|The name of the preparation||Character; dose; package||Manufacturer||Price 100%||Price after refund||In which pharmacy?|
|Amoksiklav||granules for oral suspension; 1 g (875 mg + 125 mg) (1 sachet contains: 875 mg amoxicillin, 125 mg clavulanic acid); 14 sachets||Sandoz||27.36|
Note: reimbursed drug prices are in line with the regulations in force from July 1, 2018.
The preparation contains Amoxicillin , a broad-spectrum beta-lactam antibiotic and clavulanic acid, a compound that inhibits the activity of bacterial enzymes that cause the degradation of amoxicillin. For general use in the treatment of bacterial infections.
A combined preparation containing 2 active substances, amoxicillin and clavulanic acid in the ratio of 7: 1. Amoxicillin is a semi-synthetic penicillin with a broad spectrum of antibacterial activity. Due to its chemical structure, amoxicillin is considered to be beta-lactam antibiotics characterized by the presence of a beta-lactam ring in the molecule. The structure of the beta-lactam ring is sensitive to the action of beta-lactamase enzymes produced by some bacteria. Selected beta-lactamases present in bacterial cells may cause degradation and inactivation of antibiotic molecules and are one of the reasons for bacterial resistance to beta-lactam antibiotics. The mechanism of action of all beta-lactam antibiotics is the inhibition of bacterial cell wall synthesis, which causes its weakening and consequently leads to the death of the bacterial cell.
The clavulanic acid contained in the preparation inhibits the activity of selected beta-lactamases, amoxicillin-degrading enzymes produced by resistant bacterial strains. Clavulanic acid causes bacteria whose resistance is due to the production of beta-lactamases, become sensitive to the antibiotic. The clavulanic acid alone has no clinically significant antibacterial effect.
The preparation is indicated for use in adults and children in the treatment of the following infections caused by bacteria sensitive to amoxicillin and clavulanic acid:
• acute sinusitis
• acute otitis media
• exacerbation of chronic bronchitis
• community-acquired pneumonia
• inflammation of the bladder
• skin and soft tissue infection, particularly cellulitis, infection after animal bites, severe periodontal abscesses with spreading connective tissue inflammation
• bone and joint infections, especially osteomyelitis.
Unfortunately, even if there are indications to use the preparation, it can not always be used. You can not use the product if you are allergic (you are hypersensitive) to any of the ingredients or to other antibiotics from the penicillin group.
It is contraindicated in patients who have ever experienced severe hypersensitivity reactions (eg Anaphylactic reactions ) to other beta-lactam antibiotics (cephalosporins, carbapenems or monobactams).
It is contraindicated in people with jaundice or liver problems associated with amoxicillin or clavulanic acid in the past.
Certain diseases and other circumstances may constitute a contraindication to use or indication to change the dosage of the preparation. In some situations it may be necessary to carry out specific check-ups.
Before using the preparation, be sure to consult a doctor if you have ever experienced hypersensitivity reactions to penicillins, other beta-lactam antibiotics or to other drugs or allergens. Use of the preparation in people with hypersensitivity to penicillin or severe hypersensitivity to other beta-lactam antibiotics is contraindicated.
The use of penicillins is associated with a risk of severe hypersensitivity, occasionally leading to death. The risk is increased in people with hypersensitivity to beta-lactam antibiotics and in people with atopic diseases, as well as in people allergic to many different allergens. Severe hypersensitivity reactions (including anaphylactic shock) may be life-threatening. In the event of the first symptoms of hypersensitivity, seek medical help immediately. It may be necessary to be hospitalized and appropriate treatment (sometimes emergency procedures).
If it is confirmed that the infection has caused an amoxicillin-sensitive bacterium, your doctor will prescribe the use of amoxicillin alone in place of the combined preparation (amoxicillin / clavulanic acid).
The use of the preparation is appropriate when the reduction in susceptibility to amoxicillin is associated with the presence of clavulanic acid-beta-lactamases.
The preparation should not be used to treat infections caused by penicillin resistantS. pneumoniae.
In patients with impaired renal function, taking high doses and in patients with risk factors (past seizures, epilepsy or meningitis), seizures may occur.
Do not use the preparation in patients with or suspected of having mononucleosis because of the increased risk of erythematous skin lesions, similar to a measles measles rash.
Use of Allopurinol in parallel with amoxicillin may increase the risk of cutaneous allergic reactions.
If generalized erythema with pustules and accompanying fever develops at the beginning of treatment, a doctor should be consulted immediately. These symptoms may indicate a serious skin reaction in the form of acute generalized pustular pustular disease. If it occurs, treatment must be discontinued and the use of amoxicillin in the future is contraindicated.
Long-term use of antibiotics may cause excessive development of resistant bacteria and fungi. If new bacterial or fungal infections appear during the application period, a doctor should be consulted immediately.
Caution should be exercised in patients with hepatic impairment; your doctor will advise you to regularly check your liver function.
The use of the preparation may be associated with the occurrence of liver dysfunction. Symptoms of liver dysfunction usually occur during or shortly after treatment, but may also occur up to several weeks after treatment. They are usually transient, sometimes severe, occasionally fatal. The risk of hepatic impairment is increased in people taking other medicines that are toxic to the liver and in people with severe underlying disease and in the elderly.
If diarrhea occurs during or after treatment, do not treat it yourself, but consult a physician. There is a risk of pseudomembranous colitis, sometimes of a severe course. Its clinical symptoms are caused by the stickClostridium difficile, which can multiply in the conditions of disturbance of the normal bacterial flora in the gut. Do not use drugs that inhibit intestinal peristalsis.
The monitoring of renal function, liver function and haematological parameters is recommended during long-term use.
Use of the preparation can rarely lead to prolonged prothrombin time. The use of the preparation in patients receiving anticoagulants requires regular monitoring of blood coagulation parameters. If necessary, your doctor will adjust the dosage of anticoagulants.
In patients with impaired renal function, dosage adjustment is necessary; the doctor will adjust the dosage depending on the degree of renal failure.
A high concentration of amoxicillin in the urine can cause its crystals to precipitate. If high doses of amoxicillin are used, the patient should take adequate amounts of fluids to reduce the precipitation of crystals of the drug in the urine. In patients with a catheter, the condition of the catheters and their patency should be checked regularly.
Amoxicillin may influence the results of the determination of Glucose in the urine and in the blood (possible, for example, a false positive result in the determination of urinary glucose). Clavulanic acid may cause false positive Coombs test results. Amoxicillin with clavulanic acid may affect false positive test results for fungal infections (aspergillus).
In the case of performing the tests mentioned above, please inform the physician and the persons responsible for carrying out laboratory tests on the use of amoxicillin.
Additional information about the other ingredients of the preparation:
• a preparation in the form of granules for the preparation of an oral suspension and in the form of tablets for oral suspension / tablets that disintegrate in the mouth contains aspartame, a source of phenylalanine; patients with phenylketonuria should be cautious
• the tablet formulation for oral suspension / tablets that disintegrate in the mouth contains castor oil, which can cause diarrhea and stomach problems.
Does this preparation affect the ability to drive vehicles?
There are no studies on the effect of the preparation on the ability to drive and use machines / machines. However, the preparation may cause side effects such as dizziness, allergic reactions, seizures or other symptoms that may impair your ability to drive or use machines / machines.
The preparation is in the form of granules for oral suspension, coated tablets, dispersible tablets / orodispersible tablets or powder for the preparation of an oral suspension. Use the product as directed by your doctor. Do not exceed the recommended doses, because it will not increase the effectiveness of the drug and may harm your health and life. If you have any doubts about the use of the preparation, consult your doctor.
The doctor will select the dosage individually depending on the indication, the severity of the infection, the sensitivity of the microorganisms and the patient's condition. In certain special patient groups, additional dosage adjustment is necessary.
The preparation contains amoxicillin and clavulanic acid in a ratio of 7: 1.
Adults and children weighing more than 40 kg:
Standard dose in all indications: (875 mg + 125 mg) 2 times daily.
Increased dose, in indications such as otitis media, sinusitis, lower respiratory tract infections and urinary tract infections: (875 mg + 125 mg) 3 times daily.
Children weighing less than 40 kg:
The usual recommended dose is (25 mg + 3.6 mg) / kg body weight per day to (45 mg + 6.4 mg) / kg body weight per day in 2 divided doses. In indications such as otitis media, sinusitis, lower respiratory tract infection, your doctor may recommend increasing the dose to (70 mg + 10 mg) / kg body weight per day in 2 divided doses.
There are no data on the use of doses higher than (45 mg + 6.4 mg) / kg body weight per day (formulations containing amoxicillin and clavulanic acid in a ratio of 7: 1) in children up to 2 years of age.
There are no data on the use of preparations containing amoxicillin and clavulanic acid in the ratio of 7: 1 in infants up to two months of age.
In patients with renal insufficiency the doctor will adjust the dosage depending on the degree of renal failure. If the creatinine clearance is greater than 30 ml / min, no dose adjustment is necessary. If the creatinine clearance is less than 30 ml / min, preparations containing amoxicillin and clavulanic acid in the ratio of 7: 1 should not be used.
Caution is advised in patients with hepatic impairment; your doctor will advise you to regularly check your liver function.
The doctor will determine the duration of treatment. Some infections (eg, bone marrow inflammation) require longer treatment. Do not use for more than 14 days without consulting your doctor again.
Method of administration of the drug:
Use orally. The preparation should be taken at the beginning of the meal.
In the case of a preparation in the form of granules for oral suspension, the contents of the sachet should be mixed with half a glass of water before serving.
In the case of a preparation in the form of tablets for oral suspension / tablets that disintegrate in the oral cavity, the tablet may be dissolved and mixed in a small amount of water or the tablet placed directly in the mouth and swallowed after dissolving.
For a powder formulation for oral suspension, first shake the medicine bottle to loosen the powder, then add the recommended amount of boiled, cooled water, turn the bottle upside down and shake. The bottle should be shaken before each dose. A dispensing pipette is included in the package.
During pregnancy, do not use any medicine without consulting your doctor!
It is very important that before using any medicine during pregnancy or breastfeeding, consult a physician and explain beyond any doubt the potential risks and benefits associated with the use of the drug. If you are pregnant or planning to become pregnant, please inform your prescribing physician about this medicine.
The preparation should be avoided in pregnant women, unless the doctor deems it absolutely necessary.
Before using the medication while breastfeeding, consult a doctor. Both active substances penetrate into breast milk and may cause allergy to the child. If the physician, after considering the expected benefits and possible risks, allows breastfeeding during the use of the preparation and the baby develops gastrointestinal disorders, candidiasis or skin rash, discontinue breast-feeding and consult a physician immediately.
Tell your doctor about all medicines you have recently taken, including those that are over the counter.
In particular, inform your doctor if you use:
• oral anticoagulants (eg Warfarin )
• mycophenolate mofetil (a medicine used in people with transplants).
If anticoagulants from the coumarin derivative group are used in parallel (eg warfarin, acenocoumarol), the bleeding time may be prolonged. It is recommended to regularly determine the prothrombin time or INR; strict control of these parameters is necessary after the start and end of the use of amoxicillin. It may be necessary to adjust the dosage of anticoagulants.
Amoxicillin and other penicillins may reduce the rate of excretion of methotrexate and exacerbate its toxic effects; the concentration of methotrexate in the blood should be closely monitored.
Parallel administration of the preparation and probenecid is not recommended. Probenecid may cause long-term increases in blood amoxicillin concentrations.
During the parallel use of the preparation and mycophenolate mofetil may decrease the concentration of the active metabolite - mycophenolic acid. Close clinical observation of patients is necessary for the occurrence of transplantation disorders both during the use of both preparations and for a short period after the end of antibiotic therapy.
Effect of amoxicillin on the results of laboratory tests:
Amoxicillin may influence the results of the determination of glucose in the urine and in the blood (possible, for example, a false positive result in the determination of urinary glucose). Clavulanic acid may cause false positive Coombs test results. Amoxicillin with clavulanic acid may affect false positive test results for fungal infections (aspergillus).
In the case of performing the tests mentioned above, please inform the physician and the persons responsible for carrying out laboratory tests on the use of amoxicillin.
Like all medicines, Amoksiklav, Amoksiklav Quicktab 1000 mg can cause side effects, although they will not occur in all patients who use this medicine. Remember that the expected benefits of using the drug are usually greater than the damage resulting from the occurrence of side effects.
The most common side effects that may occur after using the preparation include: diarrhea, nausea and vomiting.Often or uncommonly possible: yeast infections of the skin and mucous membranes of the mouth and genitals, indigestion, increased liver enzymes, dizziness and headaches, rash, pruritus, urticaria. Rare: transient leukopenia, thrombocytopenia. In addition, possible undesirable effects for which the frequency of their occurrence has not been determined: excessive growth of non-susceptible bacteria, hematological disorders such as hemolytic anemia, agranulocytosis (significant reduction of all granulocytes), prolonged bleeding time and prothrombin time, excessive mobility, convulsions, sterile meningitis - core, colitis, pseudomembranous enteritis (manifested by persistent diarrhea during or after treatment), hairy black tongue, hepatitis, cholestatic jaundice, interstitial nephritis, the occurrence of crystals in the urine (crystalluria). The rare or very rare but potentially serious side effects include anaphylactic type hypersensitivity reactions: angioneurotic edema (possible swelling of the lips, tongue, throat and larynx, impeding breathing), anaphylactic shock, and severe skin reactions (Stevens and Johnson syndrome, toxic epidermal necrosis epidermis, bullous exfoliative dermatitis, erythema multiforme, acute generalized pustular exanthema, serum sickness, allergic vasculitis). If you experience the first symptoms of any of the above hypersensitivity reactions, please consult your doctor immediately.
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