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ARISTADA

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Overview

What is ARISTADA?

ARISTADA contains aripiprazole lauroxil, an atypical antipsychotic.

The chemical name of aripiprazole lauroxil is 7-{4-[4-(2,3-dichlorophenyl)-piperazin-1-yl]butoxy}-2-oxo-3,4-dihydro-2H-quinolin-1-yl)methyl dodecanoate. The empirical formula is CHCNO and its molecular weight is 660.7 g/mol. The chemical structure is:

ARISTADA is available as a white to off-white sterile aqueous extended-release suspension for intramuscular injection in the following strengths of aripiprazole lauroxil (and deliverable volumes from a single-use pre-filled syringe): 441 mg (1.6 mL), 662 mg (2.4 mL), 882 mg (3.2 mL) and 1064 mg (3.9 mL). The inactive ingredients include sorbitan monolaurate (3.8 mg/mL), polysorbate 20 (1.5 mg/mL), sodium chloride (6.1 mg/mL), sodium phosphate dibasic anhydrous, sodium phosphate monobasic and water for injection.



What does ARISTADA look like?



What are the available doses of ARISTADA?

For extended-release injectable suspension: 441 mg, 662 mg, 882 mg or 1064 mg single-use pre-filled syringe ()

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

How should I use ARISTADA?

ARISTADA is indicated for treatment of schizophrenia

[see Clinical Pharmacology ()].

[see Clinical Pharmacology ()].


What interacts with ARISTADA?

Sorry No Records found


What are the warnings of ARISTADA?

Sorry No Records found


What are the precautions of ARISTADA?

Sorry No Records found


What are the side effects of ARISTADA?

Sorry No records found


What should I look out for while using ARISTADA?

ARISTADA is contraindicated in patients with a known hypersensitivity reaction to aripiprazole. Hypersensitivity reactions have ranged from pruritus/urticaria to anaphylaxis

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

see Warnings and Precautions

()].


What might happen if I take too much ARISTADA?


How should I store and handle ARISTADA?

