|The name of the preparation||Character; dose; package||Manufacturer||Price 100%||Price after refund||In which pharmacy?|
|Amotaks||granules for oral suspension; 100 mg / ml (500 mg / 5 ml); 100 ml||Polfa Tarchomin||25.86||
|Amotaks||granules for oral suspension; 100 mg / ml (500 mg / 5 ml); 60 ml||Polfa Tarchomin||16.37||
Note: reimbursed drug prices are in line with the regulations in force from July 1, 2018.
A broad-spectrum beta-lactam antibiotic used to treat bacterial infections. For general use.
The active substance is Amoxicillin . It 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 preparation is indicated for use in adults and children in the treatment of the following infections caused by bacteria sensitive to amoxicillin:
• acute sinusitis
• acute otitis media
• acute streptococcal tonsillitis and pharyngitis
• exacerbation of chronic bronchitis
• community-acquired pneumonia
• acute cystitis
• asymptomatic bacteriuria during pregnancy
• acute pyelonephritis
• typhoid and typhus
• periodontium abscess with widespread connective tissue inflammation
• infections related to joint prosthesis
• to remove (eradicate) bacteriaHelicobacter pylori
• Lyme disease (borreliosis)
• in the prevention of endocarditis.
Unfortunately, even if there are indications to use the preparation, it can not always be used. You must not use the product if you are allergic (you are hypersensitive) to any of the ingredients or other beta-lactam antibiotics (penicillin, cephalosporins, carbapenems or monobactams).
In particular, it is contraindicated in people who have a history of severe immediate hypersensitivity reactions (anaphylactic reactions) to any beta-lactam antibiotic (penicillin, cephalosporins, carbapenems or monobactams).
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 inform your doctor if you have ever experienced hypersensitivity reactions to other antibiotics, or to other medications or allergens. 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 (eg penicillins, cephalosporins, carbapenems, monobactams) and therefore the use of the preparation in this group of patients is contraindicated. The risk of hypersensitivity reactions is also increased in people with atopic diseases and in people who are allergic to many different allergens. The use of oral amoxicillin rarely causes severe symptoms of hypersensitivity and anaphylactic shock. Severe hypersensitivity reactions and Anaphylactic reactions may be life-threatening; in the event of first symptoms, seek medical help immediately. It is necessary to be hospitalized and appropriate treatment (sometimes emergency procedures).
If an allergic reaction occurs, please consult a physician who may prescribe other medicines.
In patients with impaired renal function, dosage adjustment is necessary; the doctor will adjust the dosage depending on the degree of renal failure.
High doses, renal failure and risk factors (past seizures, epilepsy or meningitis) can lead to seizures.
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, it is necessary to discontinue treatment and re-use of amoxicillin in the future is contraindicated.
Do not use the preparation in people who have or are suspected of having mononucleosis (in this case, do not use the preparation due to the increased risk of erythematous skin lesions, similar to a measles rash).
During the treatment of Lyme disease, the use of the preparation may be accompanied by the reactions of Jarisch and Herxheimer (known popularly as Herx). This reaction is a frequent effect of the antibiotic and usually resolves spontaneously. Symptoms may include headaches, muscle aches, high temperature, a feeling of disorder, malaise and rash.
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.
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.
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.
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.
If high doses of amoxicillin are used, as with other beta-lactam antibiotics, blood counts should be monitored 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). Amoxicillin may reduce the concentration of estriol in the urine of pregnant women. Amoxicillin may interfere with protein determination by calorimetric methods.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:
• granules for preparing an oral suspension contain sucrose; people with inherited disorders associated with fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency should not use the preparation; caution should be exercised in patients with diabetes;
• the preparation in the form of granules for the preparation of an oral suspension contains sodium benzoate, which may cause slight irritation to the skin, eyes and mucous membranes.
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 a granules for oral suspension, tablets or capsules. 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, dosage adjustment is necessary.
Adults and children weighing more than 40 kg:
Acute bacterial sinusitis, asymptomatic bacteriuria during pregnancy, acute pyelonephritis, periodontium abscess with widespread cellulitis, acute cystitis: 0.25-0.5 g every 8 hours or 0.75-1 g every 12 hours. In severe infections, 0.75-1 g every 8 hours. In acute cystitis, your doctor may recommend 3 g 2 times a day for 1 day.
Acute otitis media, acute streptococcal tonsillitis and pharyngitis, exacerbation of chronic bronchitis: 0.5 g every 8 hours or 0.75-1 g every 12 hours. In severe infections, 0.75-1 g every 8 hours for 10 days.
Community-acquired pneumonia, infections associated with joint prosthesis: 0.5-1 g every 8 hours.
Abdominal typhoid and typhoid: 0.5-2 g every 8 hours.
Prevention of endocarditis: 2 g 30-60 minutes before surgery.
Eradication of bacteriaHelicobacter pylori: 0.75-1 g twice daily in combination with other drugs for 7 days.
Lyme disease (Lyme disease) early form: 0.5-1 g every 8 hours, maximum 4 g daily in divided doses, for 14 days (10-21 days). Late form (systemic symptoms): 0.5-2 g every 8 hours, maximum 6 g per day in divided doses, for 10-30 days.
Children weighing less than 40 kg:
Acute bacterial sinusitis, acute otitis media, community acquired pneumonia, acute cystitis, acute pyelonephritis, periodontium abscess with widespread cellulitis: 20-90 mg / kg body weight per day in divided doses.
