Thalidone Capsule 50 mg (Thalidomide)

Adult dose

1. Erythema nodosum leprosum (adult dosage) At the start of treatment, administer 100mg orally once daily. Increase the dose by 100mg at weekly intervals only if symptoms do not improve, according to tolerability and toxicity. The maximum recommended dose is 400mg per day. A lower maintenance dose 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 concomitantly and gradually tapered or discontinued once neuritis and other symptoms improve. There is no information on a recommended maintenance dose for preventing recurrence of ENL. However, if there are risks associated with thalidomide treatment, gradual dose reduction (to discontinue treatment) is suggested every 3-6 months, decreasing the dose by 50mg every 2-4 weeks. Usually administer once in the evening to reduce central nervous system adverse effects during the day (somnolence, drowsiness, sedation). 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 40mg daily on days 1-4, 9-12, and 17-20 of each 28-day cycle. 3. Dose adjustment for adverse drug reactions For patients experiencing adverse drug reactions such as constipation, somnolence, or peripheral neuritis, consider temporarily interrupting treatment and restarting at a lower dose. For 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 interrupting or discontinuing this medicine. Permanently discontinue this medicine if angioedema, an anaphylactic reaction, grade 4 rash, exfoliative or bullous rash, Stevens-Johnson syndrome, toxic epidermal necrolysis, or drug rash with eosinophilia and systemic symptoms is suspected.

This drug should absolutely not be taken by pregnant women or women who could become pregnant, as it can cause severe congenital malformations or miscarriage. Two reliable methods of contraception must be used starting four weeks before treatment, during treatment, and for four weeks after ending treatment, with regular pregnancy tests conducted. Patients with cardiovascular diseases, especially those at risk of myocardial infarction or thrombosis, should be carefully monitored while taking this drug and take measures to minimize risk factors. This drug may frequently cause drowsiness, sedation, and lethargy, so driving or operating hazardous machinery should be avoided. Avoid taking alcohol or other sedatives concurrently. Peripheral neuropathy may commonly occur and can be severe or irreversible, so if symptoms such as numbness or pain in hands and feet appear, inform a healthcare professional immediately. Dizziness and orthostatic hypotension may occur, so rise slowly from a lying position. Neutropenia may occur, requiring regular blood tests, and in severe cases, discontinuation of the drug may be necessary. This drug can cause allergic reactions such as skin rashes, anaphylaxis, and severe skin adverse reactions, so if symptoms arise, immediately discontinue the drug and consult a healthcare professional. Additionally, the risk of infection may increase, so if there are signs of infection, prompt treatment is needed, with monitoring for reactivation of varicella zoster virus or hepatitis B virus. This drug should not be administered to breastfeeding women, and safety and efficacy in children under 12 years have not been established. In case of overdose, vital signs should be closely monitored, and appropriate supportive care is required. Caution is advised when taken with other sedatives or alcohol, as it may enhance sedative effects, and also when used with drugs that may increase the risk of thrombosis. Finally, this drug must be strictly prescribed, dispensed, and administered under a risk management program and regular consultation and monitoring are essential during use.

Congenital malformations, miscarriage, limb deficiencies, only child syndrome, bone hypoplasia, aplasia, small auricle, small or absent external ear canal, facial paralysis, anophthalmia, microphthalmia, congenital heart defects, gastrointestinal malformations, urinary tract malformations, reproductive organ malformations, myocardial infarction, venous thromboembolism, pulmonary embolism, cerebrovascular diseases, drowsiness, sedation, somnolence, altered consciousness, peripheral neuropathy, aching pain, numbness, paresthesia, dizziness, orthostatic hypotension, neutropenia, increased plasma HIV RNA levels, constipation, weakness, sensory peripheral neuropathy, orthostatic hypotension, 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, rash/desquamation, confusion, appetite loss, nausea, anxiety, restlessness, tremor, fever, weight loss, thrombosis, embolism, motor neuropathy, weight gain, dry skin, increased appetite, dyspepsia, dry mouth, gastrointestinal air trapping, abnormal liver function tests, oral candidiasis, toothache, lymphadenopathy, hyperlipidemia, elevated SGOT, restlessness, insomnia, neuroexcitability, perceptual disturbances, pharyngitis, rhinitis, sinusitis, albuminuria, hematuria, erectile dysfunction, abdominal distension, fever, photosensitivity, upper limb pain, bradycardia, hypertension, hypotension, peripheral vascular disorders, tachycardia, vasodilation, cholangitis, cholestatic jaundice, colitis, dysphagia, esophagitis, gastroenteritis, gastrointestinal disorders, gastrointestinal bleeding, gingival disorders, hepatitis, pancreatitis, parotid hypertrophy, periodontitis, stomatitis, tongue discoloration, dental abnormalities, 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, euphoria, neuralgia, neuritis, neuropathy, peripheral neuritis, psychosis, cough, emphysema, nasal bleeding, pulmonary obstruction, vesicular breath sounds, upper respiratory infection, degeneration, acne, hair loss, eczematous rash, exfoliative dermatitis, ichthyosis, perifollicular thickening, skin necrosis, seborrhea, urticaria, vesicular rash, amblyopia, hearing loss, dry eyes, eye pain, tinnitus, decreased creatinine clearance, orchitis, proteinuria, pyuria, frequency of urination, diplopia, sensory disturbance, nocturia, nodular erythema, erythroblastosis, foot drop, urinary incontinence, gynecomastia, hangover effect, hypomagnesemia, hypothyroidism, lymphedema, lymphocytopenia, uterine bleeding, migraine, mucous edema, nodular sclerosing Hodgkin's disease, ocular dyskinesia, hypouresis, pancytopenia, petechiae, purpura, Raynaud's phenomenon, gastric ulcer, suicide attempt, interstitial lung disease, severe infection, toxic epidermal necrolysis, intestinal obstruction, sexual dysfunction, tumor lysis syndrome, gastrointestinal perforation, febrile neutropenia, pancytopenia, myocardial infarction, amenorrhea, allergic reactions, hypersensitivity reactions, vascular edema, urticaria, convulsions, severe infection, gastrointestinal bleeding, liver dysfunction, hearing impairment, renal failure, worsening of Parkinson's disease, pulmonary arterial hypertension, viral infection, leukopenic vasculitis, anaphylactic reaction, progressive multifocal leukoencephalopathy, shingles, cellulitis, chest pain, chills, cyst, decreased CD4 count, facial edema, flu-like syndrome, hernia, changes in thyroid hormone levels, candidiasis, vascular edema, benign skin neoplasm, eczema, herpes simplex, incomplete Stevens-Johnson syndrome, nail disorders, pruritus, psoriasis, skin discoloration, skin abnormalities, conjunctivitis, eye disorders, urinary incontinence, retinitis, gustatory dysfunction, sleep apnea, bronchitis, pulmonary disorders, pulmonary edema, pneumonia

This medication should be stored in a tightly closed container that blocks light and should preferably be kept at a temperature below 25 degrees Celsius, even in normal room temperature. This is to prevent deterioration of the drug's components due to light and heat, thereby maintaining its efficacy.

Appearance

Gray to yellowish hard capsule containing white powder.

Package unit

14 capsules x 2 / 1 box