Talidomide Capsule 100 mg (Talidomide)

Adult dose

1. Erythema nodosum leprosum (adult dosage) At the beginning of treatment, administer 100mg orally once daily. Increase by 100mg at 1-week intervals only if symptoms do not improve, depending on 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 started concomitantly and gradually tapered or discontinued as 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 (for the purpose of discontinuation) is suggested, decreasing 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), it 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 at bedtime or at least 1 hour after the evening meal, with water. Take dexamethasone orally at 40mg per day on days 1-4, 9-12, and 17-20 of each 28-day cycle. 3. Dose adjustment according to adverse drug reactions For patients experiencing adverse drug reactions such as constipation, drowsiness, or peripheral neuritis, consider temporarily interrupting treatment and restarting at a lower dose. In patients who develop Grade 3-4 adverse drug reactions according to the National Cancer Institute Common Toxicity Criteria, consider dose reduction, treatment delay, 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. If angioedema, anaphylactic reaction, Grade 4 rash, exfoliative or bullous rash, Stevens-Johnson syndrome, toxic epidermal necrolysis, or drug reaction with eosinophilia and systemic symptoms is suspected, permanently discontinue this medicine.

This medication can cause serious congenital malformations or miscarriage if taken during pregnancy; therefore, it must not be taken by women who are pregnant or may become pregnant. This medication can have serious effects on the fetus even with just one dose, so effective contraception must be ensured before, during, and after treatment for a certain period. There is a risk of heart-related diseases or thrombosis, so patients with cardiovascular diseases or risk factors for thrombosis should take caution when using this medication, and report any symptoms to healthcare professionals immediately. This medication may cause drowsiness, lethargy, and sedation, so patients should avoid driving or operating dangerous machinery during treatment and should not take alcohol or other sedatives simultaneously. Peripheral neuropathy may frequently occur, and if symptoms such as numbness, pain, or abnormal sensations in the hands and feet occur, they should be reported immediately, and regular nerve examinations are necessary. Dizziness or orthostatic hypotension may occur, so patients should move slowly when standing up suddenly to prevent dizziness. This medication may cause a decrease in white blood cell count; therefore, regular blood tests should be conducted to monitor the condition and adjust the dosage as needed. Patients with HIV may experience elevation in viral load after taking this medication, thus regular viral testing is required. Pregnant women, women who may become pregnant, children under 12 years of age, and patients with severe blood abnormalities should not take this medication and must consult a specialist before use. While taking this medication, serious side effects such as skin rashes, seizures, irregular heartbeat, and severe infections may occur, and unusual symptoms should be reported to healthcare professionals immediately for treatment. Caution is required when this medication is used with other sedatives or drugs that increase the risk of thrombosis; patients should consult healthcare professionals regarding drug interactions during treatment. When handling this medication, care must be taken not to damage the capsules, and if powder gets on the skin, it should be washed off immediately; women who are pregnant or may become pregnant should not handle it directly. In case of an overdose, patients should visit a medical institution immediately to receive appropriate treatment; although there have been cases of recovery without aftermath from overdose, caution is necessary. Elderly patients or patients with impaired kidney or liver function should also take caution, adjusting the dosage according to symptoms and tolerability.

