Niflad ES 600mg/42.9mg Imexpharm Treatment of skin infections, chronic purulent dermatitis (4 blisters x 7 tablets)

ATC code: J01CR02

Amoxicilin is a semi -synthetic antibiotic in the penicillin group, which has a bactericidal effect due to the drug attached to one or more penicillin -mounted proteins of bacteria (PBPS) to inhibit peptidoglycan biosynthesis, an important component of bacterial cell walls. This inhibitor weakens the cell wall leading to bacteria decomposed and die.

Amoxicillin is easily destroyed by beta-lactamase enzymes and therefore the antibacterial spectrum of the monoclonal amoxicillin does not include bacteria that produce these enzymes. Clavulanic acid is a beta-lactam, structurally related to penicillin. Clavulanic acid has the ability to inhibit beta-lactamase enzymes and thus prevent inactivity to amoxicillin.

Clavulanic acid monomers do not have clinical antibacterial effects. Mobile pharmacokinetics/ pharmacokinetic association: The time of antibiotic concentration is higher than the minimum inhibitory concentration (T> MIC) is the main parameter that shows the effect of amoxicillin.

Resistance mechanism:

Two resistance mechanisms with amoxicillin combination and clavulanic acid:

Antibacterial spectrum of drugs: often sensitive bacteria:

Amoxicillin and clavulanic acid are completely dissociated in water solution in physiological pH. Both ingredients are well absorbed and quickly after drinking. The absorption of amoxicillin/ clavulanic acid is improved when taken at the beginning of the meal. Oral bioavailability of amoxicillin and clavulanic acid is about 70%. The characteristics of two plasma components are the same and the time to reach the peak concentration (TMAX) of each component is about 1 hour.

The following pharmacokinetic parameters are recorded when using amoxicillin/clavulanic acid is 45 mg/3.2 mg/kg every 12 hours for children.

Be cautious when using

Precautions when using amoxicillin/clavulanic acid for the following objects:

Patients with a history of allergies to cephem antibiotics.

Patients with family history are susceptible to allergy symptoms such as bronchial asthma, rash, urticaria ...

Patients with poor absorption, nutrition on the gastrointestinal tract and poorly.

Before starting treatment with amoxicillin/ clavulanic acid, the patient's allergic history must be carefully investigated with penicillin, cephalosporin or other beta-lactam drugs.

Severe hypersensitivity reactions and sometimes fatal (such as anaphylaxis) have been recorded in patients treated with penicillin groups. These reactions often occur in patients with a history of allergies to penicillin and other allergens. If the allergic reaction occurs, it is necessary to stop using amoxicillin/ clavulanic acid and other treatments for other appropriate treatment.

Convulsions can occur in patients with impaired renal function or high doses of drugs. Therefore, caution when taking medication for patients with renal impairment and adjusting the dose according to creatinine clearance.

Using allopurinol while being treated with amoxicillin may increase the risk of skin allergies.

Take the drug that lasts sometimes causes excessive growth of non -sensitive bacteria.

The appearance of the whole body erythema with pustules at the beginning of the treatment may be a manifestation of acute generalized exanthematous pustulosis (AGEP). If these manifestations appear, the patient should stop the drug and contraindes to any drug containing amoxicillin.

Be cautious when used in combination with amoxicillin/ clavulanic acid for patients with impaired liver function.

The side effects of the drug in the liver mainly occur in male patients, the elderly and the patient must be treated for a long time, rarely occurs in children. Typically, signs and symptoms usually occur during the process or after a short time of treatment, but in some cases, it may not be clear until several weeks after stopping treatment. These symptoms can often recover on their own. However, there are still cases of serious, even death, but very rare, mainly in patients with serious illness or use in combination with drugs that are at risk of affecting the liver.

Colitis associated with antibiotics has been reported with almost all antibacterial agents including amoxicillin and can fluctuate in a level from mild to life -threatening. Therefore, it is necessary to diagnose this disease in patients with diarrhea during or after medication. If colitis is related to antibiotics, it is necessary to stop using amoxicillin/ clavulanic acid immediately and conduct appropriate treatments. Contraindicated to use intestinal iron inhibitors in these cases.

Periodically check the functions of organs such as kidney and liver function, hematological index during long -term treatment.

