for medical use
of AMOSIN® medicine
the International unlicensed
name Amoxicillin Dosage Form Powder for preparation of suspension for intake, 125 mg, 250 mg and 500 mg
One package contains
active agent – amoxicillin trihydrate of 125 mg, 250 mg and 500 mg (in terms of amoxicillin),
excipients: povidone, a dextrose, dinatrium edetat, sodium hydrophosphate, sodium α-glutaminovokisly 1-water, food flavor, vanillin, sucrose
Powder of color, white with a yellowish shade, with a specific smell. Ready suspension represents suspension of color, white with a yellowish shade, with a specific smell
Antibacterial drugs for system use. Beta laktamnye antibacterial drugs – penicillin. Penicillin of a broad spectrum of activity. Amoxicillin.
The ATX J01CA04 code
Pharmacokinetics Absorption Absolute Bioavailability properties of amoxicillin depends on a dose and the mode of introduction and is ranging from 75 up to 90%. In doses from 250 mg to 750 mg bioavailability (parameters: AUC and/or discharge with urine) is linearly proportional to a dose. In higher doses absorbability lower. Meal does not influence absorption. Amoxicillin is acid resisting. At oral single dose in a dose of 500 mg the concentration of amoxicillin in blood makes 6 – 11 mg/l. After single dose of 3 g of amoxicillin the concentration in blood reaches 27 mg/l. The maximum concentration in blood plasma are observed in 1 – 2 hour after administration of drug.
About 17% of amoxicillin is in the state connected with proteins of plasma. Therapeutic concentration of drug is quickly reached in plasma, lungs, bronchial secretion, liquid of a middle ear, bile and urine. Amoxicillin can get through the inflamed meninx into cerebrospinal liquid. Amoxicillin passes through a placenta and in a small amount it is found in breast milk.
Biotransformation and elimination
by the Main place of removal of amoxicillin serve kidneys. About 60 – 80% of an oral dose of amoxicillin are allocated within 6 hours after reception in not changed active form through kidneys and the small fraction is excreted in bile. About 7 – 25% of a dose are metabolized to inactive penicillanic acid. Plasma elimination half-life of blood at patients with not changed function of kidneys makes 1 – 1.5 hour. At patients with a heavy renal failure the elimination half-life varies from 5 to 20 hours. Amoxicillin gives in to a hemodialysis.
Antibacterial bactericidal acid resisting drug of a broad spectrum of activity from group of semi-synthetic penicillin. Inhibits transpeptidase, breaks synthesis of a peptidoglikan (basic protein of a cell wall) during division and growth, causes lysis of bacteria.
It is active concerning aerobic gram-positive bacteria: Staphylococcus spp. (except for the 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, rezistentna to effect of amoxicillin. Action develops in 15-30 min. after introduction and lasts 8 h.
Treatment of the infectious and inflammatory diseases caused by microorganisms, sensitive to medicine:
– an upper respiratory tract infection, including infections of an ear, nose and throat: acute average otitis, acute sinusitis, tonsillitis, bacterial pharyngitis
– lower respiratory tract infections: exacerbation of chronic bronchitis, community-acquired pneumonia
– infections of the lower urinary tract: cystitis
– prevention of endocarditises: prevention at the patients entering into risk group on development of an endocarditis, for example, exposed to dental procedures
– the early localized Lyme’s disease connected with the migrating erythema (1 stage)
the Route of administration and doses
Inside to or after meal.
To adults and children 12 years are more senior (with body weight more than 40 kg): a daily dose from 750 mg to 3 g, divided into 2-3 receptions. To children at the age of 5-10 years appoint 0:25 g 3 times a day, 2-5 years – 0.125 g 3 times a day, 2 years – 20 mg/kg 3 times a day are younger. A course of treatment – 5-12 days.
In acute uncomplicated gonorrhea appoint 3 g once, at treatment of women the repeated reception of the specified dose is recommended.
In digestive tract acute infectious diseases (paratyphus, a typhoid) and bilious ways, in gynecologic infectious diseases adult – 1.5-2 g 3 times a day or on 1-1.5 g 4 times a day.
In leptospirosis adult – 0.5-0.75 g 4 times within 6-12 days.
