GEMFIBROZIL tablet

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

GEMFIBROZIL (UNII: Q8X02027X3) (GEMFIBROZIL - UNII:Q8X02027X3)

Dostupné s:

Viona Pharmaceuticals Inc

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Gemfibrozil tablets, USP are indicated as adjunctive therapy to diet for: - Treatment of adult patients with very high elevations of serum triglyceride levels (Types IV and V hyperlipidemia) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. Patients who present such risk typically have serum triglycerides over 2000 mg/dL and have elevations of VLDL-cholesterol as well as fasting chylomicrons (Type V hyperlipidemia). Subjects who consistently have total serum or plasma triglycerides below 1000 mg/dL are unlikely to present a risk of pancreatitis. Gemfibrozil tablets therapy may be considered for those subjects with triglyceride elevations between 1000 and 2000 mg/dL who have a history of pancreatitis or of recurrent abdominal pain typical of pancreatitis. It is recognized that some Type IV patients with triglycerides under 1000 mg/dL may, through dietary or alcoholic indiscretion, convert to a Type V pattern with massive triglyceride elevations accompanying fasting chylomicronemia, but the influence of gemfibrozil tablets therapy on the risk of pancreatitis in such situations has not been adequately studied. Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (VLDL). Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV, and V hyperlipoproteinemia. - Reducing the risk of developing coronary heart disease only in Type IIb patients without history of or symptoms of existing coronary heart disease who have had an inadequate response to weight loss, dietary therapy, exercise, and other pharmacologic agents (such as bile acid sequestrants and nicotinic acid, known to reduce LDL- and raise HDL-cholesterol) and who have the following triad of lipid abnormalities: low HDL-cholesterol levels in addition to elevated LDL-cholesterol and elevated triglycerides (see WARNINGS, PRECAUTIONS, and CLINICAL PHARMACOLOGY). The National Cholesterol Education Program has defined a serum HDL-cholesterol value that is consistently below 35 mg/dL as constituting an independent risk factor for coronary heart disease. Patients with significantly elevated triglycerides should be closely observed when treated with gemfibrozil. In some patients with high triglyceride levels, treatment with gemfibrozil is associated with a significant increase in LDL-cholesterol. BECAUSE OF POTENTIAL TOXICITY SUCH AS MALIGNANCY, GALLBLADDER DISEASE, ABDOMINAL PAIN LEADING TO APPENDECTOMY AND OTHER ABDOMINAL SURGERIES, AN INCREASED INCIDENCE IN NON-CORONARY MORTALITY, AND THE 44% RELATIVE INCREASE DURING THE TRIAL PERIOD IN AGE-ADJUSTED ALL-CAUSE MORTALITY SEEN WITH THE CHEMICALLY AND PHARMACOLOGICALLY RELATED DRUG, CLOFIBRATE, THE POTENTIAL BENEFIT OF GEMFIBROZIL IN TREATING TYPE IIA PATIENTS WITH ELEVATIONS OF LDL-CHOLESTEROL ONLY IS NOT LIKELY TO OUTWEIGH THE RISKS. GEMFIBROZIL TABLETS ARE ALSO NOT INDICATED FOR THE TREATMENT OF PATIENTS WITH LOW HDL-CHOLESTEROL AS THEIR ONLY LIPID ABNORMALITY. In a subgroup analysis of patients in the Helsinki Heart Study with above-median HDL-cholesterol values at baseline (greater than 46.4 mg/dL), the incidence of serious coronary events was similar for gemfibrozil and placebo subgroups (see Table I). The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcohol intake may be important factors in hypertriglyceridemia and should be managed prior to any drug therapy. Physical exercise can be an important ancillary measure, and has been associated with rises in HDL-cholesterol. Diseases contributory to hyperlipidemia such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy is sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of estrogen therapy may obviate the need for specific drug therapy of hypertriglyceridemia. The use of drugs should be considered only when reasonable attempts have been made to obtain satisfactory results with nondrug methods. If the decision is made to use drugs, the patient should be instructed that this does not reduce the importance of adhering to diet. - Hepatic or severe renal dysfunction, including primary biliary cirrhosis. - Preexisting gallbladder disease (see WARNINGS ). - Hypersensitivity to gemfibrozil. - Combination therapy of gemfibrozil with simvastatin (see WARNINGS  and PRECAUTIONS ). - Combination therapy of gemfibrozil with repaglinide (see PRECAUTIONS ). - Combination therapy of gemfibrozil with dasabuvir (see PRECAUTIONS ). - Combination therapy of gemfibrozil with selexipag (see PRECAUTIONS ).

Přehled produktů:

Gemfibrozil Tablets USP, 600 mg are white to off white colored, oval shaped, film coated tablets, debossed with "553" on one side and separating "5" & "53" with break line and plain on other side and are supplied as follows: NDC 72578-066-06 in bottles of 30 tablets NDC 72578-066-14 in bottles of 60 tablets NDC 72578-066-16 in bottles of 90 tablets NDC 72578-066-01 in bottles of 100 tablets NDC 72578-066-05 in bottles of 500 tablets NDC 72578-066-10 in bottles of 1,000 tablets NDC 72578-066-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light and humidity. Dispense in a tight, light-resistant container (USP). Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.   Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India Distributed by: Viona Pharmaceuticals Inc. Cranford, NJ 07016 Rev.: 01/23

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

GEMFIBROZIL- GEMFIBROZIL TABLET
VIONA PHARMACEUTICALS INC
----------
GEMFIBROZIL TABLETS, USP
RX ONLY
DESCRIPTION
Gemfibrozil tablets, USP is a lipid regulating agent. It is available
as tablets for oral
administration. The chemical name is
5-(2,5-dimethylphenoxy)2,2-dimethylpentanoic
acid, with the following structural formula:
The molecular formula is C
H
O and the molecular weight is 250.33. It is soluble in
alcohol, methanol and chloroform. The melting point is 58° to 61°C.
Gemfibrozil is a
white, waxy, crystalline solid which is stable under ordinary
conditions.
Each gemfibrozil tablet intended for oral administration contains 600
mg of gemfibrozil.
In addition, each tablet contains the following inactive ingredients:
colloidal silicon dioxide,
croscarmellose sodium, magnesium stearate, methyl cellulose and
microcrystalline
cellulose. Additionally each tablet contains opadry II white 33F28398
which contains
hypromellose, lactose monohydrate, polyethylene glycol, talc and
titanium dioxide.
CLINICAL PHARMACOLOGY
Gemfibrozil is a lipid regulating agent which decreases serum
triglycerides and very low
density lipoprotein (VLDL) cholesterol, and increases high density
lipoprotein (HDL)
cholesterol. While modest decreases in total and low density
lipoprotein (LDL)
cholesterol may be observed with gemfibrozil therapy, treatment of
patients with
elevated triglycerides due to Type IV hyperlipoproteinemia often
results in a rise in LDL-
cholesterol. LDL-cholesterol levels in Type IIb patients with
elevations of both serum
LDL-cholesterol and triglycerides are, in general, minimally affected
by gemfibrozil
treatment; however, gemfibrozil usually raises HDL-cholesterol
significantly in this group.
Gemfibrozil increases levels of high density lipoprotein (HDL)
subfractions HDL and
HDL , as well as apolipoproteins AI and AII. Epidemiological studies
have shown that
both low HDL-cholesterol and high LDL-cholesterol are independent risk
factors for
coronary heart disease.
In the primary prevention component of the Helsink