Zonia

ZONIA^®

ARIPIPRAZOLE

 

 

WARNING: IMPROVING MORTALITY IN FOLLOWING PATIENTS WITH PSYCHOSIS RELATED TO DEMENSIA AND SELF-KILLING AND ANTIDEPRESSION

Elderly patients with dementia associated with psychosis treated with antipsychotics have an increased risk of death. Aripiprazole is not allowed for treatment in patients with dementia associated with psychosis. (See the Warning and Caution Section)

Antidepressants increase the risk of suicidal thoughts and attitudes in adolescents and young adults in the short-term major depressive disorder (MDD) test and other psychiatric disorders tests. Consideration in using Aripiprazole in addition to other antidepressants in children, adolescents, or young adults must be balanced between risk and clinical needs. Depression and a number of other psychiatric disorders are associated with a careful increase in suicide risk and are carefully observed for clinical deterioration, suicide or unusual behavior changes. Families and nurses must be informed of the need for careful observation and communication with the doctor. Aripiprazole is not allowed to be used in pediatric patients who have depression. (See the Warning and Caution Section)

 

 

 

Composition:

Each ZONIA® 10 caplet contains Aripiprazole 10 mg

Each ZONIA® 15 tablet contains Aripiprazole 15 mg

 

Pharmacology:

As with drugs that have efficacy for schizophrenia, bipolar disorder, major depressive disorders and irritability associated with autism disorders, the mechanism of action of Aripiprazole is unknown. However, it has been suggested that the efficacy of Aripiprazole is mediated through a combination of partial agonist activity on D2 and 5-HT1A receptors and antagonistic activity at 5-HT2A receptors. The action of action on receptors other than D2, 5-HT1A, and 5-HT2A can explain several other clinical effects of Aripiprazole (for example, the effects of orthostatic hypotension observed with Aripiprazole can be explained by its antagonistic activity on alpha adrenergic receptors).

 

 

Indications:

– Schizophrenia

– Bipolar I disorder

– Additional therapy in major depressive disorders

– Irritability related to autistic disorders

– Special attention in treating children and adolescents with schizophrenia, bipolar-I disorders, and

irritability related to autistic disorders

 

 

Dosage:

Aripiprazole is given orally, once a day with or without food.

– Schizophrenia

Adult

Initial and target dose: 10 mg / day or 15 mg / day given once a day without food. Effective dose

between 10-30 mg / day. Increased dosage should not be done before 2 weeks, the time needed to

reach steady-state.

Adolescents

The recommended dose is 10 mg / day. Aripiprazole can be given without food.

 

– Bipolar I disorder

Adult

The recommended starting and target dose is 15 mg given once a day as single therapy or additional therapy with lithium and valproate. Aripiprazole can be given without food. The dosage can be increased to 30 mg / day based on clinical response. Safety doses above 30 mg / day have not been evaluated.

 

Pediatrics and adolescents

The efficacy of Aripiprazole has been established in the treatment of Pediatrics and adolescents aged 10-17 years with bipolar I disorder at a dose of 10 mg / day or 30 mg / day, respectively. The recommended dose is 10 mg / day. The initial daily dose for these patients is 2 mg / day, titrated to 5 mg / day after 2 days and up to 10 mg / day after the next 2 days. The next increase in dose should be given an increase of 5 mg / day. Aripiprazole can be given without food.

 

– Additional therapy in major depressive disorders

Adult

Dosage: 2-15 mg / day. Dosage adjustments of up to 5 mg / day should be given in stages at intervals

of not less than 1 week.

 

– Irritability disorders associated with Autism

Pediatrics and adolescent patients

Efficacy in Pediatrics and adolescents aged 6-17 years with impaired irritability associated with

autism at doses of 5-15 mg / day has been determined.

The dose must begin with 2 mg / day. The dose must then be increased to 5 mg / day, if needed can

be increased to 10 mg / day or 15 mg / day. Dosage adjustments of up to 5 mg / day should be

carried out in stages at intervals of not less than 1 week.

 

 

Presentation and Registration Number:

ZONIA 10 Kaplet  Box, 1 strip @ 10 Caplets ; DKL1808025604A1

ZONIA 15 Tablet  Box, 1 strip @ 10 tablets ; DKL1808025604B1

 

ON MEDICAL PRESCRIPTION ONLY

 

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