At a salmonellonositelstvo adult – 1.5-2 g 3 times a day within 2-4 weeks.
For prevention of an endocarditis at small surgical interventions by adult – 3-4 g for 1 h before holding a procedure. If necessary appoint a repeated dose in 8-9 h. At children the dose is reduced twice.
At patients with a renal failure at clearance of creatinine of 15-40 ml/min. the interval between receptions is increased up to 12 h, at clearance of creatinine lower than 10 ml/min. reduce a dose by 15-50%, at an anury – the maximum dose of 2 g/days.
In a clean glass flow boiled and chilled water (see the table), then pour out contents of one package and mix before receiving uniform suspension.
the dose in a package, mg
a necessary amount of water, ml
125 2.5 (1 teaspoon)
5 (2 teaspoons)
10 (4 teaspoons)
After reception to wash a glass with water, to dry up and store in a dry, clean look.
Often (³ 1% – & lt, 10%)
– discomfort in a stomach, nausea, loss of appetite, vomiting, a meteorism, a diarrhea, diarrhea, enantema (in particular on mucous a mouth), dryness in a mouth, disturbance of flavoring perception, (as a rule, the listed effects are characterized by light severity and often disappear in process of continuation of therapy or very quickly after its termination, it is possible to reduce the frequency of these complications by means of intake of amoxicillin together with food)
– skin reactions in the form of a dieback, an itching, a small tortoiseshell (the typical korepodobny dieback appears for 5-11 day from the beginning of therapy, immediate development of a small tortoiseshell demonstrates allergic reaction to amoxicillin and demands the therapy termination)
Infrequently (³ 0.1% – & lt, 1%)
– development of superinfection and colonization of resistant microorganisms or mushrooms, for example, oral and vaginal candidiasis at prolonged and repeated use of medicine
– increase in level of hepatic transaminases (tranzitorny, average degree)
It is rare (³ 0.01% – & lt, 0.1%)
– an eosinophilia and hemolytic anemia
– a laryngeal edema, a serum disease, an allergic vasculitis, an anaphylaxis and an acute anaphylaxis
– reactions from central nervous system which include hyperkinesias, dizzinesses and spasms (spasms can be observed at patients with a renal failure, epilepsy, meningitis or at the patients receiving high doses of drug)
– superficial decolouration of teeth (as a rule, decolouration is removed when toothbrushing)
– hepatitis and cholestatic jaundice
– a Quincke’s disease (Quincke’s edema), an exudative multiformny erythema, acute generalized pustulous rashes, a Lyell’s disease, Stephens-Johnson’s syndrome, a toxic epidermal necrolysis, bullous and exfoliative dermatitis
– acute interstitial nephrite, crystallurias
– medicinal fever
Very seldom (£0.01%)
– a leukopenia, a neutropenia, a granulocytopenia, a pancytopenia, anemia, myelosuppression, an agranulocytosis, lengthening of a bleeding time and prothrombin time (all changes were reversible at the therapy termination)
– at development of heavy persistent diarrhea is necessary to consider the probability of pseudomembranous colitis (in most cases caused by Clostridium difficile)
– coloring of language in black color
of the Contraindication
– hypersensitivity to drug and its components (including to other penicillin, cephalosporins, karbapenema)
– allergic diathesis
– bronchial asthma
– a pollinosis, an infectious mononucleosis, a lymphoid leukosis
– a liver failure
– digestive tract diseases in the anamnesis (especially colitis, connected with use of antibiotics)
– the lactation period
Antacids, a glycosamine, depletive, aminoglycosides – slow down and reduce Amosin’s absorption, ascorbic acid increases Amosin’s absorption.
Амосин® does not collapse in acidic environment of a stomach, meal does not influence its absorption.
Bactericidal antibiotics (including aminoglycosides, cephalosporins, Cycloserinum, Vancomycinum, rifampicin) – sinergidny action, bacteriostatic drugs (macroleads, chloramphenicol, linkozamida, tetracyclines, streptocides) – antagonistic.
Амосин® increases efficiency of indirect anticoagulants (suppressing intestinal microflora, reduces synthesis of vitamin K and the prothrombin ratio), reduces efficiency of estrogensoderzhashchy oral contraceptives, medicines in the course of which metabolism paraaminobenzoic acid, ethinylestradiol – risk of developing bleedings of ‘break’ is formed.
