What is Gadolip 45?
Gadolip 45 (Gadolip 45) helps reduce cholesterol and triglycerides (fatty acids) in the blood. High levels of these types of fat in the blood are associated with an increased risk of atherosclerosis (clogged arteries).
Gadolip 45 is used to treat high cholesterol and high triglyceride levels.
Gadolip 45 may also be used for purposes not listed in this medication guide.
Gadolip 45 indications
Primary Hypercholesterolemia or Mixed Dyslipidemia
Gadolip 45 Capsules are indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (total-c), Triglycerides (TG) and apolopoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hypercholesterolemia or mixed dyslipidemia.
Severe Hypertriglyceridemia
Gadolip 45 Capsules are also indicated as adjunctive therapy to diet for treatment of adult patients with severe hypertriglyceridemia. Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate the need for pharmacologic intervention.
Markedly elevated levels of serum triglycerides (e.g. > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of Gadolip 45 therapy on reducing this risk has not been adequately studied.
Important Limitations of Use
Gadolip 45 at a dose equivalent to 150 mg was not shown to reduce coronary heart disease morbidity and mortality in 2 large, randomized controlled trials of patients with type 2 diabetes mellitus.
How should I use Gadolip 45?
Use Gadolip 45 capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Some brands of Gadolip 45 capsules should be taken with food. Some brands may be taken with or without food. Ask your pharmacist if you should take your brand of Gadolip 45 capsules with food.
- Swallow Gadolip 45 capsules whole. Do not open, crush, dissolve, or chew before swallowing. If you cannot swallow Gadolip 45 capsules whole, tell your doctor. You may need a different medicine.
- Take Gadolip 45 capsules with a full glass of water (8 oz [240 mL]).
- If you also take a bile acid-binding resin (eg, cholestyramine), do not take it within 4 to 6 hours before or 1 hour after taking Gadolip 45 capsules. Check with your doctor if you have any questions.
- Take Gadolip 45 capsules on a regular schedule to get the most benefit from it.
- Taking Gadolip 45 capsules at the same time each day will help you remember to take it.
- Continue to take Gadolip 45 capsules even if you feel well. Do not miss any doses.
- If you miss a dose of Gadolip 45 capsules, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Gadolip 45 capsules.
Uses of Gadolip 45 in details
Use: Labeled Indications
Hypercholesterolemia or mixed dyslipidemia: Adjunctive therapy to diet for the reduction of low-density lipoprotein cholesterol (LDL-C), total cholesterol (total-C), triglycerides, and apolipoprotein B (apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in adults with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson types IIa and IIb). Use lipid-altering agents in addition to a diet restricted in saturated fat and cholesterol when response to diet and nonpharmacological interventions alone has been inadequate.
Note: While FDA-approved for hypercholesterolemia, Gadolip 45 is not a first- or second-line choice; other agents may be more suitable (ACC/AHA [Stone 2013]). In addition, use is not recommended to lower LDL-C or raise HDL-C in the absence of hypertriglyceridemia.
Hypertriglyceridemia: Adjunctive therapy to diet for treatment of adult patients with severe hypertriglyceridemia (Fredrickson types IV and V hyperlipidemia).
Off Label Uses
Primary biliary cholangitis
Data from a single-center, retrospective cohort study support the use of Gadolip 45 (in combination with ursodiol) in patients with primary biliary cholangitis (PBC) who have had an incomplete biochemical response to ursodiol monotherapy and showed significant improvement in alkaline phosphatase, a reduction in hepatic decompensation, and transplant-free survival improvement.
Gadolip 45 description
Each film-coated tablet contains Fenofibrate BP 160 mg. It also contains the following excipients: Pregelatinized starch maize, povidone, sodium lauryl sulphate, microcrystalline cellulose, crospovidone, anhydrous colloidal silica, sodium stearyl fumarate, purified water and opadry AMB OY-B-28920.
Gadolip 45 is a lipid-regulating agent. The empirical formula is C20H21O4Cl and the molecular weight is 360.83. Gadolip 45 is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester.
Gadolip 45 dosage
Gadolip 45 Dosage
Generic name: Gadolip 45 160mg
Dosage form: tablet
The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
The dose of Gadolip 45 is 160 mg once daily.
Patients should be placed on an appropriate lipid-lowering diet before receiving Gadolip 45 and should continue this diet during treatment with Gadolip 45.
Lipid levels should be monitored periodically. Therapy should be withdrawn in patients who do not have an adequate response after two months of treatment.
Gadolip 45 tablets can be given without regard to meals. Patients should be advised to swallow Gadolip 45 tablets whole. Do not crush, break, dissolve, or chew tablets.
