Sunday, February 12, 2017

Foxime

Foxime


Foxime@
Sterile Cefotaxime Sodium USP
Composition:
Foxime 0.5 g I.MJI.V.: The vial contains: Sterile cefotaxime sodium USP
equivalent to 0.5 g of cefotaxime.
The ampoule contains 5 ml sterile water for injection USP.
Foxime 1 g I.M.: The vial contains: Sterile cefotaxime sodium USP
equivalent to 1.0 g of cefotaxime.
The ampoule contains 5 ml of 1% w/v lidocaine hydrochloride injection
USB
Foxime I g I.V.: The vial contains: Sterile cefotaxime sodium USP
equivalent to 1.0 g of cefotaxime.
The ampoule contains 5 ml sterile water for injection USP.
Properties:
Foxime is an antibiotic of the cephalosporin group and has a bactericidal
effect. Its antibacterial activity against gram-negative rod-shaped
bacteria is much more stronger than that of the known cephalosporins
and penicillins, and in most pathogens its minimum bactericidal
concentration is slightly higher than its minimum inhibitory concentration.
The serum protein binding is 32-50 % depending on the method used.
Foxime I g produces high serum levels that exceed the sensitivity of
most pathogens. Foxime has a good tissue penetration. It is excreted
mainly through the kidney in an active form.
Indications:
- Severe infections caused by cefotaxime-sensitive pathogens:
- Infections of the respiratory tract, including nose and throat.
- Infections of the ear.
- Infections of the kidney and urinary tract.
- Infections of the skin and soft tissues.
- Infections of the bones and joints.
- Infections of the genital organs, including gonorrhea, (Foxime is used
in the treatment of gonorrhoea in adults).
- Infections of the abdominal region (Peritonitis, infections of the bile
ducts and GIT).
- Sepsis, endocarditis, meningitis.
- Gynaecological and obstetric infections.
- Infections of burns and other injuries.
- For the prophylaxis of infections in patients with reduced resistance
(e.g. under immunosuppressive treatment or in the presence of
neutropenia).
- Surgical prophylaxis:
- Gastrointestinal surgery.
- Genitourinary surgery.
- Obstetric and gynaecological surgery.
Cefotaxime is generally effective against the following pathogens:
Staphylococci, aerobic and anaerobic Streptococcus pneumoniae,
Neisseria spp., Haemophilus influenzae, Escherichia coli, Citrobacter
spp., Salmonella spp., Klebsiella spp., Enterobacter aerogenes, Serratia
spp., indole-positive and indole-negative Proteus spp., Yersinia
enterocolitica, Clostridium spp., and Bacteroides spp.
Pathogens with varying susceptibility are: Streptococcus faecalis,
Enterobacter cloacae, Pseudomonas aeruginosa and Bacteroids fragilis.
There is not yet sufficient clinical experience with Salmonella typhi and
paratyphi A and B infections.
Cefotaxime is not effective against Treponema pallidum and
Clostridium difficile.
Combined treatment: In severe, life-threatening infections. The
combination of Foxime with aminoglycosides is indicated without
awaiting the results of sensitivity test. The two preparations must be
administered separately, not mixed in one syringe.
Infections with Pseudomonas aeruginosa may require concomitant
treatment with other antibiotics effective against Pseudomonas.
Contraindications:
Foxime is contraindicated in patients who have shown hypersensitivity
to cefotaxime sodium or the cephalosporin group of antibiotics.
Pregnancy and Lactation:
Teratogenic Effects
Pregnancy Category B: Reproduction studies have been performed in
pregnant mice given cefotaxime sodium intravenously at doses up to
1200 mg/kg/day (0.4 times the recommended human dose based on
mg/m2) or in pregnant rats when administered intravenously at doses up
to 1200 mg/kg/day (0.8 times the recommended human dose based on
mg/m2). No evidence of embryotoxicity or teratogenicity was seen in
these studies. Although cefotaxime has been reported to cross the
placental barrier and appear in cord blood, the effect on the human fetus
is not known. There are no well-controlled studies in pregnant women.
Because animal reproductive studies are not always predictive of human
response, this drug should be used during pregnancy only if clearly
needed.
Nonteratogenic Effects
Use of the drug in women of child-bearing potential requires that the
anticipated benefit be weighed against the possible risks. In perinatal
and postnatal studies with rats, the pups in the group given
1200 mg/kg/day of cefotaxime sodium were significantlyq91ter in weight
at birth and remained smaller than pups in the control group during the
21 days of nursing.
