Restasis

Restasis Manufacturers

• Physicians Total Care, Inc.
  

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  Restasis | Physicians Total Care, Inc.

  

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  Invert the unit dose vial a few times to obtain a uniform, white, opaque emulsion before using. Instill one drop of RESTASIS® ophthalmic emulsion twice a day in each eye approximately 12 hours apart. RESTASIS® can be used concomitantly with artificial tears, allowing a 15 minute interval between products. Discard vial immediately after use.

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• Allergan, Inc.
  

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  Restasis | Northstar Rxllc

  

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  Amoxicillin and clavulanate potassium may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium is administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium should be taken at the start of a meal.

  2.1 Adults

  The usual adult dose is one 500-mg tablet of amoxicillin and clavulanate potassium every 12 hours or one 250mg tablet of amoxicillin and clavulanate potassium every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one 875-mg tablet of amoxicillin and clavulanate potassium every 12 hours or one 500-mg tablet of amoxicillin and clavulanate potassium every 8 hours. Adults who have difficulty swallowing may be given the 125 mg/5 mL or 250 mg/5 mL suspension in place of the 500-mg tablet. The 200 mg/5 mL suspension or the 400 mg/5 mL suspension may be used in place of the 875-mg tablet.

  Two 250-mg tablets of amoxicillin and clavulanate potassium should not be substituted for one 500-mg tablet of amoxicillin and clavulanate potassium. Since both the 250-mg and 500-mg tablets of amoxicillin and clavulanate potassium contain the same amount of clavulanic acid (125 mg, as the potassium salt), two 250-mg tablets are not equivalent to one 500-mg tablet of amoxicillin and clavulanate potassium.

  The 250-mg tablet of amoxicillin and clavulanate potassium and the 250-mg chewable tablet should not be substituted for each other, as they are not interchangeable. The 250-mg tablet of amoxicillin and clavulanate potassium and the 250-mg chewable tablet do not contain the same amount of clavulanic acid (as the potassium salt). The 250-mg tablet of amoxicillin and clavulanate potassium contains 125 mg of clavulanic acid, whereas the 250-mg chewable tablet contains 62.5 mg of clavulanic acid.

  2.2 Pediatric Patients

  Based on the amoxicillin component, amoxicillin and clavulanate potassium should be dosed as follows:

  Neonates and Infants Aged <12 weeks (<3 months): The recommended dose of Amoxicillin and clavulanate potassium is 30 mg/kg/day divided every 12 hours, based on the amoxicillin component. Experience with the 200 mg/5 mL formulation in this age group is limited, and thus, use of the 125 mg/5 mL oral suspension is recommended.

  Patients Aged 12 weeks (3 months) and Older: See dosing regimens provided in Table 1. The every 12 hour regimen is recommended as it is associated with significantly less diarrhea [see Clinical Studies (14.2)]. However, the every 12 hour suspension (200 mg/5 mL and 400 mg/5 mL) and chewable tablets (200 mg and 400 mg) contain aspartame and should not be used by phenylketonurics.

  Table 1. Dosing in Patients Aged 12 weeks (3 months) and Older * Each strength of suspension of amoxicillin and clavulanate potassium is available as a chewable tablet for use by older children. † Duration of therapy studied and recommended for acute otitis media is 10 days.

  DOSING REGIMEN

  Every 12 hours

  Every 8 hours

  
  
  INFECTION

  200 mg/5 mL or
  400 mg/5 mL
  oral suspension*

  125 mg/5 mL or
  250 mg/5 mL
  oral suspension*

  Otitis media†, sinusitis, lower respiratory tract infections, and more severe infections

  45 mg/kg/day
  every 12 hours

  40 mg/kg/day
  every 8 hours

  Less severe infections

  25 mg/kg/day
  every 12 hours

  20 mg/kg/day
  every 8 hours

  Patients Weighing 40 kg or More: Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations.

  The 250-mg tablet of amoxicillin and clavulanate potassium should not be used until the child weighs at least 40 kg, due to the different amoxicillin to clavulanic acid ratios in the 250-mg tablet of amoxicillin and clavulanate potassium (250 mg/125 mg) versus the 250-mg chewable tablet of amoxicillin and clavulanate potassium (250 mg/62.5 mg).

  2.3 Patients with Renal Impairment

  Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Renal impairment patients with a glomerular filtration rate of <30 mL/min should not receive the 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.

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