Dosage of Leflunomid-Mepha 20mg in details
Leflunomid-Mepha 20mg Dosage
Generic name: Leflunomid-Mepha 20mg 10mg
Dosage form: tablet, film coated
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Recommended Dosage
The recommended dosage of Leflunomid-Mepha 20mg is 20 mg once daily. Treatment may be initiated with or without a loading dose, depending upon the patient's risk of Leflunomid-Mepha 20mg-associated hepatotoxicity and Leflunomid-Mepha 20mg-associated myelosuppression. The loading dosage provides steady-state concentrations more rapidly.
- For patients who are at low risk for Leflunomid-Mepha 20mg-associated hepatotoxicity and Leflunomid-Mepha 20mg-associated myelosuppression the recommended Leflunomid-Mepha 20mg loading dosage is 100 mg once daily for 3 days. Subsequently administer 20 mg once daily.
- For patients at high risk for Leflunomid-Mepha 20mg-associated hepatotoxicity (e.g., those taking concomitant methotrexate) or Leflunomid-Mepha 20mg-associated myelosuppression (e.g., patients taking concomitant immunosuppressants), the recommended Leflunomid-Mepha 20mg dosage is 20 mg once daily without a loading dose.
The maximum recommended daily dosage is 20 mg once per day. Consider dosage reduction to 10 mg once daily for patients who are not able to tolerate 20 mg daily (i.e., for patients who experience any adverse events listed in Table 1).
Monitor patients carefully after dosage reduction and after stopping therapy with Leflunomid-Mepha 20mg, since the active metabolite of Leflunomid-Mepha 20mg, teriflunomide, is slowly eliminated from the plasma. After stopping Leflunomid-Mepha 20mg treatment, an accelerated drug elimination procedure is recommended to reduce the plasma concentrations of the active metabolite, teriflunomide. Without use of an accelerated drug elimination procedure, it may take up to 2 years to reach undetectable plasma teriflunomide concentrations after stopping Leflunomid-Mepha 20mg.
Evaluation and Testing Prior to Starting Leflunomid-Mepha 20mg
Prior to starting Leflunomid-Mepha 20mg treatment the following evaluations and tests are recommended:
- Evaluate patients for active tuberculosis and screen patients for latent tuberculosis infection
- Laboratory tests including serum alanine aminotransferase (ALT); and white blood cell, hemoglobin or hematocrit, and platelet counts
- For females of reproductive potential, pregnancy testing
- Check blood pressure
More about Leflunomid-Mepha 20mg (Leflunomid-Mepha 20mg)
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Consumer resources
- Leflunomid-Mepha 20mg
- Leflunomid-Mepha 20mg (Advanced Reading)
Professional resources
- Leflunomid-Mepha 20mg (AHFS Monograph)
- Leflunomid-Mepha 20mg (FDA)
Related treatment guides
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What other drugs will affect Leflunomid-Mepha 20mg?
Many drugs can interact with Leflunomid-Mepha 20mg. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any you start or stop using, especially:
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cholestyramine;
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aspirin, or acetaminophen (Tylenol);
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rifampin, or other tuberculosis medicine;
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an antibiotic, antifungal medicine, or sulfa drug;
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antiviral or HIV/AIDS medication;
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birth control pills or hormone replacement therapy;
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gout or arthritis medication (including gold injections);
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heart or blood pressure medication;
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medicine to treat mental illness;
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anabolic steroidsGadavistmethyltestosterone, "performance-enhancing drugs"; cancer medication; or
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cholesterol-lowering medicationGadavistCrestor, Lipitor, Vytorin, Zocor, and others;
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an NSAID (nonsteroidal anti-inflammatory drug)Gadavistibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others; or
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seizure medicationGadavistcarbamazepine, phenytoin, valproic acid, and others.
This list is not complete and many other drugs can interact with Leflunomid-Mepha 20mg. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.
