Fenofibrate

Fenofibrate Manufacturers

• Global Pharmaceuticals, Division Of Impax Laboratories Inc.
  

  ×

  Fenofibrate | Global Pharmaceuticals, Division Of Impax Laboratories Inc.

  

  ---

  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.

  The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcoholic intake may be important factors in hypertriglyceridemia and should be addressed prior to any drug therapy. Physical exercise can be an important ancillary measure. Diseases contributory to hyperlipidemia, such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy, thiazide diuretics and beta-blockers, are sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of the specific etiologic agent may obviate the need for specific drug therapy of hypertriglyceridemia.

  Lipid levels should be monitored periodically and consideration should be given to reducing the dosage of fenofibrate tablets if lipid levels fall significantly below the targeted range.

  Therapy should be withdrawn in patients who do not have an adequate response after two months of treatment with the maximum recommended dose of 120 mg once daily.

  2.2 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 4 to 8 week intervals. The maximum dose is 120 mg per day.

  2.4 Impaired Renal Function

  Treatment with fenofibrate tablets should be initiated at a 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 [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

  2.5 Geriatric Patients

  Dose selection for the elderly should be made on the basis of renal function [see Use in Specific Populations (8.5)].

  Close
  No Recall

  More Info
• Remedyrepack Inc.
  

  ×

  Fenofibrate | Remedyrepack Inc.

  

  ---

  Patients should be placed on an appropriate lipid-lowering diet before receiving fenofibrate tablets, and should continue this diet during treatment with fenofibrate tablets. Fenofibrate tablets should be given with meals, thereby optimizing the bioavailability of the medication.

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

  For adult patients with hypertriglyceridemia, the initial dose is 54 to 160 mg per day. 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 fenofibrate tablets should be initiated at a dose of 54 mg/day in patients having 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 54 mg/day.

  Lipid levels should be monitored periodically and consideration should be given to reducing the dosage of fenofibrate tablets if lipid levels fall significantly below the targeted range.

   

  Close
  No Recall

  More Info
• Northwind Pharmaceuticals
  

  ×

  Fenofibrate | Northwind Pharmaceuticals

  

  ---

  2.1 General Considerations

  Patients should be placed on an appropriate lipid-lowering diet before receiving Fenofibrate tablets for oral use, and should continue this diet during treatment with Fenofibrate tablets for oral use. Fenofibrate tablets for oral use can be given without regard to meals.

  The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcoholic intake may be important factors in hypertriglyceridemia and should be addressed prior to any drug therapy. Physical exercise can be an important ancillary measure. Diseases contributory to hyperlipidemia, such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy, thiazide diuretics and beta-blockers, are sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of the specific etiologic agent may obviate the need for specific drug therapy of hypertriglyceridemia.

  Lipid levels should be monitored periodically and consideration should be given to reducing the dosage of Fenofibrate tablets for oral use if lipid levels fall significantly below the targeted range.

  Therapy should be withdrawn in patients who do not have an adequate response after two months of treatment with the maximum recommended dose of 145 mg once daily.

  2.2 Primary Hypercholesterolemia or Mixed Dyslipidemia

  The initial dose of Fenofibrate tablets for oral use is 145 mg once daily.

  2.3 Severe Hypertriglyceridemia

  The initial dose is 48 to 145 mg per day. 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 145 mg once daily.

  2.4 Impaired Renal Function

  Treatment with Fenofibrate tablets for oral use should be initiated at a dose of 48 mg per day in patients having 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 for oral use should be avoided in patients with severe renal impairment [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

  2.5 Geriatric Patients

  Dose selection for the elderly should be made on the basis of renal function [see Use in Specific Populations (8.5)].

  Please see full information on Fenofibrate 145mg Zydus Pharmaceuticals at Permanent Link: http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1c3696b1-23c1-2992-86a0-c0882b81048d

  Close
  No Recall

  More Info
• Northwind Pharmaceuticals, Llc
  

  ×

  Fenofibrate | Northwind Pharmaceuticals, Llc

  

  ---

  The recommended initial dose is 15 mg daily (7.5 mg b.i.d.). To achieve an optimal therapeutic response, at intervals of 2 to 3 days the dosage may be increased 5 mg per day, as needed. The maximum daily dosage should not exceed 60 mg per day. In clinical trials allowing dose titration, divided doses of 20 to 30 mg per day were commonly employed.

  The bioavailability of buspirone is increased when given with food as compared to the fasted state (see CLINICAL PHARMACOLOGY). Consequently, patients should take buspirone in a consistent manner with regard to the timing of dosing; either always with or always without food.

  When buspirone is to be given with a potent inhibitor of CYP3A4, the dosage recommendations described in the PRECAUTIONS, Drug Interactions section should be followed.

  Close
  No Recall

  More Info
• Avkare, Inc.
  

  ×

  Fenofibrate | Laboratoires Clarins S.a.

  

  ---

  • apply liberally 15 minutes before sun exposure
  • apply to all skin exposed to the sun
  • children under 6 months: Ask a doctor
  • Sun Protection Measures.
  Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m. – 2 p.m.
  • wear long-sleeved shirts, pants, hats and sunglasses.
  • reapply at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating.
  

  Close
  No Recall

  More Info
• Physicians Total Care, Inc.
  

  ×

  Fenofibrate | Physicians Total Care, Inc.

  

  ---

  Patients should be placed on an appropriate lipid-lowering diet before receiving fenofibrate capsules, and should continue this diet during treatment with fenofibrate capsules. Fenofibrate capsules should be given with meals, thereby optimizing the bioavailability of the medication.

  For the treatment of adult patients with primary hypercholesterolemia or mixed hyperlipidemia, the initial dose of fenofibrate capsules is 200 mg per day.

  For adult patients with hypertriglyceridemia, the initial dose is 67 to 200 mg per day. 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 200 mg per day.

  Treatment with fenofibrate capsules should be initiated at a dose of 67 mg/day in patients having 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 67 mg/day.

  Lipid levels should be monitored periodically and consideration should be given to reducing the dosage of fenofibrate capsules if lipid levels fall significantly below the targeted range.

  Close
  No Recall

  More Info
• Remedyrepack Inc.
  

  ×

  Fenofibrate | Remedyrepack Inc.

  

  ---

  DOSAGE AND ADMINISTRATION
  Patients should be placed on an appropriate lipid-lowering diet before receiving fenofibrate capsules, and should continue this diet during treatment with fenofibrate capsules. Fenofibrate capsules should be given with meals, thereby optimizing the bioavailability of the medication.
  For the treatment of adult patients with primary hypercholesterolemia or mixed hyperlipidemia, the initial dose of fenofibrate capsules is 200 mg per day.
  For adult patients with hypertriglyceridemia, the initial dose is 67 to 200 mg per day. 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 200 mg per day.
  Treatment with fenofibrate capsules should be initiated at a dose of 67 mg/day in patients having 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 67 mg/day.
  Lipid levels should be monitored periodically and consideration should be given to reducing the dosage of fenofibrate capsules if lipid levels fall significantly below the targeted range.
  
