What is Lipidstop 200?
Lipidstop 200 (Lipidstop 200) 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).
Lipidstop 200 is used to treat high cholesterol and high triglyceride levels.
Lipidstop 200 may also be used for purposes not listed in this medication guide.
Lipidstop 200 indications
Primary Hypercholesterolemia or Mixed Dyslipidemia
Lipidstop 200 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
Lipidstop 200 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 Lipidstop 200 therapy on reducing this risk has not been adequately studied.
Important Limitations of Use
Lipidstop 200 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 Lipidstop 200?
Use Lipidstop 200 capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Some brands of Lipidstop 200 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 Lipidstop 200 capsules with food.
- Swallow Lipidstop 200 capsules whole. Do not open, crush, dissolve, or chew before swallowing. If you cannot swallow Lipidstop 200 capsules whole, tell your doctor. You may need a different medicine.
- Take Lipidstop 200 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 Lipidstop 200 capsules. Check with your doctor if you have any questions.
- Take Lipidstop 200 capsules on a regular schedule to get the most benefit from it.
- Taking Lipidstop 200 capsules at the same time each day will help you remember to take it.
- Continue to take Lipidstop 200 capsules even if you feel well. Do not miss any doses.
- If you miss a dose of Lipidstop 200 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 Lipidstop 200 capsules.
Uses of Lipidstop 200 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, Lipidstop 200 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 Lipidstop 200 (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.
Lipidstop 200 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.
Lipidstop 200 is a lipid-regulating agent. The empirical formula is C20H21O4Cl and the molecular weight is 360.83. Lipidstop 200 is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester.
Lipidstop 200 dosage
Lipidstop 200 Dosage
Generic name: Lipidstop 200 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 Lipidstop 200 is 160 mg once daily.
Patients should be placed on an appropriate lipid-lowering diet before receiving Lipidstop 200 and should continue this diet during treatment with Lipidstop 200.
Lipid levels should be monitored periodically. Therapy should be withdrawn in patients who do not have an adequate response after two months of treatment.
Lipidstop 200 tablets can be given without regard to meals. Patients should be advised to swallow Lipidstop 200 tablets whole. Do not crush, break, dissolve, or chew tablets.
More about Lipidstop 200 (Lipidstop 200)
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Consumer resources
- Lipidstop 200
- Lipidstop 200 (Advanced Reading)
- Other brands: Lipidstop 200, Lofibra, Lipofen, Lipidstop 200, More (1) »
Professional resources
- Lipidstop 200 (FDA)
- Fenofibric Acid/Lipidstop 200 (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) »
Lipidstop 200 interactions
See also:
What other drugs will affect Lipidstop 200?
Coumarin Anticoagulants
Potentiation of coumarin-type anticoagulant effect has been observed with prolongation of the PT/INR.
Caution should be exercised when Lipidstop 200 is given in conjunction with coumarin anticoagulants. Lipidstop 200 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 Lipidstop 200 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 Lipidstop 200 capsules, the lowest effective dose of Lipidstop 200 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 Lipidstop 200 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 Lipidstop 200 with colchicine.
Lipidstop 200 side effects
See also:
What are the possible side effects of Lipidstop 200?
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 Lipidstop 200. Adverse events reported by 2% or more of patients treated with Lipidstop 200 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 Lipidstop 200 and in 3.0% treated with placebo. Increases in liver tests were the most frequent events, causing discontinuation of Lipidstop 200 treatment in 1.6% of patients in double-blind trials.
Table 1: Adverse Events Reported by 2% or More of Patients Treated with Lipidstop 200 and Greater than Placebo During the Double-Blind, Placebo-Controlled Trials
BODY SYSTEM Adverse Event | Lipidstop 200* (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 Lipidstop 200 |
Clinical trials with Lipidstop 200 did not include a placebo-control arm. However, the adverse event profile of Lipidstop 200 was generally consistent with that of Lipidstop 200. The following adverse events not listed above were reported in ≥ 3% of patients taking Lipidstop 200 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 Lipidstop 200: 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.
