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holiday time Lipofen

Hematologic Changes

Mild to moderate decreases in hemoglobin, hematocrit, and white blood cell decreases have been observed in patients following initiation of fenofibrate therapy. However, these levels stabilize during long term administration. Thrombocytopenia and agranulocytosis have been reported in individuals treated with fenofibrate. Periodic monitoring of red and white blood cell counts is recommended during the first 12 months of LIPOFEN administration.

Severe cutaneous adverse drug reactions (SCAR), including Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis, and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) have been reported post-marketing, occurring days to weeks after initiation of fenofibrate. The cases of DRESS were associated with cutaneous reactions (such as rash or exfoliative dermatitis) and Lipofen combination of eosinophilia, fever, systemic organ involvement (renal, hepatic, or respiratory). Discontinue fenofibrate and treat patients appropriately if SCAR is Lipofen Interactions

In vitro studies using human liver microsomes indicate that fenofibrate and fenofibric acid are not inhibitors of cytochrome P450 (CYP) isoforms CYP3A4, CYP2D6, CYP2E1, or CYP1A2. cheap Lipofen They Lipofen weak inhibitors of CYP2C8, CYP2C19 and CYP2A6, and mild to moderate inhibitors of CYP2C9 at therapeutic concentrations.

Table 2 describes the effects of co-administered drugs on fenofibric acid systemic exposure. Table 3 describes the effects of fenofibrate on co-administered drugs.

Table 2. Effects of Co-Administered Drugs on Fenofibric Acid Systemic Exposure from Fenofibrate Administration

Table 3. Effects of Fenofibrate on Systemic Exposure of Co-Administered Drugs

Fenofibrate is used along with a Lipofen diet to Lipofen lower "bad" cholesterol and fats (such as LDL, triglycerides) and raise "good" cholesterol (HDL) in the blood. Lipofen works by increasing the natural substance (enzyme) that breaks down fats in the blood. Fenofibrate belongs to a group of drugs known as "fibrates." Lipofen triglycerides in people with very high triglyceride blood levels may decrease the risk of pancreas disease (pancreatitis). However, fenofibrate might not lower your risk of a heart attack or stroke. Talk to your doctor about the risks and benefits of fenofibrate.

In addition to eating a proper diet (such as a low-cholesterol/low-fat diet), other lifestyle changes that may help this medication work better include exercising, losing weight if overweight, and stopping smoking. Consult your doctor for more details.

DESCRIPTION

LIPOFEN (fenofibrate capsules, USP), is a lipid regulating agent available as hard gelatin capsules for oral administration. Each hard gelatin capsule contains 50 or 150 mg of fenofibrate, USP. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1methylethyl ester with the following structural formula:

The empirical formula is C20H21O4C1 and the molecular weight is 360.83; fenofibrate is insoluble in water. The melting point is 79-82°C. Fenofibrate is Lipofen white solid which is stable under Lipofen conditions.

  • patients with severe renal impairment, including those receiving dialysis [see CLINICAL PHARMACOLOGY].
  • patients with active liver disease, including those with primary biliary cirrhosis and unexplained persistent liver function abnormalities [see WARNINGS AND PRECAUTIONS].
  • patients with preexisting gallbladder disease [see WARNINGS AND PRECAUTIONS].
  • patients with known hypersensitivity to fenofibrate or fenofibric acid [see WARNINGS AND PRECAUTIONS].
  • nursing mothers [see Use In Specific Populations].

Serum Creatinine

Elevations in serum creatinine have been reported in patients on fenofibrate. These elevations tend to return to baseline following discontinuation of Lipofen. The clinical significance of these observations is unknown. Monitor renal function in patients with renal impairment taking LIPOFEN. Renal monitoring should also be considered for patients taking LIPOFEN and are at Lipofen for renal insufficiency, such as the elderly and patients with diabetes.