More about Gadolip 45 (Gadolip 45)
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Consumer resources
- Gadolip 45
- Gadolip 45 (Advanced Reading)
- Other brands: Gadolip 45, Lofibra, Lipofen, Gadolip 45, More (1) »
Professional resources
- Gadolip 45 (FDA)
- Fenofibric Acid/Gadolip 45 (AHFS Monograph)
Related treatment guides
- Hyperlipoproteinemia
- Hyperlipoproteinemia Type IIa, Elevated LDL
- Hyperlipoproteinemia Type IIb, Elevated LDL VLDL
- Hyperlipoproteinemia Type IV, Elevated VLDL
- Hyperlipoproteinemia Type V, Elevated Chylomicrons VLDL
- More (1) »
Gadolip 45 interactions
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What other drugs will affect Gadolip 45?
Coumarin Anticoagulants
Potentiation of coumarin-type anticoagulant effect has been observed with prolongation of the PT/INR.
Caution should be exercised when Gadolip 45 is given in conjunction with coumarin anticoagulants. Gadolip 45 may potentiate the anticoagulant effect of these agents resulting in prolongation of the PT/INR. To prevent bleeding complications, frequent monitoring of PT/INR and dose adjustment of the oral anticoagulant as recommended until the PT/INR has stabilized.
Immunosuppressants
Immunosuppressant agents such as cyclosporine and tacrolimus can impair renal function and because renal excretion is the primary elimination route of fibrate drugs including Gadolip 45 capsules, there is a risk that an interaction will lead to deterioration of renal function. When immunosuppressants and other potentially nephrotoxic agents are co-administered with Gadolip 45 capsules, the lowest effective dose of Gadolip 45 capsules should be employed and renal function should be monitored.
Bile-Acid Binding Resins
Since bile-acid binding resins may bind other drugs given concurrently, patients should take Gadolip 45 at least 1 hour before or 4 to 6 hours after a bile acid binding resin to avoid impeding its absorption.
Colchicine
Cases of myopathy, including rhabdomyolysis, have been reported with fenofibrates co-administered with colchicine, and caution should be exercised when prescribing Gadolip 45 with colchicine.
Gadolip 45 side effects
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What are the possible side effects of Gadolip 45?
Clinical Trials Experience
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
Fenofibric acid is the active metabolite of Gadolip 45. Adverse events reported by 2% or more of patients treated with Gadolip 45 and greater than placebo during double-blind, placebocontrolled trials are listed in Table 1. Adverse events led to discontinuation of treatment in 5.0% of patients treated with Gadolip 45 and in 3.0% treated with placebo. Increases in liver tests were the most frequent events, causing discontinuation of Gadolip 45 treatment in 1.6% of patients in double-blind trials.
Table 1: Adverse Events Reported by 2% or More of Patients Treated with Gadolip 45 and Greater than Placebo During the Double-Blind, Placebo-Controlled Trials
| BODY SYSTEM Adverse Event | Gadolip 45* (N = 439) | Placebo (N = 365) |
| BODY AS A WHOLE | ||
| Abdominal Pain | 4.6% | 4.4% |
| Back Pain | 3.4% | 2.5% |
| Headache | 3.2% | 2.7% |
| DIGESTIVE | ||
| Nausea | 2.3% | 1.9% |
| Constipation | 2.1% | 1.4% |
| INVESTIGATIONS | ||
| Abnormal Liver Tests | 7.5% | 1.4% |
| Increased AST | 3.4% | 0.5% |
| Increased ALT | 3.0% | 1.6% |
| Increased Creatine Phosphokinase | 3.0% | 1.4% |
| RESPIRATORY | ||
| Respiratory Disorder | 6.2% | 5.5% |
| Rhinitis | 2.3% | 1.1% |
| * Dosage equivalent to 135 mg Gadolip 45 |
Clinical trials with Gadolip 45 did not include a placebo-control arm. However, the adverse event profile of Gadolip 45 was generally consistent with that of Gadolip 45. The following adverse events not listed above were reported in ≥ 3% of patients taking Gadolip 45 alone:
Gastrointestinal Disorders: Diarrhea, dyspepsia
General Disorders and Administration Site Conditions: Pain
Infections and Infestations: Nasopharyngitis, sinusitis, upper respiratory tract infection
Musculoskeletal and Connective Tissue Disorders: Arthralgia, myalgia, pain in extremity
Nervous System Disorders: Dizzinesss
Postmarketing Experience
The following adverse events have been identified during postapproval use of Gadolip 45: rhabdomyolysis, pancreatitis, renal failure, muscle spasms, acute renal failure, hepatitis, cirrhosis, anemia, asthenia, and severely depressed HDL-cholesterol levels.
Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Gadolip 45 contraindications
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What is the most important information I should know about Gadolip 45?
Hypersensitivity to Gadolip 45 or fenofibric acid or to any of the excipients of Gadolip 45.
Severe renal impairment/insufficiency, including those receiving dialysis.
