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DRUGS & SUPPLEMENTS
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Mefoxin in plastic container
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Mefoxin in plastic container uses
- Indications and usage
- Contraindications
- Warnings
- Precautions
- Adverse reactions
- Overdosage
- Dosage and administration
- How supplied
- Clinical studies
- References
INDICATIONS AND USAGE
Treatment
Many infections caused by aerobic and anaerobic gram-negative bacteria resistant to some cephalosporins respond to Mefoxin in plastic container. Similarly, many infections caused by aerobic and anaerobic bacteria resistant to some penicillin antibiotics respond to treatment with Mefoxin in plastic container. Many infections caused by mixtures of susceptible aerobic and anaerobic bacteria respond to treatment with Mefoxin in plastic container.
Mefoxin in plastic container for injection is indicated for the treatment of serious infections caused by susceptible strains of the designated microorganisms in the diseases listed below.
(1) Lower respiratory tract infections, including pneumonia and lung abscess, caused by Streptococcus pneumoniae, other streptococci (excluding enterococci, e.g., Enterococcus faecalis [formerly Streptococcus faecalis]), Staphylococcus aureus (including penicillinase-producing strains), Escherichia coli, Klebsiella species, Haemophilus influenzae, and Bacteroides species.
(2) Urinary tract infections caused by Escherichia coli, Klebsiella species, Proteus mirabilis, Morganella morganii, Proteus vulgaris and Providencia species (including P. rettgeri).
(3) Intra-abdominal infections, including peritonitis and intra-abdominal abscess, caused by Escherichia coli, Klebsiella species, Bacteroides species including Bacteroides fragilis, and Clostridium species.
(4) Gynecological infections, including endometritis, pelvic cellulitis, and pelvic inflammatory disease caused by Escherichia coli, Neisseria gonorrhoeae (including penicillinase-producing strains), Bacteroides species including B. fragilis, Clostridium species, Peptococcus niger, Peptostreptococcus species, and Streptococcus agalactiae. Mefoxin in plastic container, like cephalosporins, has no activity against Chlamydia trachomatis. Therefore, when Mefoxin in plastic container is used in the treatment of patients with pelvic inflammatory disease and C. trachomatis is one of the suspected pathogens, appropriate anti-chlamydial coverage should be added.
(5) Septicemia caused by Streptococcus pneumoniae, Staphylococcus aureus (including penicillinase-producing strains), Escherichia coli, Klebsiella species, and Bacteroides species including B. fragilis.
(6) Bone and joint infections caused by Staphylococcus aureus (including penicillinase-producing strains).
(7) Skin and skin structure infections caused by Staphylococcus aureus (including penicillinase producing strains), Staphylococcus epidermidis, Streptococcus pyogenes and other streptococci (excluding enterococci e.g., Enterococcus faecalis [formerly Streptococcus faecalis]), Escherichia coli, Proteus mirabilis, Klebsiella species, Bacteroides species including B. fragilis, Clostridium species, Peptococcus niger, and Peptostreptococcus species.
Appropriate culture and susceptibility studies should be performed to determine the susceptibility of the causative organisms to Mefoxin in plastic container. Therapy may be started while awaiting the results of these studies.
In randomized comparative studies, Mefoxin in plastic container and cephalothin were comparably safe and effective in the management of infections caused by gram-positive cocci and gram-negative rods susceptible to the cephalosporins. Mefoxin in plastic container has a high degree of stability in the presence of bacterial beta-lactamases, both penicillinases and cephalosporinases.
Prevention
Mefoxin in plastic container for injection is indicated for the prophylaxis of infection in patients undergoing uncontaminated gastrointestinal surgery, vaginal hysterectomy, abdominal hysterectomy, or cesarean section.
If there are signs of infection, specimens for culture should be obtained for identification of the causative organism so that appropriate treatment may be instituted.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Mefoxin in plastic container for injection and other antibacterial drugs, Mefoxin in plastic container for injection 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.
CONTRAINDICATIONS
Mefoxin in plastic container for injection is contraindicated in patients who have shown hypersensitivity to Mefoxin in plastic container and the cephalosporin group of antibiotics.
