Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 20 February 2017

Indication(s)

INDICATIONS AND USAGE Treatment CLAFORAN is indicated for the treatment of patients with serious infections caused by susceptible strains of the designated microorganisms in the diseases listed below.

(1) Lower respiratory tract infections, including pneumonia, caused by Streptococcus pneumoniae (formerly Diplococcus pneumoniae), Streptococcus pyogenes Efficacy for this organism, in this organ system, has been studied in fewer than 10 infections.

(Group A streptococci) and other streptococci (excluding enterococci, e.g., Enterococcus faecalis), Staphylococcus aureus (penicillinase and non-penicillinase producing), Escherichia coli, Klebsiella species, Haemophilus influenzae (including ampicillin resistant strains), Haemophilus parainfluenzae, Proteus mirabilis, Serratia marcescens, Enterobacter species, indole positive Proteus and Pseudomonas species (including P. aeruginosa).

(2) Genitourinary infections.

Urinary tract infections caused by Enterococcus species, Staphylococcus epidermidis, Staphylococcus aureus, (penicillinase and non-penicillinase producing), Citrobacter species, Enterobacter species, Escherichia coli, Klebsiella species, Proteus mirabilis, Proteus vulgaris, Providencia stuartii, Morganella morganii, Providencia rettgeri, Serratia marcescens and Pseudomonas species (including P. aeruginosa).

Also, uncomplicated gonorrhea (cervical/urethral and rectal) caused by Neisseria gonorrhoeae, including penicillinase producing strains.

(3) Gynecologic infections, including pelvic inflammatory disease, endometritis and pelvic cellulitis caused by Staphylococcus epidermidis, Streptococcus species, Enterococcus species, Enterobacter species, Klebsiella species, Escherichia coli, Proteus mirabilis, Bacteroides species (including Bacteroides fragilis), Clostridium species, and anaerobic cocci (including Peptostreptococcus species and Peptococcus species) and Fusobacterium species (including F. nucleatum).

CLAFORAN

, like other cephalosporins, has no activity against Chlamydia trachomatis.

Therefore, when cephalosporins are 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.

(4) Bacteremia/Septicemia caused by Escherichia coli, Klebsiella species, and Serratia marcescens, Staphylococcus aureus and Streptococcus species (including S. pneumonia).

(5) Skin and skin structure infections caused by Staphylococcus aureus (penicillinase and non-penicillinase producing), Staphylococcus epidermidis, Streptococcus pyogenes (Group A streptococci) and other streptococci, Enterococcus species, Acinetobacter species, Escherichia coli, Citrobacter species (including C. freundii), Enterobacter species, Klebsiella species, Proteus mirabilis, Proteus vulgaris, Morganella morganii, Providencia rettgeri, Pseudomonas species, Serratia marcescens, Bacteroides species, and anaerobic cocci (including

Peptostreptococcus species and

Peptococcus species).

(6) Intra-abdominal infections including peritonitis caused by Streptococcus species, Escherichia coli, Klebsiella species, Bacteroides species, and anaerobic cocci (including Peptostreptococcus species and Peptococcus species) Proteus mirabilis, and Clostridium species.

(7) Bone and/or joint infections caused by Staphylococcus aureus (penicillinase and non-penicillinase producing strains), Streptococcus species (including S. pyogenes), Pseudomonas species (including P. aeruginosa), and Proteus mirabilis.

(8) Central nervous system infections, e.g., meningitis and ventriculitis, caused by Neisseria meningitidis, Haemophilus influenzae, Streptococcus pneumoniae, Klebsiella pneumoniae and Escherichia coli.

Although many strains of enterococci (e.g., S. faecalis) and Pseudomonas species are resistant to cefotaxime sodium in_vitro, CLAFORAN has been used successfully in treating patients with infections caused by susceptible organisms. Specimens for bacteriologic culture should be obtained prior to therapy in order to isolate and identify causative organisms and to determine their susceptibilities to CLAFORAN. Therapy may be instituted before results of susceptibility studies are known; however, once these results become available, the antibiotic treatment should be adjusted accordingly.

In certain cases of confirmed or suspected gram-positive or gram-negative sepsis or in patients with other serious infections in which the causative organism has not been identified, CLAFORAN may be used concomitantly with an aminoglycoside.

The dosage recommended in the labeling of both antibiotics may be given and depends on the severity of the infection and the patient 's condition.

Renal function should be carefully monitored, especially if higher dosages of the aminoglycosides are to be administered or if therapy is prolonged, because of the potential nephrotoxicity and ototoxicity of aminoglycoside antibiotics.