Store at room temperature 20°C to 25°C (68°F to 77°F) with excursions permitted between 15°C and 30°C (between 59°F and 86°F). Acebutolol hydrochloride capsules are available as follows:200 mg:NDC 50268-050-15 10 capsules per card, 5 cards per carton400 mg:NDC 50268-051-15 10 capsules per card, 5 cards per cartonStore at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature).Dispensed in blister punch material. For Institutional Use Only. Manufactured for:AvKARE, Inc.Pulaski, TN 38478Mfg. Rev. 01-2016-02 AV Rev. 03/16 (P) AvPAK Acebutolol hydrochloride capsules are available as follows:200 mg:NDC 50268-050-15 10 capsules per card, 5 cards per carton400 mg:NDC 50268-051-15 10 capsules per card, 5 cards per cartonStore at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature).Dispensed in blister punch material. For Institutional Use Only. Manufactured for:AvKARE, Inc.Pulaski, TN 38478Mfg. Rev. 01-2016-02 AV Rev. 03/16 (P) AvPAK Acebutolol hydrochloride capsules are available as follows:200 mg:NDC 50268-050-15 10 capsules per card, 5 cards per carton400 mg:NDC 50268-051-15 10 capsules per card, 5 cards per cartonStore at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature).Dispensed in blister punch material. For Institutional Use Only. Manufactured for:AvKARE, Inc.Pulaski, TN 38478Mfg. Rev. 01-2016-02 AV Rev. 03/16 (P) AvPAK Acebutolol hydrochloride capsules are available as follows:200 mg:NDC 50268-050-15 10 capsules per card, 5 cards per carton400 mg:NDC 50268-051-15 10 capsules per card, 5 cards per cartonStore at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature).Dispensed in blister punch material. For Institutional Use Only. Manufactured for:AvKARE, Inc.Pulaski, TN 38478Mfg. Rev. 01-2016-02 AV Rev. 03/16 (P) AvPAK Acebutolol hydrochloride capsules are available as follows:200 mg:NDC 50268-050-15 10 capsules per card, 5 cards per carton400 mg:NDC 50268-051-15 10 capsules per card, 5 cards per cartonStore at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature).Dispensed in blister punch material. For Institutional Use Only. Manufactured for:AvKARE, Inc.Pulaski, TN 38478Mfg. Rev. 01-2016-02 AV Rev. 03/16 (P) AvPAK Acebutolol hydrochloride capsules are available as follows:200 mg:NDC 50268-050-15 10 capsules per card, 5 cards per carton400 mg:NDC 50268-051-15 10 capsules per card, 5 cards per cartonStore at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature).Dispensed in blister punch material. For Institutional Use Only. Manufactured for:AvKARE, Inc.Pulaski, TN 38478Mfg. Rev. 01-2016-02 AV Rev. 03/16 (P) AvPAK Acebutolol hydrochloride capsules are available as follows:200 mg:NDC 50268-050-15 10 capsules per card, 5 cards per carton400 mg:NDC 50268-051-15 10 capsules per card, 5 cards per cartonStore at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature).Dispensed in blister punch material. For Institutional Use Only. Manufactured for:AvKARE, Inc.Pulaski, TN 38478Mfg. Rev. 01-2016-02 AV Rev. 03/16 (P) AvPAK Acebutolol hydrochloride capsules are available as follows:200 mg:NDC 50268-050-15 10 capsules per card, 5 cards per carton400 mg:NDC 50268-051-15 10 capsules per card, 5 cards per cartonStore at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature).Dispensed in blister punch material. For Institutional Use Only. Manufactured for:AvKARE, Inc.Pulaski, TN 38478Mfg. Rev. 01-2016-02 AV Rev. 03/16 (P) AvPAK Acebutolol hydrochloride capsules are available as follows:200 mg:NDC 50268-050-15 10 capsules per card, 5 cards per carton400 mg:NDC 50268-051-15 10 capsules per card, 5 cards per cartonStore at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature).Dispensed in blister punch material. For Institutional Use Only. Manufactured for:AvKARE, Inc.Pulaski, TN 38478Mfg. Rev. 01-2016-02 AV Rev. 03/16 (P) AvPAK Acebutolol hydrochloride capsules are available as follows:200 mg:NDC 50268-050-15 10 capsules per card, 5 cards per carton400 mg:NDC 50268-051-15 10 capsules per card, 5 cards per cartonStore at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature).Dispensed in blister punch material. For Institutional Use Only. Manufactured for:AvKARE, Inc.Pulaski, TN 38478Mfg. Rev. 01-2016-02 AV Rev. 03/16 (P) AvPAK Acebutolol hydrochloride capsules are available as follows:200 mg:NDC 50268-050-15 10 capsules per card, 5 cards per carton400 mg:NDC 50268-051-15 10 capsules per card, 5 cards per cartonStore at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature).Dispensed in blister punch material. For Institutional Use Only. Manufactured for:AvKARE, Inc.Pulaski, TN 38478Mfg. Rev. 01-2016-02 AV Rev. 03/16 (P) AvPAK


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Aripiprazole lauroxil is a prodrug of aripiprazole. Following intramuscular injection, aripiprazole lauroxil is likely converted by enzyme-mediated hydrolysis to N-hydroxymethyl aripiprazole, which is then hydrolyzed to aripiprazole. The mechanism of action of aripiprazole in schizophrenia is unknown. However, efficacy 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
ARISTADA is contraindicated in patients with a known hypersensitivity reaction to aripiprazole. Hypersensitivity reactions have ranged from pruritus/urticaria to anaphylaxis

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

see Warnings and Precautions

()].

Clonidine may potentiate the CNS-depressive effects of alcohol, barbiturates or other sedating drugs. If a patient receiving clonidine is also taking tricyclic antidepressants, the hypotensive effect of clonidine may be reduced, necessitating an increase in the clonidine dose. If a patient receiving clonidine is also taking neuroleptics, orthostatic regulation disturbances (e.g., orthostatic hypotension, dizziness, fatigue) may be induced or exacerbated.

Monitor heart rate in patients receiving clonidine concomitantly with agents known to affect sinus node function or AV nodal conduction e.g., digitalis, calcium channel blockers, and beta‑blockers. Sinus bradycardia resulting in hospitalization and pacemaker insertion has been reported in association with the use of clonidine concomitantly with diltiazem or verapamil.

Amitriptyline in combination with clonidine enhances the manifestation of corneal lesions in rats (see ).

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. ARISTADA is not approved for the treatment of patients with dementia-related psychosis

The following are discussed in more details 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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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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Tips

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Interactions

Interactions

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