OXACILLIN SUMMARY
Oxacillin for Injection, USP is a semisynthetic antibiotic substance derived from 6-amino-penicillanic acid. It is the sodium salt in a parenteral dosage form. The pharmacy bulk package contains oxacillin sodium monohydrate equivalent to 10 grams oxacillin. It also contains approximately 2.5 mEq of sodium and 20 mg dibasic sodium phosphate (as a buffer) per gram of oxacillin.
Oxacillin 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. (See
CLINICAL PHARMACOLOGY: Susceptibility Plate Testing).
Oxacillin may be used to initiate therapy in suspected cases of resistant staphylococcal infections prior to the availability of susceptibility test results. Oxacillin 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.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Oxacillin for Injection, USP and other antibacterial drugs, Oxacillin 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.
|
NEWS HIGHLIGHTS
Published Studies Related to Oxacillin
The use of an internal teat sealant in combination with cloxacillin dry cow therapy for the prevention of clinical and subclinical mastitis in seasonal calving dairy cows. [2010.10] Cows (n=2,053) from 6 seasonally calving dairy herds were enrolled in a trial to compare the efficacy of 2 dry cow treatments. Cows received either a combination dry cow therapy of 600 mg of cloxacillin (CL) followed by an internal teat sealant (ITS) containing 2.6 g of bismuth subnitrate in all 4 quarters immediately following their final milking for the season, or only an intramammary infusion of 600 mg of CL...
Long-term follow-up trial of oral rifampin-cotrimoxazole combination versus intravenous cloxacillin in treatment of chronic staphylococcal osteomyelitis. [2009.06] Oral therapies alternative to fluoroquinolones against staphylococcal chronic osteomyelitis have not been evaluated in comparative studies. Consecutive nonaxial Staphylococcus aureus chronic osteomyelitis cases were included in a comparative trial after debridement... Oral rifampin-cotrimoxazole treatment showed outcomes comparable to those for intravenous cloxacillin treatment.
Inhibition of flucloxacillin tubular renal secretion by piperacillin. [2008.11] AIMS: To explore the extent, time course, site(s), mechanism and possible clinical relevance of the pharmacokinetic (PK) interaction between piperacillin and flucloxacillin... CONCLUSIONS: Piperacillin inhibits renal and nonrenal elimination of flucloxacillin. This interaction seems clinically significant, as total clearance was reduced by a factor of 1.5 for the lower and 2.1 for the higher doses. PK interactions, especially with piperacillin, are likely to occur also with other beta-lactam combinations and might be useful to improve the effectiveness of antibacterial treatment.
Lack of effect of P-glycoprotein inhibition on renal clearance of dicloxacillin in patients with cystic fibrosis. [2008.07] STUDY OBJECTIVE: To determine whether upregulation of P-glycoprotein is responsible for the enhanced renal clearance of dicloxacillin in patients with cystic fibrosis... CONCLUSION: We found no significant difference in the pharmacokinetics of dicloxacillin between patients with cystic fibrosis and healthy volunteers. Renal clearance of dicloxacillin was significantly reduced in the presence of probenecid but not with cyclosporine, suggesting that the rate-limiting step in tubular secretion of dicloxacillin is uptake mediated by the organic anion transporter, and not P-glycoprotein inhibition.
Flucloxacillin alone or combined with benzylpenicillin to treat lower limb cellulitis: a randomised controlled trial. [2005.05] OBJECTIVE: To determine whether using intravenous benzylpenicillin in addition to intravenous flucloxacillin would result in a more rapid clinical response in patients with lower limb cellulitis... CONCLUSIONS: This study provides no evidence to support the addition of intravenous benzylpenicillin to intravenous flucloxacillin in the treatment of lower limb cellulitis.
Clinical Trials Related to Oxacillin
Comparison Between Amoxycillin/Clavulanic Acid and Oxacillin/Ceftriaxone for Community Acquired-pneumonia [Completed]
Objective: To compare the clinical effectiveness and hospital costs, the initial empirical
treatment, Oxacillin / Ceftriaxone and Amoxicillin / Clavulanate in children with Community
Acquired Pneumonia (CAP) severe.
Methods: Clinical prospective randomized study in children aged two months to five years of
age with a diagnosis of severe CAP, according to criteria of World Health Organization
(WHO), admitted to the Pediatrics Ward of the Hospital of the Medical School of Botucatu-
UNESP. We excluded children with comorbid disorders (primary and secondary immunodeficiency)
with acute or chronic kidney disease, referred patients receiving antibiotics proposal and
history of allergy to antibiotics proposed. We included 104 children who were randomized
into two groups to receive: Oxacillin / Ceftriaxone IV (GCO, n = 48) and Amoxicillin /
Clavulanate IV (GAA, n = 56). Patients of the GAA, after clinical improvement, has been
receiving the same oral antibiotic, and maintaining clinical stability, were discharged from
hospital, the GOC received any IV treatment. The outcomes analyzed were time to clinical
improvement (fever and tachypnea), duration of oxygen therapy, hospitalization time, need to
expand the antimicrobial spectrum progression to pleural effusion / empyema (DP / E) and
hospital costs. Treatment failure was determined by the need to expand the antimicrobial
spectrum after 48 hours of hospitalization.
Antibiotic Treatment for Infections of Short Term In-dwelling Vascular Catheters Due to Gram Positive Bacteria [Completed]
This study will treat patients who have a short term central catheter that is thought to be
infected with a specific bacteria (gram positive bacteria)
Telavancin for Treatment of Uncomplicated Staphylococcus Aureus Bacteremia [Completed]
The purpose of this study is to determine whether telavancin (TD-6424, ARBELIC) can be
safety administered to patients with bloodstream infections and whether telavancin is
effective in treating these infections.
Study of Daptomycin in Subjects Undergoing Surgery for Osteomyelitis Associated With an Infected Prosthetic Caused by Staphylococci [Completed]
Study of Daptomycin Safety and Efficacy for Complicated Skin and Skin Structure Infections (cSSSI) and Bacteremia in Renal Impairment [Terminated]
This is a multicenter, randomized, evaluator-blinded, comparator-controlled study.
Participants were to be randomized (1: 1) to daptomycin or comparator, stratified by degree
of renal impairment (creatinine clearance [CLcr] 30 - 50 milliliters per minute [mL/min]
[moderate impairment] and <30 mL/min [severe impairment]) and by type of infection
(bacteremia and complicated skin and skin structure infections [cSSSI]) to create 4 cohorts
defined as follows:
- Cohort 1: Bacteremia and CLcr <30 mL/min
- Cohort 2: Bacteremia and CLcr 30 - 50 mL/min
- Cohort 3: cSSSI and CLcr <30 mL/min
- Cohort 4: cSSSI and CLcr 30 - 50 mL/min
Participants will be treated and evaluated for safety and microbiological and clinical
efficacy in accordance with their type of infection and degree of renal impairment. Peak and
trough samples will be collected to assess exposure to daptomycin for participants on Day 1
and following the 5th dose.
Reports of Suspected Oxacillin Side Effects
Pancytopenia (5),
Toxic Epidermal Necrolysis (4),
Septic Shock (4),
Thrombocytopenia (3),
Necrotising Colitis (3),
Renal Failure (3),
Respiratory Disorder (2),
Aphasia (2),
Osteomyelitis (2),
Optic Ischaemic Neuropathy (2), more >>
|