Nursing Mothers
Foxime is excreted in human milk in low concentrations. Caution should
be exercised when Foxime is administered to a nursing woman.
Precautions:
Genitourinary System: Moniliasis and vaginitis.
Central Nervous System: Administration of high doses of beta-lactam
antibiotics, including cefotaxime, particularly in patients with renal
insufficiency may result in encephalopathy (e.g. impairment of conscious-
ness, abnormal movements and convulsions) and headache.
Liver: Transient elevations in SGOT, SGPT, serum LDH, gamma G T,
bilirubin, and serum alkaline phosphatase levels have been reported.
These laboratory abnormalities, which may also be explained by the
infection, may rarely exceed twice the upper limit of the normal range
and elicit a pattern of liver injury, usually cholestatic and most often
asymptomatic. Hepatitis, sometimes with jaundice, has been reported.
Kidney: As with some other cephalosporins, interstitial nephritis and
transient elevations of BUN and creatinine have been occasionally
observed with cefotaxime sodium.
Cutaneous: As with other cephalosporins, isolated cases of erythema
multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis
have been reported.
Cephalosporin Class Labeling
In addition to the adverse reactions listed above which have been
observed in patients treated with cefotaxime sodium, the following
adverse reactions and altered laboratory tests have been reported for
cephalosporin class antibiotics: Allergic reactions, hepatic dysfunction
including cholestasis, aplastic anemia, hemorrhage, and false-positive
test for urinary glucose. Several cephalosporins have been implicated in
triggering seizures, particularly in patients with renal impairment when
the dosage was not reduced. If seizures associated with drug therapy
occur, the drug should be discontinued. Anticonvulsant therapy can be
given if clinically indicated.
Consult your Physician or Pharmacist if any side effect is observed.
Interactions:
Effects on laboratory parameters:
In rare cases, the direct Coombs test may give false positive results in
patients on Foxime treatment. False positive results may be obtained for
urinary glucose, if it is determined by reduction methods; this can be
avoided by using enzymatic methods.
Dosage:
Dosage, mode of administration and intervals between injections
depend on the severity of the infection, sensitivity of the pathogens and
condition of the patient.
Dosage in infants and children up to 12 years old
Unless otherwise prescribed, the following doses are used:
Infants and children up to 12 years old: 50-100 mg/kg body weight daily,
divided into several equal doses at intervals of 6-12 hours. In some
cases, life-threatening infections were treated with daily quantities of
150-200 mg/kg body weight, which were well tolerated.
In premature infants, renal clearance is not yet fully developed, therefore
daily doses of 50 mg/kg body weight should not be exceeded.
For the pre-operative prophylaxis of infection, one of the above single
doses is administered before the start of surgery. Depending on the risk
of infection, the same dose may be repeated after an interval of
12 hours.
Dosage in children over 12 years old and adults
Unless otherwise prescribed, children over 12 years and adults are given
one vial of Foxime 1 g every 12 hours. In severe infections, the daily
dose may be raised to a maximum of 12 g. If the daily dose is 4 g, it may
be divided into 2 doses of 2 g each, administered at intervals of 12 hours.
For higher daily doses the intervals are reduced to 8 or 6 hours.
The following table may serve as a guide:
Daily Dose
6-12 g
Type of infection
Typical infections in
which a highly sensitive
pathogen is known or
suspected.
Infections in which
several pathogens of
high to medium
sensitivity are known or
suspected.
Unidentified infections
that cannot be
localized, and
life-threatening
conditions.
Dosage
Single Dose
lg
2-3 g
Interval
12 hours
12 hours
6-8 hours
For the treatment of gonorrhoea a single dose of 0.5 g Foxime is
administered intramuscularly. Before the start of therapy the patient
should be examined for syphilis.
Dosage in surgical prophylaxis:
Usual dosage in adults:
1 _ g I.M. or I.V. during induction of anaesthesia. The duration of
post-operative treatment must not exceed 24 hours.
Caesarian section:
1 g I.V. at clamping of the umbilical cord, followed by 1 g J.M. or I.V,
6 and 12 hours after the first dose.
Dosage in patients with impaired renal function:
In patients with a creatinine clearance of s5 ml/minute.
The maintenance dose should be reduced to half the normal dose. The
initial dose depends on the sensitivity of the pathogens and the severity
of the infection.
