Gemfibrozil 600 mg Tablet, 1,000-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Peroxisome Proliferator-activated Receptor alpha Agonist class.
Where does this data come from?
🏭 Manufacturer & labeler
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🩺 Clinical
Gemfibrozil is used to reduce the amount of cholesterol (a fat-like substance that can build up in blood vessels leading to heart attack or strokes or other medical conditions) and triglycerides (other fatty substances) in the blood. Gemfibrozil is in a class of lipid-regulating medications called fibrates. It works by reducing the production of triglycerides in the liver.
Read the full MedlinePlus article ↗- It depends on why your doctor prescribed it. For most people, it's either bringing down dangerously high triglycerides — the type that can cause pancreatitis — or, in a specific gr...
- What exactly is gemfibrozil supposed to do for me?
- Yes, timing actually matters with this one. You take it twice a day — once about 30 minutes before breakfast and once about 30 minutes before your evening meal. Taking it before yo...
- When should I take it and does it matter if I take it with food?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Gemfibrozil — tap one for details:
Gemfibrozil may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.
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Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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UNII M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
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Hypromellose 2910 is a plant-based cellulose derivative that acts as a thickener, binder, and film-coating agent. It helps control how quickly the medicine dissolves and protects the tablet or capsule from moisture and light.
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Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII NPU9M2E6L8
Methylcellulose is a plant-derived thickening agent made from cellulose. It acts as a binder to hold tablet ingredients together and a viscosity builder in liquid formulations.
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UNII 30IQX730WE
Polyethylene glycol 6000 is a synthetic polymer made from ethylene glycol units. It acts as a binder, filler, and solubilizer in medicines to help hold ingredients together, add bulk, and improve how well active drugs dissolve and absorb.
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UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
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UNII 7SEV7J4R1U
A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
10 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $0.2303 | $230.30 / 1000 tablets |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Gemfibrozil 600 mg 75834-0131-05 | Nivagen | 500 tablets | $0.103 | AB | Discontinued | — |
| Gemfibrozil 600 mg 16571-0784-06 | Rising | 60 tablets | $0.105 | AB | Availability likely | — |
| Gemfibrozil 600 mg 16714-0101-02 | Northstar | 60 tablets | $0.105 | AB | Availability likely | — |
| Gemfibrozil 600 mg 31722-0128-05 | Camber | 500 tablets | $0.105 | AB | Availability likely | — |
| Gemfibrozil 600 mg 50268-0350-15 | AvPAK | 50 tablets | $0.105 | AB | Availability likely | — |
| Gemfibrozil 600 mg 60687-0224-01 | American | 100 tablets | $0.105 | AB | Availability likely | — |
| Gemfibrozil 600 mg 65862-0624-05 | Aurobindo | 500 tablets | $0.105 | — | Availability likely | — |
| Gemfibrozil 600 mg 69097-0821-03 | Cipla | 60 tablets | $0.105 | AB | Availability likely | — |
| Gemfibrozil 600 mg 72603-0206-01 | NorthStar | 60 tablets | $0.105 | AB | Availability likely | — |
| Gemfibrozil 600 mg 76282-0225-05 | Exelan | 500 tablets | $0.105 | AB | Availability likely | — |
