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Instructions for use OSPAMOX® (OSPAMOX)

Before starting treatment, carefully collect anamnesis for the presence of hypersensitivity reactions to penicillins and cephalosporins. The possibility of cross-hypersensitivity to cephalosporins should be taken into account (noted in 10-15% of cases).

Severe, sometimes fatal (anaphylactoid) hypersensitivity reactions have been described with penicillin. The development of such reactions is more likely in individuals with a history of hypersensitivity to beta-lactam antibiotics.

In patients with impaired renal function, the excretion of amoxicillin is slowed down, and therefore it may be necessary to reduce the total daily dose of the drug depending on the degree of impairment.

Newborns, incl. In premature infants, the drug is prescribed with caution and monitoring of renal, liver and hematological parameters is carried out.

Long-term use of amoxicillin can lead to excessive proliferation of insensitive microorganisms or yeast, so treatment should be carried out under medical supervision to avoid the development of superinfection.

When amoxicillin is taken orally, anaphylactic shock and other severe allergic reactions rarely develop. However, when they develop, appropriate emergency treatment measures should be taken.

Due to the possibility of crystallization, urinary catheters should be inspected periodically. To prevent crystallization (crystalluria) when taking high doses, it is necessary to consume enough fluid and monitor diuresis.

The drug should not be used to treat bacterial infections in patients with viral infections, acute lymphoblastic leukemia or infectious mononucleosis, since its use in persons with glandular fever may provoke the appearance of an erythematous morbilliform rash.

If severe persistent diarrhea occurs, the development of pseudomembranous colitis (in most cases caused by Clostridium difficile) should be considered. In this case, amoxicillin should be stopped and appropriate treatment measures initiated. Taking drugs with antiperistaltic effects is contraindicated.

As with other beta-lactam antibiotics, blood counts should be monitored regularly during treatment with high doses of amoxicillin.

In patients with renal failure, seizures, treatment for epilepsy, and a history of meningitis, high doses of beta-lactam antibiotics may, in rare cases, precipitate seizures.

The appearance of generalized erythema with fever and pustules at the beginning of treatment may indicate the development of acute generalized exanthematous pustulosis and requires discontinuation of Ospamox; further use of the drug in such patients is contraindicated.

When amoxicillin is used simultaneously with anticoagulants, dose adjustment of the latter may be required.

Serum levels of methotrexate should be carefully monitored when coadministered with amoxicillin.

Ospamox® powder for oral suspension contains aspartame (E951), and therefore should be used with caution in patients with phenylketonuria. When calculating nutrition for patients homozygous for phenylketonuria, the amount of phenylalanine contained in aspartame should be taken into account. 5 ml of prepared oral suspension contains 8.5 mg of aspartame and 7.1 mg of sodium benzoate.

Ospamox 500mg No. 12 Tablets Dispersible

Trade name: Ospamox® DT International nonproprietary name: Amoxicillin Dosage form: dispersible Tablets, 500 mg Composition: Active ingredients Amoxicillin; 1 tablet contains amoxicillin 500 mg in the form of amoxicillin trihydrate Excipients: Magnesium stearate, aspartame (E 951), croscarmellose sodium, mannitol (E 421), talc, colloidal silicon dioxide, microcrystalline cellulose, maltodextrin, soluble starch, titanium dioxide (E 171 ), peach-apricot flavoring powder, orange flavoring powder

Description: Oblong biconvex tablets from white to slightly yellowish-white. Pharmacotherapeutic group: Beta-lactam antibacterial drugs – penicillins.

