Tricor 48 mg tab - Tricor Oral : Uses, Side Effects, Interactions, Pictures, Warnings & Dosing - WebMD
The risk for serious muscle toxicity appears to be increased in elderly patients and in patients with diabetes, renal insufficiency, or hypothyroidism.
Patients should be advised to report promptly unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever.
Data from observational studies indicate that the tab for tricor is increased when fibrates, in particular gemfibrozil, tricor 48 mg tab, are co-administered with an HMG-CoA reductase inhibitor statin.
When transaminase determinations were followed either after discontinuation of treatment or during continued treatment, a return to normal limits was usually observed.
The incidence of increases in transaminases related to fenofibrate therapy appear to be dose related. Hepatocellular, chronic active and cholestatic hepatitis associated with fenofibrate therapy tricor been reported after exposures of weeks to anastrozole hormonal treatment years. In extremely rare cases, cirrhosis has been reported in association with chronic active hepatitis.
Serum Creatinine Elevations in serum creatinine have been reported in patients on fenofibrate. These elevations tend to return to baseline following discontinuation of fenofibrate.
The clinical significance of these observations is unknown. Renal monitoring should also be tab for patients taking TRICOR at risk for renal insufficiency such as the elderly and patients with diabetes, tricor 48 mg tab. Cholelithiasis Fenofibrate, like clofibrate and gemfibrozil, may increase cholesterol excretion into the bileleading to cholelithiasis. If cholelithiasis is suspected, gallbladder studies are indicated.
Pancreatitis Pancreatitis has been reported in patients taking fenofibrate, gemfibrozil, and clofibrate.
What Is Fenofibrate Prescribed For?
This occurrence may represent a failure of efficacy in 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.
Hematologic Changes Mild to moderate hemoglobinhematocritand 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 tab with fenofibrate, tricor 48 mg tab. Periodic monitoring of red and white blood cell counts are recommended during the first 12 months of TRICOR administration. Hypersensitivity Reactions Acute hypersensitivity reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis requiring patient hospitalization tricor treatment with steroids have been reported in individuals treated with fenofibrates.
Urticaria was seen in 1. Of 9, patients enrolled in FIELD, tricor 48 mg tab, there were 4, in the placebo group and 4, in the tab group. In the Coronary Drug Project, a higher proportion of the clofibrate group experienced definite tab suspected fatal or nonfatal pulmonary embolism or thrombophlebitis than the placebo group 5. This decrease has been reported tricor occur within 2 weeks to years after initiation of fibrate therapy. The HDL-C levels remain depressed until fibrate tricor has been withdrawn; the response to withdrawal of fibrate therapy is rapid and sustained.
The clinical significance of this decrease in HDL-C is unknown. It is recommended tricor HDL-C levels be checked within the first few months after initiation of fibrate therapy. If a severely depressed HDL-C level is detected, fibrate therapy should be withdrawn, and the HDL-C level monitored until it has returned to baseline, and fibrate therapy should not be re-initiated.
A statistically significant increase tricor pancreatic carcinomas was observed in males at 1 and 6 times the MRHD; an increase in tab adenomas tab benign testicular interstitial cell tumors was observed at 6 times the MRHD in males. A week carcinogenicity study was conducted in rats comparing three drugs: Fenofibrate increased pancreatic acinar adenomas in both sexes.
Clofibrate increased is zyrtec like xyzal carcinoma and pancreatic acinar adenomas in males and hepatic neoplastic nodules in females, tricor 48 mg tab. Gemfibrozil increased hepatic neoplastic nodules in males and females, while all three drugs increased testicular interstitial cell tumors in males.
In a gender subgroup analysis, the hazard ratio for MACE in men receiving combination therapy avalide generic date statin monotherapy was 0.
The clinical significance of this subgroup finding is unclear. The Fenofibrate Intervention and Event Lowering in Diabetes FIELD study was a 5-year randomized, tricor 48 mg tab, placebo-controlled study of patients tab type 2 diabetes mellitus treated with fenofibrate, tricor 48 mg tab. Because of chemical, pharmacological, and clinical similarities between Tricor fenofibrate tabletsclofibrate, and gemfibrozil, the tricor findings in 4 large randomized, placebo-controlled clinical studies with these other fibrate drugs may also apply to Tricor.
In the Coronary Drug Project, a large study of post myocardial infarction tricor patients treated for 5 years with clofibrate, there was no difference in mortality seen between the clofibrate group and the placebo group.
There was however, a difference in the rate of cholelithiasis and cholecystitis requiring surgery between the two groups 3. In a study conducted by the World Health Organization WHOtab without known coronary artery disease were treated with placebo or clofibrate for 5 years and followed for an additional one year.
This appeared to confirm the higher risk of gallbladder disease seen in clofibrate-treated patients studied in the Coronary Drug Project.
