Consists of Ampicillin sodium or ampicillin trihydrate, oxacillin sodium
What is Oxacillin sodium?
Oxacillin sodium is an antibiotic in the penicillin group of drugs. It fights bacteria in your body.
Oxacillin sodium is used to treat many different types of infections caused by bacteria, such as a staphylococcal (also called "staph") infection.
Oxacillin sodium may also be used for other purposes not listed in this medication guide.
Oxacillin sodium indications
Oxacillin sodium is indicated in the treatment of infections caused by penicillinase producing staphylococci which have demonstrated susceptibility to the drug. Cultures and susceptibility tests should be performed initially to determine the causative organism and its susceptibility to the drug.
Oxacillin sodium may be used to initiate therapy in suspected cases of resistant staphylococcal infections prior to the availability of susceptibility test results. Oxacillin sodium should not be used in infections caused by organisms susceptible to penicillin G. If the susceptibility tests indicate that the infection is due to an organism other than a resistant Staphylococcus, therapy should not be continued with Oxacillin sodium.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Oxacillin sodium for Injection, USP and other antibacterial drugs, Oxacillin sodium 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.
How should I use Oxacillin sodium?
Use Oxacillin sodium as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Oxacillin sodium is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Oxacillin sodium at home, a health care provider will teach you how to use it. Be sure you understand how to use Oxacillin sodium. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
- Do not use Oxacillin sodium if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
- To clear up your infection completely, use Oxacillin sodium for the full course of treatment. Keep using it even if you feel better in a few days.
- Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
- If you miss a dose of Oxacillin sodium, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.
Ask your health care provider any questions you may have about how to use Oxacillin sodium.
Uses of Oxacillin sodium in details
Use: Labeled Indications
Staphylococcal infections: Treatment of infections caused by penicillinase-producing staphylococci that have demonstrated susceptibility to the drug; empiric therapy in suspected cases of resistant staphylococcal infections.
Limitations of use: Oxacillin sodium should not be used in infections caused by organisms susceptible to penicillin G.
Off Label Uses
Catheter-related bloodstream infections
IDSA clinical practice guidelines suggest that Oxacillin sodium may be used as first-line therapy for the treatment of catheter-related bloodstream infections caused by methicillin-susceptible S. aureus or methicillin-susceptible, coagulase-negative Staphylococcus species.
Skin and soft tissue necrotizing infections
Based on the Infectious Diseases Society of America (IDSA) guidelines for the diagnosis and management of skin and soft tissue infections (SSTI), Oxacillin sodium is an effective and recommended treatment for necrotizing infections of the skin, fascia, and muscle due to methicillin-sensitive Staphylococcus aureus.
Surgical site infections
Based on the Infectious Diseases Society of America (IDSA) guidelines for the diagnosis and management of skin and soft tissue infections (SSTI), Oxacillin sodium is an effective and recommended option for treatment of surgical site infections occurring after surgery of the trunk or extremity (away from the axilla or perineum). Systemic antibacterials are not routinely indicated for surgical site infections, but may be beneficial (in conjunction with suture removal plus incision and drainage) in patients with significant systemic response (eg, temperature >38.5ºC, heart rate >110 beats per minute, erythema/induration extending >5 cm from incision, WBC >12,000/mm).
Oxacillin sodium description
An antibiotic similar to flucloxacillin used in resistant staphylococci infections. [PubChem]
Oxacillin sodium dosage
Bacteriologic studies to determine the causative organisms and their susceptibility to Oxacillin sodium should always be performed. Duration of therapy varies with the type of 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 Oxacillin sodium 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. Treatment of endocarditis and osteomyelitis may require a longer duration of therapy.
With intravenous administration, particularly in elderly patients, care should be taken because of the possibility of thrombophlebitis.
| Drug | Adults | Infants and Children <40 kg (88 lbs) | Other Recommendations |
|---|---|---|---|
| Oxacillin sodium | 250 to 500 mg IM or IV every 4 to 6 hours (mild to moderate infections) | 50 mg/kg/day IM or IV in equally divided doses every 6 hours (mild to moderate infections) | |
| 1 gram IM or IV every 4 to 6 hours (severe infections) | 100 mg/kg/day IM or IV in equally divided doses every 4 to 6 hours (severe infections) | Premature and Neonates 25 mg/kg/day IM or IV |
Directions for Use
ForIntramuscular Use
Use Sterile Water for Injection, USP. Add 5.7 mL to the 1 gram vial and 11.5 mL to the 2 gram vial. Shake well until a clear solution is obtained. After reconstitution, vials will contain 250 mg of active drug per 1.5 mL of solution. The reconstituted solution is stable for 3 days at 70°F or for one week under refrigeration (40°F).
For Direct
Intravenous Use
Use Sterile Water for Injection, USP or Sodium Chloride Injection, USP. Add 10 mL to the 1 gram vial and 20 mL to the 2 gram vial. Withdraw the entire contents and administer slowly over a period of approximately 10 minutes.
