when using Abilify Solution:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal thinking; chest pain; confusion; fainting; fast, slow, or irregular heartbeat; fever, chills, or sore throat; increased sweating; involuntary movements of the tongue, face, mouth, jaw, arms, legs, or back (eg, chewing movements, puckering of mouth, puffing of cheeks); loss of control over urination; loss of coordination; muscle tremor, jerking, or stiffness; new or worsening mental or mood problems (eg, anxiety, depression, agitation, panic attacks, aggressiveness, impulsiveness, irritability, hostility, exaggerated feeling of well-being, inability to sit still); one-sided weakness; seizures; severe or persistent restlessness; shortness of breath; suicidal thoughts or attempts; swelling of the hands, ankles, or feet; symptoms of high blood sugar (eg, increased thirst, urination, or appetite; unusual weakness); trouble swallowing; trouble walking; unusual bruising; unusual tiredness or weakness; vision or speech changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Abilify Discmelt Orally Disintegrating Tablets:
 Abnormal dreams; blurred vision; constipation; dizziness; drowsiness; headache; increased appetite (in children); increased saliva production; lightheadedness; nausea; sore throat (in children); stomach upset; tiredness; trouble sleeping; vomiting; weight gain.

Seek medical attention right away if any of these SEVERE side effects occur when using Abilify Discmelt Orally Disintegrating Tablets:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal thinking; chest pain; confusion; fainting; fast, slow, or irregular heartbeat; fever, chills, or sore throat; increased sweating; involuntary movements of the tongue, face, mouth, jaw, arms, legs, or back (eg, chewing movements, puckering of mouth, puffing of cheeks); loss of control over urination; loss of coordination; muscle tremor, jerking, or stiffness; new or worsening mental or mood problems (eg, anxiety, depression, agitation, panic attacks, aggressiveness, impulsiveness, irritability, hostility, exaggerated feeling of well-being, inability to sit still); one-sided weakness; seizures; severe or persistent restlessness; shortness of breath; suicidal thoughts or attempts; swelling of the hands, ankles, or feet; symptoms of high blood sugar (eg, increased thirst, urination, or appetite; unusual weakness); trouble swallowing; trouble walking; unusual bruising; unusual tiredness or weakness; vision or speech changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Abilify
Dizziness; drowsiness; headache; nausea; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur when using Abilify:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal thinking; chest pain; confusion; fainting; fast, slow, or irregular heartbeat; fever, chills, sore throat; increased sweating; involuntary movements of the tongue, face, mouth, jaw, arms, legs, or back (eg, chewing movements, puckering of mouth, puffing of cheeks); loss of control over urination; loss of coordination; muscle tremor, jerking, or stiffness; new or worsening mental or mood problems (eg, anxiety, depression, agitation, panic attacks, aggressiveness, impulsiveness, irritability, hostility, exaggerated feeling of well-being, inability to sit still); one-sided weakness; seizures; severe or persistent restlessness; shortness of breath; suicidal thoughts or attempts; swelling of the hands, ankles, or feet; symptoms of high blood sugar (eg, increased thirst, urination, or appetite; unusual weakness); trouble swallowing; trouble walking; unusual bruising; unusual tiredness or weakness; vision or speech changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Abilify is not for use in psychotic conditions that are related to dementia. Abilify may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions.
 Stop using Abilify and call your doctor at once if you have the following symptoms: fever with stiff muscles and rapid heart rate; uncontrolled muscle movements; symptoms that come on suddenly such as numbness or weakness, severe headache, and problems with vision, speech, or balance. Abilify may impair your thinking or reactions.

Video: Treatment for Depression
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Be careful if you drive or do anything that requires you to be alert. Avoid drinking alcohol, which can increase some of the side effects of Abilify. Before you take this medicine, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by Abilify. Avoid becoming overheated or dehydrated.

Drink plenty of fluids, especially in hot weather and during exercise. It is easier to become dangerously overheated and dehydrated while you are taking Abilify.

Before you take Abilify, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by Abilify.
 Tell your doctor about all other medicines you use, especially:

a medication to treat high blood pressure or a heart condition;
carbamazepine (Carbatrol, Tegretol), phenobarbital (Luminal, Solfoton), or phenytoin (Dilantin);
rifabutin (Mycobutin) or rifampin (Rifadin, Rimactane, Rifater);
ketoconazole (Nizoral), itraconazole (Sporanox);
quinidine (Quin-G); or
fluoxetine (Prozac, Sarafem, Symbyax), fluvoxamine (Luvox), or paroxetine (Paxil).
This list is not complete and other drugs may interact with Abilify. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Get emergency medical help if you have any of these signs of an allergic reaction to Abilify: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using Abilify and call your doctor at once if you have a serious side effect such as:

fever, stiff muscles, confusion, sweating, fast or uneven heartbeats;
jerky muscle movements you cannot control;
sudden numbness or weakness, headache, confusion, or problems with vision, speech, or balance;
fever, chills, body aches, flu symptoms, sores in your mouth and throat;
increased thirst or urination, loss of appetite, fruity breath odor, drowsiness, dry skin, nausea, and vomiting;
seizure (convulsions);
thoughts of hurting yourself;
feeling like you might pass out;
jaundice (yellowing of your skin or eyes); or
urinating less than usual or not at all.
Less serious Abilify side effects may include:

choking or trouble swallowing;
dizziness, drowsiness, or weakness;
constipation, mild stomach upset;
headache, anxiety;
sleep problems (insomnia); or
weight gain.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Take Abilify exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results.

Do not take Abilify for longer than 6 weeks unless your doctor has told you to.

Abilify can be taken with or without food.

Measure liquid medicine with a special dose measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose measuring device, ask your pharmacist for one.

To take aripiprazole orally disintegrating tablets (Abilify Discmelt):

Keep the tablet in its blister pack until you are ready to take it. Open the package and peel back the foil from the tablet blister. Do not push a tablet through the foil or you may damage the tablet.
Using dry hands, remove the tablet and place it in your mouth. It will begin to dissolve right away.
Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.
Swallow several times as the tablet dissolves. If desired, you may drink liquid to help swallow the dissolved tablet.
Use Abilify regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.

Store Abilify tablets at room temperature away from moisture and heat.

Abilify liquid should be stored in the refrigerator and can be used for up to 6 months after opening.

Abilify may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.
Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.
Drinking alcohol can increase certain side effects of Abilify. Avoid becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise. It is easier to become dangerously overheated and dehydrated while you are taking Abilify.