Serious infections leading to hospitalization or death, including tuberculosis and bacterial, invasive fungal, viral, and other opportunistic infections, have occurred. Refer to the prescribing information of oral aripiprazole for the recommended dosage and administration of the oral formulation. If you are unsure of the necessary steps to safely insert andor remove nexplanon, do not attempt the procedure. Prescribing information prfluphenazine fluphenazine hydrochloride tablets usp 1 mg, 2 mg, and 5 mg therapeutic classification antipsychotic pharmacology phenothiazine derivatives appear to act on the hypothalamus, depressing various components of the.
Latuda is not approved for the treatment of patients with dementiarelated psychosis 5. Bleeding risk effient can cause significant, sometimes fatal, bleedingsee warnings and precautions 5. Place and hold the vial of the reconstituted abilify maintena suspension on a hard surface. For patients who have never taken aripiprazole, establish tolerability with oral aripiprazole prior to initiating treatment with abilify maintena. Elderly patients with dementiarelated psychosis treated with antipsychotic drugs are at an increased risk of death. Do not use effient in patients with active pathological bleeding or a history of transient ischemic attack or stroke 4. Patients with tartrazine dye hypersensitivity should avoid these products. Abilify maintena is only to be administered by intramuscular injection by a healthcare professional. Aristada aripiprazole lauroxil extendedrelease injectable. Maintena that is written for healthcare professionals. Abilify maintena fda prescribing information, side effects.
Maintena is 400 mg monthly no sooner than 26 days after the previous injection. Fda approved indications abilify maintena is indicated. Cerebrovascular adverse reactions, including stroke. The recommended starting and target dose for abilify is 10 or 15 mgday administered on a onceaday schedule without regard to meals. Aristada initio may affect the way other medicines work, and other medicines may affect how aristada initio works. Fluphenazine decanoate injection, usp package insert. Geodon can be used to treat symptoms of schizophrenia and acute manic or mixed episodes associated with bipolar disorder. There are two aripiprazole formulations for intramuscular use with different dosages, dosing frequencies, and indications. Aripiprazole is the first antipsychotic agent with d2 partial agonist properties. For the treatment of schizophrenia in adults for maintenance monotherapy treatment of bipolar i disorder in adults. May 15, 2015 the pi is different from the patient package insert ppi, which contains information intended for patients, notwithstanding that the ppi may be required as part of the fdaapproved labeling for the drug. In general, no dosage adjustments for abilify maintena are required based on age alone, gender, race, smoking status, hepatic function, or renal function.
Aristada and other medicines may affect each other causing possible serious side effects. Abilify maintena aripiprazole is indicated for the treatment of schizophrenia. Some oral preparations of fluphenazine have contained tartrazine dye. Abilify maintena is not approved for the treatment of patients with dementiarelated psychosis. Information for the user abilify maintena 300 mg powder and solvent for prolongedrelease suspension for injection abilify maintena 400 mg powder and solvent for prolongedrelease suspension for injection aripiprazole read all of this leaflet carefully before you receive this medicine because it contains important. If more than 4 weeks and less than 6 weeks have elapsed since the last injection, administer the injection as soon as possible.
Recent major changeswarnings and precautions,tardive dyskinesia5. It is available in sesame oil in sterile form for intramuscular im injection. Refer to the prescribing information for oral aripiprazole for recommendations regarding dosage adjustments due to drug interactions, for the first 21 days when the patient is taking 21 days of oral aripiprazole concomitantly with the first dose of aristada. Frequency is considered excessive when services are performed more frequently than listed in the package insert, listed below or generally accepted by. Patients with a history of a clinically significant low white blood cell count wbc or a druginduced leukopenianeutropenia should have their complete blood count cbc monitored frequently during the first few months of therapy and discontinuation of abilify should be considered at the first sign of a.
Vraylar cariprazine capsules, for oral use initial u. Abilify maintena in schizophrenia, the most commonly observed adverse reactions associated with the use of abilify maintena incidence of 5% or greater and aripiprazole incidence at least twice that for placebo were increased weight 16. Videos demonstrating insertion and removal are available online for trained healthcare providers. Full prescribing information, including boxed warning, and medication guide. When addressing missed doses of pp1m, first determine whether the patient is in the initiation or maintenance dosing phase. Highlights of prescribing information these highlights do not include all the information needed to use vraylar safely and effectively. Page 2 of 21 full prescribing information 1 indications and usage 1. Abilify maintena is a longacting aripiprazole formulation with 4week dosing intervals indicated for the treatment of schizophrenia and maintenance monotherapy of bipolar i disorder in adults. See full prescribing information for complete boxed warning contraindication. Haloperidol injection, usp for immediate release rx only warning increased mortality in elderly p atients with dementiarelated p sychosis. About aristada aripiprazole lauroxil the treatment of. Due to the halflife of oral aripiprazole, it may take up to 2 weeks to fully assess tolerability. Highlights of prescribing information these highlights do not include all the information needed to use latuda safely and effectively. The recommended starting and maintenance dose of abilify maintena is 400.
