What is Klamentin 875/125?

Klamentin 875/125 is a combination of antibiotic amoxicillin and clavulanic acid, used to treat infections in adults and children such as sinusitis, otitis media, acute pneumonia in the community. cystitis, nephritis - pyelonephritis.

Composition of the drug

1. Amoxicillin (in the form of amoxicillin trihydrate) .... 875 mg
2. Clavulanic acid (in the form of potassium clavulanate & avicel) ... 125 mg
3. Excipients q.s . ..... 1 member
4. (Colloidal silicon dioxide, polyplasdon XL, microcrystalline cellulose M112, magnesium stearate, sepifilm LP914, titanium dioxide, talc)

Dosage forms

Film-coated tablets.

Klamentin 875/125 medicine used for acute otitis media, community-acquired pneumonia, cystitis .

Pharmacodynamic

ATC Code : J01CR02

Amoxicillin is a semi-synthetic antibiotic belonging to the beta - lactam family with a wide bactericidal spectrum for many Gram positive and Gram negative bacteria due to inhibition of bacterial cell wall synthesis. But because amoxicillin is easily destroyed by beta - lactamase, amoxicillin has no effect on the bacterial strains that produce these enzymes.

Clavulanic acid has a beta - lactam structure similar to penicillin, capable of inhibiting beta - lactamase produced by most Gram-negative and Staphylococcus bacteria. In particular, clavulanic acid has a strong inhibitory effect of beta - lactamases transmitted by plasmids, causing resistance to penicillins and cephalosporins.

The combination of clavulanic acid and amoxicillin in Klamentin helps amoxicillin not be destroyed by beta - lactamase, while extending the antibacterial spectrum of amoxicillin effectively to many common bacteria resistant to amoxicillin and to other penicillins. and cephalosporins.

The bactericidal spectrum of the drug includes:

Gram-positive bacteria:

Aerobic type: Streptococcus faecalis, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus viridans, Staphylococcus aureus, Corynebacterium, Bacillus anthracis, Listeria monocytogenes.

Anaerobic types: Clostridium, Peptococcus, Peptostreptococcus species.

Gram-negative bacteria:

Aerobic type: Haemophilus influenzae, Escherichia coli, Proteus mirabilis, Proteus vulgaris, Klebsiella, Salmonella, Shigella, Bordetella, Neisseria gonorrhoeae, Neisseria meningitidis, Vibrio cholerae, Pasteurella multocida.

Anaerobic type: Bacteroides including B. fragilis.

Pharmacokinetics

Absorption: Amoxicillin and clavulanic acid are easily absorbed orally. Reaches maximum serum concentration after 1-2 hours. Absorption of the drug is not affected by food and it is best taken immediately before meals.

Distribution : After oral administration, both amoxicillin and clavulanic acid are distributed into the lungs, pleural fluid and peritoneal fluid, passing through the placenta. Amoxicillin is excreted into milk, there is no data to show that clavulanic acid is present in breast milk of nursing mothers. The oral bioavailability of amoxicillin is 90% and that of clavulanic acid is 75%. The plasma elimination half-life of amoxicillin is 1-2 hours and that of clavulanic acid is about 1 hour. 55 - 73% of amoxicillin and 25 - 45% of clavulanic acid are excreted in the urine as active.

Metabolism: Amoxicillin is metabolized very little in the body into corresponding penicilloic acid. Clavulanic acid is partially converted to low molecular weight metabolite.

Elimination : Amoxicillin and clavulanic acid are excreted mainly by the kidneys. In patients with renal insufficiency, serum concentrations of both amoxicillin and clavulanic acid are higher as well as longer elimination half-life. In patients with creatinine clearance of 9 ml / min, the half-lives of amoxicillin and clavulanic acid are 7.5 and 4.3 hours, respectively. Both amoxicillin and clavulanic acid are removed during hemodialysis. When peritoneal dialysis, clavulanic acid is also removed while only a very small amount of amoxicillin is removed. Probenecid prolongs the elimination period of amoxicillin but does not affect the elimination of clavulanic acid.

Regulation of the packaging

Box of 1 bag x 2 blisters x 7 capsules.

Point

Treatment of infections in adults and children such as sinusitis, acute otitis media, exacerbation of chronic bronchitis, community-acquired pneumonia, cystitis, nephritis - pyelonephritis. Skin and soft tissue infections such as pimples, wound infections. Bone and joint infections such as osteomyelitis.

Dosage and administration

Dosage is calculated by amoxicillin. Take the medicine right before a meal to minimize the phenomenon of intolerance to the stomach - intestines. The tablets should be swallowed whole and not chewed, if necessary, the tablet may be broken in half and swallowed and not chewed.

Adults and children over 40kg: Take 1 capsule twice a day.

Children under 40kg: Not suitable for the content and dosage form.

Elderly: No dose adjustment is necessary.

People with renal impairment:

Creatinine clearance greater than 30 ml / min: No dose adjustment is necessary.

Do not use Klamentin 875/125 in people with glomerular filtration rate below 30 ml / minute.

Hepatic impairment: There is insufficient data to make a recommended dose with caution for patients with hepatic impairment and should periodically monitor liver function.

Duration of treatment lasts from 5 to 10 days. Treatment should not exceed 14 days without re-examination.

Or as directed by a physician.

Contraindicated

Hypersensitivity to penicillins, cephalosporins, clavulanic acid or any component of the drug. History of jaundice or liver dysfunction related to amoxicillin / clavulanic acid.