WARNINGS
BEFORE THERAPY WITH 'CEFOXITIN FOR INJECTION' IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO Mefoxin in plastic container, CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. THIS PRODUCT SHOULD BE GIVEN WITH CAUTION TO PENICILLIN-SENSITIVE PATIENTS. ANTIBIOTICS SHOULD BE ADMINISTERED WITH CAUTION TO ANY PATIENT WHO HAS DEMONSTRATED SOME FORM OF ALLERGY, PARTICULARLY TO DRUGS. IF AN ALLERGIC REACTION TO 'CEFOXITIN FOR INJECTION' OCCURS, DISCONTINUE THE DRUG. SERIOUS HYPERSENSITIVITY REACTIONS MAY REQUIRE EPINEPHRINE AND OTHER EMERGENCY MEASURES.
Clostridium difficile associated diarrhea (CDAD) has been reported with the use of nearly all antibacterial agents, including Mefoxin in plastic container, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
PRECAUTIONS
General
Prescribing Mefoxin in plastic container for injection in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
The total daily dose should be reduced when Mefoxin in plastic container for injection is administered to patients with transient or persistent reduction of urinary output due to renal insufficiency, because high and prolonged serum antibiotic concentrations can occur in such individuals from usual doses.
Antibiotics (including cephalosporins) should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.
As with other antibiotics, prolonged use of Mefoxin in plastic container may result in overgrowth of nonsusceptible organisms. Repeated evaluation of the patient's condition is essential. If superinfection occurs during therapy, appropriate measures should be taken.
Information for Patients
Patients should be counseled that antibacterial drugs including Mefoxin in plastic container for injection should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Mefoxin in plastic container for injection is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Mefoxin in plastic container for injection or other antibacterial drugs in the future.
Diarrhea is a common problem caused by antibiotics, which usually ends when the antibiotic is discontinued. Sometimes after starting the treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.
Laboratory Tests
As with any potent antibacterial agent, periodic assessment of organ system functions, including renal, hepatic, and hematopoietic, is advisable during prolonged therapy.
Drug Interactions
Increased nephrotoxicity has been reported following concomitant administration of cephalosporins and aminoglycoside antibiotics.
Drug/Laboratory Test Interactions
As with cephalothin, high concentrations of Mefoxin in plastic container may interfere with measurement of serum and urine creatinine levels by the Jaffé reaction, and produce false increases of modest degree in the levels of creatinine reported. Serum samples from patients treated with Mefoxin in plastic container should not be analyzed for creatinine if withdrawn within 2 hours of drug administration.
High concentrations of Mefoxin in plastic container in the urine may interfere with measurement of urinary 17-hydroxy-corticosteroids by the Porter-Silber reaction, and produce false increases of modest degree in the levels reported.
A false-positive reaction for glucose in the urine may occur. This has been observed with CLINITEST† reagent tablets.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies in animals have not been performed with Mefoxin in plastic container to evaluate carcinogenic or mutagenic potential. Studies in rats treated intravenously with 400 mg/kg of Mefoxin in plastic container (approximately 3 times the maximum recommended human dose) revealed no effects on fertility or mating ability.
Pregnancy
Reproduction studies performed in rats and mice at parenteral doses of approximately one to seven and one-half times the maximum recommended human dose did not reveal teratogenic or fetal toxic effects, although a slight decrease in fetal weight was observed.
There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
In the rabbit, Mefoxin in plastic container was associated with a high incidence of abortion and maternal death. This was not considered to be a teratogenic effect but an expected consequence of the rabbit's unusual sensitivity to antibiotic-induced changes in the population of the microflora of the intestine.
Nursing Mothers
Mefoxin in plastic container is excreted in human milk in low concentrations. Caution should be exercised when Mefoxin in plastic container is administered to a nursing woman.
Pediatric Use
Safety and efficacy in pediatric patients from birth to 3 months of age have not yet been established. In pediatric patients 3 months of age and older, higher doses of Mefoxin in plastic container have been associated with an increased incidence of eosinophilia and elevated SGOT.
Geriatric Use
Of the 1,775 subjects who received Mefoxin in plastic container in clinical studies, 424 (24%) were 65 and over, while 124 (7%) were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out (see CLINICAL PHARMACOLOGY ).
