Ceftum Uses

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• Ceftum indications
• Uses of Ceftum in details
• Ceftum description
• Ceftum dosage
• Ceftum interactions
• Ceftum side effects
• Ceftum contraindications

What is Ceftum?

Ceftum injection is used to treat bacterial infections in many different parts of the body. It belongs to the class of medicines known as cephalosporin antibiotics. It works by killing bacteria or preventing their growth. However, Ceftum will not work for colds, flu, or other virus infections.

Ceftum is available only with your doctor's prescription.

Ceftum indications

Ceftum (Ceftum for injection, USP) is indicated for the treatment of patients with infections caused by susceptible strains of the designated organisms in the following diseases:

1.

Lower Respiratory Tract Infections, including pneumonia, caused by Pseudomonas aeruginosa and other Pseudomonas spp.; Haemophilus influenzae, including ampicillin-resistant strains; Klebsiella spp.; Enterobacter spp.; Proteus mirabilis; Escherichia coli; Serratia spp.; Citrobacter spp.; Streptococcus pneumoniae; and Staphylococcus aureus (methicillin-susceptible strains).

2.

Skin and Skin-Structure Infections caused by Pseudomonas aeruginosa; Klebsiella spp.; Escherichia coli; Proteus spp., including Proteus mirabilis and indole-positive Proteus; Enterobacter spp.; Serratia spp.; Staphylococcus aureus (methicillin-susceptible strains); and Streptococcus pyogenes (group A beta-hemolytic streptococci).

3.

Urinary Tract Infections, both complicated and uncomplicated, caused by Pseudomonas aeruginosa; Enterobacter spp.; Proteus spp., including Proteus mirabilis and indole-positive Proteus; Klebsiella spp.; and Escherichia coli.

4.

Bacterial Septicemia caused by Pseudomonas aeruginosa, Klebsiella spp., Haemophilus influenzae, Escherichia coli, Serratia spp., Streptococcus pneumoniae, and Staphylococcus aureus (methicillin-susceptible strains).

5.

Bone and Joint Infections caused by Pseudomonas aeruginosa, Klebsiella spp., Enterobacter spp., and Staphylococcus aureus (methicillin-susceptible strains).

6.

Gynecologic Infections, including endometritis, pelvic cellulitis, and other infections of the female genital tract caused by Escherichia coli.

7.

Intra-abdominal Infections, including peritonitis caused by Escherichia coli, Klebsiella spp., and Staphylococcus aureus (methicillin-susceptible strains) and polymicrobial infections caused by aerobic and anaerobic organisms and Bacteroides spp. (many strains of Bacteroides fragilis are resistant).

8.

Central Nervous System Infections, including meningitis, caused by Haemophilus influenzae and Neisseria meningitidis. Ceftum has also been used successfully in a limited number of cases of meningitis due to Pseudomonas aeruginosa and Streptococcus pneumoniae.

Ceftum (Ceftum for injection, USP) may be used alone in cases of confirmed or suspected sepsis. Ceftum has been used successfully in clinical trials as empiric therapy in cases where various concomitant therapies with other antibiotics have been used.

Ceftum may also be used concomitantly with other antibiotics, such as aminoglycosides, vancomycin and clindamycin; in severe and life-threatening infections, and in the immuno-compromised patient. When such concomitant treatment is appropriate, prescribing information in the labeling for the other antibiotics should be followed. The dose depends on the severity of the infection and the patient’s condition.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ceftum (Ceftum) and other antibacterial drugs, Ceftum (Ceftum) 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.

How should I use Ceftum?

Use Ceftum as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Ceftum is usually administered as an injection at your doctor's office, hospital, or clinic. If you are using Ceftum at home, carefully follow the injection procedures taught to you by your health care provider.
• Do not use Ceftum if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
• To clear up your infection completely, take Ceftum for the full course of treatment. Keep taking it even if you feel better in a few days.
• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
• If you miss a dose of Ceftum, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Ceftum.

