What is Nolipax?
Nolipax (Nolipax) 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).
Nolipax is used to treat high cholesterol and high triglyceride levels.
Nolipax may also be used for purposes not listed in this medication guide.
Nolipax indications
Primary Hypercholesterolemia or Mixed Dyslipidemia
Nolipax 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
Nolipax 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 Nolipax therapy on reducing this risk has not been adequately studied.
Important Limitations of Use
Nolipax 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 Nolipax?
Use Nolipax capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Some brands of Nolipax 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 Nolipax capsules with food.
- Swallow Nolipax capsules whole. Do not open, crush, dissolve, or chew before swallowing. If you cannot swallow Nolipax capsules whole, tell your doctor. You may need a different medicine.
- Take Nolipax 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 Nolipax capsules. Check with your doctor if you have any questions.
- Take Nolipax capsules on a regular schedule to get the most benefit from it.
- Taking Nolipax capsules at the same time each day will help you remember to take it.
- Continue to take Nolipax capsules even if you feel well. Do not miss any doses.
- If you miss a dose of Nolipax 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 Nolipax capsules.
Uses of Nolipax 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, Nolipax 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 Nolipax (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.
Nolipax 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.
Nolipax is a lipid-regulating agent. The empirical formula is C20H21O4Cl and the molecular weight is 360.83. Nolipax is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester.
Nolipax dosage
Nolipax Dosage
Generic name: Nolipax 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 Nolipax is 160 mg once daily.
Patients should be placed on an appropriate lipid-lowering diet before receiving Nolipax and should continue this diet during treatment with Nolipax.
Lipid levels should be monitored periodically. Therapy should be withdrawn in patients who do not have an adequate response after two months of treatment.
Nolipax tablets can be given without regard to meals. Patients should be advised to swallow Nolipax tablets whole. Do not crush, break, dissolve, or chew tablets.
More about Nolipax (Nolipax)
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Consumer resources
- Nolipax
- Nolipax (Advanced Reading)
- Other brands: Nolipax, Lofibra, Lipofen, Nolipax, More (1) »
Professional resources
- Nolipax (FDA)
- Fenofibric Acid/Nolipax (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) »
Nolipax interactions
See also:
What other drugs will affect Nolipax?
Coumarin Anticoagulants
Potentiation of coumarin-type anticoagulant effect has been observed with prolongation of the PT/INR.
Caution should be exercised when Nolipax is given in conjunction with coumarin anticoagulants. Nolipax 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 Nolipax 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 Nolipax capsules, the lowest effective dose of Nolipax 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 Nolipax 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 Nolipax with colchicine.
Nolipax side effects
See also:
What are the possible side effects of Nolipax?
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 Nolipax. Adverse events reported by 2% or more of patients treated with Nolipax 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 Nolipax and in 3.0% treated with placebo. Increases in liver tests were the most frequent events, causing discontinuation of Nolipax treatment in 1.6% of patients in double-blind trials.
Table 1: Adverse Events Reported by 2% or More of Patients Treated with Nolipax and Greater than Placebo During the Double-Blind, Placebo-Controlled Trials
| BODY SYSTEM Adverse Event | Nolipax* (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 Nolipax |
Clinical trials with Nolipax did not include a placebo-control arm. However, the adverse event profile of Nolipax was generally consistent with that of Nolipax. The following adverse events not listed above were reported in ≥ 3% of patients taking Nolipax 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 Nolipax: 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.
Nolipax contraindications
See also:
What is the most important information I should know about Nolipax?
Hypersensitivity to Nolipax or fenofibric acid or to any of the excipients of Nolipax.
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.
Nolipax contains lecithin soya as an excipient and therefore, Nolipax 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: Nolipax 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 Nolipax, taking into account the importance of Nolipax to the mother. There are no data on the excretion of Nolipax 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 Nolipax:
Fenofibrate in Italy.
