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Instructions for use HICONCIL

Suction

It is quickly and almost completely (90%) absorbed from the gastrointestinal tract. Eating does not affect absorption, the drug is not destroyed in the acidic environment of the stomach. Cmax in blood plasma is achieved 1 - 2 hours after oral administration. Concentration in blood plasma depends on the dose. The half-life is 60-90 minutes. In patients with renal failure, the half-life increases to 7 hours. The minimum concentration of amoxicillin in the blood plasma is determined another 8 hours after administration. After taking high doses, plasma and tissue concentrations increase. After taking amoxicillin in standard doses

40-45 mg/kg/day in two doses, concentrations in middle ear fluid found in studies ranged from 1 to 6 mcg/ml. At doses of 70 to 90 mg/kg/day given in two divided doses, determined amoxicillin concentrations were higher but ranged from 3 to 8 mcg after 3 hours. Amoxicillin does not accumulate in the body.

Distribution

The volume of distribution of amoxicillin is 0.3 l/kg body weight. Approximately 15-25% of amoxicillin is bound to plasma proteins. Amoxicillin penetrates well into tissues and biological fluids of the body. Cmax in biological fluids of the body is achieved 1 hour after reaching Cmax in blood plasma. Therapeutic concentrations are determined in the lungs, liver, lymph glands, uterus, lungs, mucous membrane of the paranasal sinuses, middle ear and sinus exudate. Penetrates into the exudate of the middle ear cavity. The concentration of amoxicillin is higher than in the mucous secretion of the respiratory tract. The concentration of amoxicillin in bile is 10 times higher than in blood plasma. In case of blockage of the bile ducts, the penetration of amoxicillin into the bile is minimal.

Amoxicillin penetrates into the brain tissue and cerebrospinal fluid. The degree of penetration is higher with inflammation of the brain membranes. Does not penetrate prostate tissue.

Amoxicillin crosses the placental barrier and enters the fetal circulation. Approximately 50% of the maternal plasma concentration of amoxicillin can be detected in cord blood and amniotic fluid. Amoxicillin is excreted into breast milk in small quantities.

Removal

Amoxicillin is excreted by the kidneys through glomerular filtration and tubular secretion. 50-70% of the dose taken orally is excreted unchanged in the urine, in which, after taking a dose of 250 mg, concentrations of 0.3-1.3 g/l are found. Probenecid inhibits tubular secretion. About 10-20% of amoxicillin is metabolized. The beta-lactam ring is metabolized to penicillic acid, which is excreted by the kidneys. A minimal amount is excreted in bile. After a dose of 3 g, the average concentrations found in bile are 19 mcg/ml. Concomitant use of probenecid increases the level of amoxicillin in bile. This is the minimal intrahepatic circulation of amoxicillin. The highest concentration of amoxicillin is found in breast milk, reached 5 hours after an oral dose of 1 g and is 0.81 mg/ml.

Only acute renal failure affects the pharmacokinetics of amoxicillin. Thus, dose adjustment is necessary.

Creatinine clearance	1.33-0.83	0.83-0.16	<0,16
ml/min	(80-50)	(50-10)	(10)
Amoxicillin dose
250-500 mg	8 ocloc'k	8-12 hours	12-24 hours

With peritoneal dialysis, no correction of the vine is required.

Hemodialysis removes 85% of amoxicillin. Thus, after stopping hemodialysis, the normal dose should be taken.

The pharmacokinetics of amoxicillin in children over 2 years of age is almost the same as in adults. In children aged 1-2 years, excretion occurs slightly faster; thus Cmax is reached earlier. In newborns, amoxicillin is excreted more slowly than in adults and T1/2 is longer - 3.7-4 hours.

Combination of amoxicillin with other antibiotics

Amoxicillin can be combined with aminoglycosides. This combination acts synergistically.

Amoxicillin can also be combined with quinolones.

However, it is not recommended to combine amoxicillin with bacteriostatic antibiotics (macrolides, tetracyclines) or other beta-lactam antibiotics (cephalosporins, monobactams).

