Cefixime

What is Cefixime?

• Cefixime (Suprax) is a cephalosporin antibacterial drug used to treat certain infections caused by bacteria such as bronchitis (infection of the airway tubes leading to the lungs); gonorrhea (a sexually transmitted disease); and infections of the ears, throat, tonsils, and urinary tract.

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Cefixime

構造式 Cefixime

What are the uses of this medicine?

Cefixime (Suprax) is used in the treatment of adults and pediatric patients six months and older with the following infections:

• Uncomplicated Urinary Tract Infections.
• Otitis Media.
• Pharyngitis and Tonsillitis.
• Acute Exacerbations of Chronic Bronchitis.
• Uncomplicated Gonorrhea (cervical/urethral).

How does this medicine work?

• Cefixime is a semisynthetic cephalosporin antibacterial drug.
• As with other cephalosporins, the bactericidal action of cefixime results from inhibition of cell wall synthesis.
• Cefixime is stable in the presence of certain beta-lactamase enzymes.
• As a result, certain organisms resistant to penicillins and some cephalosporins due to the presence of beta-lactamases may be susceptible to cefixime.

Cefixime has been shown to be active against most isolates of the following microorganisms: Gram-positive Bacteria:

• Streptococcus pneumoniae
• Streptococcus pyogenes

Gram-negative Bacteria:

• Escherichia coli
• Haemophilus influenzae
• Moraxella catarrhalis
• Neisseria gonorrhoeae
• Proteus mirabilis

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• known allergy to cefixime or other cephalosporins.

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), and carbamazepine (Carbatrol, Epito, Equetro, Tegretol, Teril).

Is this medicine FDA approved?

• Cefixime was patented in 1979 and approved for medical use in the United States in 1989.

How should this medicine be used?

Recommended dosage: Adults:

• The recommended dose of cefixime is 400 mg daily.
• This may be given as a 400 mg tablet or capsule daily or the 400 mg tablet may be split and given as one half tablet every 12 hours.
• For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of 400 mg is recommended.

Pediatric Patients (6 months or older):

• The recommended dose is 8 mg/kg/day of the suspension.
• This may be administered as a single daily dose or may be given in two divided doses, as 4 mg/kg every 12 hours.

Administration:

• Cefixime comes as a tablet, chewable tablet, capsule, and suspension (liquid) to take by mouth. It is usually taken with or without food every 12 or 24 hours .
• When used for the treatment of gonorrhea it may be given in a single dose.
• Take cefixime at around the same times every day.
• Shake the suspension well before each use to mix the medication evenly.
• If you are taking the chewable tablets, chew these tablets completely before swallowing; do not swallow the chewable tablets whole.
• If you have trouble chewing you may crush them before swallowing.
• Different cefixime products are absorbed by the body in different ways and cannot be substituted for one another.
• If you need to switch from one cefixime product to another, your doctor may need to adjust your dose.
• You should begin to feel better during the first few days of treatment with cefixime.
• If your symptoms do not improve or get worse, call your doctor.
• Continue to take cefixime even if you feel better.
• If you stop taking cefixime 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 Film-coated, scored Tablets: 400 mg
• Capsules: 400 mg
• Chewable Tablets: 100 mg, 150 mg and 200 mg
• Oral Suspension: 100 mg/5 mL, 200 mg/5 mL and 500 mg/5 mL

This medicine is available in fallowing brand namesː

• Suprax

What side effects can this medication cause?

The most common side effects of this medicine include:

• diarrhea, nausea, loose stools, abdominal pain, dyspepsia, and vomiting

Less common side effects which may include:

• pseudomembranous colitis
• Anaphylactic/anaphylactoid reactions (including shock and fatalities), skin rashes, urticaria, drug fever, pruritus, angioedema, and facial edema. Erythema multiforme, Stevens-Johnson syndrome, and serum sickness-like reactions
• Transient elevations in SGPT, SGOT, alkaline phosphatase, hepatitis, jaundice
• Transient elevations in BUN or creatinine, acute renal failure
• Headaches, dizziness, seizures
• Transient thrombocytopenia, leukopenia, neutropenia, prolongation in prothrombin time, elevated LDH, pancytopenia, agranulocytosis, and eosinophilia
• Hyperbilirubinemia
• Genital pruritus, vaginitis, candidiasis, toxic epidermal necrolysis

What special precautions should I follow?

• Anaphylactic/anaphylactoid reactions (including shock and fatalities) have been reported with the use of cefixime. If an allergic reaction to SUPRAX occurs, discontinue the drug.
• Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including SUPRAX, and may range in severity from mild diarrhea to fatal colitis. If CDAD is suspected or confirmed, ongoing antibacterial drug use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial drug treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
• The dose of SUPRAX should be adjusted in patients with renal impairment as well as those undergoing continuous ambulatory peritoneal dialysis (CAPD) and hemodialysis (HD).
• Cephalosporins, including SUPRAX, may be associated with a fall in prothrombin activity. Prothrombin time should be monitored in patients at risk and exogenous vitamin K administered as indicated.
• Prescribing Suprax (cefixime) in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
• Phenylalanine can be harmful to patients with phenylketonuria (PKU). SUPRAX chewable tablets contain aspartame, a source of phenylalanine. Before prescribing SUPRAX chewable tablets in a patient with PKU, consider the combined daily amount of phenylalanine from all sources, including SUPRAX chewable tablets.
• Sometimes after starting treatment with antibacterial drugs, 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 antibacterial drug. If this occurs, patients should contact their physician as soon as possible.

What to do in case of emergency/overdose?

• 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.
• Gastric lavage may be indicated; otherwise, no specific antidote exists.
• Cefixime is not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis.

Can this medicine be used in pregnancy?

• Pregnancy Category B.
• There are no adequate and well-controlled studies in pregnant women.
• Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Can this medicine be used in children?

• Safety and effectiveness of cefixime in children aged less than six months old have not been established.

What are the active and inactive ingredients in this medicine?

Active Ingredient:

• cefixime

Inactive Ingredients:'

• fd&c blue no. 1
• fd&c red no. 40
• gelatin
• cellulose, microcrystalline
• shellac
• potassium hydroxide
• magnesium stearate
• propylene glycol
• titanium dioxide
• ferrosoferric oxide
• crospovidone

Who manufactures and distributes this medicine?

Manufactured by:

• Lupin Limited
• Mandideep
• INDIA

Manufactured for:

• Lupin Pharmaceuticals, Inc.
• Baltimore, Maryland
• United States

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

• Store at 25°C (77°F); excursions permitted to 15° to 30° C (59° to 86° F).

• Dailymed label info on Cefixime
• FDA Cefixime

Cefixime Resources
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