Nafcillin Sodium

Nafcillin Sodium Manufacturers

• Sandoz Inc
  

  ×

  Nafcillin Sodium | Sandoz Inc

  

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  The usual IV dosage for adults is 500 mg every 4 hours. For severe infections, 1 g every 4 hours is recommended. Administer slowly over at least 30 to 60 minutes to minimize the risk of vein irritation and extravasation. Bacteriologic studies to determine the causative organisms and their susceptibility to nafcillin should always be performed. Duration of therapy varies with the type and severity of infection as well as the overall condition of the patient, therefore it should be determined by the clinical and bacteriological response of the patient. In severe staphylococcal infections, therapy with nafcillin should be continued for at least 14 days. Therapy should be continued for at least 48 hours after the patient has become afebrile, asymptomatic, and cultures are negative. The treatment of endocarditis and osteomyelitis may require a longer duration of therapy.

  Nafcillin-probenecid therapy is generally limited to those infections where very high serum levels of nafcillin are necessary.

  No dosage alterations are necessary for patients with renal dysfunction, including those on hemodialysis. Hemodialysis does not accelerate nafcillin clearance from the blood.

  For patients with hepatic insufficiency and renal failure, measurement of nafcillin serum levels should be performed and dosage adjusted accordingly.

  With intravenous administration, particularly in elderly patients, care should be taken because of the possibility of thrombophlebitis.

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

  Do not add supplementary medication to nafcillin for injection.

  Directions for Use

  Nafcillin For Injection vials in the ADD-Vantage Drug Delivery System are for IV use only and are to be used with ADD-Vantage diluent containers of 0.9% Sodium Chloride Injection, USP 50 mL and 100 mL, or 5% Dextrose Injection, USP, 50 mL and 100 mL.

  Reconstitute ADD-Vantage vials as directed in the Instructions for Use section.

  Only 0.9% Sodium Chloride Injection, USP, and 5% Dextrose Injection, USP are available for use in the ADD-Vantage Delivery System for intravenous infusion of nafcillin for injection. The drug concentration and the rate and volume of the infusion should be adjusted so that the total dose of nafcillin is administered before the drug loses its stability in the solution in use.

  There is no clinical experience available on the use of this agent in neonates or infants for this route of administration.

  This route of administration should be used for relatively short-term therapy (24 to 48 hours) because of the occasional occurrence of thrombophlebitis particularly in elderly patients.

  If another agent is used in conjunction with nafcillin therapy, it should not be physically mixed with nafcillin but should be administered separately.

  Instructions for Use

  To Open Diluent Container:

  Peel overwrap from the corner and remove container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually.

  To Assemble Vial and Flexible Diluent Container:

  (Use Aseptic Technique)

  1. Remove the protective covers from the top of the vial and the vial port on the diluent container as follows:
  a. To remove the breakaway vial cap, swing the pull ring over the top of the vial and pull down far enough to start the opening (see Figure 1) then pull straight up to remove the cap (see Figure 2). NOTE: Do not access vial with syringe.
  
  b. To remove the vial port cover, grasp the tab on the pull ring, pull up to break the three tie strings, then pull back to remove the cover (see Figure 3). 2. Screw the vial into the vial port until it will go no further. THE VIAL MUST BE SCREWED IN TIGHTLY TO ASSURE A SEAL. This occurs approximately 1/2 turn (180°) after the first audible click (see Figure 4). The clicking sound does not assure a seal; the vial must be turned as far as it will go. NOTE: Once vial is seated, do not attempt to remove (see Figure 4). 3. Recheck the vial to assure that it is tight by trying to turn it further in the direction of assembly. 4. Label appropriately.
  

  To Prepare Admixture:

  1. Squeeze the bottom of the diluent container gently to inflate the portion of the container surrounding the end of the drug vial. 2. With the other hand, push the drug vial down into the container telescoping the walls of the container. Grasp the inner cap of the vial through the walls of the container (see Figure 5). 3. Pull the inner cap from the drug vial (see Figure 6). Verify that the rubber stopper has been pulled out, allowing the drug and diluent to mix.
  4. Mix container contents thoroughly and use within the specified time.

