What is Lowlip?
Lowlip (Lowlip) 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).
Lowlip is used to treat high cholesterol and high triglyceride levels.
Lowlip may also be used for purposes not listed in this medication guide.
Lowlip indications
Primary Hypercholesterolemia or Mixed Dyslipidemia
Lowlip 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
Lowlip 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 Lowlip therapy on reducing this risk has not been adequately studied.
Important Limitations of Use
Lowlip 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 Lowlip?
Use Lowlip capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Some brands of Lowlip 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 Lowlip capsules with food.
- Swallow Lowlip capsules whole. Do not open, crush, dissolve, or chew before swallowing. If you cannot swallow Lowlip capsules whole, tell your doctor. You may need a different medicine.
- Take Lowlip 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 Lowlip capsules. Check with your doctor if you have any questions.
- Take Lowlip capsules on a regular schedule to get the most benefit from it.
- Taking Lowlip capsules at the same time each day will help you remember to take it.
- Continue to take Lowlip capsules even if you feel well. Do not miss any doses.
- If you miss a dose of Lowlip 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 Lowlip capsules.
Uses of Lowlip 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, Lowlip 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 Lowlip (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.
Lowlip 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.
Lowlip is a lipid-regulating agent. The empirical formula is C20H21O4Cl and the molecular weight is 360.83. Lowlip is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester.
Lowlip dosage
Lowlip Dosage
Generic name: Lowlip 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 Lowlip is 160 mg once daily.
Patients should be placed on an appropriate lipid-lowering diet before receiving Lowlip and should continue this diet during treatment with Lowlip.
Lipid levels should be monitored periodically. Therapy should be withdrawn in patients who do not have an adequate response after two months of treatment.
Lowlip tablets can be given without regard to meals. Patients should be advised to swallow Lowlip tablets whole. Do not crush, break, dissolve, or chew tablets.
More about Lowlip (Lowlip)
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Consumer resources
- Lowlip
- Lowlip (Advanced Reading)
- Other brands: Lowlip, Lofibra, Lipofen, Lowlip, More (1) »
Professional resources
- Lowlip (FDA)
- Fenofibric Acid/Lowlip (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) »
Lowlip interactions
See also:
What other drugs will affect Lowlip?
Coumarin Anticoagulants
Potentiation of coumarin-type anticoagulant effect has been observed with prolongation of the PT/INR.
Caution should be exercised when Lowlip is given in conjunction with coumarin anticoagulants. Lowlip 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 Lowlip 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 Lowlip capsules, the lowest effective dose of Lowlip 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 Lowlip 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 Lowlip with colchicine.
Lowlip side effects
See also:
What are the possible side effects of Lowlip?
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 Lowlip. Adverse events reported by 2% or more of patients treated with Lowlip 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 Lowlip and in 3.0% treated with placebo. Increases in liver tests were the most frequent events, causing discontinuation of Lowlip treatment in 1.6% of patients in double-blind trials.
Table 1: Adverse Events Reported by 2% or More of Patients Treated with Lowlip and Greater than Placebo During the Double-Blind, Placebo-Controlled Trials
BODY SYSTEM Adverse Event | Lowlip* (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 Lowlip |
Clinical trials with Lowlip did not include a placebo-control arm. However, the adverse event profile of Lowlip was generally consistent with that of Lowlip. The following adverse events not listed above were reported in ≥ 3% of patients taking Lowlip 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 Lowlip: 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.
Lowlip contraindications
See also:
What is the most important information I should know about Lowlip?
Hypersensitivity to Lowlip or fenofibric acid or to any of the excipients of Lowlip.
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.
Lowlip contains lecithin soya as an excipient and therefore, Lowlip 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: Lowlip 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 Lowlip, taking into account the importance of Lowlip to the mother. There are no data on the excretion of Lowlip 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 Lowlip:
Fenofibrate in Taiwan.
Gemfibrozil in Indonesia.
