ABILIFY MAINTENA

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Overview

What is ABILIFY MAINTENA?

Aripiprazole is an atypical antipsychotic which is present in ABILIFY MAINTENA as its monohydrate polymorphic form. Aripiprazole monohydrate is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl] butoxy]-3,4 dihydrocarbostyril monohydrate. The empirical formula is CHClNOHO and its molecular weight is 466.40. The chemical structure is:

ABILIFY MAINTENA (aripiprazole) is an extended-release injectable suspension available in 400-mg or 300-mg strength pre-filled dual chamber syringes and 400-mg or 300-mg strength vials. The labeled strengths are calculated based on the anhydrous form (aripiprazole). Inactive ingredients (per administered dose) for 400 mg and 300 mg strength products, respectively, include carboxymethyl cellulose sodium (16.64 mg and 12.48 mg), mannitol (83.2 mg and 62.4 mg), sodium phosphate monobasic monohydrate (1.48 mg and 1.11 mg) and sodium hydroxide (pH adjuster).

What does ABILIFY MAINTENA look like?

What are the available doses of ABILIFY MAINTENA?

For extended-release injectable suspension:

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What should I talk to my health care provider before I take ABILIFY MAINTENA?

How should I use ABILIFY MAINTENA?

ABILIFY MAINTENA (aripiprazole) is indicated for:

ABILIFY MAINTENA is only to be administered by intramuscular injection by a healthcare professional. The recommended starting and maintenance dose of ABILIFY MAINTENA is 400 mg monthly (no sooner than 26 days after the previous injection).

For patients who have never taken aripiprazole, establish tolerability with oral aripiprazole prior to initiating treatment with ABILIFY MAINTENA. Due to the half-life of oral aripiprazole, it may take up to 2 weeks to fully assess tolerability.

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. For patients already stable on another oral antipsychotic (and known to tolerate aripiprazole), after the first ABILIFY MAINTENA injection, continue treatment with the antipsychotic for 14 consecutive days to maintain therapeutic antipsychotic concentrations during initiation of therapy.

If there are adverse reactions with the 400 mg dosage, consider reducing the dosage to 300 mg once monthly.

What interacts with ABILIFY MAINTENA?

Sorry No Records found

What are the warnings of ABILIFY MAINTENA?

Sorry No Records found

What are the precautions of ABILIFY MAINTENA?

Sorry No Records found

What are the side effects of ABILIFY MAINTENA?

Sorry No records found

What should I look out for while using ABILIFY MAINTENA?

ABILIFY MAINTENA is contraindicated in patients with a known hypersensitivity to aripiprazole. Hypersensitivity reactions ranging from pruritus/urticaria to anaphylaxis have been reported in patients receiving aripiprazole .

What might happen if I take too much ABILIFY MAINTENA?

How should I store and handle ABILIFY MAINTENA?

Pre-filled dual chamber syringe:Store below 30°C [86°F]. Do not freeze. Protect the syringe from light by storing in the original package until time of use. Vial:Store at 25°C (77°F), excursions permitted between 15°C and 30°C (59°F to 86°F) [see USP Controlled Room Temperature].Pre-filled dual chamber syringe:Store below 30°C [86°F]. Do not freeze. Protect the syringe from light by storing in the original package until time of use. Vial:Store at 25°C (77°F), excursions permitted between 15°C and 30°C (59°F to 86°F) [see USP Controlled Room Temperature].Pre-filled dual chamber syringe:Store below 30°C [86°F]. Do not freeze. Protect the syringe from light by storing in the original package until time of use. Vial:Store at 25°C (77°F), excursions permitted between 15°C and 30°C (59°F to 86°F) [see USP Controlled Room Temperature].Pre-filled dual chamber syringe:Store below 30°C [86°F]. Do not freeze. Protect the syringe from light by storing in the original package until time of use. Vial:Store at 25°C (77°F), excursions permitted between 15°C and 30°C (59°F to 86°F) [see USP Controlled Room Temperature].Metformin Hydrochloride Tablets are available as follows:1000 mg:Bottles of 30, 60, 90, 120, 180 and 270. Metformin Hydrochloride Tablets, USP 1000 mg tablets are white to off-white, oval, biconvex, film coated tablets debossed on one side with S on the left side of bisect and G on the right side of bisect and other side 1 on the left side and 07 on the right side of the bisect.Metformin Hydrochloride Tablets are available as follows:1000 mg:Bottles of 30, 60, 90, 120, 180 and 270. Metformin Hydrochloride Tablets, USP 1000 mg tablets are white to off-white, oval, biconvex, film coated tablets debossed on one side with S on the left side of bisect and G on the right side of bisect and other side 1 on the left side and 07 on the right side of the bisect.Metformin Hydrochloride Tablets are available as follows:1000 mg:Bottles of 30, 60, 90, 120, 180 and 270. Metformin Hydrochloride Tablets, USP 1000 mg tablets are white to off-white, oval, biconvex, film coated tablets debossed on one side with S on the left side of bisect and G on the right side of bisect and other side 1 on the left side and 07 on the right side of the bisect.Metformin Hydrochloride Tablets are available as follows:1000 mg:Bottles of 30, 60, 90, 120, 180 and 270. Metformin Hydrochloride Tablets, USP 1000 mg tablets are white to off-white, oval, biconvex, film coated tablets debossed on one side with S on the left side of bisect and G on the right side of bisect and other side 1 on the left side and 07 on the right side of the bisect.

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Clinical Information

Chemical Structure

No Image found

Clinical Pharmacology

The mechanism of action of aripiprazole in the treatment of schizophrenia and bipolar I disorder is unknown.

The efficacy of aripiprazole could be mediated through a combination of partial agonist activity at dopamine D and serotonin 5-HT receptors and antagonist activity at 5-HT receptors.

Non-Clinical Toxicology

ABILIFY MAINTENA is contraindicated in patients with a known hypersensitivity to aripiprazole. Hypersensitivity reactions ranging from pruritus/urticaria to anaphylaxis have been reported in patients receiving aripiprazole .

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of 17 placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group.

Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. ABILIFY MAINTENA is not approved for the treatment of patients with dementia-related psychosis.

The following adverse reactions are discussed in more detail in other sections of the labeling:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Review

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

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