Pharmacological properties: Pharmacodynamics Amoxicillin is a semi-synthetic, broad-spectrum penicillin antibiotic that has a bactericidal effect as a result of inhibition of bacterial cell wall synthesis. Minimum inhibitory concentration (MIC) thresholds vary among susceptible organisms. Enterobacteriaceae are considered to be inhibited by amoxicillin at a concentration of 32 μg/ml. In accordance with NCCLS recommendations, M. catarrhalis (β-lactamase negative) and H. influenzae (β-lactamase negative) are considered susceptible at concentrations of 4 μg/ml; Str. pneumoniae are considered susceptible at an MIC of 8 µg/ml. Bacteria may become resistant to amoxicillin as a result of the production of beta-lactamases, changes in penicillin-binding proteins, impaired permeability to the drug, or due to special pumps that facilitate the removal of the drug from the cell. Microorganisms can simultaneously possess multiple resistance mechanisms, which explains the existence of variable and unpredictable cross-resistance to other beta-lactams and antibacterial drugs from other groups.

Indications for use: Ospamox® is indicated for the treatment of the following bacterial infections caused by amoxicillin-sensitive gram-positive and gram-negative microorganisms: - upper respiratory tract infections, including infections of the ears, nose and throat: acute otitis media, acute sinusitis and bacterial pharyngitis. - lower respiratory tract infections: exacerbation of chronic bronchitis, typical pneumonia. - genitourinary tract infections - skin and soft tissue infections - gonorrhea - Helicobacter pylori eradication - endocarditis: prevention in patients at risk of developing endocarditis, for example, those undergoing dental procedures National recommendations should be taken into account for the correct use of antibacterial drugs. Whenever possible, the susceptibility of susceptible organisms to treatment should be determined, although therapy may be initiated pending results. Method of administration and dosage: Ospamox® DT dispersible tablets are taken orally, dissolved in a small amount of water, or swallowed whole with water. To facilitate dissolution, the tablet can be broken. Absorption of the drug Ospamox® DT is not reduced when taken together with food. The dosage is determined by the severity of the infectious process and the activity of the pathogen. Treatment of infections Treatment should usually be continued for 2-3 days after the symptoms of the disease disappear. In the case of infection caused by β-hemolytic streptococcus, therapy should continue for at least 10 days to achieve the full antibacterial effect. Parenteral therapy is prescribed if oral administration is not possible or if emergency treatment for severe infections is necessary. Dosage for adults (including older patients) Standard dosage The usual daily dose is 750 mg to 3 g of amoxicillin and can be divided into 2-4 doses, in some cases a daily dose of 1.5 g of amoxicillin is recommended as a maximum. Special dosage For exacerbation of chronic bronchitis in adults, the recommended dose: 1 g twice a day. Dosage for children Children from 5 to 12 years old are prescribed 250 mg of amoxicillin 3 times a day. Ospamox® DT is not intended for use in children under 5 years of age. Dosage for patients with renal impairment In patients with severe renal impairment, recommended doses should be reduced. For patients with renal clearance less than 30 ml/min, an increase in the interval between doses or a decrease in subsequent doses is recommended. A short course of treatment in the form of a single dose of 3 g of the drug cannot be prescribed if renal function is impaired. For hemodialysis: 500 mg of the drug is administered at the end of the procedure. Prevention of endocarditis. To prevent endocarditis in patients not receiving general anesthesia, 3 g of amoxicillin is prescribed one hour before the surgical procedure, after which (6 hours later) another 3 g is prescribed if necessary. For more detailed information and a description of the categories of patients at risk endocarditis, consult local official guidelines. Side