DT Imexpharm medicine for infections (2 blisters x 7 tablets)

ATC code: J01CR02.

Operating mechanism:

Amoxicillin is a semi-synthetic antibiotic belonging to the penicillin group (beta-lactam antibiotic). Amoxicilin has bactericidal effects that attach to one or more protein of bacterial penicillin (Pbps) to inhibit peptidoglycan biosynthesis, which is a component of bacterial cell walls. Finally, the bacteria decompose by the enzymes to destroy the bacterial cell wall. Amoxicillin is easily destroyed by beta-lactamase enzymes and therefore the antibacterial spectrum of the single amoxicillin does not include bacteria that produce these enzymes.

Clavulanic acid is a beta-lactam, structurally related to penicillins. 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.

Lanam DT 400mg/57mg is a combination of amoxicillin and clavulanic acid. This combination does not change the mechanism of the effect of amoxicilin but has the effect of anti-bactericidal, expanding the effect of amoxicillin against many bacteria that produce beta-lactamase previously resistant to Amoxicillin monochromatic therapy, due to clavulanic acid with high affinity and attached to beta-lactamase of bacteria to inhibit.

Mobile pharmacokinetics/ pharmacokinetic association: The time of antibiotic concentration is higher than the minimum level of inhibitory concentration (T> MIC) is the main parameter that shows the effect of amoxicillin.

Resistance mechanism:

The two main mechanisms of resistance to amoxicillin/clavulanic acid combination are:

Inactivity by beta-lactamase is not inhibited by clavulanic acid including beta-lactamase layer B, C, D.

Change of penicillin -mounted proteins (Pbps), thus reducing the affection of antibacterial agents at the position.

A decrease in the permeability of bacterial cells or pumping mechanisms can cause or contribute to the resistance of bacteria, especially in Gram -negative bacteria.

antibacterial spectrum of the drug:

Sensitive bacteria:

Aerobic Gram -positive bacteria: Enterococcus Faecalis, Gardnerella Vaginalis, Staphylococcus aureus (methicilin sensitive), Staphylococcus spp. negative with coagulase (sensitive to methicilin), Streptococcus Agalactiae, Streptococcus Pneumoniae1, Streptococcus Pyogenes and Streptococcus spp. Other β hemolysis, Streptococcus Viridans

Aerobic gram -negative bacteria: capnocytophaga spp. Anaerobic bacteria: Bacteroides Fragilis, Fusobacterium nucleatum, Prevotella spp.

Bacteria may have problems with drug resistance:

Aerobic Gram -positive bacteria: Enterococcus Faecium $.

Aerobic gram -negative bacteria: Escherichia Coli, Klebsiella Oxytoca, Klebsiella Pneumoniae, Proteus Mirabilis, Proteus Vulgaris.

Bacteria that are inherently resistant to drugs:

Aerobic gram -negative bacteria: Acinetobacter sp., Citrobacter Freundii, Entobacter Sp., Legionella Pneumophila, Morganella Morganiiiiiiiiii, Providantia spp., Pseudomonas sp., Serratia sp., Stenotrophomonas maltophilia.Other: Chlamydophila Pneumoniae, Chlamydophila Psittaci, Coxiella Burnetii, Mycoplasma Pneumoniae.

1: All Staphylococcus spp. Resistance to methicilin are resistant to amoxicillin/clavulanic acid combination.

2: Amoxicillin/acid combination Clavulanic may not be suitable for treating streptococcus pneumoniae resistance to penicillin.

3: There have been reports on sensitive reduction strains in some countries in the European Union (EU) with a higher frequency of 10%.

4: Natural intermediate sensitivity has no resistance mechanism.

Pharmacokinetics

absorption

Amoxicillin and clavulanic acid are completely dissociated in water solution in physiological pH. Both ingredients are well absorbed and quickly after drinking. After drinking, 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.

Amoxicillin and clavulanic acid concentration in serum when using a combination of amoxicillin/clavulanic acid is equivalent to the concentration achieved when using amoxicilin or clavulanic acid separately by oral at the same dose level.

Distribution

About 25% Clavulanic acid and 18% amoxicillin associated with plasma proteins. The apparent distribution volume is about 0.3 - 0.4 l/kg for amoxicillin and about 0.2 l/kg for clavulanic acid.

