Fenogal 200mg

Treatment of Severe Hypertriglyceridemia

Fenogal 200mg is indicated as adjunctive therapy to diet to reduce ​triglycerides (TG) in patients with severe hypertriglyceridemia. Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate the need for pharmacological intervention. Markedly elevated levels of serum triglycerides (e.g. > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of Fenogal 200mg therapy on reducing this risk has not been adequately studied.

Treatment of Primary Hypercholesterolemia or Mixed Dyslipidemia

Fenogal 200mg is indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), triglycerides (TG), and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hypercholesterolemia or mixed dyslipidemia.

Limitations of Use

​ Fenogal 200mg at a dose equivalent to 135 mg of Fenogal 200mg did not reduce coronary heart disease morbidity and mortality in 2 large, randomized controlled trials of patients with type 2 diabetes mellitus.

General Considerations for Treatment

Laboratory studies should be performed to establish that lipid levels are abnormal before instituting Fenogal 200mg therapy.

Every reasonable attempt should be made to control serum lipids with non-drug methods including appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that may be contributing to the lipid abnormalities. Medications known to exacerbate hypertriglyceridemia (beta-blockers, thiazides, estrogens) should be discontinued or changed if possible, and excessive alcohol intake should be addressed before triglyceride-lowering drug therapy is considered. If the decision is made to use lipid-altering drugs, the patient should be instructed that this does not reduce the importance of adhering to diet.

Drug therapy is not indicated for patients who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of VLDL.

Fenogal 200mg (Fenogal 200mg) helps reduce cholesterol and triglycerides (fatty acids) in the blood. High levels of these types of fat in the blood are associated with an increased risk of atherosclerosis (clogged arteries).

Fenogal 200mg is used to treat high cholesterol and high triglyceride levels.

Fenogal 200mg may also be used for purposes not listed in this medication guide.

General Considerations

Patients should be placed on an appropriate lipid-lowering diet before receiving Fenogal 200mg, and should continue this diet during treatment with Fenogal 200mg. Fenogal 200mg capsules can be given without regard to meals.

Patients should be advised to swallow Fenogal 200mg 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 Fenogal 200mg 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 Fenogal 200mg 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 Fenogal 200mg 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 Fenogal 200mg 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

• Fenogal 200mg®(Fenogal 200mg) capsules, 30 mg are size '4' capsules with opaque light green cap and opaque light green body, imprinted with LUPIN logo and “Fenogal 200mg” in black ink on body, and “30” in black ink on cap, containing white to off-white pellets.
• Fenogal 200mg®(Fenogal 200mg) capsules, 90 mg are size '3' capsules with opaque dark green cap and opaque white body, imprinted with LUPIN logo and “Fenogal 200mg” in black ink on body, and “90” in black ink on cap, containing white to off-white pellets.

Storage And Handling

Fenogal 200mg® (Fenogal 200mg) Capsules, 30 mg are size '4' capsules with opaque light green cap and opaque light green body, imprinted with LUPIN logo and “Fenogal 200mg” 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

Fenogal 200mg® (Fenogal 200mg) Capsules, 90 mg are size '3' capsules with opaque dark green cap and opaque white body, imprinted with LUPIN logo and “Fenogal 200mg” 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

See also:
What is the most important information I should know about Fenogal 200mg?

Hypersensitivity to Fenogal 200mg or to any of the excipients of Fenogal 200mg, Fenogal 200mg Supra 160 mg and Fenogal 200mg 67M.

Patients with hepatic insufficiency (including biliary cirrhosis, and unexplained persistent liver function abnormality) and renal insufficiency.

Known photoallergy or phototoxic reaction during treatment with fibrates or ketoprofen, chronic or acute pancreatitis with the exception of acute pancreatitis due to severe hypertriglyceridemia, gallbladder disease and severe chronic kidney disease.

Fenogal 200mg/Fenogal 200mg Supra 160 mg: It should not be taken by patients allergic to peanut or arachis oil or soya/soybean lecithin or related products due to the risk of hypersensitivity reactions.

Use in pregnancy: Fenogal 200mg/Fenogal 200mg 67M: There are no adequate data from the use of Fenogal 200mg in pregnant woman. Animal studies have not demonstrated and teratogenic effects. Embryotoxic effects have been shown at doses in the range of maternal toxicity. The potential risk for humans is unknown. Therefore, film-coated tablet should only be used during pregnancy after a careful benefit/risk assessment.

Fenogal 200mg Supra 160 mg is contraindicated during pregnancy, in the absence of data. If unexpected pregnancy occurs while taking Fenogal 200mg, treatment should be interrupted and consult a doctor.

Use in lactation: It is unknown whether Fenogal 200mg is excreted in human milk. A risk to the newborns/infants cannot be excluded. Fenogal 200mg Supra 160 mg is contraindicated during breastfeeding in the absence of data. Therefore, Fenogal 200mg should not be used during breastfeeding in nursing mother.

Use in children: Fenogal 200mg 67M: The safety and efficacy of Fenogal 200mg in children have not yet been established. Only limited pediatric data are available. Therefore, the use of Fenogal 200mg is not recommended in pediatric subjects <18 years.