Uses of Ceftum in details

Ceftum is used to treat life threatening bacterial infection including infections of the respiratory tract, brain, ear, urinary tract, skin and soft tissues, abdomen, bones and joints.

Ceftum description

Each vial contains 1 g Ceftum (as pentahydrate) with sodium carbonate.

Ceftum is a white to cream colored, crystalline powder which is soluble in alkali and in dimethyl sulfoxide, slightly soluble in dimethylformamide, in methanol, and in water, insoluble in acetone, in alcohol, in chloroform, in dioxane, in ether in ethyl acetate and in toluene. The pH of a 10% aqueous solution is approximately 6.3. The colour of Ceftum solutions ranges from light to amber, depending on the length of storage, concentration and diluent used.

Ceftum for injection USP is a physical blend of sterile Ceftum pentahydrate and sterile sodium carbonate. Chemically, Ceftum for injection USP is 1-[[(6R,7R)-7-[2- (2-amino-4-thiazolyl)glyoxylamido]-2-carboxy-8-oxo-5-thia-1-azabicyclo [4.2.0]oct-2-en-3-yl]methyl] pyridinium hydroxide, inner salt,7²-(Z)-[O-(1-carboxy-1-methylethyl)oxime], pentahydrate. Its empirical formula is C₂₂H₂₂N₆O₇S₂·5H₂O + Na₂CO₃ with molecular weight of 636.67 + 106.00.

Ceftum dosage

Dosage depends upon the severity, sensitivity, site and type of infection and upon the age and renal function of the patient.

Use Ceftum injection by intravenous (i.v.) or deep intramuscular (i.m.) injection. Recommended i.m. injection sites are the upper outer quadrant of the gluteus maximus or lateral part of the thigh.

Ceftum solutions may be given directly into the vein or introduced into the tubing of a giving set if the patient is receiving parenteral fluids.

Adults: 1 to 6 g/day in two or three divided doses by i.v. or i.m. injection.

Urinary Tract and Less Severe Infections: 500 mg or 1 g every 12 hours.

Most Infections: 1 g every 8 hours or 2 g every 12 hours.

Very Severe Infections Particularly in Immunocompromised Patients Including those with Neutropenia: 2 g every eight or 12 hours, or 3 g every 12 hours.

Fibrocystic Adults with Pseudomonal Lung Infections: 100 to 150 mg/kg/day in three divided doses.

In adults with normal renal function 9 g/day has been used without ill effect.

When used as a prophylactic agent in prostatic surgery, 1 g should be given at the induction of anaesthesia. A second dose should be considered at the time of catheter removal.

Infants and Children (Greater Than 2 Months): 30 to 100 mg/kg/day in two or three divided doses.

Doses up to 150 mg/kg/day (maximum 6 g/day) in three divided doses may be given to infected immunocompromised or fibrocystic children or children with meningitis.

Neonates (0 to 2 Months): 25 to 60 mg/kg/day in two divided doses.

In neonates, the serum half-life of Ceftum can be three to four times that in adults.

Elderly: In view of the reduced clearance of Ceftum in acutely ill elderly patients, the daily dosage should not normally exceed 3 g, especially in those over 80 years of age.

Renal Impairment: Ceftum is excreted unchanged by the kidneys. Therefore, in patients with impaired renal function, the dosage should be reduced.

An initial loading dose of 1 g should be given. Maintenance doses should be based on creatinine clearance as shown in Table 2.

In patients with severe infections the unit dose should be increased by 50% or the dosing frequency increased. In such patients the Ceftum serum levels should be monitored and trough levels should not exceed 40 mg/L.

In children the creatinine clearance should be adjusted for body surface area or lean body mass.

Haemodialysis: The serum half-life during haemodialysis ranges from 3 to 5 hours.

Following each haemodialysis period, the maintenance dose of Ceftum recommended in Table 2 should be repeated.

