gemfibrozil

REMS

Management of type II-b hyperlipidemia (decreased high-density lipoprotein cholesterol [HDL-C], increased low-density lipoprotein cholesterol [LDL-C], increased triglycerides) in patients who do not yet have clinical coronary artery disease and have failed therapy with diet, exercise, weight loss, or other agents (niacin, bile acid sequestrants).

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity;
Severe renal impairment;
Hepatic impairment;
Primary biliary cirrhosis;
Gallbladder disease;
Concurrent use of simvastatin, repaglinide, dasabuvir, or selexipag;
OB: Avoid use during 1st trimester of pregnancy;
Lactation: Lactation.

Use Cautiously in:

OB: May be used starting in 2nd trimester of pregnancy, if needed;
Pedi: Safety and effectiveness not established in children.

Adv. Reactions/Side Effects ⬆ ⬇

Derm: alopecia, rash, urticaria

EENT: blurred vision

GI: abdominal pain, diarrhea, epigastric pain, flatulence, gallstones, heartburn, nausea, vomiting

Hemat: anemia, leukopenia

MS: myositis

Neuro: dizziness, headache

Interactions ⬆ ⬇

Drug-drug:

May ↑ levels of CYP2C8 substrates, including dabrafenib, dasabuvir, enzalutamide, loperamide, montelukast, paclitaxel, pioglitazone, or selexipag; concurrent use with dasabuvir or selexipag contraindicated.
May ↑ levels of OATP1B1 substrates, including atorvastatin, bosentan, ezetimibe, fluvastatin, glyburide, olmesartan, pitavastatin, pravastatin, repaglinide, rifampin, rosuvastatin, simvastatin, and valsartan; concurrent use with simvastatin or repaglinide is contraindicated; avoid concurrent use with other HMG-CoA reductase inhibitors.
May ↑ levels and the risk of bleeding with warfarin.
Concurrent use with colchicine may ↑ risk of rhabdomyolysis, especially in patients with renal dysfunction or older adults.
May ↓ the effect of cyclosporine.
Cholestyramine and colestipol may ↓ absorption; separate administration by ≥2 hr.

Availability ⬆ ⬇

(Generic available)

Capsules: 300 mg
Tablets: 600 mg

Route/Dosage ⬆ ⬇

PO (Adults ): 600 mg twice daily 30 min before breakfast and dinner.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Inhibits peripheral lipolysis.
Decreases triglyceride production by the liver.
Decreases production of the triglyceride carrier protein.
Increases HDL-C.

Therapeutic effects:

Decreased plasma triglycerides and increased HDL-C.

Classifications ⬆ ⬇

Therapeutic Classification: lipid-lowering agents

Pharmacologic Classification: fibric acid derivatives

Pharmacokinetics ⬆ ⬇

Absorption: Well absorbed after oral administration.

Distribution: Unknown.

Metabolism/Excretion: Some metabolism by the liver, 70% excreted by the kidneys (mostly unchanged), 6% excreted in feces.

Half-Life: 1.3–1.5 hr.

Time/Action Profile ⬆ ⬇

(triglyceride-lowering effect)

ROUTE	ONSET	PEAK	DURATION
PO	2–5 days	4 wk	several mo

Patient/Family Teaching ⬆ ⬇

Instruct patient to take medication as directed, not to skip doses or double up on missed doses. Take missed doses as soon as remembered unless almost time for next dose.
Advise patient that gemfibrozil should be used in conjunction with dietary restrictions (fat, cholesterol, carbohydrates, alcohol), exercise, and cessation of smoking.
Instruct patient to notify health care professional promptly if severe stomach pains with nausea and vomiting, fever, chills, sore throat, rash, diarrhea, muscle cramping, general abdominal discomfort, or persistent flatulence occur.
Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

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Indications ⬇