Hiconcil 500 mg No. 16 caps

Trade name Hiconcil International nonproprietary name Amoxicillin Dosage form Capsules 250 mg and 500 mg Composition One capsule contains the active substance: amoxicillin trihydrate 292.74 mg or 585.48 mg (equivalent to amoxicillin 250 mg or 500 mg) excipients: colloidal anhydrous silicon dioxide, magnesium stearate, composition capsule shells: gelatin, titanium dioxide (E 171), iron (III) oxide yellow (E172), iron (III) oxide red (E 172), azorubine (carmoisine) (E122), indigo carmine (E132) Description Hard opaque gelatin capsules size No. 2 (for a dosage of 250 mg) or No. 0 (for a dosage of 500 mg). The capsule body is beige to pink, the cap is brown to dark burgundy. The contents of the capsules are granular powder from white to slightly yellowish. Pharmacotherapeutic group Antimicrobial drugs for systemic use. Beta-lactam antibacterial drugs. Broad-spectrum penicillins. Amoxicycline. ATC code J01CA04 Pharmacological properties Pharmacokinetics Absorption Amoxicillin is stable in the acidic environment of gastric juice, about 90% of the dose taken is absorbed in the small intestine. Eating does not affect the absorption of amoxicillin. The maximum plasma concentration is reached 1 to 2 hours after oral administration and is about 5 mcg/ml after taking a dose of 250 mg and 10 mcg/ml after taking a dose of 500 mg. The half-life of amoxicillin in patients with normal renal function is 60 to 90 minutes. In patients with renal failure, the half-life increases to 7 hours. The minimum concentration of amoxicillin in the blood plasma is detected 8 hours after administration. Distribution: 15–20% of amoxicillin is bound to plasma proteins. Amoxicillin penetrates well into tissues and biological fluids of the body. The maximum concentration in biological fluids of the body is achieved 1 hour after reaching the maximum concentration in the blood plasma. Therapeutic concentrations are determined in the lungs, liver, lymph glands, uterus, ovaries, and mucous membrane of the paranasal sinuses. Penetrates into the exudate of the middle ear cavity. The concentration of amoxicillin in purulent exudate is higher than in the mucous secretion of the respiratory tract. Amoxicillin also penetrates into the pleural and peritoneal fluids and is concentrated in saliva and tears. The concentration of amoxicillin in bile is 10 times higher than in blood plasma. In case of blockage of the bile ducts, amoxicillin penetrates minimally into the bile ducts. Amoxicillin weakly penetrates the blood-brain barrier (BBB) and cerebrospinal fluid, does not penetrate prostate tissue, penetration through the BBB increases during inflammatory processes. Amoxicillin penetrates the placental barrier and enters the fetal circulation. Approximately 50% of the amoxicillin concentration is determined in fetal blood and amniotic fluid compared to maternal blood plasma. Amoxicillin passes into breast milk in minimal quantities. Excretion Amoxicillin is excreted through the kidneys by glomerular filtration and tubular secretion. From 50% to 70% of an oral dose is excreted in unchanged active form in the urine, where after taking a dose of 250 mg, concentrations range from 0.3 to 1.3 g/l. Between 10% and 20% of amoxicillin is metabolized. The beta-lactam ring is metabolized to penicillic acid, which is excreted in the urine. A minimal amount of amoxicillin is excreted in the bile. Following a 3 g dose, mean bile concentrations were 19 mcg/mL. Enterohepatic circulation of amoxicillin is minimal. The maximum concentration of amoxicillin in breast milk, achieved 5 hours after ingestion of a dose of 1 g, is 0.81 mcg/ml. In severe renal failure, dose adjustment is necessary. Creatinine clearance ml/s (ml/min) 1.33–0.83 (80–50) 0.83–0.16 (50–10) <0.16 (<10) Amoxicillin dose 250 mg – 500 mg 8 hours 8–12 hours 12–24 hours When Peritoneal dialysis does not require dose adjustment. Hemodialysis removes 85% of amoxicillin and therefore the recommended dose should be administered after hemodialysis is stopped. Pharmacodynamics The effect of amoxicillin on bacterial cells Hiconcil suppresses the last phase of bacterial cell wall formation by inhibiting the action of transpeptidases, enzymes involved in the synthesis of peptidoglycan, which is an important component of the bacterial cell wall. Bacteria produce several types of penicillin-binding proteins (PBPs). Penicillin antibiotics inhibit the action of one or more transpeptidases. Impaired peptiglycan synthesis leads to the development of a defective cell wall, which is osmotically unstable and leads to the death of the bacterial cell. Penicillins also appear to be involved in bacterial wall disruption by inhibiting the action of an inhibitor of murein hydrolase, an enzyme that is associated with cell division. Thus, amoxicillin is a bactericidal antibiotic. The time it takes for the antibiotic concentration to reach the minimum inhibitory concentration (T>MIC) is a very important factor for the successful treatment of bacterial infections with beta-lactam antibiotics. When reaching 40% of the dosing time, the maximum clinical effect of amoxicillin may develop. Antibacterial spectrum of action Amoxicillin is effective against gram-positive and some gram-negative microorganisms. Compared to penicillin, amoxicillin is less effective against Streptococcus pyogenes, Streptococcus pneumoniae and Streptococcus agalactiae; however, penicillin is more effective against enterococci and Listeria monocytogenes. The effects of amoxicillin on gram-positive anaerobic bacteria and Neisseria species are the same as those of penicillin. Because beta-lactamases destroy amoxicillin, they are ineffective against beta-lactamase-producing strains and therefore have no effect on most strains of staphylococci. Strains of Haemophilus influenzae, Haemophilus parainfluenzae, E. coli, Salmonella species. and Shigella, which do not produce beta-lactamases, are sensitive to amoxicillin. Most other gram-negative bacteria are resistant to amoxicillin. Table 1. Bacteria sensitive to amoxicillin *: Gram-positive bacteria Gram-negative bacteria Streptococcus pneumoniae Haemophilus influenzae Streptococcus pyogenes pyogenes Escherichia coli Streptococcus viridans Proteus mirabilis Streptococcus agalactiae Salmonella spp. Staphylococcus aureus Shigella spp. Enterococcus faecalis Neisseria spp. Bacillus anthracis Bordetella pertussis Listeria monocytogenes Brucella spp. Corynebacterium spp. Vibrio cholerae Clostridium spp. Pasteurella septica Helicobacter pylori

