Amoxicillin 500mg capsules
Amoxicillin trihydrate - 0,25g; Amoxicillin trihydrate - 0,5g.
Aiding substances:Lactose - 0,14g.
Weight of contents of a capsule - 0,39g; Weight of contents of a
capsule - 0,5g.
Pharmacological operation: the semisynthetic antibiotic of the second generation of group of
penicillin of antibacterial action. Amoxicillin makes inhibition of
transpeptidase. In the course of growth and reproduction breaks
synthesis of peptidoglycan (fiber of a cellular wall) and causes
Amoxicillin has a wide spectrum of action. It is active toward
aerobic gram-positive microorganisms: Staphylococcus spp.,
Streptococcus spp. and aerobic gram-negative microorganisms:
Neisseria gonorrhoeae, Neisseria meningitidis, Escherichia coli,
Shigella spp., Salmonella spp., Klebsiella spp. The microorganisms
producing penicillinase are resistant to Amoxicillin action.
Pharmacokinetics: Amoxicillin it is quickly absorbed (approximately 93 %), food
intake does not influence absorption, does not break up bilious
juice, at intake on a dose of 125 mg and 250 mg, the maximum
concentration in blood plasma is reached in 1-2 hours and makes
1.5-3 kg/ml and 3.5-5 kg/ml.
Amoxicillin has wide volume of distribution - in high concentration
it is shown in plasma, liquids, a bronchial secret (distribution is
weak in the purulent-bronchial secret), pleural and peritoneal
liquids, in the pulmonary fabric, gut mucous membrane, genitals of
the woman, prostate (gland), middle ear liquid, bones, fatty
fabric, bilious bubble (at normal function of a liver), fetus
fabrics. At double increase of dose, concentration also grows two
times. Concentration in bile 2-4 times exceeds concentration in
plasma, badly gets in blood-brain barrier, at time of meningitis in
head and spinal liquid concentration approximately 20 %,
approximately 17 % relates to fibers of plasma. Partially
metallizes with formation of inactive metabolites. The period of
semideducing 1 - 1.5 hours, 50-70 % is allocated as invariable kind
through kidneys (with the way of canalicular secretions (80 %), by
glomerular filtration - 20 %), through a liver - 10-20 %. It is
allocated in mother's milk with a small quantity. Among premature,
new borns and children till 6 months the semideducing period makes
up 3-4 hours. At infringement of kidneys function (creatinine
clearance 15 ml/minutes or less) the semideducing period increases
till 8.5 o'clock. Amoxicillin is deduced at time of hemodialysis.
Indication: Infections of respiratory ways and LOR-BODIES (bronchitis,
pneumonia, quinsy, angina, pharyngitis, sinusitis, bronchitis,
sharp average otitis), urinogenital system (urethritis, cystitis,
pyelonephritis, gonorrhoea, endometritis), infections of
gastrointestinal tract ( peritonitis, enterocolitis, cholecystitis,
belly typhus); infections of a skin and soft fabrics (erysipelas
impetigo, second infected dermatosis), leptospirosis, listeriosis,
meningitis, illness Lima (borreliosis), sepsis, dysentery,
salmonellosis, preventive maintenance of endocarditis and surgical
infections. The combined therapy at gastritis and ulcerous diseases
(in a combination with metronidazole).
Contra-indication: hypersensitivity toward penicillin and cephalosporins. Allergic
diathesis, bronchial asthma, infectious mononucleosis, lymphatic
leukemia, insufficiency of liver gastrointestinal tract disease in
the anamnesis (especially colitis, related to the reception of
antibiotics), lactation. It is carefully prescribed at time of
kidneys' insufficiency, bleeding in the anamnesis and pregnancy.
Safety measures: The patients who have heavy infringements of kidneys function, it
is necessary to increase intervals of preparation reception and
periodically supervise function of kidneys.
In pregnancy and lactation Amoxicillin it is prescribed only under
the vital indication with the account of potential risk to a fetus
or the baby.
