PANCLAV 2X
Pharmacokinetics
The main pharmacokinetic parameters of amoxicillin and clavulanic acid are similar.
Both components are well absorbed after oral administration; food intake does not affect the degree of absorption. Bioavailability is 90% for amoxicillin and 70% for clavulanic acid. Peak plasma concentrations are reached approximately 2 - 2.5 hours after administration. The maximum concentration of amoxicillin in the blood (Cmax) is about 12 μg/ml, clavulanic acid is 3.3 μg/ml. The half-life (T1/2) of amoxicillin and clavulanic acid is 1-1.5 hours. Connection with plasma proteins: amoxicillin - about 18%, clavulanic acid - 25%. The apparent volume of distribution of amoxicillin is 0.3 - 0.4 l/kg, clavulanic acid - 0.2 l/kg.
Both components are found in many organs and tissues of the body, biological fluids and pathological discharge: amoxicillin - in lung tissue, bronchial secretions and saliva; in the skin, subcutaneous, muscle and fatty tissues, in the palatine tonsils; in bone tissue and synovial fluid; intestinal mucosa, liver, gall bladder, bile, female genital organs, fetal tissues; pleural and peritoneal fluid, the contents of skin blisters, sputum, bronchial secretions (to a lesser extent in purulent discharge), in exudate from inflammation of the middle ear and paranasal sinuses; clavulanic acid - in the palatine tonsils, abdominal organs, bone, muscle and fatty tissues, synovial and peritoneal fluids, bile and purulent discharge. Neither the active components of Panclava 2X nor their metabolites accumulate in any organs or tissues.
Amoxicillin and clavulanic acid do not penetrate the intact blood-brain barrier.
Amoxicillin and clavulanic acid penetrate the placental barrier and into breast milk.
Amoxicillin is partially (10 - 25% of the absorbed dose) metabolized to inactive penicillic acid; clavulanic acid is extensively metabolized, its metabolites are excreted from the body through the kidneys, intestines and lungs.
Amoxicillin is excreted primarily by the kidneys by tubular secretion and glomerular filtration. The total clearance of the amoxicillin/clavulanic acid combination is 25 l/h. During the first 6 hours after a single dose of the drug, 60% and 40% of the administered dose of amoxicillin and clavulanic acid, respectively, are excreted from the body unchanged.
Both components are removed by hemodialysis, and to a lesser extent by peritoneal dialysis.
Elderly patients:
Due to the possible age-related decrease in renal excretory function, use with caution is recommended.
In patients with severe renal failure
The half-life increases to 7.5 hours for amoxicillin and to 4.5 hours for clavulanic acid.
Panclave 2 tabs p/o film 875mg + 125mg jar 14 pcs
Pharmacological group:
Antibiotic - semi-synthetic penicillin + beta-lactamase inhibitor.
Pharmacodynamics:
Mechanism of action Amoxicillin is a semisynthetic broad-spectrum antibiotic with activity against many gram-positive and gram-negative microorganisms. At the same time, amoxicillin is susceptible to destruction by beta-lactamases, and therefore the spectrum of activity of amoxicillin does not extend to microorganisms that produce these enzymes. Clavulanic acid is a beta-lactamase inhibitor, structurally related to penicillins, and has the ability to inactivate a wide range of beta-lactamases found in microorganisms resistant to penicillins and cephalosporins. Clavulanic acid is sufficiently effective against plasmid beta-lactamases, which most often cause bacterial resistance, and is not effective against type 1 chromosomal beta-lactamases, which are not inhibited by clavulanic acid. The presence of clavulanic acid in the drug Panklav 2X protects amoxicillin from destruction by enzymes - beta-lactamases, which allows expanding the antibacterial spectrum of amoxicillin.
Below is the activity of the combination of amoxicillin and clavulanic acid in vitro.
Bacteria usually sensitive to the combination of amoxicillin with clavulanic acid Gram-positive aerobes: Bacillus anthracis, Enterococcus faecalis, Nocardia asteroides, Listeria monocytogenes, Streptococcus pyogenes1,2, Streptococcus agalactiae1,2, Streptococcus spp. (other beta-hemolytic streptococci) 1,2, Staphylococcus aureus (sensitive to methicillin) 1, Staphylococcus saprophyticus (sensitive to methicillin), coagulase-negative staphylococci (sensitive to methicillin).
Gram-negative aerobes: Bordetella pertussis, Haemophilus influenzae1,2, Helicobacter pylori, Moraxella catarrhalis1,2, Neisseria gonorrhoeae, Pasteurella multocida, Vibrio cholera.
Gram-positive anaerobes: Clostridium spp., Peptococcus niger, Peptostreptococcus magnus, Peptostreptococcus micros, Peptostreptococcus spp.
Gram-negative anaerobes: Bacteroides spp., Bacteroides fragilis, Capnocytophaga spp., Eikenella corrodens, Fusobacterium nucleatum, Fusobacterium spp., Porphyromonas spp., Prevotella spp. Other: Borrelia burgdorferi, Leptospira icterohaemorrhagiae, Treponema pallidum.
Bacteria for which acquired resistance to the combination of amoxicillin with clavulanic acid is likely Gram-negative aerobes: Escherichia coli1, Klebsiella oxytoca, Klebsiella pneumoniae1, Klebsiella spp., Proteus mirabilis, Proteus vulgaris, Proteus spp., Salmonella spp., Shigella spp.
Gram-positive aerobes: Corynebacterium spp., Enterococcus faecium, Streptococcus pneumoniae1,2, Viridans group streptococci.
Bacteria that are naturally resistant to the combination of amoxicillin and clavulanic acid Gram-negative aerobes: Acinetobacter spp., Citrobacter freundii, Enterobacter spp., Hafnia alvei, Legionella pneumophila, Morganella morganii, Providencia spp., Pseudomonas spp., Serratia spp., Stenotrophomonas maltophilia, Yersinia enterocolitica.
Other: Chlamydia pneumoniae, Chlamydia psittaci, Chlamydia spp., Coxiella burnetii, Mycoplasma spp. 1 - for these bacteria, the clinical effectiveness of the combination of amoxicillin with clavulanic acid has been demonstrated in clinical studies.
2 - strains of these types of bacteria do not produce beta-lactamases. Sensitivity during amoxicillin monotherapy suggests similar sensitivity to the combination of amoxicillin and clavulanic acid.
Pharmacokinetics:
The main pharmacokinetic parameters of amoxicillin and clavulanic acid are similar. Both components are well absorbed after oral administration; food intake does not affect the degree of absorption. Bioavailability is 90% for amoxicillin and 70% for clavulanic acid. Peak plasma concentrations are reached approximately 2 - 2.5 hours after administration. The maximum concentration of amoxicillin in the blood (Cmax) is about 12 μg/ml, clavulanic acid is 3.3 μg/ml. The half-life (T1/2) of amoxicillin and clavulanic acid is 1-1.5 hours.
Connection with plasma proteins: amoxicillin - about 18%, clavulanic acid - 25%. The apparent volume of distribution of amoxicillin is 0.3 - 0.4 l/kg, clavulanic acid - 0.2 l/kg.
Both components are found in many organs and tissues of the body, biological fluids and pathological discharge: amoxicillin - in lung tissue, bronchial secretions and saliva; in the skin, subcutaneous, muscle and fatty tissues, in the palatine tonsils; in bone tissue and synovial fluid; intestinal mucosa, liver, gall bladder, bile, female genital organs, fetal tissues; pleural and peritoneal fluid, the contents of skin blisters, sputum, bronchial secretions (to a lesser extent in purulent discharge), in exudate from inflammation of the middle ear and paranasal sinuses; clavulanic acid - in the palatine tonsils, abdominal organs, bone, muscle and fatty tissues, synovial and peritoneal fluids, bile and purulent discharge. Neither the active components of Panclava 2X nor their metabolites accumulate in any organs or tissues.
Amoxicillin and clavulanic acid do not penetrate the intact blood-brain barrier.
Amoxicillin and clavulanic acid penetrate the placental barrier and into breast milk.
Amoxicillin is partially (10 - 25% of the absorbed dose) metabolized to inactive penicillic acid; clavulanic acid is extensively metabolized, its metabolites are excreted from the body through the kidneys, intestines and lungs.
