Fenbrat 300 Dosage

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What is the dose of your medication?

Dosage of Fenbrat 300 in details

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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General Considerations

Patients should be placed on an appropriate lipid-lowering diet before receiving Fenbrat 300, and should continue this diet during treatment with Fenbrat 300. Fenbrat 300 capsules can be given without regard to meals.

Patients should be advised to swallow Fenbrat 300 capsules whole. Do not open, crush, dissolve or chew capsules.

The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcoholic intake may be important factors in hypertriglyceridemia and should be addressed prior to any drug therapy. Physical exercise can be an important ancillary measure. Diseases contributory to hyperlipidemia, such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy, thiazide diuretics and beta-blockers, are sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of the specific etiologic agent may obviate the need for specific drug therapy of hypertriglyceridemia.

Lipid levels should be monitored periodically and consideration should be given to reducing the dosage of Fenbrat 300 if lipid levels fall significantly below the targeted range.

Therapy should be withdrawn in patients who do not have an adequate response after two months of treatment with the maximum recommended dose of 90 mg once daily.

Primary Hypercholesterolemia And Mixed Dyslipidemia

The initial dose of Fenbrat 300 is 90 mg per day.

Severe Hypertriglyceridemia

The initial dose is 30 to 90 mg per day. Dosage should be individualized according to patient response, and should be adjusted if necessary following repeat lipid determinations at 4 to 8 week intervals. The maximum dose is 90 mg per day.

Impaired Renal Function

Treatment with Fenbrat 300 should be initiated at a dose of 30 mg per day in patients having mild to moderately impaired renal function, and increased only after evaluation of the effects on renal function and lipid levels at this dose. The use of Fenbrat 300 should be avoided in patients with severe renal impairment.

Geriatric Patients

Dose selection for the elderly should be made on the basis of renal function.

How supplied

Dosage Forms And Strengths

  • Fenbrat 300®(Fenbrat 300) capsules, 30 mg are size '4' capsules with opaque light green cap and opaque light green body, imprinted with LUPIN logo and “Fenbrat 300” in black ink on body, and “30” in black ink on cap, containing white to off-white pellets.
  • Fenbrat 300®(Fenbrat 300) capsules, 90 mg are size '3' capsules with opaque dark green cap and opaque white body, imprinted with LUPIN logo and “Fenbrat 300” in black ink on body, and “90” in black ink on cap, containing white to off-white pellets.

Storage And Handling

Fenbrat 300® (Fenbrat 300) Capsules, 30 mg are size '4' capsules with opaque light green cap and opaque light green body, imprinted with LUPIN logo and “Fenbrat 300” in black ink on body, and “30” in black ink on cap, containing white to off-white pellets.

NDC 27437 -107 -06 30's Bottle

Fenbrat 300® (Fenbrat 300) Capsules, 90 mg are size '3' capsules with opaque dark green cap and opaque white body, imprinted with LUPIN logo and “Fenbrat 300” in black ink on body, and “90” in black ink on cap, containing white to off-white pellets.

NDC 27437 -108 -06 30's Bottle

NDC 27437 -108 -09 90's Bottle

NDC 27437 -108 -01 100's Bottle

Storage

Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) in a tightly closed container.

Manufactured for: Lupin Pharma, Baltimore, Maryland 21202 United States. Manufactured by: Lupin Limited, Goa -403 722 INDIA OR Lupin Limited, Pithampur (M.P.) -454 775 INDIA. Address Medical Inquiries to: Lupin Pharma Medical Inquiries, 111 South Calvert Street, 21Floor Baltimore, MD 21202 or Call: 1-800-399-2561. Revised: August 2015

What other drugs will affect Fenbrat 300?

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Fenbrat 300, especially:

  • a blood thinner such as warfarin, Coumadin;
  • medicines to treat a bowel disorder;
  • medication to prevent organ transplant rejection;
  • antiviral medications;
  • chemotherapy;
  • pain or arthritis medicines (including aspirin, Tylenol, Advil, and Aleve); or
  • any injected antibiotics.

This list is not complete. Other drugs may interact with Fenbrat 300, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Fenbrat 300 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 Fenbrat 300, 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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Anticoagulants: Fenbrat 300 enhances oral anticoagulant effect and may increase risk of bleeding. Therefore, this combination is not recommended.

Potentiation of coumarin-type anticoagulant effects has been observed with prolongation of the PT/INR.

Caution should be exercised when coumarin anticoagulants are given in conjunction with Fenbrat 300. The dosage of the anticoagulants should be reduced to maintain the PT/INR at the desired level to prevent bleeding complications. Frequent PT/INR determinations are advisable until it has been definitely determined that the PT/INR has stabilized.

Hydroxy methylglutaryl coenzyme A (HMG-CoA) Reductase Inhibitors (Statins): The combined use of Fenbrat 300 and HMG-CoA reductase inhibitors should be avoided unless the benefit of further alterations in lipid levels is likely to outweigh the increased risk of this drug combination.

The risk of serious muscle toxicity is increased if Fenbrat 300 is used concomitantly with HMG-CoA reductase inhibitors or other fibrates. Such combination therapy should be used with caution and patients monitored closely for signs of muscle toxicity.

Bile Acid Resins: Since bile acid sequestrants may bind other drugs given concurrently, patients should take Fenbrat 300 at least 1 hr before or 4-6 hrs after a bile acid binding resin to avoid impeding its absorption.

Immunosuppressants: Immunosuppressants eg, cyclosporine and tacrolimus can produce nephrotoxicity with decreases in CrCl and rises in serum creatinine, and because renal excretion is the primary elimination route of fibrate drugs including Fenbrat 300, there is a risk that an interaction will lead to deterioration. The benefits and risks of using Fenbrat 300 with immunosuppressants and other potentially nephrotoxic agents should be carefully considered and the lowest effective dose employed and renal function monitored.

Some severe cases of reversible renal function impairment have been reported during concomitant administration of Fenbrat 300 and cyclosporine. The renal function of these patients must therefore be closely monitored and the treatment with Fenbrat 300 stopped in the case of severe alteration of laboratory parameters.

Cytochrome P450 (CYP450) Enzymes: In vitro studies using human liver microsomes indicate that Fenbrat 300 and fenofibric acid are not inhibitors of CYP450 isoforms CYP3A4, CYP2D6, CYP2E1 or CYP1A2. They are weak inhibitors of CYP2C19 and CYP2A6 and mild to moderate inhibitors of CYP2C9 at therapeutic concentrations. Patients co-administered Fenbrat 300 and CYP2C19, CYP2A6 and especially CYP2C9 metabolised drugs with a narrow therapeutic index should be carefully monitored and if necessary, dose adjustment of these drugs is recommended.


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References

  1. DailyMed. "FENOFIBRATE: 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).
  2. FDA/SPL Indexing Data. "U202363UOS: 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).
  3. MeSH. "Hypolipidemic Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Fenbrat 300 are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Fenbrat 300. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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