Olanzapine Tablets USP 5mg Technical Specification: 

Product Name:       Olanzapine Tablets USP 5mg
Brand Name:Generics
Strength:2.5mg, 5mg, 10mg
Dosage Form:Tablets (Film-coated)
Route of Administration:Via oral Route
Packing:30s, 90s, 100s, 500s
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, Antidepressants, Central Nervous System
Indication: Olanzapine is used to treat certain mental/mood conditions (such as schizophrenia, bipolar disorder)
Storage:Store below 25°C in a dry place. Do not freeze. Keep the container tightly closed in order to protect from moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Olanzapine Tablets USP 5mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Olanzapine Tablets USP 5mg
    Each film coated tablet contains:
    Olanzapine USP………………….5mg
    Excipients………………………………. q.s.
    Colour: Yellow Iron Oxide

THERAPEUTIC INDICATIONS:

Olanzapine is indicated for the treatment of schizophrenia. Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response. Olanzapine is indicated for the treatment of moderate to severe manic episode.

CAUTION & WARNING:

CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH

Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Store below 25°C in a dry place. 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.

 

GENERIC NAME OF THE MEDICINAL PRODUCT:

Olanzapine Tablets USP 2.5mg
Olanzapine Tablets USP 5mg
Olanzapine Tablets USP 10mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Olanzapine Tablets USP 2.5mg
Each film coated tablet contains:
Olanzapine USP…………………...2.5mg
Excipients………………………………. q.s.
Colour: Red Oxide of Iron

b) Olanzapine Tablets USP 5mg
Each film coated tablet contains:
Olanzapine USP………………….5mg
Excipients………………………………. q.s.
Colour: Yellow Iron Oxide


c) Olanzapine Tablets USP 10mg
Each film coated tablet contains:
Olanzapine USP………………….10mg
Excipients………………………………. q.s.
Colour: Orange 5

THERAPEUTIC INDICATIONS:

Olanzapine is indicated for the treatment of schizophrenia. Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response. Olanzapine is indicated for the treatment of moderate to severe manic episode.

CAUTION & WARNING:

CAUTION:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Store below 25°C in a dry place. 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.