Ceftoren 400

Indications

Ceftoren is a broad-spectrum antibiotic indicated for the treatment of mild to moderate infections in adults and adolescents (aged 12 years or older). It targets susceptible strains of microorganisms in the following conditions:

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

Use Ceftoren only as prescribed by a registered healthcare provider.

Pharmacology

Ceftoren is a formulation of Cefditoren Pivoxil, a third-generation cephalosporin antibiotic with broad antibacterial activity. As a prodrug, Cefditoren is metabolized into its active form after absorption, where it exerts bactericidal effects by inhibiting bacterial cell wall synthesis through its interaction with penicillin-binding proteins (PBPs). It is effective against both gram-positive and gram-negative pathogens and is stable against a range of ß-lactamases, including penicillinases and some cephalosporinases.

Dosage & Administration

Ceftoren should be taken after meals for optimal absorption. Recommended dosages include:

• Community-Acquired Pneumonia: 400 mg twice daily for 14 days
• Acute Exacerbation of Chronic Bronchitis: 400 mg twice daily for 10 days
• Pharyngotonsillitis and Acute Sinusitis: 200 mg twice daily for 10 days
• Uncomplicated Skin and Soft Tissue Infections: 200 mg twice daily for 10 days

Always follow your healthcare provider’s advice for dosing and duration.

Drug Interactions

• Antacids and Famotidine: Oral absorption of Ceftoren may be reduced.
• Probenecid: Co-administration can increase Ceftoren plasma levels.
• Oral contraceptives: Ceftoren does not significantly affect the pharmacokinetics of ethinyl estradiol, the estrogen component in most oral contraceptives.

Contraindications

Ceftoren should not be used in patients with a known allergy to cephalosporins or any of its ingredients. It contains sodium caseinate (milk protein), and should not be administered to patients with a milk protein allergy (not lactose intolerance).

Side Effects

Common side effects may include:

• Diarrhea
• Nausea
• Headache
• Abdominal discomfort
• Vaginal yeast infection (moniliasis)
• Indigestion
• Vomiting
• Abnormal dreams
• Allergic reactions
• Anorexia
• Constipation
• Dizziness
• Dry mouth
• Fever

Pregnancy & Lactation

Ceftoren is classified as Pregnancy Category B. There are no well-controlled studies in pregnant women, so it should be used only when clearly needed. Animal studies show that Cefditoren is excreted in breast milk, so caution is advised when administering Ceftoren to nursing mothers.

Precautions & Warnings

• Ceftoren is not recommended for long-term use, as prolonged use of pivalate-containing compounds can lead to carnitine deficiency.
• Avoid using Ceftoren in the absence of a confirmed or suspected bacterial infection, as unnecessary use increases the risk of drug-resistant bacteria.

Use in Special Populations

• Children: Ceftoren is not recommended for use in children under 12 years of age. Safety and efficacy have not been established in this age group.
• Geriatric: No dose adjustment is required for elderly patients with normal renal function.
• Renal Impairment: No dose adjustment is necessary for mild renal impairment (CrCl: 50-80 mL/min/1.73 m²). For moderate renal impairment (CrCl: 30-49 mL/min/1.73 m²), a maximum dose of 200 mg twice daily is recommended. For severe renal impairment (CrCl: <30 mL/min/1.73 m²), 200 mg once daily is suggested. The appropriate dose for end-stage renal disease has not been determined.
• Hepatic Disease: No dose adjustment is necessary for patients with mild or moderate liver impairment.

Overdose Effects

Overdose with Ceftoren may cause nausea, vomiting, abdominal pain, diarrhea, and in severe cases, convulsions. Hemodialysis may help remove Cefditoren from the body, especially in patients with renal impairment.

Therapeutic Class

Third-Generation Cephalosporins

Storage Conditions

Store below 25°C, away from light and moisture. Keep out of reach of children.