List of Nolipax substitutes (brand and generic names) | Sort by popularity |
| Unit description / dosage (Manufacturer) | Price, USD |
| Noficon (Bangladesh) | |
| Nopid (South Korea) | |
| Normalip Pro (Germany) | |
| Capsule; Oral; Fenofibrate 200 mg (Abbott) | |
| Normolip (Colombia, Dominican Republic, El Salvador, Honduras, India) | |
| NORMOLIP Capsule/ Tablet / 300mg / 10 units (Sun Pharmaceutical Industries Ltd.) | $ 1.33 |
| Normolip 300mg CAP / 10 (Sun Pharmaceutical Industries Ltd.) | $ 1.14 |
| 300 mg x 10's (Sun Pharmaceutical Industries Ltd.) | $ 1.14 |
| Capsules; Oral; Gemfibrozil 300 mg (Sun Pharmaceutical Industries Ltd.) | |
| Normolip 300 mg Capsule (Sun Pharmaceutical Industries Ltd.) | $ 0.12 |
| NORMOLIP 300MG CAPSULE 1 strip / 10 capsules each (Sun Pharmaceutical Industries Ltd.) | $ 1.48 |
| NORMOLIP cap 300 mg x 10's (Sun Pharmaceutical Industries Ltd.) | $ 1.14 |
| Nortricol (Colombia) | |
| Novalip (Tunisia) | |
| Novalip LM (Tunisia) | |
| Novastat TG | |
| Novastat TG 10+160 Tablet (Lupin Laboratories Ltd.) | $ 0.16 |
| NOVASTAT TG 160 MG/10 MG TABLET 1 strip / 10 tablets each (Lupin Laboratories Ltd.) | $ 2.07 |
| NOVASTAT TG 160 MG/20 MG TABLET 1 strip / 10 tablets each (Lupin Laboratories Ltd.) | $ 3.37 |
| NOVASTAT TG 160 MG/5 MG TABLET 1 strip / 10 tablets each (Lupin Laboratories Ltd.) | $ 1.25 |
| Novo-Fenofibrate | |
| Capsule; Oral; Fenofibrate 100 mg | |
| Novo-fenofibrate capsule 100 mg (Novopharm Limited (Canada)) | |
| Novo-Fenofibrate Micronized | |
| Capsule; Oral; Fenofibrate 200 mg | |
| Capsule; Oral; Fenofibrate 67 mg | |
| Novo-fenofibrate Micronized capsule 200 mg (Novopharm Limited (Canada)) | |
| Novo-fenofibrate Micronized capsule 67 mg (Novopharm Limited (Canada)) | |
| Novo-Fenofibrate-S | |
| Tablet; Oral; Fenofibrate 100 mg | |
| Tablet; Oral; Fenofibrate 160 mg | |
| Nu-Fenofibrate | |
| Capsule; Oral; Fenofibrate 100 mg | |
| Nu-fenofibrate capsule 100 mg (Nu Pharm Inc (Canada)) | |
| Nubrex (Philippines) | |
| Nubrex 100 mg x 100's (Sandoz) | $ 39.71 |
| Nubrex 300 mg x 30's (Sandoz) | $ 33.00 |
| Nubrex cap 100 mg 100's (Sandoz) | $ 39.71 |
| Nubrex cap 300 mg 30's (Sandoz) | $ 21.00 |
| Nuozhituo (China) | |
| Philbisrol (Vietnam) | |
| Philbisrol 250 mg x 10 Blister x 10 Tablet | |
| PHL-Fenofibrate Micro | |
| Capsule; Oral; Fenofibrate 200 mg | |
| PHL-fenofibrate Micro capsule 200 mg (Pharmel Inc (Canada)) | |
| Planitrix (Greece) | |
| PMS-Fenofibrate Micro (Canada) | |
| Capsule; Oral; Fenofibrate 200 mg | |
| PMS-fenofibrate Micro capsule 200 mg (Pharmascience Inc (Canada)) | |
| pms-Lipisans (Vietnam) | |
| pms-Lipisans 300 mg x 3 Blister x 10 Tablet | |
| Pro-Feno-Super (Canada) | |
| Tablet; Oral; Fenofibrate 100 mg | |
| Tablet; Oral; Fenofibrate 160 mg | |
| Procetofen | |
See 1103 substitutes for Nolipax | |
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
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Information checked by Dr. Sachin Kumar, MD Pharmacology
