Amoksiklav (Amoxicillin) powder for solution for injection 1000 mg / 200 mg in vials 5pcs — Made in Poland by Sandoz — Free Delivery

Product Description

Amoxiclav is a combined preparation  that belongs to the group of beta-lactam antibiotics. Therapeutic effects are exerted by the active substances - amoxicillin - one of the best antibiotics of the penicillin series and clavulanic acid - the most powerful of the known beta-lactamase inhibitors.

The combination of these substances leads to the emergence of special properties of Amoxiclav:

• irreversible blockade of β-lactamases of microorganisms, which allows amoxicillin to have an antibacterial effect even on resistant pathogens;

• high bioavailability;

• well penetrates into most tissues and body fluids, creating a high concentration, which is necessary for the destruction of sensitive pathogenic bacteria.

The mechanism of action of amoxicillin in the composition of Amoxiclav is bactericidal activity - a violation of the synthesis of a component of the cell wall of bacteria, which causes their dissolution. Clavulanic acid is a β-lactam inhibitor and exhibits the same activity against both gram-positive and gram-negative bacteria. Protects amoxicillin from destruction by enzymes - β-lactamases, thereby expanding the spectrum of action of amoxicillin.

Benefits of using Amoxiclav:

• predictable efficacy and non-toxicity of penicillins;

• a wider spectrum of action compared to amoxicillin and oral cephalosporins due to the presence of clavulanic acid;

• applies to all age groups;

• food intake does not affect the absorption of the preparation.

Among the dosage forms, the convenience of using the Amoxiclav suspension should be noted. The product is equipped with a measuring syringe for accurate dosing. The possibility of three times application of the suspension in children minimizes the development of resistance and meets the international requirements for rational antibiotic therapy.

Indications

Amoxiclav is intended for the treatment of bacterial infections caused by microorganisms sensitive to the preparation:

• severe infections of the throat, nose, and ear (such as mastoiditis, peritonsillar infections, epiglottitis, and sinusitis with concomitant severe systemic signs and symptoms)

• exacerbation of chronic bronchitis (after confirmation of the diagnosis)

• community-acquired pneumonia

• cystitis;

• pyelonephritis;

• infections of the skin and soft tissues, including bacterial cellulitis, animal bites, severe dentoalveolar abscesses with widespread cellulite;

• infections of bones and joints, including osteomyelitis;

• intra-abdominal infections;

• genital infections in women.

Prevention of bacterial infections during extensive surgical interventions in the following areas:

• gastrointestinal tract;

• organ of the small pelvis;

• chair and neck;

• biliary tract.

When prescribing antibacterial preparations, you should be guided by the rules for their proper use.

Composition

Active ingredients: amoxicillin, clavulanic acid;

1 bottle contains 1000 mg of amoxicillin in the form of sodium salt and 200 mg of clavulanic acid in the form of potassium salt.

Amoxicillin is a semi-synthetic penicillin (beta-lactam antibiotics) that inhibits one or more enzymes, often referred to as penicillin-binding proteins (PBPs), in the biosynthetic metabolism of bacterial peptidoglycan, which is an integral structural component of the bacterial cell wall. Inhibition of peptidoglycan synthesis leads to a weakening of the cell wall, resulting in lysis and cell death.

Amoxicillin is sensitive to the degradation of beta-lactamases produced by resistant bacteria, therefore, the spectrum of activity of amoxicillin as monotherapy does not include organisms that produce these enzymes.

Clavulanic acid is a beta-lactams structurally related to penicillins. It disables some of the beta-lactamase enzymes, thereby preventing the inactivation of amoxicillin. Clavulanic acid as monotherapy does not have a clinically useful antibacterial effect.

Contraindications

Hypersensitivity to active ingredients, penicillin and other components of the preparation.

A history of a severe, immediate-type allergic reaction (eg, anaphylaxis) to another beta-lactam antibiotic (eg, cephalosporins, carbapenems, or monobactams).

A history of jaundice / liver dysfunction was caused by amoxicillin / clavulanic acid (see Adverse Reactions section).

Method of administration and dosage

Doses are given as the content of amoxicillin / clavulanic acid, unless the dose of the individual component is indicated.

When choosing a dose of a preparation to treat a specific infection, it is necessary to consider:

• expected pathogens and their suspected sensitivity to antibacterial substances (see the section "Peculiarities of use");

• severity and localization of infection;

• the age, body weight, and renal function of the patient, as described below.

If necessary, you can use alternative forms of Amoxiclav ® (for example, with large doses of amoxicillin and / or a different ratio of amoxicillin and clavulanic acid).

These dosage forms of Amoxiclav ® can be used in a daily dose of up to 3000 mg of amoxicillin and 600 mg of clavulanic acid. If it is necessary to use a higher dose of amoxicillin, a preparation with a different ratio of amoxicillin / clavulanic acid should be prescribed to avoid ultra-high daily doses of clavulanic acid.

The duration of treatment is determined by the doctor individually. Some infections (such as osteomyelitis) require long-term treatment. The duration of treatment should not exceed 14 days without evaluating the results of use and the clinical picture (see Section "Peculiarities of use").

Dosage for adults and children weighing ≥ 40 kg

The standard dose is 1000 mg / 200 mg every 8:00.

Prevention of complications during surgery.

For operations lasting less than 1:00, the recommended dose ranges from 1000 mg / 200 mg to 2000 mg / 200 mg when administered under anesthesia (a dose of 2000 mg / 200 mg can be achieved with the appropriate intravenous form of the preparation).

