THUỐC KHÁNG SINH
Amoxicillin ................................. 500 mg.
Clavulanic acid ......................... 125 mg.
Excipients ..q.s.............................. 1 tablet.
(Avicel, sodium starch glycolate, aerosil, magnesium stearate, HPMC, PEG 6000, talc, titanium dioxide).
Film coated tablets.
Box of 3 blisters x 4 film coated tablets.
Amoxicillin is a beta-lactam semi-synthetic antibiotic with a broad-spectrum of bactericidal action on many Gram-positive and Gram-negative microorganisms by inhibition of synthesis of the bacterial cell walls. However, amoxicillin is susceptible to degradation from beta-lactamases; therefore, amoxicillin has no action on beta-lactamase-producing bacteria (such as Enterobacteriaceae and Haemophilus influenzae). Clavulanic Acid - due to the fermentation of Streptomyces clavuligerus - has a beta-lactam structure related to penicillins, and is able to inhibit beta-lactamases produced by most of Gram-negative bacteria and Staphylococcus. Especially, it strongly inhibits beta-lactamases that are transmitted to plasmides causing a resistance to penicillins and cephalosporins. The combination of Clavulanic Acid and Amoxicillin in KLAMENTIN protects amoxicillin from degradation by beta-lactamases, and extends the antibacterial spectrum of amoxicillin against bacteria resistant to amoxicillin, ampicillin, or other penicillins and cephalosporins.
The antibacterial spectrum of KLAMENTIN consists of:
- Gram-positive aerobic bacteria: Bacillus anthracis, Corynebacterium species, Enterococcus faecalis, Enterococcus faecium, Listeria monocytogenes, Nocardia asteroides, Staphylococcus aureus, Coagulase negative staphylococci (including Staphylococcus epidermidis), Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus species, Streptococcus viridans.
- Gram-positive anaerobic bacteria: Clostridium species, Peptococcus species, Peptostreptococcus species.
- Gram-negative aerobic bacteria: Bordetella pertussis, Brucella species, Escherichia coli, Gardnerella vaginalis, Haemophilus influenzae, Helicobacter pylori, Klebsiella species, Legionella species, Moraxella catarrhalis (Branhamella catarrhalis), Neisseria gonorrohoeae, Neisseria meninggitidis, Pasteurella multocida, Proteur mirabilis, Proteur vulgaris, Salmonella species, Shigella species, Vibrio cholerae, Yersinia enterocollitica.
- Gram-negative anaerobic bacteria: Bacteroides species (including Bacteroides fragilis), Fusobacterum species.
- Other bacteria: Borrelia burgdorferi, Chlamydiate, Leptospira interohaemorrhagia, Treponema pallidum.
Both Amoxicillin and Clavulanic Acid are easily absorbed by oral route. The drug absorption is not affected by food, and it is the best way to take Klamentin right before meals.
For short-term treatment of:
- Severe upper respiratory tract infections (consisting of ENT, and odonto-stomatological infections) e.g. tonsillitis, sinusitis, otitis media, and alveolar abscess...
- Lower respiratory tract infections e.g. acute and chronic bronchitis, chronic bronchopneumonia, lobar pneumonia, pulmonary oedema, pulmonary abscess.
- Urogenital infections e.g. cystitis, urethritis, pyelonephritis, female genital tract infections, pelvic inflammation, gonorrhoea.
- Skin and soft tissue infections e.g. furuncles and abscesses, cellulitis, infected wounds.
- Osteoarticular tract infections e.g. endostitis.
- Other infections: septic abortion; obstetrical, intra-abdominal, and postoperative infections...
- For prevention of infections during surgeries: gastro-entero, uterus, head and neck, heart, kidney, biliary tract and joint substitutions...
Hypersensitivity to penicillins and cephalosporins.
Severe hepatic and renal impairment.
Patients with history of jaundice or hepatic dysfunction when taking penicillins.
Before prescribing KLAMENTIN, patients should be carefully asked about their known hypersensitivity to penicillins, cephalosporins or other allergenic substances.
Serious hypersensitive reactions that may be risky to survival (anaphylactic reactions) in patients treated with penicillins rarely occur in patients taking Klamentin orally.
Pregnant women and breast-feeding mothers.
The dose should be adjusted in patients with renal impairment (the creatinine clearance £ 30 ml/min.)
Prolonged treatment may cause surinfection.
Probenecid decreases the secretion of amoxicillin via renal tubuli ; thus, it may enhance the serum amoxicillin concentration.
Allopurinol increases the incidence of allergy to amoxicillin.
Caution should be taken in patients being treated with anticoagulants.
KLAMENTIN may decrease the effect of contraceptives by oral route.
KLAMENTIN may give false-positive results in tests for glucose in urine with Clinitest, Benedict's solution, Fehling's solution.
Gastrointestinal disturbances (diarrhoea, dyspepsia, nausea, vomiting), pseudomembranous colitis, candidiasis, thrombocytopenia, hypoleukemia, eosinophilia, agranulocytosis, hemolytic anemia.
Rarely (the drug administration must be discontinued): allergic reactions (prurigo, urticaria, erythema), Stevens-Johnson syndrome, Lyell syndrome, angioedema, dermatitis, hepatitis and obstructive jaundice, acute renal impairment, interstitial nephritis.
Inform your physician about any adverse effects occur during the treatment.
DOSAGE & ADMINISTRATION
The doses are referred to amoxicillin.
Adults and children > 12 years of age: 1 tablet, every 8 hours, not less than 5 days
The treatment course should not be exceeded 14 days without re-examination.
* The dose should be adjusted in cases of renal impairment: the reference to dose adjustment is as follows:
If the creatinine clearance is 15 - 30ml/min.: the usual doses should be given every 12 - 18 hrs.
If the creatinine clearance is 5 - 15ml/min.: the usual doses should be given every 20 - 36 hrs.
Adults with the creatinine clearance < 5ml/min.: the usual doses should be given every 48 hrs.
Hemodialysis patients: 1 tablet (500mg of Amoxicillin and 125mg of Clavulanic Acid) at the interval of dialyses and 1 more tablet at the end of dialysis.
Or as directed by the physician.
Read the directions carefully before use.
Consult the physician for more information.
This drug is for prescriptions only.
24 months from the manufacturing date.
Store in cool, dry place; protected from light.
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