Amoxicillin Sandoz - instructions for use, dose, side effects, contraindications

Excipients: magnesium stearate 5.0 mg / 10.0 mg, povidone 12.5 mg / 25.0 mg, sodium carboxymethyl starch (type A) 20.0 mg / 40.0 mg, microcrystalline cellulose 60.5 mg / 121 mg.

Film Sheath: titanium dioxide 0.340 mg / 0.68 mg, talc 0.535 mg / 1.07 mg, hypromellose 2.125 mg / 4.25 mg.

Description:

Oblong (0.5 g) or oval (1.0 g dosage) biconvex tablets, covered with a film coat from white to slightly yellowish, with incisions on both sides.

Pharmacotherapeutic group:Antibiotic group of semisynthetic penicillins.

ATX: & nbsp

J.01.C.A.04 Amoxicillin

Pharmacodynamics:

Amoxicillin is a semi-synthetic penicillin, which has a bactericidal effect. The mechanism of bactericidal action of amoxicillin is associated with damage to the cell membrane of bacteria that are in the stage of reproduction. Amoxicillin specifically inhibits the enzymes of bacterial cell membranes (peptidoglycans), resulting in their lysis and death.

Active with respect to:

Gram-positive aerobic bacteria

Bacillus anthracis

Corynebacterium spp. (behind exclusion 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

Other

Chlamydia spp.

Anaerobic bacteria

Bacteroides melaninogenicus

Clostridium spp.

Fusobacterium spp.

Peptostreptococcus spp.

Inactive at respect:

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.

Other

Mycoplasma spp.

Rickettsia spp.

Pharmacokinetics:

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

From 15 % up to 25% of amoxicillin binds to plasma proteins. The drug quickly penetrates into the lung tissue, bronchial secretion, middle ear fluid, bile and urine. In the absence of inflammation of the meninges amoxicillin penetrates into the cerebrospinal fluid in small amounts.With inflammation of the meninges, the concentration of the drug in the cerebrospinal fluid can be 20% of its concentration in the blood plasma. Amoxicillin penetrates the placenta and in small amounts is found in breast milk.

Up to 25 % of the administered dose is metabolized with the formation of inactive penicillic acid.

About 60 to 80% of amoxicillin stands out in unmodified form by the kidneys within 6-8 hours after taking the drug. A small amount of the drug is excreted with bile. The half-life is 1-1,5 hours. In patients with terminal renal failure, the half-life period varies from 5 to 20 hours. The drug is excreted by hemodialysis.

Indications:

Amoxicillin is indicated for infectious and inflammatory diseases caused by bacteria that are not resistant to the drug:

- infectious diseases of the upper and lower respiratory tract and ENT organs (angina, acute 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.);

- infections of the gastrointestinal tract: bacterial enteritis. Combination therapy may be required for infections caused by anaerobic microorganisms;

- Infectious and inflammatory diseases of the biliary tract (cholangitis, cholecystitis);

- eradication Helicobacter pylori (in combination with proton pump inhibitors, clarithromycin or metronidazole);

- infection of the skin and soft tissues;

- leptospirosis, listeriosis, Lyme disease (borreliosis);

- endocarditis (including prophylaxis of endocarditis during dental procedures).

Contraindications:

- hypersensitivity to penicillin and other components of the drug;

- hypersensitivity to other beta-lactam antibiotics, such as cephalosporins, carbopenems (the possibility of a cross reaction);

- Children under 3 years old (for this dosage form).

Carefully:

Carefully the drug should be used in patients with impaired renal function; severe digestive disorders, accompanied by constant vomiting and diarrhea; allergic diathesis; asthma; Pollinosis; with viral infections; with acute lymphoblastosis leukemia; infectious mononucleosis (in connection withincreased risk of erythematous skin rash); in children over the age of three.

Pregnancy and lactation:

Studies in animals have shown that amoxicillin does not have an embryotoxic, teratogenic and mutagenic effect on the fetus. However, adequate and controlled studies on the use of amoxicillin in pregnant women have not been carried out, so the use of amoxicillin during pregnancy is only possible if the intended benefit to the mother exceeds the potential risk to the fetus.

The drug is excreted in breast milk, therefore, when treating amoxicillin during lactation, it is necessary to resolve the issue of stopping breastfeeding, as it is possible to develop diarrhea and / or fungal colonization of the mucosa, as well as sensitization to beta-lactam antibiotics in a breastfeeding baby.

Dosing and Administration:

Inside.

Therapy of infections:

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

Parenteral therapy is indicated when it is not possible to perform oral and in the treatment of severe infections.

Adults doses (including elderly patients):

Standard dose:

The usual dose ranges from 750 mg to 3 grams of amoxicillin a day in several doses. In some cases, it is recommended to limit the dose to 1500 mg per day in several doses.

Short course of therapy:

Uncomplicated infections of the urinary tract: a double dose of 3 g for each administration with an interval between doses of 10-12 hours.

Baby dosage (up to 12 years):

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

Children with body weight above 40 kg should receive an adult dosage.

Dosing in renal failure:

In patients with severe renal failure, the dose should be reduced. For renal clearance less than 30 ml / min, an interval between doses or a decrease in subsequent doses is recommended. With kidney failure, short courses of therapy of 3 g are contraindicated.

Adults (including elderly patients):

Creatinine clearance ml / min	Dose	Interval between reception
>30	Dose changes are not required
10-30	500 mg	12h
< 10	500 mg	24 h

When hemodialysis: 500 mg should be administered after the end of the procedure.

