Abilify® Medication Guide

Generic name: aripiprazole

Read this Medication Guide before you start taking ABILIFY and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment.

What is the most important information I should know about ABILIFY (aripiprazole)?

(For other side effects, also see “What are the possible side effects of ABILIFY?”).

Serious side effects may happen when you take ABILIFY, including:

• Increased risk of death in elderly patients with dementia-related psychosis: Medicines like ABILIFY can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). ABILIFY is 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 is ABILIFY?

ABILIFY is a prescription medicine used to treat:

• schizophrenia in people age 13 years and older.

• bipolar I disorder in people age 10 years and older, including:

• manic or mixed episodes that happen with bipolar I disorder.

• manic or mixed episodes that happen with bipolar I disorder, when used with the medicine lithium or valproate.

• long-term treatment of bipolar I disorder.

• major depressive disorder in adults, as an add-on treatment to an antidepressant medicine when you do not get better with an antidepressant alone.

• irritability associated with autistic disorder in children and adolescents ages 6 to 17 years old.

• agitation associated with schizophrenia or bipolar disorder.

The symptoms of schizophrenia include:

• losing touch with reality (psychosis)

• seeing things or hearing voices that are not there (hallucinations)

• believing things that are not true (delusions)

• being suspicious (paranoia)

• disorganized speech and thinking

• bizarre behavior

The symptoms of bipolar I disorder include:

• extreme mood swings that include feeling depressed and high or irritable mood

• talking too fast and too much

• impulsive behavior

• having more energy and restlessness than usual

• needing less sleep than usual

The symptoms of major depressive disorder (MDD) include:

• feeling of sadness and emptiness

• loss of interest in activities that you once enjoyed and loss of energy

• problems focusing and making decisions

• feeling of worthlessness or guilt

• changes in sleep or eating patterns

• thoughts of death or suicide

The symptoms of irritability associated with autistic disorder include:

• aggressive behavior towards others

• intentionally trying to harm oneself

• temper tantrums

• quickly changing moods

The symptoms of agitation associated with schizophrenia or bipolar disorder include:

• hostility or aggressive behavior

• agitation and inner tension

• self-exhausting behavior

What should I tell my healthcare provider before taking ABILIFY?

Before taking ABILIFY, tell your healthcare provider 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 ABILIFY 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 ABILIFY will harm your unborn baby.

• breast-feeding or plans to breast-feed. It is not known if ABILIFY will pass into your breast milk. You and your healthcare provider should decide if you will take ABILIFY or breast-feed. You should not do both.

• low white blood cell count.

• phenylketonuria. ABILIFY DISCMELT Orally Disintegrating Tablets contain phenylalanine.

• any other medical conditions.

Tell your healthcare provider about all the medicines that you take or recently have taken, including prescription medicines, non-prescription medicines, herbal supplements, and vitamins.

ABILIFY and other medicines may affect each other causing possible serious side effects. ABILIFY may affect the way other medicines work, and other medicines may affect how ABILIFY works.

Your healthcare provider can tell you if it is safe to take ABILIFY with your other medicines. Do not start or stop any medicines while taking ABILIFY 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 ABILIFY?

• Take ABILIFY exactly as your healthcare provider tells you to take it.

Do not change the dose or stop taking ABILIFY yourself.

• ABILIFY can be taken with or without food.

• ABILIFY tablets should be swallowed whole.

• If you miss a dose of ABILIFY, 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 ABILIFY at the same time.

• If you have been prescribed ABILIFY DISCMELT, take it as follows:

• Do not open the blister until ready to take the DISCMELT tablet.

• To remove one DISCMELT tablet, open the package and peel back the foil on the blister to expose the tablet.

• Do not push the tablet through the foil because this could damage the tablet.

• Immediately upon opening the blister, using dry hands, remove the tablet and place the entire ABILIFY DISCMELT Orally Disintegrating Tablet on the tongue.