  Preparation for Administration:

  (Use Aseptic Technique)

  1. Confirm the activation and admixture of vial contents. 2. Check for leaks by squeezing container firmly. If leaks are found, discard unit as sterility may be impaired. 3. Close flow control clamp of administration set. 4. Remove cover from outlet port at bottom of container. 5. Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated. NOTE: See full directions on administration set carton. 6. Lift the free end of the hanger loop on the bottom of the vial, breaking the two tie strings. Bend the loop outward to lock it in the upright position, then suspend container from hanger. 7. Squeeze and release drip chamber to establish proper fluid level in chamber. 8. Open flow control clamp and clear air from set. Close clamp. 9. Attach set to venipuncture device. If device is not indwelling, prime and make venipuncture. 10. Regulate rate of administration with flow control clamp.

  WARNING: Do not use flexible container in series connections.

  At concentrations ranging from 10 to 40 mg/mL in either 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP nafcillin sodium will have utility times of 24 hours at room temperature (25°C).

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• Sandoz Inc
  

  ×

  Nafcillin Sodium | Sandoz Inc

  

  ---

  The usual IV dosage for adults is 500 mg every 4 hours. For severe infections, 1 g every 4 hours is recommended. Administer slowly over at least 30 to 60 minutes to minimize the risk of vein irritation and extravasation. Bacteriologic studies to determine the causative organisms and their susceptibility to nafcillin should always be performed. Duration of therapy varies with the type and severity of infection as well as the overall condition of the patient, therefore it should be determined by the clinical and bacteriological response of the patient. In severe staphylococcal infections, therapy with nafcillin should be continued for at least 14 days. Therapy should be continued for at least 48 hours after the patient has become afebrile, asymptomatic, and cultures are negative. The treatment of endocarditis and osteomyelitis may require a longer duration of therapy.

  Nafcillin-probenecid therapy is generally limited to those infections where very high serum levels of nafcillin are necessary.

  No dosage alterations are necessary for patients with renal dysfunction, including those on hemodialysis. Hemodialysis does not accelerate nafcillin clearance from the blood.

  For patients with hepatic insufficiency and renal failure, measurement of nafcillin serum levels should be performed and dosage adjusted accordingly.

  With intravenous administration, particularly in elderly patients, care should be taken because of the possibility of thrombophlebitis.

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

  Do not add supplementary medication to nafcillin for injection.

  Directions for Use

  Nafcillin For Injection vials in the ADD-Vantage Drug Delivery System are for IV use only and are to be used with ADD-Vantage diluent containers of 0.9% Sodium Chloride Injection, USP 50 mL and 100 mL, or 5% Dextrose Injection, USP, 50 mL and 100 mL.

  Reconstitute ADD-Vantage vials as directed in the Instructions for Use section.

  Only 0.9% Sodium Chloride Injection, USP, and 5% Dextrose Injection, USP are available for use in the ADD-Vantage Delivery System for intravenous infusion of nafcillin for injection. The drug concentration and the rate and volume of the infusion should be adjusted so that the total dose of nafcillin is administered before the drug loses its stability in the solution in use.

  There is no clinical experience available on the use of this agent in neonates or infants for this route of administration.

  This route of administration should be used for relatively short-term therapy (24 to 48 hours) because of the occasional occurrence of thrombophlebitis particularly in elderly patients.

  If another agent is used in conjunction with nafcillin therapy, it should not be physically mixed with nafcillin but should be administered separately.

  Instructions for Use

  To Open Diluent Container:

  Peel overwrap from the corner and remove container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually.

  To Assemble Vial and Flexible Diluent Container:

  (Use Aseptic Technique)

  1. Remove the protective covers from the top of the vial and the vial port on the diluent container as follows:
  a. To remove the breakaway vial cap, swing the pull ring over the top of the vial and pull down far enough to start the opening (see Figure 1) then pull straight up to remove the cap (see Figure 2). NOTE: Do not access vial with syringe.
  
  b. To remove the vial port cover, grasp the tab on the pull ring, pull up to break the three tie strings, then pull back to remove the cover (see Figure 3). 2. Screw the vial into the vial port until it will go no further. THE VIAL MUST BE SCREWED IN TIGHTLY TO ASSURE A SEAL. This occurs approximately 1/2 turn (180°) after the first audible click (see Figure 4). The clicking sound does not assure a seal; the vial must be turned as far as it will go. NOTE: Once vial is seated, do not attempt to remove (see Figure 4). 3. Recheck the vial to assure that it is tight by trying to turn it further in the direction of assembly. 4. Label appropriately.
  

