Kowa Pharmaceuticals America, Inc.

Kowa Pharmaceuticals America, Inc. Drugs

• Lipofen
  

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  Lipofen

  

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  2.1 General Considerations

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

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

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

  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 LIPOFEN. Therapy should be withdrawn in patients who do not have an adequate response after two months of treatment with the maximum recommended dose of 150 mg per day.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 LIPOFEN if lipid levels fall significantly below the targeted range.

  2.2 Primary Hypercholesterolemia or Mixed Dyslipidemia:

  The dose of LIPOFEN 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 LIPOFEN is 150 mg once daily.

  2.4 Impaired Renal Function

  In patients with mild-to-moderate renal impairment, treatment with LIPOFEN 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 LIPOFEN 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)].

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• Livalo
  

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  Livalo

  

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  2.1 General Dosing Information

  The dose range for LIVALO is 1 to 4 mg orally once daily at any time of the day with or without food. The recommended starting dose is 2 mg and the maximum dose is 4 mg. The starting dose and maintenance doses of LIVALO should be individualized according to patient characteristics, such as goal of therapy and response.

  After initiation or upon titration of LIVALO, lipid levels should be analyzed after 4 weeks and the dosage adjusted accordingly.

  2.2 Dosage in Patients with Renal Impairment

  Patients with moderate and severe renal impairment (glomerular filtration rate 30 – 59 mL/min/1.73 m2 and 15 – 29 mL/min/1.73 m2 not receiving hemodialysis, respectively) as well as end-stage renal disease receiving hemodialysis should receive a starting dose of LIVALO 1 mg once daily and a maximum dose of LIVALO 2 mg once daily.

  2.3 Use with Erythromycin

  In patients taking erythromycin, a dose of LIVALO 1 mg once daily should not be exceeded [see Drug Interactions (7.2)].

  2.4 Use with Rifampin

  In patients taking rifampin, a dose of LIVALO 2 mg once daily should not be exceeded [see Drug Interactions (7.3)].

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