Talodacapsule 100 mg (Thalidomide)

Adult dosage

1. Erythema nodosum leprosum (adult dose) At the start of treatment, administer 100mg orally once daily. Increase the dose by 100mg at 1-week intervals according to tolerability and toxicity only if symptoms do not improve. The maximum recommended dose is 400mg daily. A maintenance dose lower than the dose used to control the ongoing reaction may be used, based on monitoring of tolerability and toxicity. In patients with moderate-to-severe neuritis (due to leprosy) or other serious complications (e.g., uveitis), corticosteroids and other appropriate treatments may be initiated at the same time and gradually reduced or discontinued once neuritis and other symptoms improve. There is no information on a recommended maintenance dose for maintenance therapy to prevent recurrence of ENL. However, if there are risks associated with thalidomide treatment, gradual dose reduction (with the aim of discontinuing treatment) is suggested, reducing the dose by 50mg every 2-4 weeks over a 3-6-month period. To reduce central nervous system adverse effects during the day (drowsiness, somnolence, sedation), the dose is usually administered once in the evening. This medicine should be taken at least 1 hour after a meal. 2. Newly diagnosed multiple myeloma Administer in combination with dexamethasone in 28-day cycles. Take 200mg of this medicine once daily with water at bedtime or at least 1 hour after the evening meal. Take dexamethasone orally at a dose of 40mg daily on days 1-4, 9-12, and 17-20 of each 28-day cycle. 3. Dose adjustment according to adverse drug reactions In patients who experience adverse drug reactions such as constipation, somnolence, or peripheral neuritis, consider temporarily discontinuing treatment and restarting at a lower dose. In patients who experience grade 3-4 adverse drug reactions according to the National Cancer Institute Common Toxicity Criteria, consider dose reduction, delayed administration, or discontinuation based on clinical judgment. Allergic reactions and severe skin reactions For grade 2-3 skin rash, consider temporarily withholding or discontinuing this medicine. Permanently discontinue this medicine if angioedema, an anaphylactic reaction, a grade 4 rash, exfoliative or bullous rash, Stevens-Johnson syndrome, toxic epidermal necrolysis, or drug rash with eosinophilia and systemic symptoms is suspected.

This medication can cause severe congenital malformations or miscarriage if taken during pregnancy, so pregnant women or women who could become pregnant must not take it under any circumstances. Patients must use two or more reliable contraceptive methods during treatment and for 4 weeks after stopping the medication, and regular pregnancy tests must be conducted. Patients with cardiovascular disease or risk of thrombosis require careful monitoring while on this medication, and any symptoms of thrombosis should be reported to medical staff immediately. This drug may cause drowsiness, sedation, or somnolence, so individuals should avoid driving or operating dangerous machinery, and care should be taken to avoid taking it with alcohol or other sedatives. Peripheral neuropathy may occur; if symptoms such as numbness or pain in the hands and feet arise, this must be reported immediately and regular checks of nerve status should be conducted. Dizziness or orthostatic hypotension may occur; therefore, it is advisable to rise slowly from a sitting or lying position. Blood cell counts should be monitored, particularly if neutropenia is severe, in which case discontinuation or adjustment of dosage may be necessary. This medication should not be administered to specific patient populations, such as HIV-positive patients, those with severe neutropenia, children under 12 years of age, and patients with lactose intolerance. Care must be taken to avoid skin contact with this medication, and thorough handwashing before and after handling is required; women who could become pregnant should not handle this medication. As this medication may interact with other drugs, especially sedatives, medications that increase the risk of thrombosis, and hormonal contraceptives, consultation with professionals is recommended. Nursing mothers should avoid breastfeeding while taking this medication, and elderly patients or those with diminished kidney or liver function should have their dosages adjusted carefully. In cases of overdose, the patient's status should be closely monitored and appropriate supportive treatment should be provided. This medication must be strictly managed according to a risk management program; both patients and medical staff must rigorously adhere to the guidelines of this program.

