Amoxil Composition and dosage form
Amoxil 250mg № 10, №20
Amoxil 500mg №10, №20
Amoxicillin is active substance of Amoxil.
Pharmacodynamics
Amoxil – is an antibiotic of a broad spectrum of aminopenicillins group. It has a bactericidal effect, inhibiting the synthesis of bacterial cell wall are sensitive to the drug. It is active against gram-positive cocci – Staphylococcus spp. (except strains, producing penicillinase), Streptococcus spp., anaerobic streptococci (Peptostreptococcus, Peptococcus), microaerophilic streptococci (Streptococcus faecalis), as well as gram-positive bacteria – Bacillus anthracis, majority of strains – Corynebacterium diphtheriae, Clostridium perfringens, Clostridium tetani, Listeria monocytogenes, Erysepelothrix rhusiopathiae and Eubacterium.
Amoxil acts on gram-negative aerobic microorganisms: cocci – Neisseria gonorrhoeae, Neisseria meningitidis; bacillus – Escherichia coli, Shigella spp., Salmonella spp., Proteus mirabilis, majority of strains – Klebsiella spp., Haemophilus influenzae, Moraxella catarrhalis; spirochetes – Treponema pallidum, Treponema pertenue, Leptospira spp., Borrelia burgdorferi; chlamydia – Chlamidia trachomatis. Amoxil is active against Helicobacter pylori in combination with metronidazole. Microorganisms, producing penicillinase are resistant to the drug.
Amoxil is inactive against mycobacteria, mycoplasmas, rickettsiae, fungi, amoebae, plasmodia, viruses, as well as Pseudomonas aeruginosa and Proteus spp. (except P. Mirabillis).
Pharmacokinetics
Amoxicillin is well absorbed, reaching Cmax in blood serum within 2 hours after dosing. T ½ is 1,5 hours. It is excreted from the body unchanged by the kidneys (60-70%).
Amoxil indication
Amoxil is used in infections, caused by microorganisms sensitive to amoxicillin (Amoxil), including infections of respiratory organs; infections of digestive tract; infections of genitourinary system; infections of skin and soft tissues.
In the combination with metronidazole or clarithromycin Amoxil is used to treat diseases of digestive tract, associated with Helicobacter pylori.
Amoxil administration
Amoxil is taken by mouth (regardless of food). Dosing regimen of the drug is appointed individually, taking into account the disease characteristics.
In mild to moderate severity of infections for adults and children over 10 years, standard dosing regimen is 500-750mg 2 times a day; for children aged 3-10 years – 375mg 2 times/ daily or 250mg 3 times a day; children aged 1-3 years – 250mg 2 times/ daily or 125mg 3 times a day.
For children, daily dose of Amoxil is 30-60mg / kg of body weight, divided into 2-3 doses.
In chronic diseases, relapses, severe diseases Amoxil is appointed of 0,75-1g 3 times a day for adults; 60mg / kg of body weight a day, divided into 2-3 doses for children.
In acute uncomplicated gonorrhea 3g of the drug is prescribed in conjunction with 1 g of probenecid.
In peptic ulcer Amoxil is prescribed in the complex therapy for eradication of Helicobacter pylori by approved international schemes:
- within 7 days: 1g of amoxycillin 2 times/ daily + clarithromycin 500mg 2 times a day + omeprazole 40mg in 1 or 2 intakes;
- within 7 days: 0.75-1g of amoxicillin 2 times/ daily + metronidazole 400mg 3 times a day + omeprazole 40mg in 1 or 2 intakes.
For adults, maximum daily dose of Amoxil is 6g.
| Glomerular filtration rate, ml / min | Dosage |
| >30 | Dose adjustment is not required |
| 10–30 | Maximum dose — 500 mg 2 times/ daily |
| <10 | Maximum dose — 500 mg/ daily |
Children with renal failure (body weight up to 40kg):
| Level of creatinine clearance | Dosage |
| >30 | Dose adjustment is not required |
| 10–30 | 15mg/ kg of body weight 2 times/ daily Maximum dose — 500 mg 2 times/ daily |
| <10 | 15mg/ kg of body weight 1 times/ daily Maximum dose — 500 mg/ daily |
It is necessary to continue taking Amoxil during 2-3 days after disappearance of disease symptoms. In infections of mild to moderate severity, Amoxil is taken during 5-7 days. In infections, caused by beta-hemolytic streptococcus, treatment duration should be at least 10 days.
Amoxil contraindications
Amoxil is contraindicated to people who are allergic to amoxicillin and/ or other drug components, as well as any other penicillin antibiotics. Patients with hypersensitivity to cephalosporin antibiotics should take into account the possibility of polyvalent allergy; infectious mononucleosis; lymphatic leukemia; breastfeeding period; children under 1 year.
Amoxil side effects
Amoxil side effect can include: skin rash, itching, hives, flushing, fever, very rarely – erythema multiforme, Stevens – Johnson, toxic epidermal necrolysis, skin hyperkeratosis, bullous and exfoliative dermatitis, eczema, enanthema, anaphylactic shock and angioneurotic edema, serum sickness, vasculitis.
