Methotrexate Tablets USP 7.5mg Technical Specification:
| Product Name: | Methotrexate Tablets USP 7.5mg |
| Brand Name: | Methotrexate |
| Strength: | 2.5mg, 5 mg, 7.5mg, 10mg, 15mg |
| Dosage Form: | uncoated Tablet |
| Packing: | 4s, 100s |
| 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: | Methotrexate injection is used alone or together with other medicines to treat several types of cancer such as breast, head and neck, lung, blood, bone, lymph node, and uterus cancers. |
| 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]. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Methotrexate Tablets USP 7.5mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Methotrexate Tablets USP 7.5mg
Each uncoated tablet contains:
Methotrexate Sodium equivalent to
Methotrexate…………………..7.5 mg
Excipients…………………………q.s.
THERAPEUTIC INDICATIONS:
Methotrexate injection is used alone or together with other medicines to treat several types of cancer such as breast, head and neck, lung, blood, bone, lymph node, and uterus cancers.
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.
Warning: Cytotoxic: To be supplied against demand from Cancer Hospitals, Institutions and against prescription of a Cancer Specialist only.
Caution Pharmacist: Because of its potential to cause severe toxicity. Methotrexate therapy requires close supervision of the patient by the physician.
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].
Dosage: As directed by Oncologist.
For Oral use. Read the package insert before use.
GENERIC NAME OF THE MEDICINAL PRODUCT:
a) Methotrexate Tablets USP 2.5mg
b) Methotrexate Tablets USP 5mg
c) Methotrexate Tablets USP 7.5mg
d) Methotrexate Tablets USP 10mg
e) Methotrexate Tablets USP 15mg
b) Methotrexate Tablets USP 5mg
c) Methotrexate Tablets USP 7.5mg
d) Methotrexate Tablets USP 10mg
e) Methotrexate Tablets USP 15mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
a) Methotrexate Tablets USP 2.5mg
Each uncoated tablet contains:
Methotrexate Sodium equivalent to
Methotrexate…………………..2.5 mg
Excipients…………………………q.s.
b) Methotrexate Tablets USP 5mg
Each uncoated tablet contains:
Methotrexate Sodium equivalent to
Methotrexate.………..………..5 mg
Excipients…………………………q.s.
c) Methotrexate Tablets USP 7.5mg
Each uncoated tablet contains:
Methotrexate Sodium equivalent to
Methotrexate…………………..7.5 mg
Excipients…………………………q.s.
d) Methotrexate Tablets USP 10mg
Each uncoated tablet contains:
Methotrexate Sodium equivalent to
Methotrexate…………………..10 mg
Excipients…………………………q.s.
e) Methotrexate Tablets USP 15mg
Each uncoated tablet contains:
Methotrexate Sodium equivalent to
Methotrexate…………………..15 mg
Excipients…………………………q.s.
Each uncoated tablet contains:
Methotrexate Sodium equivalent to
Methotrexate…………………..2.5 mg
Excipients…………………………q.s.
b) Methotrexate Tablets USP 5mg
Each uncoated tablet contains:
Methotrexate Sodium equivalent to
Methotrexate.………..………..5 mg
Excipients…………………………q.s.
c) Methotrexate Tablets USP 7.5mg
Each uncoated tablet contains:
Methotrexate Sodium equivalent to
Methotrexate…………………..7.5 mg
Excipients…………………………q.s.
d) Methotrexate Tablets USP 10mg
Each uncoated tablet contains:
Methotrexate Sodium equivalent to
Methotrexate…………………..10 mg
Excipients…………………………q.s.
e) Methotrexate Tablets USP 15mg
Each uncoated tablet contains:
Methotrexate Sodium equivalent to
Methotrexate…………………..15 mg
Excipients…………………………q.s.
THERAPEUTIC INDICATIONS:
Methotrexate injection is used alone or together with other medicines to treat several types of cancer such as breast, head and neck, lung, blood, bone, lymph node, and uterus cancers.
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.
Warning: Cytotoxic: To be supplied against demand from Cancer Hospitals, Institutions and against prescription of a Cancer Specialist only.
Caution Pharmacist: Because of its potential to cause severe toxicity. Methotrexate therapy requires close supervision of the patient by the physician.
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.
Warning: Cytotoxic: To be supplied against demand from Cancer Hospitals, Institutions and against prescription of a Cancer Specialist only.
Caution Pharmacist: Because of its potential to cause severe toxicity. Methotrexate therapy requires close supervision of the patient by the physician.
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].
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.
