Hiconcile (Hiconcil)

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Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Dosage form: & nbspPowder for suspension for oral administration
Composition:

5 ml of the suspension contain:

Active substance: Amoxicillin trihydrate - 290.70 mg, which corresponds to 250 mg of amoxicillin, calculated by the content of amoxicillin 86% (in substance "as is").

Auxiliary substances: silicon dioxide colloid, anhydrous 15.00 mg, sodium benzoate 5.00 mg, acacia gum 125.00 mg, sodium citrate, anhydrous 8.00 mg, raspberry flavor 13.00 mg, strawberry flavoring 4.20 mg, flavoring lemon-mint 2.10 mg, glyceryl monooleate 5.00 mg, silicone (defoamer) 0.15 mg, lecithin 3.75 mg, sucrose to 3240.00 mg.

Description:

Powder for suspension for oral administration: crystalline powder of almost white color with the smell of fruit. The aqueous suspension, prepared in 60 ml of water, is white in color with the smell of fruit.

Pharmacotherapeutic group:antibiotic, penicillin semisynthetic
Pharmacodynamics:

Antibacterial bactericidal acid-resistant broad spectrum agent from the group of semisynthetic penicillins. Inhibits transpeptidase, violates the synthesis of peptidoglycan (the supporting protein of the cell wall) in the period of division and growth, causes bacterial lysis. It is active against aerobic gram-positive bacteria: Staphylococcus spp. (with the exception of strains producing penicillinase), Streptococcus spp., Listeria monocytogenes, Enterococcus faecalis and aerobic Gram-negative bacteria: Neisseria gonorrhoeae, Neisseria meningitidis, Haemophilus influenzae, Escherichia coli, Shigella spp., Salmonella spp, Helicobacter pylori. The microorganisms that produce β-lactamase are resistant to the action of amoxicillin.

Pharmacokinetics:

Absorption - fast, high (93%), food intake does not affect absorption, does not break down in the acidic environment of the stomach. When administered orally at a dose of 250 mg and 500 mg, the maximum concentration is 5 μg / ml and 10 μg / ml, respectively. Time to reach the maximum concentration after oral administration is 1-2 h. Has a large volume of distribution - high concentrations are found in plasma, bronchial secretion (in the purulent bronchial secretion the distribution is weak), liver, lymph nodes, uterus, ovaries, paranasal sinuses, pleural and peritoneal fluid, saliva and tear fluid, urine, contents of skin blisters, lung tissue, intestinal mucosa, middle ear fluid and paranasal sinuses, bones, adipose tissue, gallbladder (concentration in bile exceeds the concentration in the plasma 10 times - with the normal patency of the bile ducts), the tissues of the fetus.When the dose is doubled, the concentration also doubles. In amniotic fluid and vessels of the umbilical cord, the concentration of amoxicillin is about 50% of the level in the plasma of a pregnant woman. Poorly penetrates the blood-brain barrier, inflammation of the meninges (meningitis) concentrations in the cerebrospinal fluid - is increased to 20% of plasma levels. The connection with plasma proteins is 15-25%.

Partially (10-20%) is metabolized with the formation of inactive metabolites. Half-life is 1 to 1.5 hours. It is excreted by 50-70% by kidneys in unchanged form by tubular excretion (80%) and by glomerular filtration (20%), by the liver - by 10-20%. In small amounts excreted in breast milk. Half-life in preterm, newborns and children up to 6 months is 3.7-4 hours. If renal function is impaired (creatinine clearance <15 ml / min), the elimination half-life increases to 8.5 hours. Amoxicillin is removed during hemodialysis.

Indications:

Infectious-inflammatory diseases caused by microorganisms sensitive to the preparation:

- infection of the upper respiratory tract (tonsillopharyngitis, sinusitis, acute otitis media);

- infection of the lower respiratory tract (acute bacterial bronchitis, exacerbation of chronic bronchitis, community-acquired pneumonia);

- infections of the genitourinary system (pyelonephritis, pyelitis, cystitis, urethritis, endometritis, cervicitis, gonorrhea);

- abdominal infections (peritonitis, cholangitis, cholecystitis);

- eradication Helicobacter pylori in patients with peptic ulcer disease of the duodenum or stomach (always in combination with other drugs);

- infections of the skin and soft tissues (erysipelas, impetigo, secondarily infected dermatoses);

- leptospirosis, listeriosis;

- Lyme disease;

- infections of the gastrointestinal tract (enterocolitis, typhoid fever, dysentery, salmonellosis (caused by Salmonella typhi, sensitive to ampicillin), salmonella-bearing;

- prevention of bacterial endocarditis during surgical procedures in the oral cavity and upper respiratory tract.