After intravenous injection, both amoxicillin and clavulanic acid have been found in gallbladder, abdominal tissue, skin, fat, muscle tissue, fluid and abdominal fluid, bile and pus of the wound. Amoxicillin is not much distributed in cerebrospinal fluid.

Animal studies show that there is no storage of drug metabolites in the body. Like other antibiotics penicillin, amoxicillin can be distributed into breast milk. A very small amount of Clavulanic acid has also been discovered in breast milk.

both amoxicillin and clavulanic acid have passed the placenta fence.

Metabolism

About 10 - 25% amoxicillin in the starting dose is excreted in urine in the form of peniciloic acid that does not work. Clavulanic acid metabolizes a lot in the human body, excreted into urine, feces and in the form of carbon dioxid in exhaled gas.

Elimination

Amoxicillin is excreted mainly through the kidneys, while clavulanic acid is eliminated by the mechanism through both the kidneys and external kidneys.

Combining amoxicillin/clavulanic acid has an average selling time for about 1 hour and the total clearance of about 25 l/h in healthy people. Nearly 60 - 70% amoxicillin and 40 - 65% of Clavulanic acid are eliminated in urine in the form of unchanged in the first 6 hours after taking a single tablet of Clavulanic acid amoxicillin with a content of 250 mg/125 mg or 500 mg/125 mg. Different studies show that about 50 - 85% amoxicillin and 27 - 60% of clavulanic acid are eliminated through urine for 24 hours. Clavulanic acid is most eliminated in the first 2 hours after taking the drug.

Concentrated with probenecid may slow down amoxicillin, but does not affect the elimination of clavulanic acid through the kidney.

Age

Amoxicillin's sale time in children from 3 months to 2 years old is equivalent to older children and adults. In newborns (including premature babies), in the first week after birth, do not use more than 2 times/day because the emissions through the kidneys have not been fully developed. Because the elderly people have a higher impairment of renal function, it is necessary to be cautious when choosing the dose and monitoring the kidney function throughout the treatment process.

Gender

After drinking amoxicilin/clavulanic acid in healthy women and men shows that gender does not significantly affect the pharmacokinetics of both amoxicillin and clavulanic acid.

kidney failure

The total serum clearance coefficient of amoxicillin/clavulanic acid decreases corresponding to the impaired renal function. The decrease in amoxicillin clearance is more pronounced than clavulanic acid, as the ratio of amoxicillin eliminates through the kidneys is higher. Therefore, the dose for patients with renal impairment must prevent excessive accumulation of amoxicillin while maintaining the appropriate clavulanic acid level.

Hepatic failure

Patients with liver failure should be carefully indicated and monitored liver function periodically.

There is no clinical data on the use of amoxicillin/ clavulanic acid in a ratio of 7: 1 for children under 2 months old. Therefore, the proposal for these subjects has not been implemented.

or recommended dose is calculated in the form of preparation:

Weigh 15kg to less than 30 kg: 1V/time, 2 times/day. Can increase the dose of 2 capsules/time, 2 times/day.

Weigh 30kg to less than 40 kg: 1 - 2 capsules/time, 2 times/day. Can increase the dose of 3 capsules/time, 2 times/day.

Elderly: No need to adjust the dose.

Patients with renal failure: Patients with creatinine clearance (CRCI) greater than 30 a minute: No dose adjustment.

Patients with creatinine clearance below 30 ml/minute: do not recommend the use of amoxicillin/clavulanic acid in a ratio of 7: 1, so there is no data on dose adjustment.

Patients with liver failure: Precautions when using and periodically checking liver function during drug use.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.

What to do when overdose?

Overdose:

Symptoms on the gastrointestinal tract and water balance disorders, electrolytes may be an expression of overdose. Observed the urinary amoxicillin crystal, in some cases, the kidney failure.

Seism can occur in patients with renal failure or high doses.The crystal of amoxicillin has also been found in the bladder tubes, especially after using high doses through the injection. Therefore, it is necessary to periodically check the status of the bladder tubes.

How to handle:

Stop using drugs, treat symptoms on the gastrointestinal tract and monitor water and electrolyte balance.

It is possible to remove amoxicillin/ acid clavulanic from circulation by hemolysis method.

