Methotrexate

 
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Structure

Methotrexate-2.5
Each uncoated tablet contains Methotrexate IP 2.5 mg

Methotrexate-10
Each uncoated tablet contains Methotrexate IP 10 mg

Methotrexate Injection
Each ml contains Methotrexate IP 15 mg (as Methotrexate Sodium), Sodium Chloride IP 6.4 mg, Sodium Hydroxide IP to adjust pH, Water for Injection IP q.s. Contains no antimicrobial preservative

Without a Prescription

Methotrexate is an antimetabolite prescribed in the treatment of certain neoplastic diseases, severe psoriasis, and adult rheumatoid arthritis.

Neoplastic diseases
Methotrexate is prescribed in the treatment of gestational choriocarcinoma, chorioadenoma destruens and hydatidiform mole, acute lymphocytic leukemia, in the prophylaxis and treatment of meningeal leukemia and in maintenance therapy in combination with other chemotherapeutic agents.
Methotrexate is used alone or in combination with other anticancer agents in the treatment of breast cancer, epidermoid cancers of the head and neck, advanced mycosis fungoides, lung cancer, (squamous cell and small cell types) and in the treatment of advanced stage non-Hodgkin’s lymphomas.

Psoriasis
Methotrexate is prescribed in the symptomatic control of severe, recalcitrant, disabling psoriasis that is not adequately responsive to other forms of therapy.

Rheumatoid Arthritis:
Methotrexate is prescribed in the management of selected adults with severe, active, classical or definite rheumatoid arthritis (ARA criteria) who have had an insufficient therapeutic response to, or are intolerant of, an adequate trial of first-line therapy including full dose NSAIDs and usually a trial of at least one or more disease-modifying antirheumatic drugs.

Methotrexate Dosage



Neoplastic diseases
Methotrexate injection may be given by the intramuscular, intravenous, intra-arterial or intrathecal route.
Choriocarcinoma and similar trophoblastic diseases Methotrexate is administered orally or intramuscularly in doses of 15 to 30 daily for a five-day course.
Such courses are usually repeated for 3 to 5 times as required, with rest periods of one or more weeks interposed between courses, until any manifesting toxic symptoms subside.

Leukemia
When used for induction, methotrexate in doses of 3.3 /m2 in combination with 60 mg/m2 of prednisone, given daily, produced remissions in 50% of patients treated, usually within a period of 4 to 6 weeks.
When remission is achieved and supportive care has produced general clinical improvement, maintenance therapy is initiated, as follows: Methotrexate is administered 2 times weekly either by mouth or intramuscularly in total weekly doses of 30 /m2.
It has also been given in doses of 2.5 /kg intravenously every 14 days.

Meningeal leukemia
In the treatment or prophylaxis of meningeal leukemia, methotrexate must be administered intrathecally.

Lymphomas
In Burkitt’s tumor, Stages I-II, methotrexate has produced prolonged remissions in some cases. Recommended dosage is 10 to 25 /day orally for 4 to 8 days.
In Stage III, methotrexate is commonly given concomitantly with other antitumor agents.

Rheumatoid Arthritis: Recommended Starting Dosage Schedules
1.Single oral doses of 7.5 once weekly
2.Divided oral dosages of 2.5 at 12hour intervals for 3 doses given as a course once weekly.
Dosages in each schedule may be adjusted gradually to achieve an optimal response, but not ordinarily to exceed a total weekly dose of 20 .
Once response has been achieved, each schedule should be reduced, if possible, to the lowest possible effective dose.
Therapeutic response usually begins within 3 to 6 weeks and the patient may continue to improve for another 12 weeks or more.
The optimal duration of therapy is unknown.

Contraindications

Methotrexate is contraindicated if you have any of the following conditions:
Methotrexate is contraindicated in pregnant women with psoriasis or rheumatoid arthritis and should be used in the treatment of neoplastic diseases only when the potential benefit outweighs the risk to the fetus.
Women of childbearing potential should not be started on methotrexate until pregnancy is excluded and should be fully counseled on the serious risk to the fetus should they become pregnant while undergoing treatment.
Pregnancy should be avoided if either partner is receiving methotrexate during and for a minimum of three months after therapy for male patients, and during and for at least one ovulatory cycle after therapy for female patients.
Patients with psoriasis or rheumatoid arthritis with alcoholism, alcoholic liver disease, other chronic lever disease or overt or laboratory evidence of immunodeficiency syndromes should not receive methotrexate.
Patients with psoriasis or rheumatoid arthritis who have preexisting blood dyscrasias, such as bone marrow hypoplasia, leukopenia, thrombocytopenia or significant, anemia, should not receive methotrexate.
Patients with a known hypersensitivity to methotrexate should not receive the drug.

Package

- Blister pack of 10 tablets;
- Blister pack of 4 tablets;
- Vial of 2 ml;
Without Prescription (2017)