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Amoxicilline 250 Mg / 500 Mg #20 Capsules
 

 

Using instruction

Amoxicillin in capsules of 250 mg; 500 mg.

Trade name of drug: Amoxicillin.

Generic name: Amoxicillin.

ATC code: J01CA04.

Pharmacological group: Semisynthetic antibiotic of the penicillin group. 

 

Composition:

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 microorganism lysis.

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 g.

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 hemodialysis.

 

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 reactions.

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 addition.

 

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.

Packing:

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 forbidden.

Storage conditions: It is stored in a dry, dark place keep away from children, at a room temperature.

Producer: "Neopharmi" Ltd.

12th km, David Agmashenebeli alley, Tbilisi, Georgia

Tel/Fax: +995 (32) 59-57-90; 59-64-46.



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