Congenital malformations, miscarriage, limb deficiency, macrocystic dysplasia, hypoplasia of bone, abnormalities of the external ear, facial paralysis, ocular abnormalities, congenital heart defects, malformations of the digestive tract, malformations of the urinary tract, malformations of the genitalia, myocardial infarction, venous thromboembolism, arterial thromboembolism, drowsiness, sedation, somnolence, peripheral neuropathy, dizziness, orthostatic hypotension, neutropenia, increased plasma HIV RNA levels, constipation, weakness, sensory peripheral neuropathy, Stevens-Johnson syndrome, toxic epidermal necrolysis, headache, rash, eosinophilia, peripheral edema, dyspnea, hypotension, bradycardia, symptomatic hypothyroidism, increased platelet count, decreased platelet count, anemia, fatigue, hypocalcemia, edema, leukopenia, fever, confusion, loss of appetite, nausea, tremor, weight loss, thrombosis, motor neuropathy, weight gain, dry skin, muscle weakness, arthralgia, pneumonia, rash/desquamation, dry mouth, increased appetite, dyspepsia, diarrhea, oral candidiasis, toothache, anemia, lymphadenopathy, hyperlipidemia, increased SGOT, anxiety, vertigo, insomnia, excitability, paresthesia, pharyngitis, rhinitis, sinusitis, acne, dermatophytosis, nail disorder, pruritus, papular rash, sweating, albuminuria, hematuria, erectile dysfunction, abdominal swelling, photosensitivity, upper extremity pain, bradycardia, hypertension, hypotension, peripheral vascular disorder, tachycardia, vasodilation, cholecystitis, cholestatic jaundice, colitis, dysphagia, esophagitis, gastroenteritis, gastrointestinal disorder, gastrointestinal bleeding, gingival disorders, hepatitis, pancreatitis, parotid gland enlargement, periodontitis, stomatitis, tongue discoloration, tooth anomalies, aplastic anemia, macrocytic anemia, megaloblastic anemia, microcytic anemia, antidiuretic hormone abnormalities, amyloidosis, hyperbilirubinemia, increased BUN, increased creatinine, cyanosis, diabetes mellitus, electrolyte abnormalities, hyperkalemia, hyperuricemia, hypoproteinemia, increased LDH, decreased phosphorus levels, increased SGPT, arthritis, bone pain, hypertonia, joint disorders, leg cramps, myalgia, muscle weakness, periosteal disorders, abnormal thoughts, depression, anxiety, neuralgia, neuritis, psychosis, cough, emphysema, epistaxis, pulmonary embolism, bubbly sounds, upper respiratory infection, degeneration, angioedema, benign skin neoplasm, eczema, herpes simplex, incomplete Stevens-Johnson syndrome, pruritus, psoriasis, skin discoloration, skin abnormalities, amblyopia, hearing loss, dry eyes, ocular pain, tinnitus, decreased creatinine clearance, orchitis, proteinuria, pyuria, frequent urination, diplopia, dysesthesia, nocturia, erythema nodosum, erythrocytosis, foot drop, enuresis, gynecomastia, hangover effects, hypomagnesemia, hypothyroidism, lymphedema, lymphocytopenia, uterine bleeding, migraine, mucous edema, nodular sclerosing Hodgkin's disease, nystagmus, oliguria, pancytopenia, petechiae, purpura, Raynaud's phenomenon, gastric ulcer, suicide attempts, interstitial lung disease, severe infections, toxic epidermal necrolysis, intestinal obstruction, sexual dysfunction, tumor lysis syndrome, gastrointestinal perforation, febrile neutropenia, pancytopenia, myocardial infarction, amenorrhea, allergic reactions, seizures, gastrointestinal bleeding, liver dysfunction, hearing impairment, renal failure, worsening of Parkinson's disease, pulmonary arterial hypertension, viral infections, leukocytoclastic vasculitis, anaphylactic reactions, progressive multifocal leukoencephalopathy, shingles, reactivation of hepatitis B virus, sepsis, septic shock

This medication is sensitive to light, so it should be stored in a special container that does not allow light to enter. Additionally, to maintain the efficacy of the medication, it is important to store it at a cool temperature below 25 degrees Celsius.

Appearance

A hard capsule with a reddish-brown upper and lower part containing a white to grayish-white powder

Package unit

Manufacturer packaging unit