Cefuroxime

What is Cefuroxime?

• Cefuroxime (Ceftin) is a semisynthetic, broad-spectrum cephalosporin antibiotic for oral administration used to treat certain infections caused by bacteria, such as bronchitis; gonorrhea (a sexually transmitted disease); Lyme disease; and infections of the skin, ears, sinuses, throat, tonsils,, and urinary tract.

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What are the uses of this medicine?

Cefuroxime (Ceftin) is used for the treatment of the following infections due to susceptible bacteria:

• Pharyngitis/tonsillitis (adults and pediatric patients)
• Acute bacterial otitis media (pediatric patients)
• Acute bacterial maxillary sinusitis (adults and pediatric patients)
• Acute bacterial exacerbations of chronic bronchitis (adults and pediatric patients 13 years and older)
• Uncomplicated skin and skin-structure infections (adults and pediatric patients 13 years and older)
• Uncomplicated urinary tract infections (adults and pediatric patients 13 years and older)
• Uncomplicated gonorrhea (adults and pediatric patients 13 years and older)
• Early Lyme disease (adults and pediatric patients 13 years and older)

How does this medicine work?

• A second generation semi-synthetic cephalosporin and a beta-lactam antibiotic with bactericidal activity.
• Cefuroxime's effect is dependent on its binding to penicillin-binding proteins (PBPs) located in the bacterial cytoplasmic membrane.
• Binding results in the inhibition of the transpeptidase enzymes, thereby preventing cross-linking of the pentaglycine bridge with the fourth residue of the pentapeptide and interrupting consequent synthesis of peptidoglycan chains.
• As a result, cefuroxime inhibits bacterial septum and cell wall synthesis formation.

Cefuroxime axetil has been shown to be active against most isolates of the following bacteria: Gram-positive bacteria:

• Staphylococcus aureus (methicillin-susceptible isolates only)
• Streptococcus pneumoniae
• Streptococcus pyogenes

Gram-negative bacteria:

• Escherichia colia
• Klebsiella pneumoniaea
• Haemophilus influenzae
• Haemophilus parainfluenzae
• Moraxella catarrhalis
• Neisseria gonorrhoeae
• a Most extended spectrum β-lactamase (ESBL)-producing and carbapenemase-producing isolates are resistant to cefuroxime axetil.

Spirochetes:

• Borrelia burgdorferi

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Especially tell your doctor if you take:

• anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven), cimetidine
• diuretics ('water pills')
• famotidine (Pepcid)
• nizatidine (Axid)
• omeprazole (Prilosec, in Zegerid)
• pantoprazole(Protonix)
• probenecid (Probalan)
• ranitidine (Zantac)

• If you are taking antacids that contain magnesium or aluminum, take them at least 1 hour before or 2 hours after cefuroxime.

Is this medicine FDA approved?

• Cefuroxime was patented in 1971, and approved for medical use in 1977.
• In 2020, it was the 325th most commonly prescribed medication in the United States, with more than 800 thousand prescriptions.

How should this medicine be used?

Recommended dosage: In Adults and Adolescents (13 years and older): Pharyngitis/tonsillitis (mild to moderate):

• 250 mg every 12 hours for 10 days.

Acute bacterial maxillary sinusitis (mild to moderate):

• 250 mg every 12 hours for 10 days.

Acute bacterial exacerbations of chronic bronchitis (mild to moderate):

• 250 or 500 mg every 12 hours for 10 days.

Uncomplicated skin and skin-structure infections:

• 250 or 500 mg every 12 hours for 10 days.

Uncomplicated urinary tract infections:

• 250 mg every 12 hours for 7 to 10 days.

Uncomplicated gonorrhea:

• 1,000 mg as single dose.

Early Lyme disease:

• 500 mg every 12 hours for 20 days.

Pediatric Patients younger than 13 years (who can swallow tablets whole): Acute bacterial otitis media:

• 250 mg every 12 hours for 10 days.

Acute bacterial maxillary sinusitis:

• 250 mg every 12 hours for 10 days.

• Reducing the dosage of cefuroxime axetil is recommended for adult patients with severe renal impairment (creatinine clearance <30 mL/min).

