Alaway

Alaway Manufacturers

• Bausch & Lomb Incorporated
  

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  Alaway | Shanghai Lantern Cosmetic Co., Ltd.

  

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  Directions

  Wet hands thoroughly with product and rub until dry without wiping For children under 6, use only under adult supervision. Not recommended for infants

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• Bausch & Lomb Incorporated
  

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  Alaway | Carlsbad Technology, Inc.

  

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  Adults

  Ciprofloxacin Tablets should be administered orally to adults as described in the Dosage Guidelines table.

  The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient's host-defense mechanisms, and the status of renal function and hepatic function.

  The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, polymeric phosphate binders (for example, sevelamer, lanthanum carbonate ) or sucralfate, Videx® (didanosine) chewable/ buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.

  * Used in conjunction with metronidazole

  † Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure).

  ** Drug administration should begin as soon as possible after suspected or confirmed exposure.

  This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit. 6 For a discussion of ciprofloxacin serum concentrations in various human populations, see Inhalational Anthrax, Additional Information.

  Conversion of IV to Oral Dosing in Adults: Patients whose therapy is started with CIPRO IV may be switched to CIPRO Tablets or Oral Suspension when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens).

  Equivalent AUC Dosing Regimens Cipro Oral Dosage Equivalent Cipro IV Dosage 250 mg Tablet q 12 h 200 mg IV q 12 h 500 mg Tablet q 12 h 400 mg IV q 12 h 750 mg Tablet q 12 h 400 mg IV q 8 h

  Adults with Impaired Renal Function: Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:

  RECOMMENDED STARTING AND MAINTENANCE DOSES
  FOR PATIENTS WITH IMPAIRED RENAL FUNCTION

  Creatinine Clearance (mL/min)             Dose > 50 See Usual Dosage. 30 – 50 250 – 500 mg q 12 h 5 – 29 250 – 500 mg q 18 h Patients on hemodialysis or Peritoneal dialysis 250 – 500 mg q 24 h (after dialysis)

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

  Men: Creatinine clearance (mL/min) =             Weight (kg) x (140 - age)
         72 x serum creatinine (mg/dL)
  Women: 0.85 x the value calculated for men.
  The serum creatinine should represent a steady state of renal function.

  In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.

  Pediatrics

  Ciprofloxacin Tablets should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)

  Dosing and initial route of therapy (that is, IV or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg IV every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.

  * The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).

  ** Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit. 6 For a discussion of ciprofloxacin serum concentrations in various human populations, see Inhalational Anthrax In Adults and Pediatrics, Additional Information.

  Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (that is, creatinine clearance of < 50 mL/min/1.73m 2).

  PEDIATRIC DOSAGE GUIDELINES Infection Route of Administration Dose
  (mg/kg)
  Frequency Total
  Duration Complicated Urinary Tract
  or
  Pyelonephritis
  
  (patients from
  1 to 17 years of age) Intravenous 6 to 10 mg/kg
  (maximum 400 mg per dose; not to be exceeded even in patients weighing > 51 kg) Every 8 hours 10-21 days* Oral 10 mg/kg to 20 mg/kg (maximum 750 mg per dose; not to be exceeded even in patients weighing > 51 kg) Every 12 hours Inhalational Anthrax (Post- Exposure)** Intravenous 10 mg/kg
  (maximum 400 mg per dose) Every 12
  hours 60 days Oral 15 mg/kg
  (maximum 500 mg per dose) Every 12
  hours

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