Hiconcil 250 mg/5 ml 100 ml por.d/susp. for oral administration

Trade name HICONCIL International nonproprietary name Amoxicillin Dosage form Powder for the preparation of suspension for oral administration 250 mg/5 ml Composition 5 ml of suspension contain the active substance - amoxicillin trihydrate 287.0 mg (equivalent to amoxicillin 250 mg) excipients: anhydrous citric acid, sodium benzoate, aspartame (E951), talc, sodium citrate anhydrous, lemon powder flavor, peach-apricot powder flavor, orange powder flavor, galactomannan guar gum, precipitated silicon dioxide Description Powder from white to slightly yellowish in color with a fruity odor. A suspension prepared in an appropriate amount of water is white to slightly yellowish in color with a fruity odor. Pharmacotherapeutic group Antimicrobials for systemic use. Beta-lactam antibacterial drugs. Broad-spectrum penicillins. Amoxicycline. ATC code J01CA04 Pharmacological properties Pharmacokinetics Absorption Amoxicillin is stable in the acidic environment of gastric juice, about 90% of the dose taken is absorbed in the small intestine. Eating does not affect the absorption of amoxicillin. The maximum plasma concentration is reached 1-2 hours after oral administration and is about 5 mcg/ml after taking a dose of 250 mg and 10 mcg/ml after taking a dose of 500 mg. The half-life of amoxicillin in patients with normal renal function is 60 to 90 minutes. In patients with renal failure, the half-life increases to 7 hours. The minimum concentration of amoxicillin in the blood plasma is detected 8 hours after administration. Distribution: 15–20% of amoxicillin is bound to plasma proteins. Amoxicillin penetrates well into tissues and biological fluids of the body. The maximum concentration in biological fluids of the body is achieved 1 hour after reaching the maximum concentration in the blood plasma. Therapeutic concentrations are determined in the lungs, liver, lymph glands, uterus, ovaries, and mucous membrane of the paranasal sinuses. Penetrates into the exudate of the middle ear cavity. The concentration of amoxicillin in purulent exudate is higher than in the mucous secretion of the respiratory tract. Amoxicillin also penetrates into the pleural and peritoneal fluids and is concentrated in saliva and tears. The concentration of amoxicillin in bile is 10 times higher than in blood plasma. In case of blockage of the bile ducts, amoxicillin penetrates minimally into the bile ducts. Amoxicillin weakly penetrates the blood-brain barrier (BBB) and cerebrospinal fluid, does not penetrate prostate tissue, penetration through the BBB increases during inflammatory processes. Amoxicillin penetrates the placental barrier and enters the fetal circulation. Approximately 50% of the amoxicillin concentration is determined in fetal blood and amniotic fluid compared to maternal blood plasma. Amoxicillin passes into breast milk in minimal quantities. Excretion Amoxicillin is excreted through the kidneys by glomerular filtration and tubular secretion. From 50% to 70% of an oral dose is excreted in unchanged active form in the urine, where after taking a dose of 250 mg, concentrations range from 0.3 to 1.3 g/l. Between 10% and 20% of amoxicillin is metabolized. The beta-lactam ring is metabolized to penicillic acid, which is excreted in the urine. A minimal amount of amoxicillin is excreted in the bile. Following a 3 g dose, mean bile concentrations were 19 mcg/mL. Enterohepatic circulation of amoxicillin is minimal. The maximum concentration of amoxicillin in breast milk, achieved 5 hours after ingestion of a dose of 1 g, is 0.81 mcg/ml. In severe renal failure, dose adjustment is necessary. Creatinine clearance ml/s (ml/min) 1.33–0.83 (80–50) 0.83–0.16 (50–10) <0.16 (<10) Amoxicillin dose 250 mg – 500 mg 8 hours 8–12 hours 12–24 hours When Peritoneal dialysis does not require dose adjustment. Hemodialysis removes 85% of amoxicillin and therefore the recommended dose should be administered after hemodialysis