Domide 50mg TTY Bopopharm treat multi -marrow tumor, red circles leprosy (6 blisters x 10 tablets)

Dosage form Box of 6 blisters x 10 tablets
Specifications Thalidomide
Ingredient Bone marrow

Ingredient

Composition information	Content
Thalidomide	50mg

Uses

indications

Domide drugs indicated treatment in the following cases:

Multiple tumor disease:

Domide drugs in collaboration with Melphalan and Prednisolon are indicated for treatment of 65 -year -old patients with unprocessed or inadequate treatment for high -dose chemotherapy. On the response ratio. There are no controlled studies proving the possibility of increasing life time.

Domide drugs are indicated for acute treatment on skin symptoms The average and severe level of Enl disease. Learning

The impact mechanism of thalidomid is not well known. Thalidomid has immune, anti -inflammatory and anti -vascular modulation properties. In vitro and clinical research figures show that the immunosuppressive effect of this compound changes a lot under different conditions but is related to the inhibition of the production of tumor necrosis factor (NF-A and reduces the adhesive elements on the selective cell surface related to the white blood cell movement. Increasing plasma TNF-A in HIV-positive patients.

Other thalidomid immunity and anti-inflammatory properties may include inhibition of prostaLandin synthesis related to macrophages, regulating the production of interleukin-10 and interleukin-12 by mononuclear cells in peripheral blood. Using thalidomid to treat multi-tumor patients, though increasing the number of circulating NK cells, increases the plasma concentrations of Interukin-2 and Interferon-Gamma.

thalidomid inhibits vascular creation in the Intro -placental artery culture model. The circuit creation process is inhibited by thalidomid may include the reproduction of endothelial cells.

pharmacokinetics

absorption:

There is no absolute bioavailability of thalidomid in humans due to weakness in water.

In studies on healthy volunteers and people with Hansen, the average time to reach the peak concentration in plasma (TMAX) is 2.9 to 5.7 hours, showing that thalidomid is slowly absorbed by the gastrointestinal tract. The level of absorption (determined by the area below the concentration curve [AUC]) is proportional to the dose in healthy people. The peak concentration (CMAX) increases less than the dose increase rate. CMAX concentration increases less than the dose increase rate, along with increasing TMAX value, showing the weakness of thalidomid in water can handle the absorption speed. Use thalidomid simultaneously with a fat -rich meal that changes slightly ( Distribution:

In human plasma, the average protein binding is 55% and 66%, corresponding to (+)-(r)-and (-) (S) -Thalidomid. The study of thalidomid pharmacokinetics in HIV -positive patients with thalidomid 100 mg/day, thalidomid is found in semen.

Metabolism:

Currently, the accurate metabolism of thalidomid in humans has not been known. Thalidomid itself is not much metabolized in the liver, but it seems that hydrolyzed without enzymes in plasma forms many products. In a repetitive study using thalidomid 200mg for 10 healthy women in 18 days, the pharmacokinetics of thalidomid similarly each other on the first day and the last day of medication.

This shows that thalidomid does not produce or inhibit its transformation.

Era:

The average half -life is about 5 to 7 hours after taking the single dose and does not change when taking many doses.

As stated in the metabolic section, the exact metabolism of thalidomid is not known. Thalidomid itself has a renal clearance of 1.15 ml/min, less than 0.7% the dose is excreted into urine in a constant form. After the single dose, there is no thalidomid in the urine after 48 hours. Although thalidomid is hydrolyzed into some metabolic substances, only a very small amount (0.02% of the dose) 4-oll-thalidomid pharmaceuticals found in urine after using the drug 12 to 24 hours.

Before taking Domide 50mg TTY Bopopharm treat multi -marrow tumor, red circles leprosy (6 blisters x 10 tablets)

How to use

Follow all the instructions in the text agreement when using the domide. The prescription drug for women with the ability to reproduce must respond to negative pregnancy test results at the beginning of treatment and continue during treatment.