Order of reception and dosage: Preparation dosage depends on sensitivity of microorganism and
difficulty of infectious process. Usually in adults and children up
to 10 years (40 weights over kg) - 500 mg 3 times in a day. At a
heavy current of infections the dose increases from 750 mg till 1
Children from 5 till 10 years - 250 mg 3 times in a day, children
from 2 till 5 years - 125 mg 3 times in a day. For children till 2
years the daily dose makes 20 mg/kg. For newborns the dose
decreases and-or the interval between receptions increases.
At time of middle ear otitis children till 1 year - 125 mg 2 times
or 100 mg 3 times a day.
Duration of treatment makes up 5 - 10 days.
At time of sharp gonorrhoea simultaneous reception of 3 gr.
preparation is supposed in combination with 1 gr. probenecid.
At time of gastrointestinal tract and bilious ways sharp infections
(paratiph, typhoid fever), gynecologic infectious diseases in
adults - 1,5 - 2 g. 3 times in a day or 1 - 1,5 g 4 times in a day.
At time of leptospirosis in adults - 0,5-0,75 g. 4 times in a day
during 6-12 days.
To patients, with infringement of renal function, the interval
between preparation receptions increases and makes up: 10-40
ml/minutes at clearance - 12 hours, 10 ml/minutes less at clearance
- 24 hours.
Side effects: Nausea, vomiting, diarrhoeia, pain in the field of anus,
stomatitis, irritability, sleeplessness, dizziness. Difficulty of
breath, tachycardia; pain in joints, dysbacteriosis, candidiasis in
oral cavities or vaginas, hemorrhagic colitis, allergic reactions,
dermatitis, exudative enteropathy, itch, rash.
Pregnancy: Amoxicillin crosses placenta. For the purpose of precaution,
reception of Amoxicillin at pregnancy is possible only after the
doctor will estimate expected risk and advantage of treatment.
The lactation period: Amoxicillin passes in mother's milk. The child who eats such
milk, may probably develop diarrhea and fungal diseases of mucous
membrane that specifies, that it is necessary to interrupt
lactation. Development of allergic reactions also is supposed.
However, at lactation period preparation reception is permitted if
the potential superiority of its reception, justifies potential
risk associated with it.
Influence on driving and other technics: Experience has shown that Amoxicillin does not operate on ability
of concentration and reaction; however side effects can have
influence both on reaction, and to driving and other mechanisms. It
especially concerns preparation reception together with alcohol.
Overdose: Typical symptoms characterizing for Amoxicillin still are not
revealed. Even long therapy does not cause specific toxic
side-effects. Intoxication symptoms are similar to the symptoms
developing at collateral action. More often there is revealed
complaints from gastroenteric track, for example nausea, vomiting,
belly-aches and a diarrhoeia.
Treatment: There isn't specific antidote. Treatment consists symptomatic
measures at which the special attention is given to balance of
water and electrolits. Amoxicillin may eliminate by means of a
Interaction with other medical products: Other antibiotics and-or chemotherapeutic preparations: it is
impossible to accept Amoxicillin together with other those
antibiotics which inhibits bacterium growth (bacteriostatic
antibiotics, such as tetracycline, macrolide, Sulfonal or
chloramphenicol), in that case effect of Amoxicillin may reduce.
Preparations containing probenecid (for gout treatment); at
simultaneous use suppression of Amoxicillin excretion is possible,
that causes Amoxicillin level increase.
The preparations containing allopurinol (for gout treatment):
simultaneous reception can promote development of skin allergic
Dehydration preparations (diuresis): water's raised excretion
causes increase of Amoxicillin elimination, by this reason quantity
of active substances in blood decreases.
Cardiotonic preparations (digoxin): Amoxicillin may increase
absorption of digoxin.
Anticoagulants (coumarin): at simultaneous reception probably
increase the risk of bleeding.
Contraceptive preparations (contraceptives): in rare instances
efficiency of oral contraceptives can decrease. Therefore it is
desirable to intake not hormonal contraceptive preparations in
Influence on laboratory researches: In case of using so-called nonenzyme method definition of sugar
in urine, may receive false positive result. Also reveal of urobilinogen is complicated.
Primary packing: 10 capsules on a blister;
Secondary packing: two blisters in a carton box with
Issue: pharmaceutical product group II - issued a doctor's prescription.
Term of validity: 2 years.
After visual check and defect revealing, usage of preparation is
Storage conditions: It is stored in a dry, dark place keep away from children, at a