• Tablet disintegration occurs rapidly in saliva. It is recommended that ABILIFY DISCMELT be taken without liquid. However, if needed, it can be taken with liquid.

• Do not attempt to split the DISCMELT tablet.

• If you take too much ABILIFY, 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 ABILIFY?

• Do not drive, operate heavy machinery, or do other dangerous activities until you know how ABILIFY affects you. ABILIFY may make you drowsy.

• Do not drink alcohol while taking ABILIFY.

• Avoid getting over-heated or dehydrated.

• Do not over-exercise.

• In hot weather, stay inside in a cool place if possible.

• Stay out of the sun. Do not wear too much or heavy clothing.

• Drink plenty of water.

What are the possible side effects of ABILIFY?

Serious side effects have been reported with ABILIFY including: Also see “What is the most important information I should know about ABILIFY?” at the beginning of this Medication Guide.

• 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.

• High blood sugar (hyperglycemia): Increases in blood sugar can happen in some people who take ABILIFY. 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 ABILIFY and during therapy.

Call your healthcare provider if you have any of these symptoms of high blood sugar while taking ABILIFY:

• 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.

• Difficulty swallowing: may lead to aspiration and choking.

• Tardive dyskinesia: Call your healthcare provider about any movements you cannot control in your face, tongue, or other body parts. These may be signs of a serious condition. Tardive dyskinesia may not go away, even if you stop taking ABILIFY. Tardive dyskinesia may also start after you stop taking ABILIFY.

• Orthostatic hypotension (decreased blood pressure): lightheadedness or fainting when rising too quickly from a sitting or lying position.

• Low white blood cell count

• Seizures (convulsions)

Common side effects with ABILIFY in adults include:

• nausea • inner sense of restlessness/need to move

• vomiting (akathisia)

• constipation • anxiety

• headache • insomnia

• dizziness • restlessness

Common side effects with ABILIFY in children include:

• feeling sleepy • insomnia

• headache • nausea

• vomiting • stuffy nose

• fatigue • weight gain

• increased appetite • uncontrolled movement such as restlessness, tremor, muscle stiffness

These are not all the possible side effects of ABILIFY. For more information, ask your healthcare provider or pharmacist.

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 ABILIFY?

• Store ABILIFY at room temperature, between 59°F to 86°F (15°C to 30°C).

• Opened bottles of ABILIFY Oral Solution can be used for up to

6 months after opening, but not beyond the expiration date on the bottle.

Keep ABILIFY and all medicines out of the reach of children.

General information about ABILIFY

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ABILIFY for a condition for which it was not prescribed. Do not give ABILIFY to other people, even if they have the same condition. It may harm them.

This Medication Guide summarizes the most important information about ABILIFY. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about ABILIFY that was written for healthcare professionals. For more information about ABILIFY visit www.abilify.com.

What are the ingredients in ABILIFY?

Active ingredient: aripiprazole

Inactive ingredients:

Tablets: 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.

ABILIFY DISCMELT Orally Disintegrating Tablets: acesulfame potassium, aspartame (which contains phenylalanine), calcium silicate, croscarmellose sodium, crospovidone, crème de vanilla (natural and artificial flavors), magnesium stearate, microcrystalline cellulose, silicon dioxide, tartaric acid, and xylitol. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake.

ABILIFY Oral Solution: disodium edetate, fructose (200 mg per mL), glycerin, dl-lactic acid, methylparaben, propylene glycol, propylparaben, sodium hydroxide, sucrose (400 mg per mL), and purified water. The oral solution is flavored with natural orange cream and other natural flavors.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

ABILIFY is a trademark of Otsuka Pharmaceutical Company.

Source: http://packageinserts.bms.com/medguide/medguide_abilify.pdf

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Lustral tablets contain the active ingredient sertraline hydrochloride, which is a type of antidepressant known as a selective serotonin reuptake inhibitor (SSRI). (NB. Sertraline tablets are also available without a brand name, ie as the generic medicine.)

