| Product Name: | Hydroxyurea Capsules USP |
| Brand Name: | Tharolax |
| Strength: | 200mg, 300mg, 400mg, 500mg |
| Dosage Form: | Hard-Gelatin capsule |
| Packing: | 10s, 30s, 100s, 500s |
| 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: | Leukaemia (CML)Anti-Cancer |
| Indication: | Hydroxyurea is used to treat cancer of the white blood cells called chronic myeloid leukaemia (CML). It may also be given together with radiation treatment for head and neck cancer (advanced squamous cell cancer). Hydroxyurea interferes with the growth of cancer cells, which are eventually destroyed by the body. |
| Storage: | Store at 25°C (77° F); excursions permitted to 15°C to 30°C (59° to 86° F). |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Hydroxyurea Capsules USP 200mg
- Hydroxyurea Capsules USP 300mg
- Hydroxyurea Capsules USP 400mg
- Hydroxyurea Capsules USP 500mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Hydroxyurea Capsules USP 200mg
Each hard gelatin capsule contains:
Hydroxyurea USP………………200mg
Excipients……………………………….q.s.
Colors: Approved colors used in capsule shell - Hydroxyurea Capsules USP 300mg
Each hard gelatin capsule contains:
Hydroxyurea USP………………300mg
Excipients……………………………….q.s.
Colors: Approved colors used in capsule shell - Hydroxyurea Capsules USP 400mg
Each hard gelatin capsule contains:
Hydroxyurea USP………………400mg
Excipients……………………………….q.s.
Colors: Approved colors used in capsule shell - Hydroxyurea Capsules USP 500mg
Each hard gelatin capsule contains:
Hydroxyurea USP………………500mg
Excipients……………………………….q.s.
Colors: Approved colors used in capsule shell
THERAPEUTIC INDICATION:
Hydroxyurea is used to treat cancer of the white blood cells called chronic myeloid leukemia (CML). It may also be given together with radiation treatment for head and neck cancer (advanced squamous cell cancer). Hydroxyurea interferes with the growth of cancer cells, which are eventually destroyed by the body.
DIRECTION OF USE:
For Oral use only.
CAUTION & WARNING:
WARNING: Cytotoxic Agent: To be supplied on demand from cancer Hospital, Institutions & on prescription of an Oncologist only.
NOT FOR SALE WITHOUT PRESCRIPTION
CAUTION: It is dangerous to take this preparation except under medical supervision.
STORAGE & DOSAGE:
Storage: Store at 25°C (77° F); excursions permitted to 15°C to 30°C (59° to 86° F).
KEEP OUT OF THE REACH OF THE CHILDREN.
Dosage: As directed by an Oncologist.