Amoxicar plus tab. p/o 875mg/125mg in vial. No. 14 in pack. No. 1 (amoxicillin + clavulanic acid)


Pharmacological properties

Pharmacodynamics.
mechanism of action. amoxicillin is a semisynthetic penicillin (beta-lactam antibiotic) that inhibits one or more enzymes (often called 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 weakening of the cell wall, resulting in cell lysis and death. Amoxicillin is sensitive to degradation by beta-lactamases produced by resistant bacteria; therefore, the spectrum of activity of amoxicillin in monotherapy does not include organisms that produce these enzymes.

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

Pharmacokinetics/pharmacodynamics relationship. Time exceeding the MIC (TMC) is considered the main factor determining effectiveness for amoxicillin.

Mechanisms of resistance. There are two mechanisms of resistance to amoxicillin/clavulanic acid:

- inactivation of bacterial beta-lactamases, which themselves are not inhibited by clavulanic acid, including classes B, C and D;

- transformation of PBP, which reduces the affinity of the antibacterial drug to the target.

Bacterial impermeability or the reflux pump mechanism can cause or contribute to bacterial resistance, particularly in Gram-negative bacteria.

Limit values. MIC limits for amoxicillin/clavulanic acid established by the European Committee for Antimicrobial Susceptibility Testing (EUCAST):

MicroorganismsSensitivity limits, µg/ml
SensitiveModerately sensitiveResistant
Haemophilus influenzae1≤11
Moraxella catarrhalis1≤11
Staphylococcus aureus2≤22
Coagulase-negative staphylococci2≤0,250,25
Enterococcus1≤488
Streptococcus A, B, C, G5≤0,250,25
Streptococcus pneumoniae3≤0,51—22
Enterobacteriaceae1,48
Gram-negative anaerobic bacteria1≤488
Gram-positive anaerobic bacteria1≤488
Limit values ​​that do not apply to individual species1≤24—88
1Reported values ​​for amoxicillin concentrations. For the purpose of determining sensitivity, the concentration of clavulanic acid was set at 2 mg/l.
2Reported values ​​for oxacillin concentrations.

3The limit values ​​given in the table are calculated from the limit values ​​for ampicillin.

4The resistance limit value R8 mg/l means that all strains with resistance mechanisms are declared resistant.

5The limit values ​​given in the table are calculated from the limit values ​​for benzylpenicillin.

The prevalence of resistance may vary geographically and over time for individual species, so local information regarding susceptibility is desirable, especially for severe infections. If necessary, expert opinion is required if the local prevalence of resistance is such that the benefit of the drug, at least for some types of infections, is doubtful.

Pharmacokinetics

Absorption. Amoxicillin and clavulanic acid completely dissociate in aqueous solutions at physiological pH levels. Both components are quickly and well absorbed when taken orally. The bioavailability of amoxicillin and clavulanic acid is about 70% when taken orally. The plasma profiles of both components are identical, and the time to reach plasma Cmax (Tmax) for each component is approximately 1 hour.

The serum concentrations of amoxicillin and clavulanic acid that are achieved with amoxicillin/clavulanic acid are identical to those achieved with oral administration of equivalent doses of amoxicillin or clavulanic acid alone.

Distribution. About 25% of the total volume of clavulanic acid in blood plasma and 18% of the total drug in blood plasma is protein bound. The volume of distribution is about 0.3–0.4 l/kg body weight for amoxicillin and about 0.2 l/kg for clavulanic acid.

After intravenous administration, amoxicillin and clavulanic acid were detected in the gallbladder, peritoneum, skin, adipose tissue, muscle tissue, synovial and peritoneal fluid, bile and pus. Amoxicillin is not distributed sufficiently into the CSF.

Animal studies have not revealed any evidence of significant retention of substances derived from any of the components of the drug in body tissues. Amoxicillin, like most penicillins, can be detected in breast milk. Small amounts of clavulanic acid may also be found in breast milk (see Pregnancy and Lactation).

It has been established that both amoxicillin and clavulanic acid penetrate the placental barrier (see Use during pregnancy or lactation).

Biotransformation. Amoxicillin is partially excreted in the urine as inactive penicillin acid in amounts equivalent to 10–25% of the initial dose. Clavulanic acid is largely metabolized in the human body and is excreted in urine and feces and in the form of

Product description certified by the manufacturer Lek

.
Verified
Sevryukov Alexander Viktorovich

Composition of the drug

Tablets: 500 mg amoxicillin + 125 mg clavulinic acid. Other components: primellose, derivatives of silicon, magnesium and titanium, CMC, crospovidone, povidone, PET, lactose and other substances.

Tablets: 875 mg amoxicillin + 125 mg clavulinic acid. The composition of additional components is identical to the pills described above.

Powder for preparing solutions is available in three types with different contents of active substances. The ratio of amoxicillin and clavulinic acid in 5 ml of medication:

  • 125 mg + 31.25 mg
  • 250 mg + 62.5 mg
  • 400 mg + 57.10 mg

Auxiliary ingredients are given in the same composition: silicon dioxide, food stabilizer E464 (hydroxypropyl methylcellulose), sweetener, saccharin, succinic acid, flavorings and other elements.

Note!

Description of the drug Amoxiclav Quiktab table. 875mg/125mg No. 14 on this page is a simplified author’s version of the apteka911 website, created on the basis of the instructions for use.
Before purchasing or using the drug, you should consult your doctor and read the manufacturer's original instructions (attached to each package of the drug). Information about the drug is provided for informational purposes only and should not be used as a guide to self-medication. Only a doctor can decide to prescribe the drug, as well as determine the dose and methods of its use.

Release forms

Amoxicar Plus is produced in two pharmaceutical forms:

Tablets of 500 and 845 mg of amoxicillin are oval pills enclosed in a white shell. The difference is that there is a dividing strip on the surface of the latter. The tablets are packaged in plastic bottles, enclosed with instructions in a pack of thick paper. 500 mg pills – 20 pieces each, 875 mg product – 14 pieces each.

The powder for preparing the solution is a fine, free-flowing mass of white color with the taste and aroma of orange and strawberry. The drugs are packaged in dense polyethylene bottles, placed in packs with instructions and a dosage cup: powders 125 mg/31.25 mg and 250 mg/62.5 mg - 100 ml each, product 70 mg/57 mg - 70 ml each.

Precautionary measures

Before starting treatment, it is necessary to ensure that there is no history of allergic reactions to penicillins and cephalosporins. Otherwise, rapid development of hypersensitivity up to severe conditions is possible.

If long-term therapy with Amoxicar Plus is prescribed, then during its course it is necessary to monitor the state of the hematopoietic system, liver and kidney function.

It must be taken into account that during a course of treatment with the drug, the risk of developing drug resistance in microorganisms increases.

Patients with severe kidney pathologies require dosage adjustment or an increase in the interval between doses.

To avoid the development of side effects, it is better to drink Amoxicar Plus during meals.

People with impaired diuresis may develop crystalluria. To minimize the risk of its occurrence, the required level of hydration and diuresis should be maintained during treatment.

Analogs

There are other drugs that are identical in action to Amoxicar Plus.

Amoxiclav

LEK dd (Slovenia)

Price: powder (6 flasks) – 450 rubles, tablets (15 pcs.) – 275-400 rubles, powder d/susp. 109-287 rub.

A drug with a similar composition of main components and action. The antibiotic is used to treat infections of various organs. It is produced in the form of powders for injections and oral suspensions, tablets.

Contraindications and method of use are similar to Amoxicar Plus.

Pros:

  • Treats many infections
  • Affordable price.

Flaws:

  • Large tablet size
  • May cause gastrointestinal upset.

Overdose

In most cases, the medicine is accepted by the body normally. Negative phenomena that may accompany a course of Amoxicar Plus manifest themselves in the form of:

  • Nausea, vomiting
  • Nervous excitement
  • Sleep disorders, insomnia
  • Vertigo
  • Convulsive seizures (very rare).

There is no information about the development of life-threatening conditions or fatal outcome.

To eliminate the negative consequences, first of all, you need to stop the drug, rinse the stomach (if less than four hours have passed since the last dose), and give the sorbent to drink. If necessary, hemodialysis is performed.

Mode of application

The dosage and duration of taking Amoxicar Plus is determined by the treating specialist, and many indicators are taken into account: the severity of the condition, the weight and age of the patient, concomitant diseases, kidney function, etc. The duration of the course is 2 weeks. To enhance the therapeutic effect of the drug, it is better to drink it at the beginning of the meal.

Patients (from 12 years of age) or weighing more than 40 kg are recommended to take tablets depending on their dosage. When calculating, they are guided by the content of amoxicillin:

  • (500 mg): 1 t. x 3 times (interval - 8 hours)
  • (875 mg): 1 t. x 2 times (after 12 hours).

For children under 12 years of age or weighing less than 40 kg, the dosage is calculated from the ratio of 40 mg per 1 kg of weight and the resulting amount is given in three doses.

For newborns and infants up to 3 months of age, the antibiotic is given in suspension. Proportion for dosage calculation: 25 mg of amoxicillin per kilogram of weight. Give in three doses.

For babies from 3 months, the proportion is 45 mg per kilogram, taken three times a day.

The instructions for use of Amoxicar Plus in powder form advise preparing it before the first dose. To do this, the filling of the bottle is diluted in boiled water at room temperature in the proportion recommended by the doctor. After preparation, the solution retains its healing properties for a week. Keep in the refrigerator.

Cross-drug interactions

When treating with Amoxicar Plus, it is necessary to take into account the characteristics of reactions with other drugs:

  • When combined with indirect anticoagulants, the duration of bleeding may increase.
  • It is not recommended to take an antibiotic with Probenecid due to the risk of increasing the concentration of amoxicillin in the blood.
  • Combination with Allopurinol contributes to the development of skin allergies.
  • An antibiotic may reduce the effectiveness of birth control.
  • Simultaneous use with antibiotics of other groups reduces the effect of Amoxicar. It should absolutely not be combined with Rifampicin.

Side effects

Therapy with Amoxicar Plus may be accompanied by side effects of the drug. In general, the symptoms are not very pronounced and disappear after stopping the medication. Manifest in the form:

  • Nausea, vomiting
  • Diarrhea
  • Abdominal pain
  • Failure of normal liver function, activation of its enzymes
  • Hepatitis A
  • Cholestatic jaundice
  • Skin reactions (itching, rashes)
  • Erythema
  • Disorders of the hematopoietic organs
  • Headache
  • Seizures (mainly in people with kidney pathologies after taking overdoses of drugs)
  • Excited state
  • Increased nervousness, anxiety
  • Insomnia
  • Interstitial nephritis.

Contraindications

Amoxicar Plus is not prescribed for:

  • Individual reaction of the body to the main or auxiliary components
  • History of cases of hypersensitivity to antibiotics of the penicillin, cephalosporin and lactam groups
  • If there is a history of cholestatic jaundice
  • Liver dysfunction after therapy with drugs containing the same substances as Amoxicar Plus
  • Infectious mononucleosis
  • Hereditary metabolic disorder of the amino acid phenylalanine (phenylketonuria).

Drugs should be taken with caution if there is liver failure, complex kidney pathologies, and also during breastfeeding.

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