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PMS-METHOTREXATE is a brand name for Methotrexate, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: pms-METHOTREXATE is indicated for Neoplastic diseases: • Choriocarcinoma: Methotrexate – as single chemotherapy or in combination with other drugs. • Acute Lymphoblastic Leukemia – as maintenance therapy. • Head and Neck Cancer – in combination with other chemotherapies. • Metastasis of unknown primary – as palliative…
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). 4 Drug-Drug Interactions). pms-METHOTREXATE (methotrexate tablets) Page 6 of 48 Protected B / Protégé B 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions • pms-METHOTREXATE should be used only by physicians whose knowledge and experience includes the use of antimetabolite therapy because of the possibility of serious toxic reactions (see 7 WARNINGS AND PRECAUTIONS, General).
1 Pregnant Women). Therefore, use is contraindicated for women of childbearing potential until pregnancy is excluded and pregnant patients with psoriasis or rheumatoid arthritis (see 2 CONTRAINDICATIONS). 1 Dosing Considerations pms-METHOTREXATE should not be initiated in women of childbearing potential until pregnancy is excluded.
Neoplastic Diseases • Oral administration in tablet form is often preferred when low doses are being administered since absorption is rapid and effective serum levels are obtained. • pms-METHOTREXATE may only be administered by physicians experienced in the treatment of neoplasia.
Typical dosages reported in the literature for the following malignancies are listed in the following section. Psoriasis and Rheumatoid Arthritis • The patient should be fully informed of the risks involved and should be under constant supervision of the physician (see 7 WARNINGS AND PRECAUTIONS).
• All dosage schedules should be continually tailored to the individual patient. An initial test dose may be given prior to the regular dosing schedule to detect any extreme sensitivity to adverse effects (see 8 ADVERSE REACTIONS). Maximal myelosuppression usually occurs in seven to ten days.
• Both the physician and pharmacist should emphasize to the patient that the recommended dose is taken weekly in rheumatoid arthritis and psoriasis, and that mistaken daily use of the recommended dose has led to fatal toxicity. 2 Recommended Dose and Dosage Adjustments Head and Neck Cancer: Methotrexate remains the standard of therapy for patients with recurrent or metastatic disease.
It has been given in a wide variety of doses and schedules. pms-METHOTREXATE (methotrexate tablets) Page 7 of 48 Protected B / Protégé B For palliation of patients with advanced, incurable disease and acceptable renal function, it is appropriate to begin oral methotrexate with weekly doses of 40-50 mg/m2 or biweekly doses of 15 to 20 mg/m2 and escalate the dose in weekly increments until either mild toxicity or therapeutic response is achieved.
). Maximal myelosuppression usually occurs in seven to ten days. • Both the physician and pharmacist should emphasize to the patient that the recommended dose is taken weekly in rheumatoid arthritis and psoriasis, and that mistaken daily use of the recommended dose has led to fatal toxicity.
2 Recommended Dose and Dosage Adjustments Head and Neck Cancer: Methotrexate remains the standard of therapy for patients with recurrent or metastatic disease. It has been given in a wide variety of doses and schedules. pms-METHOTREXATE (methotrexate tablets) Page 7 of 48 Protected B / Protégé B For palliation of patients with advanced, incurable disease and acceptable renal function, it is appropriate to begin oral methotrexate with weekly doses of 40-50 mg/m2 or biweekly doses of 15 to 20 mg/m2 and escalate the dose in weekly increments until either mild toxicity or therapeutic response is achieved.
Choriocarcinoma and similar trophoblastic diseases:
Methotrexate is administered orally in doses of 15 to 30 mg daily for a 5-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.
The effectiveness of therapy is ordinarily evaluated by 24 - hour quantitative analysis of urinary chorionic gonadotropin hormone (beta-HCG), which should return to normal or less than 50 IU/24 hr usually after the third or fourth course and usually be followed by a complete resolution of measurable lesions in 4 to 6 weeks.
One to two courses of methotrexate after normalization of beta-HCG is usually recommended. Before each course of the drug careful clinical assessment is essential. Cyclic combination therapy of methotrexate with other antitumour drugs has been reported as being useful.
, Neurologic 01/2025 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES .................................................................................................
2 TABLE OF CONTENTS .................................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION ............................................................................
4 1 INDICATIONS .......................................................................................................................... 1 Pediatrics ....................................................................................................................
