What is Normalip Pro?
Normalip Pro (Normalip Pro) 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).
Normalip Pro is used to treat high cholesterol and high triglyceride levels.
Normalip Pro may also be used for purposes not listed in this medication guide.
Normalip Pro indications
Primary Hypercholesterolemia or Mixed Dyslipidemia
Normalip Pro 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
Normalip Pro 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 Normalip Pro therapy on reducing this risk has not been adequately studied.
Important Limitations of Use
Normalip Pro 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 Normalip Pro?
Use Normalip Pro capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Some brands of Normalip Pro 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 Normalip Pro capsules with food.
- Swallow Normalip Pro capsules whole. Do not open, crush, dissolve, or chew before swallowing. If you cannot swallow Normalip Pro capsules whole, tell your doctor. You may need a different medicine.
- Take Normalip Pro 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 Normalip Pro capsules. Check with your doctor if you have any questions.
- Take Normalip Pro capsules on a regular schedule to get the most benefit from it.
- Taking Normalip Pro capsules at the same time each day will help you remember to take it.
- Continue to take Normalip Pro capsules even if you feel well. Do not miss any doses.
- If you miss a dose of Normalip Pro 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 Normalip Pro capsules.
Uses of Normalip Pro 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, Normalip Pro 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 Normalip Pro (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.
Normalip Pro 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.
Normalip Pro is a lipid-regulating agent. The empirical formula is C20H21O4Cl and the molecular weight is 360.83. Normalip Pro is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester.
Normalip Pro dosage
Normalip Pro Dosage
Generic name: Normalip Pro 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 Normalip Pro is 160 mg once daily.
Patients should be placed on an appropriate lipid-lowering diet before receiving Normalip Pro and should continue this diet during treatment with Normalip Pro.
Lipid levels should be monitored periodically. Therapy should be withdrawn in patients who do not have an adequate response after two months of treatment.
Normalip Pro tablets can be given without regard to meals. Patients should be advised to swallow Normalip Pro tablets whole. Do not crush, break, dissolve, or chew tablets.
More about Normalip Pro (Normalip Pro)
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Consumer resources
- Normalip Pro
- Normalip Pro (Advanced Reading)
- Other brands: Normalip Pro, Lofibra, Lipofen, Normalip Pro, More (1) »
Professional resources
- Normalip Pro (FDA)
- Fenofibric Acid/Normalip Pro (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) »
Normalip Pro interactions
See also:
What other drugs will affect Normalip Pro?
Coumarin Anticoagulants
Potentiation of coumarin-type anticoagulant effect has been observed with prolongation of the PT/INR.
Caution should be exercised when Normalip Pro is given in conjunction with coumarin anticoagulants. Normalip Pro 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 Normalip Pro 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 Normalip Pro capsules, the lowest effective dose of Normalip Pro 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 Normalip Pro 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 Normalip Pro with colchicine.
Normalip Pro side effects
See also:
What are the possible side effects of Normalip Pro?
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 Normalip Pro. Adverse events reported by 2% or more of patients treated with Normalip Pro 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 Normalip Pro and in 3.0% treated with placebo. Increases in liver tests were the most frequent events, causing discontinuation of Normalip Pro treatment in 1.6% of patients in double-blind trials.
Table 1: Adverse Events Reported by 2% or More of Patients Treated with Normalip Pro and Greater than Placebo During the Double-Blind, Placebo-Controlled Trials
| BODY SYSTEM Adverse Event | Normalip Pro* (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 Normalip Pro |
Clinical trials with Normalip Pro did not include a placebo-control arm. However, the adverse event profile of Normalip Pro was generally consistent with that of Normalip Pro. The following adverse events not listed above were reported in ≥ 3% of patients taking Normalip Pro 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 Normalip Pro: 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.
Normalip Pro contraindications
See also:
What is the most important information I should know about Normalip Pro?
Hypersensitivity to Normalip Pro or fenofibric acid or to any of the excipients of Normalip Pro.
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.
Normalip Pro contains lecithin soya as an excipient and therefore, Normalip Pro 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: Normalip Pro 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 Normalip Pro, taking into account the importance of Normalip Pro to the mother. There are no data on the excretion of Normalip Pro 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 Normalip Pro:
Fenofibrate in Germany.
| Unit description / dosage (Manufacturer) | Price, USD |
| Capsule; Oral; Fenofibrate 200 mg | |
List of Normalip Pro substitutes (brand and generic names): | |
| Nopid (South Korea) | |
| 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 | |
| Procetoken (Argentina) | |
| Proctofene | |
See 1103 substitutes for Normalip Pro | |
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 Normalip Pro 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 Normalip Pro. 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
Consumer reported useful
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Information checked by Dr. Sachin Kumar, MD Pharmacology
