NIFIN 50 KIDS

COMPOSITION: Each sachet 1.5 g contains:
Cefpodoxime (as cefpodoxime proxetil)...................................................................................................... 50 mg
Excipients q.s ....................................................................................................................................... 1 sachet
(Carboxymethylcellulose sodium, hydroxypropyl cellulose, mannitol, colloidal silicon dioxide, orange-flavored powder, anhydrous citric acid, aspartame, disodium edetate, sunset yellow, PVP K30)
DOSAGE FORM: Granules for oral suspension.
PRESENTATION: Box of 24 sachets x 1.5 g
PHARMACODYNAMICS: Nifin 50 kids contains the main active ingredient cefpodoxime which is a third generation cephalosporin. Cefpodoxime is stable in the presence of a variety of beta-lactamases produced by Gram positive and Gram negative bacteria.
Spectrum:
Cefpodoxime has an expanded spectrum of activity against aerobic gram-negative bacteria compared with first and second generation cephalosporins.
Cefpodoxime is active against gram-positive cocci such as Streptococcus pneumoniae, streptococcus groups A, B, C and G and Staphylococcus aureus, beta-lactamase-producing or non-beta-lactamase-producing S. epidermidis. Cefpodoxime is also active against gram-negative cocci, gram-positive and gram-negative bacilli. The drug is active against gram-negative bacteria such as E.coli, Klebsiella, Proteus mirabilis and Citrobacter.
However, these bacteria in Vietnam are also resistant the third generation cephalosporins. This issue should be noted because it is a failure risk in treatment.
In contrast to other oral cephalosporins, cefpodoxime is stable for beta-lactamases produced by Haemophilus influenzae, Moraxella catarrhalis and Neisseria. However, this observation has not been systematically monitored in Vietnam and the activity of cefpodoxime higher than that of other oral cephalosporins has not been unknown.
Resistance:
The drug is inactive against isoxazolylpenicillin-resistant staphylococci by altering the penicillin-binding proteins (Methicillin-resistant Staphylococcus aureus (MRSA)). The MRSA is growing in Vietnam.
Cefpodoxime is less active against Proteus vulgaris, Enterobacter, Serratia marcesens and Clostridium perfringens. They sometimes had drug resistance.
Methicillin-resistant Staphylococcus aureus, Staphylococcus saprophyticus, Enterococcus faecalis, Pseudomonas aeruginosa, Pseudomonas spp., Clostridium difficile, Bacteroider fragilis, Listeria, Mycoplasma pneumoniae, Chlamydia and Legionella pneumophili are usually resistant to cephalosporins.
PHARMACOKINETICS: Cefpodoxime proxetil is absorbed from the gastrointestinal tract and is hydrolyzed to cefpodoxime by nonspecific esterases within the intestinal lumen. Absorption is increased by food intake and decreased by low gastric pH. Cefpodoxime proxetil film-coated tablets and cefpodoxime proxetil oral suspension have same bioequivalence. Cefpodoxime exhibits dose-dependent linear pharmacokinetics over the oral dosage range of 100 to 400 mg; however, the drug exhibits nonlinear, dose-dependent pharmacokinetics at doses exceeding 400 mg. There is no evidence that cefpodoxime accumulates in plasma following multiple oral doses (up to 400 mg every 12 hours) in adults with normal renal function. In geriatric adults, the pharmacokinetic parameters are similar to those in younger subjects (except the half-life). The pharmacokinetics of cefpodoxime generally are unaffected by hepatic failure, but are affected by renal failure.
Presence of food affects the bioavailability of cefpodoxime proxetil film-coated tablets, but does not appear to affect the bioavailability of cefpodoxime proxetil oral suspension. The bioavailability of cefpodoxime is about 50% and increased when the drug is administered with meals. The elimination half-life of cefpodoxime is 2 to 3 hours for those with normal renal function and is prolonged in patients with renal impairment. In healthy adults who receive a single 100-, 200-, or 400-mg dose of cefpodoxime, peak plasma concentrations of cefpodoxime are attained within 2-3 hours and average 1.4, 2.3, or 3.9 mcg/ml, respectively; plasma concentrations 8 hours after the dose average 0.29, 0.62, or 1.3 mcg/ml. In pediatric patients 1 - 17 years of age who receive a single 5-mg/kg dose of cefpodoxime as cefpodoxime proxetil oral suspension, plasma concentrations of cefpodoxime average 1.4, 2.1, 2.1, 1.7, 0.9, 0.4, and 0.09 mcg/ml at 1, 2, 3, 4, 6, 8 and 12 hours, respectively, after the dose. Cefpodoxime is 20 - 30% bound to serum proteins; binding is independent of drug concentration over the range of 0.1 - 7.1 mcg/ml. The apparent volume of distribution of cefpodoxime ranges from 0.7 - 1.15 L/kg in healthy adults with normal renal function. Cefpodoxime is well distributed into lung tissue, bronchial tissue, and pleural fluid. Distribution of cefpodoxime into CSF is very low. Cefpodoxime is distributed into milk in low concentration following oral administration.
