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Nafcillin (Nafcillin Sodium) - Summary



Nafcillin for Injection, USP is a semisynthetic antibiotic substance derived from 6-amino-penicillanic acid. It is the sodium salt in a parenteral dosage form.

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 may be used to initiate therapy in suspected cases of resistant staphylococcal infections prior to the availability of laboratory test results. The penicillinase-resistant penicillins 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 Nafcillin.

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.

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Published Studies Related to Nafcillin

Evidence of an interaction between nifedipine and nafcillin in humans. [2003.06]
AIMS: Nafcillin (Wyeth Laboratories, Philadelphia, PA, USA) has been reported to induce the metabolism of cyclosporin and warfarin, which are known substrates of cytochrome P-450 (CYP). However, there has not been any report to date on its possible interaction with nifedipine, an index substrate of the enzyme, CYP3A4... CONCLUSIONS: The results show that nafcillin pretreatment markedly increased the clearance of nifedipine and suggest that nafcillin is a potent inducer of CYP enzyme.

Randomized, double-blind trial of cefonicid and nafcillin in the treatment of skin and skin structure infections. [1990.04]
We compared treatment with one daily intravenous dose of cefonicid and multidose nafcillin in 65 patients with severe infections of the skin or skin structure. Clinical cure or improvement was achieved in 91% of the patients given cefonicid and in 87% of the patients given nafcillin (P = 0.97).The use of cefonicid may allow outpatient therapy of some severe infections.

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Clinical Trials Related to Nafcillin

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.

Patients Response to Early Switch To Oral:Osteomyelitis Study [Not yet recruiting]
Based on the current literature, investigators hypothesize that patients with osteomyelitis who are treated with the standard approach of intravenous antibiotics for the full duration of therapy will have the same clinical outcomes as patients treated with the experimental approach of intravenous antibiotics with early switch to oral antibiotics. The primary objective of this study is to compare patients with osteomyelitis treated with the standard approach of intravenous antibiotics for the full duration of therapy versus patients treated with intravenous antibiotics with an early switch to oral antibiotics in relation to clinical outcomes at 12 months after discontinuation of antibiotic therapy. Secondary objectives of the study include the evaluation of adverse events related to the use of antibiotics as well as the cost of care evaluated from the hospital perspective.

Phase 3, Multicenter, Doubleblind, Rand Dalbavancin vs Comparator in Ped Acute Hematogenous Osteomyelitis [Not yet recruiting]

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Reports of Suspected Nafcillin Side Effects

Abdominal Distension (7)Rash (6)Pyrexia (5)Endocarditis (5)Renal Failure Acute (5)Dyspnoea (5)Atrial Flutter (5)Renal Failure (5)Bacteraemia (5)Pulmonary Hypertension (4)more >>

Page last updated: 2007-05-03

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