  

  Close
  No Recall

  More Info
• Global Pharmaceuticals, Division Of Impax Laboratories Inc.
  

  ×

  Fenofibrate | Global Pharmaceuticals, Division Of Impax Laboratories Inc.

  

  ---

  Patients should be placed on an appropriate lipid-lowering diet before receiving fenofibrate tablets, and should continue this diet during treatment with fenofibrate tablets. Fenofibrate tablets should be given with meals, thereby optimizing the bioavailability of the medication.

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

  For adult patients with hypertriglyceridemia, the initial dose is 54 to 160 mg per day. 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 fenofibrate tablets should be initiated at a dose of 54 mg/day in patients having 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 54 mg/day.

  Lipid levels should be monitored periodically and consideration should be given to reducing the dosage of fenofibrate tablets if lipid levels fall significantly below the targeted range.

  Close
  No Recall

  More Info
• Physicians Total Care, Inc.
  

  ×

  Fenofibrate | Physicians Total Care, Inc.

  

  ---

  Patients should be placed on an appropriate lipid-lowering diet before receiving fenofibrate tablets, and should continue this diet during treatment with fenofibrate tablets. Fenofibrate tablets should be given with meals, thereby optimizing the bioavailability of the medication.

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

  For adult patients with hypertriglyceridemia, the initial dose is 54 to 160 mg per day. 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 fenofibrate tablets should be initiated at a dose of 54 mg/day in patients having 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 54 mg/day.

  Lipid levels should be monitored periodically and consideration should be given to reducing the dosage of fenofibrate tablets if lipid levels fall significantly below the targeted range.

  Close
  No Recall

  More Info
• St Marys Medical Park Pharmacy
  

  ×

  Fenofibrate | St Marys Medical Park Pharmacy

  

  ---

  Patients should be placed on an appropriate lipid-lowering diet before receiving fenofibrate tablets, and should continue this diet during treatment with fenofibrate tablets. Fenofibrate tablets should be given with meals, thereby optimizing the bioavailability of the medication.

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

  For adult patients with hypertriglyceridemia, the initial dose is 54 to 160 mg per day. 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 fenofibrate tablets should be initiated at a dose of 54 mg/day in patients having 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 54 mg/day.

  Lipid levels should be monitored periodically and consideration should be given to reducing the dosage of fenofibrate tablets if lipid levels fall significantly below the targeted range.

  Close
  No Recall

  More Info
• Kaiser Foundation Hospitals
  

  ×

  Fenofibrate | Kaiser Foundation Hospitals

  

  ---

  Patients should be placed on an appropriate lipid-lowering diet before receiving fenofibrate tablets, and should continue this diet during treatment with fenofibrate tablets. Fenofibrate tablets can be given without regard to meals.

  For the treatment of adult patients with primary hypercholesterolemia or mixed hyperlipidemia, the initial dose of fenofibrate tablets is 145 mg per day.

  For adult patients with hypertriglyceridemia, the initial dose is 48 to 145 mg per day. 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 145 mg per day.

  Treatment with fenofibrate tablets should be initiated at a dose of 48 mg/day in patients having having mild to moderately impaired renal function, and increased only after evaluation of the effects on renal function and lipid levels at this dose.

  Lipid levels should be monitored periodically and consideration should be given to reducing the dosage of fenofibrate tablets if lipid levels fall significantly below the targeted range.

  Close
  No Recall

  More Info
• Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
  

  ×

  Fenofibrate | Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc

  

  ---

  Patients should be placed on an appropriate lipid-lowering diet before receiving fenofibrate tablets and should continue this diet during treatment with fenofibrate. Fenofibrate tablets can be given without regard to meals.

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

  For adult patients with hypertriglyceridemia, the initial dose is 54 mg to 160 mg per day. 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 fenofibrate tablets should be initiated at a dose of 54 mg/day in patients having mild to moderately impaired renal function and increased only after evaluation of the effects on renal function and lipid levels at this dose.

  Lipid levels should be monitored periodically and consideration should be given to reducing the dosage of fenofibrate tablets if lipid levels fall significantly below the targeted range.

  Close
  No Recall

  More Info
• Mylan Pharmaceuticals Inc.
  

  ×

  Fenofibrate | Metacon Labs

  

  ---

  Prime Can Before Initial Use:
  Shake can well (until product moves inside can). Firmly strike bottom of can onto palm of hand at least three times.
  
  Hold can upright and direct initial spray to a non-skin surface. Until foam dispenses, DO NOT spray directly on the skin as the initial spray may expel cold liquid propellant. Press down on actuator for 1 to 3 seconds until foam begins to dispense. If foam does not dispense within 3 seconds, repeat priming process.
  

  WASH-OFF APPLICATION: Cleanse affected skin thoroughly and pat dry before each application. Dispense product onto fingertips. Massage the dispensed foam into the affected area and wait 10 minutes. Rinse thoroughly with water and pat dry. Treat the affected area 1 to 3 times daily, or as directed by a physician.

  LEAVE-ON APPLICATION: Cleanse affected skin thoroughly and pat dry before each application. Dispense product onto fingertips. Massage the dispensed foam into the affected area 1 to 3 times daily or as directed by a physician.

  Wipe off any excess foam from actuator after use.

  Close
  No Recall

  More Info
• Mylan Pharmaceuticals Inc.
  

  ×

  Fenofibrate | Mylan Pharmaceuticals Inc.

  

  ---

  2.1 General Considerations

  Patients should be placed on an appropriate lipid-lowering diet before receiving fenofibrate capsules, and should continue this diet during treatment with fenofibrate capsules. Fenofibrate capsules can be given without regard to meals.

  Patients should be advised to swallow fenofibrate capsules whole. Do not open, crush, dissolve or chew capsules.

  The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcoholic intake may be important factors in hypertriglyceridemia and should be addressed prior to any drug therapy. Physical exercise can be an important ancillary measure. Diseases contributory to hyperlipidemia, such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy, thiazide diuretics and beta-blockers are sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of the specific etiologic agent may obviate the need for specific drug therapy of hypertriglyceridemia.

  Lipid levels should be monitored periodically and consideration should be given to reducing the dosage of fenofibrate if lipid levels fall significantly below the targeted range.

  Therapy should be withdrawn in patients who do not have an adequate response after 2 months of treatment with the maximum recommended dose of 130 mg once daily.

  2.2 Primary Hypercholesterolemia and Mixed Dyslipidemia

  The initial dose of fenofibrate capsules is 130 mg per day.

  2.3 Severe Hypertriglyceridemia

  The initial dose is 43 mg to 130 mg per day. 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 130 mg per day.