Lipidstop 200 contraindications
See also:
What is the most important information I should know about Lipidstop 200?
Hypersensitivity to Lipidstop 200 or fenofibric acid or to any of the excipients of Lipidstop 200.
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.
Lipidstop 200 contains lecithin soya as an excipient and therefore, Lipidstop 200 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: Lipidstop 200 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 Lipidstop 200, taking into account the importance of Lipidstop 200 to the mother. There are no data on the excretion of Lipidstop 200 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 Lipidstop 200:
Fenofibrate in Vietnam.
Unit description / dosage (Manufacturer) | Price, USD |
Lipidstop 200 200 mg x 2 Blister x 10 Tablet | |
List of Lipidstop 200 substitutes (brand and generic names): | |
Lipidof (Bangladesh) | |
Lipidof micronized cap 200 mg 2 x 10's (Acme Lab) | |
Lipiduce (Philippines) | |
Lipiduce 10 mg x 3 x 10's (Hovid) | |
Lipiduce 20 mg x 3 x 10's (Hovid) | |
Lipiduce 100 mg x 100's (Hovid) | |
Lipiduce 300 mg x 100's (Hovid) | |
Lipiduce FC tab 10 mg 3 x 10's (Hovid) | |
Lipiduce FC tab 20 mg 3 x 10's (Hovid) | |
Lipiduce film-coated tab 10 mg 3 x 10's (Hovid) | |
Lipiduce film-coated tab 20 mg 3 x 10's (Hovid) | |
Lipiduce FC tab 160 mg 10 x 10's (Hovid) | |
Lipil (Italy) | |
Lipilfen (China, South Korea) | |
Lipilfen 160 mg x 30's | $ 25.74 |
Lipilo (China) | |
Lipirate (Vietnam) | |
Lipirate 100 mg x 4 Blister x 12 Tablet | |
Lipirate 100 mg x 3 Blister x 10 Tablet | |
Lipirate 100 mg x 5 Blister x 10 Tablet | |
Lipirate 160 (Vietnam) | |
Lipirate 160 160 mg x 5 Blister x 10 Tablet | |
Lipired (Bangladesh) | |
LIPIREG | |
LIPIREG 160 MG TABLET 1 strip / 10 tablets each (Alembic Pharmaceuticals Ltd) | $ 0.82 |
Lipireg 160mg Tablet (Alembic Pharmaceuticals Ltd) | $ 0.08 |
Lipirex (Czech Republic) | |
Capsule; Oral; Fenofibrate 200 mg (Sanofi-aventis) | |
Capsule; Oral; Fenofibrate 67 mg (Sanofi-aventis) | |
Lipivim (Romania) | |
Lipo Plus (Argentina) | |
Lipo Plus C (Argentina) | |
Lipo Red (Spain) | |
Lipoclar (Italy) | |
Lipofen (Portugal, Turkey, United States) | |
Capsule; Oral; Fenofibrate 100 mg (Nobel) | |
Capsule; Oral; Fenofibrate 150 mg (Nobel) | |
Capsule; Oral; Fenofibrate 50 mg (Nobel) | |
30 capsule in 1 bottle, plastic (Nobel) | |
90 capsule in 1 bottle, plastic (Nobel) | |
Lipofen capsule 150 mg/1 (Nobel) | |
Lipofen capsule 50 mg/1 (Nobel) | |
LIPOFEN SR | |
Lipofen-SR (Turkey) | |
Lipofene (Italy) | |
Lipofib (Romania) | |
Lipohexal (Czech Republic) | |
Lipolex (Egypt) | |
Lipomax 105 (Argentina) | |
Lipomax 35 (Argentina) | |
See 1103 substitutes for Lipidstop 200 |
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 Lipidstop 200 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 Lipidstop 200. 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