effects: Infections and infection - uncommon: long-term and repeated use of the drug can lead to the development of superinfection and colonization of resistant microorganisms or fungi, for example, oral and vaginal candidiasis. Blood and lymphatic system disorders - rare: Eosinophilia and hemolytic anemia - very rare: leukopenia, granulocytopenia, thrombocytopenia, pancytopenia, anemia, myelosuppression, agranulocytosis, prolongation of bleeding time and prothrombin time. All changes were reversible upon cessation of therapy. Immune system disorders - rarely: laryngeal edema, serum sickness, allergic vasculitis, anaphylaxis and anaphylactic shock in rare cases. Neurological disorders - rarely: hyperkinesis, dizziness and convulsions. Seizures may occur in patients with renal failure or in patients receiving high doses of the drug. Gastrointestinal disorders - often: discomfort, nausea, loss of appetite, vomiting, flatulence, loose stools, diarrhea, enanthemas (especially on the oral mucosa), dry mouth, impaired taste perception. As a rule, these effects are mild in severity and often disappear as therapy continues or very quickly after its cessation. The incidence of these complications can be reduced by taking amoxicillin with food. When severe persistent diarrhea develops, the possibility of a very rare complication, pseudomembranous colitis, must be considered. In such cases, the use of drugs that suppress peristalsis is contraindicated. - very rare: the appearance of a black color of the tongue. Disorders of the liver and biliary system: - infrequently: transient moderate increase in the level of liver enzymes - rarely: hepatitis, cholestatic jaundice. Damage to the skin and subcutaneous fat: - often: skin reactions in the form of exanthema, itching, urticaria; Typical morbilliform exanthema appears 5–11 days from the start of therapy. The immediate development of urticaria indicates an allergic reaction to amoxicillin and requires cessation of therapy - rare: angioedema (Angioedema), exudative erythema multiforme, acute generalized pustular rash - very rare: Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous and exfoliative dermatitis Renal disorders - rare: acute interstitial nephritis General disorders - rare: development of drug fever. Contraindications: - hypersensitivity to penicillin; the possibility of cross-allergy to other beta-lactam antibiotics, such as cephalosporins - hypersensitivity to any of the components of the drug - lymphocytic leukemia should be taken into account. Drug interactions: Concomitant use is not recommended: Allopurinol Concomitant use with allopurinol may lead to the development of allergic skin reactions. Digoxin The absorption of digoxin may increase during therapy with Ospamox®. Anticoagulants Concomitant use of amoxicillin and anticoagulants such as coumarin may increase the likelihood of bleeding due to prolongation of prothrombin time. When prescribing anticoagulants together with Ospamox®, monitoring of homeostatic parameters is required. Probenecid Probenecid inhibits the excretion of amoxicillin through the kidneys, and leads to an increase in the concentration of amoxicillin in bile and blood. Other antibiotics There is a possibility of antagonism of the action of amoxicillin with the simultaneous administration of bacteriostatic drugs: macrolides, tetracyclines, sulfonamides and chloramphenicol. Methotrexate Concomitant use of methotrexate and amoxicillin may increase the degree of methotrexate toxicity, possibly as a result of competitive inhibition of tubular renal secretion of methotrexate by amoxicillin. Amoxicillin should be used with caution with the following drugs: Oral hormonal contraceptives The use of amoxicillin can lead to a transient decrease in the concentration of estrogen and progesterone in the blood, and reduce the effectiveness of contraceptives. In this regard, it is recommended to additionally use other non-hormonal methods of contraception during treatment with amoxicillin. Incompatibility There is no data on the incompatibility of amoxicillin preparations for oral administration with other drugs.