Antidepressant medicines act on nerve cells in the brain. In the brain there are numerous different chemical compounds called neurotransmitters. These act as chemical messengers between the nerve cells. Serotonin is one such neurotransmitter and has various functions that we know of.

When serotonin is released from nerve cells in the brain it acts to lighten mood. When it is reabsorbed into the nerve cells, it no longer has an effect on mood. It is thought that when depression occurs, there may be a decreased amount of serotonin released from nerve cells in the brain.

SSRIs work by preventing serotonin from being reabsorbed back into the nerve cells in the brain. This helps prolong the mood lightening effect of any released serotonin. In this way, sertraline helps relieve depression.

Sertraline may also be used in the treatment of obsessive compulsive disorder and post-traumatic stress disorder. It is not fully understood how it works in these conditions.

It may take between two to four weeks for the benefits of this medicine to appear, so it is very important that you keep taking it, even if it doesn’t seem to make much difference at first. If you feel your depression has got worse, or if you have any distressing thoughts or feelings in these first few weeks, then you should talk to your doctor.
What is it used for?
Depression in adults
A psychiatric disorder in which tasks are excessively repeated (obsessive-compulsive disorder) in adults and children aged six years and over
Post-traumatic stress disorder in adult women
Warning!
Depression and other pschiatric illnesses are associated with an increased risk of suicidal thoughts, self-harm, and suicide. You should be aware that this medicine may not start to make you feel better for at least two to four weeks. However, it is important that you keep taking it in order for it to work properly and for you to feel better. If you feel your depression or anxiety has got worse, or if you have any distressing thoughts, or feelings about suicide or harming yourself in these first few weeks, or indeed at any point during treatment or after stopping treatment, then it is very important to talk to your doctor.
This medicine may reduce your ability to drive or operate machinery safely. Do not drive or operate machinery until you know how this medicine affects you and you are sure it won’t affect your performance.
It is recommended that you avoid drinking alcohol while taking this medicine.
SSRI antidepressants have been associated with the development of unpleasant or distressing restlessness and the need to move, often accompanied by an inability to sit or stand still. This is most likely to occur within the first few weeks of treatment. If you experience these symptoms you should consult your doctor.
Antidepressants may cause the amount of sodium in the blood to drop – a condition called hyponatraemia. This can cause symptoms such as drowsiness, confusion, muscle twitching or convulsions. Elderly people may be particularly susceptible to this effect. You should consult your doctor if you develop any of these symptoms while taking this medicine, so that your blood sodium level can be checked if necessary.
If you experience seizures (convulsions or fits) while taking this medicine, consult your doctor immediately, as you will need to stop treatment with this medicine. This also applies if you suffer from epilepsy and experience more seizures than normal after starting this medicine.
You should not suddenly stop taking this medicine, as this can cause withdrawal symptoms such as dizziness, sleep disturbances (including intense dreams), nausea, headache, a feeling of weakness, pins and needles and anxiety. Withdrawal symptoms are temporary and are not due to addiction or dependence on the medicine. They can usually be avoided by stopping the medicine gradually, usually over a period of weeks or months, depending on your individual situation. Follow the instructions given by your doctor when it is time to stop treatment with this medicine. On very rare occasions some people have experienced withdrawal symptoms after accidentally missing a dose of this medicine.
Following a review of the safety and efficacy of SSRIs to treat depression in children under 18 years of age (unlicensed use), the Committee on Safety of Medicines (CSM) has concluded that the risks of sertraline outweigh the benefits for treating depressive illness in this age group. If you are under 18 and taking sertraline for depression you should consult your doctor for advice, but do not suddenly stop taking it as this can cause withdrawal symptoms. Sertraline may be used for obsessive-compulsive disorder in children aged six years and over, but is not recommended for younger children.
Use with caution in
Elderly people
Young adults
History of suicidal behaviour or thoughts
History of mania or hypomania
People also receiving electroconvulsive therapy (ECT)
Decreased kidney function
Decreased liver function
Diabetes
Epilepsy
History of bleeding disorders
People taking medicine that affects blood clotting (eg anticoagulants such as warfarin)
Not to be used in
Children and adolescents under 18 years of age for the treatment of depressive illness
People who have taken a monoamine-oxidase inhibitor antidepressant (MAOI) in the last 14 days
Manic episodes of manic depression (bipolar affective disorder)
Severely decreased liver function
Uncontrolled epilepsy
People taking the antipsychotic medicine pimozide