| Lopid 600 mg 00071-0737-20 | Parke-Davis | 60 tablets | — | AB | FDA listed | — |
| Gemfibrozil 600 mg 00615-8354-39 | NCS | 30 tablets | — | AB | FDA listed | — |
| Gemfibrozil 600 mg 43063-0745-60 | PD-Rx | 60 tablets | — | AB | FDA listed | — |
| Gemfibrozil 600 mg 50090-5808-00 | A-S | 60 tablets | — | AB | FDA listed | — |
| Gemfibrozil 600 mg 50090-6913-00 | A-S | 60 tablets | — | AB | FDA listed | — |
| Gemfibrozil 600 mg 50090-6939-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Gemfibrozil 600 mg 50090-7233-00 | A-S | 60 tablets | — | AB | FDA listed | — |
| Gemfibrozil 600 mg 50090-7234-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Gemfibrozil 600 mg 50090-7809-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Gemfibrozil 600 mg 51655-0143-26 | Northwind | 90 tablets | — | AB | FDA listed | — |
| Gemfibrozil 600 mg 62135-0160-31 | Chartwell | 300 tablets | — | AB | FDA listed | — |
| Gemfibrozil 600 mg 63187-0772-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Gemfibrozil 600 mg 66267-0436-30 | NuCare | 30 tablets | — | AB | FDA listed | — |
| Gemfibrozil 600 mg 67046-0233-03 | Coupler | 30 tablets | — | AB | FDA listed | — |
| Gemfibrozil 600 mg 68071-1733-06 | NuCare | 60 tablets | — | AB | FDA listed | — |
| Gemfibrozil 600 mg 68071-2387-03 | NuCare | 30 tablets | — | AB | FDA listed | — |
| Gemfibrozil 600 mg 68382-0553-01 | Zydus | 100 tablets | — | — | FDA listed | — |
| Gemfibrozil 600 mg 68788-7964-03 | Preferred | 30 tablets | — | AB | FDA listed | — |
| Gemfibrozil 600 mg 70518-1563-00 | REMEDYREPACK | 45 tablets | — | AB | Discontinued | — |
| Gemfibrozil 600 mg 70518-4305-00 | REMEDYREPACK | 180 tablets | — | AB | FDA listed | — |
| Gemfibrozil 600 mgthis 70771-1431-00 | Zydus | 1000 tablets | — | — | FDA listed | — |
| Gemfibrozil 600 mg 71209-0008-03 | Cadila | 60 tablets | — | AB | FDA listed | — |
| Gemfibrozil 600 mg 71335-0051-01 | Bryant | 60 tablets | — | AB | FDA listed | — |
| Gemfibrozil 600 mg 71335-0971-01 | Bryant | 60 tablets | — | AB | Discontinued | — |
| Gemfibrozil 600 mg 71335-1902-01 | Bryant | 60 tablets | — | AB | FDA listed | — |
| Gemfibrozil 600 mg 71335-1996-01 | Bryant | 60 tablets | — | AB | FDA listed | — |
| Gemfibrozil 600 mg 71335-2025-01 | Bryant | 60 tablets | — | AB | FDA listed | — |
| Gemfibrozil 600 mg 71610-0107-53 | Aphena | 60 tablets | — | AB | FDA listed | — |
| Gemfibrozil 600 mg 71610-0200-60 | Aphena | 90 tablets | — | AB | FDA listed | — |
| Gemfibrozil 600 mg 71610-0601-53 | Aphena | 60 tablets | — | AB | FDA listed | — |
| Gemfibrozil 600 mg 71610-0824-30 | Aphena | 30 tablets | — | AB | FDA listed | — |
| Gemfibrozil 600 mg 72162-2119-06 | Bryant | 60 tablets | — | AB | FDA listed | — |
| Gemfibrozil 600 mg 72578-0066-01 | Viona | 100 tablets | — | — | FDA listed | — |
| Gemfibrozil 600 mg 72865-0186-05 | XLCare | 500 tablets | — | AB | FDA listed | — |
| Gemfibrozil 600 mg 82804-0221-90 | Proficient | 90 tablets | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Reporter sex
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 70771-1431-00 You're viewing this | 1000 TABLET in 1 BOTTLE (70771-1431-0) | 2020-02-21 | Active |
| 70771-1431-01 | 100 TABLET in 1 BOTTLE (70771-1431-1) | 2020-02-21 | Active |
| 70771-1431-03 | 30 TABLET in 1 BOTTLE (70771-1431-3) | 2020-02-21 | Active |
| 70771-1431-04 | 10 BLISTER PACK in 1 CARTON (70771-1431-4) / 10 TABLET in 1 BLISTER PACK | 2020-02-21 | Active |
| 70771-1431-05 | 500 TABLET in 1 BOTTLE (70771-1431-5) | 2020-02-21 | Active |
| 70771-1431-06 | 60 TABLET in 1 BOTTLE (70771-1431-6) | 2020-02-21 | Active |
| 70771-1431-09 | 90 TABLET in 1 BOTTLE (70771-1431-9) | 2020-02-21 | Active |
Pack size FAQ
What quantity is in NDC 70771-1431-00?
