Dosing & Uses
Dosage Forms & Strengths
tablet
- 600mg
Hypertriglyceridemia, Hypercholesterolemia
600 mg PO q12hr
Administration: 30 min before morning and evening meals
Dosage Modifications
Renal impairment
- Mild to moderate: Use caution, if baseline serum creatine in patient is >2mg/dL; deterioration of renal function reported in such patients
- Severe: Contraindicated
Hepatic impairment
- Contraindicated
Dosing Considerations
Monitor: Serum lipoproteins
If after 3 months lipid response is indadequate, discontinue therapy
May be beneficial for prophylaxis of cardiovascular events in at-risk patients, even if patients have normal levels of cholesterol.
Overdose management
- Adverse drug reactions from overdose may include peripheral neuropathy, diarrhea, increased K+, myopathy, rhabdomyolysis, acute renal failure, elevated LFT's, eye lens opacities
- Treatment is supportive
Neuronal Ceroid Lipofuscinoses (Orphan)
Orphan designation for treatment of neuronal ceroid lipofuscinoses
Sponsor
- Polaryx Therapeutics, Inc; 140 East Ridgewood Avenue, Suite 415, South Tower; Paramus, New Jersey 07652
Safety and efficacy not established
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (12)
- atorvastatin
gemfibrozil increases toxicity of atorvastatin by Other (see comment). Contraindicated. Comment: OATP1B1 inhibitors may increase risk of myopathy.
- elagolix
gemfibrozil will increase the level or effect of elagolix by Other (see comment). Contraindicated. Concomitant use of elagolix and strong OATP1B1 inhibitors is contraindicated.
- enzalutamide
gemfibrozil will increase the level or effect of enzalutamide by decreasing metabolism. Contraindicated. Increased enzalutamide exposure may increase risk of seizures; if co-administration is considered necessary, dose of enzalutamide should be reduced
- fluvastatin
gemfibrozil increases toxicity of fluvastatin by Other (see comment). Contraindicated. Comment: OATP1B1 inhibitors may increase risk of myopathy.
- mavacamten
gemfibrozil will increase the level or effect of mavacamten by affecting hepatic enzyme CYP2C19 metabolism. Contraindicated. Strong or moderate CYP2C19 inhibitors may increase mavacamten systemic exposure, resulting in heart failure due to systolic dysfunction.
- ombitasvir/paritaprevir/ritonavir & dasabuvir (DSC)
gemfibrozil will increase the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir (DSC) by decreasing metabolism. Contraindicated. Strong CYP2C8 inhibitors are shown to increase dasabuvir plasma concentrations (~10-fold), and therefore increase risk of QT prolongation
- pitavastatin
gemfibrozil increases toxicity of pitavastatin by Other (see comment). Contraindicated. Comment: OATP1B1 inhibitors may increase risk of myopathy.
- pravastatin
gemfibrozil increases toxicity of pravastatin by Other (see comment). Contraindicated. Comment: OATP1B1 inhibitors may increase risk of myopathy.
- repaglinide
gemfibrozil will increase the level or effect of repaglinide by Other (see comment). Contraindicated. Repaglinide is a CYP2C8 substrate. Gemfibrozil inhibits CYP2C8 and substantially increases repaglinide levels.
- rosuvastatin
gemfibrozil increases toxicity of rosuvastatin by Other (see comment). Contraindicated. Comment: OATP1B1 inhibitors may increase risk of myopathy.
- selexipag
gemfibrozil will increase the level or effect of selexipag by decreasing metabolism. Contraindicated. Coadministration of selexipag with strong CYP2C8 inhibitors doubled exposure to selexipag and increased exposure to the active metabolite by about 11-fold.