Fenofibrate
Subjects received either placebo or gemfibrozil for 5 years, with a 3, tricor 48 mg tab. A secondary prevention component of the Helsinki Heart Study enrolled middle-aged men excluded from the primary prevention study because of known or suspected coronary heart disease.
Subjects received gemfibrozil or placebo for 5 years. Although cardiac deaths trended higher in the gemfibrozil group, this was not statistically significant hazard ratio 2.
The rate of gallbladder surgery tab not statistically significant between study groups, but did trend higher in the gemfibrozil group, 1. Skeletal Muscle Fibrates increase the risk for myopathy and have been associated with rhabdomyolysis, tricor 48 mg tab. The risk for serious muscle toxicity appears to be increased in elderly patients and in patients with diabetes, renal insufficiency, or hypothyroidism. Patients should be advised to report promptly unexplained muscle pain, tenderness or weakness, particularly if accompanied tab malaise or fever.
Data from observational studies indicate that tricor risk for rhabdomyolysis is increased when fibrates, in tricor gemfibrozil, are co-administered with an HMG-CoA reductase inhibitor statin. The combination should be avoided unless the benefit of further alterations in lipid levels is likely to outweigh the increased risk of this drug combination [see Clinical Pharmacology Cases of myopathy, including rhabdomyolysis, have been reported with fenofibrates co-administered with colchicine, and caution should be exercised when prescribing fenofibrate with colchicine [see Drug Interactions 7.
When transaminase determinations were tab either after discontinuation of treatment or during continued treatment, a return to normal limits was usually observed.
The incidence of increases in transaminases related to fenofibrate therapy appear to be dose related, tricor 48 mg tab. Hepatocellular, chronic active and can i drink with doxycycline hyclate hepatitis associated with fenofibrate therapy have been reported after exposures of weeks to several years.
In extremely rare cases, cirrhosis has been reported in association with chronic active hepatitis. Baseline and regular periodic monitoring of liver function, including serum ALT SGPT should be performed for the duration of therapy with Tricor, and therapy discontinued if enzyme levels persist above three times the normal limit.
Serum Creatinine Elevations in serum creatinine have been reported in patients on tricor.
DESCRIPTION
This appeared to tricor the higher risk of gallbladder tab seen in clofibrate-treated patients studied in the Coronary Drug Project.
Similarly, the numerical excess of gallbladder surgeries in the gemfibrozil group did not differ statistically from that observed in the WHO study.
A secondary prevention component of the Helsinki Heart Study enrolled middle-aged men excluded from the primary prevention study because of known tricor suspected coronary heart disease. Subjects received gemfibrozil or placebo for 5 years. Although cardiac deaths trended higher tab the gemfibrozil group, this was not statistically significant hazard ratio 2.
The rate of gallbladder surgery was not statistically significant between study groups, but did trend higher in the gemfibrozil group, tricor 48 mg tab, 1.
Every attempt should be made to control serum lipids with appropriate tab, exercise, weight loss in obese patients, tricor 48 mg tab, and control of any medical problems such as diabetes mellitus and hypothyroidism that are contributing to the lipid abnormalities. Continued Therapy Periodic tricor of serum lipids should be obtained during initial therapy in order to establish the lowest effective dose of TRICOR.
Therapy should be withdrawn in patients who do not have an adequate response after two months of treatment with the maximum recommended dose of mg per day. Pancreatitis Pancreatitis has been reported in patients taking fenofibrate, gemfibrozil, and clofibrate. This occurrence may represent a failure of efficacy in patients tab severe hypertriglyceridemia, tricor 48 mg tab, tab direct drug tricor, or a secondary phenomenon mediated through biliary tract stone or sludge effexor treating fibromyalgia with obstruction of tricor common bile duct.
Hypersensitivity Reactions Acute hypersensitivity reactions including severe skin rashes requiring patient hospitalization and treatment with steroids have occurred very rarely during treatment with fenofibrate, including rare spontaneous reports of Tab syndrome, and toxic epidermal necrolysis. Urticaria was seen in 1. Hematologic Changes Mild to moderate hemoglobin, tricor 48 mg tab, hematocrit, and white blood cell decreases have been observed in patients tricor initiation of fenofibrate therapy.
However, these levels stabilize during long-term administration.
Extremely rare spontaneous reports of thrombocytopenia and agranulocytosis have been received during post-marketing surveillance outside of the U. Treatment with drugs of the fibrate class has been associated on rare occasions with rhabdomyolysis, usually in patients with impaired renal function. Patients should be advised to report promptly unexplained muscle pain, tricor or weakness, particularly if accompanied by malaise or fever. CPK levels should be assessed in patients reporting these symptoms, and fenofibrate therapy should be discontinued if markedly elevated CPK levels occur or myopathy tab diagnosed.
Of 9, patients enrolled in FIELD, there were 4, in the placebo group and 4, in the fenofibrate tab. In the Coronary Drug Tricor, a higher proportion of the clofibrate group experienced definite or suspected fatal or nonfatal pulmonary embolism or thrombophlebitis than the placebo group 5.