País: Austràlia
Idioma: anglès
Font: Department of Health (Therapeutic Goods Administration)
methotrexate sodium, Quantity: 2.742 mg (Equivalent: methotrexate, Qty 2.5 mg)
Orion Pharma (AUS) Pty Limited
Tablet, uncoated
Excipient Ingredients: microcrystalline cellulose; lactose monohydrate; magnesium stearate
Oral
30, 24
(S4) Prescription Only Medicine
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. CHEXATE 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, CHEXATE 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.
Visual Identification: Yellow, round, uncoated, flat tablet, with a cosmetic score line and engraved with ORN 57 on one side, diameter 6 mm; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2022-11-14
CHEXATE CMI 1 CHEXATE CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. WARNING: Important safety information is provided in a boxed warning in the full CMI. Read before using this medicine. 1. WHY AM I TAKING CHEXATE? CHEXATE tablets contain the active ingredient methotrexate (as sodium). CHEXATE is used to treat certain types of cancers, severe psoriasis (a skin condition) or severe rheumatoid arthritis when the condition does not improve with other medicines. For more information, see Section 1. Why am I taking CHEXATE? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I TAKE CHEXATE? Do not use if you have ever had an allergic reaction to CHEXATE or any of the ingredients listed at the end of the CMI. Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant, or are breastfeeding. For more information, see Section 2. What should I know before I take CHEXATE? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with CHEXATE and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I TAKE CHEXATE? The dose of medicine given to you will depend on the condition being treated, your medical condition, your age, your size and how well your kidneys and liver are working. More instructions can be found in Section 4. How do I take CHEXATE? in the full CMI. 5. WHAT SHOULD I KNOW WHILE TAKING CHEXATE? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are taking CHEXATE. • You and your partner must use a reliable method of contraception (e.g. birth control pills or condom) while taking CHEXATE and for at least six months after you stop treatment . • Discuss with your doctor how much water or fluids you should have since insufficient fluid intake can increase the side effects of this medici Llegiu el document complet
Page 1 of 28 AUSTRALIAN PRODUCT INFORMATION CHEXATE (METHOTREXATE (AS SODIUM) TABLETS) WARNINGS Methotrexate must be used only by physicians experienced in antimetabolite chemotherapy, or in the case of non-oncological conditions, by a specialist physician. Because of the possibility of fatal or severe toxic reactions, the patient should be fully informed by the physician of the risks involved and should be under their constant supervision. Deaths have been reported with the use of methotrexate. In the treatment of psoriasis and rheumatoid arthritis, methotrexate should be restricted to severe, recalcitrant, disabling disease which is not adequately responsive to other forms of therapy, but only when the diagnosis has been established by biopsy and/or after appropriate consultation. POTENTIAL OF FATAL TOXICITY FROM DOSING ERRORS Both the physician and the pharmacist should emphasise to the patient the importance of the weekly dosing regimen: mistaken daily use may cause serious and sometimes life-threatening or fatal toxicity (see Section 4.2 and 4.4, 4.9). For the same reason great care should be taken with dispensing to ensure the correct tablet strength of CHEXATE is given to the patient. CHEXATE is available as 2.5 mg and 10 mg tablets. ORGAN SYSTEM TOXICITY _Gastrointestinal _ Diarrhoea and ulcerative stomatitis are frequent toxic effects and require interruption of therapy; otherwise, haemorrhage enteritis and death from intestinal perforation may occur. Gastrointestinal toxicity has been reported with concomitant administration of methotrexate (usually in high doses) along with nonsteroidal anti-inflammatory agents (NSAIDs). _Haematological _ Methotrexate may produce marked depression of bone marrow, anaemia, aplastic anaemia, leukopenia, neutropenia, thrombocytopenia and bleeding. Unexpectedly severe (sometimes fatal) marrow suppression and aplastic anaemia have been reported with concomitant administration of methotrexate (usually in high doses) along with NSAIDs. _Hepatic _ Methotrexate may be hepatotox Llegiu el document complet