Expiration date: 03/2024

Active substance: Amoxicillin

The drug forms 

Coated tablets: oblong (0.5 g) or oval (1 g), biconvex, white to slightly yellowish color with notches on both sides.

Pharmachologic effect: antibacterial broad-spectrum.

Pharmacodynamics

Amoxicillin is a semisynthetic penicillin that has a bactericidal action. Mechanism of bactericidal action of amoxicillin is associated with damage to the cell membrane of bacteria in breeding stage. Amoxicillin specifically inhibits enzymes bacteria cell membranes (peptidoglycan), resulting in their death and lysis.

It is active against:

Gram positive aerobic bacteria - Bacillus anthracis, Corynebacterium spp. (Except Corynebacterium jeikeium), Enterococcus faecalis, Listeria monocytogenes, Streptococcus spp. (Including Streptococcus pneumoniae), Staphylococcus spp. (Except for strains producing penicillinase).

Gram negative aerobic bacteria -. Borrelia sp, Escherichia coli, Haemophilus spp, Helicobacter pylori, Leptospira spp, Neisseria spp, Proteus mirabilis, Salmonella spp, Shigella spp, Treponema spp, Campylobacter.......

Others - Chlamydia spp.

Anaerobic bacteria - Bacteroides melaninogenicus, Clostridium spp, Fusobacterium spp, Peptostreptococcus spp...

Not against:

Gram positive aerobic bacteria Staphylococcus (?-lactamase producing strains).

Gram-negative aerobic bacteria - Acinetobacter spp, Citrobacter spp, Enterobacter spp, Klebsiella spp, Moraxella catarrhalis, Proteus spp, Providencia spp, Pseudomonas spp, Serratia spp........

Anaerobic bacteria - Bacteroides spp.

Others - Mycoplasma spp, Rickettsia spp..

Pharmacokinetics

The absolute bioavailability of amoxicillin dose-dependent and ranges from 75 to 90%. The presence of food did not affect the drug absorption. As a result of oral administration of amoxicillin in a single dose of 500 mg of the drug concentration in plasma is 6-11 mg / l. After oral administration, Cmax in plasma achieved in 1-2 hours.

From 15 to 25% of amoxycillin binds to plasma proteins. The product quickly penetrates into the lung tissue, bronchial secretions, middle ear fluid, bile and urine. In the absence of inflammation of the meninges amoxicillin penetrates into the cerebrospinal fluid in minor amounts. When inflammation of the meninges of the drug concentration in CSF may be 20% of the plasma concentration. Amoxicillin crosses the placenta and is found in small quantities in breast milk.

Up to 25% of the administered dose is metabolized to form inactive penitsilloevoy acid.

About 60-80% of amoxicillin is excreted unchanged by the kidneys for 6-8 hours after ingestion. A small amount of the drug is excreted in the bile. T1 / 2 is 1-1.5 hours. In patients with renal disease T1 / 2 ranges from 5 to 20 hours. The drug is excreted by hemodialysis.

Testimony

Amoxicillin is indicated for infectious and inflammatory diseases caused by bacteria non-resistant to the drug:

  • infectious diseases of the upper and lower respiratory tract and ENT-organs (tonsillitis, otitis media, pharyngitis, bronchitis, pneumonia, lung abscess);
  • infectious diseases of the genitourinary system (urethritis, pyelonephritis, pyelitis, chronic bacterial prostatitis, epididymitis, cystitis, adnexitis, septic abortion, endometritis, etc.);
  • Gastrointestinal infections: bacterial enteritis. You may need a combination therapy for infections caused by anaerobic microorganisms;
  • infectious and inflammatory diseases of the biliary tract (cholangitis, cholecystitis);
  • eradication of Helicobacter pylori (in combination with a proton pump inhibitor, clarithromycin or metronidazole);
  • Skin and soft tissue infections;
  • leptospirosis, listeriosis, Lyme disease (Lyme disease);
  • endocarditis (including prevention of endocarditis during the dental procedures).

Contraindications

  • hypersensitivity to penicillin and other ingredients;
  • Hypersensitivity to other beta-lactam antibiotics such as cephalosporin, carbapenem (possibility of cross-reactions);
  • Children under 3 years of age (for a given dosage form).

With caution the drug should be used in patients with impaired renal function; severe digestive disorders, accompanied by constant vomiting and diarrhea; allergic diathesis; asthma; hay fever; viral infections; with acute lymphoblastic leukemia; infectious mononucleosis (due to an increased risk of erythematous skin rashes); in children older than three years.

Pregnancy and breast-feeding

Animal studies have shown that amoxicillin does not have embryotoxic, teratogenic and mutagenic effects on the fetus. However, adequate and well-controlled studies on the use of amoxicillin in pregnant women has not been conducted, therefore the use of amoxicillin during pregnancy is possible only if the expected benefit to the mother outweighs the potential risk to the fetus.

