Severe Cold And Flu Relief
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Questions & Answers
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Uses
Fenofibric acid delayed-release capsules are indicated as adjunctive therapy to diet to reduce triglycerides (TG) in patients with severe hypertriglyceridemia. Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate the need for pharmacological intervention. Markedly elevated levels of serum triglycerides (e.g., > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibric acid delayed-release capsules therapy on reducing this risk has not been adequately studied.
Fenofibric acid delayed-release capsules are indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), triglycerides (TG), and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hypercholesterolemia or mixed dyslipidemia.
Fenofibrate at a dose equivalent to 135 mg of fenofibric acid delayed-release capsules did not reduce coronary heart disease morbidity and mortality in 2 large, randomized controlled trials of patients with type 2 diabetes mellitus [see Warnings and Precautions (5.1)].
Laboratory studies should be performed to establish that lipid levels are abnormal before instituting fenofibric acid delayed-release capsules therapy.
Every reasonable attempt should be made to control serum lipids with non-drug methods including appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that may be contributing to the lipid abnormalities. Medications known to exacerbate hypertriglyceridemia (beta-blockers, thiazides, estrogens) should be discontinued or changed if possible, and excessive alcohol intake should be addressed before triglyceride-lowering drug therapy is considered. If the decision is made to use lipid-altering drugs, the patient should be instructed that this does not reduce the importance of adhering to diet.
Drug therapy is not indicated for patients who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of VLDL.
History
There is currently no drug history available for this drug.
Other Information
Fenofibric acid is a lipid regulating agent available as delayed-release capsules for oral administration. Each delayed-release capsule contains choline fenofibrate, equivalent to 45 mg or 135 mg of fenofibric acid. The chemical name for choline fenofibrate is Ethanaminium, 2-hydroxy-N,N,N-trimethyl-, salt with 2-[4-(4-chlorobenzoyl) phenoxy]-2-methylpropanoic acid (1:1) with the following structural formula:
The molecular formula is C22H28ClNO5 and the molecular weight is 421.91. Choline fenofibrate is freely soluble in water. The melting point is approximately 210°C. Choline fenofibrate is a white to almost white crystalline powder, which is stable under ordinary conditions.
Each delayed-release capsule contains enteric coated pellets comprised of choline fenofibrate and the following inactive ingredients: colloidal silicon dioxide, gelatin, hydroxypropyl cellulose, hypromellose, methacrylic acid copolymer type C, polysorbate 80, povidone, sodium lauryl sulfate, sodium stearyl fumarate, talc, titanium dioxide, triethyl citrate and yellow iron oxide. The 45 mg capsules also contain red iron oxide. The 135 mg capsules also contain FD&C Blue No. 2. The black imprinting ink contains ammonium hydroxide, black iron oxide, propylene glycol and shellac glaze.
Sources
Severe Cold And Flu Relief Manufacturers
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Woonsocket Prescription Center,incorporated
![Severe Cold And Flu Relief (Acetaminophen, Phenylephrine Hcl, Dextromethorphan Hbr, Guiafenesin) Tablet, Film Coated [Woonsocket Prescription Center,incorporated]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Severe Cold And Flu Relief | Mylan Pharmaceuticals Inc.
2.1 General ConsiderationsPatients should be placed on an appropriate lipid-lowering diet before receiving fenofibric acid delayed-release capsules, and should continue this diet during treatment. Fenofibric acid delayed-release capsules can be taken without regard to meals. Patients should be advised to swallow fenofibric acid delayed-release capsules whole. Do not open, crush, dissolve, or chew capsules. Serum lipids should be monitored periodically.
2.2 Severe HypertriglyceridemiaThe initial dose of fenofibric acid delayed-release capsules is 45 mg to 135 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 135 mg once daily.
2.3 Primary Hypercholesterolemia or Mixed DyslipidemiaThe dose of fenofibric acid delayed-release capsules is 135 mg once daily.
2.4 Impaired Renal FunctionTreatment with fenofibric acid delayed-release capsules should be initiated at a dose of 45 mg once daily in patients with mild to moderate renal impairment and should only be increased after evaluation of the effects on renal function and lipid levels at this dose. The use of fenofibric acid delayed-release capsules should be avoided in patients with severely impaired renal function [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
2.5 Geriatric PatientsDose selection for the elderly should be made on the basis of renal function [see Use in Specific Populations (8.5)].
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Rite Aid Corporation
Severe Cold And Flu Relief | Preferred Pharmaceuticals, Inc.
Dosage should be adjusted according to the severity of the pain and the response of the patient. However, it should be kept in mind that tolerance to hydrocodone can develop with continued use and that the incidence of untoward effects is dose related.
The usual adult dosage is one tablet every four to six hours as needed for pain. The total daily dose should not exceed 6 tablets.
![Severe Cold And Flu Relief (Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl) Suspension [Rite Aid Corporation]](https://www.recallguide.org/wp-content/themes/bootstrap/assets/img/drug-image-placeholder.jpg)
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