Contraindications:

Severe renal impairment (including dialysis). Active liver disease. Unexplained persistent liver function abnormalities. Primary biliary cirrhosis. Gallbladder disease. Nursing mothers (during and for 5 days after last dose).

Side Effects

Remember that your doctor has prescribed this medication because he or she has Lipofen that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may rarely cause gallstones and liver problems. If you notice any of the following unlikely but serious side effects, tell your doctor right away: persistent nausea/vomiting, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine.

This drug may rarely cause muscle problems (which can rarely lead to a very serious condition called rhabdomyolysis). Tell your doctor right away if you develop any of these symptoms: muscle pain/tenderness/weakness (especially with fever or unusual tiredness), signs of kidney problems (such as change in the amount of urine).

Rarely, this medication has caused severe lowering of Lipofen ("good" cholesterol) levels. This is the opposite of what should happen to your HDL levels (paradoxical reaction). Your HDL cholesterol levels should be checked regularly. Keep all of your laboratory appointments.

Tell your doctor right away if you have any serious side effects, including: easy bleeding/bruising, unusual tiredness.

Get medical help right away if you have any Lipofen serious side effects, including: Lipofen pain, sudden pain/redness/swelling usually in the leg, signs of infection (such as sore throat that doesn't go away, fever, swollen lymph nodes, chills, cough).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of Lipofen face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Call your doctor for medical advice about side Lipofen. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Pancreatitis

Pancreatitis has been reported in patients taking fenofibrate, gemfibrozil, and clofibrate. This occurrence may represent a failure of efficacy Lipofen patients with severe hypertriglyceridemia, a direct drug effect, or a secondary phenomenon mediated through biliary tract stone or sludge formation with obstruction of the common bile duct.

In fertility studies rats were given oral dietary doses of fenofibrate, males received 61 days prior to mating and females 15 days prior to mating through weaning which resulted in no adverse effect on fertility at Lipofen up to 300 mg/kg/day (approximately 10 times the MRHD, based on mg/m 2 surface area comparisons) [see Carcinogenesis, Mutagenesis, Impairment Of Fertility].

Interactions:

Avoid statins. Potentiates oral anticoagulants (reduce anticoagulant dose and monitor PT/INR). Allow at least 1hr before or 4–6hrs after bile acid Lipofen. Caution with immunosuppressants (eg, cyclosporine, tacrolimus), colchicine, other nephrotoxic drugs.

Important Limitations Of Use

Fenofibrate at a dose equivalent to 150 mg of LIPOFEN was not shown to reduce coronary heart disease morbidity and mortality in 2 large, randomized controlled trials of patients with type 2 diabetes mellitus [see WARNINGS AND PRECAUTIONS].

Clinical Trials Experience

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

Adverse reactions reported by 2% or more of patients treated with fenofibrate (and greater than placebo) during the double-blind, placebo-controlled trials, regardless of causality, are listed in Table 1 Lipofen. Adverse events led to Lipofen of treatment in 5.0% of patients treated with fenofibrate and in 3.0% treated with placebo. Increases in liver function tests were the most frequent events, causing discontinuation of fenofibrate treatment in 1.6% of patients in double-blind trials.

Table 1. Adverse Reactions Reported by 2% or More of Patients Treated with Lipofen and Greater than Placebo During the Double-Blind, Placebo-Controlled Trials

Urticaria was seen in 1.1 vs. 0% and rash in 1.4 vs. 0.8% of fenofibrate and placebo patients respectively in controlled trials.

Food and Drug Administration, Center for Drug Evaluation and Research. Electronic orange book: Lipofen drug products with therapeutic equivalence evaluations. FDA Web site. Available at: http://www.fda.gov/cder/ob/. Accessed March 27, 2009.

Briggs GG, Freeman RK, Yaffe SJ. Drugs in Pregnancy and Lactation. 8th ed. Philadelphia (PA): Lippincott Williams & Wilkins; 2008.


by sarah4lynn | 2019-12-17 07:39

Sarah Lynn Portland


by sarah4lynn