ANTARA 130mg(fenofibrate) capsules & 43mg OSCIENT Pharmaceuticals

Dosing

ANTARA® (fenofibrate capsules) 130 mg—powerful efficacy in a 130 mg capsule.

Patients should be placed on an appropriate lipid-lowering diet before receiving ANTARA 130 mg, and should continue this diet during treatment with ANTARA 130 mg. ANTARA 130 mg capsules can be taken without regard to meals.
For the treatment of adult patients with primary hypercholesterolemia or mixed hyperlipidemia, the initial dose of ANTARA is 130 mg per day.
For adult patients with hypertriglyceridemia, the initial dose is either 43 or 130 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 130 mg
per day.
Treatment with ANTARA should be initiated at a dose of 43 mg per day in patients having impaired renal function, and increased only after evaluation of the effects on renal function and lipid levels at this dose. In the elderly, the initial dose should likewise be limited to 43 mg per day.
Lipid levels should be monitored periodically and consideration be given to reducing the dosage of ANTARA 130 mg if lipid levels fall significantly below the targeted range.

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Important Safety Information

ANTARA® (fenofibrate) capsules is contraindicated in patients with hypersensitivity to fenofibrate, in patients with hepatic or severe renal dysfunction including primary biliary cirrhosis, in patients with unexplained persistent liver function abnormality, and in patients with preexisting gallbladder disease.
Fenofibrate has been associated with increases in serum transaminases. Regular periodic monitoring of liver function should be performed, for duration of therapy, and therapy discontinued if enzyme levels persist above 3 times the normal limit.
There are no adequate and well-controlled studies in pregnant women. Fenofibrate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually reduce fasting triglycerides and eliminate chylomicronemia thereby obviating the need for pharmacologic intervention. Markedly elevated levels of serum triglycerides (eg, >2000 mg/dL) may increase the risk of developing pancreatitis. ANTARA therapy on reducing this risk has not been studied.
Fenofibrate may increase cholesterol excretion into the bile, leading to cholelithiasis. If cholelithiasis is suspected, ANTARA therapy should be discontinued.
The combined use of ANTARA and HMG-CoA reductase inhibitors should be avoided unless the benefit of further alterations in lipid levels is likely to outweigh the increased risk. The combined use of fibric acid derivatives and HMG-CoA reductase inhibitors has been associated with rhabdomyolysis, markedly elevated creatine kinase levels, and myoglobinuria, leading to acute renal failure.
The use of fibrates alone including ANTARA, may occasionally be associated with myositis, myopathy, or rhabdomyolysis. Patients complaining of muscle pain, tenderness, or weakness should have prompt medical evaluation for myopathy. Discontinue ANTARA if myopathy or myositis is suspected or diagnosed.
The effect of ANTARA on coronary heart disease morbidity and mortality and noncardiovascular mortality has not been established.
Patients treated with other fibrate drugs experienced an increase in noncardiovascular and cardiovascular morbidity and mortality compared with placebo-treated patients.
Other precautions include pancreatitis, hypersensitivity reactions, and hematologic changes. Refer to full Prescribing Information for a complete list of precautions.
Caution should be exercised when coumarin anticoagulants are given in conjunction with ANTARA. The dosage of the anticoagulants should be reduced to maintain the prothrombin time/INR at the desired level to prevent bleeding complications. Frequent prothrombin time/INR determinations are advisable until it has been definitely determined that the prothrombin time/INR has stabilized.
Since bile acid sequestrants may bind other drugs given concurrently, patients should take ANTARA at least 1 hour before or 4–6 hours after a bile acid binding resin to avoid impeding its absorption.
Cyclosporine can produce nephrotoxicity with decreases in creatinine clearance and rises in serum creatinine. Because renal excretion is the primary elimination route of fibrate drugs including ANTARA, there is a risk that an interaction will lead to deterioration. The benefits and risks of using ANTARA with immunosuppressants and other potentially nephrotoxic agents should be carefully considered, and lowest effective dose employed.
Fenofibric acid is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection.
The most common (≥2% reported in clinical trials) side effects are: abnormal liver function test, including increased AST; increased ALT; CPK increase; respiratory disorder; abdominal pain; back pain; headache; diarrhea; nausea; rhinitis; asthenia; flu syndrome and constipation.

Please see full Prescribing Information.

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