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RX ITEM-Triglide 50Mg Tab 30 By Shionogi Pharma

NDC 59630-0480-30 UPC/GTIN No.3-59630-48030-1 Mfg.Part No.48030BRAND: TRIGLIDE NDC: 59630-0480-30,59630048030 UPC: 3-59630-48030-1,359630480301 Shionogi Pharma, Inc.Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scopWant to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

RX ITEM-Triglide 50Mg Tab 30 By Shionogi Pharma

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Item No.: RX843211 NDC No.59630048030 UPC No.:359630480301 NDC No.59630-0480-30 UPC/GTIN No.3-59630-48030-1 MPN 48030 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,ResearchCo.,Uni.,VA,Vet & Wholesalers in scope of practice can order this RX item. Rx Item No.Rx843211 Triglide 50mg Tab 30 by Shionogi Pharma, Item No.3843211 NDC No.59630048030 UPC No.359630480301 Other Name Triglide Therapeut

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TRIGLIDE- fenofibrate tablet
First Horizon Pharmaceutical

DESCRIPTION

TRIGLIDE� (fenofibrate) tablets, is a lipid-regulating agent available as tablets for oral administration.

Each tablet contains 50 mg or 160 mg of fenofibrate.

The chemical name for fenofibrate is 2-[4-(4- chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula:

Image from Drug Label Content


The empirical formula is C20 H21 O4 Cl and the molecular weight is 360.83; fenofibrate is insoluble in water.

The melting point is 79�C to 82�C. Fenofibrate is a white solid that is stable under ordinary conditions.

Inactive Ingredients: Each tablet also contains crospovidone, lactose monohydrate, mannitol, maltodextrin, carboxymethylcellulose sodium, egg lecithin, croscarmellose sodium, sodium lauryl sulfate, colloidal silicon dioxide, magnesium stearate, and monobasic sodium phosphate.

CLINICAL PHARMACOLOGY

A variety of clinical studies have demonstrated that elevated levels of total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), and apolipoprotein B (apo B), an LDL membrane complex, are associated with human atherosclerosis. Similarly, decreased levels of high-density lipoprotein cholesterol (HDL-C) and its transport complex, apolipoprotein A (apo A-I and apo A-II) are associated with the development of atherosclerosis. Epidemiologic investigations have established that cardiovascular morbidity and mortality vary directly with the level of TC, LDL-C, and triglycerides (TG), and inversely with the level of HDL-C. The independent effect of raising HDL-C or lowering TG on the risk of cardiovascular morbidity and mortality has not been determined. Fenofibric acid, the active metabolite of fenofibrate, produces reductions in total cholesterol, LDL cholesterol, apolipoprotein B, total triglycerides and triglyceride rich lipoprotein (VLDL) in treated patients. In addition, treatment with fenofibrate results in increases in high density lipoprotein (HDL) and apoproteins apo AI and apo AII. The effects of fenofibric acid seen in clinical practice have been explained in vivo in transgenic mice and in vitro in human hepatocyte cultures by the activation of peroxisome proliferator activated receptor α(PPARα). Through this mechanism, fenofibrate increases lipolysis and elimination of triglyceride-rich particles from plasma by activating lipoprotein lipase and reducing production of apoprotein C-III (an inhibitor of lipoprotein lipase activity). The resulting fall in TG produces an alteration in the size and composition of LDL from small, dense particles (which are thought to be atherogenic due to their susceptibility to oxidation), to large buoyant particles. These larger particles have a greater affinity for cholesterol receptors and are catabolized rapidly. Activation of PPARα also induces an increase in the synthesis of apoproteins A-I, A-II and HDL-cholesterol.

Fenofibrate also reduces serum uric acid levels in hyperuricemic and normal individuals by increasing the urinary excretion of uric acid.
INDICATIONS AND USAGE

Treatment of Hypercholesterolemia
Triglide is indicated as adjunctive therapy to diet for the reduction of LDL-C, Total-C, Triglycerides and Apo B in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Frederickson Types IIa and IIb).

Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological interventions alone has been inadequate (see National Cholesterol Education Program [NCEP] Treatment Guidelines, below).

Treatment of Hypertriglyceridemia


TRIGLIDE is indicated as adjunctive therapy to diet for treatment of adult patients with hypertriglyceridemia (Fredrickson Types IV and V hyperlipidemia).

Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually reduce fasting triglycerides and eliminate chylomicronemia thereby obviating 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 TRIGLIDE therapy on reducing this risk has not been studied.
CONTRAINDICATIONS

TRIGLIDE administration is contraindicated in the following conditions:

Hypersensitivity to fenofibrate or any of the formulation components
Severe renal dysfunction
Heptatic dysfunction, including primary biliary cirrhosis and unexplained persistent liver function abnormality
Pre-existing gallbladder disease
OVERDOSAGE

There is no specific treatment for overdose with TRIGLIDE. General supportive care of the patient is indicated, including monitoring of vital signs and observation of clinical status, should an overdose occur. If indicated, elimination of unabsorbed drug should be achieved by emesis or gastric lavage; usual precautions should be observed to maintain the airway. Because fenofibrate is highly bound to plasma proteins, hemodialysis should not be considered.

DOSAGE AND ADMINISTRATION

Patients should be placed on an appropriate lipid-lowering diet before receiving TRIGLIDE and should continue on this diet during treatment with TRIGLIDE.

TRIGLIDE may be administered with or without food.

For the treatment of adult patients with primary hypercholesterolemia or mixed hyperlipidemia, the initial dose of TRIGLIDE is 160 mg per day.

For adult patients with hypertriglyceridemia, the initial dose is 50 mg to 160 mg once daily.

Dosage should be individualized according to patient response, and should be adjusted if necessary following repeat lipid determinations at 4 to 8 week intervals.

The maximum dose is 160 mg per day.
Treatment with TRIGLIDE should be initiated at a dose of 50 mg/day in patients with impaired renal function, and increased only after evaluation of the effects on renal function and lipid levels at this dose.

In the elderly, the initial dose should likewise be limited to 50 mg/day. Lipid levels should be monitored periodically and consideration should be given to reducing the dosage of TRIGLIDE if lipid levels fall significantly below the targeted range.

NDC 59630-0480-30 UPC/GTIN No.3-59630-48030-1 Mfg.Part No.48030
RX ITEM-Triglide 50Mg Tab 30 By Shionogi
NDC 59630-0480-30 UPC/GTIN No.3-59630-48030-1 Mfg.Part No.48030

BRAND: TRIGLIDE NDC: 59630-0480-30,59630048030 UPC: 3-59630-48030-1,359630480301 Shionogi Pharma, Inc.
Triglide 50Mg Tab 30 By Shionogi Pharma
BRAND: TRIGLIDE NDC: 59630-0480-30,59630048030 UPC: 3-59630-48030-1,359630480301 Shionogi Pharma, Inc.

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
FENOFIBRATE NANOCRYSTALLI
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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