Vansen Pharma Inc.

Vansen Pharma Inc. Drugs

• Spectracef
  

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  Spectracef

  

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  (See INDICATIONS AND USAGE for Indicated Pathogens.)

  SPECTRACEF® (cefditoren pivoxil) Dosage and Administration* Adults and Adolescents (≥12 Years)

  SPECTRACEF® (cefditoren pivoxil) Dosage and Administration* Adults and Adolescents (≥12 Years)

  Type of Infection

  Dosage

  Duration (Days)

  Community-Acquired Pneumonia

  400 mg BID

  14

  Acute Bacterial Exacerbation of Chronic Bronchitis

  400 mg BID

  10

  Pharyngitis/Tonsillitis

  200mg BID

  Uncomplicated Skin and Skin Structure Infections

  *Should be taken with meals

  Patients with Renal Insufficiency

  No dose adjustment is necessary for patients with mild renal impairment (CLcr: 50-80 mL/min/1.73 m2). It is recommended that not more than 200 mg BID be administered to patients with moderate renal impairment (CLcr: 30-49 mL/min/1.73 m2) and 200 mg QD be administered to patients with severe renal impairment (CLcr: <30 mL/min/1.73 m2). The appropriate dose in patients with end-stage renal disease has not been determined.

  Patients with Hepatic Disease

  No dose adjustments are necessary for patients with mild or moderate hepatic impairment (Child-Pugh Class A or B). The pharmacokinetics of cefditoren have not been studied in patients with severe hepatic impairment (Child-Pugh Class C).

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• Factive
  

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  Factive

  

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  FACTIVE can be taken with or without food and should be swallowed whole with a liberal amount of liquid. The recommended dose of FACTIVE is 320 mg daily, according to the following table (Table 4).Table 4.  Recommended Dosage Regimen of FACTIVE

  The clinical decision regarding the use of a 5 or 7 day regimen should be guided by results of the initial sputum culture.

  The recommended dose and duration of FACTIVE should not be exceeded (see Table 2).

  Use in Renally Impaired Patients: Dose adjustment in patients with creatinine clearance >40 mL/min is not required. Modification of the dosage is recommended for patients with creatinine clearance ≤40 mL/min. Table 5 provides dosage guidelines for use in patients with renal impairment.Table 5.  Recommended Doses for Patients with Renal Impairment

  Creatinine Clearance(mL/min) Dose  >40  See Usual Dosage  ≤40  160 mg every 24 hours

  Patients requiring routine hemodialysis or continuous ambulatory peritoneal dialysis (CAPD) should receive 160 mg every 24 hours.

  When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.

  Creatinine Clearance Formula

  Women: 0.85 x the value calculated for men

  Use in Hepatically Impaired Patients: No dosage adjustment is recommended in patients with mild (Child-Pugh Class A), moderate (Child-Pugh Class B) or severe (Child-Pugh Class C) hepatic impairment.

  Use in Elderly: No dosage adjustment is recommended.

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