METHOBLASTIN methotrexate (as sodium) 2.5 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

methotrexate sodium, Quantity: 2.742 mg (Equivalent: methotrexate, Qty 2.5 mg)

Available from:

Pfizer Australia Pty Ltd

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: magnesium stearate; lactose monohydrate; microcrystalline cellulose

Administration route:

Oral

Units in package:

30 tablets, 24 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

ANTINEOPLASTIC CHEMOTHERAPY: Treatment of breast cancer, gestational choriocarcinoma, and in patients with chorioadenoma destruens and hydatidiform mole. Palliation of acute and subacute lymphocytic leukaemia. Greatest effect has been observed in palliation of acute lymphoblastic (stem cell) leukaemias. In combination with corticosteroids, methotrexate may be used for induction of remission. The drug is now most commonly used for the maintenance of induced remissions. Methoblastin is also effective in the treatment of the advanced stages (III and IV, Peters Staging System) of lymphosarcoma, particularly in children and in advanced cases of mycosis fungoides. PSORIASIS CHEMOTHERAPY: (See WARNINGS box and Section 4.4). Because of the high risk attending to its use, Methoblastin is only indicated in the symptomatic control of severe, recalcitrant, disabling psoriasis which is not adequately responsive to other forms of therapy, but only when the diagnosis has been established, as by biopsy and/or after dermatologic consultations. RHEUMATOID ARTHRITIS CHEMOTHERAPY: (See WARNINGS box and Section 4.4). Management of severe, recalcitrant, active rheumatoid arthritis in adults not responding to, or intolerant of, an adequate trial of NSAIDs and one or more disease modifying drugs. Aspirin, NSAIDs and/or low dose steroids may be continued, although the possibility of increased toxicity with concomitant use of NSAIDs including salicylate has not been fully explored. (see Section 4.4, and 4.5). Steroids may be reduced gradually in patients who respond to methotrexate. Combined use of methotrexate with gold, penicillamine, hydroxychloroquine, sulfasalazine or cytotoxic agents has not been studied and may increase the incidence of adverse effects. Rest and physiotherapy as indicated should be continued.

Product summary:

Visual Identification: Methoblastin 2.5 mg strength tablets are yellow, round, flat tablets with a diameter of 6 mm and scored and embossed with ORN 57 on one side. The score line is for identification and appearance purposes, and the tablets must not be divided.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2023-08-28