Contraindications:

- Hypersensitivity (including to other penicillins, cephalosporins, carbapenems);

- infectious mononucleosis, lymphocytic leukemia;

- congenital intolerance to fructose, glucose / galactose malabsorption syndrome or a deficiency of the enzyme sucrose-isomaltase.

Carefully:allergic reactions (including anamnesis - bronchial asthma, pollinosis), a history of gastrointestinal disease (especially colitis associated with the use of antibiotics), kidney failure, pregnancy and lactation.
Pregnancy and lactation:

The drug can be used during pregnancy only in those cases when the expected benefit for the mother exceeds the potential risk to the fetus.

Amoxicillin is excreted in small amounts into breast milk, so if necessary, it is possible to use the drug during lactation.

Dosing and Administration:

Inside, before or after eating.

The dose of the drug depends on the sensitivity of the causative agent of the infection and the localization of the infectious process.

Adults and children weighing more than 40 kg:

Usually prescribe 250 mg - 500 mg 3 times a day or 500 mg -1000 mg 2 times a day.

With sinusitis, community-acquired pneumonia and other severe infections it is recommended to prescribe 500 mg - 1000 mg 3 times a day. The maximum daily dose is 6 g.

Children with a body weight of less than 40 kg:

Usually prescribed at the rate of 20 mg - 40 mg / kg / day, divided into 3 doses or 25 mg - 45 mg / kg / day, divided into 2 doses. In cases where the probability of infection caused by a resistant Streptococcus pneumoniae, recommended higher doses - 80 mg / kg / day, divided into 3 doses or 90 mg / kg / day, divided into 2 doses. The maximum daily dose for children is 100 mg / kg / day.

Lyme disease (borreliosis):

Adults and children with a body weight above 40 kg prescribe 500 mg - 1000 mg 3 times a day. Children with body weight less than 40 kg - 50 mg / kg / day, divided into 3 doses.

Eradication Helicobacter pylori in patients with peptic ulcer of the duodenum or stomach (always in combination with other drugs):

Adults appoint 1000 mg twice a day; children - 50 mg / kg / day, divided into 2 doses.

Prophylaxis of bacterial endocarditis:

Adults recommended 3 g for 1 hour before surgery and 1.5 g - 6 hours after the procedure.

Children recommended: 50 mg / kg / day before the procedure and 25 mg / kg / day - after the procedure.

With renal insufficiency:

With moderate renal failure (creatinine clearance from 10 to 50 ml / min: and / or 0.83-1.33 ml / s), amoxicillin is recommended after 8-12 hours, and in severe renal failure (creatinine clearance <10 ml / min and / or 0.16 ml / s) after 12-24 hours.

Preparation of a suspension for oral administration:

Boiling water at room temperature should be used to prepare the suspension.

Preparation of the suspension: turn the bottle and shake gently to make the powder loose. Then open the vial and pour water to about a quarter of the vial. Close the vial and shake it thoroughly. Open the vial and add water to the label. Close the vial and shake again.

Side effects:

From the digestive system: vomiting, nausea, diarrhea; rarely - stomatitis, esophagitis, glossitis, moderate increase in activity of "liver" transaminases, goiter, change in taste, pseudomembranous enterocolitis, jaundice (benzoate increase the risk of the newborn).

From the central and peripheral nervous system: agitation, anxiety, insomnia, ataxia, confusion, behavior change, depression, peripheral neuropathy, headache, dizziness; very rarely - hallucinations and convulsions.

Allergic reactions: Urticaria, erythematous maculopapular rash, itchy skin, bronchospasm, angioedema, rhinitis, conjunctivitis; rarely - fever, skin redness, erythema, joint pain, exfoliative dermatitis, erythema poliformnaya (including Stevens -Dzhonsona syndrome); reactions similar to serum sickness; in isolated cases - anaphylactic shock.