The main route of excretion is renal (80% unchanged for 24 hours). For patients with mild renal failure (creatinine clearances of 50 - 80 ml/min), the mean plasma half-life of cefpodoxime is 3.5 hours; for patients with moderate renal failure (creatinine clearances 30 - 49 ml/min), the half-life is increased to 5.9 hours; for patients with severe renal failure (creatinine clearances 5 - 29 ml/min), the half-life is increased to 9.8 hours. Cefpodoxime is removed approximately 23% of a single oral doses of the drug is removed by a 3-hour period of dialysis. No biotransformation occurs in the liver.
INDICATIONS: For the treatment of infections caused by susceptible strains, including:
Mild to moderate lower respiratory tract infections, including acute community-acquired pneumonia caused by susceptible Streptococcus pneumoniae or Haemophilus influenzae (including beta-lactamase-producing strains) and acute exacerbations of chronic bronchitis caused by susceptible S. pneumoniae, H. influenzae or Moraxella. catarrhalis (non-beta-lactamase-producing strains). 
Substitute for penicillin in the treatment of mild to moderate upper respiratory tract infections (including pharyngitis, tonsillitis, etc.) caused by susceptible Streptococcus pyogenes.
Acute maxillary sinusitis caused by Haemophilus influenzae (including beta-lactamase-producing strains), Streptococcus pneumoniae and Moraxella catarrhalis.
Acute otitis media caused by susceptible S. pneumoniae, H. influenzae (including beta-lactamase-producing strains), or B. catarrhalis.
Mild to moderate urinary tract infections caused by susceptible E.coli, Klebsiella pneumoniae, Proteus mirabilis or Staphylococcus saprophyticus.
Uncomplicated gonorrhea caused by penicillinase-producing strains of Neisseria gonorrhoea or nonpenicillinase-producing strains of the organism.
Skin infections caused by Staphylococcus aureus (including penicillinase-producing strains) or susceptible Streptococcus pyogenes.
CONTRAINDICATIONS: Hypersensitivity to any of the ingredients of the drug and other cephalosporins.
Previous history of hypersensitivity reactions to penicillins or other beta-lactam antibiotics.
PRECAUTIONS: Cefpodoxime should not be used in the treatment of atypical pneumonia caused by organisms such as Legionella, Mycoplasma and Chlamydia. Cefpodoxime is not recommended for the treatment of pneumonia due to S.pneumoniae.
In case of hypersensitivity reactions, treatment with cefpodoxime must be discontinued immediately and adequate emergency measures must be initiated.
Before beginning treatment, it should be established whether the patient has a history of hypersensitivity reactions to other cephalosporins, penicillins, or other drugs.
In cases of renal insufficiency it may be necessary to adjust the dosage regimen.
Cefpodoxime should always be prescribed with caution in patients with a history of gastrointestinal disease, particularly colitis. As with other antibiotics, the prolonged use of cefpodoxime may result in the overgrowth of non-
susceptible organisms (Candida and Clostridium difficile). Pseudomembranous colitis has been reported with cefpodoxime proxetil.
Individuals with phenylketonuria and other individuals who must restrict their intake of phenylalanine should be warned the product contains aspartame (Because aspartame is metabolized in the gastrointestinal tract to phenylalanine).
The excipient sunset yellow can cause allergy.
PREGNANCY AND LACTATION:
Caution should be exercised when prescribing to pregnant women and nursing mothers.
There are no or limited amount of data from the use of cefpodoxime in pregnant women; however, the use of cefpodoxime may be considered during pregnancy if necessary.