Careful

A history of hypersensitivity reactions to penicillins, cephalosporins or other allergens should be consulted before initiating treatment with amoxicillin / clavulanic acid.

Hypersensitivity (anaphylaxis) and sometimes fatal reports have been reported in patients treated with penicillin. These reactions are more common in patients with a history of hypersensitivity to penicillins.

Prolonged treatment may cause superinfection due to overgrowth of non-susceptible bacteria.

Pay attention to the elderly, patients with a history of jaundice / liver dysfunction due to amoxicillin and potassium clavulanate because clavulanic acid increases the risk of cholestasis in the liver. The signs and symptoms of cholestatic jaundice are less common with medication but can be severe. However, these symptoms usually recover after a few weeks of stopping treatment.

Differential diagnosis is required to detect cases of C. difficile diarrhea and pseudomembranous colitis.

Must periodically check hematological index, liver and kidney function during treatment.

Prothrombin time abnormality (INR increase) has been reported but is rare in patients receiving amoxicillin / clavulanic acid and oral anticoagulants. Appropriate monitoring should be followed when anticoagulants are prescribed simultaneously. It may be necessary to adjust the dose of oral anticoagulants to maintain the desired level of anticoagulation.

Amoxicillin / clavulanic acid dose should be adjusted in patients with renal impairment (see Dosage and administration).

Crystalluria has been observed in patients with reduced urinary excretion but is very rare, mainly when patients are given by infusion. Patients should be advised to drink enough water to maintain the amount of urine excreted during high doses of amoxicillin to reduce the likelihood of urinary amoxicillin crystals (see Overdose).

Pregnant and lactating women:

There is no evidence of any adverse effects on the fetus, but during pregnancy should be used only when clearly needed.

Be careful when using the drug during breastfeeding because the drug is excreted in a small amount into breast milk, the adverse effects for the nursing infant are unknown. Stop breastfeeding if you have to take medicine.

Effects of drugs on the ability to drive and operate machines:

The drug can cause dizziness, headache, so be cautious when operating machinery, driving trains, people working on high altitude and other cases.

Drug interactions

Drugs can cause prolonged bleeding and blood clotting times, so be careful with patients who are being treated with anticoagulants (warfarin).

Methotrexate: Increases hematologic toxicity of methotrexate due to inhibition of renal tubular penicillin antibiotics.

Probenecid reduces the excretion of amoxicillin in the renal tubules, thereby increasing the concentration of amoxicillin in the blood.

Mycophenolate mofetil: In patients taking mycophenolate mofetil, reports of a 50% reduction in the pre-dose concentration of mycophenolic acid metabolite after the start of oral amoxicillin combined with clavulanic acid. However, changes in pre-dose concentrations may not accurately represent changes in overall exposure to mycophenolic acid. No need to adjust the dose of mycophenolate mofetil when there is insufficient evidence of loss of organ transplant function. Clinical close monitoring is required during use of this drug with antibiotics.

It may reduce the effects of oral contraceptives.

Concomitant use of allopurinol while taking amoxicillin may increase the likelihood of allergic skin reactions. There are no data on the use of amoxicillin / clavulanic acid with allopurinol.

Amoxicillin has been reported to influence the urine glucose test by means of copper sulfate (Clinitest), but does not affect the glucose oxidase test (Clinistix).

Unwanted effects

Common, ADR> 1/100:

Gastrointestinal: Diarrhea, nausea, vomiting.

Skin: rash, itching.

Uncommon, 1/1000

Blood: Increased eosinophils.

Liver: Hepatitis, cholestatic jaundice, increased transaminase. May be severe and last for several months.

Other: Candida vaginitis, dizziness, headache, fever, fatigue.

Rarely, ADR

Body: Anaphylactic reaction, Quincke edema.

Blood: Thrombocytopenia, leukopenia, hemolytic anemia.

Gastrointestinal: Pseudomembranous colitis.

Skin: Stevens-Johnson syndrome, erythema multiforme, dermatitis, epidermal necrolysis due to poisoning.

Kidney: Interstitial nephritis.

Instructions on how to tackle ADR:

If allergic reactions occur such as erythema, Quincke edema, anaphylactic shock, Stevens-Johnson syndrome, amoxicillin therapy must be discontinued and immediate emergency treatment with adrenalin, oxygen breathing, intravenous corticosteroid therapy and Ventilation, including intubation and should never be treated with penicillins or cephalosporins.

Pseudomembranous colitis: If mild, discontinue the drug. If severe (likely due to Clostridium difficile), rehydration and electrolytes, use anti-Clostridium antibiotics (metronidazole, vancomycin).

How to handle when overdose

Symptom:

1. Gastrointestinal symptoms and electrolyte balance disorders may be indicative of an overdose.
2. Amoxicillinuria crystals have been observed in some cases leading to kidney failure.
3. Seizures may occur in patients with impaired renal function or in high doses.

To solve:

1. Symptoms of the gastrointestinal tract can be treated with caution on water and electrolyte balance.
2. Hemodialysis can be used to remove medications from the circulation.
3. Read the directions carefully before use.
4. If you need further information, please consult your doctor.
5. This drug is for a doctor's prescription.

Note: Use within 30 days after opening aluminum bags.

Storage conditions

Store in dry places, not exceeding 30 ^o C, protect from light.

Due date

24 months from the date of manufacture.

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