  2.4 Impaired Renal Function

  Treatment with fenofibrate capsules should be initiated at a dose of 43 mg per day in patients having 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 capsules should be avoided in patients with severe renal impairment [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

  2.5 Geriatric Patients

  Dose selection for the elderly should be made on the basis of renal function [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

  Close
  No Recall

  More Info
• Ncs Healthcare Of Ky, Inc Dba Vangard Labs
  

  ×

  Fenofibrate | Ncs Healthcare Of Ky, Inc Dba Vangard Labs

  

  ---

  Patients should be placed on an appropriate lipid-lowering diet before receiving fenofibrate capsules, and should continue this diet during treatment with fenofibrate capsules. Fenofibrate capsules should be given with meals, thereby optimizing the bioavailability of the medication.

  For the treatment of adult patients with primary hypercholesterolemia or mixed hyperlipidemia, the initial dose of fenofibrate capsules is 200 mg per day.

  For adult patients with hypertriglyceridemia, the initial dose is 67 to 200 mg per day. 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 200 mg per day.

  Treatment with fenofibrate capsules should be initiated at a dose of 67 mg/day in patients having 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 67 mg/day.

  Lipid levels should be monitored periodically and consideration should be given to reducing the dosage of fenofibrate capsules if lipid levels fall significantly below the targeted range.

  Close
  No Recall

  More Info
• Lupin Pharmaceuticals, Inc.
  

  ×

  Fenofibrate | Lupin Pharmaceuticals, Inc.

  

  ---

  2.1 General Considerations

  Patients should be placed on an appropriate lipid-lowering diet before receiving fenofibrate capsules, and should continue this diet during treatment with fenofibrate. Fenofibrate capsules can be given without regard to meals.

  Patients should be advised to swallow fenofibrate capsules whole. Do not open, crush, dissolve or chew capsules.

  The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcoholic intake may be important factors in hypertriglyceridemia and should be addressed prior to any drug therapy. Physical exercise can be an important ancillary measure. Diseases contributory to hyperlipidemia, such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy, thiazide diuretics and beta-blockers are sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of the specific etiologic agent may obviate the need for specific drug therapy of hypertriglyceridemia.

  Lipid levels should be monitored periodically and consideration should be given to reducing the dosage of fenofibrate if lipid levels fall significantly below the targeted range.

  Therapy should be withdrawn in patients who do not have an adequate response after two months of treatment with the maximum recommended dose of 130 mg once daily.

  2.2 Primary Hypercholesterolemia and Mixed Dyslipidemia

  The initial dose of fenofibrate capsules is 130 mg per day.

  2.3 Severe Hypertriglyceridemia

  The initial dose is 43 to 130 mg per day. 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 130 mg per day.

  2.4 Impaired Renal Function

  Treatment with fenofibrate should be initiated at a dose of 43 mg per day in patients having 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 should be avoided in patients with severe renal impairment [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

  2.5 Geriatric Patients

  Dose selection for the elderly should be made on the basis of renal function [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

  Close
  No Recall

  More Info
• Ranbaxy Pharmaceuticals Inc.
  

  ×

  Fenofibrate | Ranbaxy Pharmaceuticals Inc.

  

  ---

  Patients should be placed on an appropriate lipid-lowering diet before receiving fenofibrate tablets, and should continue this diet during treatment with fenofibrate tablets. Fenofibrate tablets should be given with meals, thereby optimizing the bioavailability of the medication.

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

  For adult patients with hypertriglyceridemia, the initial dose is 54 to 160 mg per day. 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 fenofibrate tablets should be initiated at a dose of 54 mg/day in patients having 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 54 mg/day.

  Lipid levels should be monitored periodically and consideration should be given to reducing the dosage of fenofibrate tablets if lipid levels fall significantly below the targeted range.

  Close
  No Recall

  More Info
• St Marys Medical Park Pharmacy
  

  ×

  Fenofibrate | St Marys Medical Park Pharmacy

  

  ---

  Patients should be placed on an appropriate lipid-lowering diet before receiving fenofibrate capsules, and should continue this diet during treatment with fenofibrate capsules. Fenofibrate capsules should be given with meals, thereby optimizing the bioavailability of the medication.

  For the treatment of adult patients with primary hypercholesterolemia or mixed hyperlipidemia, the initial dose of fenofibrate capsules is 200 mg per day.

  For adult patients with hypertriglyceridemia, the initial dose is 67 to 200 mg per day. 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 200 mg per day.

  Treatment with fenofibrate capsules should be initiated at a dose of 67 mg/day in patients having 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 67 mg/day.

  Lipid levels should be monitored periodically and consideration should be given to reducing the dosage of fenofibrate capsules if lipid levels fall significantly below the targeted range.

  Close
  No Recall

  More Info
• Teva Pharmaceuticals Usa Inc
  

  ×

  Fenofibrate | Teva Pharmaceuticals Usa Inc

  

  ---

  2.1 General Considerations

  Patients should be placed on an appropriate lipid-lowering diet before receiving Fenofibrate tablets for oral use, and should continue this diet during treatment with Fenofibrate tablets for oral use. Fenofibrate tablets for oral use can be given without regard to meals.

  The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcoholic intake may be important factors in hypertriglyceridemia and should be addressed prior to any drug therapy. Physical exercise can be an important ancillary measure. Diseases contributory to hyperlipidemia, such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy, thiazide diuretics and beta-blockers, are sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of the specific etiologic agent may obviate the need for specific drug therapy of hypertriglyceridemia.

  Lipid levels should be monitored periodically and consideration should be given to reducing the dosage of Fenofibrate tablets for oral use if lipid levels fall significantly below the targeted range.

  Therapy should be withdrawn in patients who do not have an adequate response after two months of treatment with the maximum recommended dose of 145 mg once daily.

  2.2 Primary Hypercholesterolemia or Mixed Dyslipidemia

  The initial dose of Fenofibrate tablets for oral use is 145 mg once daily.

  2.3 Severe Hypertriglyceridemia

  The initial dose is 48 to 145 mg per day. 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 145 mg once daily.

  2.4 Impaired Renal Function

  Treatment with Fenofibrate tablets for oral use should be initiated at a dose of 48 mg per day in patients having 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 for oral use should be avoided in patients with severe renal impairment [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

  2.5 Geriatric Patients

  Dose selection for the elderly should be made on the basis of renal function [see Use in Specific Populations (8.5)].

  2.5 Geriatric Patients

  Dose selection for the elderly should be made on the basis of renal function [see Use in Specific Populations (8.5)].

  Close
  No Recall

  More Info
• Unit Dose Services
  

  ×

  Fenofibrate | Unit Dose Services

  

  ---

  Patients should be placed on an appropriate lipid-lowering diet before receiving fenofibrate capsules, and should continue this diet during treatment with fenofibrate capsules. Fenofibrate capsules should be given with meals, thereby optimizing the bioavailability of the medication.