is stopped. Pharmacodynamics The effect of amoxicillin on bacterial cells Hiconcil suppresses the last phase of bacterial cell wall formation by inhibiting the action of transpeptidases, enzymes involved in the synthesis of peptidoglycan, which is an important component of the bacterial cell wall. Bacteria produce several types of penicillin-binding proteins (PBPs). Penicillin antibiotics inhibit the action of one or more transpeptidases. Impaired peptiglycan synthesis leads to the development of a defective cell wall, which is osmotically unstable and leads to the death of the bacterial cell. Penicillins also appear to be involved in bacterial wall disruption by inhibiting the action of an inhibitor of murein hydrolase, an enzyme that is associated with cell division. Thus, amoxicillin is a bactericidal antibiotic. The time it takes for the antibiotic concentration to reach the minimum inhibitory concentration (T>MIC) is a very important factor for the successful treatment of bacterial infections with beta-lactam antibiotics. When reaching 40% of the dosing time, the maximum clinical effect of amoxicillin may develop. Antibacterial spectrum of action Amoxicillin is effective against gram-positive and some gram-negative microorganisms. Compared to penicillin, amoxicillin is less effective against Streptococcus pyogenes, Streptococcus pneumoniae and Streptococcus agalactiae; however, penicillin is more effective against enterococci and Listeria monocytogenes. The effects of amoxicillin on gram-positive anaerobic bacteria and Neisseria species are the same as those of penicillin. Because beta-lactamases destroy amoxicillin, they are ineffective against beta-lactamase-producing strains and therefore have no effect on most strains of staphylococci. Strains of Haemophilus influenzae, Haemophilus parainfluenzae, E. coli, Salmonella species. and Shigella, which do not produce beta-lactamases, are sensitive to amoxicillin. Most other gram-negative bacteria are resistant to amoxicillin. Table 1. Bacteria sensitive to amoxicillin *: Gram-positive bacteria Gram-negative bacteria Streptococcus pneumoniae Haemophilus influenzae Streptococcus pyogenes pyogenes Escherichia coli Streptococcus viridans Proteus mirabilis Streptococcus agalactiae Salmonella spp. Staphylococcus aureus Shigella spp. Enterococcus faecalis Neisseria spp. Bacillus anthracis Bordetella pertussis Listeria monocytogenes Brucella spp. Corynebacterium spp. Vibrio cholerae Clostridium spp. Pasteurella septica

Special instructions for the use of the drug Hiconcil

In case of severe allergic reactions, the drug is discontinued, antihistamines are prescribed, and, if necessary, epinephrine, corticosteroids. Skin rash most often occurs when the drug is prescribed to patients with infectious mononucleosis. In some cases, cross-hypersensitivity to cephalosporins and penicillins may occur. Microorganisms resistant to ampicillin often exhibit cross-resistance to amoxicillin. Caution is advised if severe diarrhea develops, as this may indicate the presence of pseudomembranous colitis. During treatment with Hiconcil, when determining blood glucose levels using the reduction method, the results may be distorted. In severe renal failure (glomerular filtration ≤10 ml/min), the interval between two successive doses should be increased to 12–24 hours. The drug should be used with caution during pregnancy and lactation.

Use of the drug Hiconcil

Take orally with a sufficient amount of liquid 3 times a day, regardless of meals. Depending on the age (body weight) and severity of the infectious process, a single dose of the drug can be: for children aged 1–2 years (10 kg) - 2.5–5 ml of suspension (1/2–1 measuring spoon); 6 years (20 kg) - 1 capsule (250 mg) or 1-2 scoops of suspension; 10 years (30 kg) - 1 capsule (250 mg) or 2-3 scoops of suspension; 12 years (40 kg) - 250–500 mg (in capsules or the appropriate amount of suspension); for children weighing 40 kg and adults - 250–1000 mg (capsules).