It is possible that nephrotoxicity may be potentiated if CLAFORAN is used concomitantly with an aminoglycoside.

Prevention The administration of CLAFORAN preoperatively reduces the incidence of certain infections in patients undergoing surgical procedures (e.g., abdominal or vaginal hysterectomy, gastrointestinal and genitourinary tract surgery) that may be classified as contaminated or potentially contaminated.

In patients undergoing cesarean section, intraoperative (after clamping the umbilical cord) and postoperative use of CLAFORAN may also reduce the incidence of certain postoperative infections.

See DOSAGE AND ADMINISTRATION section.

Effective use for elective surgery depends on the time of administration.

To achieve effective tissue levels, CLAFORAN should be given 1/2 or 1 1/2 hours before surgery.

See DOSAGE AND ADMINISTRATION section.

For patients undergoing gastrointestinal surgery, preoperative bowel preparation by mechanical cleansing as well as with a non-absorbable antibiotic (e.g., neomycin) is recommended.

If there are signs of infection, specimens for culture should be obtained for identification of the causative organism so that appropriate therapy may be instituted.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of CLAFORAN and other antibacterial drugs, CLAFORAN 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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Advisory information

contraindications
CONTRAINDICATIONS CLAFORAN is contraindicated in patients who have shown hypersensitivity to cefotaxime sodium, or the cephalosporin group of antibiotics.
Special warnings and precautions

PRECAUTIONS General Prescribing CLAFORAN 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.

CLAFORAN 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 CLAFORAN 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 mL/min/1.73 m2.

When only serum creatinine is available, the following formula5 (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)?

(140 - age) Males: 72?

serum creatinine Females: 0.85?

above value As with other antibiotics, prolonged use of CLAFORAN 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.

Leukopenia, neutropenia, granulocytopenia and, more rarely, bone marrow failure, pancytopenia, or agranulocytosis may develop during treatment with CLAFORAN.

For courses of treatment lasting longer than 10 days, blood counts should therefore be monitored and treatment discontinuation should be considered in case of abnormal results.

CLAFORAN, like other parenteral anti-infective drugs, may be locally irritating to tissues.

In most cases, perivascular extravasation of CLAFORAN responds to changing of the infusion site.

In rare instances, extensive perivascular extravasation of CLAFORAN 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.

Information for patients Patients should be counseled that antibacterial drugs including CLAFORAN should only be used to treat bacterial infections.

They do not treat viral infections (e.g., the common cold).

When CLAFORAN 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 CLAFORAN 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 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.

Drug Interactions As with other cephalosporins, CLAFORAN may potentiate the nephrotoxic effects of nephrotoxic drugs such as aminoglycosides, NSAIDs, and furosemide.

Probenecid interferes with the renal tubular transfer of cefotaxime, decreasing the total clearance of cefotaxime by approximately 50 % and increasing the plasma concentrations of cefotaxime.

Administration of cefotaxime in excess of 6 grams/day should be avoided in patients receiving probenecid (see CLINICAL PHARMACOLOGY, Drug Interactions).

Drug/Laboratory Test Interactions Cephalosporins, including cefotaxime sodium, are known to occasionally induce a positive direct Coombs ' test.

A false-positive reaction for glucose in the urine may occur with copper reduction tests (Benedict 's or Fehling 's solution or with CLINITEST tablets), but not with enzyme-based tests for glycosuria.

(e.g., CLINISTIX or TesTape).

There are no reports in published literature that link elevations of plasma glucose levels to the use of cefotaxime.

Carcinogenesis, Mutagenesis Lifetime studies in animals to evaluate carcinogenic potential have not been conducted.

CLAFORAN was not mutagenic in the mouse micronucleus test or in the Ames test.

CLAFORAN did not impair fertility to rats when administered subcutaneously at doses up to 250 mg/kg/day (0.2 times the maximum recommended human dose based on mg/ m2) or in mice when administered intravenously at doses up to 2000 mg/kg/day (0.7 times the recommended human dose based on mg/ m2).

Pregnancy Teratogenic Effects Pregnancy Category B: Reproduction studies have been performed in pregnant mice given CLAFORAN 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 CLAFORAN were significantly lighter in weight at birth and remained smaller than pups in the control group during the 21 days of nursing.

Nursing Mothers CLAFORAN is excreted in human milk in low concentrations.

Caution should be exercised when CLAFORAN is administered to a nursing woman.

Pediatric Use See Precautions above regarding perivascular extravasation.

The potential for toxic effects in pediatric patients from chemicals that may leach from the plastic in single dose Galaxy® Containers (premixed CLAFORAN Injection) has not been determined.