  For the treatment of adult patients with primary hypercholesterolemia or mixed hyperlipidemia, the initial dose of fenofibrate capsules is 200 mg per day.

  For adult patients with hypertriglyceridemia, the initial dose is 67 to 200 mg per day. 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 200 mg per day.

  Treatment with fenofibrate capsules should be initiated at a dose of 67 mg/day in patients having 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 67 mg/day.

  Lipid levels should be monitored periodically and consideration should be given to reducing the dosage of fenofibrate capsules if lipid levels fall significantly below the targeted range.

  Close
  No Recall

  More Info
• Unit Dose Services
  

  ×

  Fenofibrate | Unit Dose Services

  

  ---

  Patients should be placed on an appropriate lipid-lowering diet before receiving fenofibrate capsules, and should continue this diet during treatment with fenofibrate capsules. Fenofibrate capsules should be given with meals, thereby optimizing the bioavailability of the medication.

  For the treatment of adult patients with primary hypercholesterolemia or mixed hyperlipidemia, the initial dose of fenofibrate capsules is 200 mg per day.

  For adult patients with hypertriglyceridemia, the initial dose is 67 to 200 mg per day. 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 200 mg per day.

  Treatment with fenofibrate capsules should be initiated at a dose of 67 mg/day in patients having 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 67 mg/day.

  Lipid levels should be monitored periodically and consideration should be given to reducing the dosage of fenofibrate capsules if lipid levels fall significantly below the targeted range.

  Close
  No Recall

  More Info
• Unit Dose Services
  

  ×

  Fenofibrate | Unit Dose Services

  

  ---

  Patients should be placed on an appropriate lipid-lowering diet before receiving fenofibrate tablets, and should continue this diet during treatment with fenofibrate tablets. Fenofibrate tablets should be given with meals, thereby optimizing the bioavailability of the medication.

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

  For adult patients with hypertriglyceridemia, the initial dose is 54 to 160 mg per day. 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 fenofibrate tablets should be initiated at a dose of 54 mg/day in patients having 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 54 mg/day.

  Lipid levels should be monitored periodically and consideration should be given to reducing the dosage of fenofibrate tablets if lipid levels fall significantly below the targeted range.

  Close
  No Recall

  More Info
• Lake Erie Medical Dba Quality Care Products Llc
  

  ×

  Fenofibrate | Lake Erie Medical Dba Quality Care Products Llc

  

  ---

  Patients should be placed on an appropriate lipid-lowering diet before receiving fenofibrate capsules, and should continue this diet during treatment with fenofibrate capsules. Fenofibrate capsules should be given with meals, thereby optimizing the bioavailability of the medication.

  For the treatment of adult patients with primary hypercholesterolemia or mixed hyperlipidemia, the initial dose of fenofibrate capsules is 200 mg per day.

  For adult patients with hypertriglyceridemia, the initial dose is 67 to 200 mg per day. 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 200 mg per day.

  Treatment with fenofibrate capsules should be initiated at a dose of 67 mg/day in patients having 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 67 mg/day.

  Lipid levels should be monitored periodically and consideration should be given to reducing the dosage of fenofibrate capsules if lipid levels fall significantly below the targeted range.

  Close
  No Recall

  More Info
• Mylan Pharmaceuticals Inc.
  

  ×

  Fenofibrate | Mylan Pharmaceuticals Inc.

  

  ---

  2.1 General Considerations

  Patients should be placed on an appropriate lipid-lowering diet before receiving fenofibrate tablets and should continue this diet during treatment with fenofibrate tablets. Fenofibrate tablets can be given without regard to meals.

  The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcoholic intake may be important factors in hypertriglyceridemia and should be addressed prior to any drug therapy. Physical exercise can be an important ancillary measure. Diseases contributory to hyperlipidemia, such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy, thiazide diuretics and beta-blockers, are sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of the specific etiologic agent may obviate the need for specific drug therapy of hypertriglyceridemia.

  Lipid levels should be monitored periodically and consideration should be given to reducing the dosage of fenofibrate tablets if lipid levels fall significantly below the targeted range.

  Therapy should be withdrawn in patients who do not have an adequate response after 2 months of treatment with the maximum recommended dose of 145 mg once daily.

  2.2 Primary Hypercholesterolemia or Mixed Dyslipidemia

  The initial dose of fenofibrate tablets is 145 mg once daily.

  2.3 Severe Hypertriglyceridemia

  The initial dose is 48 mg to 145 mg per day. 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 145 mg once daily.

  2.4 Impaired Renal Function

  Treatment with fenofibrate tablets should be initiated at a dose of 48 mg per day in patients having 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 [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

  2.5 Geriatric Patients

  Dose selection for the elderly should be made on the basis of renal function [see Use in Specific Populations (8.5)].

  Close
  No Recall

  More Info
• Clinical Solutions Wholesale
  

  ×

  Fenofibrate | Clinical Solutions Wholesale

  

  ---

  Patients should be placed on an appropriate lipid-lowering diet before receiving fenofibrate tablets, and should continue this diet during treatment with fenofibrate tablets. Fenofibrate tablets should be given with meals, thereby optimizing the bioavailability of the medication.

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

  For adult patients with hypertriglyceridemia, the initial dose is 54 to 160 mg per day. 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 fenofibrate tablets should be initiated at a dose of 54 mg/day in patients having 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 54 mg/day.

  Lipid levels should be monitored periodically and consideration should be given to reducing the dosage of fenofibrate tablets if lipid levels fall significantly below the targeted range.

  Close
  No Recall

  More Info
• American Health Packaging
  

  ×

  Fenofibrate | Akorn, Inc.

  

  ---

  Timolol Maleate Ophthalmic Solution is available in concentrations of 0.25 and 0.5 percent. The usual starting dose is one drop of 0.25 percent timolol in the affected eye(s) twice a day. If the clinical response is not adequate, the dosage may be changed to one drop of 0.5 percent solution in the affected eye(s) twice a day.

  Since in some patients the pressure-lowering response to timolol may require a few weeks to stabilize, evaluation should include a determination of intraocular pressure after approximately 4 weeks of treatment with timolol.

  If the intraocular pressure is maintained at satisfactory levels, the dosage schedule may be changed to one drop once a day in the affected eye(s). Because of diurnal variations in intraocular pressure, satisfactory response to the once-a-day dose is best determined by measuring the intraocular pressure at different times during the day.

  Dosages above one drop of 0.5 percent timolol twice a day generally have not been shown to produce further reduction in intraocular pressure. If the patient's intraocular pressure is still not at a satisfactory level on this regimen, concomitant therapy with other agent(s) for lowering intraocular pressure can be instituted. The concomitant use of two topical beta-adrenergic blocking agents is not recommended. (See PRECAUTIONS, Drug Interactions, Beta-adrenergic blocking agents.)

