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Basic Drug Info
Drug Name:MEFOXIN
Manufacturer:Merck & Co., Inc.
Other Info:

INSTRUCTIONS FOR USE OF MEFOXIN ®Registered trademark of MERCK & CO., Inc.(Cefoxitin for Injection) (Formerly called Sterile Cefoxitin Sodium) IN ADD-Vantage®VIALS For IV Use Only.INSTRUCTIONS FOR USETo Open Diluent Container:Peel overwrap from the corner and remove container.

Some opacity of the plastic due to moisture absorption during the sterilization process may be observed.

This is normal and does not affect the solution quality or safety.

The opacity will diminish gradually.To Assemble Vial and Flexible Diluent Container:(Use Aseptic Technique)Remove the protective covers from the top of the vial and the vial port on the diluent container as follows:To remove the breakaway vial cap, swing the pull ring over the top of the vial and pull down far enough to start the opening.

(SEE FIGURE 1.) Pull the ring approximately half way around the cap and then pull straight up to remove the cap.

(SEE FIGURE 2.) NOTE: DO NOT ACCESS VIAL WITH SYRINGE.To remove the vial port cover, grasp the tab on the pull ring, pull up to break the three tie strings, then pull back to remove the cover.

(SEE FIGURE 3.)Screw the vial into the vial port until it will go no further.

THE VIAL MUST BE SCREWED IN TIGHTLY TO ASSURE A SEAL.

This occurs approximately ½ turn (180°) after the first audible click.

(SEE FIGURE 4.) The clicking sound does not assure a seal; the vial must be turned as far as it will go.

NOTE: Once vial is seated, do not attempt to remove.

(SEE FIGURE 4.)Recheck the vial to assure that it is tight by trying to turn it further in the direction of assembly.Label appropriately.To Prepare Admixture:Squeeze the bottom of the diluent container gently to inflate the portion of the container surrounding the end of the drug vial.With the other hand, push the drug vial down into the container telescoping the walls of the container.

Grasp the inner cap of the vial through the walls of the container.

(SEE FIGURE 5.)Pull the inner cap from the drug vial.

(SEE FIGURE 6.) Verify that the rubber stopper has been pulled out, allowing the drug and diluent to mix.Mix container contents thoroughly and use within the specified time.Preparation for Administration:(Use Aseptic Technique)Confirm the activation and admixture of vial contents.Check for leaks by squeezing container firmly.

If leaks are found, discard unit as sterility may be impaired.Close flow control clamp of administration set.Remove cover from outlet port at bottom of container.Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated.

NOTE: See full directions on administration set carton.Lift the free end of the hanger loop on the bottom of the vial, breaking the two tie strings.

Bend the loop outward to lock it in the upright position, then suspend container from hanger.Squeeze and release drip chamber to establish proper fluid level in chamber.Open flow control clamp and clear air from set.

Close clamp.Attach set to venipuncture device.

If device is not indwelling, prime and make venipuncture.Regulate rate of administration with flow control clamp.WARNING: Do not use flexible container in series connections.StabilityMEFOXIN (Cefoxitin for Injection) 1 gram or 2 gram single dose ADD-Vantage® vials should be prepared with ADD-Vantage® diluent containers containing 50 mL or 100 mL of either 0.9 percent Sodium Chloride Injection or 5 percent Dextrose Injection.

When prepared with either of these diluents, MEFOXIN (Cefoxitin for Injection) maintains satisfactory potency for 24 hours at room temperature.Before administering, see accompanying package circular for MEFOXIN (Cefoxitin for Injection).Issued August 1996Printed in USA 7464705



Clinical Trials:


Indications and Usage

MEFOXIN is indicated for the treatment of serious infections caused by susceptible strains of the designated microorganisms in the diseases listed below.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.Urinary tract infections caused by Escherichia coli, Klebsiella species, Proteus mirabilis, Morganella morganii, Proteus vulgaris and Providencia species (including P. rettgeri).Intra-abdominal infections, including peritonitis and intra-abdominal abscess, caused by Escherichia coli, Klebsiella species, Bacteroides species including Bacteroides fragilis, and Clostridium species.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, like cephalosporins, has no activity against Chlamydia trachomatis.

Therefore, when MEFOXIN 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.Septicemia caused by Streptococcus pneumoniae, Staphylococcus aureus (including penicillinase-producing strains), Escherichia coli, Klebsiella species, and Bacteroides species including B. fragilis.Bone and joint infections caused by Staphylococcus aureus (including penicillinase-producing strains).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.

Therapy may be started while awaiting the results of these studies.In randomized comparative studies, MEFOXIN 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 has a high degree of stability in the presence of bacterial beta-lactamases, both penicillinases and cephalosporinases.Many infections caused by aerobic and anaerobic gram-negative bacteria resistant to some cephalosporins respond to MEFOXIN.

Similarly, many infections caused by aerobic and anaerobic bacteria resistant to some penicillin antibiotics (ampicillin, carbenicillin, penicillin G) respond to treatment with MEFOXIN.

Many infections caused by mixtures of susceptible aerobic and anaerobic bacteria respond to treatment with MEFOXIN.
Infection -- Invasion of the host organism by microorganisms that can cause pathological conditions or diseases.

Disease -- A definite pathologic process with a characteristic set of signs and symptoms. It may affect the whole body or any of its parts, and its etiology, pathology, and prognosis may be known or unknown.

Lower respiratory tract infection --

Pneumonia -- Inflammation of any part, segment or lobe, of the lung parenchyma.

Lung Abscess -- Solitary or multiple collections of PUS within the lung parenchyma as a result of infection by bacteria, protozoa, or other agents.

Urinary tract infection -- Inflammatory responses of the epithelium of the URINARY TRACT to microbial invasions. They are often bacterial infections with associated BACTERIURIA and PYURIA.

Abdominal Infection --

Peritonitis -- INFLAMMATION of the PERITONEUM lining the ABDOMINAL CAVITY as the result of infectious, autoimmune, or chemical processes. Primary peritonitis is due to infection of the PERITONEAL CAVITY via hematogenous or lymphatic spread and without intra-abdominal source. Secondary peritonitis arises from the ABDOMINAL CAVITY itself through RUPTURE or ABSCESS of intra-abdominal organs.

Endometritis -- Inflammation of the ENDOMETRIUM, usually caused by intrauterine infections. Endometritis is the most common cause of postpartum fever.

Parametritis -- Inflammation of the parametrium, the connective tissue of the pelvic floor, extending from the subserous coat of the uterus laterally between the layers of the BROAD LIGAMENT.

Pelvic Inflammatory Disease -- A spectrum of inflammation involving the female upper genital tract and the supporting tissues. It is usually caused by an ascending infection of organisms from the endocervix. Infection may be confined to the uterus (ENDOMETRITIS), the FALLOPIAN TUBES; (SALPINGITIS); the ovaries (OOPHORITIS), the supporting ligaments (PARAMETRITIS), or may involve several of the above uterine appendages. Such inflammation can lead to functional impairment and infertility.

Septicemia -- systemic disease associated with presence and persistance of pathogenic microorganisms or their toxins in the blood.

Arthropathy associated with infection --

skin infection -- Skin diseases caused by bacteria, fungi, parasites, or viruses.

Contraindications
MEFOXIN is contraindicated in patients who have shown hypersensitivity to cefoxitin and the cephalosporin group of antibiotics.
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Warnings

BEFORE THERAPY WITH ‘MEFOXIN’ IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEFOXITIN, 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 ‘MEFOXIN’ 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, 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.

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