Amoksiklav (Amoxicillin) powder for solution for injection 250mg/62.5mg in 5ml in a 25g bottle for preparation of 100 ml of suspension— 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 appearance of the 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;
• it penetrates well 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.

Amoxiclav when prescribed to patients of different age categories and severity of the disease.

Benefits of using Amoxiclav:

• predictable efficacy and non-toxicity of penicillins;
• a wider spectrum of action compared with 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 using the suspension three times in children minimizes the development of resistance and complies with international requirements for rational antibiotic therapy.

Indications

Treatment in adults and children of bacterial infections caused by microorganisms sensitive to the preparation:

• acute bacterial sinusitis (confirmed);
• acute otitis media;
• confirmed exacerbation of chronic bronchitis;
• community-acquired pneumonia;
• cystitis;
• pyelonephritis;
• infections of the skin and soft tissues, incl. cellulite, animal bites, severe dentoalveolar abscesses with widespread cellulite;
• infections of bones and joints, incl. osteomyelitis.

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

Composition

Active ingredients in 5 ml suspension

• amoxicillin in the form of trihydrate - 125 mg
• clavulanic acid in the form of potassium salt - 31.25 mg
• Excipients: anhydrous citric acid, anhydrous sodium citrate, sodium carboxymethylcellulose-microcrystalline cellulose, xanthan gum, anhydrous colloidal silicon dioxide, silicon dioxide, strawberry flavor, sodium benzoate (E 211), sodium saccharin, mannitol (E 421).

Contraindications

Hypersensitivity to the components of the preparation, to any antibacterial agents of the penicillin group.

A history of severe hypersensitivity reactions (including anaphylaxis) associated with the use of other β-lactam agents (including cephalosporins, carbapenems or monobactams).

A history of jaundice or liver dysfunction associated with the use of amoxicillin / clavulanate.

Method of administration and dosage

Doses are indicated in units of amoxicillin / clavulanic acid.

When choosing a dose of Amoxiclav ®, you should take into account:

• expected pathogenic microorganisms and their possible sensitivity to active substances;
• the severity and localization of the infection;
• the patient's age, body weight, and renal function.

If necessary, the advisability of using alternative forms of Amoxiclav ® (for example, containing higher doses of amoxicillin and / or a different ratio of amoxicillin and clavulanic acid) should be considered.

The duration of therapy depends on the course of the disease. Treatment should not continue for more than 14 days without assessing the patient's condition.

Adults and children weighing ≥ 40 kg: 500 mg / 125 mg 3 times a day.

Children weighing <40 kg: from 20 mg / 5 mg per 1 kg of body weight per day (for mild to moderate infections) to 60 mg / 15 mg per 1 kg of body weight per day (for severe infections) in the form of three individual doses. The maximum daily dose is 2400 mg / 600 mg.

Children under 2 years of age should use a dose of no more than 40 mg / 10 mg / kg of body weight per day.

There are no clinical data on the use of Amoxiclav ® in the form of a suspension for the treatment of children under 2 months of age, therefore there are no dosage recommendations.

Mode of application

For optimal absorption and to reduce possible side effects from the digestive tract, the preparation should be taken at the beginning of a meal.

Treatment can be started with parenteral administration of the preparation, and then continue with the form of the preparation for oral administration.

Preparation of 100 ml suspension: before use, check the integrity of the lid that closes. Shake the bottle to separate the powder from the sides and bottom. Add drinking water in two portions (first in 2/3, and then up to the circular mark on the bottle in the form of a depression in the glass), shaking the bottle each time. SHAKE WELL BEFORE EACH TAKE!

Application features

Use during pregnancy or lactation

Pregnancy. Reproductive studies on animals of oral and parenteral forms of Amoxiclav did not reveal a teratogenic effect. In one study involving women with premature rupture of the membranes of the fetus, it was reported that the prophylactic use of Amoxiclav may be associated with an increased risk of necrotizing enterocolitis in newborns. As with the use of other medicines, the use of the preparation during pregnancy, especially in the first trimester, should be avoided, 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. Amoxiclav during breastfeeding can be used only when, in the opinion of the doctor, the benefit from the use will prevail the risk.

Children

The preparation in the form of a suspension is prescribed for children aged 2 months.

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

Studies to study the ability of the preparation to influence the reaction rate when driving vehicles or other mechanisms have not been carried out. However, adverse reactions (eg, allergic reactions, dizziness, convulsions) may occur that may affect the ability to drive a car or other mechanisms.

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.

Deposition of amoxicillin in bladder catheters has been reported, predominantly after high-dose administration. The patency of the catheters should be checked regularly.

Treatment

Gastrointestinal disorders can be treated symptomatically by paying attention to fluid / electrolyte balance.

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

Interaction with other medicinal products and other forms of interaction

The simultaneous use of probenecid is not recommended. Probenecid reduces the renal tubular secretion of amoxicillin. Simultaneous use with Amoxiclav ® can lead to an increase in the level of amoxicillin in the blood plasma for a long time, but does not affect the level of clavulanic acid.

Concomitant use of allopurinol during treatment with amoxicillin may increase the likelihood of allergic reactions. There are no data regarding the simultaneous use of allopurinol and Amoxiclav ®.

Like other antibiotics, Amoxiclav ® can affect the intestinal flora, which leads to a decrease in estrogen reabsorption and a decrease in the effectiveness of combined oral contraceptives.

Some reports indicate an increase in the level of the international normalized ratio (INR) in patients who are treated with acenocoumarol or warfarin and are taking amoxicillin. If such use is necessary, prothrombin time or INR level should be carefully monitored with the addition or discontinuation of treatment with a combined preparation containing amoxicillin.

Amoxiclav® should not be used in conjunction with bacteriostatic chemotherapeutic agents / antibiotics (chloramphenicol, macrolides, tetracyclines or sulfonamides), since in vitro such combinations have an antagonistic effect.

The simultaneous use of Amoxiclav ® and methotrexate may increase the toxicity of the latter (leukopenia, thrombocytopenia, skin ulceration).

With the simultaneous use of a combination of amoxicillin with clavulanic acid and mycophenolate mofetil, it was reported about a decrease in the concentration of the active metabolite of mycophenolic acid in blood plasma by about 50%. This change in pre-dose level may not fully correspond to a change in total mycophenolic acid 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 in its original packaging to protect against moisture.

Keep out of the reach of children.

Store the vial with the finished suspension tightly closed at 2-8 ° C; use within 7 days.

Shelf life is 2 years.