  Close
  No Recall

  More Info
• Lake Erie Medical Dba Quality Care Products Llc
  

  ×

  Fenofibrate | Lake Erie Medical Dba Quality Care Products Llc

  

  ---

  Patients should be placed on an appropriate lipid-lowering diet before receiving fenofibrate tablets, and should continue this diet during treatment with fenofibrate tablets. Fenofibrate tablets should be given with meals, thereby optimizing the bioavailability of the medication.

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

  For adult patients with hypertriglyceridemia, the initial dose is 54 to 160 mg per day. 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 fenofibrate tablets should be initiated at a dose of 54 mg/day in patients having 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 54 mg/day.

  Lipid levels should be monitored periodically and consideration should be given to reducing the dosage of fenofibrate tablets if lipid levels fall significantly below the targeted range.

  Close
  No Recall

  More Info
• Apotex Corp.
  

  ×

  Fenofibrate | Apotex Corp.

  

  ---

  2.1 General Considerations

  Patients should be placed on an appropriate lipid-lowering diet before receiving fenofibrate capsules, and should continue this diet during treatment with fenofibrate capsules. Fenofibrate capsules can be given without regard to meals.

  Patients should be advised to swallow fenofibrate capsules whole. Do not open, crush, dissolve or chew capsules.

  The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcoholic intake may be important factors in hypertriglyceridemia and should be addressed prior to any drug therapy. Physical exercise can be an important ancillary measure. Diseases contributory to hyperlipidemia, such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy, thiazide diuretics and beta-blockers are sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of the specific etiologic agent may obviate the need for specific drug therapy of hypertriglyceridemia.

  Lipid levels should be monitored periodically and consideration should be given to reducing the dosage of fenofibrate capsules if lipid levels fall significantly below the targeted range.

  Therapy should be withdrawn in patients who do not have an adequate response after two months of treatment with the maximum recommended dose of 130 mg once daily.

  2.2 Primary Hypercholesterolemia and Mixed Dyslipidemia

  The initial dose of fenofibrate capsules is 130 mg per day.

  2.3 Severe Hypertriglyceridemia

  The initial dose is 43 to 130 mg per day. 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 130 mg per day.

  2.4 Impaired Renal Function

  Treatment with fenofibrate capsules should be initiated at a dose of 43 mg per day in patients having 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 capsules should be avoided in patients with severe renal impairment [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

  2.5 Geriatric Patients

  Dose selection for the elderly should be made on the basis of renal function [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

  Close
  No Recall

  More Info
• Lupin Pharmaceuticals, Inc.
  

  ×

  Fenofibrate | Lupin Pharmaceuticals, Inc.

  

  ---

  2.1 General Considerations

  Patients should be placed on an appropriate lipid-lowering diet before receiving fenofibrate, and should continue this diet during treatment with fenofibrate. Fenofibrate tablets can be given without regard to meals.

  The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcoholic intake may be important factors in hypertriglyceridemia and should be addressed prior to any drug therapy. Physical exercise can be an important ancillary measure. Diseases contributory to hyperlipidemia, such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy, thiazide diuretics and beta-blockers, are sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of the specific etiologic agent may obviate the need for specific drug therapy of hypertriglyceridemia.

  Lipid levels should be monitored periodically and consideration should be given to reducing the dosage of fenofibrate if lipid levels fall significantly below the targeted range.

  Therapy should be withdrawn in patients who do not have an adequate response after two months of treatment with the maximum recommended dose of 145 mg once daily.

  2.2 Primary Hypercholesterolemia or Mixed Dyslipidemia

  The initial dose of fenofibrate is 145 mg once daily.

  2.3 Severe Hypertriglyceridemia

  The initial dose is 48 to 145 mg per day. 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 145 mg once daily.

  2.4 Impaired Renal Function

  Treatment with fenofibrate should be initiated at a dose of 48 mg per day in patients having 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 should be avoided in patients with severe renal impairment [see USE IN SPECIFIC POPULATIONS (8.6)  and CLINICAL PHARMACOLOGY (12.3)]

  2.5 Geriatric Patients

  Dose selection for the elderly should be made on the basis of renal function [see USE IN SPECIFIC POPULATIONS (8.5)].

  Close
  No Recall

  More Info
• Aidarex Pharmaceuticals Llc
  

  ×

  Fenofibrate | Aidarex Pharmaceuticals Llc

  

  ---

  Patients should be placed on an appropriate lipid-lowering diet before receiving fenofibrate tablets, and should continue this diet during treatment with fenofibrate tablets. Fenofibrate tablets should be given with meals, thereby optimizing the bioavailability of the medication.

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

  For adult patients with hypertriglyceridemia, the initial dose is 54 to 160 mg per day. 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 fenofibrate tablets should be initiated at a dose of 54 mg/day in patients having 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 54 mg/day.

  Lipid levels should be monitored periodically and consideration should be given to reducing the dosage of fenofibrate tablets if lipid levels fall significantly below the targeted range.

  Close
  No Recall

  More Info
• American Health Packaging
  

  ×

  Fenofibrate | American Health Packaging

  

  ---

  Patients should be placed on an appropriate lipid-lowering diet before receiving fenofibrate tablets, and should continue this diet during treatment with fenofibrate tablets. Fenofibrate tablets should be given with meals, thereby optimizing the bioavailability of the medication.

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

  For adult patients with hypertriglyceridemia, the initial dose is 54 to 160 mg per day. 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 fenofibrate tablets should be initiated at a dose of 54 mg/day in patients having 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 54 mg/day.

  Lipid levels should be monitored periodically and consideration should be given to reducing the dosage of fenofibrate tablets if lipid levels fall significantly below the targeted range.

  Close
  No Recall

  More Info
• American Health Packaging
  

  ×

  Fenofibrate | American Health Packaging

  

  ---

  2.1 General Considerations

  Patients should be placed on an appropriate lipid-lowering diet before receiving fenofibrate, and should continue this diet during treatment with fenofibrate. Fenofibrate tablets can be given without regard to meals.

  The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcoholic intake may be important factors in hypertriglyceridemia and should be addressed prior to any drug therapy. Physical exercise can be an important ancillary measure. Diseases contributory to hyperlipidemia, such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy, thiazide diuretics and beta-blockers, are sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of the specific etiologic agent may obviate the need for specific drug therapy of hypertriglyceridemia.

  Lipid levels should be monitored periodically and consideration should be given to reducing the dosage of fenofibrate if lipid levels fall significantly below the targeted range.

  Therapy should be withdrawn in patients who do not have an adequate response after two months of treatment with the maximum recommended dose of 145 mg once daily.

  2.2 Primary Hypercholesterolemia or Mixed Dyslipidemia

  The initial dose of fenofibrate is 145 mg once daily.

  2.3 Severe Hypertriglyceridemia

  The initial dose is 48 to 145 mg per day. 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 145 mg once daily.