This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function (see DOSAGE AND ADMINISTRATION and PRECAUTIONS ).
ADVERSE REACTIONS
Mefoxin in plastic container is generally well tolerated. The most common adverse reactions have been local reactions following intravenous injection. Other adverse reactions have been encountered infrequently.
Local Reactions
Thrombophlebitis has occurred with intravenous administration.
Allergic Reactions
Rash, urticaria, flushing, pruritus, eosinophilia, fever, dyspnea, and other allergic reactions including anaphylaxis, interstitial nephritis and angioedema have been noted.
Cardiovascular
Hypotension.
Gastrointestinal
Diarrhea, including documented pseudomembranous colitis which can appear during or after antibiotic treatment. Nausea and vomiting have been reported rarely.
Neuromuscular
Possible exacerbation of myasthenia gravis.
Blood
Eosinophilia, leukopenia including granulocytopenia, neutropenia, anemia, including hemolytic anemia, thrombocytopenia, and bone marrow depression. A positive direct Coombs test may develop in some individuals, especially those with azotemia.
Liver Function
Transient elevations in SGOT, SGPT, serum LDH, and serum alkaline phosphatase; and jaundice have been reported.
Renal Function
Elevations in serum creatinine and/or blood urea nitrogen levels have been observed. As with the cephalosporins, acute renal failure has been reported rarely. The role of Mefoxin in plastic container in changes in renal function tests is difficult to assess, since factors predisposing to prerenal azotemia or to impaired renal function usually have been present.
In addition to the adverse reactions listed above which have been observed in patients treated with Mefoxin in plastic container, the following adverse reactions and altered laboratory test results have been reported for cephalosporin class antibiotics: Urticaria, erythema multiforme, Stevens-Johnson syndrome, serum sickness-like reactions, abdominal pain, colitis, renal dysfunction, toxic nephropathy, false-positive test for urinary glucose, hepatic dysfunction including cholestasis, elevated bilirubin, aplastic anemia, hemorrhage, prolonged prothrombin time, pancytopenia, agranulocytosis, superinfection, vaginitis including vaginal candidiasis.
Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced. (See DOSAGE AND ADMINISTRATION.) If seizures associated with drug therapy occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated.
OVERDOSAGE
The acute intravenous LD50 in the adult female mouse and rabbit was about 8.0 g/kg and greater than 1.0 g/kg, respectively. The acute intraperitoneal LD50 in the adult rat was greater than 10 g/kg.
DOSAGE AND ADMINISTRATION
The intent of this pharmacy bulk package is for the preparation of solution for intravenous infusion only.
TREATMENT
Adults
The usual adult dosage range is 1 gram to 2 grams every 6 to 8 hours. Dosage should be determined by susceptibility of the causative organisms, severity of infection, and the condition of the patient.
If C. trachomatis is a suspected pathogen, appropriate anti-chlamydial coverage should be added, because Mefoxin in plastic container sodium has no activity against this organism.
Mefoxin in plastic container for injection may be used in patients with reduced renal function with the following dosage adjustments:
In adults with renal insufficiency, an initial loading dose of 1 gram to 2 grams may be given. After a loading dose, the recommendations for maintenance dosage (Table 4) may be used as a guide.
When only the serum creatinine level is available, the following formula (based on sex, weight, and age of the patient) may be used to convert this value into creatinine clearance. The serum creatinine should represent a steady state of renal function.
| Males: | Weight (kg) × (140–age) |
| 72 × serum creatinine (mg/100 mL) | |
| Females: | 0.85 × above value |
In patients undergoing hemodialysis, the loading dose of 1 gram to 2 grams should be given after each hemodialysis, and the maintenance dose should be given as indicated in Table 4.
Antibiotic therapy for group A beta-hemolytic streptococcal infections should be maintained for at least 10 days to guard against the risk of rheumatic fever or glomerulonephritis. In staphylococcal and other infections involving a collection of pus, surgical drainage should be carried out where indicated.
Pediatric Patients
The recommended dosage in pediatric patients 3 months of age and older is 80 to 160 mg/kg of body weight per day divided into four to six equal doses. The higher dosages should be used for more severe or serious infections. The total daily dosage should not exceed 12 grams.
