Amoxiclav, pills 500mg+125mg 15pcs

Composition

1 tablet (625 mg) contains:

Active ingredients:

amoxicillin (in the form of trihydrate) 500 mg,

clavulanic acid (in the form of potassium salt) 125 mg.

Auxiliary substances:

colloidal silicon dioxide 9.00 mg,

crospovidone 45.00 mg,

croscarmellose sodium 35.00 mg,

magnesium stearate 20.00 mg,

microcrystalline cellulose up to 1060 mg.

Film coating of the tablet:  hypromellose 17.696 mg, ethylcellulose 0.864 mg, polysorbate 80-0.960 mg, triethyl citrate 0.976 mg, titanium dioxide 9.360 mg, talc 2.144 mg

Pharmacological action

Antibiotic-penicillin semi-synthetic+beta-lactamase inhibitor

ATX Code: J01CR02.

PHARMACOLOGICAL PROPERTIES

Pharmacodynamics

Amoxiclav® is a combination of amoxicillin and clavulanic acid.

Amoxicillin is a semi-synthetic penicillin (beta-lactam antibiotic) that inhibits one or more enzymes (often referred to as penicillin-binding proteins, PSBs) in the biosynthetic pathway of peptidoglycan, which is an integral structural component of the bacterial cell wall. Inhibition of peptidoglycan synthesis leads to a loss of cell wall strength, which usually leads to lysis and death of microbial cells. ‘

Amoxicillin is destroyed by the action of beta-lactamases produced by resistant bacteria, so the spectrum of activity of one amoxicillin does not include microorganisms that produce these enzymes.

Clavulanic acid is a beta-lactam structurally related to penicillins. It inhibits some beta-lactamases, thereby preventing inactivation of amoxicillin and expanding its spectrum of activity, including bacteria that are usually resistant to amoxicillin, as well as to other penicillins and cephalosporins. Clavulanic acid itself does not have a clinically significant antibacterial effect.

The drug Amoxiclav® it has a bactericidal effect in vivo on the following microorganisms:

Gram-positive aerobes Staphylococcus aureus* Streptococcus pneumoniae Streptococcus pyosenes Gram-negative aerobes Enterobacter spp. β Escherichia coli * Haemophilus influenzae* Species of the genus Klebsiella * Moraxella catarrhalis*(Branhamella catarrhalis)

The drug Amoxiclav® it has a bactericidal effect in vitro on the following microorganisms (however, the clinical dependence is still unknown):

Gram-positive aerobes Bacillis anthracis* Types of the genus Corynebacterium Enterococcus faecalis* Enterococcus faecium* Listeria monocytogenes Nocardia asteroides Coagulase-negative staphylococci* (including Staphylococcus epidermidis) Streptococcus agalactiae Other species of the genus Streptococcus Streptococcus viridans Gram-positive anaerobes:  Species of the genus Clostridium Types of the genus Peptococcus Types of the genus Peptostreptococcus Gram-negative aerobes Bordetella pertussis Species of the genus Brucella Gardnerella vaginalis Helicobacter pylori Kinds of genus Legionella Neisseria gonorrhoeae* Neisseria meningitidis* Pasteurella multocida Proteus mirabilis* Proteus vulgaris* Species of the genus Salmonella* Types of the genus Shigella* Vibrio cholerae Yersinia enterocolitica* Gram-negative anaerobes Types of the genus Bacteroides* (including Bacteroides fragilis) Species of the genus Fusobacterium* Other services:  Borrelia burgdorferi, Chlamydia spp., Leptospira icterohaemorrhagiae, Treponema pallidum.

*Some strains of these bacterial species produce beta-lactamases, which contributes to their insensitivity to monotherapy with amoxicillin beta – most strains of these bacteria are resistant to the combination of amoxicillin/clavulanic acid in vitro, but the clinical effectiveness of this combination has been demonstrated in the treatment of urinary tract infections caused by these strains.

Indications

• pneumonia,
• urinary tract
• infections, skin and soft tissue
• infections, blood poisoning, peritonitis, bone and joint infections, inflammation of the appendages.

Use during pregnancy and lactation

Animal studies have not revealed data on the dangers of taking the drug during pregnancy and its effect on fetal embryonic development. In one study in women with premature rupture of the amniotic membranes, it was found that preventive use of amoxicillin/clavulanic acid may be associated with an increased risk of developing necrotizing enterocolitis in newborns. During pregnancy and lactation, the drug is used only if the intended benefit to the mother exceeds the potential risk to the fetus and child. Amoxicillin and clavulanic acid pass into breast milk in small amounts. children who are breastfed may develop sensitization, diarrhea, and candidiasis of the oral mucosa. When taking Amoxiclav®, it is necessary to decide whether to stop breastfeeding.