  To Prepare Admixture:

  1. Squeeze the bottom of the diluent container gently to inflate the portion of the container surrounding the end of the drug vial. 2. With the other hand, push the drug vial down into the container telescoping the walls of the container. Grasp the inner cap of the vial through the walls of the container (see Figure 5). 3. Pull the inner cap from the drug vial (see Figure 6). Verify that the rubber stopper has been pulled out, allowing the drug and diluent to mix.
  4. Mix container contents thoroughly and use within the specified time.

  Preparation for Administration:

  (Use Aseptic Technique)

  1. Confirm the activation and admixture of vial contents. 2. Check for leaks by squeezing container firmly. If leaks are found, discard unit as sterility may be impaired. 3. Close flow control clamp of administration set. 4. Remove cover from outlet port at bottom of container. 5. Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated. NOTE: See full directions on administration set carton. 6. Lift the free end of the hanger loop on the bottom of the vial, breaking the two tie strings. Bend the loop outward to lock it in the upright position, then suspend container from hanger. 7. Squeeze and release drip chamber to establish proper fluid level in chamber. 8. Open flow control clamp and clear air from set. Close clamp. 9. Attach set to venipuncture device. If device is not indwelling, prime and make venipuncture. 10. Regulate rate of administration with flow control clamp.

  WARNING: Do not use flexible container in series connections.

  At concentrations ranging from 10 to 40 mg/mL in either 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP nafcillin sodium will have utility times of 24 hours at room temperature (25°C).

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• Teva Parenteral Medicines, Inc.
  

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  Nafcillin Sodium | Teva Parenteral Medicines, Inc.

  

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  Nafcillin for Injection is available for intramuscular and intravenous use. The penicillinase-resistant penicillins are available for oral administration and for intramuscular and intravenous injection. The sodium salts of methicillin, oxacillin, and nafcillin may be administered parenterally and the sodium salts of cloxacillin, dicloxacillin, oxacillin, and nafcillin are available for oral use. The usual I.V dosage for adults is 500 mg every 4 hours. For severe infections, 1 gram every 4 hours is recommended. Administer slowly over at least 30 to 60 minutes to minimize the risk of vein irritation and extravasation.

  RECOMMENDED DOSAGE FOR NAFCILLIN FOR INJECTION, USP Drug
  Adults
  Infants and Children
  <40 kg (88 lbs)
  Other Recommendations
  Nafcillin
  500 mg IM every 4 to 6 hours.
  IV every 4 hours
  25 mg/kg IM twice daily
  Neonates 10 mg/kg IM twice daily
  Nafcillin
  1 gram IM or IV every 4 hours (severe infections)
  
  
  

  Bacteriologic studies to determine the causative organisms and their susceptibility to nafcillin should always be performed. Duration of therapy varies with the type and severity of infection as well as the overall condition of the patient; therefore, it should be determined by the clinical and bacteriological response of the patient. In severe staphylococcal infections, therapy with nafcillin should be continued for at least 14 days. Therapy should be continued for at least 48 hours after the patient has become afebrile, asymptomatic, and cultures are negative. The treatment of endocarditis and osteomyelitis may require a longer duration of therapy.

  Concurrent administration of the penicillinase- resistant penicillins and probenecid increases and prolongs serum penicillin levels. Probenecid decreases the apparent volume of distribution and slows the rate of excretion by competitively inhibiting renal tubular secretion of penicillin. Nafcillin-probenecid therapy is generally limited to those infections where very high serum levels of nafcillin are necessary.

  No dosage alterations are necessary for patients with renal dysfunction, including those on hemodialysis. Hemodialysis does not accelerate nafcillin clearance from the blood.

  For patients with hepatic insufficiency and renal failure, measurement of nafcillin serum levels should be performed and dosage adjusted accordingly.

