Amoxiclav, powder for suspension 400mg+57mg/5ml,17.5g

Composition

5 ml of ready-made suspension. amoxicillin (trihydrate) 400 mg clavulanic acid (potassium salt) 57 mg

Auxiliary substances:

citric acid (anhydrous) – 2.694 mg,

sodium citrate (anhydrous) – 8.335 mg,

microcrystalline cellulose and sodium carmellose – 28.1 mg,

xanthan gum 10 mg,

silicon dioxide colloid – 16.667 mg,

silicon dioxide – 217 mg,

the wild cherry flavor,4 mg,

lemon flavor,4 mg,

sodium saccharin – 5.5 mg,

mannitol – 1250 mg

Pharmacological action

Amoxiclav is a combination of amoxicillin, a semi-synthetic penicillin with a broad spectrum of antibacterial activity, and clavulanic acid, an irreversible beta-lactamase inhibitor. Clavulanic acid forms a stable inactivated complex with these enzymes and ensures the resistance of amoxicillin to the effects of beta-lactamases produced by microorganisms.

Clavulanic acid, similar in structure to beta-lactam antibiotics, has a weak intrinsic antibacterial activity.

Amoxiclav has a wide spectrum of antibacterial action.

Active against amoxicillin-sensitive strains, including beta-lactamase-producing strains, including aerobic gram-positive bacteria:  Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus viridans, Streptococcus bovis, Staphylococcus aureus (except methicillin-resistant strains), Staphylococcus epidermidis (except methicillin-resistant strains), Staphylococcus saprophyticus, Listeria spp., Enterococcus spp. ; aerobic gram-negative bacteria:  Bordetella pertussis, Brucella spp., Campylobacter jejuni, Escherichia coli, Gardnerella vaginalis, Haemophilus influenzae, Haemophilus ducreyi, Klebsiella spp., Moraxella catarrhalis, Neisseria gonorrhoeae, Neisseria meningitidis, Pasteurella multocida, Proteus spp., Salmonella spp., Shigella spp., Vibrio cholerae, Yersinia enterocolitica, Helicobacter pylori, Eikenella corrodens; Anaerobic Gram-positive bacteria :  Peptococcus spp., Peptostreptococcus spp., Clostridium spp., Actinomyces israelii, Fusobacterium spp., Prevotella spp., Gram-negative Anaerobes:  Bacteroides spp.

Indications

Infections caused by sensitive strains of microorganisms:

— infections of the upper respiratory tract and ENT organs (including acute and chronic sinusitis, acute and chronic otitis media, retropharyngeal abscess, tonsillitis, pharyngitis);

— infections of the lower respiratory tract (including acute bronchitis with bacterial superinfection, chronic bronchitis, pneumonia);

— urinary tract infections;

gynecological infections;

infections of skin and soft tissues, including bites animals and humans;

infection of the bone and connective tissues;

infection of the biliary tract (cholecystitis, cholangitis);

— odontogenic infection.

Contraindications

-hypersensitivity to any of the components of the drug;

– a history of hypersensitivity to penicillins, cephalosporins and other beta-lactam antibiotics—

– a history of indications of cholestatic jaundice and/or other liver function disorders caused by taking amoxicillin/clavulanic acid;

— infectious mononucleosis and lymphocytic leukemia.

With caution, the drug should be used for a history of pseudomembranous colitis, with liver failure, severe renal impairment, as well as during lactation.

Side effects

Side effects in most cases are mild and transient.

From the digestive system:  loss of appetite, nausea, vomiting, diarrhea; rarely-abdominal pain, liver function disorders, increased activity of liver enzymes (ALT or AST); in isolated cases – cholestatic jaundice, hepatitis, pseudomembranous colitis.

Allergic reactions:  pruritus, urticaria, erythematous rash; rarely-erythema multiforme, angioedema, anaphylactic shock, allergic vasculitis; in rare cases-exfoliative dermatitis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis.