Thalidomid treatment must be started and controlled under the supervision of physicians with experience in chemotherapy and immunodeficiency, fully understanding the risk of thalidomid treatment and control requirements.

To reduce the effects on the central nervous system such as drowsiness, dozing off, sedation during the day, usually taking 1 dose of thalidomid in the evening. Thalidomid capsules should be used for at least 1 hour after eating.

Dosage

multiple marrow disease

The total treatment time depends on the tolerance and progression of each patient.

Coordinate with Melphalan and Prednison: recommend using 200mg of domide daily. Should use up to 12 cycles for 4 weeks (28 days).

Dexamethasone combination: recommends using 200 mg of domide daily. Should use up to 4 cycles for 4 weeks (28 days). Dexamethasone dose is 40 mg orally on April 1, 9 - 12, and 17 - 20 every 28 days.

Patients with side effects such as constipation, excessive sleep, or peripheral neuropathy may suspend medication or use at lower doses. When the side effects are reduced, vow to start taking the drug at a lower doses or re -use of the previous dose depending on the clinical evaluation.

For elderly patients with poor exercise, it is possible to improve tolerance by the initial treatment at the dose of 50 mg/day and increase this dose to 200 mg/day for 4 weeks.

Red halo leprosy (ENL)

For 1 stage of enlel on the skin, it is recommended to start using a domide at a dose of 100 mg to 300 mg/day, drink once with water, should take before sleep, at least after dinner 1 hour. Patients under 50 kg should start low doses.

Patients with severe enlic reactions on the skin, or previous people who have needed a higher dose to control the reaction, should start using a domide at a dose of up to 400 mg/day oral 1 time when sleeping or dividing the dose of drinking with water, at least 1 hour after eating.

For patients with severe neuritis combined with the Enl reaction, it may start using corticosteroids simultaneously with the domide. The use of steroids can decrease and stop when neuritis is relieved.

Should use the domide continuously until the signs and symptoms have been reduced, usually at least 2 weeks ago can gradually reduce the drug for the patient, down 50 mg every 2 to 4 weeks.

There are no thalidomid -controlled studies for maintenance treatment to avoid recurrence of Enl for recommendations on maintenance dose. Patients with a history of long -term maintenance treatment to avoid the recurrence of the skin on the skin or people with halo when reducing the dose should maintain the minimum dose to control the reaction. Should try reducing the dose every 3 to 6 months, down 50mg every 2 to 4 weeks.

Patients do not use double dose of domide if they have forgotten the dose first. In this case, the patient forgot to take 1 dose of domide, so they should drink as soon as possible but the drinking time is not close to the next drink.

Dosage adjustment in treatment

may need to slow down or reduce the dose depending on the level of toxicity.

Blood thrombosis

Should prevent blood vessel thrombosis for at least the first 5 months of treatment, especially in patients at risk of thrombosis. Blood spare drugs such as low molecular heparin or warfarin are recommended.

Should decide to use blood pressure prevention measures after careful assessment of potential risks of each patient.

If the patient has any blockage thrombosis during thalidomid combination treatment, stop treatment and start with standard anticoagulant therapy. Once the patient has stabilized anticoagulant treatment and has controlled the complications of blood vessel thrombosis, may start using thalidomid again at the initial dose depending on the evaluation of benefits and risks. Patients should continue taking anticoagulants during thalidomid treatment.

Peripheral neuropathy

If patients with peripheral neuropathy in thalidomid combination treatment should stop treatment. Continue to control the patient until the patient reaches the first degree of neuropathy, which can start treating with 50% of the previous dose. At any time, if the patient has 3 or 4 neuropathy, the treatment should be stopped.

Patients with kidney or liver failure

There are no specific studies in patients with renal failure or liver failure.

