Mercaptopurine Tablets USP 50mg Technical Specification:
| Product Name: | Mercaptopurine Tablets USP 50mg |
| Brand Name: | Mercaptopurine |
| Strength: | 10mg, 50mg |
| Dosage Form: | uncoated Tablet |
| Packing: | 10s, 25s, 30s, 60s, 250s |
| 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 |
| Indication: | Mercaptopurine is used in combination with other medicines as maintenance treatment of acute lymphoblastic leukemia. It belongs to the group of medicines known as antimetabolites. Mercaptopurine interferes with the growth of cancer cells, which are eventually destroyed. |
| Storage: | Store at 20°C to 25°C (68° F to 77° F); excursions permitted to 15°C to 30°C (59° to 86° F) [see USP Controlled Room Temperature]. Protect from moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Mercaptopurine Tablets USP 50mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Mercaptopurine Tablets USP 50mg
Each uncoated tablet contains:
Mercaptopurine USP..………….50mg
Excipients……………………………..q.s.
Colours: Iron Oxide Yellow
THERAPEUTIC INDICATIONS:
Mercaptopurine is used in combination with other medicines as maintenance treatment of acute lymphoblastic leukemia. It belongs to the group of medicines known as antimetabolites. Mercaptopurine interferes with the growth of cancer cells, which are eventually destroyed.
CAUTION & WARNING:
CAUTION: It is dangerous to take this preparation except under medical supervision.
WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an oncologist/ Cancer Hospital/ Institution only.
Do not take in larger doses or more frequently or for a longer time than specifically directed by the physician. Periodic blood counts are necessary to determine proper dose and to avoid ill effects.
Dispense in a tight, light-resistant container as defined in the USP using a child resistant closure.
Keep container tightly closed.
Keep out of reach and sight of children.
Swallow complete tablet, do not crush or chew.
STORAGE & DOSAGE:
Storage: Store at 20°C to 25°C (68° F to 77° F); excursions permitted to 15°C to 30°C (59° to 86° F) [see USP Controlled Room Temperature]. Protect from moisture.
Dosage: As directed by Oncologist.
For Oral use. Read the package insert before use.
GENERIC NAME OF THE MEDICINAL PRODUCT:
a) Mercaptopurine Tablets USP 10mg
b) Mercaptopurine Tablets USP 50mg
b) Mercaptopurine Tablets USP 50mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
a) Mercaptopurine Tablets USP 10mg
Each uncoated tablet contains:
Mercaptopurine USP..………….10mg
Excipients……………………………..q.s.
Colours: Titanium Dioxide USP
b) Mercaptopurine Tablets USP 50mg
Each uncoated tablet contains:
Mercaptopurine USP…………...50mg
Excipients………………………….…q.s.
Colours: Iron Oxide Yellow
Each uncoated tablet contains:
Mercaptopurine USP..………….10mg
Excipients……………………………..q.s.
Colours: Titanium Dioxide USP
b) Mercaptopurine Tablets USP 50mg
Each uncoated tablet contains:
Mercaptopurine USP…………...50mg
Excipients………………………….…q.s.
Colours: Iron Oxide Yellow
THERAPEUTIC INDICATIONS:
Mercaptopurine is used in combination with other medicines as maintenance treatment of acute lymphoblastic leukemia. It belongs to the group of medicines known as antimetabolites. Mercaptopurine interferes with the growth of cancer cells, which are eventually destroyed.
CAUTION & WARNING:
CAUTION: It is dangerous to take this preparation except under medical supervision.
WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an oncologist/ Cancer Hospital/ Institution only.
Do not take in larger doses or more frequently or for a longer time than specifically directed by the physician. Periodic blood counts are necessary to determine proper dose and to avoid ill effects.
Dispense in a tight, light-resistant container as defined in the USP using a child resistant closure.
Keep container tightly closed.
Keep out of reach and sight of children.
Swallow complete tablet, do not crush or chew.
WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an oncologist/ Cancer Hospital/ Institution only.
Do not take in larger doses or more frequently or for a longer time than specifically directed by the physician. Periodic blood counts are necessary to determine proper dose and to avoid ill effects.
Dispense in a tight, light-resistant container as defined in the USP using a child resistant closure.
Keep container tightly closed.
Keep out of reach and sight of children.
Swallow complete tablet, do not crush or chew.
STORAGE & DOSAGE:
Storage: Store at 20°C to 25°C (68° F to 77° F); excursions permitted to 15°C to 30°C (59° to 86° F) [see USP Controlled Room Temperature]. Protect from moisture.
Dosage: As directed by Oncologist.
For Oral use. Read the package insert before use.
Dosage: As directed by Oncologist.
For Oral use. Read the package insert before use.
