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INVEGA

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Overview

What is INVEGA?

Paliperidone, the active ingredient in INVEGA Extended-Release Tablets, is a psychotropic agent belonging to the chemical class of benzisoxazole derivatives. INVEGA contains a racemic mixture of (+)- and (-)- paliperidone. The chemical name is (±)-3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is CHFNO and its molecular weight is 426.49. The structural formula is:

Paliperidone is sparingly soluble in 0.1N HCl and methylene chloride; practically insoluble in water, 0.1N NaOH, and hexane; and slightly soluble in N,N-dimethylformamide.

INVEGA (paliperidone) Extended-Release Tablets are available in 1.5 mg (orange-brown), 3 mg (white), 6 mg (beige), and 9 mg (pink) strengths. INVEGA utilizes OROS osmotic drug-release technology .

Inactive ingredients are carnauba wax, cellulose acetate, hydroxyethyl cellulose, propylene glycol, polyethylene glycol, polyethylene oxides, povidone, sodium chloride, stearic acid, butylated hydroxytoluene, hypromellose, titanium dioxide, and iron oxides. The 3 mg tablets also contain lactose monohydrate and triacetin.



What does INVEGA look like?



What are the available doses of INVEGA?

Tablets: 1.5 mg, 3 mg, 6 mg, and 9 mg ()

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

How should I use INVEGA?

INVEGA (paliperidone) Extended-Release Tablets are indicated for the treatment of schizophrenia .

The efficacy of INVEGA in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents, as well as one maintenance trial in adults.

Tablet should be swallowed whole and should not be chewed, divided, or crushed. ()


What interacts with INVEGA?

Sorry No Records found


What are the warnings of INVEGA?

Sorry No Records found


What are the precautions of INVEGA?

Sorry No Records found


What are the side effects of INVEGA?

Sorry No records found


What should I look out for while using INVEGA?

INVEGA is contraindicated in patients with a known hypersensitivity to either paliperidone or risperidone, or to any of the excipients in the INVEGA formulation. Hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported in patients treated with risperidone and in patients treated with paliperidone. Paliperidone is a metabolite of risperidone.

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. INVEGA (paliperidone) Extended-Release Tablets is not approved for the treatment of patients with dementia-related psychosis.


What might happen if I take too much INVEGA?


How should I store and handle INVEGA?

INVEGA (paliperidone) Extended-Release Tablets are available in the following strengths and packages. All tablets are capsule-shaped.1.5 mg tablets are orange-brown and imprinted with "PAL 1.5", and are available in bottles of 30 (NDC 50458-554-01).3 mg tablets are white and imprinted with "PAL 3", and are available in bottles of 30 (NDC 50458-550-01) and hospital unit dose packs of 100 (NDC 50458-550-10).6 mg tablets are beige and imprinted with "PAL 6", and are available in bottles of 30 (NDC 50458-551-01) and hospital unit dose packs of 100 (NDC 50458-551-10).9 mg tablets are pink and imprinted with "PAL 9", and are available in bottles of 30 (NDC 50458-552-01) and hospital unit dose packs of 100 (NDC 50458-552-10).INVEGA (paliperidone) Extended-Release Tablets are available in the following strengths and packages. All tablets are capsule-shaped.1.5 mg tablets are orange-brown and imprinted with "PAL 1.5", and are available in bottles of 30 (NDC 50458-554-01).3 mg tablets are white and imprinted with "PAL 3", and are available in bottles of 30 (NDC 50458-550-01) and hospital unit dose packs of 100 (NDC 50458-550-10).6 mg tablets are beige and imprinted with "PAL 6", and are available in bottles of 30 (NDC 50458-551-01) and hospital unit dose packs of 100 (NDC 50458-551-10).9 mg tablets are pink and imprinted with "PAL 9", and are available in bottles of 30 (NDC 50458-552-01) and hospital unit dose packs of 100 (NDC 50458-552-10).INVEGA (paliperidone) Extended-Release Tablets are available in the following strengths and packages. All tablets are capsule-shaped.1.5 mg tablets are orange-brown and imprinted with "PAL 1.5", and are available in bottles of 30 (NDC 50458-554-01).3 mg tablets are white and imprinted with "PAL 3", and are available in bottles of 30 (NDC 50458-550-01) and hospital unit dose packs of 100 (NDC 50458-550-10).6 mg tablets are beige and imprinted with "PAL 6", and are available in bottles of 30 (NDC 50458-551-01) and hospital unit dose packs of 100 (NDC 50458-551-10).9 mg tablets are pink and imprinted with "PAL 9", and are available in bottles of 30 (NDC 50458-552-01) and hospital unit dose packs of 100 (NDC 50458-552-10).INVEGA (paliperidone) Extended-Release Tablets are available in the following strengths and packages. All tablets are capsule-shaped.1.5 mg tablets are orange-brown and imprinted with "PAL 1.5", and are available in bottles of 30 (NDC 50458-554-01).3 mg tablets are white and imprinted with "PAL 3", and are available in bottles of 30 (NDC 50458-550-01) and hospital unit dose packs of 100 (NDC 50458-550-10).6 mg tablets are beige and imprinted with "PAL 6", and are available in bottles of 30 (NDC 50458-551-01) and hospital unit dose packs of 100 (NDC 50458-551-10).9 mg tablets are pink and imprinted with "PAL 9", and are available in bottles of 30 (NDC 50458-552-01) and hospital unit dose packs of 100 (NDC 50458-552-10).INVEGA (paliperidone) Extended-Release Tablets are available in the following strengths and packages. All tablets are capsule-shaped.1.5 mg tablets are orange-brown and imprinted with "PAL 1.5", and are available in bottles of 30 (NDC 50458-554-01).3 mg tablets are white and imprinted with "PAL 3", and are available in bottles of 30 (NDC 50458-550-01) and hospital unit dose packs of 100 (NDC 50458-550-10).6 mg tablets are beige and imprinted with "PAL 6", and are available in bottles of 30 (NDC 50458-551-01) and hospital unit dose packs of 100 (NDC 50458-551-10).9 mg tablets are pink and imprinted with "PAL 9", and are available in bottles of 30 (NDC 50458-552-01) and hospital unit dose packs of 100 (NDC 50458-552-10).


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Paliperidone is the major active metabolite of risperidone. The mechanism of action of paliperidone, as with other drugs having efficacy in schizophrenia, is unknown, but it has been proposed that the drug's therapeutic activity in schizophrenia is mediated through a combination of central dopamine Type 2 (D) and serotonin Type 2 (5HT) receptor antagonism.

Non-Clinical Toxicology
INVEGA is contraindicated in patients with a known hypersensitivity to either paliperidone or risperidone, or to any of the excipients in the INVEGA formulation. Hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported in patients treated with risperidone and in patients treated with paliperidone. Paliperidone is a metabolite of risperidone.

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. INVEGA (paliperidone) Extended-Release Tablets is not approved for the treatment of patients with dementia-related psychosis.

See .

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. INVEGA (paliperidone) is not approved for the treatment of dementia-related psychosis .

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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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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

Interactions

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