Amoxiclav, powder for suspension 400mg+57mg/5ml,35g

Composition

5 ml of ready-made suspension. contains: Active ingredients: amoxicillin (in the form of trihydrate) 400 mg, clavulanic acid (in the form of potassium salt) 57 mg.

Auxiliary substances:

citric acid anhydrous,

sodium citrate anhydrous,

microcrystalline cellulose,

sodium carmellose,

xanthan gum,

colloidal silicon dioxide,

silicon dioxide,

sodium saccharinate,

mannitol,

flavors (strawberry, wild cherry, lemon).

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 broad 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

Infectious and inflammatory diseases caused by microorganisms sensitive to amoxicillin+clavulanic acid:  • upper respiratory tract and ENT infections (acute and chronic sinusitis, acute and chronic otitis media, pharyngeal abscess, tonsillitis, pharyngitis); • lower respiratory tract infections (acute bronchitis with bacterial superinfection, chronic bronchitis, pneumonia); • urinary tract infections (for example, cystitis, urethritis, pyelonephritis); • gynecological infections; • skin and soft tissue infections, including animal bites, etc. • bone and connective tissue infections; • biliary tract infections (cholecystitis, cholangitis); * odontogenic infections.

Contraindications

* hypersensitivity to any of the components of the drug; • history of hypersensitivity to penicillins, cephalosporins and other beta-lactam antibiotics; • a history of cholestatic jaundice and/or liver dysfunction caused by amoxicillin / clavulanic acid; • infectious mononucleosis; • lymphocytic leukemia.

With caution: with a history of pseudomembranous colitis, diseases of the gastrointestinal tract, liver failure, severe renal dysfunction, pregnancy, lactation, when used simultaneously with anticoagulants.

Side effects

Side effects in most cases are mild and transient.

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

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

Other services:  rarely – development of superinfection (including candidiasis); reversible increase in prothrombin time (when combined with anticoagulants).

Interaction

Antacids, glucosamine, laxatives, aminoglycosides slow down absorption, ascorbic acid increases absorption.

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

Concomitant use of Amoxiclav and methotrexate increases the toxicity of methotrexate.

Co-use with allopurinol increases the incidence of exanthema. Concomitant use with disulfiram should be avoided.

Reduces the effectiveness of drugs that produce paraaminobenzoic acid and ethinyl estradiol in the process of metabolism — the risk of breakthrough bleeding.

The literature describes rare cases of increased INR in patients with the combined use of acenocoumarol or warfarin and amoxicillin. If concomitant use with anticoagulants is necessary, PV or INR should be carefully monitored when prescribing or discontinuing the drug.

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

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:  abdominal pain, diarrhea, vomiting; possibly also agitation, insomnia, dizziness; in isolated cases – convulsions.

Treatment:  in 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; the patient should be under medical supervision, if necessary, symptomatic therapy should be carried out. Hemodialysis is effective.

Functional features

The main pharmacokinetic parameters of amoxicillin and clavulanic acid are similar.

Suction

Both components are well absorbed after ingestion of the drug, food intake does not affect the degree of absorption. Cmax in blood plasma is reached 1 h after use. _{Cmax values are}3-12 mcg / ml for amoxicillin (depending on the dose), and about 2 mcg/ml for clavulanic acid.

Distribution

Both components are characterized by a good volume of distribution in body fluids and tissues (lungs, middle ear, pleural and peritoneal fluids, uterus, ovaries, etc. ). Amoxicillin also penetrates synovial fluid, liver, prostate gland, palatine tonsils, muscle tissue, gallbladder, sinus secretions, saliva, bronchial secretions.

Amoxicillin and clavulanic acid do not penetrate the BBB in non-inflamed meninges.

Amoxicillin and clavulanic acid penetrate the placental barrier and are excreted in trace concentrations in breast milk. Amoxicillin and clavulanic acid are characterized by low binding to plasma proteins.

Metabolism

Amoxicillin is partially metabolized, and clavulanic acid is apparently extensively metabolized.

Deduction

Amoxicillin is excreted by the kidneys almost unchanged by tubular secretion and glomerular filtration. Clavulanic acid is eliminated by glomerular filtration, partly as metabolites. Small amounts can be excreted through the intestines and lungs. T_1/2 of amoxicillin and clavulanic acid is 1-1.5 h

. Pharmacokinetics in special clinical cases

In severe renal failure, T_1/2 increases to 7.5 hours for amoxicillin and 4.5 hours for clavulanic acid. Both components are removed by hemodialysis and minor amounts by peritoneal dialysis.

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.

Form of production

Powder for the preparation of a suspension for oral use from white to yellowish-white in color; the prepared suspension is homogeneous, from almost white to yellowish in color, homogeneous.

Active ingredient

Amoxicillin, Clavulanic Acid

Conditions of release from pharmacies

By prescription

Dosage form

suspension for oral use

Purpose

Children as prescribed by a doctor, Children over 3 months of age

Indications

Angina, Sinusitis, Pneumonia, Otitis Media, Bronchitis, Periodontitis, Urinary Tract Infections, Osteomyelitis