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

Excipients: polyvinylpyrrolidone (povidone), glucose (dextrose), disodium ethylenediamine salt N,N,N’,N’-TetpaytocycMr.oth acid 2-water (Trilon B) (disodium edetate), sodium phosphate disubstituted (sodium hydrophosphate), sodium a-glutamic acid 1-water, food flavors, vanillin, sugar (sucrose).

Description:

Powder white with a yellowish hue of color, with a specific smell. Ready-made suspension of white with a yellowish tint of color, with a specific odor.

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; and aerobic Gram-negative bacteria: Neisseria gonorrhoeae, Neisseria meningitidis, Escherichia coli, Shigella spp., Salmonella spp., Klebsiella spp. The microorganisms producing penicillinase are resistant to the action of amoxicillin. The action develops 15-30 minutes after administration and lasts 8 hours.

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 125 and 250 mg, the maximum concentration is 1.5-3 μg / ml and 3.5-5 μg / ml, respectively. The time to reach the maximum concentration after oral administration is 1-2 hours. Has a large volume of distribution - high concentrations are detected in plasma, sputum, bronchial secretion (in the purulent bronchial secretion the distribution is weak), pleural and peritoneal fluid, urine, contents of skin blisters, lung tissue, intestinal mucosa, female genital organs, prostate gland, middle ear fluid, bone, adipose tissue tissue, gall bladder (with normal liver function), fetal tissues. When the dose is doubled, the concentration also doubles. Concentration in bile exceeds the concentration in plasma by 2-4 times.In amniotic fluid and vessels of the umbilical cord, the concentration of amoxicillin is 25-30% of the level in the plasma of a pregnant woman. Poor penetration of the hemato-encephalic barrier, with inflammation of the meninges (meningitis), the concentration in the cerebrospinal fluid is about 20%. The connection with plasma proteins is 17%.

Partially metabolized with the formation of inactive metabolites. Half-life is 1-1.5 hours. It is excreted 50-70% by kidneys in unchanged form by tubular excretion (80%) and glomerular filtration (20%), liver - 10-20%. In small amounts excreted in breast milk. Half-life in preterm, newborns and children up to 6 months is 3-4 hours. If renal function is impaired (creatinine clearance less than or equal to 15 ml / min), the elimination half-life increases to 8.5 hours. Amoxicillin is removed during hemodialysis.

Indications:

Bacterial infections caused by sensitive microflora: infections of the respiratory tract and ENT organs (sinusitis, pharyngitis, tonsillitis, acute otitis media, bronchitis, pneumonia), urogenital system (pyelonephritis, pyelitis, cystitis, urethritis, gonorrhea, endometritis, cervicitis) intestinal tract (peritonitis, enterocolitis, typhoid fever, cholangitis, cholecystitis),infections of the skin and soft tissues (erysipelas, impetigo, secondarily infected dermatoses), leptospirosis, listeriosis, Lyme disease (borreliosis), dysentery, salmonellosis, salmonella, meningitis, endocarditis (prophylaxis), sepsis.

Contraindications:

Hypersensitivity (including to other penicillins, cephalosporins, carbapenems), allergic diathesis, bronchial asthma, pollinosis, infectious mononucleosis, lymphocytic leukemia, liver failure, gastrointestinal disease in history (especially colitis associated with the use of antibiotics), lactation period.

Carefully:

Pregnancy, renal insufficiency, bleeding in the anamnesis.

Dosing and Administration:

Inside, before or after eating.

Adults and children over 10 years of age (with a body weight of more than 40 kg) are prescribed 0.5 g 3 times a day; in severe infection - 0.75-1 g 3 times a day. Children aged 5-10 years are prescribed 0.25 g three times a day; 2-5 years - 0.125 g 3 times a day; younger than 2 years - 20 mg / kg 3 times a day. The course of treatment is 5-12 days.

In acute uncomplicated gonorrhea appoint 3 g once; in the treatment of women, repeated intake of this dose is recommended.

In acute infectious diseases of the gastrointestinal tract (paratyphoid, typhoid) and biliary tract, with gynecological infectious diseases adults - 1.5-2 g 3 times a day or 1-1.5 g 4 times a day.

When leptospirosis adults - 0.5-0.75 g 4 times a day for 6-12 days.

With salmonella carrying adults - 1.5-2 g 3 times a day for 2-4 weeks.

For the prevention of endocarditis with small surgical interventions for adults - 3-4 g for 1 h before the procedure. If necessary, appoint a second dose after 8-9 hours. In children, the dose is reduced by half.