  2.4 Impaired Renal Function

  Treatment with fenofibrate should be initiated at a dose of 48 mg per day in patients having 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 should be avoided in patients with severe renal impairment [see USE IN SPECIFIC POPULATIONS (8.6)  and CLINICAL PHARMACOLOGY (12.3)]

  2.5 Geriatric Patients

  Dose selection for the elderly should be made on the basis of renal function [see USE IN SPECIFIC POPULATIONS (8.5)].

  Close
  No Recall

  More Info
• Zydus Pharmaceuticals Usa Inc
  

  ×

  Fenofibrate | Zydus Pharmaceuticals Usa Inc

  

  ---

  2.1 General Considerations

  Patients should be placed on an appropriate lipid-lowering diet before receiving Fenofibrate tablets for oral use, and should continue this diet during treatment with Fenofibrate tablets for oral use. Fenofibrate tablets for oral use can be given without regard to meals.

  The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcoholic intake may be important factors in hypertriglyceridemia and should be addressed prior to any drug therapy. Physical exercise can be an important ancillary measure. Diseases contributory to hyperlipidemia, such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy, thiazide diuretics and beta-blockers, are sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of the specific etiologic agent may obviate the need for specific drug therapy of hypertriglyceridemia.

  Lipid levels should be monitored periodically and consideration should be given to reducing the dosage of Fenofibrate tablets for oral use if lipid levels fall significantly below the targeted range.

  Therapy should be withdrawn in patients who do not have an adequate response after two months of treatment with the maximum recommended dose of 145 mg once daily.

  2.2 Primary Hypercholesterolemia or Mixed Dyslipidemia

  The initial dose of Fenofibrate tablets for oral use is 145 mg once daily.

  2.3 Severe Hypertriglyceridemia

  The initial dose is 48 to 145 mg per day. 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 145 mg once daily.

  2.4 Impaired Renal Function

  Treatment with Fenofibrate tablets for oral use should be initiated at a dose of 48 mg per day in patients having 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 for oral use should be avoided in patients with severe renal impairment [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

  2.5 Geriatric Patients

  Dose selection for the elderly should be made on the basis of renal function [see Use in Specific Populations (8.5)].

  2.5 Geriatric Patients

  Dose selection for the elderly should be made on the basis of renal function [see Use in Specific Populations (8.5)].

  Close
  No Recall

  More Info
• Mylan Pharmaceuticals Inc.
  

  ×

  Fenofibrate | Mylan Pharmaceuticals Inc.

  

  ---

  2.1 General Considerations

  Patients should be placed on an appropriate lipid-lowering diet before receiving fenofibrate tablets, and should continue this diet during treatment with fenofibrate tablets. Fenofibrate tablets should be given with meals, thereby optimizing the bioavailability of the medication.

  The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcoholic intake may be important factors in hypertriglyceridemia and should be addressed prior to any drug therapy. Physical exercise can be an important ancillary measure. Diseases contributory to hyperlipidemia, such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy, thiazide diuretics and beta-blockers, are sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of the specific etiologic agent may obviate the need for specific drug therapy of hypertriglyceridemia.

  Lipid levels should be monitored periodically and consideration should be given to reducing the dosage of fenofibrate tablets if lipid levels fall significantly below the targeted range.

  Therapy should be withdrawn in patients who do not have an adequate response after 2 months of treatment with the maximum recommended dose of 160 mg once daily.

  2.2 Primary Hypercholesterolemia or Mixed Dyslipidemia

  The initial dose of fenofibrate tablets is 160 mg once daily.

  2.3 Severe Hypertriglyceridemia

  The initial dose is 54 mg to 160 mg per day. 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 once daily.

  2.4 Impaired Renal Function

  Treatment with fenofibrate tablets should be initiated at a dose of 54 mg per day in patients having 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 [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

  2.5 Geriatric Patients

  Dose selection for the elderly should be made on the basis of renal function [see Use in Specific Populations (8.5)].

  Close
  No Recall

  More Info
• Dr. Reddy’s Laboratories Limited
  

  ×

  Fenofibrate | Dr. Reddy's Laboratories Limited

  

  ---

  2.1 General Considerations

  Patients should be placed on an appropriate lipid-lowering diet before receiving fenofibrate capsules, and should continue this diet during treatment with fenofibrate capsules. Fenofibrate capsules can be given without regard to meals.  

  Patients should be advised to swallow fenofibrate capsules whole. Do not open, crush, dissolve or chew capsules.  

  The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcoholic intake may be important factors in hypertriglyceridemia and should be addressed prior to any drug therapy. Physical exercise can be an important ancillary measure. Diseases contributory to hyperlipidemia, such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy, thiazide diuretics and beta-blockers are sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of the specific etiologic agent may obviate the need for specific drug therapy of hypertriglyceridemia.

  Lipid levels should be monitored periodically and consideration should be given to reducing the dosage of fenofibrate if lipid levels fall significantly below the targeted range.  

  Therapy should be withdrawn in patients who do not have an adequate response after two months of treatment with the maximum recommended dose of 130 mg once daily.

  2.2 Hypercholesterolemia and Mixed Dyslipidemia

  The initial dose of fenofibrate capsules is 130 mg per day.

  2.3 Severe Hypertriglyceridemia

  The initial dose is 43 to 130 mg per day. 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 130 mg per day.

  2.4 Impaired Renal Function

  Treatment with fenofibrate  capsules should be initiated at a dose of 43 mg per day in patients having 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 capsules should be avoided in patients with severe renal impairment [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

  2.5 Geriatric Patients

  Dose selection for the elderly should be made on the basis of renal function [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

  Close
  No Recall

  More Info
• St Marys Medical Park Pharmacy
  

  ×

  Fenofibrate | St Marys Medical Park Pharmacy

  

  ---

  Patients should be placed on an appropriate lipid-lowering diet before receiving fenofibrate capsules, and should continue this diet during treatment with fenofibrate capsules. Fenofibrate capsules should be given with meals, thereby optimizing the bioavailability of the medication.

  For the treatment of adult patients with primary hypercholesterolemia or mixed hyperlipidemia, the initial dose of fenofibrate capsules is 200 mg per day.

  For adult patients with hypertriglyceridemia, the initial dose is 67 to 200 mg per day. 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 200 mg per day.

  Treatment with fenofibrate capsules should be initiated at a dose of 67 mg/day in patients having 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 67 mg/day.

  Lipid levels should be monitored periodically and consideration should be given to reducing the dosage of fenofibrate capsules if lipid levels fall significantly below the targeted range.

  Close
  No Recall

  More Info
• H2-pharma, Llc
  

  ×

  Fenofibrate | H2-pharma, Llc

  

  ---

  2.1 General Considerations

  Fenofibrate capsules should be given with meals thereby optimizing the absorption of the medication.

  Patients should be advised to swallow fenofibrate capsules whole. Do not open, crush, dissolve or chew capsules.

