Childrens Cough And Chest Congestion Dm

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• Cvs Pharmacy, Inc.
  

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  Childrens Cough And Chest Congestion Dm | Sagent Pharmaceuticals

  

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  2.1 Adult Population

  The recommended adult dosages are outlined in Table 1. Cefazolin for Injection should be administered intramuscularly (IM) or intravenously (IV) over approximately 30 minutes.

  Table 1: Recommended Dosing Schedule in Adult Patients with CrCl Greater Than or Equal To 55 mL/min.

  * In rare instances, doses of up to 12 grams of cefazolin per day have been used.

  Site and Type of Infection Dose Frequency Moderate to severe infections 500 mg to 1 gram every 6 to 8 hours Mild infections caused by susceptible gram-positive cocci 250 mg to 500 mg every 8 hours Acute, uncomplicated urinary tract infections 1 gram every 12 hours Pneumococcal pneumonia 500 mg every 12 hours Severe, life-threatening infections (e.g., endocarditis, septicemia)* 1 gram to 1.5 grams every 6 hours 2.2 Perioperative Prophylactic Use

  To prevent postoperative infection in contaminated or potentially contaminated surgery, recommended doses are:

  1 gram IV or IM administered ½ hour to 1 hour prior to the start of surgery. For lengthy operative procedures (e.g., 2 hours or more), 500 mg to 1 gram IV or IM during surgery (administration modified depending on the duration of the operative procedure). 500 mg to 1 gram IV or IM every 6 to 8 hours for 24 hours postoperatively.

  It is important that (i) the preoperative dose be given just prior (1/2 hour to 1 hour) to the start of surgery so that adequate antibacterial concentrations are present in the serum and tissues at the time of initial surgical incision; and (ii) Cefazolin for Injection be administered, if necessary, at appropriate intervals during surgery to provide sufficient concentrations of the antibacterial drug at the anticipated moments of greatest exposure to infective organisms.

  The prophylactic administration of Cefazolin for Injection should usually be discontinued within a 24-hour period after the surgical procedure. In surgery where the occurrence of infection may be particularly devastating (e.g., open-heart surgery and prosthetic arthroplasty), the prophylactic administration of cefazolin may be continued for 3 to 5 days following the completion of surgery.

  2.3 Patients with Renal Impairment

  Cefazolin for Injection may be used in patients with renal impairment with the dosage adjustments outlined in Table 2. All reduced dosage recommendations apply after an initial loading dose appropriate to the severity of the infection.

  Table 2: Dosage Adjustment for Patients with Renal Impairment Creatinine Clearance Dose Frequency 55 mL/min. or greater full dose normal frequency 35 to 54 mL/min. full dose every 8 hours or longer 11 to 34 mL/min. 1/2 usual dose every 12 hours 10 mL/min. or less 1/2 usual dose every 18 to 24 hours 2.4 Pediatric Dosage

  In pediatric patients, a total daily dosage of 25 to 50 mg per kg (approximately 10 to 20 mg per pound) of body weight, divided into 3 or 4 equal doses, is effective for most mild to moderately severe infections. Total daily dosage may be increased to 100 mg per kg (45 mg per pound) of body weight for severe infections. Since safety for use in premature infants and in neonates has not been established, the use of Cefazolin for Injection in these patients is not recommended.

  Table 3: Pediatric Dosage Guide
  Weight 25 mg/kg/day
  Divided into 3 Doses 25 mg/kg/day
  Divided into 4 Doses
  
  
  Lbs
  
  
  Kg
  Approximate Single Dose mg/q 8 h Vol. (mL) needed with dilution of
  125 mg/mL
  Approximate Single Dose mg/q 6 h Vol. (mL) needed with dilution of
  125 mg/mL 10
  20
  30
  40
  50 4.5
  9
  13.6
  18.1
  22.7 40 mg
  75 mg
  115 mg
  150 mg
  190 mg 0.35 mL
  0.6 mL
  0.9 mL
  1.2 mL
  1.5 mL 30 mg
  55 mg
  85 mg
  115 mg
  140 mg 0.25 mL
  0.45 mL
  0.7 mL
  0.9 mL
  1.1 mL  
  Weight 50 mg/kg/day
  Divided into 3 Doses 50 mg/kg/day
  Divided into 4 Doses
  