For Administration by
Intravenous Drip
Reconstitute as directed above (For Direct
Intravenous Use) prior to diluting with
Intravenous Solution.
| Concentration mg/mL | Sterile Water for Injection USP | 0.9% Sodium Chloride Injection, USP | M/6 Molar Sodium Lactate Solution | 5% Dextrose in water | 5% Dextrose in 0.45% sodium chloride | 10% Invert Sugar Injection, USP | Lactated Ringers Solution |
|---|---|---|---|---|---|---|---|
| ROOM TEMPERATURE (25°C) | |||||||
| 10-100 | 4 Days | 4 Days | |||||
| 10-30 | 24 Hrs | 24 Hrs | |||||
| 0.5-2 | 6 Hrs | 6 Hrs | 6 Hrs | ||||
| REFRIGERATION (4°C) | |||||||
| 10-100 | 7 Days | 7 Days | |||||
| 10-30 | 4 Days | 4 Days | 4 Days | 4 Days | 4 Days | ||
| FROZEN (-15°C) | |||||||
| 50-100 | 30 Days | ||||||
| 250/1.5 mL | 30 Days | ||||||
| 100 | 30 Days | ||||||
| 10-100 | 30 Days | 30 Days | 30 Days | 30 Days | 30 Days | ||
Stability studies on Oxacillin sodium sodium at concentrations of 0.5 mg/mL and 2 mg/mL in various intravenous solutions listed below indicate the drug will lose less than 10% activity at room temperature (70°F) during a 6-hour period.
IV Solution
5% Dextrose in Normal Saline
10% D-Fructose in Water
10% D-Fructose in Normal Saline
Lactated Potassic Saline Injection
10% Invert Sugar in Normal Saline
10% Invert Sugar Plus 0.3% Potassium Chloride in Water
Travert 10% Electrolyte #1
Travert 10% Electrolyte #2
Travert 10% Electrolyte #3
Only those solutions listed above should be used for the intravenous infusion of Oxacillin sodium sodium. 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 Oxacillin sodium is administered before the drug loses its stability in the solution in use.
If another agent is used in conjunction with Oxacillin sodium therapy, it should not be physically mixed with Oxacillin sodium but should be administered separately.
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 Oxacillin sodium for Injection, USP.
Oxacillin sodium interactions
See also:
What other drugs will affect Oxacillin sodium?
Tetracycline, a bacteriostatic antibiotic, may antagonize the bactericidal effect of penicillin and concurrent use of these drugs should be avoided.
Oxacillin sodium (Oxacillin sodium (Oxacillin sodium for injection) for injection) blood levels may be prolonged by concurrent administration of probenecid which blocks the renal tubular secretion of penicillins.
Oxacillin sodium side effects
See also:
What are the possible side effects of Oxacillin sodium?
Body as a Whole
The reported incidence of allergic reactions to penicillin ranges from 0.7 to 10 percent. Sensitization is usually the result of treatment but some individuals have had immediate reactions when first treated. In such cases, it is thought that the patients may have had prior exposure to the drug via trace amounts present in milk and vaccines.
Two types of allergic reactions to penicillins are noted clinically, immediate and delayed.
Immediate reactions usually occur within 20 minutes of administration and range in severity from urticaria and pruritus to angioneurotic edema, laryngospasm, bronchospasm, hypotension, vascular collapse and death. Such immediate anaphylactic reactions are very rare and usually occur after parenteral therapy but have occurred in patients receiving oral therapy. Another type of immediate reaction, an accelerated reaction, may occur between 20 minutes and 48 hours after administration and may include urticaria, pruritus, and fever. Although laryngeal edema, laryngospasm, and hypotension occasionally occur, fatality is uncommon.
Delayed allergic reactions to penicillin therapy usually occur after 48 hours and sometimes as late as 2 to 4 weeks after initiation of therapy.
Manifestations of this type of reaction include serum sickness-like symptoms (i.e., fever, malaise, urticaria, myalgia, arthralgia, abdominal pain) and various skin rashes. Nausea, vomiting, diarrhea, stomatitis, black or hairy tongue, and other symptoms of gastrointestinal irritation may occur, especially during oral penicillin therapy.
Nervous System Reactions
Neurotoxic reactions similar to those observed with penicillin G may occur with large intravenous doses of Oxacillin sodium, especially with patients with renal insufficiency.
Urogenital Reactions
Renal tubular damage and interstitial nephritis have been associated with the administration of Oxacillin sodium. Manifestations of this reaction may include rash, fever, eosinophilia, hematuria, proteinuria, and renal insufficiency. Nephropathy induced by penicillins does not appear to be dose-related and is generally reversible upon prompt discontinuation of therapy.
Gastrointestinal Reactions
Pseudomembranous colitis has been reported with the use of Oxacillin sodium. The onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment.
Metabolic Reactions
Agranulocytosis, neutropenia, and bone marrow depression have been associated with the use of Oxacillin sodium. Hepatotoxicity, characterized by fever, nausea, and vomiting associated with abnormal liver function tests, mainly elevated SGOT levels, has been associated with the use of Oxacillin sodium.
To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Oxacillin sodium contraindications
See also:
What is the most important information I should know about Oxacillin sodium?
A history of a hypersensitivity (anaphylactic) reaction to any penicillin is a contraindication.
Active ingredient matches for Ampicillin sodium or ampicillin trihydrate/oxacillin sodium:
Ampicillin sodium or ampicillin trihydrate/oxacillin sodium
References
- DailyMed. "OXACILLIN SODIUM: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- PubChem. "oxacillin". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
- DrugBank. "oxacillin". http://www.drugbank.ca/drugs/DB00713 (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