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

  The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcoholic intake may be important factors in hypertriglyceridemia and should be addressed prior to any drug therapy. Physical exercise can be an important ancillary measure. Diseases contributory to hyperlipidemia, such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy, thiazide diuretics and beta-blockers, are sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of the specific etiologic agent may obviate the need for specific drug therapy of hypertriglyceridemia.

  Periodic determination of serum lipids should be obtained during initial therapy in order to establish the lowest effective dose of fenofibrate. Therapy should be withdrawn in patients who do not have an adequate response after two months of treatment with the maximum recommended dose of 150 mg per day.

  Consideration should be given to reducing the dosage of fenofibrate if lipid levels fall significantly below the targeted range.

  2.2 Primary Hypercholesterolemia or Mixed Dyslipidemia

  The dose of fenofibrate capsules is 150 mg once daily.

  2.3 Severe Hypertriglyceridemia

  The initial dose is 50 to 150 mg per day. Dosage should be individualized according to patient response, and should be adjusted if necessary following repeat lipid determination at 4 to 8 week intervals.

  The maximum dose of fenofibrate capsules is 150 mg once daily.

  2.4 Impaired Renal Function

  In patients with mild-to-moderate renal impairment, treatment with fenofibrate capsules should be initiated at a dose of 50 mg per day, and increased only after evaluation of the effects on renal function and lipid levels at this dose. The use of fenofibrate should be avoided in patients with severe renal impairment [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

  2.5 Geriatric Patients

  Dose selection for the elderly should be made on the basis of renal function [see Use in Specific Populations (8.5) and Clinical Pharmacology (12.3)].

  Close
  No Recall

  More Info
• Northwind Pharmaceuticals
  

  ×

  Fenofibrate | Northwind Pharmaceuticals

  

  ---

  There is currently no dosage information available for this product. We apologize for any inconvenience.

  Close
  No Recall

  More Info
• Northwind Pharmaceuticals
  

  ×

  Fenofibrate | Northwind Pharmaceuticals

  

  ---

  There is currently no dosage information available for this product. We apologize for any inconvenience.

  Close
  No Recall

  More Info
• Mylan Institutional Inc.
  

  ×

  Fenofibrate | Mylan Institutional Inc.

  

  ---

  2.1 General Considerations

  Patients should be placed on an appropriate lipid-lowering diet before receiving fenofibrate tablets and should continue this diet during treatment with fenofibrate tablets. Fenofibrate tablets can be given without regard to meals.

  The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcoholic intake may be important factors in hypertriglyceridemia and should be addressed prior to any drug therapy. Physical exercise can be an important ancillary measure. Diseases contributory to hyperlipidemia, such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy, thiazide diuretics and beta-blockers, are sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of the specific etiologic agent may obviate the need for specific drug therapy of hypertriglyceridemia.

  Lipid levels should be monitored periodically and consideration should be given to reducing the dosage of fenofibrate tablets if lipid levels fall significantly below the targeted range.

  Therapy should be withdrawn in patients who do not have an adequate response after 2 months of treatment with the maximum recommended dose of 145 mg once daily.

  2.2 Primary Hypercholesterolemia or Mixed Dyslipidemia

  The initial dose of fenofibrate tablets is 145 mg once daily.

  2.3 Severe Hypertriglyceridemia

  The initial dose is 48 mg to 145 mg per day. 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 145 mg once daily.

  2.4 Impaired Renal Function

  Treatment with fenofibrate tablets should be initiated at a dose of 48 mg per day in patients having 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 [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

  2.5 Geriatric Patients

  Dose selection for the elderly should be made on the basis of renal function [see Use in Specific Populations (8.5)].

  Close
  No Recall

  More Info
• Global Pharmaceuticals, Division Of Impax Laboratories Inc.
  

  ×

  Fenofibrate | Global Pharmaceuticals, Division Of Impax Laboratories Inc.

  

  ---

  Patients should be placed on an appropriate lipid-lowering diet before receiving fenofibrate capsules, and should continue this diet during treatment with fenofibrate capsules. Fenofibrate capsules should be given with meals, thereby optimizing the bioavailability of the medication.

  For the treatment of adult patients with primary hypercholesterolemia or mixed hyperlipidemia, the initial dose of fenofibrate capsules is 200 mg per day.

  For adult patients with hypertriglyceridemia, the initial dose is 67 to 200 mg per day. 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 200 mg per day.

  Treatment with fenofibrate capsules should be initiated at a dose of 67 mg/day in patients having 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 67 mg/day.

  Lipid levels should be monitored periodically and consideration should be given to reducing the dosage of fenofibrate capsules if lipid levels fall significantly below the targeted range.

  Close
  No Recall

  More Info
• Carilion Materials Management
  

  ×

  Fenofibrate | Carilion Materials Management

  

  ---

  2.1 General Considerations

  Patients should be placed on an appropriate lipid-lowering diet before receiving Fenofibrate tablets for oral use, and should continue this diet during treatment with Fenofibrate tablets for oral use. Fenofibrate tablets for oral use can be given without regard to meals.

  The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcoholic intake may be important factors in hypertriglyceridemia and should be addressed prior to any drug therapy. Physical exercise can be an important ancillary measure. Diseases contributory to hyperlipidemia, such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy, thiazide diuretics and beta-blockers, are sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of the specific etiologic agent may obviate the need for specific drug therapy of hypertriglyceridemia.

  Lipid levels should be monitored periodically and consideration should be given to reducing the dosage of Fenofibrate tablets for oral use if lipid levels fall significantly below the targeted range.

  Therapy should be withdrawn in patients who do not have an adequate response after two months of treatment with the maximum recommended dose of 145 mg once daily.

  2.2 Primary Hypercholesterolemia or Mixed Dyslipidemia

  The initial dose of Fenofibrate tablets for oral use is 145 mg once daily.

  2.3 Severe Hypertriglyceridemia

  The initial dose is 48 to 145 mg per day. 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 145 mg once daily.

  2.4 Impaired Renal Function

  Treatment with Fenofibrate tablets for oral use should be initiated at a dose of 48 mg per day in patients having 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 for oral use should be avoided in patients with severe renal impairment . [see Use in Specific Populations and Clinical Pharmacology ] (8.6)(12.3)

  2.5 Geriatric Patients

  Dose selection for the elderly should be made on the basis of renal function . [see Use in Specific Populations ] (8.5)

  2.5 Geriatric Patients

  Dose selection for the elderly should be made on the basis of renal function . [see Use in Specific Populations ] (8.5)

  Close
  No Recall

  More Info
• Carilion Materials Management
  

  ×

  Fenofibrate | Carilion Materials Management

  

  ---

  2.1 General Considerations

  Patients should be placed on an appropriate lipid-lowering diet before receiving Fenofibrate tablets for oral use, and should continue this diet during treatment with Fenofibrate tablets for oral use. Fenofibrate tablets for oral use can be given without regard to meals.