  
  Lbs
  
  
  Kg
  Approximate Single Dose mg/q 8 h Vol. (mL) needed with dilution of
  225 mg/mL
  Approximate Single Dose mg/q 6 h Vol. (mL) needed with dilution of
  225 mg/mL 10
  20
  30
  40
  50 4.5
  9
  13.6
  18.1
  22.7 75 mg
  150 mg
  225 mg
  300 mg
  375 mg 0.35 mL
  0.7 mL
  1 mL
  1.35 mL
  1.7 mL 55 mg
  110 mg
  170 mg
  225 mg
  285 mg 0.25 mL
  0.5 mL
  0.75 mL
  1 mL
  1.25 mL

  In pediatric patients with mild to moderate renal impairment (creatinine clearance of 70 to 40 mL/min.), 60 percent of the normal daily dose given in equally divided doses every 12 hours should be sufficient. In patients with moderate impairment (creatinine clearance of 40 to 20 mL/min.), 25 percent of the normal daily dose given in equally divided doses every 12 hours should be adequate. Pediatric patients with severe renal impairment (creatinine clearance of 20 to 5 mL/min.) may be given 10 percent of the normal daily dose every 24 hours. All dosage recommendations apply after an initial loading dose.

  2.5 Preparation for Use of Cefazolin for Injection

  Reconstitution

  Preparation of Parenteral Solution

  Parenteral drug products should be SHAKEN WELL when reconstituted, and inspected visually for particulate matter prior to administration. If particulate matter is evident in reconstituted fluids, the drug solutions should be discarded.

  When reconstituted or diluted according to the instructions below, Cefazolin for Injection is stable for 24 hours at room temperature or for 10 days if stored under refrigeration (5°C or 41°F). Reconstituted solutions may range in color from pale yellow to yellow without a change in potency.

  Single-Dose Vials

  For IM injection, IV direct (bolus) injection or IV infusion, reconstitute with Sterile Water for Injection according to the following table. SHAKE WELL.

  Table 4: Reconstitution Instructions
  Vial Size Amount of Diluent Approximate
  Concentration Approximate
  Available Volume 500 mg 2 mL 225 mg/mL 2.2 mL 1 gram 2.5 mL 330 mg/mL 3 mL

  Administration

  Intramuscular Administration

  Reconstitute vials with Sterile Water for Injection according to the dilution table above. Shake well until dissolved. Cefazolin for Injection should be injected into a large muscle mass. Pain on injection is infrequent with Cefazolin for Injection.

  Intravenous Administration

  Direct (bolus) injection: Following reconstitution according to the above table, further dilute vials with approximately 5 mL Sterile Water for Injection. Inject the solution slowly over 3 to 5 minutes, directly or through tubing for patients receiving parenteral fluids (see list below).

  Intermittent or continuous infusion: Dilute reconstituted Cefazolin for Injection in 50 to 100 mL of one of the following solutions:

    Sodium Chloride Injection, USP   5% or 10% Dextrose Injection, USP   5% Dextrose in Lactated Ringer's Injection, USP   5% Dextrose and 0.9% Sodium Chloride Injection, USP   5% Dextrose and 0.45% Sodium Chloride Injection, USP   5% Dextrose and 0.2% Sodium Chloride Injection, USP   Lactated Ringer's Injection, USP   Invert Sugar 5% or 10% in Sterile Water for Injection   Ringer's Injection, USP   5% Sodium Bicarbonate Injection, USP

  Prior to administration parenteral drug products should be inspected visually for particulate matter and discoloration whenever solution and container permit.

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