Cefditoren

What is Cefditoren?

• Cefditoren (Spectracef) as cefditoren pivoxil, a semi-synthetic cephalosporin antibiotic for oral administration used to treat certain infections caused by bacteria such as bronchitis (infection of the airway tubes leading to the lungs); pneumonia; and infections of the skin, throat, and tonsils.

Cefditoren pivoxil

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Cefditoren

Cefditorenpivoxil

What are the uses of this medicine?

Cefditoren (Spectracef) used for the treatment of mild to moderate infections in adults and adolescents (12 years of age or older) which are caused by susceptible strains as fallows:

• Acute Bacterial [[Exacerbation] of Chronic Bronchitis caused by Haemophilus influenzae (including ß-lactamase-producing strains), Haemophilus parainfluenzae (including ß-lactamase producing strains), Streptococcus pneumoniae (penicillin susceptible strains only), or Moraxella catarrhalis (including ß-lactamase-producing strains).

• Community-Acquired Pneumonia caused by Haemophilus influenzae (including ß-lactamase-producing strains), Haemophilus parainfluenzae (including ß-lactamase-producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), or Moraxella catarrhalis (including ß-lactamase producing strains).

• Pharyngitis/Tonsillitis caused by Streptococcus pyogenes.

• Uncomplicated Skin and Skin-Structure Infections caused by Staphylococcus aureus (including ß-lactamase-producing strains) or Streptococcus pyogenes.

NOTE: Cefditoren Pivoxil is effective in the eradication of Streptococcus pyogenes from the oropharynx. Cefditoren Pivoxil Tablets has not been studied for the prevention of rheumatic fever following Streptococcus pyogenes pharyngitis/tonsillitis. Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever.

How does this medicine work?

• Cefditoren - a semisynthetic, broad spectrum, beta lactamase resistant, third generation cephalosporin with antibacterial activity.
• Cefditoren binds to and inactivates penicillin binding proteins (pbps) located on the inner membrane of the bacterial cell wall.
• Pbps are enzymes involved in the terminal stages of assembling the bacterial cell wall and in reshaping the cell wall during growth and division. Inactivation of pbps interferes with the cross linkage of peptidoglycan chains necessary for bacterial cell wall strength and rigidity.
• This results in the weakening of the bacterial cell wall and causes cell lysis.
• Cefditoren is stable in the presence of a variety of ß-lactamases, including penicillinases and some cephalosporinases.

Cefditoren has been shown to be active against most strains of the following bacteria: Aerobic Gram-Positive Microorganisms:

• Staphylococcus aureus (methicillin-susceptible strains, including ß-lactamase-producing strains)

Note: Cefditoren is inactive against methicillin-resistant Staphylococcus aureus

• Streptococcus pneumoniae (penicillin-susceptible strains only)
• Streptococcus pyogenes

Aerobic Gram-Negative Microorganisms:

• Haemophilus influenzae (including ß-lactamase-producing strains)
• Haemophilus parainfluenzae (including ß-lactamase-producing strains)
• Moraxella catarrhalis (including ß-lactamase-producing strains)

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• known allergy to the cephalosporin class of antibiotics or any of its components.
• carnitine deficiency or inborn errors of metabolism that may result in clinically significant carnitine deficiency.

• Cefditoren Pivoxil tablets contain sodium caseinate, a milk protein. Patients with milk protein hypersensitivity should not be administered Cefditoren Pivoxil.

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.

Be sure to mention any of the following:

• antacids (Maalox, Mylanta, Tums, others)
• anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven)
• medications that block stomach acid such as cimetidine , famotidine (Pepcid), nizatidine (Axid) and ranitidine (Zantac)
• medications that decrease stomach acid such as dexlansoprazole (Dexilant), esomeprazole (Nexium, in Vimvo), lansoprazole (Prevacid, in Prevpac), omeprazole (Prilosec, in Zegerid), pantoprazole (Protonix), and rabeprazole (Aciphex)
• probenecid (Probalan)

Is this medicine FDA approved?

• Yes, it was FDA approved.
• Cefditoren pivoxil is available as 200 and 400 mg tablets in the United States.
• It was marketed under the trade name Spectracef by Vansen Pharma Inc.

How should this medicine be used?