Peritoneal Dialysis: Ceftum may be used in peritoneal dialysis and continuous ambulatory peritoneal dialysis (CAPD).

In addition to i.v. use, Ceftum can be incorporated into the dialysis fluid (usually 125 to 250 mg for 2 litres of dialysis solution).

For patients in renal failure on continuous arteriovenous haemodialysis or high-flux haemofiltration in intensive therapy units; 1 g daily either as a single dose or in divided doses. For low-flux haemofiltration, follow the dosage recommended under impaired renal function.

For patients on venovenous haemofiltration and venovenous haemodialysis, follow the dosage recommendations in Tables 3 and 4.

Ceftum interactions

See also:
What other drugs will affect Ceftum?

Probenecid: Concomitant administration of 2 g of oral probenecid does not affect the pharmacokinetics of Ceftum, presumably because Ceftum is excreted principally by glomerular filtration.

Aminoglycosides: In vitro studies indicate that the antibacterial activity of Ceftum and aminoglycosides may be additive or synergistic against some organisms including some strains of Ps. aeruginosa and Enterobacteriaceae. However, synergism is unpredictable and antagonism has also occurred in vitro when Ceftum was used in combination with an aminoglycoside especially with the organisms with high-level resistance.

Concurrent use of aminoglycosides and cephalosporins may increase the risk of nephrotoxicity during therapy. Although this effect has not been reported to date with Ceftum, the manufacturer states that the possibility that nephrotoxicity may be potentiated if the drug is used concomitantly with an aminoglycoside should be considered.

Chloramphenicol: Chloramphenicol has been reported to antagonize the bactericidal activity of beta-lactam antibiotics including Ceftum, in vitro, and the possibility of in vivo antagonism should be considered. Therefore, it is recommended that combined therapy with chloramphenicol and Ceftum be avoided, particularly when bactericidal activity is considered important.

Beta-Lactam Antibiotics: Although a synergistic or partially synergistic effect has occurred in vitro against a few strains of Ps. aeruginosa when Ceftum and carbenicillin, cefsulodin, mezlocillin, or piperacillin were used concomitantly, use of Ceftum and another cephalosporin or an extended-spectrum penicillin has generally resulted in an effect that was only slightly additive or indifferent against Ps. aeruginosa. In addition, the combination of Ceftum and cefoxitin has been antagonistic in vitro against Ps. aeruginosa. The clinical importance is unclear, but concomitant use of Ceftum and ampicillin in vitro has resulted in antagonism against group B streptococci and Listeria monocytogenes. Combination of Ceftum and clavulanic acid, a beta-lactamase inhibitor, is synergistic against some strains of B. fragilis resistant to Ceftum alone. The combination was not effective against other Bacteroides, such as B. distasonis, that are not beta-lactamase producers.

Diuretics: Although concomitant use of cephalosporins and potent diuretics (e.g., furosemide) reportedly may adversely affect renal function, this effect apparently did not occur when furosemide was used concomitantly with Ceftum in a few patients.

Alteration in Laboratory Values: Positive direct Coombs' test is known to develop in individuals during treatment with the cephalosporin group of antibiotics, including Ceftum. In laboratory tests a false-positive reaction to glucose may occur with reducing substances but not with the use of specific glucose oxidase methods.

As with other beta-lactam antibiotics, granulocytopenia and more rarely, agranulocytosis may develop during treatment with Ceftum, particularly if given over long periods. For courses of treatment lasting longer than 10 days, blood counts should therefore be monitored.

Ceftum side effects

See also:
What are the possible side effects of Ceftum?

Ceftum is generally well tolerated. The incidence of adverse reactions associated with the administration of Ceftum was low in clinical trials. The most common were local reactions following IV injection and allergic and gastrointestinal reactions. Other adverse reactions were encountered infrequently. No disulfiram-like reactions were reported.