These dosage recommendations are based on experience in adults.
Mode and duration of administration:
Foxime solutions should be administered as soon as they have been
prepared. A pale yellowish color of the solution does not mean an
impairment of the antibiotic efficacy.
Foxime

General 
Prescribing Foxime 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. Foxime should be prescribed with caution in 
individuals with a history of gastrointestinal disease, particularly colitis. 
Because high and prolonged serum antibiotic concentrations can occur 
from usual doses in patients with transient or persistent reduction of 
urinary output because of renal insufficiency, the total daily dosage 
should be reduced when Foxime is administered to such patients. 
Continued dosage should be determined by degree of renal impairment, 
severity of infection, and susceptibility of the causative organism. 
Although there is no clinical evidence supporting the necessity of 
changing the dosage of cefotaxime sodium in patients with even 
profound renal dysfunction, it is suggested that, until further data are 
obtained, the dose of cefotaxime sodium be halved in patients with 
estimated creatinine clearances of less than 20 mlJrnin/I .73 rn2. When 
only serum creatinine 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. 
Weight (kg) x (140 - age) 
Males: 72 x serum creatinine 
Females: 0.85 x above value 
As with other antibiotics, prolonged use of Foxime 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. As with other beta-lactam 
antibiotics, granulocytopenia and, more rarely, agranulocytosis may 
develop during treatment with Foxime, particularly if given over long 
periods. For courses of treatment lasting longer than 10 days, blood 
counts should therefore be monitored. Foxime, like other parenteral 
anti-infective drugs, may be locally irritating to tissues. In most cases, 
perivascular extravasation of Foxime responds to changing of the 
infusion site. In rare instances, extensive perivascular extravasation of 
Foxime may result in tissue damage and require surgical treatment. To 
minimize the potential for tissue inflammation, infusion sites should be 
monitored regularly and changed when appropriate. 
Warnings: 
BEFORE THERAPY WITH FOXIME IS INSTITUTED: CAREFUL 
INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE 
PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO 
CEFOTAXIME SODIUM, CEPHALOSPORINS, PENICILLINS, OR 
OTHER DRUGS. THIS PRODUCT SHOULD BE GIVEN WITH 
CAUTION TO PATIENTS WITH TYPE 1 HYPERSENSITIVITY 
REACTIONS TO PENICILLIN. 
ANTIBIOTICS SHOULD BE ADMINISTERED WITH CAUTION TO ANY 
PATIENT WHO HAS DEMONSTRATED SOME FORM OF ALLERGY, 
PARTICULARLY TO DRUGS. IF AN ALLERGIC REACTION TO 
FOXIME OCCURS, DISCONTINUE TREATMENT WITH THE DRUG. 
SERIOUS HYPERSENSITIVITY REACTIONS MAY REQUIRE 
EPINEPHRINE AND OTHER EMERGENCY MEASURES.•uring 
post-marketing surveillance, a potentially life-threatening arrhythmia was 
reported in each of six patients who received a rapid (less than 
60 seconds) bolus injection of cefotaxime through a central venous 
catheter. Therefore, cefotaxime should only be administered as 
instructed in the dosage section. Clostridium difficile associated diarrhea 
(CDAD) has been reported with use of nearly all antibacterial agents, 
including Foxime, 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. diffici/e. 
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. 
Adverse reactions: 
Foxime is generally well tolerated. The most common adverse reactions 
have been local reactions following 1M or IV injection. Other adverse 
reactions have been encountered infrequently. 
The most frequent adverse reactions (greater than 1 are: 
Local (4.3%): Injection site inflammation with IV administration. Pain, 
induration, and tenderness after 1M injection. 
Hypersensitivity (2.4%): Rash, pruritus, fever, eosinophilia and less 
frequently urticaria and anaphylaxis (e.g., angioedema, bronchospasm, 
malaise possibly culminating in shock). 
Gastrointestinal (1.4%): Colitis, diarrhea, nausea, and vomiting. 
Symptoms of pseudomembranous colitis can appear during or after 
antibiotic treatment. Nausea and vomiting have been reported rarely 
Less frequent adverse reactions (less than 1%) are: 
Cardiovascular System: Potentially life-threatening arrhythmias 
following rapid (less than 60 seconds) bolus administration via central 
venous catheter have been observed. 