Amoxil side effects from the digestive tract are: nausea, vomiting, diarrhea, loss of appetite, dry mouth, taste disorder, abdominal bloating, discomfort and abdominal pain, colitis (including pseudomembranous, hemorrhagic), tongue color change (black “hairy” tongue).
- Amoxil side effect from the urinary system is: rarely – interstitial nephritis;
Amoxil side effects from the hematopoietic organs are: rarely – hemolytic anemia, reversible thrombocytopenia, eosinophilia, reversible leukopenia (including neutropenia, agranulocytosis), increase of prothrombin time.
Amoxil side effects from the liver and biliary system are: a moderate increase in liver enzymes level, very rarely – hepatitis, jaundice.
Amoxil side effects from the central and peripheral nervous system are: rarely – anxiety, restlessness, insomnia, loss of consciousness, behavioral disorder, hyperkinesia, dizziness, headache. Convulsions are possible in patients with renal disorder.
Other Amoxil side effects are: weakness, the development of superinfection, candidiasis of mucous membranes, false-positive results when determining the glucose level in the urine by non-enzymatically methods and when conducting tests to determine the urobilinogen.
Special instructions
It is necessary to exclude the presence of patient’s hypersensitivity to the drugs group of penicillin and cephalosporin before treatment.
Prolonged or repeated use of Amoxil can lead to the rapid growth of resistant microflora and the development of superinfection.
Patients with severe disorders of the gastrointestinal tract function, that are accompanied by diarrhea and vomiting, should not use oral forms of amoxicillin that is associated with the absorption decrease risk.
It is necessary carefully to appoint Amoxil for patients with allergic diathesis and asthma in history. Amoxil also should be carefully prescribed for patients with viral infections , acute leukemia due to the increased risk of erythematous skin rash.
Dosage adjustment of Amoxil is needed for patients with renal disorder.
High concentrations of amoxicillin in urine can be the cause of the medication sediment formation in a catheter. Therefore, catheters should be regularly washed. Therefore, catheters should be regularly washed off.
There is the possibility of crystalluria development in patients with reduced diuresis, taking Amoxil (predominantly parenterally). When taking Amoxil high doses, it is recommended to drink plenty of liquids and to maintain an adequate diuresis to reduce the probability of amoxicillin crystals formation.
Amoxil can change the teeth enamel color in children, so it is necessary strictly to observe oral hygiene.
In the case of anaphylactic shock and other serious allergic reactions, it is necessary to conduct an appropriate first aid measures – artificial respiration, intravenous injection of epinephrine, the use of antihistamines, glucocorticosteroids, oxygen therapy, mechanical ventilation. Patients should be under medical supervision.
Use of Amoxil during pregnancy and breastfeeding
Teratogenic effect of amoxicillin is not revealed. However, if there is a need to prescribe the drug during pregnancy, it is necessary in advance to assess the ratio of potential risk for the fetus and the expected benefit for women.
Amoxil in a small amount passes into breast milk. Use of Amoxil is possible during breastfeeding, however in order to prevent the probable sensitization of child, it is recommended to stop breastfeed.
Amoxil is contraindicated for children under 1 year.
People who drive vehicles or work with other mechanisms should cautiously take Amoxil due to the risk of possible side effects from the nervous system.
Amoxil contraindications
Simultaneous use of Amoxil and oral contraceptives leads to the reduction of efficiency of the latter, as well as there is a possibility of bleeding.
Amoxil increases the digoxin absorption. Amoxil also reduces clearance and increases the methotrexate toxicity. Excretion of Amoxil from the body by the kidneys is reduced during simultaneous use with probenecid, oxyphenbutazone, phenylbutazone, acetylsalicylic acid, indomethacin, sulfinpyrazone.
Drugs with bacteriostatic effect (tetracyclines, macrolides,chloramphenicol) can neutralize the bactericidal effect of Amoxil.
Artificial diuresis leads to a decrease of Amoxil concentration in the blood serum by increasing its elimination.
In simultaneous use of Amoxil with allopurinol is possible an increase of allergic reactions frequency from the skin.
Amoxil absorption is reduced in simultaneous use with antacids.
In simultaneous use of Amoxil with anticoagulants is necessary to monitor prothrombin time, since the probability of bleeding increases.
Diarrhea can reduce Amoxil effectiveness and absorption of other drugs.
Amoxil can decrease estradiol concentration in the urine of pregnant women.
Amoxil overdose
Amoxil overdose symptoms are: nausea, vomiting, diarrhea, water and electrolyte imbalance.
Amoxil overdose treatment: stomach lavage, use of enterosorbents, (activated charcoal), saline laxatives, correction of water and electrolyte balance, hemodialysis is used if needed.
Storage
Store Amoxil at room temperature away from moisture, heat and light.
Patent for active substance Amoxicillin has expired, so it is produced by tens of pharmaceutical companies and is marketed under many trade names, including: Actimoxi, Alphamox, Amoksibos, Amoxiclav Sandoz, Amoxin, Amoksiklav, Amoxibiotic, Amoxicilina, Apo-Amoxi, Bactox, Betalaktam, Cilamox, Curam, Dedoxil, Dispermox, Duomox, Enhancin, Gimalxina, Geramox, Hiconcil, Isimoxin, Trimox.
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