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.
Pregnancy and Breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.
The safety of this medicine in pregnancy has not been established. It should therefore be used with caution during pregnancy, and only if the benefits to the mother outweigh any risks to the foetus. Seek medical advice from your doctor.
This medicine passes into breast milk, however the effect of this on the nursing infant is unknown. For this reason women who need to take this medicine should consider not breastfeeding. Seek medical advice from your doctor.
Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.
Disturbances of the gut such as nausea, vomiting, diarrhoea or abdominal pain
Indigestion (dyspepsia)
Loss of appetite
Shaking, usually of the hands (tremor)
Dizziness
Difficulty in sleeping (insomnia)
Sleepiness (somnolence)
Increased sweating
Dry mouth
Sexual problems
Headache
Anxiety and agitation
Pins and needles (paraesthesia)
Changes in blood pressure
Seizures
Loss of memory (amnesia)
Liver disorders

The side effects listed above may not include all of the side effects reported by the drug’s manufacturer.

For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.
How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to ensure that the combination is safe.

Sertraline should not be taken at the same time as monoamine oxidase inhibitor medicines (MAOIs). These include monoamine oxidase inhibitor antidepressants such as phenelzine, tranylcypromine and moclobemide, the antibiotic linezolid and the anti-Parkinson’s medicine selegiline. Sertraline should not be started until at least at least a day after stopping moclobemide or linezolid, and at least two weeks after stopping other monoamine oxidase inhibitors. Similarly, treatment with any MAOIs should not be started until at least two weeks after stopping treatment with sertraline.

Sertraline must not be taken with the antipsychotic medicine pimozide.

Sertraline should not be taken in combination with benzodiazepines or other tranquilisers by people who need to drive or operate machinary.

There may be an increased risk of side effects if sertraline is taken with the following medicines, which also enhance the activity of serotonin in the brain:
lithium
triptans for migraine, eg sumatriptan
tramadol
tryptophan.

The herbal remedy St John’s wort should not be taken with sertraline for the same reason.

Sertraline may increase the blood levels of the following medicines:
clozapine
some tricyclic antidepressants (imipramine, desipramine, nortriptyline and possibly amitriptyline).

Sertraline may increase the effect of anti-blood-clotting medicines (anticoagulants) such as warfarin, and this may increase the risk of bleeding. If you are taking an anticoagulant with this medicine, your blood clotting time should be regularly monitored.

As SSRIs have been associated with bleeding abnormalities, the following medicines, which are known to affect the ability of the blood to clot, should be used with caution with sertraline:
tricyclic antidepressants
some antipsychotic medicines
some antisickness medicines, eg prochlorperazine
aspirin and non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen
ticlopidine
dipyridamole.

Treatment with this medicine may alter control of blood sugar in people with diabetes, who may need an adjustment in their dose of insulin or antidiabetic tablets. People with diabetes should discuss this with their doctor.

Sertraline blood levels may be increased by cimetidine and this may increase the risk of sertraline side effects.
Other medicines containing the same active ingredient

Sertraline tablets are available without a brand name, ie as the generic medicine.

