Pain Relief Pm Extra Strength Aspirin Free

Pain Relief Pm Extra Strength Aspirin Free Manufacturers

• Safeway, Inc.
  

  ×

  Pain Relief Pm Extra Strength Aspirin Free | Sun Pharmaceutical Industries, Inc.

  

  ---

  2.1 Important Dosing and Administration Information

  In selecting a digoxin dosing regimen, it is important to consider factors that affect digoxin blood levels (e.g., body weight, age, renal function, concomitant drugs) since toxic levels of digoxin are only slightly higher than therapeutic levels. Dosing can be either initiated with a loading dose followed by maintenance dosing if rapid titration is desired or initiated with maintenance dosing without a loading dose.

  Consider interruption or reduction in digoxin dose prior to electrical cardioversion [see Warnings and Precautions (5.4)].

  Use digoxin solution to obtain the appropriate dose in infants, young pediatric patients, or patients with very low body weight.

  2.2 Loading Dosing Regimen in Adults and Pediatric Patients

  For adults and pediatric patients if a loading dosage is to be given, administer half the total   loading dose initially, then ¼ the loading dose every 6 to 8 hours twice, with careful assessment of clinical response and toxicity before each dose. The recommended loading dose is displayed in Table 1.

  
  Table 1. Recommended Digoxin Oral Loading Dose

  
  Age
   
   
   
  5 to 10 years
  Total Oral Loading Dose (mcg/kg)
  Administer half the total loading dose initially,
  then ¼ the loading dose every 6 to 8 hours twice
  Adults and pediatric patients over 10 years
  mcg=micrograms
  10-15
  
  2.3 Maintenance Dosing in Adults and Pediatric Patients Over 10 Years Old

  The maintenance dose is based on lean body weight, renal function, age, and concomitant products [see Clinical Pharmacology (12.3)].

  The recommended starting maintenance dose in adults and pediatric patients over 10 years old with normal renal function is given in Table 2. Doses may be increased every 2 weeks according to clinical response, serum drug levels, and toxicity.

  Table 2. Recommended Starting Digoxin Maintenance Dosage in Adults and Pediatric Patients Over 10 Years Old

  
  
  Age
  Total Oral Maintenance Dose, mcg/kg/day
  (given once daily)
  Adults and pediatric patients over 10 years
  3.4 to 5.1
  

  
  Table 3 provides the recommended (once daily) maintenance dose for adults and pediatric patients over 10years old (to be given once daily) according to lean body weight and renal function. The doses are based on studies in adult patients with heart failure. Alternatively, the maintenance dose may be estimated by the following formula (peak body stores lost each day through elimination):

  
  

  Total Maintenance Dose = Loading Dose (i.e., Peak Body Stores) x % Daily Loss/100

  (% Daily Loss = 14 + Creatinine clearance/5)

  
  

  Reduce the dose of digoxin in patients whose lean weight is an abnormally small fraction of their total body mass because of obesity or edema.

  Table 3. Recommended Maintenance Dose (in micrograms given once daily) of Digoxin in Pediatric Patients Over 10 Years Old and Adults by Lean Body Weight and by Renal Functionª

  
  Corrected Creatinine Clearance b
  Lean Body Weightd
  Number of days Before Steady
  State Achievedc
  Kg
  40
  50
  60
  70
  80
  90
  100
  10 mL/min
   
  62.5*
  125
  125
  187.5
  187.5
  187.5
  250
  19
  20 mL/min
   
  125
  125
  125
  187.5
  187.5
  250
  250
  16
  30 mL/min
   
  125
  125
  187.5
  187.5
  250
  250
  312.5
  14
  40 mL/min
   
  125
  187.5
  187.5
  250
  250
  312.5
  312.5
  13
  50 mL/min
   
  125
  187.5
  187.5
  250
  250
  312.5
  312.5
  12
  60 mL/min
   
  125
  187.5
  250
  250
  312.5
  312.5
  375
  11
  70 mL/min
   
  187.5
  187.5
  250
  250
  312.5
  375
  375
  10
  80 mL/min
   
  187.5
  187.5
  250
  312.5
  312.5
  375
  437.5
  9
  90 mL/min
   
  187.5
  250
  250
  312.5
  375
  437.5
  437.5
  8
  100 mL/min
   
  187.5
  250
  312.5
  312.5
  375
  437.5
  500
  7
  

  a Doses are rounded to the nearest dose possible using whole and/or half digoxin tablets. Recommended doses approximately 30 percent lower than the calculated dose are designated with an *. Monitor digoxin levels in patients receiving these initial doses and increase dose if needed.

  bFor adults, creatinine clearance was corrected to 70-kg body weight or 1.73 m2 body surface area. If only serum creatinine concentrations (Scr) are available, a corrected Ccr may be estimated in men as (140 – Age)/Scr. For women, this result should be multiplied by 0.85.