At this time no recommendation is made for pediatric patients from birth to 3 months of age (see PRECAUTIONS ).
In pediatric patients with renal insufficiency, the dosage and frequency of dosage should be modified consistent with the recommendations for adults.
PREVENTION
Effective prophylactic use depends on the time of administration. Mefoxin in plastic container for injection usually should be given one-half to one hour before the operation, which is sufficient time to achieve effective levels in the wound during the procedure. Prophylactic administration should usually be stopped within 24 hours since continuing administration of any antibiotic increases the possibility of adverse reactions but, in the majority of surgical procedures, does not reduce the incidence of subsequent infection.
For prophylactic use in uncontaminated gastrointestinal surgery, vaginal hysterectomy, or abdominal hysterectomy, the following doses are recommended:
Adults
2 grams administered intravenously just prior to surgery followed by 2 grams every 6 hours after the first dose for no more than 24 hours.
Pediatric Patients (3 months and older)
30 to 40 mg/kg doses may be given at the times designated above.
Cesarean Section Patients
For patients undergoing cesarean section, either a single 2 gram dose administered intravenously as soon as the umbilical cord is clamped OR a 3-dose regimen consisting of 2 grams given intravenously as soon as the umbilical cord is clamped followed by 2 grams 4 and 8 hours after the initial dose is recommended.
| Type of Infection | Daily Dosage | Frequency and Route |
|---|---|---|
| Uncomplicated forms | 3 to 4 grams | 1 gram every 6 to 8 hours IV |
| Moderately severe or severe infections | 6 to 8 grams | 1 gram every 4 hours or 2 grams every 6 to 8 hours IV |
| Infections commonly needing antibiotics in higher dosage (e.g., gas gangrene) | 12 grams | 2 grams every 4 hours or 3 grams every 6 hours IV |
| Renal Function | Creatinine Clearance (mL/min) | Dose (grams) | Frequency |
|---|---|---|---|
| Mild impairment | 50 to 30 | 1 to 2 | every 8 to 12 hours |
| Moderate impairment | 29 to10 | 1 to 2 | every 12 to 24 hours |
| Severe impairment | 9 to 5 | 0.5 to 1 | every 12 to 24 hours |
| Essentially no function | <5 | 0.5 to 1 | every 24 to 48 hours |
| Strength | Amount of Diluent to be Added (mL) | Approximate Withdrawable Volume (mL) | Approximate Average Concentration (mg/mL) |
|---|---|---|---|
| 1 gram Vial | 10 | 10.5 | 95 |
| 2 gram Vial | 10 or 20 | 11.1 or 21 | 180 or 95 |
| 10 gram Bulk | 43 or 93 | 49 or 98.5 | 200 or 100 |
PREPARATION OF SOLUTION
Table 5 is provided for convenience in constituting Mefoxin in plastic container for injection for intravenous administration.
For Pharmacy Bulk Packages
The 10 gram bulk packages should be constituted with 43 or 93 mL of Sterile Water for Injection, Bacteriostatic Water for Injection, 0.9 percent Sodium Chloride Injection, or 5 percent Dextrose Injection. CAUTION: THE 10 GRAM BULK STOCK SOLUTION IS NOT FOR DIRECT INFUSION. These primary solutions may be further diluted in 50 mL to 1000 mL of the diluents listed under the Pharmacy Bulk Packages portion of the COMPATIBILITY AND STABILITY section.
Benzyl alcohol as a preservative has been associated with toxicity in neonates. While toxicity has not been demonstrated in pediatric patients greater than 3 months of age, in whom use of Mefoxin in plastic container for injection may be indicated, small pediatric patients in this age range may also be at risk for benzyl alcohol toxicity. Therefore, diluent containing benzyl alcohol should not be used when Mefoxin in plastic container for injection is constituted for administration to pediatric patients in this age range.
ADMINISTRATION
Mefoxin in plastic container for injection may be administered intravenously after constitution.
The intent of this pharmacy bulk package is for the preparation of solution for intravenous infusion only.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
Intravenous Administration
The intravenous route is preferable for patients with bacteremia, bacterial septicemia, or other severe or life-threatening infections, or for patients who may be poor risks because of lowered resistance resulting from such debilitating conditions as malnutrition, trauma, surgery, diabetes, heart failure, or malignancy, particularly if shock is present or impending.