Impaired renal function in children weighing less than 40 kg:

Clearance creatinine ml / min	Dose	Interval between reception
>30	Dose changes are not required
10-30	15 mg / kg	12h
< 10	15 mg / kg	24 h

Prophylaxis of endocarditis

For the prevention of endocarditis in patients who are not under general anesthesia, 3 g of amoxicillin should be given 1 hour before the operation and, if necessary, 3 more grams after 6 hours.

Children are recommended to appoint amoxicillin in a dose of 50 mg / kg.

For more detailed information and a description of the categories of patients at risk for endocarditis, refer to local official guidelines.

Side effects:

Frequency of development of side effects is stated in accordance with the following gradation: very frequent - 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

From the side of the cardiovascular system: frequent: tachycardia, phlebitis; rare: lowering blood pressure; highly rare: interval lengthening QT.

On the part of 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: nervousness, agitation, anxiety, ataxia, behavior change, peripheral neuropathy, anxiety, sleep disturbance, depression, paresthesia, tremor, confusion, convulsions; very rare: hyperstasy, impaired vision, smell and tactile sensitivity, hallucinations.

From the genitourinary system: rare: interstitial nephritis, an increase in the serum creatinine concentration.

From the gastrointestinal tract and liver: dysbacteriosis, taste change, stomatitis, glossitis; Frequent: nausea, diarrhea, increased liver function (ALT, ACT, alkaline phosphatase, y-glutamyltransferase), an increase in the serum bilirubin concentration; rare: vomiting, dyspepsia, epigastric pain, hepatitis, cholestatic jaundice; very rare: acute liver failure, diarrhea with an admixture of blood, pseudomembranous colitis, the appearance of a black color of the tongue.

From the musculoskeletal system: rare: arthralgia, myalgia, tendon diseases including tendonitis; very rare: rupture of the tendon (bilateral and 48 hours after the start of treatment), muscle weakness, rhabdomyolysis.

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

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

From the respiratory system: rare: bronchospasm, dyspnoea; very rare: allergic pneumonitis.

Are common: rare: general weakness; very rare: fever.

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

Overdose:

Symptoms: nausea, vomiting, diarrhea, disturbance of water-electrolyte balance, nephrotoxicity, crystalluria, epileptic seizures. Treatment: reception of activated charcoal, symptomatic therapy, correction of disturbance of water-electrolyte balance, hemodialysis is possible.

Interaction:

Possible increase in absorption time digoxin on the background of therapy Amoxicillin Sandoz®.

Probenecid reduces the excretion of amoxicillin by the kidneys and increases the concentration of amoxicillin in bile and blood.

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

It is not recommended simultaneous use of amoxicillin and disulfiram.

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

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

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

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.

Special instructions:

Before appointment Amoxicillin Sandoz® should ensure that strains of microorganisms that cause infectious disease are sensitive to the drug.

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

In the treatment of mild diarrhea against the background of course treatment should be avoided anti-diarrheal drugs,reducing peristalsis of the intestine; it is possible to use kaolin- or attapulgite-containing antidiarrheal drugs. With severe diarrhea, you should see a doctor.

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

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 patients who have increased sensitivity to penicillins, there may be cross-allergic reactions with other beta-lactam antibiotics.

Treatment necessarily continues for another 48 to 72 hours after the disappearance of clinical signs of the disease.

With the simultaneous use of estrogen-containing oral contraceptives and amoxicillin,or additional methods of contraception.

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

Particular care is recommended for patients with allergic diathesis or bronchial asthma, gastrointestinal diseases in history (in particular, colitis caused by antibiotic treatment). With long-term admission Amoxicillin Sandoz® should be simultaneously prescribed nystatin, levorin or other antifungal agents.

During treatment is not recommended to use ethanol.

Application Amoxicillin Sandoz® does not affect the results of enzymatic analysis of glucosuria, but it is possible that false-positive urine tests for glucose are possible.

At the time of taking the drug Amoxicillin Sandoz® is recommended to drink a large amount of liquid to prevent the formation of crystals of amoxicillin in the urine.

Special precautions when destroying an unused preparation

There is no need for special precautions when destroying an unused preparation.

Effect on the ability to drive transp. cf. and fur:Because of the likelihood of side effects such as drowsiness, headache and confusion, care should be taken when practicing potentially dangerous activities that require a high concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Tablets, film-coated, 0.5 g and 1 g.

Packaging:

Dosage 0.5 g

Primary packaging

For 10 or 12 tablets in a blister of PVC / PVDC / aluminum.

Secondary packaging

Individual packing

For 1 blister (containing 12 tablets) in a cardboard box with instructions for use.

Packing for hospitals

For 100 blisters (containing 10 tablets) with an equal number of instructions for use in a cardboard box.

Dosage: 1.0 g

Primary packaging

For 6 or 10 tablets in a blister of PVC / PVDC / aluminum.

Secondary packaging

Individual packing

For 2 blisters (containing 6 tablets each) in a cardboard box with instructions for use.

Packing for hospitals

For 100 blisters (containing 10 tablets) with an equal number of instructions for use in a cardboard box.

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life:

4 years.

Do not use at the end of the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N011270 / 01

Date of registration:06.08.2010

The owner of the registration certificate:Sandoz GmbHSandoz GmbH Austria

Manufacturer: & nbsp

SANDOZ, GmbH Austria

Representation: & nbspSANDOZ SANDOZ Switzerland

Information update date: & nbsp17.04.2014

Illustrated instructions

Instructions

Amoxicillin Sandoz® (Amoxicillin Sandoz®)