Cefditoren

Cefditoren is an antibiotic medicine used to treat a variety of bacterial infections. It is effective in infections of the respiratory tract (eg. pneumonia), urinary tract, ear, nasal sinus, throat, and some sexually transmitted diseases. Cefditoren should be taken with food to avoid an upset stomach. Take it regularly at evenly spaced intervals as per the schedule prescribed by your doctor. Taking it at the same time every day will help you to remember to take it. The dose will depend on what you are being treated for, but you should always complete a full course of this antibiotic as prescribed by your doctor. Do not stop taking it until you have finished, even when you feel better. If you stop taking it early, some bacteria may survive and the infection may come back. It will not work for viral infections such as flu or the common cold. Using any antibiotic when you do not need it can make it less effective for future infections. The most common side effects include headache, vomiting, nausea, indigestion, stomach pain, and diarrhea. These are usually mild but let your doctor know if they bother you or last more than a few days. Before using it, you should tell your doctor if you are allergic to any antibiotics or have any kidney or liver problems. You should also let your healthcare team know all other medicines you are taking as they may affect, or be affected by, this medicine. Pregnant and breastfeeding mothers should consult their doctor before using it.

• Bacterial infections
• Acute Bacterial Exacerbation of Chronic Bronchitis
• Community Acquired Pneumonia
• Pharyngitis
• Tonsillitis
• Uncomplicated Skin and Skin-Structure Infections

Cefditoren is a preparation of Cefditoren Pivoxil which is a broad spectrum third generation cephalosporin antibiotic. Cefditoren is a prodrug which is hydrolyzed by esterases during absorption, and the drug is distributed in the circulating blood as active Cefditoren. Cefditoren has antibacterial activity against gram-positive and gram-negative pathogens. The bactericidal activity of Cefditoren results from the inhibition of cell wall synthesis via affinity for penicillin- binding proteins (PBPs). Cefditoren is stable in the presence of a variety of ß-lactamases, including penicillinases and some cephalosporinases.

Cefditoren is an antibiotic. It kills the bacteria by preventing them from forming the bacterial protective covering (cell wall) which is needed for them to survive.

Adult Dose (Oral):
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, Uncomplicated skin and skin structure infections: 200 mg twice daily for 10 days.

Child Dose: 12 years old: As in adults.

Renal Dose: Renal impairment: CrCl (ml/min) 30-49 Maximum: 200 mg twice daily; <30 Maximum: 200 mg once daily.

Hepatic Dose: No dose adjustment for mild to moderate hepatic impairment. Caution in severe liver disease.

Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Cefditoren is to be taken with food.

If you miss a dose of Cefditoren, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular schedule. Do not double the dose.

Common Side Effects:

• Diarrhea
• Nausea
• Headache
• Abdominal pain
• Vaginal moniliasis
• Dyspepsia
• Vomiting
• Abnormal dreams
• Allergic reaction
• Anorexia
• Constipation
• Dizziness
• Dry mouth
• Fever

• [UNSAFE] Cefditoren may decrease alertness, affect your vision or make you feel sleepy and dizzy. Do not drive if these symptoms occur.
• Your doctor has prescribed Cefditoren to cure your infection and improve your symptoms. Do not skip any doses and finish the full course of treatment even if you feel better. Stopping it early may make the infection harder to treat.
• Take it with food to avoid an upset stomach.
• Discontinue Cefditoren and inform your doctor immediately if you get a rash, itchy skin, swelling of face and mouth, or have difficulty in breathing.
• Diarrhea may occur as a side effect but should stop when your course is complete. Inform your doctor if it does not stop or if you find blood in your stools.
• Avoid consuming alcohol while taking Cefditoren as it may cause increased side effects.
• Cefditoren 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.
• Prescribing Cefditoren 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.

• Hypersensitivity to Cefditoren, other cephalosporins, or milk proteins.
• Carnitine deficiency.
• Patients with milk protein hypersensitivity (not lactose intolerance) should not be administered Cefditoren.

Reduced oral bioavailability when coadministered with antacids or H2-receptor antagonists. Probenecid may increase plasma concentration and prolong half-life of Cefditoren. May enhance anticoagulant effect of vitamin K antagonists (e.g., warfarin).

Famotidine (intravenous administration) reduced the oral absorption of Cefditoren. As with other ß-lactam antibiotics, co-administration of probenecid with Cefditoren Pivoxil resulted in an increase in the plasma exposure of Cefditoren. Multiple doses of Cefditoren had no effect on the pharmacokinetics of ethinyl estradiol, the estrogenic component in most oral contraceptives.

[SAFE] Consuming alcohol with Cefditoren does not cause any harmful side effects.

[SAFE IF PRESCRIBED] Cefditoren is generally considered safe to use during pregnancy. Animal studies have shown low or no adverse effects to the developing baby; however, there are limited human studies. Pregnancy Category B. There are no adequate and well-controlled studies in pregnant women. Cefditoren should be used during pregnancy only if clearly needed.

[SAFE IF PRESCRIBED] Cefditoren is safe to use during breastfeeding. Human studies suggest that the drug does not pass into the breastmilk in a significant amount and is not harmful to the baby. Animal studies show that Cefditoren is excreted in breast milk. Caution should be exercised when Cefditoren is administered to nursing women. Avoid prolonged use of Cefditoren, since it may have possible effects such as rash and diarrhea.

Use of Cefditoren is not recommended for pediatric patients less than 12 years of age. The safety and efficacy of Cefditoren tablets in this population, including any effects of altered carnitine concentration, have not been established.

No dose adjustments are necessary for geriatric patients with normal (for their age) renal function.

[CAUTION] Cefditoren should be used with caution in patients with kidney disease. Dose adjustment of Cefditoren may be needed. Please consult your doctor.

No dose adjustment is necessary for patients with mild renal impairment (ClCr: 50-80 mL/min/1.73 m2). It is recommended that not more than 200 mg BID be administered to patients with moderate renal impairment (ClCr: 30-49 mL/min/1.73 m2) and 200 mg QD be administered to patients with severe renal impairment (ClCr: <30 mL/min/1.73 m2). The appropriate dose in patients with end-stage renal disease has not been determined.

[CAUTION] Cefditoren should be used with caution in patients with severe liver disease. Dose adjustment of Cefditoren may be needed. Please consult your doctor. Limited information is available on use of Cefditoren in patients with severe liver disease. No dose adjustments are necessary for patients with mild or moderate hepatic impairment.

Information on Cefditoren overdosage in humans is not available. However, with other ß-lactam antibiotics, adverse effects following overdosage have included nausea, vomiting, epigastric distress, diarrhea, and convulsions. Hemodialysis may aid in the removal of Cefditoren from the body, particularly if renal function is compromised.

Keep below 25°C temperature, away from light & moisture. Keep out of the reach of children.

Cefditoren Pivoxil