Abilify fda prescribing information, side effects and uses. Dosage forms and strengths these highlights do not include. Variable segments circle adobe illustrator cs6 macintosh 20161104t11. Zyprexa relprevv is the longacting salt formulation of olanzapine, olanzapine pamoate, and is administered every 2 to 4 weeks for the treatment of schizophrenia in. Effient can cause significant, sometimes fatal, bleeding 5. Aristada initio and other medicines may affect each other causing possible serious side effects. Schizophrenia treatment abilify maintena aripiprazole. Abilify maintena is presented as a sterile, singledose, lyophilised powder for reconstitution with water for injections to give a prolongedrelease suspension for injection to deliver 400 mg of. Once the initiation dosing phase of paliperidone palmitate monthly longacting injection pp1m is completed, the maintenance dose is administered every 4 weeks.
The excipients are carmellose sodium, mannitol, monobasic monohydrate sodium phosphate and sodium hydroxide. The incidence of syncopal episodes is approximately 1% in patients. Call the merck national service center at 18778884231 if you have any questions. The pi is different from the patient package insert ppi, which contains information intended for patients, notwithstanding that the ppi may be required as part of the fdaapproved labeling for the drug. After the first abilify maintena injection, administer oral aripiprazole 10 mg to 20 mg for 14 consecutive days to achieve therapeutic aripiprazole concentrations during initiation of therapy. This may cause the white collar to loosen or detach. Aristada initio is not intended for repeated dosing. Abilify maintena fda prescribing information, side. Invega sustenna paliperidone palmitate is an atypical antipsychotic. Invega trinza paliperidone palmitate a 3month injection, is an atypical antipsychotic indicated for the treatment of schizophrenia in patients after they have been adequately treated with invega sustenna 1month paliperidone palmitate for at least four months. Protect the syringe from light by storing in the original package until time of use. Increased mortality in elderly patients with dementia related psychosis see full prescribing information for complete boxed warning. Treatment of schizophrenia in adults 1 maintenance monotherapy treatment of bipolar i disorder in adults 1 dosage and administration only to be administered by intramuscular injection in the deltoid or gluteal.
Reactions have ranged from pruritusurticaria to anaphylaxis. Fda approves deltoid injection site for abilify maintena. Increased incidence of cerebrovascular adverse reactions e. See full prescribing information for complete boxed warning. Abilify maintena is an atypical antipsychotic indicated for. Fluphenazine hydrochloride injection solution is for intramuscular administration only and contains several parabens as preservatives, and should be avoided in patients with paraben hypersensitivity. Abilify aripiprazole injection for intramuscular use is a clear, colorless solution available as a readytouse, 9. Latuda lurasidone hydrochloride tablets, for oral use initial u. Instructions for use please read complete instructions prior to use for deltoid or gluteal intramuscular injection only for intramuscular injection only. Dosing and administration information for abilify maintena. Aristada initio aripiprazole lauroxil extended release injectable suspension, for intramuscular use. Attach the syringe to the when the cap is vial adapter with a firm clockwise twisting motion until it feels snug. In general, no dosage adjustments for abilify maintena are required based on age alone, gender, race, smoking status, hepatic function, or renal function dcs.
Before you receive aristada initio, tell your healthcare provider about all of your medical conditions, including if you. Highlights of prescribing information these highlights do not include all the information needed to use risperidone tablets safely and effectively. Efficacy was demonstrated in a placebo controlled, randomizedwithdrawal maintenance trial in patients with schizophrenia and additional support for efficacy was. Maintena is intended for intramuscular injection only.
Do not use effient in patients with active pathological bleeding or a history of transient ischemic attack or strokesee contraindications 4. Geodon is a type of prescription medicine called a psychotropic, also known as an atypical antipsychotic. Abilify is contraindicated in patients with a history of a hypersensitivity reaction to aripiprazole. Paliperidone palmitate monthly longacting injection. Aristada initio aripiprazole lauroxil and aristada.
Geodon can also be used as maintenance treatment of bipolar disorder when added to lithium or valproate. Dosage forms and strengths these highlights do not. Learn about abilify maintena aripiprazole for schizophrenia and bipolar i disorder in adults. Elderly patients with dementiarelated psychosis treated with antipsychotic drugs are at an in. Discover the clinical overview and additional supportive studies. Haloperidol decanoate injection package insert haloperidol decanoate injection for im injection only rx only descpription haloperidol decanoate is the decanoate ester of the butyrophenone, haloperidol. Prescribing information prfluphenazine fluphenazine. Aripiprazole longacting injections abilify maintena, aristada reference number. Dosing and administration information for patients. Attach the adaptersyringe assembly to the vial by holding the outside of the adapter and pushing the adapters spike firmly through the rubber stopper, until the adapter snaps in place see figure 16. Highlights of prescribing information nexplanon safely and. See full prescribing information for risperidone tablets. Aripiprazole monohydrate abilify maintena and aripiprazole lauroxil aristada are atypical antipsychotics. Administer one intramuscular injection of aristada initio 675 mg in.
Abilify maintena aripiprazole extendedrelease injectable. Longacting injectable aripiprazole for adult schizophrenia. Fluphenazine decanoate injection, usp package insert fluphenazine decanoate injection, usp 25 mgml rx only description fluphenazine decanoate is the decanoate ester of a trifluoromethyl phenothiazine derivative. Abilify has been systematically evaluated and shown to be effective in a dose range of 10 to 30 mgday, when administered as the tablet. Abilify maintena is an injection given in your arm or buttock by your healthcare provider 1 time every month. There are two ways to initiate treatment with aristada. Based on the placebocontrolled trial of abilify maintena in schizophrenia, the most commonly observed adverse reactions associated with the use of abilify maintena in patients incidence of 5% or greater and aripiprazole incidence at least twice that for placebo were increased weight 16.
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