- simvastatin
gemfibrozil, simvastatin. Either increases effects of the other by pharmacodynamic synergism. Contraindicated. Contraindicated with other lipid-lowering drugs that can cause myopathy.
gemfibrozil will increase the level or effect of simvastatin by Other (see comment). Contraindicated. OATP1B1 inhibitors may increase risk of myopathy
Serious - Use Alternative (22)
- abrocitinib
gemfibrozil will increase the level or effect of abrocitinib by decreasing metabolism. Avoid or Use Alternate Drug. Abrocitinib is a CYP2C9 and CYP2C19 substrate. Drugs that are moderate-to-strong inhibitors of both CYP2C9 and CYP2C19 increase systemic exposure of abrocitinib and its active metabolites, which may increase adverse effects.
- atorvastatin
gemfibrozil, atorvastatin. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Gemfibrozil may further increase risk for rhabdomyolysis when added to optimal statin regimen to further decrease TG and increase HDLs.
- belinostat
gemfibrozil will increase the level or effect of belinostat by decreasing metabolism. Avoid or Use Alternate Drug. Strong UGT inhibitors decrease metabolism of belinostat; reduce belinostat starting dose to 750 mg/m2 when coadministered with UGT inhibitors or in patients known to be homozygous for the UGT1A1*28 allele
- cilostazol
gemfibrozil increases toxicity of cilostazol by affecting hepatic enzyme CYP2C19 metabolism. Avoid or Use Alternate Drug. Decrease cilostazol dose by 50%; serum levels of 3,4-dehydrocilostazol (active metabolite) increased by strong CYP2C19 inhibitors.
- colchicine
colchicine, gemfibrozil. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Increased risk of rhabdomyolysis (incl a fatality).
- dabrafenib
gemfibrozil increases levels of dabrafenib by decreasing metabolism. Avoid or Use Alternate Drug. Strong CYP2C8 inhibitors may increase dabrafenib levels.
- eluxadoline
gemfibrozil increases levels of eluxadoline by decreasing metabolism. Avoid or Use Alternate Drug. Decrease eluxadoline dose to 75 mg PO BID if coadministered with OATP1B1 inhibitors. .
- erdafitinib
gemfibrozil will increase the level or effect of erdafitinib by affecting hepatic enzyme CYP2C9/10 metabolism. Avoid or Use Alternate Drug. If unable to avoid coadministration with strong CYP2C9 inhibitors, monitor closely for adverse reactions and consider decreasing dose accordingly. If strong CYP2C9 inhibitor is discontinued, consider increasing erdafitinib dose in the absence of any drug-related toxicities.
- fluvastatin
gemfibrozil, fluvastatin. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Gemfibrozil may further increase risk for rhabdomyolysis when added to optimal statin regimen to further decrease TG and increase HDLs.
- irinotecan
gemfibrozil will increase the level or effect of irinotecan by decreasing metabolism. Avoid or Use Alternate Drug. UGT1A1 inhibitors decrease irinotecan metabolism
- irinotecan liposomal
gemfibrozil will increase the level or effect of irinotecan liposomal by decreasing metabolism. Avoid or Use Alternate Drug. UGT1A1 inhibitors decrease irinotecan metabolism
- lovastatin
gemfibrozil, lovastatin. Either increases effects of the other by Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. Gemfibrozil may further increase risk for rhabdomyolysis when added to optimal statin regimen to further decrease TG and increase HDLs. Do not exceed 20 mg/day of lovastatin.
- pexidartinib
gemfibrozil will increase the level or effect of pexidartinib by Other (see comment). Avoid or Use Alternate Drug. Pexdartinib is a UGTA4 substrate. Reduce pexdartinib dose if concomitant use of UGT inhibitors cannot be avoided (refer to drug monograph dosage modifications). After discontinuing the CYP3A4 inhibitor for 3 elimination half-lives, may resume previous pexidartinib dose.
- pioglitazone
gemfibrozil will increase the level or effect of pioglitazone by decreasing metabolism. Avoid or Use Alternate Drug.
- pirfenidone
gemfibrozil will increase the level or effect of pirfenidone by affecting hepatic enzyme CYP1A2 metabolism. Avoid or Use Alternate Drug. Avoid; coadministration of pirfenidone and moderate CYP1A2 inhibitors result in moderately increased exposure to pirfenidone; if unable to avoid, decrease dose of moderate CYP1A2 inhibitor
- pitavastatin
gemfibrozil, pitavastatin. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Gemfibrozil may further increase risk for rhabdomyolysis when added to optimal statin regimen to further decrease TG and increase HDLs.