In patients with impaired renal function with creatinine clearance of 15-40 ml / min, the interval between doses is increased to 12 h; when creatinine clearance is less than 10 ml / min, the dose is reduced by 15-50%; with anuria - the maximum dose of 2 g / day.

Preparation of the suspension.

Single-dose package.

In a clean cup, boiled and cooled water is poured (see the table), then the contents of one packet are poured and mixed until a homogeneous suspension is obtained.

dose in the package, mg	Required amount of water, ml
125	2,5
250	5
500	10

After taking the glass, rinse with water, dry and store in a dry, clean place.

Bottle or bank.

62 ml of boiled and chilled water or distilled water are added to a vial or jar containing 5 g of amoxicillin. In 1 ml of the finished suspension contains 50 mg of amoxicillin. Suspension before use is shaken. Dosage the suspension with a double-spoon: a large spoon contains 5 ml (0.25 g), a small one - 2.5 ml (0.125 g) or a spoon with two labels: the lower one corresponds to 2.5 ml (0.125 g) and the upper one - 5 ml (0.25 g ).

Side effects:

Allergic reactions: hives, skin flushing, erythema, angioedema, rhinitis, conjunctivitis; rarely - fever, joint pain, eosinophilia, exfoliative dermatitis, polymeric exudative erythema, Stevens-Johnson syndrome; reactions similar to serum sickness; in isolated cases - anaphylactic shock.

From the digestive system: dysbacteriosis, taste change, vomiting, nausea, diarrhea, stomatitis, glossitis, impaired liver function, moderate increase in the activity of "liver" transaminases, pseudomembranous enterocolitis.

From the nervous system: agitation, anxiety, insomnia, ataxia, confusion, behavior change, depression, peripheral neuropathy, headache, dizziness, convulsive reactions.

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

Other: shortness of breath, tachycardia, interstitial nephritis, Candidiasis of the vagina, superinfection (especially in patients with chronic diseases or reduced resistance of the body).

Overdose:

Symptoms: nausea, vomiting, diarrhea, disturbance of water-electrolyte balance (as a consequence of vomiting and diarrhea). Treatment: gastric lavage, Activated carbon, salt laxatives, preparations for maintaining 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) - synergistic effect; bacteriostatic drugs (macrolides, chloramphenicol, lincosamides, tetracyclines, sulfonamides) - antagonistic.

Increases the effectiveness of indirect anticoagulants (suppressing the intestinal microflora, reduces the synthesis of vitamin K and prothrombin index); reduces the effectiveness of estrogen-containing oral contraceptives,medicines, in the process of metabolism of which paraaminobenzoic acid is formed, ethinyl estradiol - the risk of bleeding "breakthrough".

Diuretics, allopurinol, oxyphenbutazone, phenylbutazone, non-steroidal anti-inflammatory drugs; drugs that block tubular secretion - reducing tubular secretion, increase concentration.

Allopurinol increases the risk of skin rash.

Reduces clearance and increases the toxicity of methotrexate.

Increases the absorption of digoxin.

Special instructions:

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

It is possible to develop superinfection due to the growth of insensitive microflora, which requires a corresponding change in antibacterial therapy.

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 should be avoided antidiarrheal drugs,reducing peristalsis of the intestine; 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.

Form release / dosage:

Powder for suspension for oral administration 250 mg / 5 ml; 125 mg, 250 mg and 500 mg.

Packaging:

60 g of powder (5 g of active substance) in cans of orange glass or in polyethylene bottles. Each jar or bottle with instructions for use and a spoon for taking medicines or a dose of a dispensing chemist is placed in a pack of cardboard.

1.5, 3g or 6g (125mg, 250mg or 500mg of active substance, respectively) of the powder in single dose packs. 10, 20 or 40 single-dose packages with a plastic cup (or without a glass) and the instructions for use are placed in a pack of cardboard.

Storage conditions:

In a dry, protected from light place, at a temperature of 15 to 25 ° C.

The ready suspension is stored in the refrigerator for no more than 10 days.

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:LS-001736

Date of registration:13.08.2010

Expiration Date:Unlimited

The owner of the registration certificate:POLLO, LLC POLLO, LLC Russia

Manufacturer: & nbsp

SYNTHESIS, OJSC Russia

Information update date: & nbsp19.08.2017

Illustrated instructions

Instructions

Amosin® (Amosin®)