General MedicationsINTRAMUSCULAR / INTRAVENOUSHigh Alert

NAFCILLIN SODIUM

Standard Dose

DOSAGE AND ADMINISTRATION Nafcillin for Injection is available for intramuscular and intravenous 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. The treatment of endocarditis and osteomyelitis may require a longer duration of therapy. No dosage alterations are necessary for patients with renal dysfunction, including those on hemodialysis. Hemodialysis does not accelerate nafcillin clearance from the blood. 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. 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 mg/mL Sterile water for Injection , USP Sodium Chloride Injection USP Sodium Lactate Solution USP (M/6 Molar) Dextrose injection USP (5%) Dextrose and sodium chloride injection USP (5% Dextrose and 0.45% Sodium Chloride) Invert Sugar Injection USP (10%) Lactated Ringer’s Injection USP 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.

Max Dose

See official label

Primary Use

INDICATIONS AND USAGE Nafcillin is indicated in the treatment of infections caused by penicillinase-producing staphylococci which have demonstrated susceptibility to the drug.

Summary

Indications and usage INDICATIONS AND USAGE Nafcillin is indicated in the treatment of infections caused by penicillinase-producing staphylococci which have demonstrated susceptibility to the drug.

Culture and susceptibility tests should be performed initially to determine the causative organism and its susceptibility to the drug (see CLINICAL PHARMACOLOGY — Susceptibility Test Methods .

Structured Monograph

Clinical summary

Indications and usage INDICATIONS AND USAGE Nafcillin is indicated in the treatment of infections caused by penicillinase-producing staphylococci which have demonstrated susceptibility to the drug. Culture and susceptibility tests should be performed initially to determine the causative organism and its susceptibility to the drug (see CLINICAL PHARMACOLOGY — Susceptibility Test Methods . Nafcillin should not be used in infections caused by organisms susceptible to penicillin G. If the susceptibility tests indicate that the infection is due to methicillin-resistant Staphylococcus sp., therapy with Nafcillin for Injection, USP should be discontinued and alternative therapy provided. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Nafcillin for Injection, USP and other antibacterial drugs, Nafcillin for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Dosage and administration DOSAGE AND ADMINISTRATION Nafcillin for Injection is available for intramuscular and intravenous 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. The treatment of endocarditis and osteomyelitis may require a longer duration of therapy. No dosage alterations are necessary for patients with renal dysfunction, including those on hemodialysis. Hemodialysis does not accelerate nafcillin clearance from the blood. 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. 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 mg/mL Sterile water for Injection , USP Sodium Chloride Injection USP Sodium Lactate Solution USP (M/6 Molar) Dextrose injection USP (5%) Dextrose and sodium chloride injection USP (5% Dextrose and 0.45% Sodium Chloride) Invert Sugar Injection USP (10%) Lactated Ringer’s Injection USP 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 (-1

Monitoring

• WARNINGS Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy.
• These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens.
• Before initiating therapy with Nafcillin, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens.
• If an allergic reaction occurs, Nafcillin should be discontinued and appropriate therapy instituted.

Interaction Notes

• Review official label interaction section.