Leflunomid-Mepha 20mg interactions
Following oral administration, Leflunomid-Mepha 20mg is metabolized to an active metabolite, teriflunomide, which is responsible for essentially all of Leflunomid-Mepha 20mg's in vivo activity. Drug interaction studies have been conducted with both Leflunomid-Mepha 20mg (Leflunomid-Mepha 20mg) and with its active metabolite, teriflunomide, where the metabolite was directly administered to the test subjects.
Effect of Potent CYP and Transporter Inducers
Leflunomid-Mepha 20mg is metabolized by CYP450 metabolizing enzymes. Concomitant use of Leflunomid-Mepha 20mg and rifampin, a potent inducer of CYP and transporters, increased the plasma concentration of teriflunomide by 40%. However, when co-administered with the metabolite, teriflunomide, rifampin did not affect its pharmacokinetics. No dosage adjustment is recommended for Leflunomid-Mepha 20mg when coadministered with rifampin. Because of the potential for Leflunomid-Mepha 20mg concentrations to continue to increase with multiple dosing, caution should be used if patients are to be receiving both Leflunomid-Mepha 20mg and rifampin.
Effect on CYP2C8 Substrates
Teriflunomide is an inhibitor of CYP2C8 in vivo. In patients taking Leflunomid-Mepha 20mg, exposure of drugs metabolized by CYP2C8 (e.g., paclitaxel, pioglitazone, repaglinide, rosiglitazone) may be increased. Monitor these patients and adjust the dose of the concomitant drug(s) metabolized by CYP2C8 as required.
Effect on Warfarin
Coadministration of Leflunomid-Mepha 20mg with warfarin requires close monitoring of the international normalized ratio (INR) because teriflunomide, the active metabolite of Leflunomid-Mepha 20mg, may decrease peak INR by approximately 25%.
Effect on oral Contraceptives
Teriflunomide may increase the systemic exposures of ethinylestradiol and levonorgestrel. Consideration should be given to the type or dose of contraceptives used in combination with Leflunomid-Mepha 20mg.
Effect on CYP1A2 Substrates
Teriflunomide, the active metabolite of Leflunomid-Mepha 20mg, may be a weak inducer of CYP1A2 in vivo. In patients taking Leflunomid-Mepha 20mg, exposure of drugs metabolized by CYP1A2 (e.g., alosetron, duloxetine, theophylline, tizanidine) may be reduced. Monitor these patients and adjust the dose of the concomitant drug(s) metabolized by CYP1A2 as required.
Effect on Organic Anion Transporter 3 (OAT3) Substrates
Teriflunomide inhibits the activity of OAT3 in vivo. In patients taking Leflunomid-Mepha 20mg, exposure of drugs which are OAT3 substrates (e.g., cefaclor, cimetidine, ciprofloxacin, penicillin G, ketoprofen, furosemide, methotrexate, zidovudine) may be increased. Monitor these patients and adjust the dose of the concomitant drug(s) which are OAT3 substrates as required.
Effect on BCRP and Organic Anion Transporting Polypeptide B1 and B3 (OATP1B1/1B3) Substrates
Teriflunomide inhibits the activity of BCRP and OATP1B1/1B3 in vivo. For a patient taking Leflunomid-Mepha 20mg, the dose of rosuvastatin should not exceed 10 mg once daily. For other substrates of BCRP (e.g., mitoxantrone) and drugs in the OATP family (e.g., methotrexate, rifampin), especially HMG-Co reductase inhibitors (e.g., atorvastatin, nateglinide, pravastatin, repaglinide, and simvastatin), consider reducing the dose of these drugs and monitor patients closely for signs and symptoms of increased exposures to the drugs while patients are taking Leflunomid-Mepha 20mg.
References
- DailyMed. "LEFLUNOMIDE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- FDA/SPL Indexing Data. "G162GK9U4W: The UNique Ingredient Identifier (UNII) is an alphanumeric substance identifier from the joint FDA/USP Substance Registration System (SRS).". https://www.fda.gov/ForIndustry/Data... (accessed September 17, 2018).
- MeSH. "Immunosuppressive Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology