Amoksiklav 2x 1000mg Lek medicine for infection treatment (2 blisters x 5 tablets)

Dosage form Box of 2 blisters x 5 tablets
Specifications Amoxicillin, clavulanic acid
Ingredient Tonsillitis, otitis media, sinusitis, acute bronchitis, chronic bronchitis, pneumonia

Ingredient

Composition information	Content
Amoxicillin	875mg
Clavulanic Acid	125mg

Uses

Indications

Amoksiklav drugs are indicated for the following infections in adults and children:

Sinusitis caused by acute bacteria (identified).

acute otitis media .

Exacection of chronic bronchitis (diagnosed).

Pneumonia is suffering from the community.

Cystitis .

nephritis , pyelonephritis.

Skin and soft tissue infections, especially cellular inflammation, bite of animals, heavy tooth abscess with spreading tissue tissue.

bacteria and joint infections, especially osteomyelitis.

Should consider the official guide on the use of appropriate antibacterial drugs.

Pharmacology

Therapy Pharmacology Group: Beta-Lactam antibacterial drugs; combination of penicillin antibiotics with beta-lactamase inhibitors.

ATC code: J01CR02

Mechanism of action

Amoxicillin is a semi -synthetic penicillin (beta -lactam antibiotic), inhibiting one or more enzymes (often called penicillin -PBP - PBP) proteins in bacterial peptidoglycan biosynthesis - an indispensable structural component of bacterial cell walls. The synthesis of peptidoglycan leads to cellular weaknesses, which is often followed by cellularization and cell death.

Amoxicillin is easily degenerated by beta-lactamase created by resistance bacteria, so the active spectrum of solitary amoxicillin does not include organisms that produce these enzymes.

Clavulanic acid is a beta-lactam related structure structure with the structure of penicillin. It indifferent to some beta-lactamase enzymes, thus preventing amoxicillin activity. Slone clavulanic acid does not produce clinical useful antibacterial effects.

Mobile pharmacokinetic/pharmacokinetic relationship (PK/PD): Time on minimum inhibitory concentration (T> MIC) is thought to be the main decisive factor of the efficiency of amoxicillin.

resistance mechanism

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

Inactivity due to bacterial beta-lactamase that they themselves are not inhibited by clavulanic acid, including groups B, C and D.

Change of penicillin -mounted protein (PBP) reduces the affection of antibacterial drugs on targets.

The non -absorbing of bacteria or the pumping mechanism can lead to or contribute to the resistance of bacteria, especially for gram -negative bacteria.

The level of threshold

Minimum inhibitory levels for amoxicillin/clavulanic acid according to the test of the European Commission for antibacterial sensitivity (EUCAST).

bacteria

Sensitive threshold concentration (µg/ml)

Intermediate sensitivity

resistance

≤ 1

≤ 2

≤ 0.25

Enterococcus1

≤ 4

≤ 0.25

0.25

streptococcus pneumoniae3

≤ 0.5

1 - 2

≤ 8

≤ 4

≤ 2

4 - 8

2 The recorded values are for Oxacillin .

3 The threshold concentration value in the table is based on the value of the threshold of ampicillin .

4 concentrations of resistance threshold R> 8mg/l ensure that all the isolation with anti -drug mechanisms are reported against resistance.

5 The value of the threshold in the table is based on the level of the threshold of benzylpenicillin .

Antibiotic resistance may vary by geographical and time -time regions for selected bacteria and information about local resistance is necessary, especially when treating severe infections.

When necessary, consult experts on local antibiotic resistance information when there is doubt about the use of antibiotics in some cases of infection.

Common sensitive strains

Gram -positive aerobic bacteria: Enterococcus Faecalis, Gardnerella Vaginalis, Staphylococcus aureus (Methicillin) £, negative -coagulase staphylococci (methicillin sensitive) £, Streptococcus agalactiae, Streptococcus pneumoniae1, Streptococcus pyogenes and beta-haemolytic streptococci, streptococcus viridans.

Gram -negative anaerobic bacteria: capnocytophaga spp. Anaerobic bacteria: Bacteroides Fragilis, Fusobacterium nucleatum, Prevotella spp.

species with resistance can cause trouble

Gram -positive aerobic bacteria: Enterococcus Faecium $.

Gram -negative aerobic bacteria: Escherichia Coli, Klebsiella Oxytoca, Klebsiella Pneumoniae, Proteus Mirabilis, Proteus Vulgaris.

resistant bacteria

Gram -negative aerobic bacteria: Acinetobacter sp., Citrobacter Freundii, Entobacter sp., Legionella Pneumophila, Morganella Morganiiiiiiiiiiiii, Providia spp., Pseudomonas sp., Serratia sp., Stenotrophomonas maltophilia.

Other bacteria: Chlamydophila Pneumoniae, Chlamydophila Psittaci, Coxiella Burneti, Mycoplasma Pneumoniae.

$ natural intermediaries in the absence of resistance.

£ All the anti -methicillin staphylococci staphicillin/clavulanic acid resistant.

1 Streptococcus Pneumoniae is completely sensitive to penicillin that can be treated with amoxicillin/clavulanic acid as presented. Bacteria show that reduced sensitivity to penicillin should not be treated as presented.

2 sensitive reduction strains have been reported in some EU countries with a higher frequency of 10%.

pharmacokinetic

absorption

amoxicillin and clavulanic acid are completely dissociated in water solutions in physiological pH. Both of these components are absorbed quickly and well by oral.

Amoxicillin/Clavulanic acid is optimally absorbed when taken at the beginning of the meal. After oral use, Amoxicillin and Clavulanic acid have a bioavailability of about 70%. Plasma data of both components is similar and the time reaches the peak concentration (TMAX) in each case of about 1 hour.

The pharmacokinetic results for a study in which amoxicillin/clavulanic acid (tablets 875mg/125mg used 2 times/day) are used when hungry on healthy volunteers presented below.

Average dynamic pharmacokinetic parameters (± standard deviation, sd) tmax*

auc
(0-24h)

t1/2

(mg) µg/ml)

(Hour) (hour) ± 12.31

1,19
± 0.21

10.16
± 3.04 0.96
± 0.12 of amoxicillin and clavulanic acid achieved with amoxicillin/clavulanic acid similar to the concentration achieved when using the doses equivalent to Amoxicillin or Clavulanic acid alone by oral.

Distribution

About 25% of the total amount of plasma clavulanic acid and 18% of amoxicillin in plasma is associated with protein. The apparent distribution volume is about 0.3 - 0.4 liters/kg for amoxicillin and about 0.2 liters/kg for clavulanic acid.

After using intravenous sugar, both amoxicillin and clavulanic acid are found in the gallbladder, abdominal tissue, skin, fat, muscle tissue, fluid fluid, abdominal fluid, bile and latex. Amoxicillin is not fully distributed in cerebrospinal fluid.

Animal studies show that there is no evidence of retention in the derivative tissue from drugs with statistical significance for each ingredient.

Amoxicillin, like most penicillin, can be found in breast milk. The amount of clavulanic acid can also be detected in breast milk.

both amoxicillin and clavulanic acid have been shown to be able to pass the placenta fence.

Biological Change

Amoxicillin is partially eliminated through the urine in the form of penicilloic acid that is not active in the equivalent number of 10 - 25% of the original dose. Clavulanic acid is strongly metabolized in humans and is eliminated in urine and fertilizer in the form of air carbon dioxide exhaled.

Elimination

The main excretion line for amoxicillin is through the kidneys, while clavulanic acid is excreted by the mechanisms through the kidney and no kidneys.

Amoxicillin/Clavulanic acid has an average time for sale about an hour and the average total total clearance of about 25 liters/hour in healthy people. About 60 - 70% of amoxicillin and 40 - 65% of clavulanic acid are excreted in the form of unchanged urine in the first 6 hours after taking the single dose of single tablets amoxicillin/clavulanic 250mg/125mg or 500mg/125mg.

Different studies have recorded the excretion of urine by 50 - 85% for amoxicillin and about 27-60% for clavulanic acid after a 24 -hour period. In the case of clavulanic acid, the largest amount of drugs is excreted in the first 2 hours after taking the drug.

Simultaneous use with probenecid slows down amoxicillin elimination but does not slow down the elimination of clavulanic acid through the kidney.

Age

Amoxicillin's waste time is the same for children about 3 months to 2 years old, older children and adults. For very young children (including premature babies) in the first week of life, the distance of drug use should not exceed 2 times/day due to the excretion of the kidneys. Because older patients are more likely to be impaired renal function, need to be cautious when choosing the dose and monitoring of kidney function can be helpful.

gender

After using amoxicillin/clavulanic acid orally for healthy men and women, gender does not affect statistically significant about the pharmacokinetic parameters of amoxicillin or clavulanic acid.

kidney failure

Amoxicillin/acid clearance Clavulanic acid in serum decreases proportional to renal function. The decrease in the clearance of the drug is more pronounced for amoxicillin than clavulanic acid, as the higher amoxicillin ratio is excreted through the kidney. Therefore, the dosage in renal failure must prevent excessive amoxicillin accumulation while maintaining a complete Clavulanic acid level.

Hepatic failure

Patients with liver failure should be cautious about dosage and monitor liver function at regular distances.

Before taking Amoksiklav 2x 1000mg Lek medicine for infection treatment (2 blisters x 5 tablets)

How to use

take the pill at the beginning of the meal or near the meal.

Use the doses evenly separately during the day, at least 4 hours apart. Do not use 2 doses in 1 hour.

Do not take this medicine for more than 2 weeks. If you still feel unwell, you should see the doctor again.

Dosage

always use amoksiklav exactly as prescribed by the doctor. Please ask the doctor or pharmacist if not sure.

adults and children weighing 40kg or more

Common dose: 1 tablet, 2 times/day.

Higher dose: 1 tablet, 3 times/day.

Children weighs under 40kg

Children 6 years of age or less is best to be treated with amoxicillin/clavulanic acid oral or packed.

Ask the doctor or pharmacist for advice when taking AMOKSIKLAV 1000mg tablets for children weighing under 40kg.

Patients with kidney and liver problems

If the patient has kidney problems, the dose may change. The doctor may choose another content or another drug.

If the patient has liver problems, the patient may be more frequent blood test to check the activity of the liver.

What to do when overdose?

Symptoms and overdose signs

Symptoms of the gastrointestinal tract and disorders of fluid balance, electrolytes may be obvious. In some cases, the amoxicillin crystal has been observed leading to kidney failure .

Convulsions can occur in patients with renal function or in high -dose users.

There has been an amoxicillin report that causes precipitation in the bladder catheter, mainly after intravenous injection at large doses. Should maintain regular checkups.

Treatment of poisoning

Symptoms of the gastrointestinal tract can be treated as symptoms, note the water/electrolyte balance.

Amoxicillin/Clavulanic acid can be eliminated from circulation due to hemolysis.

What to do when forgetting 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double dose to compensate for missed dose.

Side Effects

When using Amoksiklav medicine, you may experience unwanted effects (ADR).

Unwanted effects are often reported as diarrhea , nausea and vomiting.

Unwanted effects are collected from clinical studies and after -sales reports of amoxicillin/clavulanic acid, arranged according to MEDDRA's organ classification system listed below.

The term below is used to classify the level of unwanted effects:

Very common (≥ 1/10).

Common (≥ 1/100 to

Not common (≥ 1/1000 to

Rare (≥ 1/10000 to

Very rare (

Unknown (cannot be evaluated based on existing data).

Infections and parasites

Common: Candida infection in the mucosa.

Unknown: The bacteria are not too sensitive to grow too much.

Blood disorders and lymphatic systems

Rare: Reducing white blood cells (including neutropenia), platelet reduction.

unknown: recovery granulocytes,

hemolytic anemia, prolong bleeding time and prothrombin time.

immune system disorders

Unknown: Neurology, anaphylactic shock, serum like serum, hypersensitivity.

Nervous system disorders

Not common: dizziness, headache .

unknown: Hypermath with recovery, convulsions, sterile meningitis.

Gastrointestinal disorders

Very common: diarrhea.

Common: Nausea, vomiting.

Not common: indigestion .

Unknown: antibiotic colitis, black tongue.

Liver disorder

Not common: increase AST or ALT.

Unknown: Hepatitis, jaundice stasis.

Skin disorders and subcutaneous tissues

Not common: rash, itching, urticaria.

Rare: Diverse roses.

Unknown: Stevens-Johnson syndrome, poisoned epidermal necrosis, flaking dermatitis, pustules syndrome of acute skin (AGEP).

Kidney and urinary disorders

Unknown: interstitial nephritis, urinary crystals.

Notify the doctor with unwanted effects when using the drug.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

Do not use amoksiklay if you:

Allergic (hypersensitivity to amoxicillin, clavulanic acid, penicillin or any other component of Amoksiklav 1000mg.

Has suffered from severe (hypersensitivity) allergic reactions to any other antibiotics. This may include skin rash or swelling or neck.

There have been liver or jaundice problems when using an antibiotic .

Do not use amoksiklay if in any case above. If not sure, consult a doctor or pharmacist before taking Amoksiklav 1000.

Be cautious when using

Before starting treatment with amoksiklav, should carefully check the hypersensitivity reaction to penicillin, cephalosporin and other beta-lactam antibiotics.

There have been reports on serious hypersensitivity and death ( anaphylaxis ) in patients treated with penicillin. These cases often occur in patients with a history of hypersensitivity to penicillin or allergic atopic. If any allergic reaction occurs, it is necessary to stop treating with Amoksiklav, immediately and apply alternative treatment.

In the case of infection that is shown by amoxicillin -sensitive bacteria, the transfer from amoksiklav, to use amoxicillin should be considered according to the official instructions.

Seism can occur in patients with renal impairment or in patients with high doses.

Avoid using Amoksiklav if suspected single leukemia due to the appearance of measles rash is related to this condition after using amoxicillin.

Simultaneous use of allopurinol during treatment with amoxicillin may increase the risk of allergic reactions in the skin.

Use for a long time can cause excessive growth of uncertainty bacteria.

The body of the whole body erythematosus combined with pustules at the beginning of treatment may be a symptom of the whole body pustular syndrome (AGEP). If this symptom occurs, it is necessary to stop treating with amoksiklav and contraindicated with the use of amoxicillin.

Amoksiklav should be used carefully in patients with evidence of liver function impairment.

Liver problems have been reported mainly in male and older patients and may be related to prolonged treatment. These issues are rarely reported in children. In all object groups, signs and symptoms often occur during or immediately after treatment but in some cases it may appear several weeks after the end of the treatment. These problems often recover. Liver problems may also be severe or in some extremely rare cases that have reported death. These cases mostly occur in patients with serious illness or use simultaneously with drugs that are at risk of liver toxicity.

Antibiotic colitis has been reported in most antibiotic groups and can fluctuate from mild to life -threatening. Therefore, it is important to consider diagnosis in patients with diarrhea during or after antibiotic treatment. If antibiotic colitis, Amoksiklav must be stopped immediately, the doctor needs appropriate advice and treatment. Contraindicated anti -motion drugs in this case.

Recommended the functional assessment of organs including kidney, liver and hematoma during prolonged treatment.

Rarely reports on the effect of increasing blood clotting time in patients using amoxicillin /Clavulanic Acid. When used simultaneously with anticoagulants need to be monitored appropriately. Changing oral anticoagulant dose may be necessary to maintain the desired concentration of anticoagulants.

In patients with renal failure, appropriate dose adjustment is based on the degree of renal failure.

In patients with a decrease in urine, it rarely observes the urinary crystal, often occurs in patients taking injection drugs. During the use of amoxicillin in high doses, it is advisable to maintain enough drinking water and urine to minimize the risk of crystal crystals, in patients with bladder catheter, should maintain regular tests (see overdose).

During amoxicillin treatment, it is recommended to use the enzyme method when testing urine glucose because the method of non -enzyme can cause fake positive results.

The presence of clavulanic acid in amoksiklav can cause non -characteristic links between IgG and albumin by red cell membranes, resulting in false positive results in the Coombs solution.

There have been a positive report when using the Bio-Rad Laboratories Platelia Aspergillus EIA test in patients who have been confirmed to be immune to Aspergillus when using amoxicillin/clavulanic acid. The cross-reaction between polysaccharide-aspergillus and polyfuranose with the Bio-Rad Laboratories Platelia Aspergillus Eia test has been reported. Therefore, positive results in patients using amoxicillin/clavulanic acid should be carefully interpreted and confirmed by other diagnostic methods.

The ability to drive and operate machinery

There has been no research on impact on the ability to drive and operate machinery. However, unwanted effects may occur (for example, allergic reactions, dizziness, convulsions), which can affect the ability to drive and operate machinery.

Pregnancy

Animal research does not show direct or indirect effects on pregnancy, division/fetal development, childbirth or post -menstrual development. The data is limited in the use of amoxicillin/clavulanic acid during pregnancy in humans that cannot indicate the increased risk of birth defects. In a single study in premature women, early rupture of amniotic fluid has been reported that the prophylactic treatment with amoxicillin/clavulanic acid may be associated with increased risk of infant necrosis. Should avoid using drugs during pregnancy, except for being considered truly practical benefits by the physician.

Breastfeeding period

Both substances are excreted breast milk (the effect of clavulanic acid on infants is not known). Therefore, diarrhea and fungal infections in the mucosa can occur in breastfeeding, so it may be necessary to stop breastfeeding. Amoxicillin/Clavulanic Acid can be used during breastfeeding after being considered the risk/benefit by the physician.

Medicinal interaction

Anticoagulant drugs for oral form

Oral anticoagulants and penicillin antibiotics have been widely used in practice and there is no report on interaction. However, in the literature, there are international standardized ratios (INR) in patients maintaining the use of acenocoumarol or warfarin and are added amoxicillin. If simultaneous use is needed, should carefully monitor bleeding time or international standardization ratio (INR) when extra or stop using amoxicillin. In addition, adjusting the anticoagulant dose may be necessary.

methotrexate

Penicillin can reduce methotrexate secretion that increases the risk of toxicity.

Probenecid

Do not recommend simultaneous use with Probenecid.

Probenecid reduces amoxicillin secretion in the renal tubules.

Concentrated use with probenecid may cause increased and prolonged the concentration of amoxicillin in the blood but does not affect the level of clavulanic acid.

mycophenolat mofetil

In patients using Mycophenolat Mofetil, there has been a report on reducing the level of the dose of metabolites with mycophenolic acid activity (MPA) approximately 50% after using amoxicillin and oral clavulanic acid. The change of concentration before the dose may not represent the overall change of MPA exposure. Therefore, the change of doses of mycophenolat mofetil is not necessary in the absence of clinical evidence in grafting dysfunction. However, closely monitoring should be performed during the simultaneous use of drugs and short time after the end of antibiotic treatment.

Storage

Leave a cool place, avoid light, temperatures below 30⁰C.

To be out of reach of children.

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