- pravastatin
gemfibrozil, pravastatin. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Gemfibrozil may further increase risk for rhabdomyolysis when added to optimal statin regimen to further decrease TG and increase HDLs.
- revefenacin
gemfibrozil increases levels of revefenacin by Other (see comment). Avoid or Use Alternate Drug. Comment: OATP1B1 and OATP1B3 transport inhibitors may increase systemic exposure of revefenacin's active metabolite. Coadministration not recommended.
- rosiglitazone
gemfibrozil will increase the level or effect of rosiglitazone by decreasing metabolism. Avoid or Use Alternate Drug.
- rosuvastatin
gemfibrozil, rosuvastatin. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Gemfibrozil may further increase risk for rhabdomyolysis when added to optimal statin regimen to further decrease TG and increase HDLs. If concomitant use cannot be avoided, initiate rosuvastatin at 5 mg once daily; the dose of rosuvastatin should not exceed 10 mg once daily.
- siponimod
gemfibrozil will increase the level or effect of siponimod by affecting hepatic enzyme CYP2C9/10 metabolism. Avoid or Use Alternate Drug. Coadministration of siponimod with drugs that cause moderate CYP2C9 AND a moderate or strong CYP3A4 inhibition is not recommended. Caution if siponimod coadministered with moderate CYP2C9 inhibitors alone.
- tucatinib
gemfibrozil will increase the level or effect of tucatinib by Other (see comment). Avoid or Use Alternate Drug. Coadministration of tucatinib (a CYP2C8 substrate) with a strong or moderate CYP2C8 inhibitors increases tucatinib plasma concentrations and risk of toxicities.
Monitor Closely (41)
- apalutamide
gemfibrozil will increase the level or effect of apalutamide by Other (see comment). Use Caution/Monitor. Coadministration of apalutamide with strong CYP2C8 inhibitors does not require initial dosage modification; however, dose reduction may be needed based on tolerability.
apalutamide will decrease the level or effect of gemfibrozil by increasing elimination. Use Caution/Monitor. Apalutamide induces UGT and may decrease systemic exposure of drugs that are UGT substrates. - atogepant
gemfibrozil will increase the level or effect of atogepant by Other (see comment). Modify Therapy/Monitor Closely. Recommended dosage of atogepant (an OATP1B1 substrate) with concomitant use of OATP inhibitors is 10 mg or 30 mg qDay.
- belzutifan
gemfibrozil will increase the level or effect of belzutifan by affecting hepatic enzyme CYP2C19 metabolism. Modify Therapy/Monitor Closely. Belzutifan is a CYP2C19 substrate. Coadministration with CYP2C19 inhibitors may increase incidence or severity of adverse effects. Monitor for anemia and hypoxia and reduce belzutifan dose as recommended.
- bexarotene
gemfibrozil increases levels of bexarotene by unspecified interaction mechanism. Use Caution/Monitor.
- cannabidiol
gemfibrozil will increase the level or effect of cannabidiol by affecting hepatic enzyme CYP2C19 metabolism. Modify Therapy/Monitor Closely. Consider reducing the cannabidiol dose when coadministered with a strong CYP2C19 inhibitor.
cannabidiol will increase the level or effect of gemfibrozil by Other (see comment). Modify Therapy/Monitor Closely. Cannabidiol may potentially inhibit UGT2B7 activity. Consider reducing the dose when concomitantly using UGT2B7 substrates. - chlorpropamide
gemfibrozil increases effects of chlorpropamide by plasma protein binding competition. Use Caution/Monitor. Hypoglycemia; increased risk in hypoalbuminemia.
- cholestyramine
cholestyramine decreases levels of gemfibrozil by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.