Active liver disease/dysfunction/insufficiency, including those with primary biliary cirrhosis and unexplained persistent liver function abnormalities eg, persistent elevations in serum transaminases. Pre-existing gallbladder disease.
Photoallergy or phototoxic reaction during treatment with fibrates or ketoprofen.
Chronic or acute pancreatitis with the exception of acute pancreatitis due to severe hypertriglyceridemia.
Gadolip 45 contains lecithin soya as an excipient and therefore, Gadolip 45 should not be taken with allergic to peanut or arachis oil or soya lecithin, or related products due to the risk of hypersensitivity reactions.
Use in lactation: Gadolip 45 should not be used in nursing mothers. Because of the potential for tumorigenicity seen in animal studies, a decision should be made whether to discontinue nursing or to discontinue Gadolip 45, taking into account the importance of Gadolip 45 to the mother. There are no data on the excretion of Gadolip 45 and/or its metabolites into breast milk.
Use in children: Safety and effectiveness in pediatric patients aged <18 years have not been established.
Active ingredient matches for Gadolip 45:
Fenofibrate in Argentina.
List of Gadolip 45 substitutes (brand and generic names) | Sort by popularity |
| Unit description / dosage (Manufacturer) | Price, USD |
| Gadolip 135 (Argentina) | |
| Gardenal Sodium (Lebanon) | |
| Gen-Fenofibrate (Canada) | |
| Gen-Fenofibrate 200 mg x 100's | |
| Gen-Fenofibrate Micro (Malaysia) | |
| Capsule; Oral; Fenofibrate 200 mg | |
| Gen-Fenofibrate Micro 200 mg x 100's | |
| Grofibrat (Poland) | |
| Guan Zhi Ning (China) | |
| Hafenthyl (Vietnam) | |
| Hafenthyl Supra 160 mg x 3 Blister x 10 Tablet | |
| Hafenthyl 100 mg x 3 Blister x 10 Tablet | |
| Hafenthyl 200 mg x 3 Blister x 10 Tablet | |
| Hafenthyl 300 mg x 3 Blister x 10 Tablet | |
| Hicholfen (Indonesia) | |
| Hipofithy (Brazil) | |
| Hyperchol (Indonesia) | |
| Hyperchol 100 mg x 4 x 12's (Ikapharmindo) | $ 16.74 |
| Hyperchol 300 mg x 3 x 10's (Ikapharmindo) | $ 27.90 |
| Hyperchol 200 M 200 mg x 5 x 6's (Ikapharmindo) | $ 31.00 |
| Hyperchol/Hyperchol 200 M (Indonesia) | |
| Hypolip (Hungary, Tunisia) | |
| Katalip (Slovenia) | |
| Ke Li Qing (China) | |
| Kemifib (Egypt) | |
| Lexemin (Hong Kong, Malaysia, Singapore, Thailand) | |
| Lexemin 300 mg x 10 x 10's (Unison) | |
| Lexemin 100 mg x 10 x 10's (Unison) | |
| Lexemin / micronized 200 mg x 10 x 10's (Unison) | |
| Lexemin 300 mg x 10 x 10's (Unison) | |
| Lexemin / micronized 160 mg x 10 x 10's (Unison) | |
| Lexemin 160 mg x 10 x 10's (Unison) | |
| Lexemin cap 100 mg 10 x 10's (Unison) | |
| Lexemin cap 300 mg 10 x 10's (Unison) | |
| Lexemin tab 160 mg / micronized 10 x 10's (Unison) | |
| Lexemin FC tab 160 mg 10 x 10's (Unison) | |
| Lexemin-M (Hongkong) | |
| Lifemore (Vietnam) | |
| Lifemore 200 mg x 10 Blister x 10 Tablet | |
| Lifemore 200 mg x 1 Bottle 100 Tablet | |
| Lifen (Indonesia, Taiwan) | |
| Lifen 500 mg | |
| Lifen 200M 200 mg x 3 x 10's | $ 33.48 |
| Lifen 200M (Indonesia) | |
| Lifenoz-U (Taiwan) | |
| Lifenoz-U 160 mg | |
| Lifibrat (Vietnam) | |
| Lifibrat 100 mg x 4 Blister x 10 Tablet, 10 Blister x 10 Tablet | |
| Lifibrat 200 mg x 3 Blister x 10 Tablet, 10 Blister x 10 Tablet | |
| Lifibrat 300 mg x 3 Blister x 10 Tablet, 10 Blister x 10 Tablet | |
| Lifibrat 100 mg x 4 Blister x 10 Tablet | |
See 1103 substitutes for Gadolip 45 | |
References
- DailyMed. "FENOFIBRATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- PubChem. "fenofibrate". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
- DrugBank. "fenofibrate". http://www.drugbank.ca/drugs/DB01039 (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Gadolip 45 are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Gadolip 45. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
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Information checked by Dr. Sachin Kumar, MD Pharmacology
