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These brands contain the same active ingredient (Thalidomide). Same strength and form. Confirm the switch with your doctor or pharmacist.
More from Thalimide
Other strengths and forms by Beacon Pharmaceuticals PLC
Indications & Uses
Midothal, combined with dexamethasone, is used to treat patients newly diagnosed with multiple myeloma (MM). Midothal is also used to treat the skin symptoms of moderate to severe erythema nodosum leprosum (ENL) flare-ups, and to help prevent and control these skin symptoms from recurring as a maintenance therapy.
Pharmacology
Cellular effects of thalidomide occur through its binding target cereblon, a component of a cullin ring E3 ubiquitin ligase enzyme complex. The medicine has immunomodulatory, anti-inflammatory and antiangiogenic properties. In vitro studies and clinical trials suggest that its immune effects may stem from suppressing excess production of tumor necrosis factor-alpha (TNF-a) and reducing certain cell surface adhesion molecules that leukocytes use to migrate. Other anti-inflammatory and immunomodulatory actions may include reduced macrophage involvement in prostaglandin synthesis, along with changes in interleukin-10 and interleukin-12 production by peripheral blood mononuclear cells. In patients with multiple myeloma, treatment with thalidomide is accompanied by a rise in circulating natural killer cells and higher plasma levels of interleukin-2 and interferon-gamma. Among the cellular processes involved in angiogenesis, thalidomide is thought to inhibit the proliferation of endothelial cells.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Multiple Myeloma: The recommended dosing of thalidomide in combination with dexamethasone is 200 mg once daily, taken orally with water in 28-day treatment cycles, preferably at bedtime and at least 1 hour after the evening meal.
Erythema Nodosum Leprosum: The recommended dosing of thalidomide for an episode of cutaneous ENL is 100 to 300 mg per day, taken orally once daily with water, preferably at bedtime and at least 1 hour after the evening meal.
Patients weighing less than 50 kilograms should begin dosing at the low end of this range. A higher dosage range should be considered for patients with a severe cutaneous ENL reaction, or for those who have previously needed higher doses to control the reaction (possibly up to 400 mg per day), taken once daily at bedtime or in divided doses with water, at least 1 hour after meals. Using corticosteroids alongside thalidomide should be considered for patients with moderate to severe neuritis linked to a severe ENL reaction. Steroid use can be tapered and stopped once the neuritis has improved. The higher dosage of thalidomide should be continued until signs and symptoms of the active reaction have subsided, usually for at least 2 weeks. Patients can then be tapered off the medication in 50 mg decrements every 2 to 4 weeks.
Side Effects
The side effects reported most often with thalidomide are fatigue, low blood calcium (hypocalcemia), edema, constipation, sensory neuropathy, dyspnea, muscle weakness, leukopenia, neutropenia, rash or desquamation, confusion, anorexia, nausea, anxiety or agitation, tremor, fever, weight loss, thrombosis or embolism, motor neuropathy, weight gain, dizziness, and dry skin.
Cautions & Contraindications
Warnings & Precautions
Embryo-Fetal Toxicity: Midothal is a powerful human teratogen that induces a high frequency of severe and life-threatening birth defects, even after a single dose. Mortality at or shortly after birth has been reported in about 40% of infants. When there is no satisfactory alternative treatment, females of reproductive potential may be treated with Midothal provided adequate precautions are taken to avoid pregnancy. There are no specific data available regarding the reproductive risks of cutaneous absorption or inhalation of Midothal; however, females of reproductive potential should avoid contact with Midothal Capsules. If there is contact with non-intact Midothal capsules or the powder contents, the exposed area should be washed with soap and water. If healthcare providers or other care givers are exposed to body fluids from patients receiving Midothal, the exposed area should be washed with soap and water. Appropriate precautions should be utilized, such as wearing gloves, to prevent the potential cutaneous exposure to Midothal. Blood Donation: Patients must not donate blood during treatment with Midothal and for 4 weeks following discontinuation of the drug. Venous and Arterial Thromboembolism: The use of Midothal in patients with MM results in an increased risk of venous thromboembolism, such as deep venous thrombosis and pulmonary embolism. This risk increases significantly when Midothal is used in combination with standard chemotherapeutic agents including dexamethasone. Thromboprophylaxis should be considered based on an assessment of individual patients' underlying risk factors. Patients and physicians should be observant for the signs and symptoms of thromboembolism. Thrombocytopenia: Thrombocytopenia, including Grade 3 or 4 occurrences, has been reported in association with the clinical use of Midothal. Blood counts, including platelet counts, should be monitored. Dose reduction, delay, or discontinuation may be required. Patients should be monitored for signs and symptoms of bleeding including petechiae, epistaxis, and gastrointestinal bleeding, especially if concomitant medication may increase the risk of bleeding. Drowsiness and Somnolence: Midothal frequently causes drowsiness and somnolence. Patients should be instructed to avoid situations where drowsiness may be a problem and not to take other medications that may cause drowsiness without adequate medical advice. Patients should be advised of the possible impairment of mental and/or physical abilities required for the performance of hazardous tasks, such as driving a car or operating other complex or dangerous machinery. Dose reductions may be required. Peripheral Neuropathy: Midothal is known to cause nerve damage that may be permanent. Peripheral neuropathy is a common (over 10%) and potentially severe adverse reaction to treatment with Midothal that may be irreversible. Peripheral neuropathy generally occurs following chronic use over a period of months; however, peripheral neuropathy following relatively short term use has been reported. Medications known to be associated with neuropathy should be used with caution in patients receiving Midothal. Dizziness and Orthostatic Hypotension: Patients should also be advised that Midothal may cause dizziness and orthostatic hypotension and that they should therefore sit upright for a few minutes prior to standing up from a recumbent position. Neutropenia: Decreased white blood cell counts, including neutropenia, have been reported in association with the clinical use of Midothal. Treatment should not be initiated with an absolute neutrophil count (ANC) below 750 per cubic millimeter. White blood cell count and differential should be monitored on an ongoing basis, especially in patients who may be more prone to neutropenia, such as patients who are HIV seropositive. If ANC decreases to below 750 per cubic millimeter while on treatment, the patient's medication regimen should be re evaluated, and if the neutropenia persists, consideration should be given to withholding Midothal if clinically appropriate.