- diazepam intranasal
gemfibrozil will increase the level or effect of diazepam intranasal by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor. Strong or moderate CYP2C19 inhibitors may decrease rate of diazepam elimination, thereby increasing adverse reactions to diazepam.
- diclofenac
gemfibrozil will increase the level or effect of diclofenac by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. Do not exceed diclofenac dose of 50 mg BID
- dronabinol
gemfibrozil will increase the level or effect of dronabinol by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. Dronabinol is a CYP2C9 substrate.
- eluxadoline
gemfibrozil increases levels of eluxadoline by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. As a precautionary measure due to incomplete information on the metabolism of eluxadoline, use caution when coadministered with strong CYP2C9/10 inhibitors.
gemfibrozil increases levels of eluxadoline by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor. As a precautionary measure due to incomplete information on the metabolism of eluxadoline, use caution when coadministered with strong CYP2C19 inhibitors. - flibanserin
gemfibrozil will increase the level or effect of flibanserin by affecting hepatic enzyme CYP2C19 metabolism. Modify Therapy/Monitor Closely. Coadministration of flibanserin with strong CYP2C19 inhibitors may increase flibanserin exposure and increase the risk of hypotension, syncope, and CNS depression.
- glecaprevir/pibrentasvir
gemfibrozil will increase the level or effect of glecaprevir/pibrentasvir by decreasing metabolism. Use Caution/Monitor. Caution when coadministering glecaprevir/pibrentasvir with OATP1B1/OATP1B3 inhibitors
- glimepiride
gemfibrozil increases effects of glimepiride by plasma protein binding competition. Use Caution/Monitor. Hypoglycemia; increased risk in hypoalbuminemia.
- glipizide
gemfibrozil increases effects of glipizide by plasma protein binding competition. Use Caution/Monitor. Hypoglycemia; increased risk in hypoalbuminemia.
- glyburide
gemfibrozil increases effects of glyburide by plasma protein binding competition. Use Caution/Monitor. Hypoglycemia; increased risk in hypoalbuminemia.
gemfibrozil increases levels of glyburide by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. Strong CYP2C9 inhibitors may decrease glyburide metabolism. - insulin aspart
gemfibrozil increases effects of insulin aspart by unspecified interaction mechanism. Use Caution/Monitor. Hypoglycemia; increased risk in hypoalbuminemia.
- insulin degludec
gemfibrozil, insulin degludec. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Both drugs decrease blood glucose.
- insulin degludec/insulin aspart
gemfibrozil, insulin degludec/insulin aspart. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Both drugs decrease blood glucose.
- insulin detemir
gemfibrozil increases effects of insulin detemir by unspecified interaction mechanism. Use Caution/Monitor. Hypoglycemia; increased risk in hypoalbuminemia.
- insulin glargine
gemfibrozil increases effects of insulin glargine by unspecified interaction mechanism. Use Caution/Monitor. Hypoglycemia; increased risk in hypoalbuminemia.
- insulin glulisine
gemfibrozil increases effects of insulin glulisine by unspecified interaction mechanism. Use Caution/Monitor. Hypoglycemia; increased risk in hypoalbuminemia.
- insulin inhaled
gemfibrozil, insulin inhaled. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Both drugs decrease blood glucose.
- insulin lispro
gemfibrozil increases effects of insulin lispro by unspecified interaction mechanism. Use Caution/Monitor. Hypoglycemia; increased risk in hypoalbuminemia.
- insulin NPH
gemfibrozil increases effects of insulin NPH by unspecified interaction mechanism. Use Caution/Monitor. Hypoglycemia; increased risk in hypoalbuminemia.
- insulin regular human
gemfibrozil increases effects of insulin regular human by unspecified interaction mechanism. Use Caution/Monitor. Hypoglycemia; increased risk in hypoalbuminemia.
- lacosamide
gemfibrozil increases levels of lacosamide by affecting hepatic enzyme CYP2C9/10 metabolism. Modify Therapy/Monitor Closely. Consider decreasing lacosamide dose when coadministered with strong CYP2C9 inhibitors.