Unit description / dosage (Manufacturer) | Price, USD |
Lowlip 20 mg x 3 Blister x 10 Tablet | |
Lowlip 40 mg x 3 Blister x 10 Tablet | |
List of Lowlip substitutes (brand and generic names): | |
Lowin (Hong Kong) | |
Lowin NA Eye Drop (Duopharma) | $ 0.54 |
Lowpirol (South Korea) | |
Lozil (Brazil) | |
Luo Ping (China) | |
Luxacor | |
Capsule; Oral; Fenofibrate 100 mg | |
Capsule; Oral; Fenofibrate 150 mg | |
Capsule; Oral; Fenofibrate 50 mg | |
Magnofen (Argentina) | |
Manobrozil (Thailand) | |
Manobrozil 300 mg x 100's (March Pharma) | |
Manobrozil 300 mg x 500's (March Pharma) | |
Manobrozil 600 mg x 100's (March Pharma) | |
Manobrozil 600 mg x 500's (March Pharma) | |
Manobrozil cap 300 mg 100's (March Pharma) | |
Manobrozil cap 300 mg 500's (March Pharma) | |
Manobrozil tab 600 mg 100's (March Pharma) | |
Manobrozil tab 600 mg 500's (March Pharma) | |
Marbrozil (Hong Kong) | |
Mariston (Thailand) | |
Medopid (Vietnam) | |
Medopid 300 mg x 10 Blister x 10 Tablet | |
Medothyl (Vietnam) | |
Medothyl 300 mg x 10 Blister x 3 Tablet | |
Mersikol (Indonesia) | |
Mersikol 300 mg x 100's (Mersifarma TM) | $ 21.70 |
Mersikol 600 mg x 30's (Mersifarma TM) | $ 13.64 |
Mersikol 900 mg x 30's (Mersifarma TM) | $ 18.60 |
Micolip | |
Milpid (Thailand) | |
Milpid 600 600 mg x 10 x 10's | |
Milpid 900 900 mg x 10 x 10's | |
Milpid 600/Milpid 900 (Thailand) | |
Milpid 600 tab 600 mg 10 x 10's (Millimed) | |
Milpid 900 tab 900 mg 10 x 10's (Millimed) | |
Minilip (Hungary) | |
Mint-Fenofibrate (Canada) | |
Minuslip (Argentina) | |
Mylan-Fenofibrate Micro | |
Capsule; Oral; Fenofibrate 200 mg | |
Mylan-fenofibrate Micro capsule 200 mg (Mylan Pharmaceuticals Ulc (Canada)) | |
Mylan-Gemfibrozil | |
Capsule; Oral; Gemfibrozil 300 mg | |
Tablet; Oral; Gemfibrozil 600 mg | |
Capsules; Oral; Gemfibrozil 300 mg | |
Tablets; Oral; Gemfibrozil 600 mg | |
Mylan-gemfibrozil capsule 300 mg (Mylan Pharmaceuticals Ulc (Canada)) | |
Mylan-gemfibrozil tablet 600 mg (Mylan Pharmaceuticals Ulc (Canada)) | |
Naftilan (China) | |
Nanofib (Lebanon) | |
Neo-Disterin (Greece) | |
See 1654 substitutes for Lowlip |
References
- DailyMed. "GEMFIBROZIL: 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).
- 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. "gemfibrozil". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Lowlip 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 Lowlip. 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
No survey data has been collected yet1 consumer reported price estimates
Was the price you paid to purchase the drug reasonable? Did you feel it was expensive?The below mentioned numbers have been reported by ndrugs.com website users about whether the Lowlip drug is expensive or inexpensive. There is a mixed opinion among users. The rating about the cost of the drug depends on factors like which brand drug the patient purchased, how effective it was for the price paid, the country or place the drug is marketed, and the economic condition of the patient. The users who feel the drug is expensive can look for an alternative brand drug or a generic drug to save the cost.
Users | % | ||
---|---|---|---|
Not expensive | 1 | 100.0% |
Consumer reported time for results
No survey data has been collected yetConsumer reported age
No survey data has been collected yetConsumer reviews
There are no reviews yet. Be the first to write one! |
Information checked by Dr. Sachin Kumar, MD Pharmacology