In an emergency, call the 115 emergency center immediately or go to the nearest local health station.

What to do when you forget 1 dose?

Take the medicine as soon as you remember. Use the next dose after at least 4 hours. Do not use double doses to compensate for missed dose. Do not use double dose to compensate for missed dose.

Instructions on how to handle ADR:

If allergic reactions occur such as erythema, edema, anaphylactic shock, Stevens-Johnson syndrome, should be stopped, immediately treated emergency treatment with Adrenalin, oxygen breathing, intravenous corticoid therapy and ventilation, including internal trachea and never being treated with drugs containing antibiotic components of penicilin groups or cephalosporin.

fake colitis:

Be cautious when used

Before starting treatment with Lanam DT 400mg/57mg, 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 and serious side effects) have been recorded in patients treated with penicillin drugs. 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.

During treatment with Lanam DT 400mg/57mg, if the bacteria have been identified as sensitive to amoxicillin, it is possible to switch to single amoxicillin.

This drug is not suitable for treating bacterial infections caused by bacteria that have been resistant to beta-lactam antibiotics under the intermediary mechanism of beta-lactamase enzymes inhibited by clavulanic acid. Do not use this medication to treat bacterial infections caused by s.pneumonia resistant to penicillin.

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

Avoid using amoxicillin/acid Clavulanic acid for patients suspected of having a mononulocytic hypertension because these patients are at risk of measles rash when using amoxicillin.

Using alopurinol 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 a whole body erythema with pustules at the beginning of the treatment may be a manifestation of the acute pustules syndrome (AGEP). If these manifestations appear, the patient should stop the drug and contraindes to any preparation 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 serious cases, even death,

But very rare, mainly in patients with serious illness or used in combination with drugs at risk 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 the fake colitis is caused by antibiotics, it is necessary to stop using amoxicillin/ clavulanic acid immediately and conduct appropriate treatments. The anti -peristalgic 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.

Dosage for patients with renal failure should be adjusted depending on the degree of renal failure (see the dose - Usage section).

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 sufficient oral fluids and excluded in the urine 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 5 alum lake and Indigo Carmin Lake, so it should 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, some unwanted effects of the drug such as allergic reactions, dizziness, convulsions ... can reduce the patient's concentration and reaction ability. Therefore, caution when using the drug for these objects. If the patient has the above unwanted effects, it is not advisable to drive or operate machinery.

Use drugs for women during pregnancy and lactation

Pregnant women:

Animal studies show that the drug is not directly or indirectly harmful to pregnancy, embryo/ fetal development, birth or development after birth.

Data on the use of amoxicillin/ clavulanic acid in pregnant women also shows that it does not increase the risk of birth defects in children, however, these research data are still limited. A single study in premature women due to early rupture of amniotic fluid reported prophylactic treatment with amoxicillin/ clavulanic acid may increase the risk of necrotizing bowel infections in infants.

Therefore, patients should avoid taking the drug during pregnancy, unless the doctor is prescribed.

breastfeeding women:

Amoxicilin and clavulanic acid are both breast milk (no information about the effect of clavulanic acid on breastfed babies). This can lead to diarrhea or fungal infection on mucous membranes in breastfed babies, thus stop breastfeeding to ensure safety for babies. Children's sensitivity to drugs should be considered.

Amoxicilin/Clavulanic Acid is only used during breastfeeding after being evaluated by a doctor between the benefits and potential risks.

Interactive drug

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 increasing 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 using Lanam DT 400mg/57mg. Can adjust anticoagulant dose if needed.

methotrexate:

Penicillin antibiotics reduce methotrexate secretion, thus increasing the toxicity of methotrexate.

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.

mycophenolat mofetil:

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

Oral contraceptives:

Like antibiotics with broad effects, the drug can reduce the effectiveness of oral contraceptives.

nifedipin:

Increase amoxicillin absorption.

Pliers:

There may be antagonists between amoxicillin and bactericidal bacteria such as fusidic acid, chloramphenicol, tetracyclin.

alopurinol:

Patients with hyperuricemia when using alopurinol along with amoxicillin will increase the ability of amoxicillin.

Diagnostic tests:

Glucose test in urine: During treatment with amoxicilin, so

Use the glucose oxidase enzyme method when needed to test glucose in the urine because the enzyme methods can give fake 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.