2 Geriatrics .................................................................................................................... 4 2 CONTRAINDICATIONS.............................................................................................................
5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ........................................................................ 6 4 DOSAGE AND ADMINISTRATION.............................................................................................
1 Dosing Considerations ................................................................................................. 2 Recommended Dose and Dosage Adjustments ............................................................. 5 Missed Dose ................................................................................................................
9 5 OVERDOSAGE......................................................................................................................... 9 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ...........................................
pms-METHOTREXATE is contraindicated: • In patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, COMPOSITION AND PACKAGING.
• In pregnant patients 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. • In women of childbearing potential until pregnancy is excluded.
• In nursing mothers. • In patients with psoriasis or rheumatoid arthritis with alcoholism, alcoholic liver disease or other chronic liver disease. • In patients with psoriasis or rheumatoid arthritis who have overt or laboratory evidence of immunodeficiency syndromes.
• In patients with psoriasis or rheumatoid arthritis who have pre-existing blood dyscrasias, such as bone marrow hypoplasia, leucopenia, thrombocytopenia or significant anemia. 1 Special Populations; and
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Choriocarcinoma and similar trophoblastic diseases:
Methotrexate is administered orally in doses of 15 to 30 mg daily for a 5-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.
The effectiveness of therapy is ordinarily evaluated by 24 - hour quantitative analysis of urinary chorionic gonadotropin hormone (beta-HCG), which should return to normal or less than 50 IU/24 hr usually after the third or fourth course and usually be followed by a complete resolution of measurable lesions in 4 to 6 weeks.
One to two courses of methotrexate after normalization of beta-HCG is usually recommended. Before each course of the drug careful clinical assessment is essential. Cyclic combination therapy of methotrexate with other antitumour drugs has been reported as being useful.
Since hydatidiform mole may precede choriocarcinoma, prophylactic chemotherapy with pms- METHOTREXATE has been recommended. Chorioadenoma destruens is considered to be an invasive form of hydatidiform mole. pms- METHOTREXATE is administered in these disease states in doses similar to those recommended for choriocarcinoma.
Lymphomas:
In Burkitt's tumour, Stages I-II, methotrexate has produced prolonged remissions in some cases. Recommended dosage is 10 to 25 mg/day orally for 4 to 8 days. In Stage III, methotrexate is commonly given concomitantly with other antitumour agents.
Treatment in all stages usually consists of several courses of the drug interposed with 7-to-10-day rest periods. 5 mg/kg daily. The treatment of choice for localized histologically aggressive lymphoma is primary combination chemotherapy with or without involved-field radiation therapy.
Mycosis Fungoides (cutaneous T-cell lymphoma) Therapy with methotrexate appears to produce clinical responses in up to 50% of patients treated, but chemotherapy is not curative. 5 to 10 mg daily by mouth for several weeks or months.
Dose levels of drug and adjustment of dose regimen by reduction or cessation of drug are guided by patient response and hematologic monitoring. Leukemia Acute lymphoblastic leukemia (ALL) in children and young adolescents is the most responsive to present day chemotherapy.
In young adults and older patients, clinical remission is more difficult to obtain, and early relapse is more common. pms-METHOTREXATE (methotrexate tablets) Page 8 of 48 Protected B / Protégé B Methotrexate alone or in combination with steroids was used initially for induction of remission in ALL.
More recently corticosteroid therapy, in combination with other antileukemic drugs or in cyclic combinations with methotrexate included has appeared to produce rapid and effective remissions. 3 mg/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.
Methotrexate in combination with other agents appears to be the drug of choice for securing maintenance of drug-induced remissions. When remission is achieved and supportive […]
Since hydatidiform mole may precede choriocarcinoma, prophylactic chemotherapy with pms- METHOTREXATE has been recommended. Chorioadenoma destruens is considered to be an invasive form of hydatidiform mole. pms- METHOTREXATE is administered in these disease states in doses similar to those recommended for choriocarcinoma.
Lymphomas:
In Burkitt's tumour, Stages I-II, methotrexate has produced prolonged remissions in some cases. Recommended dosage is 10 to 25 mg/day orally for 4 to 8 days. In Stage III, methotrexate is commonly given concomitantly with other antitumour agents.
Treatment in all stages usually consists of several courses of the drug interposed with 7-to-10-day rest periods. 5 mg/kg daily. The treatment of choice for localized histologically aggressive lymphoma is primary combination chemotherapy with or without involved-field radiation therapy.