Source: http://www.netdoctor.co.uk/medicines/100001555.html

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Source: http://theicarusproject.net/downloads/ComingOffPsychDrugsHarmReductGuide1Edonline.pdf

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Use:
Anticonvulsant, antimanic agent. Epilepsy: Adults and children > 12 years – initially, 100-200 mg once or twice a day; increased in divided doses until best response obtained. Optimal daily dosage: 800-1200 mg. Rarely, some adults may require 1600 mg/day. As soon as disappearance of seizures has been obtained and maintained, reduce dosage very gradually to minimum effective dose. Children 6-12 years: Initially, 100 mg in divided doses on first day; increased by 100mg/day until best response obtained. Maximum daily dosage: 1000mg.

Trigeminal neuralgia: Initially, 100 mg twice daily; increased by 200 mg/day until pain is relieved, usually at 200-800 mg/day (occasionally, 1200 mg/day). Reduce or discontinue Tegretol, if possible, at intervals of not more than 3 months.

Mania and bipolar disorders: Initially, 200-400 mg/day in divided doses (400-600 mg/day may be used in acute mania); increased gradually until symptoms are controlled or a total daily dose of 1600 mg is achieved. Usual dose is 400-1200 mg/day in divided doses.

With lithium, neuroleptics: start with 100-200 mg/day and increase gradually. Daily dose > 800 mg is rarely required.

Tegretol tablets, Chewtabs and suspension: Take in 2-4 divided doses daily, with food. CR tablets may be divided or swallowed unchewed with liquid during or after a meal. Suspension: Start with low doses and increase slowly to avoid adverse reactions. When switching from tablets to suspension, give the same amount of drug daily, but in smaller, more frequent doses (i.e. twice daily tablets could be switched to 3 times daily suspension).

Contraindications:
AV block, hepatic disease, a history of bone marrow depression, acute intermittent porphyria or serious blood disorders. Hypersensitivity to carbamazepine or tricyclics. Not to be given with, or within 14 days of starting or stopping MAOI therapy.

Precautions:
Pregnancy, lactation: Weigh possible risks vs. potential benefits. Elderly patients. Urinary retention, increased intraocular pressure, cardiovascular disorders, activation of behavioral disorders, exacerbation of seizures. Perform periodic ophthalmic examinations, evaluations of renal, hepatic and bone marrow function. Abrupt cessation of Tegretol may precipitate seizures. Cross-hypersensitivity with phenytoin and oxcarbazepine.

Side effects:
Drowsiness, headache, ataxia, vertigo, fatigue, diplopia, dizziness, nausea, vomiting, allergic skin reactions, edema, fluid retention, dry mouth, leucopenia, eosinophilia. Rarely, serious hematologic, hepatic, cardiovascular and dermatologic reactions (stop therapy).

Interactions:
Se Contraindications. Plasma levels of carbamazepine increased by macrolide antibiotics, isoniazid, verapamil, danazol, fluvoxamine, grapefruit juice, azole antifungals, loratadine, ritonavir, diltiazem, fluoxetine, cimetidine. Carbamazepine may lower plasma levels of anticonvulsants, oral contraceptive, oral anticoagulants, digoxin, cyclosporine, levothyroxine, dehydropyridine calcium channel blockers, doxycycline, TCAs, estrogens/progestrogens, corticosteroids, benzodiazepines, haloperidol, protease inhibitors for HIV treatment, olanzapine, risperidone. Plasma levels of carbamazepine may be reduced by phenytoin, Phenobarbital, rifampin, oxcarbazepine, St.John’sWort, valproic acid, phesuximide. Combined use of carbamazepine with lithium or haloperidol may increase risk of neurotoxic side effects.

Patient tips:
Avoid alcoholic beverages. Call physician immediately if seizures worsen. Caution re drowsiness, dizziness (NB driving).

Supplied:
200 mg tablets, 100 mg and 200 mg Chewtabs, 200 mg and 400 mg CR (controlled-release) tablets, 100 mg/5mL oral suspension.

Source: http://www.mentalhealth.com/drug/p30-t01.html

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