What is Gardenal Sodium?
Gardenal Sodium (Gardenal Sodium) 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).
Gardenal Sodium is used to treat high cholesterol and high triglyceride levels.
Gardenal Sodium may also be used for purposes not listed in this medication guide.
Gardenal Sodium indications
Primary Hypercholesterolemia or Mixed Dyslipidemia
Gardenal Sodium 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
Gardenal Sodium 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 Gardenal Sodium therapy on reducing this risk has not been adequately studied.
Important Limitations of Use
Gardenal Sodium 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 Gardenal Sodium?
Use Gardenal Sodium capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Some brands of Gardenal Sodium 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 Gardenal Sodium capsules with food.
- Swallow Gardenal Sodium capsules whole. Do not open, crush, dissolve, or chew before swallowing. If you cannot swallow Gardenal Sodium capsules whole, tell your doctor. You may need a different medicine.
- Take Gardenal Sodium 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 Gardenal Sodium capsules. Check with your doctor if you have any questions.
- Take Gardenal Sodium capsules on a regular schedule to get the most benefit from it.
- Taking Gardenal Sodium capsules at the same time each day will help you remember to take it.
- Continue to take Gardenal Sodium capsules even if you feel well. Do not miss any doses.
- If you miss a dose of Gardenal Sodium 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 Gardenal Sodium capsules.
Uses of Gardenal Sodium 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, Gardenal Sodium 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 Gardenal Sodium (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.
Gardenal Sodium 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.
Gardenal Sodium is a lipid-regulating agent. The empirical formula is C20H21O4Cl and the molecular weight is 360.83. Gardenal Sodium is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester.
Gardenal Sodium dosage
Gardenal Sodium Dosage
Generic name: Gardenal Sodium 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 Gardenal Sodium is 160 mg once daily.
Patients should be placed on an appropriate lipid-lowering diet before receiving Gardenal Sodium and should continue this diet during treatment with Gardenal Sodium.
Lipid levels should be monitored periodically. Therapy should be withdrawn in patients who do not have an adequate response after two months of treatment.
Gardenal Sodium tablets can be given without regard to meals. Patients should be advised to swallow Gardenal Sodium tablets whole. Do not crush, break, dissolve, or chew tablets.
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Consumer resources
- Gardenal Sodium
- Gardenal Sodium (Advanced Reading)
- Other brands: Gardenal Sodium, Lofibra, Lipofen, Gardenal Sodium, More (1) »
Professional resources
- Gardenal Sodium (FDA)
- Fenofibric Acid/Gardenal Sodium (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) »
Gardenal Sodium interactions
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What other drugs will affect Gardenal Sodium?
Coumarin Anticoagulants
Potentiation of coumarin-type anticoagulant effect has been observed with prolongation of the PT/INR.
Caution should be exercised when Gardenal Sodium is given in conjunction with coumarin anticoagulants. Gardenal Sodium 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 Gardenal Sodium 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 Gardenal Sodium capsules, the lowest effective dose of Gardenal Sodium 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 Gardenal Sodium 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 Gardenal Sodium with colchicine.
Gardenal Sodium side effects
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What are the possible side effects of Gardenal Sodium?
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 Gardenal Sodium. Adverse events reported by 2% or more of patients treated with Gardenal Sodium 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 Gardenal Sodium and in 3.0% treated with placebo. Increases in liver tests were the most frequent events, causing discontinuation of Gardenal Sodium treatment in 1.6% of patients in double-blind trials.
Table 1: Adverse Events Reported by 2% or More of Patients Treated with Gardenal Sodium and Greater than Placebo During the Double-Blind, Placebo-Controlled Trials
| BODY SYSTEM Adverse Event | Gardenal Sodium* (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 Gardenal Sodium |
Clinical trials with Gardenal Sodium did not include a placebo-control arm. However, the adverse event profile of Gardenal Sodium was generally consistent with that of Gardenal Sodium. The following adverse events not listed above were reported in ≥ 3% of patients taking Gardenal Sodium 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 Gardenal Sodium: 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.
Gardenal Sodium contraindications
See also:
What is the most important information I should know about Gardenal Sodium?
Hypersensitivity to Gardenal Sodium or fenofibric acid or to any of the excipients of Gardenal Sodium.
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.
Gardenal Sodium contains lecithin soya as an excipient and therefore, Gardenal Sodium 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: Gardenal Sodium 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 Gardenal Sodium, taking into account the importance of Gardenal Sodium to the mother. There are no data on the excretion of Gardenal Sodium 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 Gardenal Sodium:
Fenofibrate in Lebanon.
List of Gardenal Sodium substitutes (brand and generic names) | Sort by popularity |
| Unit description / dosage (Manufacturer) | Price, USD |
| Gadolip 45 (Argentina) | |
| 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 | |
| Lifibrat 100 mg x 10 Blister x 10 Tablet | |
See 1103 substitutes for Gardenal Sodium | |
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 Gardenal Sodium 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 Gardenal Sodium. 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