Prothrombin time has been reported in patients treated with amoxicillin/ clavulanic acid, but it rarely occurs. The patient's condition should be monitored when used simultaneously with anticoagulants. It is possible to adjust the oral anticoagulant dose if necessary to maintain the concentration of anticoagulants as desired.

Very rare cases of urinary crystal phenomenon in patients who reduce urine excretion, mainly in patients taking drugs in the form of injection. Patients should maintain enough oral fluid and the amount of urine output to reduce the ability to cause urinary amoxicillin crystals, especially when taking the drug in high doses. In patients with urinary tract placement, regular checkpoints need catheter.

During the treatment of amoxicillin, the glucose oxidase enzyme should be used when the glucose test is needed in the urine because of the non -enzyme methods that can give false positive results.

Clavulanic acid in the drug can cause nonsense cohesion of IgG and albumin on the membrane of red blood cells, resulting in a false positive result of the Coombs solution.

The drug can cause false positive testing Bio-Rad Laboratories Platelia Aspergillus EIA due to cross-reactions with polysaccharids and polyfuranose are not Aspergillus. Therefore, for patients who are taking amoxicilin and clavulanic acid, cautious if there is a positive result when testing by this method and should be further determined by other diagnostic methods.

Information related to the excipients of the drug:

The drug contains fd & c yellow 6 alum lake color excipients so it is necessary to be cautious when taking the drug for patients with atopic allergies.

The effect of drugs on driving and operating machinery

There are no studies on the effects of the drug on the ability to drive and operate machinery. However, because the drug can cause some unwanted effects such as allergic reactions, dizziness, convulsions ... Therefore, patients should not drive or operate machinery while taking the drug.

Use drugs for women during pregnancy and lactation

Due to the safety of treatment with amoxicillin/ acid Clavulanic acid for pregnant women and breastfeeding has not been studied, so only use drugs for these subjects when it is really necessary and after assessing the benefits for mothers surpass the risk of breastfed babies/ breastfeeding.

Drug interaction

Interaction of drugs:

Probenecid:

Avoid simultaneously with Probenecid. Probenecid reduces amoxicillin secretion in the renal tubules, thus increasing and prolonging the concentration of amoxicillin in the blood but does not affect clavulanic acid.

Oral anticoagulant drugs:

Oral anticoagulants and penicillin antibiotics have been widely used in reality without noting any interactions. However, in the literature, it refers to the extension of prothrombin time, increasing the international normalization index (INR) in patients using acenocoumarol or warfarin simultaneously with amoxicillin. If it is necessary to use simultaneously, should carefully monitor Prothrombin or INR time when starting or stopping Niflad ES. Can adjust anticoagulant dose if needed.

Oral contraceptive pills:

The drug can reduce the effectiveness of oral contraceptives due to drugs that change the intestinal bacteria and inhibit the intestinal reabsorption of oral contraceptive pills.

mycophenolat mofetil:

In patients who are taking Mycophenolat Mofetil, there has been a report on the 50% reduction of concentration before the dose of metabolites with mycophenolic acid activity (MPA) after treatment with amoxicilin/ clavulanic acid. The change of concentration before this dose may not exactly show changes in the overall MPa exposure level. Therefore, it is not necessary to adjust the dose of mycophenolat mofetil without clinical evidence of grafted complications. However, clinical monitoring should be closely monitored during the use of the drug and a short time after stopping treatment with antibiotics.

Diagnostic tests:

Glucose test in urine: During the treatment with amoxicillin, the glucose glucose enzyme should be used when the glucose test is needed in the urine because of the non -enzyme method that can give false positive results.

Coombs: Clavulanic acid causes narrative cohesion of IgG and albumin on the membrane of red blood cells, resulting in a false positive result of the Coombs solution.

Bio-Rad Laboratories Platelia Aspergillus Eia: The drug can cause fake positive testing Bio-Rad Laboratories Platelia Aspergillus EIA due to cross-reactions with polysaccharides and polyfuranose are not Aspergillus. Therefore, for patients who are taking amoxicilin and clavulanic acid, cautious if there is a positive result when testing by this method and should be further determined by other diagnostic methods.

The cavalry of the drug:

Due to the lack of studies on the correspondence of the drug, not mixing this drug with other drugs.