Diuretics, Allopyrinolum, oksifenbutazon, the phenylbutazone, non-steroidal anti-inflammatory drugs, drugs blocking canalicular secretion – reducing canalicular secretion, increase concentration.
Allopyrinolum increases risk of developing skin rash.
Reduces clearance and increases toxicity of a methotrexate.
Strengthens digoxin absorption.
The profound diuresis leads to decrease in concentration of drug in blood owing to increase in elimination of amoxicillin.
It is recommended when determining presence of glucose in urine against the background of use of amoxicillin to use enzymatic glyukozooksidazny methods. When using chemical methods high concentration of amoxicillin in urine can be the cause of false positive takes of a research.
Amoxicillin can reduce amount of estriol in urine at pregnant women.
At high concentrations amoxicillin can reduce results of level of glucose in blood sera.
When using colorimetric methods, amoxicillin can interfere with protein definition.
With care: pregnancy, a renal failure, bleedings in the anamnesis.
At course treatment it is necessary to carry out control of a condition of function of bodies of a hemopoiesis, a liver and kidneys.
Development of superinfection due to growth of microflora, insensitive to it, is possible that demands corresponding change of antibacterial therapy.
At treatment of patients with bacteremia the development of reaction of a bacteriolysis (Yarisha-Gerksgeymer’s reaction) is possible.
At the patients having hypersensitivity to penicillin cross allergic reactions with tsefalosporinovy antibiotics are possible.
At treatment of slight diarrhea against the background of course treatment it is necessary to avoid the antidiarrheal drugs reducing an intestines vermicular movement, it is possible to use a kaolin – or attapulgitsoderzhashchy antidiarrheal means. In heavy diarrhea it is necessary to see a doctor.
Treatment surely continues 48-72 more h after disappearance of clinical signs of a disease.
At use of amoxicillin in high doses for the purpose of minimization of risk of an amoksitsillinovy crystalluria it is important to watch adequacy of consumption and removal of liquid.
Amosin should not be applied to treatment of bacterial infections at patients with viral infections, an acute lymphoblastoid leukosis or an infectious mononucleosis (in connection with the increased risk of erythematic rash on skin).
As well as at use of other antibacterial agents, at use of high doses of amoxicillin it is necessary to control blood indicators regularly.
In the presence of heavy disorders from digestive tract with diarrhea and vomiting it is not necessary to apply Amosin® as these states can reduce its absorbability. Purpose of a parenteral form of amoxicillin is recommended to such patients.
At simultaneous use of estrogensoderzhashchy oral contraceptives and amoxicillin, it is necessary to use whenever possible other or additional methods of contraception.
Use of drug during pregnancy is possible when the expected advantage for mother exceeds potential risk for a fruit.
Duration of use should not exceed 7-10 days.
The feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
was not messages about Amosin’s influence on driving or work with mechanisms. Nevertheless, some patients can have a headache and dizziness. At their emergence the patient has to observe special precautionary measures during the driving and work with mechanisms.
Symptoms: nausea, vomiting, diarrhea, disturbance of water and electrolytic balance (as a result of vomiting and diarrhea).
Treatment: gastric lavage, intake of activated carbon, salt laxatives, if necessary drugs for maintenance of water and electrolytic balance, a hemodialysis.
A form of release and packing
of 1.5 g, 3 g or 6 g (125 mg, 250 mg or 500 mg of active ingredient respectively) powder in heat-sealable one-dose packages from material of the combined multilayered.
10 one-dose packages of the instruction for medical use in the state and Russian languages place in a pack from cardboard.
To Store storage conditions in the dry, protected from light place, at a temperature from 15 °C to 25 °C.
To store out of children’s reach!
not to use a period of storage after an expiration date.
According to the prescription.
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Ph./fax (3522) 48-16-89
Owner of the registration certificate
of LLC POLLO,
640000, Russian Federation, Kurgan, Lenin St., 5, office 320.
The address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products
of STOFARM LLP,
000100, Republic of Kazakhstan, Kostanay region, Kostanay, Uralskaya St., 14
ph. 714 228 01 79