No recommendations for these patients. Patients with severe organs should be monitored for careful effects.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.What to do when overdose? There is no death report at a dose of up to 14.4g and all patients recover without sequelae. There is no specific antidote for thalidomid overdose.

In case of overdose, patient signs should be controlled and appropriate supportive measures to maintain blood pressure and respiratory condition.

In an emergency, call the 115 emergency center immediately or go to the nearest local health station.

What to do when you forget 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double dose to compensate for missed dose.

Side Effects

The most dangerous effect of thalidomid is the ability to cause monsters in humans. The risk of severe fetal defects, mainly short or death, is especially high during pregnancy. The dangerous time is evaluated depending on the source of information, from 35 to 50 days after the last period. The risk of fetal defects other than this time is not known, but may also be important. Based on the current knowledge, do not use thalidomid at any time in pregnancy.

Because Thalidomid is present in the semen of patients taking drugs, men who use Thalidomid must always use condoms when having sex with women with fertility.

Thalidomid also causes drowsiness/dozing off, peripheral neuropathy, dizziness/posture hypotension, neutrophilic leukemia, increased HIV virus.

There has been a susceptibility report to thalidomid and slow heart rate in patients treated with thalidomid.

Sleep, dizziness, rash are the most common side effects when using thalidomid.

Thalidomid has been studied in controlled and uncontrolled clinical trials in patients with multiple marrow, ENL, and HIV -positive patients. Moreover, Thalidomid has been studied for more than 20 years with different indications. Side effects from these studies are summarized in the following sections.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

contraindicated

contraindicated domide drugs in the following cases:

Pregnant: Type X

Due to the ability to cause monsters known even if only one dose, thalidomid has contraindicated in pregnant women and women who are likely to be pregnant. When there is no alternative treatment, pregnant women can also be treated with thalidomid with adequate caution to avoid pregnancy. Women must commit or abstain from heterosexual sex or use two reliable contraceptive measures including at least one highly effective method (for example: placing a ring, contraceptive hormone, sperm or vasectomy that starts 4 weeks before starting thalidomid treatment, during thalidomid treatment and continues 4 weeks after thalidomid treatment. can use two other highly effective measures.

Women who are likely to be pregnant before thalidomid treatment must be tested to see if they are pregnant (sensitivity of at least 50miu/ml), not prescribed this drug until receiving negative pregnancy test reports. 24 -hour test should be performed before starting thalidomid and every 4 weeks for women with normal menstrual cycle or every 2 weeks with women with abnormal menstrual periods. Pregnancy and advice must be checked if the patient forgets the cycle or has abnormalities in menstrual bleeding. If pregnant during thalidomid treatment, thalidomid should be stopped immediately. In these cases, patients should be transferred to obstetricians with experience in toxicity with reproduction to evaluate and consult.

Because thalidomid is present in the semen of patients taking drugs, men when using thalidomid must always use condoms when having sex with any woman with fertility. The risk for the fetus from the semen of men is not known.

thalidomid has contraindicated in patients sensitive to drugs or other ingredients of the drug.

Be cautious when using

vigilance

Fetal defects:

Thalidomid can cause serious fetal defects in humans. The patient should only be used for thalidomid when prescribed and not sharing thalidomid with anyone else. Because Thalidomid is present in the semen of men who use drugs, men who use drugs must always use condoms when having sex with any woman who is able to reproduce. The risk for the fetus from the semen of men is not known.

thrombosis:

Using thalidomid in myeloid pain increases the risk of venous thrombosis, such as deep veins and pulmonary blood vessels. This risk increases significantly when using thalidomid combined with standard valence drugs including Devamethasone. In a controlled study, the ratio of venous thrombosis is 22.5% in patients using thalidomid in combination with dexamethasone compared to 4.9% in patients only using dexamethasone (P = 0.002). Patients and physicians recommend monitoring signs and symptoms of thrombosis. The patient should be instructed to find medical assistance if there are still shortness, chest pain, arms or legs. The figures show that appropriate patients may be beneficial when treated with anticoagulant or aspirin.