  The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcoholic intake may be important factors in hypertriglyceridemia and should be addressed prior to any drug therapy. Physical exercise can be an important ancillary measure. Diseases contributory to hyperlipidemia, such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy, thiazide diuretics and beta-blockers, are sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of the specific etiologic agent may obviate the need for specific drug therapy of hypertriglyceridemia.

  Lipid levels should be monitored periodically and consideration should be given to reducing the dosage of Fenofibrate tablets for oral use if lipid levels fall significantly below the targeted range.

  Therapy should be withdrawn in patients who do not have an adequate response after two months of treatment with the maximum recommended dose of 145 mg once daily.

  2.2 Primary Hypercholesterolemia or Mixed Dyslipidemia

  The initial dose of Fenofibrate tablets for oral use is 145 mg once daily.

  2.3 Severe Hypertriglyceridemia

  The initial dose is 48 to 145 mg per day. 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 145 mg once daily.

  2.4 Impaired Renal Function

  Treatment with Fenofibrate tablets for oral use should be initiated at a dose of 48 mg per day in patients having 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 for oral use should be avoided in patients with severe renal impairment . [see Use in Specific Populations and Clinical Pharmacology ] (8.6)(12.3)

  2.5 Geriatric Patients

  Dose selection for the elderly should be made on the basis of renal function . [see Use in Specific Populations ] (8.5)

  2.5 Geriatric Patients

  Dose selection for the elderly should be made on the basis of renal function . [see Use in Specific Populations ] (8.5)

  Close
  No Recall

  More Info
• Oceanside Pharmaceuticals
  

  ×

  Fenofibrate | Oceanside Pharmaceuticals

  

  ---

  2.1 General Considerations

  Patients should be placed on an appropriate lipid-lowering diet before receiving fenofibrate tablets, and should continue this diet during treatment with fenofibrate tablets. Fenofibrate tablets can be given without regard to meals.

  The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcoholic intake may be important factors in hypertriglyceridemia and should be addressed prior to any drug therapy. Physical exercise can be an important ancillary measure. Diseases contributory to hyperlipidemia, such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy, thiazide diuretics and beta-blockers, are sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of the specific etiologic agent may obviate the need for specific drug therapy of hypertriglyceridemia.

  Lipid levels should be monitored periodically and consideration should be given to reducing the dosage of fenofibrate tablets if lipid levels fall significantly below the targeted range.

  Therapy should be withdrawn in patients who do not have an adequate response after two months of treatment with the maximum recommended dose of 145 mg once daily.

  2.2 Primary Hypercholesterolemia or Mixed Dyslipidemia

  The initial dose of fenofibrate tablets is 145 mg once daily.

  2.3 Severe Hypertriglyceridemia

  The initial dose is 48 to 145 mg per day. 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 145 mg once daily.

  2.4 Impaired Renal Function

  Treatment with fenofibrate tablets should be initiated at a dose of 48 mg per day in patients having 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 [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

  2.5 Geriatric Patients

  Dose selection for the elderly should be made on the basis of renal function [see Use in Specific Populations (8.5)].

  Close
  No Recall

  More Info
• Bryant Ranch Prepack
  

  ×

  Fenofibrate | Bryant Ranch Prepack

  

  ---

  Patients should be placed on an appropriate lipid-lowering diet before receiving fenofibrate tablets, and should continue this diet during treatment with fenofibrate tablets. Fenofibrate tablets should be given with meals, thereby optimizing the bioavailability of the medication.

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

  For adult patients with hypertriglyceridemia, the initial dose is 54 to 160 mg per day. 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 fenofibrate tablets should be initiated at a dose of 54 mg/day in patients having 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 54 mg/day.

  Lipid levels should be monitored periodically and consideration should be given to reducing the dosage of fenofibrate tablets if lipid levels fall significantly below the targeted range.

  Close
  No Recall

  More Info
• Perrigo New York Inc
  

  ×

  Fenofibrate | Perrigo New York Inc

  

  ---

  2.1 General Considerations

  Patients should be placed on an appropriate lipid-lowering diet before receiving fenofibrate tablets, and should continue this diet during treatment with fenofibrate tablets. Fenofibrate tablets can be given without regard to meals.

  The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcoholic intake may be important factors in hypertriglyceridemia and should be addressed prior to any drug therapy. Physical exercise can be an important ancillary measure. Diseases contributory to hyperlipidemia, such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy, thiazide diuretics and beta-blockers, are sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of the specific etiologic agent may obviate the need for specific drug therapy of hypertriglyceridemia.

  Lipid levels should be monitored periodically and consideration should be given to reducing the dosage of fenofibrate tablets if lipid levels fall significantly below the targeted range.

  Therapy should be withdrawn in patients who do not have an adequate response after two months of treatment with the maximum recommended dose of 145 mg once daily.

  2.2 Primary Hypercholesterolemia or Mixed Dyslipidemia

  The initial dose of fenofibrate tablets is 145 mg once daily.

  2.3 Severe Hypertriglyceridemia

  The initial dose is 48 to 145 mg per day. 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 145 mg once daily.

  2.4 Impaired Renal Function

  Treatment with fenofibrate tablets should be initiated at a dose of 48 mg per day in patients having 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 [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

  2.5 Geriatric Patients

  Dose selection for the elderly should be made on the basis of renal function [see Use in Specific Populations (8.5)].

  Close
  No Recall

  More Info
• Avpak
  

  ×

  Fenofibrate | Avpak

  

  ---

  Patients should be placed on an appropriate lipid-lowering diet before receiving fenofibrate tablets, and should continue this diet during treatment with fenofibrate tablets. Fenofibrate tablets should be given with meals, thereby optimizing the bioavailability of the medication.

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

  For adult patients with hypertriglyceridemia, the initial dose is 54 to 160 mg per day. 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 fenofibrate tablets should be initiated at a dose of 54 mg/day in patients having 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 54 mg/day.

  Lipid levels should be monitored periodically and consideration should be given to reducing the dosage of fenofibrate tablets if lipid levels fall significantly below the targeted range.

  Close
  No Recall

  More Info
• Directrx
  

  ×

  Fenofibrate | Directrx

  

  ---

  Patients should be placed on an appropriate lipid-lowering diet before receiving fenofibrate tablets, and should continue this diet during treatment with fenofibrate tablets. Fenofibrate tablets should be given with meals, thereby optimizing the bioavailability of the medication.

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

  For adult patients with hypertriglyceridemia, the initial dose is 54 to 160 mg per day. 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 fenofibrate tablets should be initiated at a dose of 54 mg/day in patients having 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 54 mg/day.

  Lipid levels should be monitored periodically and consideration should be given to reducing the dosage of fenofibrate tablets if lipid levels fall significantly below the targeted range.

  Close
  No Recall

  More Info