During infusion of the solution containing Mefoxin in plastic container, it is advisable to temporarily discontinue administration of any other solutions at the same site.
For the administration of higher doses by continuous intravenous infusion, a solution of Mefoxin in plastic container may be added to an intravenous bottle containing 5 percent Dextrose Injection, 0.9 percent Sodium Chloride Injection, or 5 percent Dextrose and 0.9 percent Sodium Chloride Injection. BUTTERFLY®†† or scalp vein-type needles are preferred for this type of infusion.
Solutions of Mefoxin in plastic container, like those of most beta-lactam antibiotics, should not be added to aminoglycoside solutions because of potential interaction. However, Mefoxin in plastic container and aminoglycosides may be administered separately to the same patient.
COMPATIBILITY AND STABILITY
Pharmacy Bulk Packages
Mefoxin in plastic container for injection, as supplied in the bulk package and constituted to 1 gram/10 mL with Sterile Water for Injection, Bacteriostatic Water for Injection,, 0.9 percent Sodium Chloride Injection, or 5 percent Dextrose Injection, maintains satisfactory potency for 4 hours at room temperature.
These primary solutions may be further diluted in 50 mL to 1000 mL of the following diluents and maintain potency for an additional 18 hours at room temperature or an additional 48 hours under refrigeration:
0.9 percent Sodium Chloride Injection
5 percent or 10 percent Dextrose Injection
5 percent Dextrose and 0.9 percent Sodium Chloride Injection
5 percent Dextrose Injection with 0.2 percent or 0.45 percent Sodium Chloride Injection.
Lactated Ringer's Injection
5 percent Dextrose in Lactated Ringer's Injection
5 percent Sodium Bicarbonate Injection
M/6 sodium lactate solution
Mannitol 5% and 10%
After the periods mentioned above, any unused solutions should be discarded.
Directions for Dispensing: Pharmacy Bulk Package-Not for Direct Infusion
The Pharmacy Bulk Package is for use in a pharmacy admixture service only under a laminar flow hood. Entry into the vial must be made only one time with a sterile transfer set or other sterile dispensing device, and the contents dispensed in aliquots using aseptic technique. The use of syringe and needle is not recommended as it may cause leakage (see DOSAGE AND ADMINISTRATION ). AFTER INITIAL ENTRY, USE ENTIRE CONTENTS OF VIAL PROMPTLY. ANY UNUSED PORTION MUST BE DISCARDED WITHIN 4 HOURS.
HOW SUPPLIED
Sterile Mefoxin in plastic container for injection is a dry white to off-white powder supplied in vials containing Mefoxin in plastic container sodium as follows:
Each Pharmacy Bulk Package contains Mefoxin in plastic container sodium equivalent to 10 grams Mefoxin in plastic container
| Unit of Sale | Strength | Each |
|---|---|---|
| NDC 60505-0761-4 Carton containing 10 | 10 Grams | NDC 60505-0761-1 Vial |
Also available as vials containing Mefoxin in plastic container sodium equivalent to 1 gram or 2 grams Mefoxin in plastic container.
| Unit of Sale | Strength | Each |
|---|---|---|
| NDC 60505-0759-5 Carton containing 25 | 1 Gram | NDC 60505-0759-1 Vial |
| NDC 60505-0760-5 Carton containing 25 | 2 Grams | NDC 60505-0760-1 Vial |
Special storage instructions
Mefoxin in plastic container for injection in the dry state should be stored between 2 to 25°C (36 to 77°F). Avoid exposure to temperatures above 50°C. The dry material as well as solutions tend to darken, depending on storage conditions; product potency, however, is not adversely affected.