Contraindications
Thalidomide must not be used by women who are pregnant, as it can cause serious harm to the developing fetus. It should also not be used by anyone known to be hypersensitive to thalidomide or any of its components.
Pregnancy & Breastfeeding
Pregnancy: Thalidomide can cause harm to the embryo and fetus when it is given to a pregnant woman. This is based on how the medicine works and on both human and animal data. It is contraindicated during pregnancy. If it is used during pregnancy, or if the patient becomes pregnant while taking it, she should be told about the possible risk to the fetus. If pregnancy does occur during treatment, the medicine should be stopped immediately.
Lactation: Nothing is known about whether thalidomide passes into human milk, what it does to a breastfed child, or whether it affects milk production. Many drugs do pass into breast milk, and thalidomide could cause adverse reactions in a breastfed child. For this reason, women should be advised not to breastfeed during treatment with thalidomide.
Females and Males of Reproductive Potential, Pregnancy Testing: Females of reproductive potential must have 2 negative pregnancy tests before starting thalidomide. The first test should be done within 10 to 14 days, and the second within 24 hours before thalidomide is prescribed. Once treatment has started, and also during any dose interruptions, pregnancy testing should be done weekly for the first 4 weeks. After that, it should be repeated every 4 weeks in women with regular menstrual cycles. If the cycles are irregular, testing should be done every 2 weeks.
Contraception: Females of reproductive potential must commit either to avoiding heterosexual sexual intercourse completely and continuously, or to using 2 reliable methods of birth control at the same time. Contraception must start 4 weeks before treatment with thalidomide begins. It must continue during therapy and during dose interruptions, and for 4 weeks after thalidomide is stopped.
Males: Thalidomide is present in the semen of men who take it. So a man must always use a latex or synthetic condom during any sexual contact with females of reproductive potential while he is taking thalidomide, during dose interruptions, and for up to 28 days after stopping it.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Use in Special Populations
Pediatric Use: Thalidomide has not been shown to be safe or effective in children below 12 years of age.
Geriatric Use: Patients over 65 years of age had higher rates of atrial fibrillation, constipation, fatigue, nausea, hypokalemia, deep venous thrombosis, hyperglycemia and pulmonary embolism than patients under 65 years of age.
Storage
Keep Thalidomide in a cool, dry place where the temperature stays below 30°C. Protect it from light. Always keep it out of the reach of children.
Drug Interactions
Common questions about Thalimide 50 mg
What is Thalimide 50 mg Capsule?
Thalimide 50 mg Capsule is a medicine that contains Thalidomide. It is made by Beacon Pharmaceuticals PLC. It belongs to the Immunosuppressant group of medicines.
What is Thalimide used for?
Midothal, combined with dexamethasone, is used to treat patients newly diagnosed with multiple myeloma (MM). Midothal is also used to treat the skin symptoms of moderate to severe erythema nodosum leprosum (ENL) flare-ups, and to help prevent and control these skin symptoms from recurring as a maintenance therapy.
What are the side effects of Thalimide?
The side effects reported most often with thalidomide are fatigue, low blood calcium (hypocalcemia), edema, constipation, sensory neuropathy, dyspnea, muscle weakness, leukopenia, neutropenia, rash or desquamation, confusion, anorexia, nausea, anxiety or agitation, tremor, fever, weight loss, thrombosis or embolism, motor neuropathy, weight gain, dizziness, and dry skin.
Can I take Thalimide during pregnancy or while breastfeeding?
Pregnancy: Thalidomide can cause harm to the embryo and fetus when it is given to a pregnant woman. This is based on how the medicine works and on both human and animal data. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
How should I store Thalimide?
Keep Thalidomide in a cool, dry place where the temperature stays below 30°C. Protect it from light.
Can I take other medicines with Thalimide?
Some medicines can interact with Thalidomide, for example: Carbamazepine, Griseofulvin, Phenytoin, Zoledronic Acid [For hypercalcemia], Metronidazole, Dexamethasone. Tell your doctor or pharmacist about every medicine you take.
Is there a cheaper medicine with the same ingredient?
Midothal by Incepta Pharmaceuticals Ltd. has the same ingredient and strength for ৳30.00 per unit, compared with ৳50.00 for Thalimide. Ask your doctor or pharmacist before switching.
Do I need a prescription for Thalimide?
Thalimide is a prescription (Rx) medicine. Take it as your doctor advises.