Mycosis Fungoides (cutaneous T-cell lymphoma) Therapy with methotrexate appears to produce clinical responses in up to 50% of patients treated, but chemotherapy is not curative. 5 to 10 mg daily by mouth for several weeks or months.
Dose levels of drug and adjustment of dose regimen by reduction or cessation of drug are guided by patient response and hematologic monitoring. Leukemia Acute lymphoblastic leukemia (ALL) in children and young adolescents is the most responsive to present day chemotherapy.
In young adults and older patients, clinical remission is more difficult to obtain, and early relapse is more common. pms-METHOTREXATE (methotrexate tablets) Page 8 of 48 Protected B / Protégé B Methotrexate alone or in combination with steroids was used initially for induction of remission in ALL.
More recently corticosteroid therapy, in combination with other antileukemic drugs or in cyclic combinations with methotrexate included has appeared to produce rapid and effective remissions. 3 mg/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.
Methotrexate in combination with other agents appears to be the drug of choice for securing maintenance of drug-induced remissions. When remission is achieved and supportive care has produced general clinical improvement, maintenance therapy is initiated, as follows: methotrexate is administered 2 times weekly by mouth in total weekly doses of 30 mg/m2.
If and when relapse does occur, re-induction of remission can again usually be obtained by repeating the initial induction regimen. A variety of combination chemotherapy regimens have been used for both induction and maintenance therapy in ALL.
Psoriasis Recommended starting dose schedules: • Weekly single oral, dose schedule: 10 to 25 mg per week until adequate response is achieved. 0 mg at 12-hour intervals for 3 doses, repeated weekly. Dosages in each schedule may be gradually adjusted to achieve optimal clinical response; 25 mg/week should not ordinarily be exceeded.
Once optimal clinical response has been achieved, the dosage schedule should be reduced to the lowest possible effective dose and to the longest possible rest period. 5 mg once weekly. 5 mg at 12-hour intervals for 3 doses given as a course once weekly.
Dosages in each schedule may be gradually adjusted to achieve optimal clinical response, but not ordinarily to exceed a total weekly dose of 20 mg. Therapeutic response usually begins within 3 to 6 weeks and the patient may continue to improve for another 12 weeks or more.
Upon achieving the therapeutically desired result, dosage should be reduced gradually to the lowest possible effective maintenance dose. The optimal duration of therapy is unknown; limited data from long-term studies indicate that the initial clinical improvement is maintained for at least 2 years with continued therapy.
pms-METHOTREXATE (methotrexate […]
10 7 WARNINGS AND PRECAUTIONS............................................................................................ 1 Special Populations....................................................................................................
1 Pregnant Women....................................................................................................... 2 Breast-feeding ...........................................................................................................
3 Pediatrics .................................................................................................................. 4 Geriatrics ..................................................................................................................
19 8 ADVERSE REACTIONS ........................................................................................................... 1 Adverse Reaction Overview........................................................................................
4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data Clinical Trial Findings.......................................................................................... 5 Post-Market Adverse Reactions ..................................................................................
21 9 DRUG INTERACTIONS ........................................................................................................... 1 Serious Drug Interactions ...........................................................................................
2 Drug Interactions Overview........................................................................................ 3 Drug-Behaviour Interactions ......................................................................................
4 Drug-Drug Interactions .............................................................................................. 5 Drug-Food Interactions ..............................................................................................
6 Drug-Herb Interactions .............................................................................................. 7 Drug-Laboratory Test Interactions ..............................................................................
29 10 CLINICAL PHARMACOLOGY.................................................................................................. 1 Mechanism of Action .................................................................................................
2 Pharmacodynamics ................................................................................................... 3 Pharmacokinetics ......................................................................................................
31 11 STORAGE, STABILITY AND DISPOSAL ..................................................................................... 34 12 SPECIAL HANDLING INSTRUCTIONS ......................................................................................
34 PART II: SCIENTIFIC INFORMATION ............................................................................................. 36 13 PHARMACEUTICAL INFORMATION .......................................................................................
36 14 CLINICAL TRIALS ................................................................................................................... 37 15 MICROBIOLOGY....................................................................................................................
37 16 NON-CLINICAL TOXICOLOGY ................................................................................................. 37 PATIENT MEDICATION INFORMATION ........................................................................................
39 pms-METHOTREXATE (methotrexate tablets) Page 4 of 48 Protected B / Protégé B PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS pms-METHOTREXATE […]