AMOSIN

Active material: Amoksiцillin
When ATH: J01CA04
CCF: Antibiotics penicillin broad spectrum, collapsing penicillinase
ICD-10 codes (testimony): A01, A02, A03, A27, A32, A39, A40, A41, A46, A54, A69.2, G00, H66, i33, J01, J02, J03, J04, J15, J20, J31, J32, J35.0, J37, J42, K52, K65.0, K81.0, K81.1, K83.0, L01, L02, L03, L08.0, L30.3, N10, N11, N30, N34, N41, N70, N71, N72
When CSF: 06.01.02.01.01
Manufacturer: Synthesis of (Russia)

Pharmaceutical form, composition and packaging

Capsules gelatin, white, №0; contents of capsules – White granules.

Excipients: potato starch.

Composition of gelatin capsules: Titanium dioxide, metilgidroksiʙenzoat, propyl, acetic acid, gelatin.

10 PC. – packings Valium planimetric (2) – packs cardboard.

Pills white or nearly white, Valium, a facet and Valium.

Excipients: potato starch, magnesium stearate, calcium stearate, magnesium hydrosilicate (talc), povidone (kollidon 90F).

10 PC. – packings Valium planimetric (1) – packs cardboard.

Powder for oral suspension white with a yellowish tint, and odor; cooked suspension white with a yellowish Sheen color, and odor.

Excipients: polyvinylpyrrolidone (povidone), dextrose, disodium edetate (Trilon b) (disodium эdetat), sodium phosphate dibasic (sodium hydrogen phosphate), sodium α-glutamate monohydrate, food flavoring, vanillin, sucrose.

1.5 g – adjust the packages (10) – packs cardboard.

Powder for oral suspension white with a yellowish tint, and odor; cooked suspension white with a yellowish Sheen color, and odor.

Excipients: polyvinylpyrrolidone (povidone), dextrose, disodium edetate (Trilon b) (disodium эdetat), sodium phosphate dibasic (sodium hydrogen phosphate), sodium α-glutamate monohydrate, food flavoring, vanillin, sucrose.

3 g – adjust the packages (10) – packs cardboard.

Powder for oral suspension white with a yellowish tint, and odor; cooked suspension white with a yellowish Sheen color, and odor.

Excipients: polyvinylpyrrolidone (povidone), dextrose, disodium edetate (Trilon b) (disodium эdetat), sodium phosphate dibasic (sodium hydrogen phosphate), sodium α-glutamate monohydrate, food flavoring, vanillin, sucrose.

6 g – adjust the packages (10) – packs cardboard.

Pharmacological action

Broad-spectrum antibiotic group semisynthetic Penicillins. Effective bactericidal. Ingibiruet transpeptidazu, violate synthesis peptidoglicana (reference cell wall polymer) during the period of Division and growth, lysis of bacteria. Is acid.

It is active against Aerobic gram-positive bacteria: Staphylococcus spp. (except for strains, producing penicillinase), Streptococcus spp.; Aerobic Gram-negative bacteria: Neisseria gonorrhoeae, Neisseria meningitidis, Bacillus anthracis, Listeria monocytogenes, Helicobacter pylori, Klebsiella spp.

Organisms, penicillinase, resistant to the effects of amoxicillin.

Effects develops over 15-30 min after the introduction and continues 8 no.

Pharmacokinetics

Absorption

Once inside quickly and almost completely amoxicillin (93%) absorbed from the gastrointestinal tract. Eating does not affect the absorption of the drug, not destroyed in the acidic stomach Wednesday. C_max the active substance in plasma is through 1-2 no. When administered at a dose of 125 mg 250 mg C_max in plasma is 1.5-3 ug / ml 3.5-5 ug / ml, respectively.

Distribution

Has a large volume of distribution: in high concentrations detected in plasma, mokrote, bronchial secretions (in gnanom bronhialnom secret distribution weak), pleural and peritoneal fluid, urine, contents of skin blisters, lung tissue, intestinal mucosa, female genital mutilation, prostate, middle ear fluid, bones, fat tissue, gallbladder (in normal liver function), fetal tissue. When increasing doses in 2 times concentration also increases in 2 times. Concentration in bile exceeds the concentration in plasma in 2-4 times. In the amniotic fluid and umbilical vessels concentration amoxicillin – 25-30% the level of plasma in pregnant women. Poor penetrate the BBB, When brain nerve membranes (meningitis) concentration in cerebrospinal fluid – about 20%.