Special instructions: During the course of treatment, it is necessary to monitor the state of the function of the hematopoietic organs, liver and kidneys. In patients with severely impaired renal function, adequate adjustment of the dosage regimen and increased intervals between doses of medications are required. It is possible that superinfection may develop due to the growth of microflora that is insensitive to it, which requires a corresponding change in antibacterial therapy. If allergic reactions occur, the drug should be discontinued and the usual treatment with adrenaline, antihistamines and glucocorticoids should be prescribed. If a maculopapular rash appears, treatment can be continued only in case of life-threatening conditions under strict supervision. During therapy, adequate fluid intake and maintaining sufficient diuresis are extremely important. In patients with cholangitis or cholecystitis, antibiotics can be prescribed only if the disease is mild and in the absence of cholestasis. It is advisable to dynamically determine the number of blood cells in order to identify antibody-dependent reactions of the hematopoietic system and hemolytic anemia. Before starting treatment for gonorrhea, in patients with suspected primary syphilitic lesions, it is necessary to conduct a dark-field study. All other patients with suspected concomitant syphilis should undergo serologic testing over at least 4 months. Features of the effect of the drug on the ability to drive a car and work with potentially dangerous mechanisms have not been identified. Overdose: Overdose symptoms: amoxicillin usually does not cause acute toxic effects, even with accidental ingestion of high doses. An overdose can be manifested by symptoms of gastrointestinal disorders and disturbances in water and electrolyte balance. In patients with severe renal impairment, overdose of large doses of amoxicillin may be accompanied by signs of nephrotoxicity and crystalluria. Treatment: There is no specific antidote for amoxicillin. Therapy includes the administration of activated charcoal (there are usually no indications for gastric lavage) or symptomatic measures. Particular attention should be paid to maintaining fluid and electrolyte balance. Hemodialysis may be used.

