Fibrocit Uses

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What is Fibrocit?

Fibrocit 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).

Fibrocit is used together with diet to treat very high cholesterol and triglyceride levels in people with pancreatitis.

Fibrocit is also used to lower the risk of stroke, heart attack, or other heart complications in people with high cholesterol and triglycerides who have not been helped by other treatment methods.

Fibrocit may also be used for purposes not listed in this medication guide.

Fibrocit indications

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Fibrocit tablets are indicated as adjunctive therapy to diet for:

1.
Treatment of adult patients with very high elevations of serum triglyceride levels (Types IV and V hyperlipidemia) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. Patients who present such risk typically have serum triglycerides over 2000 mg/dL and have elevations of VLDL-cholesterol as well as fasting chylomicrons (Type V hyperlipidemia). Subjects who consistently have total serum or plasma triglycerides below 1000 mg/dL are unlikely to present a risk of pancreatitis. Fibrocit therapy may be considered for those subjects with triglyceride elevations between 1000 and 2000 mg/dL who have a history of pancreatitis or of recurrent abdominal pain typical of pancreatitis. It is recognized that some Type IV patients with triglycerides under 1000 mg/dL may, through dietary or alcoholic indiscretion, convert to a Type V pattern with massive triglyceride elevations accompanying fasting chylomicronemia, but the influence of Fibrocit therapy on the risk of pancreatitis in such situations has not been adequately studied. Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (VLDL). Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV, and V hyperlipoproteinemia.
2.
Reducing the risk of developing coronary heart disease only in Type IIb patients without history of or symptoms of existing coronary heart disease who have had an inadequate response to weight loss, dietary therapy, exercise, and other pharmacologic agents (such as bile acid sequestrants and nicotinic acid, known to reduce LDL- and raise HDL-cholesterol) and who have the following triad of lipid abnormalities: low HDL-cholesterol levels in addition to elevated LDL-cholesterol and elevated triglycerides. The National Cholesterol Education Program has defined a serum HDL-cholesterol value that is consistently below 35 mg/dL as constituting an independent risk factor for coronary heart disease. Patients with significantly elevated triglycerides should be closely observed when treated with Fibrocit. In some patients with high triglyceride levels, treatment with Fibrocit is associated with a significant increase in LDL-cholesterol. BECAUSE OF POTENTIAL TOXICITY SUCH AS MALIGNANCY, GALLBLADDER DISEASE, ABDOMINAL PAIN LEADING TO APPENDECTOMY AND OTHER ABDOMINAL SURGERIES, AN INCREASED INCIDENCE IN NON-CORONARY MORTALITY, AND THE 44% RELATIVE INCREASE DURING THE TRIAL PERIOD IN AGE-ADJUSTED ALL-CAUSE MORTALITY SEEN WITH THE CHEMICALLY AND PHARMACOLOGICALLY RELATED DRUG, CLOFIBRATE, THE POTENTIAL BENEFIT OF Fibrocit IN TREATING TYPE IIA PATIENTS WITH ELEVATIONS OF LDL-CHOLESTEROL ONLY IS NOT LIKELY TO OUTWEIGH THE RISKS. Fibrocit IS ALSO NOT INDICATED FOR THE TREATMENT OF PATIENTS WITH LOW HDL-CHOLESTEROL AS THEIR ONLY LIPID ABNORMALITY.

In a subgroup analysis of patients in the Helsinki Heart Study with above-median HDL-cholesterol values at baseline (greater than 46.4 mg/dL), the incidence of serious coronary events was similar for Fibrocit and placebo subgroups.

The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcohol intake may be important factors in hypertriglyceridemia and should be managed prior to any drug therapy. Physical exercise can be an important ancillary measure, and has been associated with rises in HDL-cholesterol. Diseases contributory to hyperlipidemia such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy is sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of estrogen therapy may obviate the need for specific drug therapy of hypertriglyceridemia. The use of drugs should be considered only when reasonable attempts have been made to obtain satisfactory results with nondrug methods. If the decision is made to use drugs, the patient should be instructed that this does not reduce the importance of adhering to diet.