Contraindications

* Hypersensitivity to the components of the drug;• history of hypersensitivity to penicillins, cephalosporins, and other beta-lactam antibiotics;• history of cholestatic jaundice and / or other liver function disorders caused by amoxicillin/clavulanic acid use;• infectious mononucleosis and lymphocytic leukemia;• children under 12 years of age or with a body weight of less than 40 kg.

With caution

Pseudomembranous colitis in the anamnesis, diseases of the gastrointestinal tract, liver failure, severe renal dysfunction, pregnancy, lactation, when used simultaneously with anticoagulants.

Side effects

According to the World Health Organization (WHO), adverse events are classified according to their frequency as follows: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10000, <1/1000), and very rare (From the gastrointestinal tract: – very often:  diarrhea;- often:  nausea, vomiting. Nausea is most often observed when ingested at high doses. If disorders of the gastrointestinal tract are confirmed, they can be eliminated if you take the drug at the beginning of a meal. – infrequently:  indigestion; – very rare:  antibiotic-associated colitis (including hemorrhagic colitis and pseudomembranous colitis), black “hairy” tongue, gastritis, stomatitis. Liver and biliary tract disorders: – infrequently:  increased activity of alanine aminotransferase (ALT) and / or aspartate aminotransferase (AST). These reactions are observed in patients receiving beta-lactam antibiotics, but their clinical significance is unknown. – very rarely:  cholestatic jaundice, hepatitis, increased alkaline phosphatase activity, increased bilirubin activity in blood plasma. Hepatic adverse reactions have been observed mainly in men and elderly patients and may be associated with long-term therapy. These adverse reactions are very rare in children. These signs and symptoms usually occur during or immediately after the end of therapy, but in some cases they may not appear for several weeks after the end of therapy. Adverse reactions are usually reversible. Adverse reactions from the liver can be severe, and in extremely rare cases, fatal outcomes have been reported. In almost all cases, these were people with serious comorbidities or those receiving potentially hepatotoxic drugs at the same time. Immune system disorders: very rare:  angioedema, anaphylactic reactions, allergic vasculitis; From the blood and lymphatic system: – rarely:  reversible leukopenia (including neutropenia), thrombocytopenia; – very rare:  reversible agranulocytosis, hemolytic anemia, reversible increase in prothrombin time, reversible increase in time, – bleeding, eosinophilia, thrombocytosis. Nervous system disorders: – infrequently:  dizziness, headache;- very rarely:  seizures (may occur in patients with impaired renal function, as well as when taking high doses of the drug), reversible hyperactivity, aseptic meningitis, anxiety, insomnia, behavior changes, agitation. Skin and subcutaneous tissue disorders: – infrequently:  skin rash, pruritus, urticaria; – rarely:  exudative erythema multiforme; – very rare:  exfoliative dermatitis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, serum-like syndrome, toxic epidermal necrolysis. Renal and urinary tract disorders: very rare:  interstitial nephritis, crystalluria, hematuria. Infectious and parasitic diseases: common:  candidiasis of the skin and mucous membranes. Other: frequency unknown:  growth of insensitive microorganisms.

Interaction

Antacids, glucosamine, laxatives, aminoglycosides slow down absorption, ascorbic acid increases absorption. Diuretics, allopurinol, phenylbutazone, nonsteroidal anti-inflammatory drugs (NSAIDs) and other drugs that block tubular secretion (probenecid), increase the concentration of amoxicillin (clavulanic acid is excreted mainly by glomerular filtration). Concomitant use of Amoxiclav and probenecid may lead to increased and persistent blood levels of amoxicillin, but not clavulanic acid, so concomitant use with probenecid is not recommended. Concomitant use of Amoxiclav and methotrexate increases the toxicity of methotrexate. The use of the drug together with allopurinol may lead to the development of allergic skin reactions. Currently, there are no data on the simultaneous use of a combination of amoxicillin with clavulanic acid and allopurinol. Concomitant use with disulfiram should be avoided. Reduces the effectiveness of drugs that produce para-aminobenzoic acid and ethinyl estradiol in the process of metabolism – the risk of developing “breakthrough” bleeding. The literature describes rare cases of an increase in the international normalized ratio (INR) in patients with the combined use of acenocoumarol or warfarin and amoxicillin. If concomitant use with anticoagulants is necessary, it is necessary to regularly monitor the protrobinovannoe time or INR when prescribing or discontinuing the drug, it may be necessary to adjust the dose of anticoagulants for oral use. When used concomitantly with rifampicin, mutual weakening of the antibacterial effect is possible. The drug Amoxiclav® should not be used simultaneously in combination with bacteriostatic antibiotics (macrolides, tetracyclines), sulfonamides due to the possible decrease in the effectiveness of the drug Amoxiclav®. Amoxiclav reduces the effectiveness of oral contraceptives. In patients treated with mycophenolate mofetil, after starting the combination of amoxicillin with clavulanic acid, the concentration of the active metabolite, mycophenolic acid, decreased by approximately 50% before taking the next dose of the drug. Changes in this concentration may not accurately reflect overall changes in mycophenolic acid exposure.

