Cefinir 300mg 10 tablets

ATC Classification Code J01DD15 Composition and Dosage Form Film-coated tablets: 10 pcs. per pack. 1 tab. Cefdinir........................................................300 mg Excipients: Titanium dioxide as coloring agent. Suspension: 100 ml per bottle. 5 ml Cefdinir.........................................................125 mg Excipients: Sodium benzoate as preservative and strawberry and cream flavors. Clinical-Pharmacological Group Third-generation cephalosporin. Pharmacological Properties Cefinir suspension contains the active substance Cefdinir, a broad-spectrum semi-synthetic cephalosporin. Cefdinir is a third-generation cephalosporin that exhibits bactericidal activity by inhibiting the synthesis of bacterial cell walls. Microorganisms resistant to penicillin and specific cephalosporins are susceptible to Cefdinir. Compared to other cephalosporins, Cefdinir has greater similarity to S. Aureus penicillin-binding protein 3, 2, 1 and E. Faecalis penicillin-binding protein 2 and 3. Cefdinir inhibits the excretion of neutrophil myeloperoxidase through mediators during neutrophil stimulation. Microbiology Cefdinir has been shown to be effective against the following microorganisms: Aerobic Gram-positive microorganisms: Staphylococcus Aureus (including beta-lactamase producing strains, except methicillin-resistant strains); Streptococcus pneumoniae (penicillin-susceptible strains only); Streptococcus pyogenes; Staphylococcus epidermidis (methicillin-susceptible strains only); Streptococcus agalactiae; Streptococcus viridans species. Aerobic Gram-negative microorganisms: Haemophilus influenzae (including beta-lactamase producing strains); Haemophilus parainfluenzae (including beta-lactamase producing strains); Moraxella catarrhalis (including beta-lactamase producing strains); Citrobacter diversus; Escherichia coli; Klebsiella pneumoniae; Proteus mirabilis. Pharmacokinetics Absorption: Peak plasma concentration is achieved 2-4 hours after oral administration of the dose. The absolute bioavailability of Cefdinir is 25%. It is taken independently of food. In children aged 6-12 months, after a single dose of 7 mg/kg of Cefdinir, Cmax (µg/ml), Tmax (h), AUC (µg*h/ml) are 2.30, 2.2, 8.31 respectively, and after a single dose of 14 mg/kg of Cefdinir - 3.86, 1.8, 13.4 respectively. Multiple Dosing: Cefdinir does not accumulate in plasma after once or twice daily dosing in patients with normal renal function. Distribution: The mean volume of distribution in children is 0.67 L/kg (±0.29). Cefdinir is 60-70% bound to plasma proteins in both adults and children; binding is concentration-independent. Metabolism and Excretion: Cefdinir is not significantly metabolized. It is excreted by the kidneys, and the mean plasma half-life (T1/2) is 1.7 hours. Cefdinir clearance is reduced in patients with renal dysfunction. Since the drug is primarily excreted by the kidneys, the dose should be adjusted in patients with impaired renal function and in patients on hemodialysis. Indications Cefinir suspension is indicated for the treatment of the following bacterial infections: - Acute bacterial otitis media: caused by Haemophilus influenzae (including beta-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including beta-lactamase producing strains); - Acute maxillary sinusitis: caused by Haemophilus influenzae (including beta-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including beta-lactamase producing strains); - Acute bacterial rhinosinusitis: caused by Haemophilus influenzae (including beta-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including beta-lactamase producing strains); - Pharyngitis/tonsillitis: caused by Streptococcus pyogenes; - Uncomplicated skin infections: caused by Staphylococcus aureus (including beta-lactamase producing strains) and Streptococcus pyogenes. Dosage Regimen Dosing and treatment for pediatric patients aged 6-12 months are provided in the table below. The total daily dose for all infections is 14 mg/kg up to a maximum dose of 600 mg per day. Once-daily dosing for 10 days is as effective as twice-daily dosing. Once-daily dosing has not been studied for skin infections, so in this case, Cefinir oral suspension is taken twice daily. Cefinir oral suspension can be taken independently of food. Cefinir Dosing Table for Pediatric Patients Aged 6-12 Months Infection Type Dose Duration Acute bacterial otitis media 7 mg/kg every 12 hours or 14 mg/kg once daily 5-10 days 10 days Acute maxillary sinusitis 7 mg/kg every 12 hours or 14 mg/kg once daily 10 days 10 days Pharyngitis/tonsillitis 7 mg/kg every 12 hours or 14 mg/kg once daily 5-10 days 10 days Uncomplicated skin infections 7 mg/kg every 12 hours 10 days Cefinir Oral Suspension Pediatric Dosing Table Weight 125 mg/ml 9 kg 2.5 ml every 12 hours or 5 ml once daily 18 kg 5 ml every 12 hours or 10 ml once daily 27 kg 7.5 ml every 12 hours or 15 ml once daily 36 kg 10 ml every 12 hours or 20 ml once daily ³43 kg 12 ml every 12 hours or 24 ml once daily For pediatric patients weighing ≥43 kg, the maximum