What is the difference between NDC 70771-1431-00 and NDC 70771-1431-03?
What NDC number is used to bill for this package of Gemfibrozil 600 mg Tablet?
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE 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, espec…
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION The recommended dose for adults is 1200 mg administered in two divided doses 30 minutes before the morning and evening meals (see CLINICAL PHARMACOLOGY ).
⛔ Contraindications ▾
CONTRAINDICATIONS 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 ).
⚠️ Warnings ▾
WARNINGS 1. Because of chemical, pharmacological, and clinical similarities between gemfibrozil and clofibrate, the adverse findings with clofibrate in two large clinical studies may also apply to gemfibrozil. In the first of those studies, the Coronary Drug Project, 1000 subjects with previous myocardial infarction were treated for five years with clofibrate.
There was no difference in mortality between the clofibrate-treated subjects and 3000 placebo-treated subjects, but twice as many clofibrate-treated subjects developed cholelithiasis and cholecystitis requiring surgery. In the other study, conducted by the World Health Organization (WHO), 5000 subjects without known coronary heart disease were treated with clofibrate for five years and followed one year beyond. There was a statistically significant (44%) higher age-adjusted total mortality in the clofibrate-treated group than in a comparable placebo-treated control group during the trial period.
The excess mortality was due to a 33% increase in non-cardiovascular causes, including malignancy, post-cholecystectomy complications, and pancreatitis. The higher risk of clofibrate-treated subjects for gallbladder disease was confirmed. Because of the more limited size of the Helsinki Heart Study, the observed difference in mortality from any cause between the gemfibrozil and placebo groups is not statistically significantly different from the 29% excess mortality reported in the clofibrate group in the separate WHO study at the nine year follow-up (see CLINICAL PHARMACOLOGY ).
Noncoronary heart disease related mortality showed an excess in the group originally randomized to gemfibrozil primarily due to cancer deaths observed during the open-label extension. During the five year primary prevention component of the Helsinki Heart Study, mortality from any cause was 44 (2.2%) in the gemfibrozil group and 43 (2.1%) in the placebo group; including the 3.5 year follow-up period since the trial was completed, cumulative mortality from any cause was 101 (4.9%) in the gemfibrozil group and 83 (4.1%) in the group originally randomized to placebo (hazard ratio 1:20 in favor of placebo).
Because of the more limited size of the Helsinki Heart Study, the observed difference in mortality from any cause between the gemfibrozil and placebo groups at Year-5 or at Year-8.5 is not statistically significantly different from the 29% excess mortality reported in the clofibrate group in the separate WHO study at the nine year follow-up. Noncoronary heart disease related mortality showed an excess in the group originally randomized to gemfibrozil at the 8.5 year follow-up (65 gemfibrozil versus 45 placebo noncoronary deaths).
The incidence of cancer (excluding basal cell carcinoma) discovered during the trial and in the 3.5 years after the trial was completed was 51 (2.5%) in both originally randomized groups. In addition, there were 16 basal cell carcinomas in the group originally randomized to gemfibrozil and 9 in the group originally randomized to placebo (p=0.22). There were 30 (1.5%) deaths attributed to cancer in the group originally randomized to gemfibrozil and 18 (0.9%) in the group originally randomized to placebo (p=0.11).
Adverse outcomes, including coronary events, were higher in gemfibrozil patients in a corresponding study in men with a history of known or suspected coronary heart disease in the secondary prevention component of the Helsinki Heart Study (see CLINICAL PHARMACOLOGY ). A comparative carcinogenicity study was also done in rats comparing three drugs in this class: fenofibrate (10 and 60 mg/kg; 0.3 and 1.6 times the human dose, respectively), clofibrate (400 mg/kg; 1.6 times the human dose), and gemfibrozil (250 mg/kg; 1.7 times the human dose).