Plasma protein binding – 17%.

In a small amount excreted in breast milk.

Metabolism

Amoxicillin is partially metabolised education inactive metabolites.

Deduction

T_1/2 Amoxicillin is 1-1.5 no. Amoxicillin is displayed on 50-70% with urine in an unmodified form by kanalzeva excretion (80%) and clubockova filtering (20%), the bile – 10-20%.Premature, infants and children under 6 months – 3-4 no.

Pharmacokinetics in special clinical situations

Premature, infants and children under 6 months T_{1/2 ^is} 3-4 no.

If the kidney function (CC ≤ 15 ml / min) T_1/2 amoxicillin increases to 8.5 no.

Amoxicillin is removed with hemodialysis.

Testimony

Infectious-inflammatory diseases, caused by susceptible to malaria infections:

- Respiratory infections (incl. bronchitis, pneumonia);

- Infections of upper respiratory tract (incl. sinusitis, pharyngitis, tonsillitis, acute otitis media);

- Infections of the genitourinary system (incl. pyelonephritis, pyelitis, cystitis, uretrit, gonorrhea);

- Gynecological infections (incl. endometritis, cervicitis);

- Infections of the digestive tract (incl. peritonitis, enterocolitis, typhoid fever, kholangit, cholecystitis);

- Infections of the skin and soft tissues (incl. mug, impetigo, secondarily infected dermatitis);

-leptospirosis;

-Listeriosis;

- Lyme disease (ʙorrelioz);

- Dysentery;

-salmonellosis, salmonellonositelstvo;

- Meningitis;

— endocarditis (prevention);

- Sepsis.

Dosage regimen

The drug is taken orally, before or after eating. The mode set individually, taking into account the severity of the disease, susceptibility to the drug, the patient's age.

Adults and children over 10 years (body weight >40 kg) appoint 500 mg 3 times / day, with severe disease – by 0.75-1 g 3 times / day.

Children aged 5 to 10 years appoint 250 mg 3 times / day, aged 2 to 5 years – by 125 mg 3 times / day, aged 2 years – 20 mg / kg / day 3 admission. A course of treatment – 5-12 days. Children under the age of 5 years the drug is prescribed in form of a suspension.

For the treatment of acute uncomplicated gonorrhea the drug is prescribed in a dose 3 g once; It is recommended in the treatment of women re-employment specified dose.

At acute infectious diseases of DIGESTIVE TRACT (paratifы, typhoid fever) and biliary tract, gynecological infectious diseases adult appoint 1.5-2 g 3 times / day, or 1-1.5 g 4 times / day.

At leptospiroze adult appoint 500-750 mg 4 times / day for 6-12 days.

At sal′monellonositel′stve adult – by 1.5-2 g 3 times / day for 2-4 Sun.

To prophylaxis of endocarditis in small surgical interventions adult administered at a dose of 3-4 d for 1 hours before the procedure. If necessary, designate a repeated dose 8-9 no. In children dose reduced by half.

In patients with impaired renal function (KK from 15 to 40 ml / min) the interval between meals increase to 12 no, in end stage chronic renal failure (CC<10 ml / min) dose Amosina^® must be reduced by 15-50% or increase the interval between meals to 24 no, at anurii – The maximum dose is 2 g / day.

Rules suspension

Odnodozovyj package

In a clean glass pour prokipâčenuû and chilled water in quantity, specified in table, then pour out the contents of one packet and mix before reception of a homogeneous slurry.

After taking the Cup to rinse water, dry and store in a dry place, clean place.

Side effect

Allergic reactions: perhaps – hives, dermahemia, эritema, angioedema, rhinitis, conjunctivitis; rarely – fever, joint pain, eozinofilija, exfoliative dermatitis, erythema multiforme exudative, Stevens-Johnson syndrome, reaction, similar to serum sickness; in a few cases – anaphylactic shock.