Geriatric Use Of the 1409 subjects in clinical studies of cefotaxime, 632 (45 %) were 65 and over, while 258 (18 %) 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 can not be ruled out.

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 PRECAUTIONS, General).

Adverse reactions

ADVERSE REACTIONS Clinical Trials Experience CLAFORAN is generally well tolerated.

The most common adverse reactions have been local reactions following IM 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 IM injection.

Hypersensitivity (2.4 %) - Rash, pruritus, fever, eosinophilia.

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: Hematologic System - Neutropenia, leukopenia, have been reported.

Some individuals have developed positive direct Coombs Tests during treatment with CLAFORAN and other cephalosporin antibiotics.

Genitourinary System - Moniliasis, vaginitis.

Central Nervous System -

Headache.

Liver - Transient elevations in AST, ALT, serum LDH, and serum alkaline phosphatase levels have been reported.

Kidney - As with some other cephalosporins, transient elevations of BUN have been occasionally observed with CLAFORAN. Post-Marketing Experience The following adverse reactions have been identified during post-approval use of CLAFORAN.

Because these reactions were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Cardiovascular System - Potentially life-threatening arrhythmias following rapid (less than 60 seconds) bolus administration via central venous catheter have been observed.

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 consciousness, abnormal movements and convulsions).

Dizziness has also been reported.

Cutaneous - As with other cephalosporins, isolated cases of toxic epidermal necrolysis, Stevens-Johnson syndrome, and erythema multiforme have been reported.

Acute generalized exanthematous pustulosis (AGEP) has also been reported.

General disorders and administration site conditions - Inflammatory reactions at the injection site, including phlebitis/thrombophlebitis.

Hematologic System - Hemolytic anemia, agranulocytosis, thrombocytopenia, pancytopenia, bone marrow failure.

Hypersensitivity - Anaphylaxis (e.g., angioedema, bronchospasm, malaise possibly culminating in shock), urticaria.

Kidney - Interstitial nephritis, transient elevations of creatinine, acute renal failure.

Liver - Hepatitis, jaundice, cholestasis, elevations of gamma GT and bilirubin.

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.

See DOSAGE AND ADMINISTRATION and OVERDOSAGE.

If seizures associated with drug therapy occur, the drug should be discontinued.

Anticonvulsant therapy can be given if clinically indicated.

Usage information

Dosing and administration

DOSAGE AND ADMINISTRATION Adults Dosage and route of administration should be determined by susceptibility of the causative organisms, severity of the infection, and the condition of the patient (see table for dosage guideline).

CLAFORAN may be administered IM or IV after reconstitution.

Premixed CLAFORAN Injection is intended for IV administration after thawing.

The maximum daily dosage should not exceed 12 grams.

GUIDELINES FOR DOSAGE OF CLAFORAN Type of Infection Daily Dose (grams) Frequency and Route Gonococcal urethritis/cervicitis in males and females 0.5 0.5 gram IM (single dose) Rectal gonorrhea in females 0.5 0.5 gram IM (single dose) Rectal gonorrhea in males 1 1 gram IM (single dose) Uncomplicated infections 2 1 gram every 12 hours IM or IV Moderate to severe infections 3-6 1-2 grams every 8 hours IM or IV Infections commonly needing antibiotics in higher dosage (e.g., septicemia) 6-8 2 grams every 6-8 hours IV Life-threatening infections up to 12 2 grams every 4 hours IV

If C. trachomatis is a suspected pathogen, appropriate anti-chlamydial coverage should be added, because cefotaxime sodium has no activity against this organism.

To prevent postoperative infection in contaminated or potentially contaminated surgery, the recommended dose is a single 1 gram IM or IV administered 30 to 90 minutes prior to start of surgery.

Cesarean Section Patients The first dose of 1 gram is administered intravenously as soon as the umbilical cord is clamped.

The second and third doses should be given as 1 gram intravenously or intramuscularly at 6 and 12 hours after the first dose.

Neonates, Infants, and Children The following dosage schedule is recommended: Neonates (birth to 1 month): 0-1 week of age 50 mg/kg per dose every 12 hours IV 1-4 weeks of age 50 mg/kg per dose every 8 hours IV It is not necessary to differentiate between premature and normal-gestational age infants.

Infants and Children (1 month to 12 years): For body weights less than 50 kg, the recommended daily dose is 50 to 180 mg/kg IM or IV body weight divided into four to six equal doses.

The higher dosages should be used for more severe or serious infections, including meningitis.

For body weights 50 kg or more, the usual adult dosage should be used; the maximum daily dosage should not exceed 12 grams.

