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
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
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.
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.
Dosage: As directed by the Physician.
Attach dispensing label as per end county.