Sleep and falling asleep:

Thalidomid often causes drowsiness and dozing off. Patients should be instructed to avoid situations where they sleep in trouble, and do not use other drugs that can cause drowsiness without the physician's advice. It is recommended that patients may be able to reduce their physical and mental ability to do dangerous jobs, such as driving or operating complex or dangerous machines.

Peripheral neuropathy:

Thalidomid is known to cause long -term nerve damage. Peripheral neuropathy is a common side effect when thalidomid treatment does not recover, may be severe. The peripheral menstrual disease usually occurs when used for months: however, there are also reports on the case when using it for a short time. It is unclear the contact with the dose accumulation. Symptoms that sometimes occur when thalidomid treatment is discontinued, can gradually or not less.

A few reports on neuropathy when treating Enl although long treatment time. However, it is difficult to distinguish thalidomid neuropathy with common neuropathy in Hansen, so it is difficult to determine exactly the rate of neuropathy caused by thalidomids in enlid patients treated with thalidomid.

Patients should be checked monthly in the first 3 months of thalidomid treatment to see that the drug may detect early signs of neuropathy including tremor, throbbing or hand and feet pain.

The patient should then be periodically evaluated during treatment. Patients should be consulted regularly, ask the disease, evaluate the signs and symptoms of peripheral neuropathy. The physiological testing should be considered, including measurement of the intensity of the sensory nerve in the beginning and every 6 months to detect asymptomatic neuropathy. If there is a neuropathic disease, thalidomid should be stopped immediately to avoid further damage. Usually, thalidomid should only be used when neurological disease returns to its original state. Avoid using drugs that affect neuropathy when treating patients using thalidomid.

Dizziness and posture hypotension:

It is recommended that patients with thalidomids can cause dizziness and posture hypotension, so patients should sit straight in minutes before standing up from the lying position.

Neutral leukemia:

leukopenia including neutrophils has been reported when using clinical thalidomids.

Do not start treatment when neutral leukemia (ANC) below 750/mm3. Blood recipes and periodic changes should be controlled, especially in patients who tend to lack neutrophils, such as HIV -positive patients. If the ANC drops below 750/mm3 during treatment, the medication regime should be evaluated, and if the neutrophils shortage are prolonged, it is advisable to consider stopping thalidomid.

Increase the amount of HIV virus:

A study with random placebo control with thalidomid in HIV -positive patients, the level of HIV in plasma increases (average change = 0.42 log10 copy/ml, p = 0.04 compared to placebo). The same trend is also observed in a second study conducted in HIV -positive patients. The importance of this increase in clinically is not known. Both studies have been conducted before treatment with high antiviral drugs.

Before the clinical importance of this finding is well known, the virus should be checked after the first and third month of treatment and every three months later.

Precautions

General:

Only thalidomid is known to cause fetal defects. There is currently no data on skin absorption or thalidomid inhalation in women who are likely to get pregnant, and do not know if these contacts cause fetal defects. The patient should not open Thalidomid capsules and the administrator in the blister until drinking. If contact with Thalidomid capsules is not intact or powder in the tablet, wash the skin in contact with soap and water.

thalidomid is present in serum and semen of patients using thalidomid. If medical staff or other careers are exposed to the patient's body fluids using thalidomid, should be cautious as wearing gloves to avoid skin contact with thalidomid or contact area should be washed with soap and water.

Increase:

Increase colds with thalidomid has been reported. Signs and symptoms include red rugged floating, fever, tachycardia, hypotension, and if severe may need to stop the kite. If the reaction occurs when using the drug again, thalidomid should be stopped.

The bradycardia related to thalidomid has been reported. Some cases of bradycardia have been reported, some cases need medical intervention.

Clinical importance and reasons for bradycardia in patients treated with thalidomid are not known.