- lesinurad
gemfibrozil will increase the level or effect of lesinurad by affecting hepatic enzyme CYP2C9/10 metabolism. Modify Therapy/Monitor Closely.
- letermovir
gemfibrozil increases levels of letermovir by decreasing metabolism. Use Caution/Monitor. Coadminstration of letermovir, an OATP1B1/3 substrate, with OATP1B1/3 inhibitors may increase letermovir plasma concentrations.
- montelukast
gemfibrozil will increase the level or effect of montelukast by decreasing metabolism. Use Caution/Monitor.
- ospemifene
gemfibrozil increases levels of ospemifene by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor.
gemfibrozil increases levels of ospemifene by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. - ozanimod
gemfibrozil will increase the level or effect of ozanimod by Other (see comment). Modify Therapy/Monitor Closely. Coadministration of ozanimod (a CYP2C8 substrate) with strong CYP2C8 inhibitors increases the exposure of the active metabolites (CC112273 and CC1084037) of ozanimod, which may increase the risk of ozanimod adverse reactions. Therefore, coadministration of ozanimod with strong CYP2C8 inhibitors is not recommended.
- paclitaxel
gemfibrozil increases levels of paclitaxel by altering metabolism. Use Caution/Monitor. Gemfibrozil inhibits CYP2C8.
gemfibrozil will increase the level or effect of paclitaxel by Other (see comment). Modify Therapy/Monitor Closely. Paclitaxel levels/toxicity may increase when coadministered with CYP2C8 inhibitors - paclitaxel protein bound
gemfibrozil increases levels of paclitaxel protein bound by altering metabolism. Use Caution/Monitor. Gemfibrozil inhibits CYP2C8.
gemfibrozil will increase the level or effect of paclitaxel protein bound by Other (see comment). Modify Therapy/Monitor Closely. Paclitaxel levels/toxicity may increase when coadministered with CYP2C8 inhibitors - sacubitril/valsartan
gemfibrozil will increase the level or effect of sacubitril/valsartan by Other (see comment). Use Caution/Monitor. The results from an in vitro study with human liver tissue indicate that valsartan is a substrate of the hepatic uptake transporter OATP1B1; coadministration with OATP1B1 inhibitors may increase valsartan systemic exposure
- terbinafine
gemfibrozil will increase the level or effect of terbinafine by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor.
- tofacitinib
gemfibrozil increases levels of tofacitinib by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor. No specific dose adjustment recommended when tofacitinib coadministered with potent CYP2C19 inhibitors; decrease tofacitinib dose if coadministered with both moderate CYP3A4 and potent CYP2C19 inhibitors .
- tolazamide
gemfibrozil increases effects of tolazamide by plasma protein binding competition. Use Caution/Monitor. Hypoglycemia; increased risk in hypoalbuminemia.
- tolbutamide
gemfibrozil increases effects of tolbutamide by plasma protein binding competition. Use Caution/Monitor. Hypoglycemia; increased risk in hypoalbuminemia.
- valsartan
gemfibrozil will increase the level or effect of valsartan by Other (see comment). Use Caution/Monitor. The results from an in vitro study with human liver tissue indicate that valsartan is a substrate of the hepatic uptake transporter OATP1B1; coadministration with OATP1B1 inhibitors may increase valsartan systemic exposure
- warfarin
gemfibrozil will increase the level or effect of warfarin by affecting hepatic enzyme CYP2C9/10 metabolism. Modify Therapy/Monitor Closely. If coadministered, consider decreasing warfarin dose by one-fourth to one-third.
Minor (4)
- colestipol
colestipol decreases levels of gemfibrozil by inhibition of GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown.
- ezetimibe
gemfibrozil increases levels of ezetimibe by enhancing GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown.
- loperamide
gemfibrozil will increase the level or effect of loperamide by decreasing metabolism. Minor/Significance Unknown.
- octacosanol
octacosanol increases effects of gemfibrozil by pharmacodynamic synergism. Minor/Significance Unknown.
