The dose of a drug and dosage of the drug are two different terminologies. Dose is defined as the quantity or amount of medicine given by the doctor or taken by the patient at a given period. Dosage is the regimen prescribed by the doctor about how many days and how many times per day the drug is to be taken in specified dose by the patient. The dose is expressed in mg for tablets or gm, micro gm sometimes, ml for syrups or drops for kids syrups. The dose is not fixed for a drug for all conditions, and it changes according to the condition or a disease. It also changes on the age of the patient.
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Leflunomid Apotex 10 mg Dosage
Generic name: Leflunomid Apotex 10 mg 10mg
Dosage form: tablet, film coated
The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
Recommended Dosage
The recommended dosage of Leflunomid Apotex 10 mg is 20 mg once daily. Treatment may be initiated with or without a loading dose, depending upon the patient's risk of Leflunomid Apotex 10 mg-associated hepatotoxicity and Leflunomid Apotex 10 mg-associated myelosuppression. The loading dosage provides steady-state concentrations more rapidly.
For patients who are at low risk for Leflunomid Apotex 10 mg-associated hepatotoxicity and Leflunomid Apotex 10 mg-associated myelosuppression the recommended Leflunomid Apotex 10 mg loading dosage is 100 mg once daily for 3 days. Subsequently administer 20 mg once daily.
For patients at high risk for Leflunomid Apotex 10 mg-associated hepatotoxicity (e.g., those taking concomitant methotrexate) or Leflunomid Apotex 10 mg-associated myelosuppression (e.g., patients taking concomitant immunosuppressants), the recommended Leflunomid Apotex 10 mg 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 Apotex 10 mg, since the active metabolite of Leflunomid Apotex 10 mg, teriflunomide, is slowly eliminated from the plasma. After stopping Leflunomid Apotex 10 mg 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 Apotex 10 mg.
Evaluation and Testing Prior to Starting Leflunomid Apotex 10 mg
Prior to starting Leflunomid Apotex 10 mg 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
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What other drugs will affect Leflunomid Apotex 10 mg?
Before taking Leflunomid Apotex 10 mg, tell your doctor if you are taking cholestyramine (Questran, Prevalite, LoCHOLEST) or rifampin (Rifadin, Rimactane).
Also tell your doctor if you are using medications that can weaken your immune system, such as:
Leflunomid Apotex 10 mg can harm your liver. This effect is increased when you also use other medicines harmful to the liver, such as:
acetaminophen (Tylenol);
tuberculosis medications;
birth control pills or hormone replacement therapy;
other arthritis medications such as auranofin (Ridaura) or aurothioglucose (Solganol);
an ACE inhibitor such as benazepril (Lotensin), enalapril (Vasotec), lisinopril (Prinivil, Zestril), quinapril (Accupril), ramipril (Altace), and others;
an antibiotic such as dapsone or erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole);
an antifungal medication such as fluconazole (Diflucan), itraconazole (Sporanox), or ketoconazole (Nizoral);
cholesterol medications such as niacin (Advicor, Niaspan, Niacor, Slo-Niacin, and others), atorvastatin (Lipitor, Caduet), simvastatin (Zocor, Simcor, Vytorin), and others;
HIV/AIDS medications such as abacavir/lamivudine/zidovudine (Trizivir), lamivudine (Combivir, Epivir), nevirapine (Viramune), tenofovir (Viread), or zidovudine (Retrovir);
an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Arthrotec, Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze), indomethacin (Indocin), meloxicam (Mobic), and others; or
seizure medications such as carbamazepine (Carbatrol, Tegretol), phenytoin (Dilantin), felbamate (Felbatol), valproic acid (Depakene).
This list is not complete and other drugs may interact with Leflunomid Apotex 10 mg. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
Leflunomid Apotex 10 mg interactions
Interactions are the effects that happen when the drug is taken along with the food or when taken with other medications. Suppose if you are taking a drug Leflunomid Apotex 10 mg, it may have interactions with specific foods and specific medications. It will not interact with all foods and medications. The interactions vary from drug to drug. You need to be aware of interactions of the medicine you take. Most medications may interact with alcohol, tobacco, so be cautious.
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Following oral administration, Leflunomid Apotex 10 mg is metabolized to an active metabolite, teriflunomide, which is responsible for essentially all of Leflunomid Apotex 10 mg's in vivo activity. Drug interaction studies have been conducted with both Leflunomid Apotex 10 mg (Leflunomid Apotex 10 mg) and with its active metabolite, teriflunomide, where the metabolite was directly administered to the test subjects.
Effect of Potent CYP and Transporter Inducers
Leflunomid Apotex 10 mg is metabolized by CYP450 metabolizing enzymes. Concomitant use of Leflunomid Apotex 10 mg 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 Apotex 10 mg when coadministered with rifampin. Because of the potential for Leflunomid Apotex 10 mg concentrations to continue to increase with multiple dosing, caution should be used if patients are to be receiving both Leflunomid Apotex 10 mg and rifampin.
Effect on CYP2C8 Substrates
Teriflunomide is an inhibitor of CYP2C8 in vivo. In patients taking Leflunomid Apotex 10 mg, 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 Apotex 10 mg with warfarin requires close monitoring of the international normalized ratio (INR) because teriflunomide, the active metabolite of Leflunomid Apotex 10 mg, 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 Apotex 10 mg.
Effect on CYP1A2 Substrates
Teriflunomide, the active metabolite of Leflunomid Apotex 10 mg, may be a weak inducer of CYP1A2 in vivo. In patients taking Leflunomid Apotex 10 mg, 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 Apotex 10 mg, 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 Apotex 10 mg, 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 Apotex 10 mg.
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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).
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