The following adverse effects from clinical trials were considered to be either related to Ceftum therapy or were of uncertain etiology:

Local Effects, reported in fewer than 2% of patients, were phlebitis and inflammation at the site of injection (1 in 69 patients).

Hypersensitivity Reactions, reported in 2% of patients, were pruritus, rash, and fever. Immediate reactions, generally manifested by rash and/or pruritus, occurred in 1 in 285 patients. Toxic epidermal necrolysis, Stevens-Johnson syndrome, and erythema multiforme have also been reported with cephalosporin antibiotics, including Ceftum. Angioedema and anaphylaxis (bronchospasm and/or hypotension) have been reported very rarely.

Gastrointestinal Symptoms, reported in fewer than 2% of patients, were diarrhea (1 in 78), nausea (1 in 156), vomiting (1 in 500), and abdominal pain (1 in 416). The onset of pseudomembranous colitis symptoms may occur during or after treatment.

Central Nervous System Reactions (fewer than 1%) included headache, dizziness, and paresthesia.

Seizures have been reported with several cephalosporins, including Ceftum. In addition, encephalopathy, coma, asterixis, neuromuscular excitability, and myoclonia have been reported in renally impaired patients treated with unadjusted dosing regimens of Ceftum.

Less Frequent Adverse Events (fewer than 1%) were candidiasis (including oral thrush) and vaginitis.

Hematologic

Rare cases of hemolytic anemia have been reported.

Laboratory Test Changes noted during clinical trials with Ceftum (Ceftum for injection, USP) were transient and included: eosinophilia (1 in 13), positive Coombs test without hemolysis (1 in 23), thrombocytosis (1 in 45), and slight elevations in one or more of the hepatic enzymes, aspartate aminotransferase (AST, SGOT) (1 in 16), alanine aminotransferase (ALT, SGPT) (1 in 15), LDH (1 in 18), GGT (1 in 19) and alkaline phosphatase (1 in 23). As with some other cephalosporins, transient elevations of blood urea, blood urea nitrogen, and/or serum creatinine were observed occasionally. Transient leukopenia, neutropenia, agranulocytosis, thrombocytopenia, and lymphocytosis were seen very rarely.

Postmarketing Experience with Ceftum (Ceftum for injection, USP) Products

In addition to the adverse events reported during clinical trials, the following events have been observed during clinical practice in patients treated with Ceftum and were reported spontaneously. For some of these events, data are insufficient to allow an estimate of incidence or to establish causation.

General

Anaphylaxis; allergic reactions, which, in rare instances, were severe (e.g., cardiopulmonary arrest); urticaria; pain at injection site.

Hepatobiliary Tract

Hyperbilirubinemia, jaundice.

Renal and Genitourinary

Renal impairment.

Cephalosporin-Class Adverse Reactions

In addition to the adverse reactions listed above that have been observed in patients treated with Ceftum, the following adverse reactions and altered laboratory tests have been reported for cephalosporin-class antibiotics:

Adverse Reactions

Colitis, toxic nephropathy, hepatic dysfunction including cholestasis, aplastic anemia, hemorrhage.

Altered Laboratory Tests

Prolonged prothrombin time, false-positive test for urinary glucose, pancytopenia.

Ceftum contraindications

See also:
What is the most important information I should know about Ceftum?

Hypersensitivity Reactions to Ceftum or the Cephalosporin Class of Antibiotics, Penicillins, or Other Beta-lactam Antibiotics

Ceftum for Injection USP and Dextrose Injection USP is contraindicated in patients who have a history of immediate hypersensitivity reactions (e.g., anaphylaxis, serious skin reactions) to Ceftum or the cephalosporin class of antibiotics, penicillins, or other beta-lactam antibiotics.

Active ingredient matches for Ceftum:

Ceftazidime in India, Indonesia.

Cefuroxime in India, Indonesia.

References

1. DailyMed. "CEFTAZIDIME: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
2. PubChem. "ceftazidime". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
3. PubChem. "cefuroxime". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology