AMOXIMED 1200 [Amoxicillin + Clavulanic Acid] 1000 + 200 mg Powder for IV solution

AMOXIMED

instructions for medical use of the medicinal product

Tradename

Amoximed, Amoximed

grouping name

Amoxicillin + Clavulanic acid, Amoxicillin + C lavulanic acid

Composition

Each vial contains:

active ingredients: amoxicillin C P (as amoxicillin sodium) 1000 mg

clavulanic acid SR (as potassium clavulanate) 200 mg

Dosage form

Lyophilized powder for solution for injection.

Pharmacotherapeutic group

Antibiotic, semi-synthetic penicillin + beta-lactamase inhibitor .

Pharmacological properties

Amoximed - a combined preparation of amoxicillin and clavulanic acid, a beta-lactamase inhibitor. It acts bactericidal, inhibits the synthesis of the bacterial wall.

Pharmacodynamics

Amoxicillin is active against aerobic gram-positive bacteria (including beta-lactamase producing strains): Staphylococcus aureus; aerobic gram-negative bacteria : Enterobacter spp., Escherichia coli, Haemophilus influenzae, Klebsiella spp., Moraxella catarrhalis. The following pathogens are sensitive only in vitro: Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus anthracis, Streptococcus pneumoniae, Streptococcus viridans, Enterococcus faecalis, Corynebacterium spp., Listeria monocytogenes; anaerobic Clostridium spp., Peptococcus spp., Peptostreptococcus spp.; as well as aerobic gram-negative bacteria (including beta-lactamase producing strains): Proteus mirabilis, Proteus vulgaris, Salmonella spp., Shigella spp., Bordetella pertussis, Yersinia enterocolitica, Gardnerella vaginalis, Neisseria meningitidis, Neisseria gonorrhoeae, Haemophilus ducreyi, Yersinia multocida ( formerly Pasteurella), Campylobacter jejuni; anaerobic gram-negative bacteria (including beta-lactamase producing strains): Bacteroides spp., including Bacteroides fragilis.

Clavulanic acid inhibits II, III, IV and V types of beta-lactamases, is not active against type I beta-lactamases produced by Pseudomonas aeruginosa, Serratia spp., Acinetobacter spp. It has a high tropism for penicillinases, due to which it forms a stable complex with the enzyme, which prevents the enzymatic degradation of amoxicillin under the influence of beta-lactamases.

Pharmacokinetics

The main pharmacokinetic parameters of amoxicillin and clavulanic acid are similar. The maximum plasma concentration after a bolus injection of 1.2 g (1000 mg + 200 mg) of the drug is 105.4 mg / l for amoxicillin and 28.5 mg / l for clavulanic acid. 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 the synovial fluid, liver, prostate gland, palatine tonsils, muscle tissue, gallbladder, sinus secretions, saliva and bronchial secretions.

Amoxicillin and clavulanic acid do not cross the blood-brain barrier in non-inflamed meninges.

The maximum concentration in body fluids is observed 1 hour after administration. Amoxicillin and clavulanic acid cross the placental barrier and are excreted in breast milk in trace concentrations.

Amoxicillin and clavulanic acid are characterized by low plasma protein binding.

Amoxicillin is partially metabolized, clavulanic acid is exposed, apparently, to an intensive metabolism.

Amoxicillin is excreted by the kidneys almost unchanged by tubular secretion and glomerular filtration. Clavulanic acid is excreted by glomerular filtration, partly as metabolites. Small amounts can be excreted through the intestines and lungs. The half-life of amoxicillin and clavulanic acid is 1-1.5 hours. In patients with severe renal insufficiency, the half-life increases to 7.5 hours for amoxicillin and up to 4.5 hours for clavulanic acid.

Both components are removed by hemodialysis and minor amounts by peritoneal dialysis.

Indications for use

Treatment of infectious and inflammatory diseases caused by susceptible pathogens:

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

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

- infections of the genitourinary system and pelvic organs (pyelonephritis, pyelitis, cystitis, urethritis, prostatitis, cervicitis, salpingitis, salpingo-oophoritis, tubo-ovarian abscess, endometritis, bacterial vaginitis, septic abortion, postpartum sepsis, pelvic peritonitis, soft chancre, gonorrhea);

- infections of the skin and soft tissues (erysipelas, impetigo, secondarily infected dermatoses, abscess, phlegmon, wound infection); osteomyelitis;

- infections of bone and connective tissues;

- infections of the abdominal cavity, incl. biliary tract (cholecystitis, cholangitis);

- odontogenic infections;

- postoperative infections, prevention of infections after surgical interventions.

Contraindications

- hypersensitivity to amoxicillin and other penicillins, clavulanic acid, to other beta-lactam antibiotics (cephalosporins, carbapenems, monobactams);

- cholestatic jaundice and / or other abnormal liver function caused by the use of amoxicillin / clavulanic acid in history;

- infectious mononucleosis and lymphocytic leukemia.

Dosage and administration

Intravenously.

The dosage regimen depends on the severity of the infection, the age, body weight and renal function of the patient.

Adults and children over 12 years old and weighing more than 40 kg

Mild to moderate infections: 1000 mg/200 mg every 8 hours.

Severe infections: 1000 mg/200 mg every 4 to 6 hours.

Prevention in surgery

Surgical interventions lasting less than 1 hour: 1000 mg / 200 mg during induction of anesthesia.

Surgical interventions lasting more than 1 hour: 1 dose of 1000 mg / 200 mg during induction of anesthesia and then up to 4 doses of 1000 mg / 200 mg within 24 hours.

Patients with impaired night function

Dosing adjustments are based on the maximum recommended dose of amoxicillin.

Patients on hemodialysis

Dosing adjustments are based on the maximum recommended dose of amoxicillin. The initial dose is 1000 mg / 200 mg, then 500 mg / 100 mg every 24 hours and an additional 500 mg / 100 mg at the end of the hemodialysis session (to compensate for the decrease in the concentration of amoxicillin and clavulanic acid in the blood plasma).

Patients with impaired liver function

Treatment is carried out with caution; regularly monitor liver function. Elderly patients

Dose adjustment is not required.

Children

For children weighing less than 40 kg, the dose is calculated depending on body weight.

Less than 3 months weighing less than 4 kg (25 mg/5 mg)/kg every 12 hours

Less than 3 months of age with a body weight of more than 4 kg (25 mg / 5 mg) / kg every 8 hours.

In children under the age of 3 months, the drug is administered only slowly by infusion over 30-40 minutes.

From 3 months to 12 years

(25mg/5mg)/kg every 6-8 hours depending on the severity of the infection

Children with impaired renal function

Dosing adjustments are based on the maximum recommended dose of amoxicillin

Children on hemodialysis

Adjustment of dosing regimen is based on the maximum recommended dose of amoxicillin - (25 mg / 5 mg) / kg every 24 hours and additionally (12.5 mg / 2.5) mg / kg at the end of the hemodialysis session (to compensate for the decrease in the concentration of amoxicillin and clavulanic acid in blood plasma) and further (25 mg / 5 mg) / kg per day.

Children with impaired liver function

Treatment is carried out with caution; regularly monitor liver function.

Preparation of solutions for intravenous injections.

Bolus intravenous injection

Dissolve the contents of a 1.2 g vial (1000 mg + 200 mg) in 20 ml of water for injection. Inject the finished solution slowly over 3-4 minutes directly into a vein or through a catheter.

The resulting solution must be administered within 20 minutes after dilution.

Infusion administration

To prepare a solution for infusion administration, further dilution of the bolus solution prepared as described above is necessary: the prepared solution containing 1.2 g (1000 mg + 200 mg) of the drug is added to 100 ml of one of the infusion solutions: 0.9% sodium chloride solution, sodium lactate solution for intravenous administration, Ringer's solution, Hartman's lactate Ringer's solution. The duration of the infusion is 30-40 minutes.

The course of treatment is 5-14 days. With a decrease in the severity of symptoms, a transition to oral forms of the drug is recommended to continue therapy.

Special instructions and precautions

In patients with hypersensitivity to penicillins, cross-allergic reactions with cephalosporin antibiotics are possible.

This combination is not recommended for suspected infectious mononucleosis.

Use with caution in patients with impaired liver and kidney function.

During the course of treatment, it is necessary to monitor the state of the function of the hematopoietic organs, liver and kidneys.

Perhaps the development of superinfection due to the growth of microflora insensitive to it, which requires a corresponding change in antibiotic therapy.

When using high doses of amoxicillin, it is necessary to maintain adequate fluid intake and diuresis to reduce the likelihood of amoxicillin crystal formation.

Influence on the ability to drive vehicles and control mechanisms

Due to the possibility of developing side effects from the central nervous system, such as: dizziness, headache, convulsions, during treatment, care should be taken when driving and engaging in other activities that require concentration and speed of psychomotor reactions.

Use during pregnancy and during breastfeeding

During pregnancy and during breastfeeding