Low concentrations of cefpodoxime are excreted into human milk, but it may affect the breast-fed infants such as: disordered intestinal flora, direct impact on body infant and a misleading result of antibiogramme. A decision should be made to discontinue nursing in the mother during treatment with cefpodoxime.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES: Dizziness has been reported during treatment with cefpodoxime and may affect the ability to drive and use machines.
INTERACTIONS: Histamine H2-antagonists and antacids reduce the bioavailability of cefpodoxime.
Probenecid reduces the excretion of cephalosporins.
Cephalosporins potentially enhance the anticoagulant effect of coumarins and reduce the contraceptive effect of oestrogens.
Close monitoring of renal function is advised when cefpodoxime is administered concomitantly with aminoglycosides and/or diuretics of known nephrotoxic potential.
ADVERSE EFFECTS: Adverse drug reactions are listed below by system organ class and frequency. Frequencies are defined as: very common (>1/10), common (>1/100, <1/10), uncommon (>1/1000, <1/100), rare (>1/10000, <1/1000), very rare (<1/10000).
Blood disorders:
Rare: Reduction in haemoglobin, thrombocytopenia, leucopenia and eosinophilia.
Very rare: Haemolytic anaemia.
Nervous system disorders:
Uncommon: Headache, paraesthesia, dizziness.
Ear disorders:
Uncommon: Tinnitus.
Gastrointestinal disorders:
Common: Gastric pressure, nausea, vomiting, abdominal pain, flatulence, diarrhoea.
Bloody diarrhoea can occur as a symptom of enterocolitis.
The possibility of pseudomembranous enterocolitis should be considered if severe or persistent diarrhoea occurs during or after treatment.
Metabolism and nutrition disorders:
Common: Loss of appetite.
Immune system disorders:
Hypersensitivity reactions of all degrees of severity have been observed.
Very rare: Anaphylactic reactions, bronchospasm, purpura and angioedema.
Renal and urinary disorders:
Very rare: Slight increases in blood urea and creatinine.
Hepato-biliary disorders:
Rare: Transient moderate elevations of AST, ALT, alkaline phosphatase, bilirubin.
Very rare: Liver damage.
Skin and subcutaneous tissue disorders:
Uncommon: Hypersensitivity reactions, rash, urticaria, pruritus.
Very rare: Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme.
Infections: There can be multiplication of non-sensitive micro-organisms.
Systemic disorders and administration site conditions:
Uncommon: Asthenia or malaise.
Inform your physician about any adverse effects occur during the treatment.
Treatment of ADRs: Discontinue treatment with cefpodoxime.
OVERDOSAGE: The symptoms include nausea, vomiting, epigastric distress, and diarrhea.
Management: Supportive measures are almost indicated to remove cefpodoxime from the body and symptomatic treatment is practiced same as other cephalosporins.
DOSAGE & ADMINISTRATION: The drug content should be dissolved in a sufficient amount of water (about
5 - 10 ml of water for one sachet); stir well before use.
The drug may be administered without regard to meals.
Note: The suspension should be orally taken right after dissolved.
       Once opened, the drug sachet should be closed tightly; avoid desiccation to ensure drug quality.
Usual dose:
Children 2 months to 12 years of age: oral dose of 10 mg/kg/day in 2 divided doses every 12 hours (up to
400 mg/day).
Recommended dose: Children 2 months to 12 years of age:
Acute otitis media: 5 mg/kg (up to 200 mg) twice daily every 12 hours for 5 days.
Pharyngitis and tonsillitis: 5 mg/kg (up to 100 mg) twice daily every 12 hours for 5 - 10 days.
Acute maxillary sinusitis: 5 mg/kg (up to 200 mg) twice daily every 12 hours for 10 days.
Dosage in renal failure: Modification of cefpodoxime dosage is required depending on degree of renal failure. Patients with creatinine clearances less than 30 ml/minute and non-hemodialysis should receive the usual dose of cefpodoxime given once every 24 hours.
Patients maintained on hemodialysis should receive the usual dose 3 times weekly following dialysis.
Or as directed by the physician.
Read the directions carefully before use.   
Consult the physician for more information.
This drug is for prescription only.    
Shelf-life: 36 months from the manufacturing date.
Storage conditions: Store in dry places, not exceeding 30oC, protect from light.
Specifications: Manufacturer's.