Recommended dosage: Adults and Adolescents (≥12 Years):

• Community-acquired pneumonia: 400 mg twice daily for 14 days
• Acute bacterial exacerbation of chronic bronchitis: 400 mg twice daily for 10 days
• Pharyngitis/tonsillitis, otitis media, sinusitis: 200 mg twice daily for 10 days
• Uncomplicated skin and skin structure infections: 200 mg twice daily for 10 days

Children (2 months to 12 years of age): Pneumonia, otitis media or sinusitis:

• 3 mg/kg/dose, 3 times a day, after meals.
• The dosage may be increased up to 6 mg/kg/dose as needed, but not exceed the maximum dose for adults.

For children with diseases other than above:

• 3 mg/kg/dose, 3 times a day after meals.
• The dosage may be adjusted according to the disease or the patients age and symptoms, but not exceed the maximum dose for adults.
• Safety in low birth weight infants and newborns has not been established.

Administration:

• Cefditoren comes as a tablet to take by mouth.
• It is usually taken every 12 hours with the morning and evening meals for 10 to 14 days, depending on the condition being treated.
• Take cefditoren at around the same times every day.
• You should begin to feel better during your first few days of treatment with cefditoren.
• If your symptoms do not improve or get worse, call your doctor.
• Take cefditoren until you finish the prescription, even if you feel better.
• If you stop taking cefditoren too soon or skip doses, your infection may not be completely cured and 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 Cefditoren Pivoxil tablets contain 200 mg or 400 mg of cefditoren as cefditoren pivoxil

This medicine is available in fallowing brand namesː

• Spectracef

What side effects can this medication cause?

The most common side effects of this medicine include:

• Diarhea
• Nausea
• Headache
• Abdominal Pain
• Vaginal Moniliasis
• Dyspepsia
• Vomiting

Cefditoren may cause serious side effects which may include:

• watery or bloody stools, stomach cramps, or fever during treatment or for up to two or more months after stopping treatment
• hives
• rash
• itching
• difficulty breathing or swallowing
• closing of the throat
• a return of fever, sore throat, chills, or other signs of infection

What special precautions should I follow?

• Pseudomembranous colitis has been reported with nearly all antibacterial agents, including cefditoren pivoxil, and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents.
• Treatment with antibacterial agents alters normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile (C. difficile) is a primary cause of antibiotic-associated colitis.
• Prescribing Cefditoren Pivoxil 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.
• Cefditoren Pivoxil is not recommended when prolonged antibiotic treatment is necessary, since other pivalate-containing compounds have caused clinical manifestations of carnitine deficiency when used over a period of months.
• Patients should be counseled that antibacterial drugs including Cefditoren Pivoxil 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 Cefditoren Pivoxil or other antibacterial drugs in the future.
• Cefditoren Pivoxil should be taken with meals to enhance absorption.
• Cefditoren Pivoxil may be taken concomitantly with oral contraceptives.
• It is not recommended that Cefditoren Pivoxil be taken concomitantly with antacids or other drugs taken to reduce stomach acids
• Cefditoren Pivoxil tablets contain sodium caseinate, a milk protein. Patients with milk protein hypersensitivity (not lactose intolerance) should not be administered Cefditoren Pivoxil.
• Cefditoren was detected in the breast milk of lactating rats. Because many drugs are excreted in human breast milk, caution should be exercised when cefditoren pivoxil is administered to nursing women.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• nausea, vomiting, epigastric distress, diarrhea, and convulsions.
• Certain effects, such as diarrhea and soft stool lasting for a few days were observed in some animals as expected with most oral antibiotics due to inhibition of intestinal microflora.

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.
• Hemodialysis may aid in the removal of cefditoren from the body, particularly if renal function is compromised.
• Treat overdosage symptomatically and institute supportive measures as required.

Can this medicine be used in pregnancy?

• Pregnancy Category B.
• There are, however, no adequate and 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.

Can this medicine be used in children?

• Use of cefditoren pivoxil is not recommended for pediatric patients less than 12 years of age.

What are the active and inactive ingredients in this medicine?

• Active ingredient:cefditoren pivoxil
• Inactive ingredients:croscarmellose sodium, mannitol, magnesium stearate, sodium caseinate (a milk protein), and sodium tripolyphosphate.
• The tablet coating contains carnauba wax, hypromellose, polyethylene glycol, and titanium dioxide.
• Tablets are printed with ink containing opacode blue S-1-10533.

Who manufactures and distributes this medicine?

Manufactured by:

• Tedec-Meiji Farma, S.A
• Madrid, Spain

Distributed by:

• Pharma RomLev Inc.
• Westmount, QC

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

• Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).
• Protect from light and moisture.
• Dispense in a tight, light-resistant container.

• Dailymed label info on Cefditoren
• FDA Cefditoren

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