DRUGS & SUPPLEMENTS

Cefalekol

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Cefalekol uses


INDICATIONS AND USAGE

Treatment

Cefalekol for Injection, USP is indicated for the treatment of patients with serious infections caused by susceptible strains of the designated microorganisms in the diseases listed below.

Lower respiratory tract infections, including pneumonia, caused by Streptococcus pneumoniae (formerly Diplococcus pneumoniae), Streptococcus pyogenes* (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*).

Cefalekol for Injection, USP, 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. pneumoniae).

(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*.

(*) Efficacy for this organism, in this organ system, has been studied in fewer than 10 infections.

Although many strains of enterococci (e.g., S. faecalis) and Pseudomonas species are resistant to Cefalekol sodium in vitro, Cefalekol for Injection, USP 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 Cefalekol. 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, Cefalekol for Injection, USP 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 Cefalekol for Injection, USP is used concomitantly with an aminoglycoside.

Prevention

The administration of Cefalekol for Injection, USP 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 Cefalekol for Injection, USP 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, Cefalekol for Injection, USP 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 Cefalekol for Injection, USP and other antibacterial drugs, Cefalekol for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

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CONTRAINDICATIONS

Cefalekol is contraindicated in patients who have shown hypersensitivity to Cefalekol sodium, or the cephalosporin group of antibiotics.

WARNINGS

BEFORE THERAPY WITH Cefalekol IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO Cefalekol SODIUM, CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. THIS PRODUCT SHOULD BE GIVEN WITH CAUTION TO PATIENTS WITH TYPE I 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 Cefalekol OCCURS, DISCONTINUE TREATMENT WITH THE DRUG. SERIOUS HYPERSENSITIVITY REACTIONS MAY REQUIRE EPINEPHRINE AND OTHER EMERGENCY MEASURES.

During 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 Cefalekol through a central venous catheter. Therefore, Cefalekol should only be administered as instructed in the  DOSAGE AND ADMINISTRATION  section.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Cefalekol, 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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PRECAUTIONS

General

Prescribing Cefalekol 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.

Cefalekol 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 Cefalekol 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 Cefalekol sodium in patients with even profound renal dysfunction, it is suggested that, until further data are obtained, the dose of Cefalekol 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 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 × serum creatinine

Females: 0.85 × above value

As with other antibiotics, prolonged use of Cefalekol 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 Cefalekol, particularly if given over long periods. For courses of treatment lasting longer than 10 days, blood counts should therefore be monitored.

Cefalekol, like other parenteral anti-infective drugs, may be locally irritating to tissues. In most cases, perivascular extravasation of Cefalekol responds to changing of the infusion site. In rare instances, extensive perivascular extravasation of Cefalekol 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 Cefalekol should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Cefalekol 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 Cefalekol 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

Increased nephrotoxicity has been reported following concomitant administration of cephalosporins and aminoglycoside antibiotics.

Probenecid interferes with the renal tubular transfer of Cefalekol, decreasing the total clearance of Cefalekol by approximately 50% and increasing the plasma concentrations of Cefalekol. Administration of Cefalekol in excess of 6 grams/day should be avoided in patients receiving probenecid.

Drug/Laboratory Test Interactions

Cephalosporins, including Cefalekol 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 Cefalekol.

Carcinogenesis, Mutagenesis

Lifetime studies in animals to evaluate carcinogenic potential have not been conducted. Cefalekol was not mutagenic in the mouse micronucleus test or in the Ames test. Cefalekol did not impair fertility to rats when administered subcutaneously at doses up to 250 mg/kg/day  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 Cefalekol 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 Cefalekol 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 Cefalekol were significantly lighter in weight at birth and remained smaller than pups in the control group during the 21 days of nursing.

Nursing Mothers

Cefalekol is excreted in human milk in low concentrations. Caution should be exercised when Cefalekol is administered to a nursing woman.

Pediatric Use

See PRECAUTIONS above regarding perivascular extravasation.

Geriatric Use

Of the 1409 subjects in clinical studies of Cefalekol, 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 cannot 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 ).

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ADVERSE REACTIONS

Clinical Trials Experience

Cefalekol 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 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, transient leukopenia, have been reported. Some individuals have developed positive direct Coombs Tests during treatment with Cefalekol 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 Cefalekol.

Post-Marketing Experience

The following adverse reactions have been identified during post-approval use of Cefalekol. 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 Cefalekol, particularly in patients with renal insufficiency may result in encephalopathy (e.g. impairment of consciousness, abnormal movements and convulsions).

Cutaneous - As with other cephalosporins, isolated cases of toxic epidermal necrolysis,

Stevens‑Johnson syndrome, and erythema multiforme have been reported.

Hematologic System - Hemolytic anemia, agranulocytosis, thrombocytopenia.

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

Kidney - Interstitial nephritis, transient elevations of creatinine.

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

In addition to the adverse reactions listed above which have been observed in patients treated with Cefalekol 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.

To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceutical Corp. at 1-877‑233-2001 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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OVERDOSAGE

The acute toxicity of Cefalekol was evaluated in neonatal and adult mice and rats. Significant mortality was seen at parenteral doses in excess of 6000 mg/kg/day in all groups. Common toxic signs in animals that died were a decrease in spontaneous activity, tonic and clonic convulsions, dyspnea, hypothermia, and cyanosis. Cefalekol sodium overdosage has occurred in patients. Most cases have shown no overt toxicity. The most frequent reactions were elevations of BUN and creatinine. There is a risk of reversible encephalopathy in cases of administration of high doses of beta-lactam antibiotics including Cefalekol.  No specific antidote exists. Patients who receive an acute overdosage should be carefully observed and given supportive treatment.