The drug is excreted in breast milk, so the treatment of amoxicillin during lactation is necessary to resolve the issue of termination of breastfeeding, as may develop diarrhea and / or fungal colonization of the mucous membrane, as well as sensitization to beta-lactam antibiotics in nursing baby.

Side effects

The frequency of side effects is set out in accordance with the following gradation: very often - more than 10%; frequent - from 1 to 10%; infrequent - from 0.1 to 1%; Rare - from 0.01 to 0.1%; very rare - less than 0.01%.

From the CCC: Frequent - tachycardia, phlebitis; rare - decrease in blood pressure; very rare - elongation of the QT interval.

From the blood and lymphatic system: frequent - eosinophilia, leukopenia; rare - neutropenia, thrombocytopenia, agranulocytosis; very rare - anemia (including hemolytic), thrombocytopenic purpura, pancytopenia.

From the nervous system: frequent - drowsiness, headache, dizziness; rare - anxiety, agitation, anxiety, ataxia, behavioral changes, peripheral neuropathy, anxiety, sleep disturbances, depression, paraesthesia, tremor, confusion, convulsions; very rare - hypersthesia, visual, olfactory and tactile sensitivity, hallucinations.

With the genitourinary system: rare - interstitial nephritis, an increase in the concentration of creatinine in the blood serum.

On the part of the digestive tract and liver: goiter, change in taste, stomatitis, glossitis; frequent - nausea, diarrhea, increase in liver parameters (ALT, AST, alkaline phosphatase, gamma-glutamyl), increase in serum bilirubin concentration; rare - vomiting, indigestion, pain in the epigastric, hepatitis, cholestatic jaundice; very rare - acute liver failure, diarrhea mixed with blood, pseudomembranous colitis, the appearance of black color language.

From the musculoskeletal system: rarely - arthralgia, myalgia, tendon disorders including tendinitis; very rare - tendon rupture (can be two-way, and 48 hours after the start of treatment), muscle weakness, rhabdomyolysis.

Skin: Frequent - pruritus, rash; rare - urticaria; very rare - photosensitivity, swelling of the skin and mucous membranes, malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome).

From endocrine system: rare - anorexia; very rare - hypoglycemia, particularly in patients with diabetes mellitus.

With the respiratory system: rarely - bronchospasm, dyspnea; very rare - allergic pneumonitis.

General: rare - general weakness; very rare - fever.

Other: shortness of breath, vaginal candidiasis; rare - superinfection (especially in patients with chronic diseases or low resistance of the body), reactions similar to serum sickness; isolated cases - anaphylactic shock.

Interaction

May increase the absorption of digoxin time during therapy with Amoxicillin Sandoz®.

Probenecid decreases renal excretion of amoxicillin and amoxicillin concentration increases in bile and blood.

Avoid the simultaneous use of amoxicillin and other bacteriostatic drugs (macrolides, tetracyclines, sulfonamides, chloramphenicol) because of the possibility of antagonism. With simultaneous use of aminoglycosides and amoxicillin may develop sinnergicheskogo effect.

Not recommended simultaneous use of amoxicillin and disulfiram.

With simultaneous use of amoxicillin and methotrexate may increase the toxicity of the first, probably because of the competitive inhibition of renal tubular secretion of methotrexate amoxicillin.

Antacids, glucosamine, laxatives, drugs, food, aminoglycosides slow down and reduce the absorption, ascorbic acid increases the absorption of amoxicillin.

It improves the effectiveness of indirect anticoagulants (suppressing the intestinal microflora, reduces the synthesis of vitamin K and prothrombin index); estrogensoderzhaschih reduces the effectiveness of oral contraceptives; drugs in the metabolism that produce para-aminobenzoic acid (PABA), products of ethinyl estradiol - the risk of "breakthrough" bleeding.

Diuretics, allopurinol, oxyphenbutazone, phenylbutazone, nonsteroidal anti-inflammatory drugs and other drugs that block tubular secretion, increase the concentration of amoxicillin in the blood.

Allopurinol increases the risk of skin rash.

Dosing and Administration

Inside.

infections Therapy

Generally, treatment is recommended to continue for 2-3 days after the disappearance of symptoms. In case of infections caused by ?-hemolytic streptococcus, complete eradication of the pathogen requires therapy for at least 10 days.

Parenteral therapy is indicated for the impossibility of the oral and in the treatment of severe infections.

Adult dosage (including elderly patients)

Standard dosage: The usual dose ranges from 750 mg to 3 g amoxicillin daily in divided doses. In some cases, it is recommended to restrict the dose of 1500 mg / day in divided doses.

A short course of therapy: uncomplicated urinary tract infections - twice-daily formulation of the 3 g with an interval between doses of 10-12 hours.

