Table 19.
Tabular summary
| Methotrexate | |
|---|---|
| First approved in Germany | |
| Lantarel® | 1991 (Psoriasis vulgaris) |
| Metex® 7.5/10 mg | 1992 (Psoriasis vulgaris) |
| Metex® 2.5 mg | 2004 (Psoriasis vulgaris) |
| Recommended control parameters | Complete blood count (Hb, HCT, differential blood count, platelets), renal function (serum creatinine, urea, urine sediment), liver values (serum transaminases), III-procollagen amino terminal propeptides |
| Recommended initial dosage | 5–15 mg per week |
| Recommended maintenance dosage | 5–22.5 mg per week depending on effect |
| Expected beginning of clinical effect | After 4–8 weeks |
| Response rate | PASI 75 in approximately 60% of the patients at the end of the induction phase of 16 weeks (LE 3) |
| Important contraindications (limited selection) | Absolute contraindications: |
| Desire to have children (for both men and women), pregnancy and nursing, inadequate contraception, drug consumption, alcoholism, known sensitivity to active ingredient methotrexate (e.g. pulmonary toxicity), bone marrow dysfunction, severe liver disease, severe infections, immunodeficiency, active peptic ulcers, hematologic changes (leucopenia, thrombocytopenia, anemia), renal failure | |
| Relative contraindications: | |
| Kidney disorders, liver disorders, history of arsenic consumption , chronic congestive cardio-myopathy, adiposity, old age, diabetes mellitus, history of hepatitis, lack of patient compliance, ulcerative colitis, diarrhea, NSAID use, gastritis | |
| Important ADRs (limited selection) | Liver fibrosis/cirrhosis, pneumonia/alveolitis, bone marrow depression, renal damage, alopecia (reversible), nausea, weariness, vomiting, elevated transaminases, infection, gastrointestinal ulcerations, nephrotoxicity |
| Important drug interactions (limited selection) | Cyclosporine, salicylates, sulfonamides, probenecide, penicillin, colchicin, NSAIDs (naproxene, ibuprofene, etc.), ethanol, co-trimoxazole, pyrimethamine, chloramphenicol, sulfonamides, prostaglandin synthesis inhibitors, cytostatics, probenecide, barbiturates, phenytoin, retinoids, sulfonamides, sulfonylurea, tetracyclines, co-trimoxazol, chloramphenicol, dipyridamole, retinoids, ethanol, leflunomide |
| Other | Consistent avoidance of alcohol, X-ray of the lungs prior to beginning therapy |