Bosulif

Bosulif Manufacturers

• U.s. Pharmaceuticals
  

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  Bosulif | Direct Rx

  

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

  Except for gonorrhea, 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  Gonorrhea
   Acute, uncomplicated ano-genital and urethral infections in males and females 3 grams as single oral dose  Prepubertal children: 50 mg/kg amoxicillin for oral suspension, combined with 25 mg/kg probenecid as a single dose.
   Note: Since probenecid is contraindicated in children under 2 years, do not use this regimen in children under 2 years of age.

  2.2 Dosing in Neonates and Infants Aged12 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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• Pfizer Laboratories Div Pfizer Inc
  

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  Bosulif | American Regent, Inc.

  

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  WARNING: This is a potent drug: It must be diluted before administration to the patient.
  
  Dopamine Hydrochloride Injection, USP is administered (only after dilution) by intravenous infusion.

  Suggested Dilution: Transfer contents of one or more ampuls or vials by aseptic technique to either 250 mL or 500 mL of one of the following sterile intravenous solutions:

  Sodium Chloride Injection, USP Dextrose (5%) Injection, USP Dextrose (5%) and Sodium Chloride (0.9%) Injection, USP 5% Dextrose in 0.45% Sodium Chloride Solution Injection, USP Dextrose (5%) and Lactated Ringer’s Solution Injection Sodium Lactate Injection, USP (1/6 Molar) Lactated Ringer’s Injection, USP

  Dopamine Hydrochloride Injection, USP has been found to be stable for a minimum of 24 hours after dilution in the sterile intravenous solutions listed above. However, as with all intravenous admixtures, dilution should be made just prior to administration.

  Do NOT add Dopamine Hydrochloride to Sodium Bicarbonate Injection, USP or other alkaline intravenous solutions, since the drug is inactivated in alkaline solution.

  Rate of Administration: Dopamine Hydrochloride Injection, USP, after dilution, is administered intravenously by infusion through a suitable intravenous catheter or needle. When administering Dopamine Hydrochloride (or any potent medication) by continuous intravenous infusion, it is advisable to use a precision volume control intravenous set.  Each patient must be individually titrated to the desired hemodynamic or renal response to dopamine.

  Administration rates greater than 50 mcg/kg/minute have safely been used in advanced circulatory decompensation states. If unnecessary fluid expansion is of concern, adjustment of drug concentration may be preferred over increasing the flow rate of a less concentrated dilution.

  Suggested Regimen:

  1. When appropriate, increase blood volume with whole blood or plasma until central venous pressure is 10 to 15 cm H2O or pulmonary wedge pressure is 14 to 18 mm Hg.

  2. Begin infusion of diluted solution at doses of 2 to 5 mcg/kg/minute of Dopamine Hydrochloride in patients who are likely to respond to modest increments of heart force and renal perfusion.

  In more seriously ill patients, begin infusion of diluted solution at doses of 5 mcg/kg/minute of Dopamine Hydrochloride and increase gradually using 5 to 10 mcg/kg/minute increments up to 20 to 50 mcg/kg/minute as needed. If doses in excess of 50 mcg/kg/minute are required, it is advisable to check urine output frequently. Should urinary flow begin to decrease in the absence of hypotension, reduction of dopamine dosage should be considered. Multiclinic trials have shown that more than 50% of the patients have been satisfactorily maintained on doses of dopamine less than 20 mcg/kg/minute. In patients who do not respond to these doses with adequate arterial pressures or urine flow, additional increments of dopamine may be given in an effort to produce an appropriate arterial pressure and central perfusion.

  3. Treatment of all patients requires constant evaluation of therapy in terms of the blood volume, augmentation of cardiac contractility, and distribution of peripheral perfusion. Dosage of dopamine should be adjusted according to the patient’s response, with particular attention to diminution of established urine flow rate, increasing tachycardia or development of new dysrhythmias as indices for decreasing or temporarily suspending the dosage.

  4. As with all potent intravenously administered drugs, care should be taken to control the rate of administration to avoid inadvertent administration of a bolus of drug.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

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