How should I use Fibrocit?

Use Fibrocit as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ask your health care provider any questions you may have about how to use Fibrocit.

Uses of Fibrocit in details

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Fibrocit along with diet and exercise is used for the treatment of high levels of triglycerides (type of fat) in the blood.

Fibrocit description

Fibrocit also contains the following excipients: Corn starch, polysorbate, silicon dioxide, denatured alcohol, silica, hydroxypropyl cellulose, purified water, microcrystalline cellulose, calcium stearate, methyl hydroxybenzoate, propyl hydroxybenzoate, macrogol, hypromellose, opaspray, candelilla wax, pregelatinized starch, starch sodium glycollate, magnesium stearate, opadry white, hydroxypropyl methyl cellulose, titanium dioxide, talc, polydimethyl siloxane and polyethylene glycol.

Fibrocit, a non-halogenated phenoxypentanoic acid, is 5-(2,5-dimethylphenoxy)-2,2-dimethylpentanoic acid. It has an empirical formula of C15H22O3 and a molecular weight of 250.35.

Fibrocit is a white compound with a melting point of 58-61°C. Its solubility is 0.0019% in water and in acid, and over 1% in dilute base. Fibrocit is stable under ordinary conditions.

Fibrocit dosage

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General: Lipid levels should be measured on >1 occasion, to ascertain that the levels are consistently abnormal. Before instituting therapy with Fibrocit, every attempt should be made to control serum lipids with appropriate diet, limiting alcohol intake, exercise and weight loss in obese patients, as well as controlling other medical problems eg, diabetes mellitus or hypothyroidism which may contribute to the abnormal lipid levels. The patient should continue a standard cholesterol-lowering diet during treatment with Fibrocit. Periodic determinations of serum lipids should be obtained during treatment with Fibrocit. Fibrocit should be withdrawn or additional therapy instituted if the lipid response is inadequate after 3 months.

Recommended Daily Dose: 900-1,200 mg. Maximum Daily Dose: 1,500 mg.

The 900-mg dose is given as a single dose ½ hr before the evening meal. The 1,200-mg dose is given in 2 divided doses, ½ hr before the morning and evening meals.

Use in Patients with Hepatic Dysfunction: See Contraindications and Precautions.

Use in Patients with Renal Dysfunction: See Contraindications and Precautions.

Fibrocit interactions

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What other drugs will affect Fibrocit?

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Anticoagulants: Caution should be exercised when warfarin is given in conjunction with Fibrocit. The dosage of warfarin should be reduced to maintain the prothrombin time at the desired level to prevent bleeding complications. Frequent prothrombin time determinations are advisable until it has been definitely determined that the prothrombin time has stabilized.

HMG-CoA Reductase Inhibitors: The concomitant administration of Fibrocit with simvastatin is contraindicated. There have been reports of severe myositis and myoglobinuria (rhabdomyolysis) when Fibrocit and HMG-CoA reductase inhibitors were used concomitantly.

Bile Acid-Binding Resins: Reduced bioavailability of Fibrocit may result when given simultaneously with resin-granule drugs eg, colestipol. Administration of the drugs ≥2 hrs apart is recommended.

Repaglinide: In healthy volunteers, co-administration with Fibrocit increased the plasma concentration of repaglinide and prolonged its hypoglycemic effects. Co-administration of Fibrocit and repaglinide increases the risk for severe hypoglycemia and is contraindicated.

Colchicine: Risk of neuromuscular toxicity and rhabdomyolysis may be increased with concomitant administration of colchicine and Fibrocit. This risk may be increased in the elderly and in patients with hepatic or renal dysfunction. Symptoms usually last between 1 week and several months after colchicine withdrawal. Clinical and biological monitoring is recommended, especially at the start of combined treatment.

Fibrocit side effects

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What are the possible side effects of Fibrocit?