CLINICAL STUDIES
A prospective, randomized, double-blind, placebo-controlled clinical trial was conducted to determine the efficacy of short-term prophylaxis with Mefoxin in plastic container for injection in patients undergoing cesarean section who were at high risk for subsequent endometritis because of ruptured membranes. Patients were randomized to receive either three doses of placebo (n=58), a single dose of Mefoxin in plastic container for injection (2 g) followed by two doses of placebo (n=64), or a three-dose regimen of Mefoxin in plastic container for injection (each dose consisting of 2 g) (n=60), given intravenously, usually beginning at the time of clamping of the umbilical cord, with the second and third doses given 4 and 8 hours post-operatively. Endometritis occurred in 16/58 (27.6%) patients given placebo, 5/63 (7.9%) patients given a single dose of Mefoxin in plastic container for injection, and 3/58 (5.2%) patients given three doses of Mefoxin in plastic container for injection. The differences between the two groups treated with Mefoxin in plastic container for injection and placebo with respect to endometritis were statistically significant (p<0.01) in favor of Mefoxin in plastic container for injection. The differences between the one-dose and three-dose regimens of Mefoxin in plastic container for injection were not statistically significant.
Two double-blind, randomized studies compared the efficacy of a single 2 gram intravenous dose of Mefoxin in plastic container for injection to a single 2 gram intravenous dose of cefotetan in the prevention of surgical site-related infection (major morbidity) and non-site-related infections (minor morbidity) in patients following cesarean section. In the first study, 82/98 (83.7%) patients treated with Mefoxin in plastic container for injection and 71/95 (74.7%) patients treated with cefotetan experienced no major or minor morbidity. The difference in the outcomes in this study (95% CI: –0.03, +0.21) was not statistically significant. In the second study, 65/75 (86.7%) patients treated with Mefoxin in plastic container for injection and 62/76 (81.6%) patients treated with cefotetan experienced no major or minor morbidity. The difference in the outcomes in this study (95% CI: –0.08, +0.18) was not statistically significant.
In clinical trials of patients with intra-abdominal infections due to Bacteroides fragilis group microorganisms, eradication rates at 1 to 2 weeks posttreatment for isolates were in the range of 70% to 80%. Eradication rates for individual species are listed below:
| Bacteroides distasonis | 7/10 | (70%) | |
| Bacteroides fragilis | 26/33 | (79%) | |
| Bacteroides ovatus | 10/13 | (77%) | |
| B. thetaiotaomicron | 13/18 | (72%) |
REFERENCES
- Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard - Tenth Edition, CLSI Document M07-A10, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2015.
- Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Seventh Informational Supplement, CLSI document M100-S27, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2017.
- Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Disk Diffusion Susceptibility Tests; Approved Standard - Twelfth Edition, CLSI Document M02-A12, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2015.
- Clinical and Laboratory Standards Institute (CLSI). Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved Standard - Eighth Edition, CLSI document M11-A8. Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2012.
- Carver PL, Nightingale CH and Quintiliani R. Pharmacokinetics and pharmacodynamics of total and unbound Mefoxin in plastic container and cefotetan in healthy volunteers. Journal of Antimicrobial Chemotherapy (1989) 23, 99–106
- CLSI 8 – 11 January 2005 Report (e 284) [Dudley, Jones, Craig and Ambrose]
† Clinitest is a trademark of Siemens Healthcare Diagnostics Inc.
††Registered trademark of Abbott Laboratories, Inc.
Mfg. by: Hospira Healthcare India Pvt. Ltd.
Irungattukottai - 602 105, India
Mfg. for: Apotex Corp.
Weston, FL 33326
LAB-1129-1.0
August 2017
NDC 60505-0761-1
Mefoxin in plastic container
for Injection, USP
PHARMACY BULK PACKAGE
NOT FOR DIRECT INFUSION
10 Grams*
For Intravenous Use Only**
CAUTION: NOT FOR DIRECT INFUSION
Rx Only
APOTEX CORP.
Mefoxin in plastic container pharmaceutical active ingredients containing related brand and generic drugs:
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References
- Dailymed."CEFOXITIN AND DEXTROSE (CEFOXITIN SODIUM) INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
- "cefoxitin". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).
- "cefoxitin". http://www.drugbank.ca/drugs/DB0133... (accessed August 28, 2018).
Frequently asked Questions
Can i drive or operate heavy machine after consuming Mefoxin in plastic container?Depending on the reaction of the Mefoxin in plastic container after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Mefoxin in plastic container not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.
Is Mefoxin in plastic container addictive or habit forming?Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
Review
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The information was verified by Dr. Rachana Salvi, MD Pharmacology