Acute streptococcal tonsillitis and pharyngitis: 40-90 mg / kg body weight per day in divided doses.
Abdominal typhoid and typhoid: 100 mg / kg body weight per day in 3 divided doses.
Prevention of endocarditis: 50 mg / kg body weight 30-60 minutes before surgery.
Lyme disease (Lyme disease) early form: 25-50 mg / kg body weight per day in 3 divided doses, for 10-21 days. Late form (systemic symptoms): 100 mg / kg body weight per day in 3 divided doses, for 10-30 days.
Greater efficacy is seen when using the product 3 times a day and therefore the use twice a day is recommended only when the dose used is close to the upper limit of the recommended range.
In patients with renal insufficiency, your doctor will prescribe a dose depending on the degree of renal failure. If the creatinine clearance is greater than 30 ml / min, there is no need to change the dosing schedule. If the creatinine clearance is less than 30 ml / min, your doctor will advise you to increase the interval between doses and reduce the daily dose, as shown in the diagram below.
Adults: if the creatinine clearance is in the range of 10-30 ml / min, a maximum of 500 mg 2 times a day is used, and if the creatinine clearance is less than 10 ml / min, 500 mg once daily is used. In patients undergoing dialysis, the doctor will determine the dosage.
Children with a body weight of less than 40 kg: if creatinine clearance is between 10-30 ml / min, 15 mg / kg body weight 2 times daily (maximum 500 mg twice daily) is used, and if creatinine clearance is lower 10 mg / kg body weight once daily (up to 500 mg once daily).
In patients with impaired hepatic function, caution should be exercised and the liver function monitored regularly.
Method of administration of the drug:
The preparation can be taken regardless of meals.
Preparation in the form of tablets: the tablet should be swallowed with water. The tablet can be divided into two halves, in the place of visible depression.
Preparation in the form of capsules: the capsule should be swallowed whole (do not open the capsule) with water.
Preparation in the form of granules for the preparation of an oral suspension: to prepare the suspension, first shake the bottle slightly to disperse the granules. Then pour the boiled cold water into the bottle to a level slightly below the line, close the bottle and shake it immediately. After the foam has settled, slowly fill with water to the mark marked on the bottle. Shake again vigorously. The resulting white or slightly yellow suspension is ready for use. The prepared suspension is taken by mouth, metering a dose using a measuring spoon or a dispenser attached to the package. The suspension should be shaken vigorously before each use.
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.
In pregnant women, the preparation can be used only when, in the doctor's opinion, it is absolutely necessary and when the physician is of the opinion that the expected benefits clearly outweigh the possible risks.
Before using the medication while breastfeeding, consult a doctor. Amoxicillin is excreted in breast milk and may cause sensitization of 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.
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 )
• oral hormonal contraceptives.
Parallel administration of the preparation and probenecid is not recommended. Probenecid may cause long-term increases in blood amoxicillin concentrations.
The parallel use of the preparation and allopurinol is not recommended as the risk of allergic skin reactions increases.
Tetracyclines and other bacteriostatic agents may affect the efficacy of amoxicillin.
If anticoagulants from the coumarin 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 may increase the toxic effects of methotrexate; the concentration of methotrexate in the blood should be closely monitored. Amoxicillin decreases the rate of methotrexate excretion.
The preparation may reduce the effectiveness of oral hormonal contraceptives. Decreased contraceptive effectiveness may persist for some time. Consult a physician.
Forced diuresis increases the excretion of amoxicillin and decreases its concentration in the blood.
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). Amoxicillin may reduce the concentration of estriol in the urine of pregnant women. Amoxicillin may interfere with protein determination by calorimetric methods.
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, Amotaks can also 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.
Frequent or uncommon: superinfection with resistant bacteria or yeasts as a result of prolonged and repeated use of amoxicillin (eg fungal infection of the oral mucosa and vagina), nausea, vomiting, diarrhea, loss of appetite, bloating, rash (including around the mouth) ), dryness of the oral mucosa, taste disturbances, slight and transient elevation of liver enzymes, morphea, pruritus, urticaria (if urticaria occurs immediately after starting treatment, this indicates an allergic reaction and requires immediate medical consultation). Rare: hemolytic anemia, eosinophilia, hepatitis, cholestatic jaundice, acute interstitial nephritis, urinary crystals (crystalluria), drug-induced fever. 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, acute generalized pustular exanthema, erythema multiform exudate, serum sickness, allergic vasculitis). If you experience the first symptoms of any of the above hypersensitivity reactions, please consult your doctor immediately. Very rare side effects include dizziness, agitation, excessive mobility, seizures (in case of renal dysfunction, high doses of the drug, in patients with epilepsy and patients with meningitis), candidiasis (candidiasis) of the skin and membranes mucous, haematological abnormalities such as anemia, thrombocytopenia, leukopenia / neutropenia / agranulocytosis (decrease in the number of white blood cells or leukocytes / neutrophils or neutrophils / significant reduction in the number of all granulocytes), prolonged bleeding time and prothrombin time, bone marrow suppression, as well as pseudomembranous enteritis (manifested by persistent diarrhea during or after treatment), black hairy tongue.
During the treatment of Lyme disease, the use of the preparation may be accompanied by the reactions of Jarisch and Herxheimer (popularly known as Herx), the symptoms of which may include: headaches, muscle pain, elevated temperature, feeling of disorder, malaise and rash.
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