Hikontsil - instructions for use, dose, side effects, contraindications

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

Excipients: silicon dioxide colloid, anhydrous 1.50 mg, magnesium stearate 2.90 mg.

Capsule shell composition:

Case of the capsule: titanium dioxide E-171 2.0000%, iron oxide red oxide E-172 0,0500%, iron oxide pigment yellow E-172 0.1000%, gelatin EP up to 100%.

Capsule cover: titanium dioxide E-171 1.0000%, indigo carmine dye FD & C blue 2 E-132 0.0420%, azorubin E-122 dye 0.5943%, gelatin EP up to 100%.

1 capsule 500 mg contains:

Active substance: Amoxicillin trihydrate 581.40 mg, which corresponds to 500 mg of amoxicillin, calculated according to the content of amoxicillin 86% (by substance "as is").

Excipients: silicon dioxide colloid, anhydrous 3.00 mg, magnesium stearate 5.80 mg.

Capsule shell composition:

Case of the capsule: titanium dioxide E-171 2.0000%, iron oxide red oxide E-172 0,0500%, iron oxide pigment yellow E-172 0.1000%, gelatin EP up to 100%.

Capsule cover: titanium dioxide E-171 1.0000%, indigo carmine dye FD & C blue 2 E-132 0.0420%, azorubin E-122 dye 0.5943%, gelatin EP up to 100%.

Description:

Hard opaque gelatin capsules (250 mg: capsules No. 2, 500 mg: capsules No. 0), capsule body - pink, cap capsule - brown.

Contents of the capsule: finely granular powder from white to slightly yellowish color.

Pharmacotherapeutic group:antibiotic, penicillin semisynthetic

ATX: & nbsp

J.01.C.A.04 Amoxicillin

Pharmacodynamics:

Antibacterial bactericidal acid-resistant broad spectrum agent from the group of semisynthetic penicillins. It inhibits transpeptidase, breaks 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. Microorganisms producing 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. The time to reach the maximum concentration after oral administration is 1 to 2 hours.Has a large volume of distribution - high concentrations are found in the plasma, bronchial secretion (in - purulent bronchial secretion weak distribution), liver, lymph nodes, uterus, ovaries, paranasal sinuses, pleural and peritoneal fluid, saliva and tear fluid, urine, skin blisters , lung tissue, intestinal mucosa, middle ear fluid and paranasal sinuses, bones, adipose tissue, gall bladder (concentration in bile exceeds the concentration in plasma by 10 times - with normal walking bile ducts), fetal tissues. 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.If the 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 divisions. 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 (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;

- children up to 3 years (for this dosage form).

Carefully:allergic reactions (including history of bronchial asthma, pollinosis, hypersensitivity to acetylsalicylic acid), 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 infection, the severity of the disease and the localization of the infectious process.

To ensure the following dosage regimen for children under 12 years of age, it is preferable to take the drug Hiconcil in the dosage form - a powder for the preparation of a suspension for oral administration,250 mg / 5ml.

Adults and children over 13 years of age and / or body weight of 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 from 3 to 5 years of age and / or body weight of 15 kg and 19 kg:

Usually appoint: 250 mg 2 times a day. In cases where the probability of infection caused by a resistant Streptococcus pneumoniae, higher doses are recommended - 500 mg 2-3 times a day.

Children from 5 to 13 years and / or body weight of 19 kg and 40 kg:

Usually recommend: 250 mg 3 times a day. In cases where the probability of infection caused by a resistant Streptococcus pneumoniae, recommended higher doses - 500-1000 mg 3 times a day.

The maximum daily dose for children is 100 mg / kg / day.

Lyme disease (borreliosis):

Adults and children over 13 years of age and / or with a body weight above 40 kg prescribe 500 mg - 1000 mg 3 times a day.

Children from 3 to 5 years and / or with a body weight of 15 - 19 kg: 250 mg 3 times a day; 6-12 years and / or body weight of 20-40 kg: 500 mg 2-3 times a day (at the rate of 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 and children over 13 years of age and / or with a body weight above 40 kg appoint 1000 mg twice a day; children from 3 to 5 years and / or with a body weight of 15 - 19 kg: 250-500 mg twice a day; 5-12 years and / or body weight of 20-40 kg: 500-1000 mg 2 times a day (at the rate of 50 mg / kg / day, divided into 2 doses).

Prophylaxis of bacterial endocarditis:

Adults and children over 13 years of age and / or body weight above 40 kg: it is recommended 3 g for 1 hour before surgery (or at the rate of 50 mg / kg / day) and 1.5 g - 6 hours after the procedure (or at the rate of 25 mg / kg / day).

Children are recommended:

- from 3 to 5 years and / or with a body weight of 15-19 kg: 750-1000 mg (at the rate of 50 mg / kg / day) before the procedure and 250-500 mg (at the rate of 25 mg / kg / day) - after the procedure;

- 5-12 years and / or body weight of 20-40 kg: 1000-2000 mg (at the rate of 50 mg / kg / day) before the procedure and 500-1000 g (at the rate of 25 mg / kg / day) - after the procedure;

With renal failure:

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.

Side effects:

From the digestive system: vomiting, nausea, diarrhea; rarely - stomatitis, esophagitis, glossitis, moderate increase in the activity of "liver" transaminases, dysbacteriosis, taste change; very rarely - pseudomembranous enterocolitis.

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 skin rash, skin itching, bronchospasm, angioedema, rhinitis, conjunctivitis; rarely - fever, skin hyperemia, erythema, joint pain, exfoliative dermatitis, polymeric exudative erythema (including Stevens-Johnson syndrome); reactions similar to serum sickness; in isolated cases - anaphylactic shock.

Laboratory indicators: rarely - neutropenia, thrombocytopenic purpura, anemia, eosinophilia, leukopenia (more often in elderly patients).

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

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: increases the 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:

At 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.

Azo dye (E122) can cause allergic reactions (including exacerbation of bronchial asthma); are more frequent in patients with intolerance to acetylsalicylic acid in the anamnesis.

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.

In case of renal insufficiency, it is necessary to adjust the dosage regimen (see section "Method of administration and dose").

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:

Capsules of 250 mg and 500 mg.

Packaging:8 capsules per blister. 2 blisters per pack of cardboard along with instructions for use.

Storage conditions:

Store in a dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:П N014216 / 02

Date of registration:05.02.2009

The owner of the registration certificate:KRKA, dd, Novo mesto, AOKRKA, dd, Novo mesto, AO

Manufacturer: & nbsp

SANDOZ, GmbH Austria

Representation: & nbspKRKA KRKA Slovenia

Information update date: & nbsp27.02.2014

Illustrated instructions

Instructions

Hiconcile (Hiconcil)