DOSAGE AND ADMINISTRATION

The intent of this Pharmacy Bulk Package is for the preparation of solutions for intravenous infusion only. Dosing references to the intramuscular route of administration are for informational purposes only.

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. Cefalekol may be administered IM or IV after reconstitution. The maximum daily dosage should not exceed 12 grams.

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 Cefalekol 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 :

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 Cefalekol 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.

DIRECTIONS FOR PROPER USE OF PHARMACY BULK PACKAGE:

The 10 gram Pharmacy Bulk Package should be penetrated ONLY ONE TIME utilizing a suitable sterile transfer device or dispensing set and should be reconstituted with 47 mL of diluent for an approximate concentration of 200 mg/mL or 97 mL of diluent for an approximate concentration of 100 mg/mL withdrawable volume 102 mL), in a suitable work area such as a laminar flow hood, using aseptic technique. Shake to dissolve; inspect for particulate matter and discoloration prior to use. Stock solutions may be further diluted for IV infusion with diluents as listed in  COMPATIBILITY AND STABILITY  section. The reconstituted content of the 10 g Pharmacy Bulk Package should be withdrawn immediately, using a suitable sterile transfer device or dispensing set which allows measured dispensing of the contents. However, if it is not possible, aliquoting operations must be completed within four hours of reconstitution. Discard the reconstituted stock solution 4 hours after initial entry. Solutions of Cefalekol range from very pale yellow to light amber, depending on concentration, diluent used, and length and condition of storage.


Reconstituted Bulk Solutions Should Not Be Used For Direct Infusion


NOTE: Solutions of Cefalekol must not be admixed with aminoglycoside solutions. If Cefalekol 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 Cefalekol IN 14 ML OF STERILE WATER FOR INJECTION IS ISOTONIC.

IM Administration: As with all IM preparations, Cefalekol 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. Cefalekol 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 Cefalekol, 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 Cefalekol may be added to IV bottles containing the solutions discussed below.

COMPATIBILITY AND STABILITY

Solutions of Cefalekol reconstituted as described above ( DIRECTIONS FOR PROPER USE OF PHARMACY BULK PACKAGE ) should be discarded 4 hours after initial entry.

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.

NOTE: Cefalekol solutions exhibit maximum stability in the pH 5-7 range. Solutions of Cefalekol 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.

HOW SUPPLIED

Sterile Cefalekol for Injection, USP, in Pharmacy Bulk Packages, is a dry off-white to pale yellow crystalline powder containing Cefalekol sodium as follows:

10 g Cefalekol (free acid equivalent) in bottles, packages of 1 (NDC 0143-9935-01); NOT FOR DIRECT ADMINISTRATION.

Also available:

500 mg Cefalekol (free acid equivalent) vials in packages of 10 (NDC 0143-9930-10)

1 g Cefalekol (free acid equivalent) vials in packages of 25 (NDC 0143-9931-25)

2 g Cefalekol (free acid equivalent) vials in packages of 25 (NDC 0143-9933-25)

NOTE: Cefalekol for Injection, USP in the dry state should be stored at 20º to 25°C (68º to 77°F).

The dry material as well as solutions tend to darken depending on storage conditions and should be protected from elevated temperatures and excessive light.

REFERENCES

  • Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial  Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard - Ninth Edition. CLSI document M07-A9, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2012.
  • Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobials Susceptibility Tests; Twenty-Third Informational Supplement. CLSI document M100-S23, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2013.
  • Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard - Eleventh Edition. CLSI document M02-A11, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2012.
  • 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.
  • Cockcroft, D.W. and Gault, M.H.: Prediction of Creatinine Clearance from Serum Creatinine, Nephron 16:31–41, 1976.

Travasol® is manufactured by Clintec. 

 

 

 

Manufactured by:

HIKMA FARMACÊUTICA (PORTUGAL), S.A.

Estrada do Rio da Mó, 8, 8A e 8B - Fervença - 2705 – 906 Terrugem SNT, PORTUGAL

 

Distributed by:

WEST-WARD PHARMACEUTICAL CORP.

Eatontown, NJ 07724 USA

 

 

Revised: June 2014

PIN106-WES/4

Cefalekol pharmaceutical active ingredients containing related brand and generic drugs:

infoActive ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Cefalekol available forms, composition, doses:

infoForm of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Cefalekol destination | category:

infoDestination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Cefalekol Anatomical Therapeutic Chemical codes:

infoA medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Cefalekol pharmaceutical companies:

infoPharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. "cefotaxime". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).
  2. "cefotaxime". http://www.drugbank.ca/drugs/DB0049... (accessed August 28, 2018).
  3. "N2GI8B1GK7: The UNique Ingredient Identifier (UNII) is an alphanumeric substance identifier from the joint FDA/USP Substance Registration System (SRS).". https://www.fda.gov/ForIndustry/Dat... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Cefalekol?

Depending on the reaction of the Cefalekol after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Cefalekol 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 Cefalekol 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.

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Review

sDrugs.com conducted a study on Cefalekol, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Cefalekol consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Arunabha Ray, MD Pharmacology

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