Pancreatic acinar adenomas were increased in males and females on fenofibrate; hepatocellular carcinoma and pancreatic acinar adenomas were increased in males and hepatic neoplastic nodules in females treated with clofibrate; hepatic…
🤒 Adverse Reactions ▾
ADVERSE REACTIONS In the double-blind controlled phase of the primary prevention component of the Helsinki Heart Study, 2046 patients received gemfibrozil for up to five years. In that study, the following adverse reactions were statistically more frequent in subjects in the gemfibrozil group: GEMFIBROZIL (N = 2046) PLACEBO (N = 2035) Frequency in percent of subjects Gastrointestinal reactions 34.2
23.8Dyspepsia 19.6
11.9Abdominal pain 9.8
5.6Acute appendicitis (histologically confirmed in most cases where data were available) 1.2
0.6Atrial fibrillation 0.7
0.1Adverse events reported by more than 1% of subjects, but without a significant difference between groups: Diarrhea 7.2
6.5Fatigue 3.8
3.5Nausea/Vomiting 2.5
2.1Eczema 1.9
1.2Rash 1.7
1.3Vertigo 1.5
1.3Constipation 1.4
1.3Headache 1.2
1.1Gallbladder surgery was performed in 0.9% of gemfibrozil and 0.5% of placebo subjects in the primary prevention component, a 64% excess, which is not statistically different from the excess of gallbladder surgery observed in the clofibrate group compared to the placebo group of the WHO study. Gallbladder surgery was also performed more frequently in the gemfibrozil group compared to the placebo group (1.9% versus 0.3%, p=0.07) in the secondary prevention component. A statistically significant increase in appendectomy in the gemfibrozil group was seen also in the secondary prevention component (6 on gemfibrozil versus 0 on placebo, p=0.014).
Nervous system and special senses adverse reactions were more common in the gemfibrozil group. These included hypesthesia, paresthesias, and taste perversion. Other adverse reactions that were more common among gemfibrozil treatment group subjects but where a causal relationship was not established include cataracts, peripheral vascular disease, and intracerebral hemorrhage.
From other studies it seems probable that gemfibrozil is causally related to the occurrence of MUSCULOSKELETAL SYMPTOMS (see WARNINGS ), and to ABNORMAL LIVER FUNCTION TESTS and HEMATOLOGIC CHANGES (see PRECAUTIONS ). Reports of viral and bacterial infections (common cold, cough, urinary tract infections) were more common in gemfibrozil treated patients in other controlled clinical trials of 805 patients. Additional adverse reactions that have been reported for gemfibrozil tablets are listed below by system.
These are categorized according to whether a causal relationship to treatment with gemfibrozil tablets is probable or not established: CAUSAL RELATIONSHIP PROBABLE CAUSAL RELATIONSHIP NOT ESTABLISHED General: weight loss Cardiac: extrasystoles Gastrointestinal: cholestatic jaundice pancreatitis hepatoma colitis Central Nervous System: dizziness somnolence paresthesia peripheral neuritis decreased libido depression depression headache confusion convulsions syncope Eye: blurred vision retinal edema Genitourinary: impotence decreased male fertility renal dysfunction Musculoskeletal: myopathy myasthenia myalgia painful extremities arthralgia synovitis rhabdomyolysis (see WARNINGS and Drug Interactions under PRECAUTIONS ) Clinical Laboratory: increased creatine phosphokinase increased bilirubin increased liver transaminases (AST, ALT) increased alkaline phosphatase positive antinuclear antibody Hematopoietic: anemia leukopenia bone marrow hypoplasia eosinophilia thrombocytopenia Immunologic: angioedema laryngeal edema urticaria anaphylaxis Lupus-like syndrome vasculitis Integumentary: exfoliative dermatitis rash dermatitis pruritus alopecia photosensitivity Additional adverse reactions that have been reported include cholecystitis and cholelithiasis (see WARNINGS ).