Use Fenogal 200mg capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Some brands of Fenogal 200mg capsules should be taken with food. Some brands may be taken with or without food. Ask your pharmacist if you should take your brand of Fenogal 200mg capsules with food.
• Swallow Fenogal 200mg capsules whole. Do not open, crush, dissolve, or chew before swallowing. If you cannot swallow Fenogal 200mg capsules whole, tell your doctor. You may need a different medicine.
• Take Fenogal 200mg capsules with a full glass of water (8 oz [240 mL]).
• If you also take a bile acid-binding resin (eg, cholestyramine), do not take it within 4 to 6 hours before or 1 hour after taking Fenogal 200mg capsules. Check with your doctor if you have any questions.
• Take Fenogal 200mg capsules on a regular schedule to get the most benefit from it.
• Taking Fenogal 200mg capsules at the same time each day will help you remember to take it.
• Continue to take Fenogal 200mg capsules even if you feel well. Do not miss any doses.
• If you miss a dose of Fenogal 200mg capsules, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Fenogal 200mg capsules.

Use: Labeled Indications

Hypercholesterolemia or mixed dyslipidemia: Adjunctive therapy to diet for the reduction of low-density lipoprotein cholesterol (LDL-C), total cholesterol (total-C), triglycerides, and apolipoprotein B (apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in adults with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson types IIa and IIb). Use lipid-altering agents in addition to a diet restricted in saturated fat and cholesterol when response to diet and nonpharmacological interventions alone has been inadequate.

Note: While FDA-approved for hypercholesterolemia, Fenogal 200mg is not a first- or second-line choice; other agents may be more suitable (ACC/AHA [Stone 2013]). In addition, use is not recommended to lower LDL-C or raise HDL-C in the absence of hypertriglyceridemia.

Hypertriglyceridemia: Adjunctive therapy to diet for treatment of adult patients with severe hypertriglyceridemia (Fredrickson types IV and V hyperlipidemia).

Off Label Uses

Primary biliary cholangitis

Data from a single-center, retrospective cohort study support the use of Fenogal 200mg (in combination with ursodiol) in patients with primary biliary cholangitis (PBC) who have had an incomplete biochemical response to ursodiol monotherapy and showed significant improvement in alkaline phosphatase, a reduction in hepatic decompensation, and transplant-free survival improvement.

See also:
What other drugs will affect Fenogal 200mg?

Anticoagulants: Fenogal 200mg 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 Fenogal 200mg. 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 Fenogal 200mg 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 Fenogal 200mg 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 Fenogal 200mg 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 Fenogal 200mg, there is a risk that an interaction will lead to deterioration. The benefits and risks of using Fenogal 200mg 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 Fenogal 200mg and cyclosporine. The renal function of these patients must therefore be closely monitored and the treatment with Fenogal 200mg stopped in the case of severe alteration of laboratory parameters.

Cytochrome P450 (CYP450) Enzymes: In vitro studies using human liver microsomes indicate that Fenogal 200mg 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 Fenogal 200mg 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.

See also:
What are the possible side effects of Fenogal 200mg?

Clinical Trials Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

Fenofibric acid is the active metabolite of Fenogal 200mg. Adverse events reported by 2% or more of patients treated with Fenogal 200mg and greater than placebo during double-blind, placebocontrolled trials are listed in Table 1. Adverse events led to discontinuation of treatment in 5.0% of patients treated with Fenogal 200mg and in 3.0% treated with placebo. Increases in liver tests were the most frequent events, causing discontinuation of Fenogal 200mg treatment in 1.6% of patients in double-blind trials.

Table 1: Adverse Events Reported by 2% or More of Patients Treated with Fenogal 200mg and Greater than Placebo During the Double-Blind, Placebo-Controlled Trials

Clinical trials with Fenogal 200mg did not include a placebo-control arm. However, the adverse event profile of Fenogal 200mg was generally consistent with that of Fenogal 200mg. The following adverse events not listed above were reported in ≥ 3% of patients taking Fenogal 200mg alone:

Gastrointestinal Disorders: Diarrhea, dyspepsia

General Disorders and Administration Site Conditions: Pain

Infections and Infestations: Nasopharyngitis, sinusitis, upper respiratory tract infection

Musculoskeletal and Connective Tissue Disorders: Arthralgia, myalgia, pain in extremity

Nervous System Disorders: Dizzinesss

Postmarketing Experience

The following adverse events have been identified during postapproval use of Fenogal 200mg: rhabdomyolysis, pancreatitis, renal failure, muscle spasms, acute renal failure, hepatitis, cirrhosis, anemia, asthenia, and severely depressed HDL-cholesterol levels.

Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Each film-coated tablet contains Fenofibrate BP 160 mg. It also contains the following excipients: Pregelatinized starch maize, povidone, sodium lauryl sulphate, microcrystalline cellulose, crospovidone, anhydrous colloidal silica, sodium stearyl fumarate, purified water and opadry AMB OY-B-28920.

Fenogal 200mg is a lipid-regulating agent. The empirical formula is C₂₀H₂₁O₄Cl and the molecular weight is 360.83. Fenogal 200mg is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester.