Mimod

Indications

Mimod is indicated for the treatment of Rheumatoid arthritis

Contraindications

Pregnant or potentially pregnant women Patients with severe hepatic disorder Patients with peptic ulcer Patients with a history of Hypersensitivity to the ingredients of this drug Patients receiving warfarin

Adverse Effects

The major adverse effects in studies were ALT (GPT) increase in (18.55% cases), AST (GOT) increase in (16.54% cases), γ-GTP increase in (15.72% cases) and Al-P increase in (14.91% cases), NAG increase in (9.02% cases), urinary β2 microglobulin increase in (7.39% cases), total bile acid increase in (5.71% cases), abdominal pain in (5.51% cases), There were (5.14% cases) of rash

Mechanism of Action

Mimod (Iguratimod) Inhibits the production of Ig & various inflammatory cytokines Mimod (Iguratimod) stimulates development of Osteoblast, Mimod (Iguratimod) inhibits formation of osteoclast

Pharmacokinetics

The plasma concentration of Iguratimod reached the maximum about 4 hours after administration, and the concentration changed slightly higher in the elderly than in the non-elderly. The plasma concentration reached a steady state from the 10th day. Adults: Cmax (1.60 μg / mL) tmax (3.3 hr) AUC 0-12 (12.2 μg · hr / mL) t 1/2 (73.3 hr) Elderly: Cmax (1.72 μg / mL) tmax (3.9 hr) AUC 0-12 (12.2 μg · hr / mL) t 1/2 (61.8.3 hr)

Drug Use in Pregnancy

Administration to pregnant women, pregnant women, lactating women, etc. Do not administer to pregnant women or women who may be pregnant. [A study on rat embryo / fetal development that examined the effects of teratogenicity (cardiac / macrovascular abnormalities) and increased early fetal mortality on the fetal ductus arteriosus in lategestation rats. Tube contraction is observed.

Drug Use in Renal Impairment

Renal impairment: The incidence of side effects may increase.

Drug Use in Hepatic Impairment

Hepatic impairment: Contraindicated

Drug Use in Pediatric Population

Safety for children has not been established

Drug Use in Geriatric Population

In a clinical pharmacology study in healthy adult males, plasma concentrations in the elderly remained slightly higher than those in the non-elderly. In clinical studies of single administration of this drug, there was no difference in efficacy and incidence of side effects, but in the combined study with methotrexate, the incidence of adverse drug reactions was higher in the elderly than in non-elderly patients. In general, elderly people often have decreased physiological functions, and it is presumed that side effects are likely to occur. Therefore, administration should be performed while observing the patient’s condition.