How to take, course of use and dosage

Inside.

The dosage regimen is set individually depending on the age, body weight, kidney function of the patient, as well as the severity of the infection.

Amoxiclav® is recommended to be taken at the beginning of a meal for optimal absorption and reduction of possible side effects from the digestive system.

The course of treatment is 5-14 days. The duration of treatment is determined by the attending physician. Treatment should not be continued for more than 14 days without a second medical examination. Adults and children 12 years and older or weighing 40 kg or more:

For the treatment of mild to moderate infections – 1 tablet 250 mg+125 mg every 8 hours (3 times a day).

For the treatment of severe infections and respiratory infections – 1 tablet 500 mg+125 mg every 8 hours (3 times a day) or 1 tablet 875 mg+125 mg every 12 hours (2 times a day).

Since 250 mg+125 mg and 500 mg+125 mg combination tablets of amoxicillin and clavulanic acid contain the same amount of clavulanic acid – 125 mg,2 250 mg+125 mg tablets are not equivalent to 1 500 mg+125 mg tablet.

Patients with impaired renal function

Dose adjustment is based on the maximum recommended dose of amoxicillin and is based on creatinine clearance (CC) values.

Patients with impaired liver function

Amoxiclav should be administered with caution. Regular monitoring of liver function should be performed.

It does not require correction of the dosage regimen for elderly patients. In elderly patients with impaired renal function, the dose should be adjusted in the same way as in adult patients with impaired renal function.

Overdose

There are no reports of fatal or life-threatening side effects due to overdose of the drug. In most cases, overdose symptoms include gastrointestinal disorders (abdominal pain, diarrhea, vomiting) and water-electrolyte balance disorders. There have been reports of crystalluria caused by amoxicillin use, which in some cases led to the development of renal failure. Seizures may occur in patients with renal insufficiency or in patients receiving high doses of the drug. In case of overdose, the patient should be under the supervision of a doctor, treatment is symptomatic. In the case of a recent intake (less than 4 hours), gastric lavage should be performed and activated charcoal should be prescribed to reduce absorption. Amoxicillin/clavulanic acid is removed by hemodialysis.

Special instructions

Before starting treatment, the patient should be interviewed for a history of hypersensitivity reactions to penicillins, cephalosporins, or other beta-lactam antibiotics. In patients with hypersensitivity to penicillins, cross-allergic reactions with cephalosporin antibiotics are possible. During the course of treatment, it is necessary to monitor the state of function of the hematopoietic organs, liver, and kidneys.

In patients with severe renal impairment, adequate dose adjustment or increased dose intervals are required. In order to reduce the risk of side effects from the gastrointestinal tract, you should take the drug with meals.

It is possible to develop superinfection due to the growth of microflora insensitive to amoxicillin, which requires a corresponding change in antibacterial therapy.

In patients with impaired renal function, as well as when taking high doses of the drug, convulsions may occur.

It is not recommended to use the drug in patients with suspected infectious mononucleosis.

If antibiotic-associated colitis occurs, you should immediately stop taking Amoxiclav®, consult a doctor and start appropriate treatment. Drugs that inhibit peristalsis are contraindicated in such situations.

Crystalluria is very rare in patients with reduced diuresis. When using high doses of amoxicillin, it is recommended to take sufficient fluids and maintain adequate diuresis to reduce the likelihood of amoxicillin crystals forming. Laboratory tests: high concentrations of amoxicillin give a false positive reaction to urine glucose when using Benedict’s reagent or Fehling’s solution.

It is recommended to use enzymatic reactions with glucosidase.

Clavulanic acid can cause non-specific binding of immunoglobulin G (IgG) and albumin to the membranes of red blood cells, which leads to false positive results of the Coombs test.

Special precautions when disposing of an unused medicinal product.

There is no need for special precautions when disposing of unused Amoxiclav®.

Influence on the ability to drive vehicles and mechanisms

If you develop adverse reactions from the nervous system (for example, dizziness, convulsions), you should refrain from driving a car and engaging in other activities that require increased concentration of attention and speed of psychomotor reactions.

Form of production

Film-coated tablets

Storage conditions

In a dry place, at a temperature not exceeding 25 °C

Shelf life

2 years

Active ingredient

Amoxicillin, Clavulanic Acid

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

Children over 12 years of age, Adults as prescribed by a doctor, Children as prescribed by a doctor, Nursing mothers as prescribed by a doctor, Pregnant women as prescribed by a doctor

Indications

Bronchitis, Sore Throat, Periodontitis, Otitis Media, Pneumonia, Osteomyelitis, Sinusitis, Urinary tract infections