Aripiprazole Tablets USP 30mg

GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Aripiprazole Tablets USP 2mg
B) Aripiprazole Tablets USP 5mg
C) Aripiprazole Tablets USP 10mg
D) Aripiprazole Tablets USP 15mg
E) Aripiprazole Tablets USP 20mg
F) Aripiprazole Tablets USP 30mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Aripiprazole Tablets USP 2mg
Each film coated tablet contains:
Aripiprazole………………2mg
Excipients…………………. q.s.
Colour: Yellow Oxide of Iron

B) Aripiprazole Tablets USP 5mg
Each film coated tablet contains:
Aripiprazole………………5mg
Excipients……………………q.s.
Colour: Quinoline Yellow Lake

C) Aripiprazole Tablets USP 10mg
Each film coated tablet contains:
Aripiprazole….………….10mg
Excipients…………………...q.s.
Colour: D&C Orange 4

D) Aripiprazole Tablets USP 15mg
Each film coated tablet contains:
Aripiprazole……………...15mg
Excipients…………………………q.s.
Colour: Carmoisine Lake

E) Aripiprazole Tablets USP 20mg
Each film-coated tablet contains:
Aripiprazole….………….20mg
Excipients…………………...q.s.
Colour: Titanium Dioxide

F) Aripiprazole Tablets USP 30mg
Each film coated tablet contains:
Aripiprazole……………….30mg
Excipients…………………………q.s.
Colour: Quinoline Yellow

THERAPEUTIC INDICATIONS:

Aripiprazole is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older. Aripiprazole is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment.

CAUTION & WARNING:

CAUTION:
Read enclosed leaflet before use.
keep medicine out of reach of children.
swallow whole does not chew or crush
ANY UNUSED MEDICINAL PRODUCT OR WASTE MATERIAL SHOULD BE DISPOSED OF IN ACCORDANCE WITH LOCAL REQUIREMENTS
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Protect form moisture at a temperature not exceeding 30˚C. Do not freeze. Keep the container tightly closed in order to protect from moisture.
Dosage: As directed by the Physician.
Attach dispensing label as per end county.

Aripiprazole Tablets USP 30mg Technical Specification:

Product Name:     Aripiprazole Tablets USP
Brand Name:Generic
Strength:2mg, 5mg, 10mg, 15mg, 20mg, 30mg
Dosage Form:Tablets (Film-coated)
Route of Administration:Via oral Route
Packing:30s, 90s, 100s, 500s, 1000s
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Antipsychotic (SGA) or atypical antipsychotic, Central nervous system
Indication: Aripiprazole is a medication that works in the brain to treat schizophrenia and other mental/mood disorders (such as bipolar disorder, Tourette’s syndrome, and irritability associated with autistic disorder).
Storage:Protect from moisture at a temperature not exceeding 30˚C. Do not freeze. Keep the container tightly closed in order to protect it from moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  •  Aripiprazole Tablets USP 2mg
  • Aripiprazole Tablets USP 5mg
  • Aripiprazole Tablets USP 10mg
  • Aripiprazole Tablets USP 15mg
  • Aripiprazole Tablets USP 20mg
  • Aripiprazole Tablets USP 30mg

 QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Aripiprazole Tablets USP 2mg
    Each film-coated tablet contains:
    Aripiprazole………………2mg
    Excipients…………………. q.s.
    Colour: Yellow Oxide of Iron.
  • Aripiprazole Tablets USP 5mg
    Each film-coated tablet contains:
    Aripiprazole………………5mg
    Excipients……………………q.s.
    Colour: Quinoline Yellow Lake.
  • Aripiprazole Tablets USP 10mg
    Each film-coated tablet contains:
    Aripiprazole….………….10mg
    Excipients……………………q.s.
    Colour: D&C Orange 4.
  • Aripiprazole Tablets USP 15mg
    Each film-coated tablet contains:
    Aripiprazole………………15mg
    Excipients…………………………q.s.
    Colour: Carmoisine Lake.
  • Aripiprazole Tablets USP 20mg
    Each film-coated tablet contains:
    Aripiprazole….………….20mg
    Excipients……………………q.s.
    Colour: Titanium Dioxide
  • Aripiprazole Tablets USP 30mg
    Each film-coated tablet contains:
    Aripiprazole……………….30mg
    Excipients…………………………q.s.
    Colour: Quinoline Yellow.

THERAPEUTIC INDICATIONS:

Aripiprazole is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older. Aripiprazole is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment.

CAUTION & WARNING:

CAUTION: Read the enclosed leaflet before use.
Keep the medicine out of reach of children.
Swallow whole does not chew or crush.
ANY UNUSED MEDICINAL PRODUCT OR WASTE MATERIAL SHOULD BE DISPOSED OF IN ACCORDANCE WITH LOCAL REQUIREMENTS.
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Protect from moisture at a temperature not exceeding 30˚C. Do not freeze. Keep the container tightly closed in order to protect it from moisture.
Dosage:  As directed by the Physician.
Attach dispensing label as per end county.