Adverse Effects
>10%
Dyspepsia (20%)
1-10%
Abdominal pain (10%)
Atrial fibrillation (1%)
Diarrhea (7%)
Fatigue (4%)
N/V (3%)
Eczema (2%)
Rash (2%)
Vertigo (2%)
Constipation (1%)
Headache (1%)
<1%
Myalgia
Rhabdomyolysis (especially with admin with statin)
Acute appendicitis
Cholelithiasis
Angioedema
Hypokalemia
Eosinophilia
Myopathy
Synovitis
Taste disturbance
Xerostomia
Flatulence
Rash
Warnings
Contraindications
Hypersensitivity
Severe liver/renal disease
Primary biliary cirrhosis
Preexisting gallbladder disease
Coadministration with repaglinide, simvastatin, selexipag, or dasabuvir
Cautions
If response inadequate after 3 months, discontinue gemfibrozil
Risk for myopathy/rhabdomyolysis increases with renal impairment
Risk for myopathy/rhabdomyolysis increases with concurrent HMG-CoA reductase inhibitors use (eg, atorvastatin, pravastatin)
If coadministered with anticoagulants, reduce anticoagulant dose and monitor prothrombin time until stabilized
Coadministration with bile acid resin binding agents decreases gemfibrozil AUC by 30%
May increase risk of malignancy
Rule out secondary causes of hyperlipidemia prior to initiating therapy; discontinue if lipid response not seen
Use with caution in patients taking warfarin; adjustments in warfarin may be required
Cases of cholelithiasis reported with gemfibrozil therapy; gemfibrozil may increase cholesterol excretion into bile; if cholelithiasis suspected, perform gallbladder studies; discontinue therapy if gallstones found
Coadministration with repaglinide shown to increase repaglinide plasma concentrations (8-fold increase); prolongs hypoglycemic effect; may result in severe hypoglycemia
Gemfibrozil inhibits CYP2C8 enzyme activity; may increase exposure of CYP2C8 substrates; consider dose reduction of CYP2C8 substrates when administered concomitantly
Gemfibrozil may increase exposure of OATP1B1 drug substrates when administered concomitantly; consider dose reduction of OATP1B1 substrates when administered concomitantly
Myopathy, including rhabdomyolysis, reported with chronic administration of colchicine at therapeutic doses; use caution, especially in the elderly and patients with renal dysfunction
Rarely, severe anemia, leukopenia, thrombocytopenia, and bone marrow hypoplasia reported; periodic blood counts are recommended during first 12 months of therapy
Elevations in serum transaminases seen with use; periodic liver function studies recommended; therapy should be terminated if abnormalities persist
Worsening renal insufficiency upon addition of therapy in individuals with baseline plasma creatinine >2.0 mg/dL reported; in such patients, consider the use of alternative therapy against risks and benefits of a lower dose of metformin
Gemfibrozil may increase enzalutamide levels when administered concomitantly, which may increase risk of seizures; if coadministration necessary, reduce enzalutamide dose
Pregnancy & Lactation
Pregnancy
There are no adequate and well-controlled studies in pregnant women; drug should be used during pregnancy only if potential benefit justifies potential risk to fetus
Drug has shown to produce adverse effects in rats and rabbits at doses between 0.5 and 3 times the human dose (based on surface area); administration to female rats at 2 times human dose (based on surface area) before and throughout gestation caused a dose-related decrease in conception rate, an increase in stillborns, and a slight reduction in pup weight during lactation; there were also dose-related increased skeletal variations; anophthalmia occurred, but rarely
Administration of 0.6 and 2 times the human dose (based on surface area) of LOPID to female rats from gestation day 15 through weaning caused dose-related decreases in birth weight and suppressions of pup growth during lactation
Administration of 1 and 3 times the human dose (based on surface area) to female rabbits during organogenesis caused a dose-related decrease in litter size and, at high dose, an increased incidence of parietal bone variations
Lactation
It is not known whether drug is excreted in human milk; because many drugs are excreted in human milk and because of potential for tumorigenicity shown for drug in animal studies, a decision should be made whether to discontinue nursing or to discontinue drug, taking into account the importance of the drug to the mother
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Inhibits peripheral lipolysis; decreases hepatic uptake of free fatty acids, which may in turn inhibit secretion of VLDL; may increase HDL-cholesterol (mechanism unknown)
Absorption
Peak serum time: 1-2 hr
Distribution