Amoxicillin is excreted primarily by the kidneys by tubular secretion and glomerular filtration. The total clearance of the amoxicillin/clavulanic acid combination is 25 l/h. During the first 6 hours after a single dose of the drug, 60% and 40% of the administered dose of amoxicillin and clavulanic acid, respectively, are excreted from the body unchanged.
Both components are removed by hemodialysis, and to a lesser extent by peritoneal dialysis.
Elderly patients: due to the possible age-related decrease in renal excretory function, use with caution is recommended.
In patients with severe renal impairment, the half-life increases to 7.5 hours for amoxicillin and to 4.5 hours for clavulanic acid.
Panclave 2X tablets 875 mg + 125 mg 14 pcs. in Novosibirsk
Inside,
drinking water; at the beginning of a meal (in order to reduce the risk of side effects from the gastrointestinal tract), 2 times a day, strictly observing the interval between doses of 12 hours.
Film-coated tablets
Adults and children over 12 years of age (body weight ≥40 kg)
Take 1 tablet. 2 times a day, every 12 hours.
The maximum daily dose of amoxicillin for adults is 6 g, for children - 45 mg/kg/day.
The maximum daily dose of clavulanic acid for adults (in the form of potassium clavulanate) is 600 mg, for children - 10 mg/kg/day.
The course of treatment is 5–14 days; is established individually, taking into account the characteristics of the pathogen, localization and severity of the infection. Treatment should not continue for more than 14 days without repeated medical examination.
Dosing for renal failure
Tablets 875/125 mg should be used only in patients with Cl creatinine more than 30 ml/min, and no dose adjustment is required.
Patients on peritoneal dialysis do not require dose adjustment. Patients on hemodialysis may require dose adjustment of the drug.
Powder for suspension for oral administration
Dosage with a measuring spoon, taking into account that 5 ml of the finished suspension contains amoxicillin 400 mg/clavulanic acid 57 mg. Take with 0.5–1 glass of water.
The dose of Panclava 2X is prescribed by a doctor, taking into account the characteristics of the pathogen, the location and severity of the infection. The dosage regimen is set individually, depending on age, body weight (for children) and kidney function. The course of treatment is 5–14 days; installed individually.
For infections that require a long course of therapy (for example, osteomyelitis), exceeding the maximum recommended course of therapy of 14 days is possible only after a thorough assessment by the doctor of the patient’s condition, the achieved and expected therapeutic effects and risks.
The maximum daily dose of amoxicillin for adults is 6 g, for children - 45 mg/kg/day. The maximum daily dose of clavulanic acid for adults (in the form of potassium clavulanate) is 600 mg, for children - 10 mg/kg/day.
Adults and children over 12 years of age (body weight ≥40 kg)
Standard dosage regimen for all indications:
2 scoops (800/114 mg) 2 times a day, every 12 hours.
Children from 2 to 12 years (body weight ≥40 kg)
| Daily dose (for amoxicillin) | Child's weight | Age appropriate | Amount of finished suspension |
| 25 mg/kg | 13–21 kg | 2–6 years | 2.5 ml 2 times a day |
| 22–40 kg | 7–12 years | 5 ml 2 times a day | |
| 45 mg/kg | 13–21 kg | 2–6 years | 5 ml 2 times a day |
| 22–40 kg | 7–12 years | 10 ml 2 times a day |
Children from 3 months to 3 years
| Child's weight | Daily dose 25 mg/kg (for amoxicillin) | Daily dose 45 mg/kg (for amoxicillin) |
| 5 kg | 0.8 ml 2 times a day | 1.4 ml 2 times a day |
| 6 kg | 0.9 ml 2 times a day | 1.7 ml 2 times a day |
| 7 kg | 1.1 ml 2 times a day | 2 ml 2 times a day |
| 8 kg | 1.3 ml 2 times a day | 2.3 ml 2 times a day |
| 9 kg | 1.4 ml 2 times a day | 2.5 ml 2 times a day |
| 10 kg | 1.6 ml 2 times a day | 2.8 ml 2 times a day |
| 11 kg | 1.7 ml 2 times a day | 3.1 ml 2 times a day |
| 12 kg | 1.9 ml 2 times a day | 3.4 ml 2 times a day |
The daily dose for children over 3 months and up to 12 years (body weight ≥40 kg) is 25–45 mg/kg/day (based on amoxicillin), divided into two doses every 12 hours. Low doses of the drug (25 mg /kg/day) are used to treat skin and soft tissue infections, as well as recurrent tonsillitis. High doses of the drug (45 mg/kg/day) are used to treat diseases such as otitis media, sinusitis, lower respiratory tract and urinary tract infections. The duration of treatment for acute uncomplicated otitis media is 5–7 days, in children – 7–10 days.
Children and adults with kidney failure
When creatinine Cl is less than 30 ml/min, the drug at this dose is not recommended; if creatinine Cl is more than 30 ml/min, there is not enough substantiated data to develop special recommendations on the dosage regimen. Both a reduction in the dose of the drug and an increase in the interval between doses are allowed.
Preparation of suspension for oral administration
Water is gradually added to the bottle with the powder up to the mark (distilled water or boiled and cooled) and shaken until the powder is evenly wet (about 30 s). If the level of the prepared suspension is below the mark on the bottle label, add water again to the mark and shake.
The prepared suspension must be shaken before each dose.
Important!
If a dose is missed, you should take the tablet (or suspension) as soon as possible without waiting for the next dose.
Next, observe equal intervals of time between doses - 12 hours each. You should never take a double dose to make up for a missed dose of medication!
Release form
Film-coated tablets, 875 mg + 125 mg. 14 tablets each. in a brown glass jar (type III), sealed with a plastic lid with silica gel and tamper evident. 1 jar is placed in a cardboard pack.
Powder for the preparation of suspension for oral administration, (400 mg + 57 mg)/5 ml. 15 g or 30 g of powder in a glass bottle of III hydrolytic class, sealed with a screw-on plastic cap with first opening control. On the top side of the cap there is a diagram for opening the bottle. 1 fl. complete with a measuring spoon, volume 5 ml, with a line for volume 2.5 ml, placed in a cardboard pack.
Nosological classification (ICD-10)
- H66.9 Otitis media, unspecified
- J01 Acute sinusitis
- J02 Acute pharyngitis
- J03 Acute tonsillitis [tonsillitis]
- J06 Acute upper respiratory tract infections of multiple and unspecified localization
- J18 Pneumonia without specifying the pathogen
- J20 Acute bronchitis
- J22 Acute respiratory infection of the lower respiratory tract, unspecified
- J31.2 Chronic pharyngitis
- J32 Chronic sinusitis
- J35.0 Chronic tonsillitis
- J36 Peritonsillar abscess
- J42 Chronic bronchitis, unspecified
- K81 Cholecystitis
- K83.0 Cholangitis
- L08.9 Local infection of skin and subcutaneous tissue, unspecified
- M00.9 Pyogenic arthritis, unspecified (infectious)
- M79.9 Soft tissue disease, unspecified
- M86 Osteomyelitis
- M89.9 Bone disease, unspecified
- N39.0 Urinary tract infection without established location
- N73.9 Inflammatory diseases of the female pelvic organs, unspecified
- Z01.2 Dental examination
Compound
| Film-coated tablets | 1 table |
| core | |
| active substances: | |
| amoxicillin (as amoxicillin trihydrate) | 875 mg |
| clavulanic acid (in the form of a mixture of potassium clavulanate and MCC (1:1) | 125 mg |
| excipients: MCC - 510.35 mg; sodium carboxymethyl starch (type A) - 32.8 mg; magnesium stearate - 32 mg; colloidal silicon dioxide anhydrous - 24 mg; butylhydrocyanisole - 0.85 mg | |
| film shell: hypromellose - 34.84 mg; titanium dioxide E171 - 17.42 mg; propylene glycol - 8.17 mg; talc - 3.57 mg |
| Powder for the preparation of suspension for oral administration (ready-made suspension) | 5 ml |
| active substances: | |
| amoxicillin (as amoxicillin trihydrate) | 400 mg |
| clavulanic acid (in the form of a mixture of potassium clavulanate and syloid (1:1) | 57 mg |
| excipients: silicon dioxide - 436.143 mg; hypromellose - 100 mg; sodium saccharinate - 10 mg; xanthan gum - 10 mg; colloidal silicon dioxide - 3.2 mg; succinic acid - 1.5 mg; strawberry flavor - 53.571 mg |