Administration:

• Cefuroxime comes as a tablet and a suspension to take by mouth.
• It is usually taken every 12 hours for 5-10 days, depending on the condition being treated.
• Administer cefuroxime axetil tablets as described in the appropriate dosage guidelines.
• Take the suspension with food
• cefuroxime axetil tablets can be taken with or without food.
• Pediatric patients (aged 13 years and older) who cannot swallow the cefuroxime axetil tablets whole should receive cefuroxime axetil for oral suspension because the tablet has a strong, persistent bitter taste when crushed.
• Different cefuroxime products are absorbed by the body in different ways and cannot be substituted for one another. If you need to switch from one cefuroxime product to another, your doctor may need to adjust your dose.
• Shake the suspension well before each use to mix the medication evenly.
• Take cefuroxime until you finish the prescription, even if you feel better.
• If you stop taking cefuroxime too soon or skip doses, your infection may not be completely treated, and the bacteria may become resistant to antibiotics.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 250 mg and 500 mg
• As suspension (liquid)

This medicine is available in fallowing brand namesː

• Ceftin

What side effects can this medication cause?

The most common side effects of this medicine include:

• diarrhea, nausea/vomiting, Jarisch-Herxheimer reaction, and vaginitis (early Lyme disease), Eosinophilia, transient elevation in AST, Transient elevation in ALT, Transient elevation in LDH

Less common but serious side effects may include:

• Anaphylactic Reactions

What special precautions should I follow?

• Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on β-lactam antibacterials, including cefuroxime axetil. Before initiating therapy with cefuroxime axetil, inquire about previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens. If an allergic reaction occurs, discontinue cefuroxime axetil and institute appropriate therapy.
• Clostridium difficile- associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including cefuroxime axetil, 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.
• 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.
• The possibility of superinfections with fungal or bacterial pathogens should be considered during therapy.
• Prescribing cefuroxime axetil either 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.
• A false-positive result for glucose in the urine may occur with copper reduction tests, and a false-negative result for blood/plasma glucose may occur with ferricyanide tests in subjects receiving cefuroxime axetil.
• Instruct patients to swallow the tablet whole, without crushing the tablet. Patients who cannot swallow the tablet whole should receive the oral suspension.
• Inform patients that antibacterial drugs, including cefuroxime axetil, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold).
• 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 cefuroxime axetil or other antibacterial drugs in the future.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• convulsions
• encephalopathy

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• Serum levels of cefuroxime can be reduced by hemodialysis and peritoneal dialysis.

Can this medicine be used in pregnancy?

• Use of cefuroxime axetil, in pregnant women have not established drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

Can this medicine be used in children?

• The safety and effectiveness of cefuroxime axetil have been established for pediatric patients aged 3 months to 12 years.

What are the active and inactive ingredients in this medicine?

Active Ingredient:

• CEFUROXIME AXETIL

Inactive Ingredients:

• MICROCRYSTALLINE CELLULOSE
• CROSCARMELLOSE SODIUM
• SODIUM LAURYL SULFATE
• SILICON DIOXIDE
• CALCIUM STEARATE
• CALCIUM CARBONATE
• CROSPOVIDONE
• HYPROMELLOSE 2910
• TITANIUM DIOXIDE
• PROPYLENE GLYCOL
• FD&C BLUE NO. 1
• ALUMINUM OXIDE

Who manufactures and distributes this medicine?

Tablets:

• Alkem Laboratories Ltd.,
• INDIA.

Distributed by:

• Ascend Laboratories, LLC
• Parsippany, NJ

Oral suspension:

Manufactured for:

• Ranbaxy Pharmaceuticals Inc.
• Jacksonville, FL USA

What should I know about storage and disposal of this medication?

Tablets:

• Store at 20° to 25°C (68° to 77°F).

Oral suspension:

• Before reconstitution, store dry powder between 20 - 25° C (68 - 77° F).
• After reconstitution, immediately store suspension between 2 - 8° C (36 - 46° F), in a refrigerator.
• DISCARD AFTER 10 DAYS.

• Dailymed label info on Cefuroxime
• FDA Cefuroxime

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