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Rx Item-Antara 30mg fenofibrate micronized Cap 30 by Lupin Pharma

RX253179 253179 NDC No. 27437-0107-06 27437-107-06 27437010706 2743710706 UPC/GTIN No. 3-27437-10706-6 327437-107066 327437107066  MPN 710706RX253179 253179 NDC No. 27437-0107-06 27437-107-06 27437010706 2743710706 UPC/GTIN No. 3-27437-10706-6 327437-107066 327437107066  MPN 710706Only 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-Antara 30mg fenofibrate micronized Cap 30 by Lupin Pharma

$207.09$199.99

RX253179 253179 NDC No. 27437-0107-06 27437-107-06 27437010706 2743710706 UPC/GTIN No. 3-27437-10706-6 327437-107066 327437107066 MPN 710706 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 scope of practice can order this RX Item. Rx Item No. Rx253179 Antara 30mg Cap 30 by Lupin Pharma. Item No. 3253179 NDC No. 27437010706 UPC No. 327437107066 Other

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Clinical Information
Gen. Code and Des.
71642 fenofibrate,micronized ORAL CAPSULE 30 MG
GCN and Des.
35559 fenofibrate,micronized ORAL CAPSULE 30 MG
Strength
30MG
Dose Form
CAPSULE
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family

AHFS Class
24060600 FIBRIC ACID DERIVATIVES
Active Ingredients
7846 fenofibrate,micronized
Inactive Ingredients
10138 blue dye
10143 yellow dye
13405 soy
2549 gelatin 9000708
2598 sucrose 57501
9284 sulfur dioxide 7446095

FENOFIBRATE- fenofibrate tablet
Oceanside Pharmaceuticals
DESCRIPTION
Fenofibrate Tablets, is lipid regulating agent available as tablets for oral administration. Each tablet contains 40 mg or 120 mg fenofibrate. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl este
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? to 82?C. Fenofibrate is white solid which is stable under ordinary conditions.
Mechanism of Action
The lipid-lowering 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 alpha (PPAR?). 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 decrease 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 greater affinity for cholesterol receptors and are catabolized rapidly. Activation of PPAR? 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.
PATIENT COUNSELING info.
Patients should be advised:
?
of the potential benefits and risks of fenofibrate tablets
?
not to use fenofibrate tablets if there is known hypersensitivity to fenofibrate or fenofibric acid.
?
that if they are taking coumarin anticoagulants, fenofibrate tablets may increase their anticoagulant effect, and increased monitoring may be necessary.
?
of medications that should not be taken in combination with fenofibrate tablets.
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to continue to follow an appropriate lipid-modifying diet while taking fenofibrate tablets.
?
to take fenofibrate tablets once daily, without regard to food, at the prescribed dose, swallowing each tablet whole.
?
to inform their physician of all medications, supplements, and herbal preparations they are taking and any change to their medical condition. Patients should also be advised to inform their physicians prescribing new medication that they are taking fenofibrate tablets.
?
to inform their physician of any muscle pain, tenderness, or weakness; onset of abdominal pain; or any other new symptoms

INDICATIONS AND USAGE
1.1 Primary Hypercholesterolemia and Mixed Dyslipidemia
Fenofibrate tablets are indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), Triglycerides (TG), and apolipoprotein (Apo B), and to increase high-density lipoprotein (HDL-C) in adult patients with primary hypercholesterolemia or mixed dyslipidemia.
Severe Hypertriglyceridemia
Fenofibrate tablets 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 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.
DOSAGE AND ADMINISTRATION
2.1 General Considerations
Fenofibrate tablets should be given with food to optimize the absorption of the medicine. Patients should be advised to swallow fenofibrate tablets whole. Do not crush, dissolve or chew tablets. Primary Hypercholesterolemia or Mixed Dyslipidemia
The initial dose of fenofibrate tablets is 120 mg per day.
2.3 Severe Hypertriglyceridemia
The initial dose is 40 to 120 mg per day. Dosage should be individualized according to patient response, and should be adjusted if necessary following repeat lipid determinations at to week intervals. The maximum dose is 120 mg per day.
2.4 Impaired Renal Function
Treatment with fenofibrate tablets should be initiated at dose of 40 mg per day in patients with mild to moderately impaired renal function, and increased only after evaluation of the effects on renal function and lipid levels at this dose. The use of fenofibrate tablets should be avoided in patients with severe renal impairment
Fenofibrate tablets are contraindicated in:
?
patients with severe renal dysfunction, including those receiving dialysis [see Clinical Pharmacology
?
patients with active liver disease, including those with primary biliary cirrhosis and unexplained persistent liver function abnormalities [see Warnings and Precautions
?
patients with pre-existing gallbladder disease [see Warnings and Precautions

Skeletal Muscle
Fibrates increase the risk for myopathy and have been associated with rhabdomyolysis. The risk for serious muscle toxicity appears to be increased in elderly patients and in patients with diabetes, renal insufficiency, or hypothyroidism.
Cholelithiasis
Fenofibrate, like clofibrate and gemfibrozil, may increase cholesterol excretion into the bile, leading to cholelithiasis. If cholelithiasis is suspected, gallbladder studies are indicated. Fenofibrate tablet therapy should be discontinued if gallstones are found.
Serum Creatinine
Elevations in serum creatinine have been reported in patients on fenofibrate. These elevations tend to return to baseline following discontinuation of fenofibrate. The clinical significance of these observations is unknown
Pancreatitis
Pancreatitis has been reported in patients taking fenofibrate, gemfibrozil, and clofibrate. This occurrence may represent failure of efficacy in patients with severe hypertriglyceridemia, direct drug effect, or secondary phenomenon mediated through biliary tract stone or sludge formation with obstruction of the common bile duct
Pregnancy Category C.

RX253179 253179 NDC No. 27437-0107-06 27437-107-06 27437010706 2743710706 UPC/GTIN No. 3-27437-10706-6 327437-107066 327437107066  MPN 710706
Antara 30mg Cap 30 by Lupin Pharma
RX253179 253179 NDC No. 27437-0107-06 27437-107-06 27437010706 2743710706 UPC/GTIN No. 3-27437-10706-6 327437-107066 327437107066 MPN 710706

RX253179 253179 NDC No. 27437-0107-06 27437-107-06 27437010706 2743710706 UPC/GTIN No. 3-27437-10706-6 327437-107066 327437107066  MPN 710706
Lupin Pharma
RX253179 253179 NDC No. 27437-0107-06 27437-107-06 27437010706 2743710706 UPC/GTIN No. 3-27437-10706-6 327437-107066 327437107066 MPN 710706

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
Click above for FENOFIBRIC
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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Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.
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Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.