  With intravenous administration, particularly in elderly patients, care should be taken because of the possibility of thrombophlebitis.

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

  Do not add supplementary medication to Nafcillin.

  Oral preparations of the penicillinase-resistant penicillins should not be used as initial therapy in serious life-threatening infections (see PRECAUTIONS, General ). Oral therapy with the penicillinase-resistant penicillins may be used to follow-up the previous use of a parenteral agent as soon as the clinical condition warrants. For intramuscular gluteal injections, care should be taken to avoid sciatic nerve injury. With intravenous administration, particularly in elderly patients, care should be taken because of the possibility of thrombophlebitis.

  DIRECTIONS FOR USE

  For Intramuscular Use

  Reconstitute with Sterile Water for Injection, USP, 0.9% Sodium Chloride Injection, USP or Bacteriostatic Water for Injection, USP (with benzyl alcohol or parabens); add 3.4 mL to the 1 g vial for 4 mL resulting solution and 6.6 mL to the 2 g vial for 8 mL resulting solution. All reconstituted vials have a concentration of 250 mg per mL.

  The clear solution should be administered by deep intragluteal injection immediately after reconstitution.

  Reconstituted Stability

  Reconstitute with the required amount of Sterile Water for Injection, USP, 0.9% Sodium Chloride Injection, USP or Bacteriostatic Water for Injection, USP (with benzyl alcohol or parabens). The resulting solutions are stable for 3 days at room temperature or 7 days under refrigeration and 90 days frozen.

  For Direct Intravenous Use

  The required amount of drug should be diluted in 15 to 30 mL of Sterile Water for Injection, USP or Sodium Chloride Injection, USP and injected over a 5- to 10- minute period. This may be accomplished through the tubing of an intravenous infusion if desirable.

  For Administration by Intravenous Drip

  Reconstitute as directed above (For Intravenous Use) prior to diluting with intravenous solution.

  STABILITY PERIODS FOR NAFCILLIN FOR INJECTION, USP*

  *IMPORTANT: This chemical stability information in no way indicates that it would be acceptable practice to use this product well after the preparation time. Good professional practice suggests that a product should be used as soon after preparation as feasible.
  

  Concentration
  Sterile water
  Sodium
  Sodium
  Dextrose
  Dextrose and
  Invert Sugar
  Lactated
  mg/mL
  for Injection,
  Chloride
  Lactate
  injection
  sodium
  Injection
  Ringer’s
  
  USP
  Injection
  Solution
  USP (5%)
  chloride
  USP (10%)
  Injection
  
  
  USP (0.9%)
  USP (M/6
  
  injection USP
  
  USP
  
  
  
  Molar)
  
  (5% Dextrose
  
  
  
  
  
  
  
  and 0.45%
  
  
  
  
  
  
  
  Sodium
  
  
  
  
  
  
  
  Chloride)
  
  
  ROOM TEMPERATURE (25° C)
  10-200
  24 Hrs
  24 Hrs
  
  
  
  
  
  30
  
  
  24 Hrs
  
  
  
  
  2-30
  
  
  
  24 Hrs
  24 Hrs
  
  
  10-30
  
  
  
  
  
  24 Hrs
  24 Hrs
  REFRIGERATION (4° C)
  10-200
  7 Days
  7 Days
  
  
  
  
  
  10-30
  
  
  7 Days
  7 Days
  7 Days
  7 Days
  7 Days
  FROZEN (-15° C)
  250
  90 Days
  90 Days
  
  
  
  
  
  10-250
  
  
  90 Days
  90 Days
  90 Days
  90 Days
  90 Days
  

  Only those solutions listed above should be used for the intravenous infusion of nafcillin sodium, USP. The concentration of the antibiotic should fall within the range specified. The drug concentration and the rate and volume of the infusion should be adjusted so that the total dose of nafcillin is administered before the drug loses its stability in the solution in use.

  There is no clinical experience available on the use of this agent in neonates or infants for this route of administration.

  This route of administration should be used for relatively short-term therapy (24 to 48 hours) because of the occasional occurrence of thrombophlebitis particularly in elderly patients.

  If another agent is used in conjunction with nafcillin therapy, it should not be physically mixed with nafcillin but should be administered separately.

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