🆘 Overdosage ▾
OVERDOSAGE There have been reported cases of overdosage with gemfibrozil tablets. In one case, a 7-year-old child recovered after ingesting up to 9 grams of gemfibrozil tablets. Symptoms reported with overdosage were abdominal cramps, abnormal liver function tests, diarrhea, increased CPK, joint and muscle pain, nausea and vomiting. Symptomatic supportive measures should be taken, should an overdose occur.
🧬 Clinical Pharmacology ▾
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 2 and HDL 3 , 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 Helsinki Heart Study, in which 4081 male patients between the ages of 40 and 55 were studied in a randomized, double-blind, placebo-controlled fashion, gemfibrozil therapy was associated with significant reductions in total plasma triglycerides and a significant increase in high density lipoprotein cholesterol.
Moderate reductions in total plasma cholesterol and low density lipoprotein cholesterol were observed for the gemfibrozil treatment group as a whole, but the lipid response was heterogeneous, especially among different Fredrickson types. The study involved subjects with serum non-HDL-cholesterol of over 200 mg/dL and no previous history of coronary heart disease. Over the five-year study period, the gemfibrozil group experienced a 1.4% absolute (34% relative) reduction in the rate of serious coronary events (sudden cardiac deaths plus fatal and nonfatal myocardial infarctions) compared to placebo, p=0.04 (see Table I).
There was a 37% relative reduction in the rate of nonfatal myocardial infarction compared to placebo, equivalent to a treatment-related difference of 13.1 events per thousand persons. Deaths from any cause during the double-blind portion of the study totaled 44 (2.2%) in the gemfibrozil randomization group and 43 (2.1%) in the placebo group. Table I Reduction in CHD Rates (events per 1000 patients) by Baseline Lipids 1 in the Helsinki Heart Study, Years 0 to 5 2 1 lipid values in mg/dL at baseline 2 P = placebo group; L= gemfibrozil group 3 difference in rates between placebo and gemfibrozil groups 4 fatal and nonfatal myocardial infarctions plus sudden cardiac deaths (events per 1000 patients over 5 years) All Patients LDL-C>175; HDL-C>46.4 LDL-C>175; TG>177 LDL-C>175; TG>200; HDL-C<35 P L Dif 3 P L Dif P L Dif P L Dif Incidence of Events 4 41 27 14 32 29 3 71 44 27 149 64 85 Among Fredrickson types, during the 5-year double-blind portion of the primary prevention component of the Helsinki Heart Study, the greatest reduction in the incidence of serious coronary events occurred in Type IIb patients who had elevations of both LDL-cholesterol and total plasma triglycerides.
This subgroup of Type IIb gemfibrozil group patients had a lower mean HDL-cholesterol level at baseline than the Type IIa subgroup that had elevations of LDL-cholesterol and normal plasma triglycerides. The mean increase in HDL-cholesterol among the Type IIb patients in this study was 12.6% compared to placebo. The mean change in LDL-cholesterol among Type IIb patients was –4.1% with gemfibrozil compared to a rise of 3.9% in the placebo subgroup.
The Type IIb subjects in the Helsinki Heart Study had 26 fewer coronary events per thousand persons over five years in the gemfibrozil group compared to placebo. The difference in coronary events was substantially greater between gemfibrozil and placebo for that subgroup of patients with the triad of LDL-cholesterol >175 mg/dL (>4.5 mmol), triglycerides >200 mg/dL (>2.2 mmol), and H…
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED 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 70771-1431-3 in bottles of 30 tablets NDC 70771-1431-6 in bottles of 60 tablets NDC 70771-1431-9 in bottles of 90 tablets NDC 70771-1431-1 in bottles of 100 tablets NDC 70771-1431-5 in bottles of 500 tablets NDC 70771-1431-0 in bottles of 1,000 tablets NDC 70771-1431-4 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 Rev.: 12/23
📋 Description ▾
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 15 H 22 O 3 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.
Structure