CLEDOMOX 625 Tenamyd medicine for infections (2 blisters x 7 tablets)

Clavulanic acid due to the fermentation of Streptomyces Clavuligerus, which has a beta-lactam structure similar to penicillin, is capable of inhibiting beta-lactamase due to the majority of Gram-negative bacteria and Staphylococcus. Especially, it has a strong inhibition effect of beta - lactamase transmitted via plasmid that resists penicillins and cephalosporins.

Clavulanic acid helps amoxicillin not to be destroyed by beta - lactamase, and expand the antibacterial spectrum of amoxicillin effectively to many common bacteria that have resisted amoxicillin, resistant penicillins and cephalosporins.

It is possible to see Amoxicilin and Clavulanate as an antibacterial poison for pneumoccus, streptococcus beta beta, staphylococcus (penicillin sensitive strains are not affected by penicillinase), Haemophilus influenzae and Branhamella Catatrhalis including strong biomedic products Beta - Beta - lactamase. In short, 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 type: Clostridium, peptococcus, peptostreptococcus.

Gram -negative bacteria

Aerobic type: Haemophilus Influenzae, Escherichia Coli, Proteus Mirabilis, Proteus vulgaris, Klebsiella, Salmonella, Shigella, Bordetella, Neisseria Gonorrhoeae, Neisseria Meningitidis, Vibrio Cholerae, Pasteurae Multocida.

Anaerobic type: Bacterioides including B.fragis.

Pharmacokinetics

absorption

Amoxicilin and Clavulanat are easy to absorb through oral. The concentration of these 2 substances in the serum is maximum after 1-2 hours of taking the medicine. With a dose of 250mg (or 500mg), there will be 5 micrograms/ml (or 8 - 9 micrograms/ml) amoxicillin and about 3 micrograms/ml of clavulanate acid in serum. After 1 hour oral 20 mg/kg amoxicillin + 5mg/kg potassium clavulanate, there will be an average of 8.7 micrograms/ml of amoxicillin and 3.0 micrograms/ml of potassium clavulanate in serum. The absorption of the drug is not affected by food and it is best to drink right before meals.

Distribution

Amoxicillin and potassium clavulanate are all distributed into the lungs, pleura and peritomolys. Only a small amount of amoxicilin and potassium clavulanate into the meninges are not inflamed, when the meninges are inflamed, the drug may be added to the meninges. Amoxicillin is attached to plasma proteins 17 - 20%, clavulanic acid is attached to plasma proteins 22 - 30% with drug concentration of 1 - 100 mcg/ml. Amoxicillin and potassium clavulanat quickly enter the placenta, amoxicillin and potassium clavulanate distribution of small amounts in breast milk.

Metabolism

Amoxicillin is partially excreted in urine in the form of penicilloic acid that does not work with the equivalent of 10 to 25% of the initial dose. Potassium clavulanate is strongly metabolized in humans and eliminates urine and feces in the form of carbondioxide in the air.

Elimination

Amoxicillin's disposal time in serum is 1-2 hours and of potassium clavulanate is about 1 hour. 55 - 70% amoxicillin and 30 - 40% of potassium clavulanate are discharged through water in the form of operation. Probenecid extends the excretion time of amoxicilin but does not affect the elimination of potassium clavulanate.

Be cautious when using

should carefully ask the history of hypersensitivity reaction to penicillin, cephalosporin or other allergens before the beginning of cedomox treatment.

There have been reports on severe hypersensitivity reactions and sometimes fatal (anaphylaxis) in patients treated with penicillin. These reactions are more common in patients with a history of hypersensitivity to penicillin. If the hypersensory reaction occurs, it is necessary to stop treating with amoxicillin/clavulanic acid and find another appropriate drug instead.

Avoid using CLEDOMOX if suspected of mononucleosis of the infection due to the appearance of measles rash related to this condition after using amoxicillin.

For long -lasting use can sometimes cause non -sensitive bacteria.

Palm of fake colitis has been reported when using antibiotics and with mild to life -threatening severity. Therefore, this diagnostic consideration is very important in patients with diarrhea during or after antibiotics. If diarrhea is a lot or prolonged or a patient with abdominal pain, it should be stopped immediately and checked for additional patients.

Overall, CLEDOMOX tolerates well and has a low -toxic toxicity of penicillin antibiotics.

Periodically check the function of organs, including liver, kidneys and hematopoietic function at prolonged treatment.

There have been reports on abnormal extension of prothrombin time (Inr increasing) but rarely in patients using Cledomox and oral anticoagulants. Should follow the appropriate monitoring when anticoagulants are prescribed simultaneously.

may need to adjust the dose of anti -bronze drugs for oral use to maintain the desired anticoagulant level.

Observed changes in liver function tests in several patients using CLEDOMOX.

The clinical significance of these changes is uncertain. Caution should be used in patients with signs of liver dysfunction.

Rarely reports jaundice on the face, may be heavy but often recovered. Signs and symptoms may not become clear until 6 weeks after stopping treatment.

Should adjust the dose of CLEDOMOX in patients with renal failure as recommended.

Convulsions can occur in patients with renal function or high doses.

Observed the urinary crystal in patients who reduce urine secretion but very dangerous, mainly when patients use infusion. It is recommended that patients maintain enough water and the amount of urine excreted during the time of using high doses of amoxicillin to reduce the possibility of the occurrence of urinary amoxicillin crystals.

Use drugs for women during pregnancy and lactation

Pregnancy

Studies on fertility on animals (the most mice and rats) when taking oral medication and infusion does not show the birth effect.

In a single study in premature women due to early amniotic fluid rupture (PPROM), there was a report on preventive treatment with drugs that may be associated with increased risk of necrotizing bowelectitis in infants.

Like all other drugs, should avoid medication during pregnancy, especially in the first three months, unless the doctor thinks it is necessary.

Breastfeeding period

Unknown the effects of clavulanic on breastfeeding, can cause diarrhea, mucous mucous fungal infection in breastfed babies. Therefore, only use medication for breastfeeding women when considering benefits and risks.

The effect of the drug on the ability to drive and operate machinery

has not observed the unwanted effect on the ability to drive or operate machinery, but there are cases of dizziness headache during the use of the drug.

Drug interaction

is not recommended to use simultaneously with Probenecid. Probenecid reduces the excretion of amoxicilincqua renal tubules. Use simultaneously can cause increased and prolonged the concentration of amoxicillin in the blood but does not affect clavulanate acid.

Concomitant use of Allopurinol during treatment with amoxicillin may cause an increase in the likelihood of allergic reactions on the skin. There is no data on the use of amoxicillin and clavulanate acid with allopurinol.

Like other antibiotics, the drug can affect the intestinal bacteria that leads to the reduction of re -absorption of the estrogen and reducing the effectiveness of oral contraceptives used in combination.

In the literature, there are rare cases of Inr in patients using acenocoumarol or warfarin and are prescribed a batch of amoxicillin. If necessary to prescribe simultaneously, should carefully monitor Prothrombin or INR time when starting or stopping medication.

In patients who are taking Mycophenolate Mofeti, there has been a report on the decrease in the dose before the metabolic metabolic acid (MPA) of about 50% after starting oral amoxicillin combined with clavulanic acid. The change of concentration before the dose may not exactly show changes in the overall MPa exposure level.