In the double-blind controlled phase of the Helsinki Heart Study, 2,046 patients received Fibrocit for up to 5 years. In that study, the following adverse reactions were statistically more frequent in subjects in the Fibrocit group: See table.

Additional adverse reactions that have been reported where a causal relationship to treatment with Fibrocit are probably: Hepatobiliary Disorders: Cholestatic jaundice.

Gastrointestinal Disorders: Pancreatitis.

Nervous System Disorders: Dizziness, somnolence, paresthesia, peripheral neuritis, headache.

Psychiatric Disorders: Decreased libido, depression.

Eye Disorders: Blurred vision.

Reproductive System and Breast Disorders: Impotence.

Musculoskeletal and Connective Tissue Disorders: Arthralgia, synovitis, myalgia, myopathy, myasthenia, painful extremities, rhabdomyolysis.

Skin and Subcutaneous Tissue Disorders: Exfoliative dermatitis, rash, dermatitis, pruritus, angioedema, urticaria.

Respiratory, Thoracic and Mediastinal Disorders: Laryngeal edema.

Blood and Lymphatic System Disorders: Severe anemia, leukopenia, thrombocytopenia, eosinophilia, bone marrow hypoplasia.

Additional adverse reactions that have been reported included photosensitivity, alopecia, cholecystitis and cholelithiasis.

Fibrocit contraindications

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What is the most important information I should know about Fibrocit?

1.
Hepatic or severe renal dysfunction, including primary biliary cirrhosis.
2.
Preexisting gallbladder disease.
3.
Hypersensitivity to Fibrocit.
4.
Combination therapy of Fibrocit with simvastatin.
5.
Combination therapy of Fibrocit with repaglinide.
6.
Combination therapy of Fibrocit with dasabuvir.

Active ingredient matches for Fibrocit:

Gemfibrozil in Italy.


List of Fibrocit substitutes (brand and generic names)

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Unit description / dosage (Manufacturer)Price, USD
Fibrolip 200 mg Capsule (Emcure Pharmaceuticals Ltd.)$ 0.07
FIBROLIP 200MG CAPSULE 1 strip / 10 capsules each (Emcure Pharmaceuticals Ltd.)$ 1.48
Fibrolip 200mg Capsule (Emcure Pharmaceuticals Ltd.)$ 0.15
Fibropid 300 300 mg x 10 x 10's
Fibropid 300 300 mg x 500's
Fibrozo 300 mg x 100's
G.F.B-600 600 mg x 10 x 10's
Gem-S 600 mg x 100's, 500's
Gembit 300 mg x 100's
Gembit 300 mg x 500's
Gembo 300 mg x 10 Blister x 10 Tablet
Gembril 600 mg x 100's
Gembropac 300 mg x 500's
Gembropac 300 mg x 1, 000's
Gemd 300 mg x 6 x 10's (Yung shin)
Gemd 300 mg x 1000's (Yung shin)
Gemd 600 mg x 6 x 10's (Yung shin)
Gemd 600 mg x 1000's (Yung shin)
Tablets, Film-Coated; Oral; Gemfibrozil 600 mg (Yung shin)
Gemd YSP 600 mg x 10 x 10's
Tablet, Film-Coated; Oral; Gemfibrozil 450 mg (1a)
Tablet, Film-Coated; Oral; Gemfibrozil 600 mg (1a)
Tablets, Film-Coated; Oral; Gemfibrozil 450 mg (1a)
Tablets, Film-Coated; Oral; Gemfibrozil 600 mg (1a)
Gemfibril 300 mg x 10 x 10's (Siam Bheasach)
Gemfibril 600 mg x 10 x 10's (Siam Bheasach)
Gemfibril cap 300 mg 10 x 10's (Siam Bheasach)

References

  1. 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).
  2. PubChem. "gemfibrozil". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  3. DrugBank. "gemfibrozil". http://www.drugbank.ca/drugs/DB01241 (accessed September 17, 2018).

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