Australia - English - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - gemfibrozil, quantity: 600 mg - tablet, film coated - excipient ingredients: crospovidone; polysorbate 80; magnesium stearate; colloidal anhydrous silica; microcrystalline cellulose; hyprolose; pregelatinised maize starch; titanium dioxide; lactose monohydrate; hypromellose; macrogol 4000 - lipigem is indicated as an adjunct to diet and other therapeutic measures for: *severe hypertriglyceridaemia (type iv and v) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. *dyslipidaemia associated with diabetes. *reduction of risk of coronary heart disease in patients with type iia and iib hypercholesterolaemia. because of potential toxicity such as malignancy, gallbladder disease, abdominal pain leading to appendectomy and other abdominal surgeries, an increased incidence in noncoronary mortality, and the 29% increase in all-cause mortality seen with the chemically and pharmacologically related drug, clofibrate, the potential benefits of gemfibrozil in treating type iia patients with elevations of ldl-cholesterol only are not likely to outweigh the risks. in a subgroup analysis of patients in the helsinki heart study with above-median hdl-cholesterol values at baseline (greater than 1.2mmol/l), the incidence of serious coronary events was similar for gemfibrozil and placebo subgroups. note: lipigem is indicated when exercise, weight loss and specific dietary or other nondrug measures such as limiting alcohol intake have failed. other medical disorders such as hypothyroidism and diabetes should be controlled as much as possible. periodic determination of serum lipids should be obtained during treatment with lipigem. the drug should be withdrawn or additional therapy instituted if the lipid response is deemed inadequate after three months.

Australia - English - Department of Health (Therapeutic Goods Administration)

medis pharma pty ltd - gemfibrozil, quantity: 600 mg - tablet, film coated - excipient ingredients: hyprolose; colloidal anhydrous silica; pregelatinised maize starch; calcium stearate; microcrystalline cellulose; polysorbate 80; titanium dioxide; hypromellose; indigo carmine; macrogol 4000 - gemfibrozil is indicated as an adjunct to diet and other therapeutic measures for the following: * severe hypertriglyceridaemia (types iv and v) in persons who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. * dyslipidaemia associated with diabetes. * reduction of risk of coronary heart disease in patients with type iia and iib hypercholesterolaemia. * because of potential toxicity such as malignancy, gall bladder disease, abdominal pain leading to appendicectomy and other abdominal surgeries, an increased incidence in noncoronary mortality, and the 29% increase in all-cause mortality seen with the chemically and pharmacologically related drug clofibrate, the potential benefits of gemfibrozil in treating type iia patients with elevations of ldl choleserol only is not likely to outweigh the risks. in a subgroup analysis of patients in the helsinki heart study with above median hdl cholesterol values at baseline (greater than 1.2mmol/l), the incidence of serious coronary events was similar for gemfibrozil and placebo subgroups. note: gemfibrozil is indicated when exercise, weight loss and specific dietary or other non-drug measures such as limiting alcohol intake have failed. other medical disorders such as hypothyroidism and diabetes should be controlled as much as possible. periodic determinations of serum lipids should be obtained during treatment with gemfibrozil. the drug should be withdrawn or additionals therapy instituted if the lipid response is deemed inadequate after three months.

Australia - English - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - clofibrate, quantity: 500 mg - capsule, soft - excipient ingredients: glycerol; sorbitol; sodium propyl hydroxybenzoate; gelatin; sodium ethyl hydroxybenzoate - this product accepted for registration as 'currently supplied' at the time of commencement of the act. updated pregnancy risk category was approved as specified in the letter of 1 july 1992 from dr b. varma. indicated treatment: 1. primary dysbetalipoprotinaemia (type iii hyperlipidaemia) that does not respond adequately to diet; and 2. adult patients with very high serum triglyceride levels (types iv and v hyperlipidaemia) who present a risk of abdominal pain and who do not respond adequately to a determined dietary effort to control them. patients with triglycerides in excess of 750mg per decilitre are likely to present such a risk. indications as at 15 june 1994: col is indicated for primary dysbetalipoproteinaemia (type iii hyperlipidaemia) that does not respond adequately to diet. col may also be considered for the treatment of adult patients with very high serum triglyceride levels (types iv and v hyperlipidaemia) who present a risk of abdominal pain and pancreatitis and who do not respond adequately t

United States - English - NLM (National Library of Medicine)

epic pharma, llc - gemfibrozil (unii: q8x02027x3) (gemfibrozil - unii:q8x02027x3) - gemfibrozil 600 mg - gemfibrozil tablets, usp are indicated as adjunctive therapy to diet for: 1. 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 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 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. 2. 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 is 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 repaglinide (see precautions ). - combination therapy of gemfibrozil with simvastatin (see warnings and precautions ). - combination therapy of gemfibrozil with dasabuvir (see precautions ). - combination therapy of gemfibrozil with selexipag (see precautions ).

United States - English - NLM (National Library of Medicine)

puracap laboratories llc dba blu pharmaceuticals - gemfibrozil (unii: q8x02027x3) (gemfibrozil - unii:q8x02027x3) - gemfibrozil 600 mg - gemfibrozil tablets, usp are indicated as adjunctive therapy to diet for: 1. 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 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 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. 2. 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 is 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. 1. hepatic or severe renal dysfunction, including primary biliary cirrhosis. 2. preexisting gallbladder disease (see warnings). 3. hypersensitivity to gemfibrozil. 4. combination therapy of gemfibrozil with simvastatin (see warnings and precautions). 5. combination therapy of gemfibrozil with repaglinide (see precautions). 6. combination therapy of gemfibrozil with dasabuvir (see precautions). 7. combination therapy of gemfibrozil with selexipag (see precautions).

United States - English - NLM (National Library of Medicine)

zydus lifesciences limited - gemfibrozil (unii: q8x02027x3) (gemfibrozil - unii:q8x02027x3) - 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 ).

United States - English - NLM (National Library of Medicine)

viona pharmaceuticals inc - gemfibrozil (unii: q8x02027x3) (gemfibrozil - unii:q8x02027x3) - 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 ).

United States - English - NLM (National Library of Medicine)

american health packaging - gemfibrozil (unii: q8x02027x3) (gemfibrozil - unii:q8x02027x3) - gemfibrozil 600 mg - 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 2,000 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 1,000 mg/dl are unlikely to present a risk of pancreatitis. gemfibrozil therapy may be considered for those subjects with triglyceride elevations between 1,000 and 2,000 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 1,000 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 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 is 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 ).

United States - English - NLM (National Library of Medicine)

remedyrepack inc. - gemfibrozil (unii: q8x02027x3) (gemfibrozil - unii:q8x02027x3) - gemfibrozil tablets are indicated as adjunctive therapy to diet for: 1. 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 2,000 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 1,000 mg/dl are unlikely to present a risk of pancreatitis. gemfibrozil therapy may be considered for those subjects with triglyceride elevations between 1,000 and 2,000 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 1,000 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 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. 2. 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 is 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 ).

Australia - English - Department of Health (Therapeutic Goods Administration)

apotex pty ltd - gemfibrozil -