For operations lasting more than 1:00, the recommended dose ranges from 1000 mg / 200 mg to 2000 mg / 200 mg; when administered under anesthesia, a dose of 1000 mg / 200 mg can be administered 3 times within 24 hours.

If there are clinical signs of infection during surgery, a course of treatment with intravenous or oral administration of the preparation should be prescribed in the postoperative period.

Dosage for children weighing <40 kg.

Children 3 months and older: 25 mg / 5 mg / kg every 8:00.

Children under 3 months of age or weighing less than 4 kg: 25 mg / 5 mg / kg body weight every 12:00.

Features of preparation administration.

Amoxiclav ® is administered by intravenous injection (jet) or by periodic infusion (drip). The preparation  should not be administered intramuscularly.

For children under 3 months of age, Amoxiclav ® is prescribed only as an intravenous infusion.

Treatment can begin with the introduction of Amoxiclav ® and continue with oral forms.

Preparation of solution for intravenous injection.

500 mg / 100 mg dissolve the contents of the vial in 10 ml of water for injection (final volume 10.5 ml)

1000 mg / 200 mg dissolve the contents of the vial in 20 ml of water for injection (final volume 20.9 ml).

The reconstituted solutions have a yellowish (pale straw) color. Use only clear solutions. The solution should be used within 20 minutes after recovery, inject the preparation slowly over 3-4 minutes directly into a vein or through a catheter, drip.

Preparing solution for intravenous infusion

Reconstituted, as shown above, the 500 mg / 100 mg solution is then added without delay to 50 ml of infusion fluid or 1000 mg / 200 mg solution - up to 100 ml of infusion fluid (it is better to use a mini-container or burette). The infusion should be carried out within 30-40 minutes.

The solution for infusion is chemically and physically stable for 2-3 hours at 25 ° C or 8:00 at 5 ° C. From a microbiological point of view, it is better to inject the prepared solution immediately.

Various solvents can be used for intravenous infusion. A satisfactory concentration of the antibiotic is maintained at 5 ° C and at room temperature (25 ° C) in the recommended volumes indicated in the instructions.

Application features

Use during pregnancy or lactation

Pregnancy. Reproductive studies on animals of oral and parenteral forms of Amoxiclav ® did not reveal any teratogenic effect. One study in women with premature rupture of the membranes of the fetus reported that prophylactic use of the preparation may be associated with an increased risk of necrotizing enterocolitis in newborns. As with the use of other medicines, the use of Amoxiclav ® should be avoided during pregnancy, especially in the first trimester, unless, in the opinion of the doctor, such use is necessary.

Breastfeeding period. Both active components of the preparation are excreted in breast milk (there is no information on the effect of clavulanic acid on a breastfed infant). Accordingly, a breastfed infant may develop diarrhea and a fungal infection of the mucous membranes, so breastfeeding should be discontinued. The possibility of allergic reactions should be taken into account. During breastfeeding, Amoxiclav® can be used only when, in the opinion of the doctor, the benefit from the use will prevail the risk.

Children

Apply to children from the first days of life.

The ability to influence the reaction rate when driving or driving other mechanisms

Studies on the ability of the preparation to influence the reaction rate when driving vehicles or other mechanisms have not been conducted. However, undesirable effects (such as allergic reactions, dizziness, convulsions) may occur, which may affect the ability to drive a car or other mechanisms (see Section "Adverse Reactions").

Overdose

Symptoms Symptoms of gastrointestinal disorders and fluid and electrolyte imbalances may occur. Crystalluria was observed associated with the intake of amoxicillin, which in some cases led to renal failure (see section "Peculiarities of use").

In patients with impaired renal function and in patients taking high doses of the preparation, seizures may occur.

The sedimentation of amoxicillin in the bladder catheters was recorded, mainly after the introduction of high doses. You should regularly check the patency of the catheters (see Section "Peculiarities of use").

Treatment. The gastrointestinal tract can be treated symptomatically by paying attention to fluid / electrolyte balance.

Amoxicillin / clavulanic acid can be removed from the bloodstream by hemodialysis.

Adverse Reactions

The most commonly reported adverse reactions to the preparation were diarrhea, nausea, and vomiting.

Interaction with other medicinal products and other types of interactions

Oral anticoagulants. Oral anticoagulants and penicillin antibiotics are widely used in practice in the absence of reports of interactions. However, cases of an increase in the international normalization coefficient have been described in patients taking acenocoumarol or warfarin and in which course of treatment with amoxicillin was prescribed. If concomitant administration of preparations is necessary, the prothrombin index or the international normalization ratio (INR) should be carefully monitored when adding or discontinuing amoxicillin. In addition, it may be necessary to adjust the dose of anticoagulants for oral administration (see Sections "Peculiarities of use" and "Adverse reactions").

Methotrexate. Penicillins can reduce the excretion of methotrexate, causing a potential increase in toxicity.

Probenecid. The simultaneous use of probenecid is not recommended. Probenecid reduces the renal tubular secretion of amoxicillin. The simultaneous use of probenecid can lead to an increase in the level and duration of amoxicillin (but not clavulanic acid) in the blood.

Mofetila mycophenolate. In patients who are treated with mycophenolate mofetil, after the start of oral amoxicillin with clavulanic acid, the pre-dose concentration of the active metabolite of IFC may decrease by about 50%. This change in pre-dose level may not fully match the change in overall IFC exposure. Thus, a change in mycophenolate mofetil dosage is usually not required unless there is clinical evidence of graft dysfunction. However, close observation is necessary during joint use and for some time after antibiotic therapy.

Storage conditions

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life is 2 years.