Steven - Johnson syndrome and toxic skin necrosis:

Serious skin reactions including Steven-Johnson syndrome and toxic skin necrosis, death, have been reported. Should be stopped, thalidomid if the skin is red on the skin and only reuses when the clinical evaluation is appropriate. If redness is peeling, hemorrhage or bulging or if the symptoms of Steven-Johnson or skin necrosis are suspected, do not use thalidomid.

epilepsy:

Although not reported in controlled clinical trials before bringing the drug to the market, there are reports on epilepsy status including strong seizures when taking clinical drugs after the drug has been approved. Because these events were voluntarily reported, they did not know the number of patients, so the frequency could not be assessed. Most of these patients have epilepsy, until now it is not known whether Thalidomid has affected the cause of epilepsy or not.

When treated with Thành Thoiidomid, patients with a history of epilepsy or risk factors leading to epilepsy need to be carefully monitored for clinical changes that can cause acute epilepsy.

Information for patients:

Should guide patients on thalidomid's teratogenicity and the necessary cautions that are easy to eliminate the possibility of the fetus as a written agreement and the warnings in this prescription. The patient should only be used for thalidomids according to the prescription of the physician and obey all the terms of the written agreement.

Should guide patients not to open capsules and hold tablets in the blister until taken.

Should guide patients should not divide the drug to anyone.

Should guide patients is thalidomid often causes drowsiness and falls. Patients should avoid situations where drowsiness can cause problems and do not use other drugs that can cause drowsiness without the doctor's advice. It is recommended that patients with physical and mental abilities may be reduced affecting the implementation of dangerous operations such as driving or operating complex machines.

Should guide patients is thalidomid that can cause increased drowsiness when drinking alcohol.

Should guide patients, thalidomid, can cause peripheral neuropathy with signs of starting, throbbing or pain or pain in the feet or hands. And patients should report these phenomena immediately to prescribed physicians.

Should guide patients, thalidomids can cause dizziness and posture hypotension, and therefore, patients should be straight a few minutes before standing up from their lying position.

Should guide patients without blood donation while taking Thalidomid.

Moreover, the male patient is absolutely not allowed to donate sperm while taking Thalidomid.

Instruct patients and signs and symptoms of thrombosis and seek medical help if symptoms such as short breath, chest pain, or arm edema.

Lactose intolerance:

Lactose capsules. Patients with rare genetic problems such as galactose intolerance, lapp lactase deficiency or glucose-galactose absorption disorders should not be used.

Testing:

Pregnant test:

Women who are likely to be pregnant before thalidomid treatment must be tested to see if they are pregnant (sensitivity of at least 50miu/ml), not prescribed this drug until receiving negative pregnancy test reports. 24 -hour test should be performed before starting thalidomid and every 4 weeks for women with normal menstrual cycle or every 2 weeks with women with abnormal menstrual periods. Pregnancy and advice must be checked for patients who forget the cycle or have abnormalities in menstrual bleeding.

Abuse and drug dependence:

There is no physical and mental dependence report when using thalidomid. But patients need to avoid abuse as sleeping pills. However, like sedatives/sleeping pills, Thalidomid is reported to create a habit for patients for the effect of falling asleep.

The effect of drugs on driving and operating machinery

should recommend patients about being able to reduce the physical and mental ability needed to do dangerous jobs, such as driving or operating complex or dangerous machines.

Use drugs for women during pregnancy and lactation

Pregnant classification: Type X

Due to the known person's known teratial ability in humans, thalidomid has contraindicated in pregnant women or may be pregnant, and those who do not use two as required contraceptive measures or those who do not constantly abstain from the heterosexual sex. If thalidomid is used during pregnancy it can cause serious fetal defects, or fetal death. Never use thalidomid for pregnant women or will be pregnant while taking the drug. Even if pregnant women only take a single dose (1 tablet 50 mg) can cause defects to the fetus. If pregnant during treatment, the drug must be stopped immediately. In these cases, patients should be transferred to obstetricians with experience in reproductive toxicity to evaluate and advise. If there is any doubt about fetal exposure to thalidomid, it is necessary to immediately report to the physician.