  For pediatric patients, the modified Schwartz equation may be used. The formula is based on height in cm and Scr in mg/dL where k is a constant. Ccr is corrected to 1.73 m2 body surface area. During the first year of life, the value of k is 0.33 for pre-term babies and 0.45 for term infants. The k is 0.55 for pediatric patients and adolescent girls and 0.7 for adolescent boys.

  GFR (mL/min/1.73 m2) = (k x Height)/Scr

  c If no loading dose administered.

  d The doses listed assume average body composition.

  
  
  2.4 Maintenance Dosing in Pediatric Patients Less Than 10 Years Old

  The starting maintenance dose for heart failure in pediatric patients less than 10 years old is based on lean body weight, renal function, age, and concomitant products [see Clinical Pharmacology (12.3)]. The recommended starting maintenance dose for pediatric patients between 5 years and 10 years old is given in Table 4. These recommendations assume the presence of normal renal function.

  
  

  Table 4. Recommended Starting Digoxin Maintenance Dosage in Pediatric Patients Between 5 years and 10 Years Old

  
  Age
  Oral Maintenance Dose mcg/kg/day
  5 years to 10 years
  6.4 to 12.9
  3.2 to 6.4 Twice daily
  
  

  Table 5 provides average daily maintenance dose requirements for pediatric patients between 5 and 10 years old (to be given twice daily) with heart failure based on age, lean body weight, and renal function.

  Table 5. Recommended Maintenance Dose (in micrograms given TWICE daily) of Digoxin in Pediatric Patients between 5 and 10 Years of Agea Based upon Lean Body Weight and Renal Function a,b  

  
  
  Corrected Creatinine
  Clearance c
  Lean Body Weight
  Number of Days Before Steady State Acheivedd
  Kg
  20
  30
  40
  50
  60
  10 mL/min
   
  -
  62.5
  62.5*
  125
  125
  19
  20 mL/min
   
  62.5
  62.5
  125
  125
  125
  16
  30 mL/min
   
  62.5
  62.5*
  125
  125
  187.5
  14
  40 mL/min
   
  62.5
  62.5*
  125
  187.5
  187.5
  13
  50 mL/min
   
  62.5
  125
  125
  187.5
  187.5
  12
  60 mL/min
   
  62.5
  125
  125
  187.5
  250
  11
  70mL/min
   
  62.5
  125
  187.5
  187.5
  250
  10
  80mL/min
   
  62.5*
  125
  187.5
  187.5
  250
  9
  90mL/min
   
  62.5*
  125
  187.5
  250
  250
  8
  100mL/min
   
  62.5*
  125
  187.5
  250
  312.5
  7
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  

  aRecommended are doses to be given twice daily.

  bThe doses are rounded to the nearest dose possible using whole and/or half digoxin tablets.

  Recommended doses approximately 30 percent lower than the calculated dose are designated with an *. Monitor digoxin levels in patients receiving these initial doses and increase dose if needed

  c The modified Schwartz equation may be used to estimate creatinine clearance. See footnote b under Table 3.

  d If no loading dose administered.

  
  
  
  
  
  
  2.5 Monitoring to Assess Safety, Efficacy, and Therapeutic Blood Levels

  Monitor for signs and symptoms of digoxin toxicity and clinical response. Adjust dose based on toxicity, efficacy, and blood levels.

  Serum digoxin levels less than 0.5 ng/mL have been associated with diminished efficacy, while levels above 2 ng/mL have been associated with increased toxicity without increased benefit.

  
  

  Interpret the serum digoxin concentration in the overall clinical context, and do not use an isolated measurement of serum digoxin concentration as the basis for increasing or decreasing the digoxin dose.

  Serum digoxin concentrations may be falsely elevated by endogenous digoxin-like substances [see Drug Interactions (7.4)]. If the assay is sensitive to these substances, consider obtaining a baseline digoxin level before starting digoxin and correct post-treatment values by the reported baseline level.

  
  

  Obtain serum digoxin concentrations just before the next scheduled digoxin dose or at least 6 hours after the last dose. The digoxin concentration is likely to be 10% to 25% lower when sampled right before the next dose (24 hours after dosing) compared to sampling 8 hours after dosing (using once-daily dosing).

  However, there will be only minor differences in digoxin concentrations using twice daily dosing whether sampling is done at 8 or 12 hours after a dose.

  2.6 Switching from Intravenous Digoxin to Oral Digoxin

  When switching from intravenous to oral digoxin formulations, make allowances for differences in bioavailability when calculating maintenance dosages (see Table 6).

  
  

  Table 6. Comparison of the Systemic Availability and Equivalent Doses of Oral and Intravenous Digoxin

   
  Absolute Bioavailability
  Equivalent Doses
  Digoxin Tablets
  60-80%
  62.5
  125
  250
  500
  Digoxin Intravenous Injection
  100%
  50
  100
  200
  400
  
  
  
  

  Close
  No Recall

  More Info