KLAMENTIN 500 62,5

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COMPOSITION:
Amoxicillin (as amoxicillin trihydrate) ................... 500 mg
Clavulanic acid (as potassium clavulanate) ........... 62.5 mg
Excipients.q.s .................................................... 1 sachet
(Aerosil, avicel M112, sodium benzoate, anhydrous citric acid, sodium citrate, aspartame, strawberry-flavored powder, PVP K30, mannitol 60).
DOSAGE FORM: Granules for oral suspension.
PRESENTATION: Box of 24 sachets x 2 g.
PHARMACODYNAMICS: Amoxicillin is a beta-lactam semi-synthetic antibiotic with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms due to inhibition of bacterial cell wall synthesis. Amoxicillin is, however, easily destroyed by beta - lactamases and, therefore, it is inactive against beta-lactamases producing microorganisms. Clavulanic acid has beta-lactam structure resembling that of penicillin. It is an inhibitor of beta-lactamases produced by Gram-negative bacteria and staphylococci.
Clavulanic acid is particularly active against the plasmid medicated beta-lactamases, resulting in resistance to penicillins and cephalosporins. The combination of clavulanic acid and amoxicillin in Klamentin helps to protect amoxicillin from degradation by beta-lactamases, and effectively extends the antibacterial spectrum of amoxicillin to include many bacteria normally resistant to amoxicillin and microorganisms resistant to other penicillins and cephalosporins.
The bactericidal spectrum of activity:
Gram-positive bacteria:
Aerobic bacteria: Streptococcus faecalis, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus viridans, Staphylococcus aureus, Corynebacterium, Bacillus anthracis, Listeria monocytogenes.
Anaerobic bacteria: Clostridium, Peptococcus, Peptostreptococcus.
Gram-negative bacteria:
Aerobic bacteria: Haemophilus influenzae, Escherichia coli, Proteus mirabilis, Proteus vulgaris, strains of Klebsiella, Salmonella, Shigella, Bordetella, Neisseria gonorrhoeae, Neisseria meningitidis, Vibrio cholerae, Pasteurella multocida.
Anaerobic bacteria: Bacteroides including B. fragilis.
PHARMACOKINETICS: Amoxicillin and clavulanic acid are well absorbed by oral administration and achieve the maximum serum concentrations after 1 - 2 hours. Absorption of Klamentin is not affected by food; Klamentin should be taken right before meals. Oral bioavailability of amoxicillin is 90% and that of clavulanic acid is 75%. The serum half-life of amoxicillin is 1 - 2 hours and that of clavulanic acid is about 1 hour. Approximately 55% to 70% of the amoxicillin and approximately 30% to 40% of the clavulanic acid are excreted unchanged in urine. Concurrent administration of probenecid prolongs the excretion of amoxicillin elimination but not influence the excretion of clavulanic acid.
INDICATIONS:
For short-term treatment of infections of upper and lower respiratory tract, urinary tract, skin and soft tissue, bone, and joint. Klamentin is bactericidal to a variety of bacteria including beta-lactamases producing microorganisms resistant to ampicillin and amoxicillin.
CONTRAINDICATIONS:
Hypersensitivity to penicillins and cephalosporins. Severe hepatic and renal impairment. A history of jaundice or hepatic dysfunction during receiving penicillin. Infectious mononucleosis.
PRECAUTIONS: The dose should be adjusted in renal-impaired patients. Prolonged use of Klamentin is reported to cause superinfection.
PREGNANCY AND LACTATION:
There is no evidence on harms of this drug in foetus; therefore, just use in really required cases during pregnancy.
Caution should be exercised in nursing women.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES: The effect of this drug on the ability to drive and use machines is rarely reported.
INTERACTIONS: Probenecid decreases renal tubular secretion of amoxicillin; thus, it may result in increased blood levels of amoxicillin.
Klamentin may prolong the bleeding and clotting time. Klamentin may reduce the efficacy of oral contraceptives.
ADVERSE EFFECTS: Common: Diarrhoea, nausea, vomiting.
Less common: Hypereosinophilia. Hepatitis, obstructive jaundice. Pruritus, erythema, skin rash.
Rare: Anaphylactic reaction, Quincke’s edema, thrombocytopenia, hypoleukemia, hemolytic anemia, pseudomembranous colitis, Stevens-Johnson syndrome. Interstitial nephritis.
Inform your physician about any adverse effects occur during the treatment.
OVERDOSAGE: Following overdose, Klamentin rarely induces accidents because of its good absorption even high doses. However, some acute reactions depend on hypersensitive states in each individual. Risk of hyperpotassemia is reported when using high doses since clavulanic acid is used in the form of potassium salts. It is removed from the circulation by hemodialysis.
DOSAGE & ADMINISTRATION: Dissolve the drug in sufficient water (about 5 - 10 ml for 1 sachet), stir well before use.
The dose is based on amoxicillin component. The drug should be taken immediately before meals to reduce the drug intolerance in the stomach and intestine.
Children aged 3 months and older: 
- Otitis media, sinusitis, respiratory infections, and more severe infections: 45 mg/ kg body-weight/ day, in 2 divided doses.
- Less severe infections: 25 mg/ kg body-weight/ day, in 2 divided doses.
Children ³ 40 kg: as the adult dose.
Adults:
Mild to moderate infections: 1000/125 mg (2 sachets) twice daily.
Severe infections (including recurrent and chronic urinary tract infections, lower respiratory tract infections): 1000/125 mg (2 sachets), 3 times daily
Duration of therapy is 5 - 10 days and should not be exceeded 14 days without re-examination.
Or as directed by the physician.
Read the directions carefully before use.
Consult the physician for more information.
This drug is for prescriptions only.
Shelf-life: 36 months from the manufacturing date.
Storage conditions:
Store in dry places, not exceeding 30oC, protect from light.
Specifications: Manufacturer's.

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