Menacef 125 mg/5 mL dry powder for oral solutionMenacef 250 mg/5 mL dry powder for oral solutionMenacef 300 mg capsule

Menacef

COMPOSITION: Each 5 mL contains 125 mg or 250 mg cefdinir as active product. Each capsule contains 300 mg cefdinir as active product. Auxiliary products for oral solution: Contains water-free citric acid, sodium citrate, xanthan gum, sodium benzoate, guar gum, colloidal silicon dioxide, magnesium stearate, strawberry flavoring and sugar. Auxiliary products for capsule: Colloidal silicon dioxide, polyoxyl 40 stearate, magnesium stearate, carboxymethylcellulose calcium, erythrosine (E127), tartrazine (E102), titanium dioxide (E171), gelatin. PHARMACOLOGICAL PROPERTIES: Pharmacotherapeutic group: Systemic antibacterial agents/3. generation cephalosporins. ATC code: J01DD15. Cefdinir is a semi-synthetic 3. generation oral cephalosporin with a broad spectrum. Cefdinir, a beta-lactam antibiotic like penicillins, exerts its bactericidal activity by inhibiting cell wall synthesis. Cefdinir maintains its peak blood concentration for 1.8 hours. Although blood levels decrease afterwards, its bactericidal effect can last for 18-26 hours due to its high plasma protein binding (70%). Cefdinir is not metabolized. Its activity depends on the mother (basic?) drug. Cefdinir is basically removed by kidneys and mean plasma elimination half-life is (t½) 1.7 (±0.6) hours.INDICATIONS: 125 mg/5 mL Solution: In treatment of acute bacterial otitis media, acute maxillary sinusitis, acute bacterial rhino-sinusitis, pharyngitis/tonsillitis, uncomplicated skin infections; 250 mg/5 mL Solution: In treatment of community- acquired pneumonia in adults and adolescents, acute exacerbations of chronic bronchitis, acute maxillary sinusitis, pharyngitis/tonsillitis, uncomplicated skin and soft tissue infections; in children between the ages of 6 months-12 years, treatment of acute bacterial otitis media, acute maxillary sinusitis, pharyngitis/tonsillitis, uncomplicated skin and soft tissue infections. 300 mg Capsule: Community-acquired pneumonia, acute exacerbation of chronic bronchitis, acute maxillary sinusitis, pharyngitis/ tonsillitis is indicated for the treatment of uncomplicated skin infections.CONTRAINDICATIONS: Contraindicated in patiens known to have an allergy to cephalosporin group of antibiotics or to any of the ingredients contained in the product. WARNINGS AND PRECAUTIONS: Prior to initiation of therapy, the patients should be investigated for hypersensitivity to ceftinir, other cephalosporins, penicillins or any other drugs. Diarrhea associated with Clostridium difficile (CDİD) was reported with all antibacterial agents such as Menacef and its severity can range from mild diarrhea to fatal colitis. Treatment with antibacterial agents interferes with the normal flora of intestines and causes development of C. difficile. If CDID development is suspected or diagnosed, the antibiotic treatment being administered cannot be used directly against C. difficile and treatment may be discontinued. As with other broad spectrum antibiotics, ceftinir should be administered with caution in patients with a history of colitis. As with other broad spectrum antibiotics, it can cause development of resistant microorganisms with prolonged therapies. Ceftinir dosage should be adjusted in patients with renal failure (creatinine clearance <30 mL/min). Pregnancy and Lactation: Pregnancy Category is B. Pregnancy: It should not be used during pregnancy unless found necessary by the physician. Lactation: Following administration of the maximum dosage of 600 mg, ceftinir was not

detected in mother’s milk. Effects on driving and machine use: Effects on driving and machine used were not reported.

SIDE EFFECTS/ADVERSE EFFECTS: The observed side effects were mostly mild and limited. In adults and adolescents, the most frequently reported unwanted effects were diarrhea, vaginal monyliasis,

nausea, headache, abdominal pain and vaginitis. In clinical trials conducted with oral ceftinir, clinically significant laboratory changes were reported regardless of association with ceftinir treatment. DRUG INTERACTIONS: Interactions with other medicinal products and other ways of interaction: In case aluminum and magnesium-containing products, antacids and probenecid have to be administered during cefdinir use, antacids and probenecid have to be administered at least 2 hours prior to or after cefdinir use. When cefdinir is administered concomitantly with a therapeutical iron support that contains 60 mg essential iron or with vitamins that contain 10 mg essential iron, cefdinir absorption is decreased at a rate of 80% and 31%, respectively. Effect of food that contains basic iron (fats that contain iron at breakfast) on cefdinir was not evaluated. Since combined therapy with potentially nephrotoxic products (such as, aminoglycosides, antibiotics, colistin, polymixin B, viomicin) and potent diuretics (etacrinit acid, furosemide) can cause increases in renal failure, renal function should be closely monitored in these type of therapies. In patients where cephalosporins and coumarin anticoagulants are used concomitantly, prolongation of prothrombine time with or without hemorrhage was reported in isolated cases. Nifedipine, a calcium channel blocker, was reported to augment the bioavailability of another antibiotic from the cephalosporin group by up to 70%. DOSAGE AND ADMINISTRATION: The effects of a single dose daily for 10 days is equivalent to a twice daily dosage. It should be given twice a day in pneumonia and skin infections. For all infections: Solution: Total daily dose for ages between 6 months-12 years is 14 mg/kg (for acute bacterial otitis media and pharyngitis, 5-10 days; for other infections, 10 days). Maximum daily dose is 600 mg. Capsule: Daily total dose of is 600 mg for 13 years and older adolescents and adults (acute exacerbation of chronic bronchitis and pharyngitis / tonsillitis 5-10 days, 10 days for other infections). The maximum daily dose is 600 mg. Administration: Only for oral use. Menacef can be taken before or after a meal. Additional information for special populations: Renal Failure: In adult patients with creatinine clearance <30mL/min, ceftinir should be administered 300 mg/day. Liver failure: A major part of cefdinir is excreted by kidneys un-metabolized and no dosage adjustment is necessary in liver failure. Pediatric population: Efficacy and safety have not been established in children below the age of 6 years. Geriatric population: In elderly patients with no renal failure, no dosage adjustment is required. OVERDOSAGE AND TREATMENT: No data is available for sefdinir overdose and its treatment in humans. Since hemodialysis removes sefdinir from the body immediately in renal failure patients, this helps in avoiding serious toxicity cases. STORAGE CONDITIONS: It should be stored at room temperature below 30°C. Keep away from light and humidity. After reconstructing the solution, it can be stored at 25°C for 10 days. Shelf life is 36 months.HOW SUPPLIED AND PACKAGE CONTENTS: MENACEF 125 mg/5mL 100 mL dry powder for oral solution and MENACEF 250 mg/5mL 100 mL dry powder for oral solution, in glass bottles (with 100 ml line); in packages. MENACEF 300 mg 10 and 20 capsule, blister. Sold under prescription. Please contact our company for further details: http://www.mn.com.tr.LICENCE HOLDER AND ADDRESS: Mustafa Nevzat İlaç Sanayii A.Ş. Pak İş Merkezi, Prof. Dr.

Bülent Tarcan Sok. No: 5/1 34349 Gayrettepe/İstanbul.PRODUCER FIRM AND ADDRESS: Mustafa Nevzat İlaç Sanayii A.Ş. Sanayi Cad. No:13,

34530 Yenibosna - Bahçelievler/İstanbul.

Menacef