Congenital malformations, miscarriage, limb deficiency, syndactyly, bone hypoplasia, acondroplasia, microtia, small or absent external auditory canal, facial paralysis, anophthalmia, microphthalmia, congenital heart defects, gastrointestinal malformations, urinary tract malformations, genital malformations, myocardial infarction, thrombosis, venous thromboembolism, pulmonary embolism, cerebrovascular disease, drowsiness, lethargy, sedation, consciousness impairment, peripheral neuropathy, aching pain, numbness, dysesthesia, dizziness, orthostatic hypotension, neutropenia, increase in HIV virus count, constipation, muscular 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, confusion, loss of appetite, nausea, anxiety, tremor, fever, weight loss, weight gain, leukopenia, rash/desquamation, confusion, motor neuropathy, level of consciousness decline, pneumonia, insomnia, hyperesthesia, infection, pulmonary embolism, confusion state, ear and labyrinth abnormalities, vertigo, acne, fungal dermatitis, nail disorders, pruritus, maculopapular rash, sweating, albuminuria, hematuria, erectile dysfunction, abdominal pain, injury from accidents, muscular weakness, back pain, chills, facial edema, fatigue, neck pain, neck stiffness, diarrhea, oral candidiasis, toothache, anemia, lymphadenopathy, hyperlipidemia, increased SGOT, anxiety, dizziness, pharyngitis, rhinitis, sinusitis, angioedema, anaphylaxis reaction, vasodilation, hypertension, tachycardia, atrial fibrillation, myocardial ischemia, deep vein thrombosis, heart attack, heart failure, auscultatory murmur, palpitations, pericarditis, orthostatic hypotension, syncope, thrombotic venous inflammation, thrombosis, cholangitis, cholestasis jaundice, colitis, dysphagia, esophagitis, gastroenteritis, gastrointestinal disorders, gastrointestinal bleeding, gingival disorders, hepatitis, pancreatitis, parotid gland enlargement, periodontitis, stomatitis, tongue discoloration, dental anomalies, aplastic anemia, macrocytic anemia, megaloblastic anemia, microcytic anemia, vitamin deficiency, dehydration, hypercholesterolemia, hypoglycemia, increased alkaline phosphatase, increased lipase, increased serum creatinine, cyanosis, diabetes, edema, electrolyte imbalance, hyperkalemia, hyperuricemia, hypoproteinemia, increased LDH, decreased phosphorus level, increased SGPT, arthritis, bone pain, hypertonia, joint disorders, leg cramps, myalgia, muscle weakness, periosteal disorders, abnormal thinking, forgetfulness, overactivity, neuralgia, neuritis, neuropathy, peripheral neuritis, psychosis, cough, emphysema, nasal bleeding, pulmonary embolism, crackles, upper respiratory tract infection, degeneration, eczematous rash, exfoliative dermatitis, ichthyosis, follicular thickening, skin necrosis, seborrhea, urticaria, vesicular rash, amblyopia, hearing loss, dry eyes, eye pain, tinnitus, decreased creatinine clearance, orchitis, proteinuria, pyuria, frequent urination, ascites, AIDS, allergic reaction, cellulitis, chest pain, cyst, decreased CD4 count, facial edema, influenza syndrome, hernia, changes in thyroid hormone levels, photosensitivity, sarcoma, sepsis, viral infection, angina, arrhythmia, cerebral ischemia, cerebrovascular disorder, congestive heart failure, deep venous thrombosis, peripheral vascular disorder, syncope, tachycardia, thrombotic venous inflammation, thrombosis, bile duct obstruction, intestinal obstruction, vomiting, acute kidney failure, amenorrhea, aphthous stomatitis, carpal tunnel syndrome, chronic myeloid leukemia, diplopia, dysesthesia, nocturia, nodular erythema, erythroleukemia, foot drop, incontinence, gynecomastia, hangover effect, hypomagnesemia, hypothyroidism, lymphedema, lymphocytopenia, uterine bleeding, migraine, mucinous edema, nodular sclerosing Hodgkin's lymphoma, nystagmus, oliguria, pancytopenia, petechiae, purpura, Raynaud's phenomenon, gastric ulcer, suicide attempt, interstitial lung disease, hearing impairment, renal failure, exacerbation of Parkinson's disease, pulmonary arterial hypertension, leukocytoclastic vasculitis, anaphylactic reaction, progressive multifocal leukoencephalopathy

This medication is sensitive to light and must be stored in a sealed container that blocks light. Additionally, it is important to store it in a cool place, specifically below 25 degrees Celsius, to maintain its effectiveness.

Appearance

An opaque green hard capsule containing white powder

Package unit

Package Unit Additional - 30 capsules/blister [/box], Package Unit Additional - 28 capsules/blister [/box]