Protein bound: 99%
Metabolism
Enterohepatic circulation
Elimination
Half-life: 1.5 hr
Excretion: Urine (70%); feces (6%)
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Lopid oral - | 600 mg tablet |  | |
| gemfibrozil oral - | 600 mg tablet |  | |
| gemfibrozil oral - | 600 mg tablet |  | |
| gemfibrozil oral - | 600 mg tablet |  | |
| gemfibrozil oral - | 600 mg tablet | | |
| gemfibrozil oral - | 600 mg tablet |  | |
| gemfibrozil oral - | 600 mg tablet |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
gemfibrozil oral
GEMFIBROZIL - ORAL
(jem-FYE-broh-zill)
COMMON BRAND NAME(S): Lopid
USES: Gemfibrozil is used along with a proper diet to help lower fats (triglycerides) and raise "good" cholesterol (HDL) in the blood. It may also help to lower "bad" cholesterol (LDL). Gemfibrozil belongs to a group of drugs known as "fibrates." It works by decreasing the amount of fat produced by the liver. Lowering triglycerides in people with very high triglyceride blood levels may decrease the risk of pancreas disease (pancreatitis). However, gemfibrozil might not lower your risk of a heart attack or stroke. Talk to your doctor about the risk and benefits of gemfibrozil.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, drinking less alcohol, losing weight if overweight, and stopping smoking.
HOW TO USE: Take this medication by mouth as directed by your doctor, usually twice a day (30 minutes before your morning and evening meals).Dosage is based on your medical condition and response to treatment.If you also take certain other drugs to lower your cholesterol (bile acid-binding resins such as cholestyramine or colestipol), take gemfibrozil at least 1 hour before or at least 4-6 hours after taking these medications. These products can react with gemfibrozil, preventing its full absorption.Take this medication regularly in order to get the most benefit from it. Remember to take it at the same times each day. Keep taking this medication even if you feel well. Most people with high cholesterol/triglycerides do not feel sick.It is very important to continue to follow your doctor's advice about diet and exercise. It may take up to 3 months before you get the full benefit of this drug.
SIDE EFFECTS: Stomach upset, stomach/abdominal pain, or unusual taste may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged 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. Tell your doctor right away if you notice any of these serious side effects: severe stomach/abdominal pain, persistent nausea/vomiting, 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).Tell your doctor right away if you have any serious side effects, including: signs of infection (such as fever, persistent sore throat), easy bruising/bleeding, unusual tiredness, irregular heartbeat, numbness/tingling of arms/legs.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 the 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.In the US -Call your doctor for medical advice about side effects. 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.
PRECAUTIONS: Before taking gemfibrozil, tell your doctor or pharmacist if you are allergic to it; or to other "fibrates" (such as fenofibrate); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease (such as biliary cholangitis, hepatitis), gallbladder disease, kidney disease, alcohol use.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using gemfibrozil. Gemfibrozil may harm an unborn baby. Consult your doctor for more details. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: asunaprevir, "blood thinners" (such as warfarin), colchicine, repaglinide, "statin" drugs (such as atorvastatin, lovastatin, simvastatin).This medication can slow down the removal of other medications from your body, which may affect how they work. Examples of affected drugs include elagolix, irinotecan, pioglitazone, selexipag, a certain combination product used to treat chronic hepatitis C (ombitasvir/paritaprevir/ritonavir/dasabuvir), among others.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Do not share this medication with others.Laboratory and/or medical tests (such as cholesterol/triglyceride levels, kidney/liver function tests, complete blood count) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.
MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.
STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised February 2022. Copyright(c) 2022 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
Adding plans allows you to compare formulary status to other drugs in the same class.
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.