Because thalidomid is present in the semen of patients taking male medications, thalidomid must always use condoms when having sex with any woman who is able to reproduce. The risk for the fetus from the male semen of patients using thalidomid has not been known.

A toxic study on reproduction before and after birth has been conducted in pregnant female rabbits. Increase the rate of miscarriage and pregnancy toxicity at the lowest oral dose of 30 mg/kg/day (about 1.5 times the maximum dose in humans based on BSA) and at all higher doses. Increase the birth rate of newborn at oral dose> 50 mg/kg/day (about 7.5 times the highest dose in BSA -based people). Do not slow down the development after birth, including the ability to learn and memorize with oral doses in female rabbits 150 mg/kg/day (thalidomid concentration in milk average from 22 to 36 g/ml),

Used in breastfeeding women:

It is unknown whether thalidomid is excreted in breast milk or not. Because there are many drugs excreted in breast milk and due to the risk of serious side effects in children from Thalidomid, the decision to stop breastfeeding or stop taking the drug depends on the importance of the drug for the mother.

Drug interaction

Interactive drugs and other types of interactions

Thalidomid is reported to increase the sedation of barbiturates, alcohol, clepopromazin, and reserpin.

Peripheral neuropathy: The drugs known to be related to peripheral neuropathy should be used cautiously in patients using thalidomid.

Oral contraceptives: In 10 healthy, pharmacokinetic women of Norethindron and Ethinyl Estradiol after taking 1 single dose of research. The result is the same when there is or without thalidomid 200 mg/day in a stable state.

important drug interaction is not thalidomid

Medications affecting Hormone contraceptives

Use contraceptives simultaneously with HIV Protease, Griseofulvin, Modafinil, Penicillin, Rifampin, Rifampin, Phenytonin, Carbamazepin, or some herbs such as St. John's Wort can reduce the effectiveness of birth control pills by up to 1 month after stopping these drugs. Therefore, women who use one or more these drugs must use two effective methods of contraception or highly effective measures or abstain from sexual intercourse during thalidomid.

Cancer, mutations, affecting reproduction

Cancer studies for 2 years have been conducted in male and female mice. There is no effect of creating tumors at the highest dose of 3000 mg/kg/day in the male and female mice (38 times higher than the highest dose in humans is 400 mg based on the body surface area (BSA]), and 3000 mg/kg/day in the female mouse (75 times higher than the dosage dose in humans based on i3SA), and 300 mg/kg/day in the maximum of the male rats based on the maximum dosage based on BSA).

thalidomid does not cause mutations or gene toxicity according to the tests: AMES bacterial mutation test (S.typhimurium and E.coli), testing of egg cell mutations in the mouse.

(AS52/XPRT) and reproductive experiments in Vivo mouse

Studies on reproduction have been conducted in male and female rabbits, no effects of drugs for mating and fertilization at the highest oral dose of 100 mg/kg/day for cabbage rabbits and 500 mg/kg/day for male rabbits (5 and 25 times higher than the maximum dosage in humans based on BSA). Histological and pathological effects of the province have been seen in the male rabbits at a dose of> 30 mg/kg/day (about 1.5 times the maximum dose in humans based on BSA).

Use in children

Safety and effectiveness in children under 12 years of age have not been established.

Used in the elderly:

Of the total number of people participating in clinical trials in thalidomid and dexamethasone, 50%> 65 years and 15%> 75 years old. There is no difference in safety and effectiveness between these patients and younger patients, and in another report, there is no difference in response between the elderly, and the younger people, but it cannot exclude the fact that some elderly people are more sensitive to the drug.

Storage

Leave a cool place, avoid light, temperature below 30⁰C.

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