Hematologic System: Neutropenia, transient leukopenia, eosinophilia, 
a ranuloc osis have been reported. Some 
Impairmen o e 
The duration of treatment depends on the patient's response it must be 
continued for at least three days after normalization of the body 
temperature. 
Sodium bicarbonate solution must not be mixed with Foxime. 
Reconstitution: 
- For the 0.5 g I.M. or I.V injection, dissolve the contents of one vial using 
2 ml of sterile water for injection. 
Pain resulting from J.M. injection can be prevented by dissolving 
Foxime 0.5 g in 2 ml lidocaine solution 1%. An intravascular injection 
must then be strictly avoided. 
- For the 1 g I.M. injection, dissolve the contents of one vial using 4 ml 
from the lidocaine hydrochloride ampoule. 
Pain resulting from the I.M. injection can be prevented by dissolving 
Foxime 1 g in 4 ml lidocaine solution 1%. An intravascular injection 
must then be strictly avoided. It is advisable not to inject more than 
4 ml into either side. If the daily dose exceeds 2 g or if Foxime 1 g is 
administered more than twice daily, intravenous injection is to be 
preferred. 
- For the I g I.V. injection, dissolve the contents of one vial using 4 ml of 
sterile water for injection. 
Compatibility and Stability: 
Solutions of Foxime sterile reconstituted as described above 
(reconstitution) remain chemically stable (potency remains above 90%) 
as follows when stored in original containers and disposable plastic 
syringes: 
Reconstituted 
Stability at or 
Strength Concentration 
Stability under 
Refrigeration 
(at or below 50C) 
500 mg 
vial 1M 
I g vial 1M 
500 mg 
vial IV 
1 g vial IV 
mg/mL 
230 
50 
95 
below 220C 
12 hours 
12 hours 
24 hours 
24 hours 
Original 
containers 
7 days 
7 days 
7 days 
7 days 
Plastic 
syringes 
5 days 
5 days 
5 days 
5 days 
Reconstituted solutions stored in original containers and plastic syringes 
remain stable for 13 weeks frozen. 
Special notes: 
Emergency measures to be taken if anaphylactic shock occurs 
The following measures are generally recommended: At the first signs of 
anaphylactic shock (sweating, nausea, cyanosis) stop the injection 
immediately but leave the venous cannula in place or perform venous 
cannulation. In addition to the usual emergency measures, ensure that 
the patient is kept flat with the legs raised and airways patent. 
Emergency drug therapy 
Immediate epinephrine (adrenaline) I.V.; dilute 1 ml of commercially 
available epinephrine solution I :IOOO to 10 ml. In the first instance slowly 
inject 1 ml of this dilution (equivalent to 0.1 mg epinephrine) while 
monitoring pulse and blood pressure (watch for disturbances of cardiac 
rhythm). The administration of epinephrine may be repeated. Then 
glucocorticoids I.V.: e.g. 250-1000 mg methylprednisolone. The 
glucocorticoid administration may be repeated. 
Subsequently volume substitution I.V.: e.g. plasma expanders, human 
albumin, balanced electrolyte solution. 
Other therapeutic measures: Artificial respiration, oxygen inhalation, 
calcium, antihistaminics. 
Pharmaceutical Precautions: 
Keep at temperature below 25 oc. 
Keep contents in the carton until consumed. 
Do not use beyond the expiry date or if the product shows any signs of 
deterioration. 
Presentations: 
Foxime 0.5 g I.MJI.V.: A carton containing one vial and one 5 ml 
ampoule of sterile water for injection. 
Foxime 1 g I.M.: A carton containing one vial and one 5 ml ampoule of 
lidocaine hydrochloride solution. 
This presentation should never be used for I.V. administration. 
Foxime 1 g I.V.: A carton containing one vial and one 5 ml ampoule of 
sterile water for injection. 
This presentation may also be used for I.M. administration. 
@ is a trademark. 
THIS IS A MEDICAMENT 
- Medicament is a product which affects your health and its consumption 
contrary to instructions is dangerous for you. 
- Strictly follow the doctor's prescription, the method of use and the 
instructions of the pharmacist who sold the medicament. 
- The doctor and the pharmacist are experts in medicine, its benefits and 
risks. 
- Do not by yourself interrupt the period of treatment prescribed for you. 
- Do not repeat the same prescription without consulting your doctor. 
Keep medicament out of reach of children. 
Council of Arab Health Ministers & Union of Arab Pharmacists.