Children's dosage (under 12 years)

The daily dose for children is 25-50 mg / kg / day in divided doses (up to 60 mg / kg / day), depending on the indication and the severity of the disease.

Children weighing more than 40 kg should receive the adult dosage.

Dosage in renal insufficiency

Patients with severe renal insufficiency, the dose should be reduced. When renal clearance less than 30 ml / min is recommended to increase the interval between doses or decrease subsequent doses. In renal insufficiency, contraindicated short courses of therapy for 3 years

Adults (including elderly):

Creatinine clearance ml / min
 dose mg
interval between doses, h
> 30
dose change is required
 -
10-30
500 
12
<10 
500 
24

In hemodialysis: 500 mg should be administered after the procedure.

Renal impairment in children weighing less than 40 kg:

Creatinine clearance ml / min
 dose mg
interval between doses, h
> 30
dose change is required
 -
10-30
15
12
<10 
15
24

Endocarditis prophylaxis

For the prevention of endocarditis in patients not under general anesthesia should be administered 3 grams of amoxicillin 1 hour before surgery and, if necessary, an additional 3 g every 6 hours.

Children are encouraged to nominate amoxicillin at 50 mg / kg.

For more information and descriptions of categories of patients at risk for endocarditis, contact your local official guidelines.

Overdose

Symptoms include nausea, vomiting, diarrhea, disruption of water and electrolyte balance, renal toxicity, crystalluria, epileptic seizures.

Treatment: reception activated carbon, symptomatic therapy, correction of violations of water-electrolyte balance, hemodialysis possible.

Special instructions

Before prescribing Amoxicillin Sandoz® make sure that the strains of microorganisms that cause infectious disease, are sensitive to the drug.

In severe infectious and inflammatory gastrointestinal processes involving prolonged diarrhea or nausea, it is recommended not to take Amoxicillin Sandoz® inside because of possible low absorption of the drug.

In the treatment of mild diarrhea on the background of a course of treatment should be avoided antidiarrhoeal drugs that reduce intestinal motility; You can use kaolin or attapulgitsoderzhaschie antidiarrheal drugs. In severe diarrhea should consult a doctor.

To exclude the development of pseudomembranous colitis (caused by Clostridium difficile) With the development of severe persistent diarrhea. In this case, Sandoz® Amoxicillin should be discontinued and appropriate treatment. Thus drugs that slow down the motility of the gastrointestinal tract, are contraindicated.

In exchange treatment is necessary to monitor the state functions of blood, liver and kidneys.

Perhaps the development of superinfection due to growth insensitive to it microflora, which requires a corresponding change in antibiotic therapy.

In patients with increased sensitivity to penicillins, possible allergic cross-reactivity with other beta-lactam antibiotics.

Treatment continues for sure 48-72 hours after the disappearance of clinical signs of disease.

With simultaneous use of oral contraceptives and estrogensoderjath amoxicillin should be possible to use other or additional contraceptive methods.

Amoxicillin Sandoz® not recommended for the treatment of acute respiratory viral infections due to low efficiency.

Particular caution is recommended that the patients with atopic diathesis or bronchial asthma, gastrointestinal diseases in history (in particular, colitis caused by treatment with antibiotics).

Chronic administration of Amoxicillin Sandoz® should appoint a Nystatin, Levorinum or other antifungals.

During treatment is not recommended to use ethanol.

Application Amoxicillin Sandoz® no effect on the results of enzymatic analysis glycosuria, but there may be false positive urine tests for glucose.

While receiving the drug Amoxicillin Sandoz® recommended to drink plenty of fluids to prevent the formation of crystals in the urine of amoxicillin.

Effects on ability to drive and perform other activities that require concentration and speed of psychomotor reactions

Because of the likelihood of side effects such as drowsiness, headache and confusion, you should be careful when engaging in potentially hazardous activities that require high concentration and psychomotor speed reactions.

Release Form

Film-coated tablets, 0.5 g and 1 g

Dosage 0.5 g

Primary Packaging: 10 or 12 Table. in a blister made of PVC / PVDC / aluminum.

Secondary packaging: individual packing - 1 blister (containing 12 tab.) In a cardboard box; packaging for hospitals - 100 blisters (containing 10 tab.) in a cardboard box.

Dosage 1 g

Primary Packaging: - 6 or Table 10. in a blister made of PVC / PVDC / aluminum.

Secondary packaging: individual packing - 2 blisters (containing 6 Table.) In a cardboard box; packaging for hospitals - 100 blisters (containing 10 tab.) in a cardboard box.

Manufacturer

Sandoz GmbH, Biohemishtrasse, 10, A-6250 Kundl, Austria.

Storage conditions

The temperature is not above 25 ° C.

Keep out of the reach of children.

Shelf-life: 4 years.

Do not use beyond the expiration date printed on the package.

Amoxicillin