daily dose is 600 mg. Instructions for Preparing Cefinir Oral Suspension: Pour boiled and cooled water into the bottle up to half the mark and shake well. Wait 5 minutes until a homogeneous solution is obtained. Add water up to the mark and shake again. After mixing, the suspension can be stored for 10 days at controlled room temperature. Shake the oral suspension well before use. Dosing and duration of treatment with Cefinir tablets for adults and children over 13 years of age are given in the table: Infection Type Dose Duration Community-acquired pneumonia 300 mg every 12 hours 10 days Acute exacerbation of chronic bronchitis 300 mg every 12 hours or 600 mg once daily 5-10 days 10 days Acute maxillary sinusitis 300 mg every 12 hours or 600 mg once daily 10 days 10 days Angina/tonsillitis 300 mg every 12 hours or 600 mg once daily 5-10 days 10 days Uncomplicated skin infections 300 mg every 12 hours 10 days The daily dose should not exceed 600 mg. Use in the Elderly: Dose adjustment is not required in elderly patients except for those with renal insufficiency. Use in Patients with Renal Insufficiency: In adult patients with creatinine clearance <30 ml/min, the dose is 300 mg once daily. Hemodialysis removes Cefdinir from the body. The recommended initial dose is 300 mg (or 7 mg/kg) every other day. 300 mg (or 7 mg/kg) is taken after each hemodialysis procedure. The subsequent dose is 300 mg (or 7 mg/kg) every other day. Side Effects Side effects after Cefdinir use are mild and self-limiting. The most common side effects are diarrhea, vaginal candidiasis, nausea, headache, abdominal pain, and vaginitis. In case of unexpected side effects, consult your doctor. Contraindications The drug is contraindicated in patients with hypersensitivity to antibiotics of the cephalosporin group. Pregnancy and Lactation Category B drug. Adequate and well-controlled studies in pregnant women have not been conducted, so the drug is used during pregnancy only when absolutely necessary. The drug was not detected in breast milk when a single dose of 600 mg was administered. Special Precautions Before starting therapy with Cefdinir, a check should be performed to determine if the patient has a history of hypersensitivity reactions to Cefdinir, other cephalosporins, penicillin, or other drugs. Caution should be exercised if Cefdinir is given to patients with hypersensitivity to penicillin, as cross-hypersensitivity reactions between beta-lactam antibiotics have been reported and may occur in up to 10% of patients with a history of penicillin allergy. If an allergic reaction to Cefdinir occurs, discontinue the drug. In case of severe hypersensitivity reactions, treatment with epinephrine and other emergency measures, including intravenous infusion, intravenous antihistamines, corticosteroids, vasopressors, and airway management with oxygen, is necessary. Cases of pseudomembranous colitis have been reported with almost all antibacterial agents, including Cefdinir. Therefore, caution is advised in patients experiencing diarrhea after taking antibacterial agents. Antibacterial treatment alters the normal flora of the intestine. Studies indicate that toxins produced by Clostridium difficile are the primary cause of antibiotic-associated colitis. In case of diagnosis of pseudomembranous colitis, appropriate therapy should be initiated. In mild cases of pseudomembranous colitis, discontinuation of the drug is often sufficient. In moderate to severe cases, attention should be paid to fluid and electrolyte management, protein supplements, and treatment with antibacterial agents clinically effective against Clostridium difficile. Like other broad-spectrum antibiotics, prolonged treatment may lead to an overgrowth of resistant organisms. Close monitoring of the patient is important. If superinfection occurs, appropriate alternative treatment should be initiated. Like other broad-spectrum antibiotics, Cefdinir should be administered with caution to patients with a history of colitis. In patients with renal insufficiency (creatinine clearance <30 ml/min), the dose of Cefdinir should be adjusted. Driving and Operating Machinery: No effects on the ability to drive or operate machinery have been reported. Overdose There is no data on overdose in humans. Signs and symptoms of toxicity from overdose of other beta-lactam antibiotics include nausea, vomiting, epigastric distress, diarrhea, and seizures. Cefdinir is removed from the body by hemodialysis. Drug Interactions Cefdinir should be taken at least 2 hours before or after taking antacids if used concurrently with aluminum- or magnesium-containing antacids. Like other drugs, probenecid inhibits the renal excretion of Cefdinir. If Cefdinir is taken with iron-containing products, it should be taken at least 2 hours before or after taking these products. Storage Conditions and Expiration Date The product should be stored at a temperature not exceeding 25°C, out of reach of children. Expiration Date 2 years. Conditions of Dispensing from Pharmacy: The product is dispensed by prescription only.