Hematopoietic and lymphatic system disorders:  rarely-reversible leukopenia (including neutropenia), thrombocytopenia; very rarely-hemolytic anemia, reversible increase in prothrombin time (when combined with anticoagulants), eosinophilia, pancytopenia.

Nervous system disorders:  dizziness, headache; very rarely – convulsions (may occur in patients with impaired renal function when taking the drug in high doses), hyperactivity, anxiety, insomnia.

From the urinary system:  very rarely – interstitial nephritis, crystalluria.

Other services:  rarely-development of superinfection (including candidiasis).

Interaction

When the drug Amoxiclav® is used simultaneously with antacids, glucosamine, laxatives, aminoglycosides, absorption slows down, with ascorbic acid – increases.

Diuretics, allopurinol, phenylbutazone, NSAIDs, and other drugs that block tubular secretion increase the concentration of amoxicillin (clavulanic acid is mainly eliminated by glomerular filtration).

Concomitant use of Amoxiclav increases the toxicity of methotrexate.

Concomitant use of Amoxiclav with allopurinol increases the incidence of exanthema.

Concomitant use with disulfiram should be avoided.

In some cases, taking the drug may prolong the prothrombin time, and therefore caution should be exercised when prescribing anticoagulants and Amoxiclav®at the same time.

The combination of amoxicillin with rifampicin is antagonistic (there is a mutual weakening of the antibacterial effect).

Amoxiclav® should not be used simultaneously with bacteriostatic antibiotics (macrolides, tetracyclines), sulfonamides due to the possible decrease in the effectiveness of Amoxiclav.

Probenecid reduces the elimination of amoxicillin by increasing its serum concentration.

Antibiotics reduce the effectiveness of oral contraceptives.

How to take, course of use and dosage

Inside.

Daily doses of suspension 400 mg + 57 mg/5 ml are calculated per 1 kg of body weight, depending on the severity of the infection and are 25-45 mg/kg of body weight/day (in terms of amoxicillin), divided into 2 doses.

To facilitate proper dosing, each package of 400 mg + 57 mg/5 ml suspension is equipped with a dosage pipette, graduated simultaneously by 1,2,3,4,5 ml and 4 equal parts.

The recommended dosage of suspensions depends on the child’s body weight and the severity of the infection.

Suspension powder 400 mg + 57 mg/5 ml: shake the bottle vigorously, add 59 ml of water (up to the mark) in two doses, shaking well each time until the powder is completely dissolved.

Overdose

There are no reports of fatal or life-threatening side effects due to overdose of the drug.

Symptoms:  in most cases – disorders of the gastrointestinal tract (abdominal pain, diarrhea, vomiting), possibly also anxiety, insomnia, dizziness; in some cases-convulsive seizures.

Treatment:  the patient should be under medical supervision; symptomatic therapy. In the case of recent use of the drug (less than 4 hours), gastric lavage should be performed and activated charcoal should be prescribed to reduce the absorption of the drug. Amoxicillin / potassium clavunate is removed by hemodialysis.

Special instructions

During the course of treatment, the functions of the hematopoietic organs, liver and kidneys should be monitored.

In patients with severe renal impairment, adequate adjustment of the dosage regimen or an increase in the intervals between dosing is required.

In order to reduce the risk of adverse reactions from the gastrointestinal tract, the drug should be taken with meals.

Laboratory tests: high concentrations of amoxicillin give a false positive reaction to urine glucose when using Benedict’s reagent or Felling’s solution. It is recommended to use enzymatic reactions with glucosidase.

Influence on the ability to drive motor vehicles and manage mechanisms

There are no data on the negative effect of Amoxiclav in the recommended doses on the ability to drive a car or work with mechanisms.

Active ingredient

Amoxicillin, Clavulanic Acid

Conditions of release from pharmacies

By prescription

Dosage form

suspension for oral use

Purpose

Children older than 3 months, Children as prescribed by a doctor

Indications

Sore Throat, Urinary Tract Infections, Bronchitis, Skin Infections, Cholecystitis, Sinusitis, Osteomyelitis, Otitis Media, Tonsillitis, Pharyngitis, Periodontitis