Multi-symptom Non-aspirin Cold Nighttime

Multi-symptom Non-aspirin Cold Nighttime Manufacturers

• Value Merchandisers Company, Inc.
  

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  Multi-symptom Non-aspirin Cold Nighttime | Aurobindo Pharma Limited

  

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  2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age
  

  Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.

  
  Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age Infection Severitya Usual Adult Dose Usual Dose for Children > 3 Monthsb a Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections.
  b The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.
   Ear/Nose/Throat
   Skin/Skin Structure
   Genitourinary Tract
  Mild/Moderate
  500 mg every 12 hours
  or
  250 mg every 8 hours
   25 mg/kg/day in divided doses every 12 hours
   or
   20 mg/kg/day in divided doses every 8 hours
  Severe
  875 mg every 12 hours
  or
  500 mg every 8 hours
   45 mg/kg/day in divided doses every 12 hours
   or
   40 mg/kg/day in divided doses every 8 hours
   Lower Respiratory Tract
  Mild/Moderate or Severe
  875 mg every 12 hours
  or
  500 mg every 8 hours
   45 mg/kg/day in divided doses every 12 hours
   or
   40 mg/kg/day in divided doses every 8 hours
  2.2 Dosing in Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)
  

  Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.  Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin for oral suspension is

  30 mg/kg/day divided every 12 hours.  There are currently no dosing recommendations for pediatric patients with impaired renal function.

  2.3 Dosing for H. pylori Infection
  

  Triple therapy:The recommended adult oral dose is 1 gram amoxicillin for oral suspension, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days.
  
  Dual therapy:The recommended adult oral dose is 1 gram amoxicillin for oral suspension and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days.
  
  Please refer to clarithromycin and lansoprazole full prescribing information.

  2.4 Dosing in Renal Impairment Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/min. should not receive a 875 mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis. 2.5 Directions for Mixing Oral Suspension
  

  Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (see Table 2) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.

  
  Table 2. Amount of Water for Mixing Oral Suspension Strength Bottle Size Amount of Water
  Required for
  Reconstitution Oral Suspension 200 mg/5 mL
  50 mL
  35 mL
  75 mL
  52 mL
  100 mL
  69 mL
  Oral Suspension 400 mg/5 mL
  50 mL
  35 mL
  75 mL
  52 mL
  100 mL
  69 mL
  

  After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately.
  
  NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration is preferable, but not required.

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