Laboratory indicators: neutropenia, thrombocytopenic purpura, anemia, eosinophilia, and leukopenia.

Other: tachycardia, interstitial nephritis, vaginal candidiasis, superinfection (especially in patients with chronic diseases or reduced resistance of the body).

Overdose:

Symptoms: nausea, vomiting, diarrhea, crystalluria, violation of water-electrolyte balance (as a consequence of vomiting and diarrhea), convulsions, agitation, confusion. Treatment: symptomatic - gastric lavage, Activated carbon, salt laxatives, medicines to maintain the water-electrolyte balance, hemodialysis.

Interaction:

Antacids, glucosamine, laxatives, food, aminoglycosides - slow down and reduce absorption; ascorbic acid increases absorption.

Bactericidal antibiotics (including aminoglycosides, cephalosporins, cycloserine, vancomycin, rifampicin, quinolones) have a synergistic effect; bacteriostatic drugs (macrolides, chloramphenicol, lincosamides, tetracyclines, sulfonamides) - antagonistic (decreases the effectiveness of amoxicillin).

Increases efficiency indirect anticoagulants (suppressing the intestinal microflora, reduces the synthesis of vitamin K and prothrombin index); reduces efficiency estrogen-containing oral contraceptives, drugs, in the process of metabolism of which forms para-aminobenzoic acid, ethinyl estradiol - risk of bleeding "breakthrough".

Diuretics, allopurinol, oxyphenbutazone, phenylbutazone, non-steroidal anti-inflammatory drugs and drugs that block tubular secretion - reducing tubular secretion, increase the concentration of amoxicillin in the blood.

Simultaneous appointment with allopurinol: increased risk of skin rash. Reduces clearance and increases toxicity methotrexate.

Increases the absorption of digoxin.

During treatment with amoxicillin, false positive tests of Coombs' test and the presence of glucose in the urine are possible.

Special instructions:

In course treatment it is necessary to monitor the status of the functions of the organs of hematopoiesis, liver and kidneys.

With prolonged use, it is possible to develop cases of superinfection, candidiasis (especially vulvovaginal candidiasis).

In case of severe, persistent diarrhea, which may indicate pseudomembranous colitis, discontinue taking the medication and consult a physician. In the treatment of patients with bacteremia, the development of a bacteriolysis reaction (the Yarisch-Gerxheimer reaction) is possible.

In patients who are hypersensitive to penicillins, there may be cross-allergic reactions with cephalosporin antibiotics.

In the treatment of mild diarrhea against the background of course treatment, antidiarrheal drugs should be avoided, which reduce intestinal peristalsis; it is possible to use kaolin- or attapulgite-containing antidiarrhoeic agents. With severe diarrhea, you should see a doctor.

Treatment necessarily continues for another 48-72 hours after the disappearance of clinical signs of the disease.

With the simultaneous use of estrogen-containing oral contraceptives and amoxicillin, other or additional methods of contraception should be used whenever possible.

It is necessary to adjust the dosage regimen (see section "Method of administration and dose").

In 5 ml of the suspension for ingestion contains 2.7 g of sucrose, so Hiconcil, powder for oral suspension is not recommended for patients with congenital fructose intolerance, glucose / galactose malabsorption syndrome or isomaltase sugarase deficiency.

Effect on the ability to drive transp. cf. and fur:There is no evidence of the effect of amoxicillin on the ability to drive a car or other mechanical means.
Form release / dosage:

Powder for the preparation of a suspension for oral administration, 250 mg / 5ml.

Packaging:

64.8 g of powder are placed in a brown flask (type III) graduated in 100 ml with a polyethylene lid "cap - to - cap", white color.

1 bottle complete with a dispensing spoon made of polyethylene is placed in a pack of cardboard together with instructions for use.
Storage conditions:

In the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life of the finished suspension: suitable for 7 days at a temperature of no higher than 25 ° C or 14 days in the refrigerator.

Shelf life:

3 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription
Registration number:П N014216 / 01
Date of registration:22.07.2008
Date of cancellation:2018-04-09
The owner of the registration certificate:KRKA, dd, Novo mesto, AOKRKA, dd, Novo mesto, AO
Manufacturer: & nbsp
Representation: & nbspKRKA KRKA Slovenia
Information update date: & nbsp09.04.2018
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