Geriatric Use 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 PRECAUTIONS, General and PRECAUTIONS, Geriatric Use.

) Impaired Renal Function see PRECAUTIONS, General.

NOTE: As with antibiotic therapy in general, administration of CLAFORAN should be continued for a minimum of 48 to 72 hours after the patient defervesces or after evidence of bacterial eradication has been obtained; a minimum of 10 days of treatment is recommended for infections caused by Group A beta-hemolytic streptococci in order to guard against the risk of rheumatic fever or glomerulonephritis; frequent bacteriologic and clinical appraisal is necessary during therapy of chronic urinary tract infection and may be required for several months after therapy has been completed; persistent infections may require treatment of several weeks and doses smaller than those indicated above should not be used.

Preparation of CLAFORAN Sterile CLAFORAN for IM or IV administration should be reconstituted as follows:

Strength Diluent (mL) Withdrawable Volume (mL) Approximate Concentration (mg/mL) 500 mg vialin conventional vials (IM) 2 2.2 230 1g vial (IM) 3 3.4 300 2g vial (IM) 5 6.0 330 500 mg vial (IV) 10 10.2 50 1g vial (IV) 10 10.4 95 2g vial (IV) 10 11.0 180 1g infusion 50-100 50-100 20-10 2g infusion 50-100 50-100 40-20 Shake to dissolve; inspect for particulate matter and discoloration prior to use.

Solutions of CLAFORAN range from very pale yellow to light amber, depending on concentration, diluent used, and length and condition of storage.

For intramuscular use Reconstitute VIALS with Sterile Water for Injection or Bacteriostatic Water for Injection as described above.

For intravenous use Reconstitute VIALS with at least 10 mL of Sterile Water for Injection.

Reconstitute INFUSION BOTTLES with 50 or 100 mL of 0.9 % Sodium Chloride Injection or 5 % Dextrose Injection.

For other diluents, see COMPATIBILITY AND STABILITY section.

NOTE: Solutions of CLAFORAN must not be admixed with aminoglycoside solutions.

If CLAFORAN and aminoglycosides are to be administered to the same patient, they must be administered separately and not as mixed injection.

A SOLUTION OF 1 G CLAFORAN IN 14 ML OF STERILE WATER FOR INJECTION IS ISOTONIC. IM Administration As with all IM preparations, CLAFORAN should be injected well within the body of a relatively large muscle such as the upper outer quadrant of the buttock (i.e., gluteus maximus); aspiration is necessary to avoid inadvertent injection into a blood vessel.

Individual IM doses of 2 grams may be given if the dose is divided and is administered in different intramuscular sites.

IV Administration The IV route is preferable for patients with bacteremia, bacterial septicemia, peritonitis, meningitis, 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.

For intermittent IV administration, a solution containing 1 gram or 2 grams in 10 mL of Sterile Water for Injection can be injected over a period of three to five minutes.

Cefotaxime should not be administered over a period of less than three minutes.

(See WARNINGS).

With an infusion system, it may also be given over a longer period of time through the tubing system by which the patient may be receiving other IV solutions.

However, during infusion of the solution containing CLAFORAN, it is advisable to discontinue temporarily the administration of other solutions at the same site.

For the administration of higher doses by continuous IV infusion, a solution of CLAFORAN may be added to IV bottles containing the solutions discussed below.

Directions for use of CLAFORAN Injection in Galaxy® Container (PL 2040 Plastic) CLAFORAN Injection in Galaxy® Containers (PL 2040 plastic) is for continuous or intermittent infusion using sterile equipment.

Storage Store in a freezer capable of maintaining a temperature of - 20°C/- 4°F. Thawing of Plastic Container Thaw frozen container at room temperature or under refrigeration (at or below 5°C).

[DO NOT FORCE THAW BY IMMERSION IN WATER BATHS OR BY MICROWAVE IRRADIATION.]

Check for minute leaks by squeezing container firmly.

If leaks are detected, discard solution as sterility may be impaired.

DO

NOT ADD SUPPLEMENTARY

MEDICATION.

The container should be visually inspected.

Components of the solution may precipitate in the frozen state and will dissolve upon reaching room temperature with little or no agitation.

Potency is not affected.

Agitate after solution has reached room temperature.

If after visual inspection the solution remains cloudy or if an insoluble precipitate is noted or if any seals or outlet ports are not intact, the container should be discarded.

The thawed solution is stable for 10 days under refrigeration (at or below 5°C) or 24 hours at or below 22°C. Do not refreeze thawed antibiotics.

CAUTION: Do not use plastic containers in series connections.

Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is complete.

Preparation for Intravenous Administration Suspend container from eyelet support.

Remove protector from outlet port at bottom of container.

Attach administration set.

Refer to complete directions accompanying set.

Preparation of CLAFORAN Sterile in ADD-Vantage System CLAFORAN Sterile 1 g or 2 g may be reconstituted in 50 mL or 100 mL of 5 % Dextrose or 0.9 % Sodium Chloride in the ADD-Vantage diluent container.

Refer to enclosed

separate INSTRUCTIONS FOR ADD-VANTAGE SYSTEM. Compatibility and Stability Solutions of CLAFORAN Sterile reconstituted as described above (Preparation of CLAFORAN Sterile) remain chemically stable (potency remains above 90 %) as follows when stored in original containers and disposable plastic syringes: Strength Reconstituted Concentration mg/mL Stability at or below 22°C Stability under Refrigeration (at or below 5°C) Original Containers Plastic Syringes 500 mg vial IM 230 12 hours 7 days 5 days 1g vial IM 300 12 hours 7 days 5 days 2g vial IM 330 12 hours 7 days 5 days 500 mg vial IV 50 24 hours 7 days 5 days 1g vial IV 95 24 hours 7 days 5 days 2g vial IV 180 12 hours 7 days 5 days 1g infusion bottle 10-20 24 hours 10 days 2g infusion bottle 20-40 24 hours 10 days Reconstituted solutions stored in original

containers and plastic syringes remain stable for 13 weeks frozen.

Reconstituted solutions may be further diluted up to 1000 mL with the following solutions and maintain satisfactory potency for 24 hours at or below 22°C, and at least 5 days under refrigeration (at or below 5°C): 0.9 % Sodium Chloride Injection; 5 or 10 % Dextrose Injection; 5 % Dextrose and 0.9 % Sodium Chloride Injection, 5 % Dextrose and 0.45 % Sodium Chloride Injection; 5 % Dextrose and 0.2 % Sodium Chloride Injection; Lactated Ringer 's Solution; Sodium Lactate Injection (M/6); 10 % Invert Sugar Injection, 8.5 % Travasol® (Amino Acid) Injection without Electrolytes.

Solutions of CLAFORAN Sterile reconstituted in 0.9 % Sodium Chloride Injection or 5 % Dextrose Injection in Viaflex® plastic containers maintain satisfactory potency for 24 hours at or below 22°C, 5 days under refrigeration (at or below 5°C) and 13 weeks frozen.

Solutions of CLAFORAN Sterile reconstituted in 0.9 % Sodium Chloride Injection or 5 % Dextrose Injection in the ADD-Vantage flexible containers maintain satisfactory potency for 24 hours at or below 22°C. DO NOT FREEZE. NOTE: CLAFORAN solutions exhibit maximum stability in the pH 5-7 range.

Solutions of CLAFORAN should not be prepared with diluents having a pH above 7.5, such as Sodium Bicarbonate Injection.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Pregnancy and lactation
Nursing Mothers CLAFORAN is excreted in human milk in low concentrations. Caution should be exercised when CLAFORAN is administered to a nursing woman.

Interactions

Drug Interactions A single intravenous dose and oral dose of probenecid (500 mg each) followed by two oral doses of probenecid 500 mg at approximately hourly intervals administered to three healthy male subjects receiving a continuous infusion of cefotaxime increased the steady-state plasma concentration of cefotaxime by approximately 80 %.

In another study, administration of oral probenecid 500 mg every 6 hours to six healthy male subjects with cefotaxime 1 gram infused over 5 minutes decreased the total clearance of cefotaxime by approximately 50 %.

Additionally, no disulfiram-like reactions were reported in a study conducted in 22 healthy volunteers administered CLAFORAN and ethanol.

More information

Category Value
Authorisation number NDA050547
Orphan designation No
Product NDC 0039-0037,0039-0017,0039-0038,0039-0024,0039-0019,0039-0018,0039-0023,0039-0020
Date Last Revised 30-04-2015
Type HUMAN PRESCRIPTION DRUG
RXCUI 309068
Storage and handling NOTE: Store Premixed CLAFORAN Injection at or below -20°C/-4°F. [See Directions for use of CLAFORAN Injection in Galaxy® Containers (PL 2040 Plastic) ]. CLAFORAN Injection supplied as a frozen, iso-osmotic, sterile, nonpyrogenic solution in Galaxy® Containers (PL 2040 plastic) is manufactured for sanofi-aventis U.S. LLC by Baxter Healthcare Corporation.
Marketing authorisation holder Sanofi-Aventis U.S. LLC