From the digestive system: dysbiosis, change in taste, vomiting, nausea, diarrhea, stomatitis, glossitis, abnormal liver function, a moderate increase in liver transaminases; rarely – pseudomembranous enterocolitis.

From the central and peripheral nervous system: excitation, anxiety, insomnia, ataxia, confusion, behavior change, depression, perifericheskaya neuropathy, headache, dizziness, convulsive reaction.

From the urinary system: rarely – interstitial nephritis.

From the hematopoietic system: leukopenia, neutropenia, trombotsitopenicheskaya purpura, anemia.

Other: labored breathing, tachycardia, vaginal candidiasis, superimposed infection (especially in patients with a chronic illness or reduced resistance of the organism).

Contraindications

— Allergic Diathesis;

- Bronchial asthma, pollen disease;

- Infectious mononucleosis;

- Lymphocytic leukemia;

- Liver failure;

-gastrointestinal diseases in history (especially colitis, associated with the use of antibiotics);

- Lactation (breast-feeding);

- Hypersensitivity to the drug;

-hypersensitivity to other Penicillins, cephalosporins, carbapenems);

- Children up to age 3 years (for tablets and capsules)

FROM caution should be prescribed during pregnancy, renal failure, as well as in the history of guidance on bleeding.

Pregnancy and lactation

Use of the drug during pregnancy is possible only in cases, when the anticipated benefits of therapy to the mother outweighs the potential risk to the fetus.

Use is contraindicated in lactation. If necessary, the use of lactation should stop breastfeeding.

Cautions

During the course of treatment Amosinom^® There is a need to monitor the status of the functions of the organs of Hematopoiesis, liver and kidneys.

Probably superinfection due to growth of insensitive to amoxicillin microflora, which requires a corresponding change in antimicrobial therapy.

In the treatment of patients with bakteriemiej rarely develops reaction bakterioliza (Jarisch-Herxheimer).

Patients, with hypersensitivity to penicillins, possible cross-allergic reaction cephalosporin antibiotic.

In the treatment of mild diarrhea against the backdrop of Amosina^® You should avoid protivodiarejnyh drugs, reduce peristalsis; You can use kaolin- or attapulgitsoderzhaschie antidiarrheals. When severe diarrhea should undertake the differential diagnosis and assign appropriate therapy.

Treatment should continue for another 48-72 hours after the disappearance of clinical signs of disease.

With simultaneous use of oral contraceptives and estrogensoderjath amoxicillin should be, possibly, use additional methods of contraception.

Overdose

Symptoms: nausea, vomiting, diarrhea, disruption of water and electrolyte balance (as a consequence of vomiting and diarrhea).

Treatment: gastric lavage, Activated carbon, saline laxatives; measures, aimed at maintaining vodno-elektrolitnogo balance; hemodialysis.

Drug Interactions

Antacids, Glucosamine, laxatives, food, antibiotics group aminoglikozidov while applying slow and reduce absorption of amoxicillin; vitamin C – improves its absorption.

Bactericidal antibiotics (incl. aminoglikozidy, cephalosporins, cycloserine, vancomycin, rifampicin) show synergy with amoxicillin; bacteriostatic drugs (makrolidы, chloramphenicol, lincosamides, tetracikliny, sulfonamides) – antagonizm.

Amoxicillin together improves the efficiency of indirect anticoagulants (suppressing the intestinal microflora, It reduces the synthesis of vitamin K and prothrombin index); reduces the effectiveness of estrogensoderjath oral contraceptives, ethinyl estradiol (risk of intermenstrual bleeding), and drugs, in the process of metabolism which formed a pair-aminobensanaya acid.

Diuretic, allopurinol, oksifenʙutazon, phenylbutazone, NSAID drugs, block tubular secretion, together with the application Amosinom^® reducing kanalzevu secretion, increase the concentration of amoxicillin.

If you are applying to Amosina^® with allopourinolom increases the risk of skin rashes.

Amoxicillin while applying reduces clearance and increases the toxicity of methotrexate.

Amoxicillin together enhances absorption of Digoxin.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

List B. The drug should be stored out of reach of children, dry, protected from light. Powder for suspension should be stored at a temperature between 15° to 25° c. Tablets and capsules should be stored at a temperature of no higher than 25° c. Shelf life – 2 year.