a) Capecitabine Tablets USP 150mg
b) Capecitabine Tablets USP 500mg
GENERIC NAME OF THE MEDICINAL PRODUCT:
QUALITATIVE AND QUANTITATIVE COMPOSITION:
a) Capecitabine Tablets USP 150mg
Each film-coated tablet contains:
Capecitabine USP ……………….150mg
Excipients…………………………….q.s.
Colours: Red Oxide of Iron
b) Capecitabine Tablets USP 500mg
Each film-coated tablet contains:
Capecitabine USP ……………….500mg
Excipients…………………………….q.s.
Colours: Titanium Dioxide USP
Each film-coated tablet contains:
Capecitabine USP ……………….150mg
Excipients…………………………….q.s.
Colours: Red Oxide of Iron
b) Capecitabine Tablets USP 500mg
Each film-coated tablet contains:
Capecitabine USP ……………….500mg
Excipients…………………………….q.s.
Colours: Titanium Dioxide USP
THERAPEUTIC INDICATIONS:
Capecitabine is used to help treat patients with Dukes' C colon cancer (colon cancer that has spread to lymph nodes in the area close to the colon), after having surgery. This medicine is also used to treat metastatic colorectal cancer (cancer of the colon or rectum that has spread to other parts of the body).
CAUTION & WARNING:
CAUTION: It is dangerous to take this preparation except under medical supervision.
CAUTION: Potent cytotoxic agent handle with great care. Use only after reading the directions on pack insert.
Procedures for safe handling of cytotoxic drugs should be followed.
WARNING: Cytotoxic Agent: To be sold by retail on the prescription of Oncologist/ Cancer Hospital/ Institution only.
WARNING: To be supplied against demand from Cancer Hospitals, Institutions and against prescription of a Cancer Specialist only.
PHARMACIST: PLEASE DISPENSE WITH MEDICATION GUIDE PROVIDED SEPARATELY.
Aluminium-aluminium blister - The medical product does not require any special storage condition. PVC/PVdc-aluminium blister.
Swallow capecitabine tablets whole with water within 30 minutes of a meal.
Do not crush or cut capecitabine tablets.
Keep out of reach and sight of children.
CAUTION: Potent cytotoxic agent handle with great care. Use only after reading the directions on pack insert.
Procedures for safe handling of cytotoxic drugs should be followed.
WARNING: Cytotoxic Agent: To be sold by retail on the prescription of Oncologist/ Cancer Hospital/ Institution only.
WARNING: To be supplied against demand from Cancer Hospitals, Institutions and against prescription of a Cancer Specialist only.
PHARMACIST: PLEASE DISPENSE WITH MEDICATION GUIDE PROVIDED SEPARATELY.
Aluminium-aluminium blister - The medical product does not require any special storage condition. PVC/PVdc-aluminium blister.
Swallow capecitabine tablets whole with water within 30 minutes of a meal.
Do not crush or cut capecitabine tablets.
Keep out of reach and sight of children.
STORAGE & DOSAGE:
Storage: Store at 20°C to 25°C (68° to 77° F) [see USP Controlled Room Temperature].
Do not refrigerate.
Dosage: As directed by the Physician.
For dosage recommendations and other important prescribing information, read accompanying insert.
Do not refrigerate.
Dosage: As directed by the Physician.
For dosage recommendations and other important prescribing information, read accompanying insert.
Capecitabine Tablets USP 500mg Technical Specification:
| Product Name: | Capecitabine Tablets USP 500mg |
| Brand Name: | Xlotabin |
| Strength: | 150mg, 500mg |
| Dosage Form: | Film-coated tablets |
| Packing: | 10s, 30s, 100s Blisters 30 Tab Bottle, 60 Tab Bottle, 120 Tab Bottle |
| Route of Administration: | For Oral Use Only |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Anti-Cancer, Cytotoxic Agent, Breast cancer |
| Indication: | Capecitabine is used to help treat patients with Dukes’ C colon cancer (colon cancer that has spread to lymph nodes in the area close to the colon), after having surgery. This medicine is also used to treat metastatic colorectal cancer (cancer of the colon or rectum that has spread to other parts of the body). |
| Storage: | Store at 20°C to 25°C (68° to 77° F) [see USP Controlled Room Temperature]. Do not refrigerate. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Capecitabine Tablets USP 500mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Capecitabine Tablets USP 500mg
Each film-coated tablet contains:
Capecitabine USP ……………….500mg
Excipients…………………………….q.s.
Colours: Titanium Dioxide USP
THERAPEUTIC INDICATIONS:
Capecitabine is used to help treat patients with Dukes’ C colon cancer (colon cancer that has spread to lymph nodes in the area close to the colon), after having surgery. This medicine is also used to treat metastatic colorectal cancer (cancer of the colon or rectum that has spread to other parts of the body).
CAUTION & WARNING:
CAUTION: It is dangerous to take this preparation except under medical supervision.
CAUTION: Potent cytotoxic agent handle with great care. Use only after reading the directions on pack insert.
Procedures for safe handling of cytotoxic drugs should be followed.
WARNING: Cytotoxic Agent: To be sold by retail on the prescription of Oncologist/ Cancer Hospital/ Institution only.
WARNING: To be supplied against demand from Cancer Hospitals, Institutions and against prescription of a Cancer Specialist only.
PHARMACIST: PLEASE DISPENSE WITH MEDICATION GUIDE PROVIDED SEPARATELY.
Aluminium-aluminium blister – The medical product does not require any special storage condition. PVC/PVdc-aluminium blister.
Swallow capecitabine tablets whole with water within 30 minutes of a meal.
Do not crush or cut capecitabine tablets.
Keep out of reach and sight of children.
STORAGE & DOSAGE:
Storage: Store at 20°C to 25°C (68° to 77° F) [see USP Controlled Room Temperature].
Do not refrigerate.
Dosage: As directed by the Physician.
For dosage recommendations and other important prescribing information, read accompanying insert.