Ospamox 125 mg/5 ml 60 ml gran.d/susp. for oral administration

Instructions for medical use of the drug Ospamox® Trade name Ospamox® International nonproprietary name Amoxicillin Dosage form Powder for the preparation of suspension for oral administration 125 mg/5 ml and 250 mg/5 ml Composition 5 ml of suspension contains the active substance: amoxicillin 125.00 mg (in the form amoxicillin trihydrate 146.40 mg) or 250.00 mg (in the form of amoxicillin trihydrate 287.00 mg), excipients: lemon flavor, peach-apricot flavor, anhydrous citric acid, sodium benzoate, aspartame, talc, trisodium citrate anhydrous, orange flavor, guar, silicon dioxide besieged. Description White to slightly yellowish powder, with a fruity odor characteristic of the active substance. The prepared suspension is white to slightly yellowish in color, with a fruity odor characteristic of the active substance and a bitter-sweet taste. Pharmacotherapeutic group Antibacterial drugs for systemic use - Penicillins. Beta-lactam antibacterial drugs. Broad-spectrum penicillins. Amoxicillin. ATC code J01CA04 Pharmacological properties Pharmacokinetics Absorption The absolute bioavailability of amoxicillin depends on the dose and mode of administration and ranges from 75 to 90%. At doses from 250 mg to 750 mg, bioavailability (parameters: AUC and/or urinary excretion) is linearly proportional to the dose. At higher doses, absorption is lower. Eating does not affect absorption. Amoxicillin is acid-fast. With a single oral dose of 500 mg, the concentration of amoxicillin in the blood is 6–11 mg/l. After a single dose of 3 g of amoxicillin, the concentration in the blood reaches 27 mg/l. Maximum concentrations in blood plasma are observed 1 to 2 hours after taking the drug. Distribution About 17% of amoxicillin is bound to plasma proteins. Therapeutic concentrations of the drug are quickly achieved in plasma, lungs, bronchial secretions, middle ear fluid, bile and urine. Amoxicillin can penetrate through the inflamed meninges into the cerebrospinal fluid. Amoxicillin passes through the placenta and is found in small amounts in breast milk. Biotransformation and elimination The main site of elimination of amoxicillin is the kidneys. About 60–80% of an oral dose of amoxicillin is excreted within 6 hours after administration in unchanged active form through the kidneys and a small fraction is excreted into bile. Approximately 7–25% of the dose is metabolized to inactive penicillanic acid. The half-life from plasma in patients with unchanged renal function is 1 – 1.5 hours. In patients with severe renal impairment, the half-life varies from 5 to 20 hours. Amoxicillin is amenable to hemodialysis. Pharmacodynamics Amoxicillin is a semisynthetic penicillin antibiotic that has a bactericidal effect as a result of inhibition of bacterial cell wall synthesis. MIC thresholds vary for different susceptible organisms. Enterobacteriaceae are considered to be inhibited by amoxicillin at a concentration of <8 μg/ml of amoxicillin and resistant at a concentration of > 32 μg/ml. According to NCCLS guidelines and using NCCLS-specified methods, M. catarrhalis (β-lactamase negative) and H. influenzae (β-lactamase negative) are considered susceptible at concentrations < 1 μg/mL and resistant at > 4 μg/mL; Str. pneumoniae are considered susceptible when the MIC is < 2 μg/ml and resistant when > 8 μg/ml. The prevalence of resistant strains varies geographically and seasonally. Sensitive microorganisms Gram-positive aerobes: Enterococcus faecalis$, Listeria monocytogenes, Streptococcus agalactiae, Streptococcus bovis, Streptococcus pyogenes* Gram-negative aerobes: Helicobacter pylori Anaerobes: Peptostreptococci Others: Borrelia Insensitive microorganisms Gram-positive aerobes: Enterococcus faecium$, Streptococcus pneumoniae*+, Streptococcus viridans Gram-negative aerobes : Escherichia coli+, Haemophilus influenzae*, Haemophilus para-influenzae*, Moraxella catarrhalis+, Proteus mirabilis Anaerobes: Prevoltella, Fusobacterium spp. Resistant microorganisms Gram-positive aerobes: Staphylococcus aureus Gram-negative aerobes: Acinetobacter spp, Citrobacter spp, Enterobacter spp, Klebsiella spp, Legionella, Morganella morganii, Proteus vulgaris, Providencia spp, Pseudomonas spp, Serratia spp Anaerobes: Bacteroides fragilis Others: Chlamydia, Mycoplasma, Rickettsia* Clinical efficacy has been shown for sensitive strains when used as indicated + resistance level > $50 families with natural intermediate resistance Bacteria may become resistant to amoxicillin as a result of the production of beta-lactamases that hydrolyze aminopenicillins (which can be inhibited by clavulonic acid), changes in penicillin-binding proteins, impaired permeability to the drug, or due to the operation of special pumps that pump the drug out of the cell. There is variable and unpredictable cross-resistance to other beta-lactams and antibacterial drugs from other groups. Indications for use Treatment of infectious and inflammatory diseases caused by drug-sensitive microorganisms: - upper respiratory tract infections, including ear, nose and throat infections: acute otitis media, acute sinusitis, tonsillitis, bacterial pharyngitis - lower respiratory tract infections: exacerbation of chronic bronchitis , community-acquired pneumonia - lower urinary tract infections: cystitis - prevention of endocarditis: prevention in patients at risk for the development of endocarditis, for example, those undergoing dental procedures - early localized Lyme disease associated with erythema migrans (stage 1) - eradication of Helicobacter Pylori: in combination therapy with another antibacterial agent and an antiulcer agent in adult patients with gastric and duodenal ulcers associated with Helicobacter pylori. Method of administration and dosage The dosage of the drug Ospamox depends on age, body weight, the state of kidney function, the severity of the disease and the location of the infection. Standard dosage Adults and children over 12 years of age (body weight over 40 kg): daily dose from 750 mg to 3 g, divided into 2-3 doses. Typically, the suspension is not prescribed to adults and children weighing more than 40 kg; this group of patients is recommended to prescribe the drug in tablets (for example, Ospamox, film-coated tablets 500 mg and 1000 mg). Children under 12 years of age (body weight less than 40 kg): daily dose 40-90 mg/kg body weight/day, divided into 2-3 doses depending on the indication, severity of the disease and sensitivity to microorganisms. The maximum daily dose is 3 g. For children whose body weight exceeds 40 kg, the same dose as for adults is usually recommended. Special recommendations For tonsillitis, prescribe 50 mg/kg body weight/day, divided into 2 doses. For early localized Lyme disease, 50 mg/kg body weight/day is prescribed, divided into 3 doses over 14-21 days. Prevention of endocarditis To prevent endocarditis, patients not receiving general anesthesia are prescribed 3000 mg of amoxicillin 1 hour before the surgical procedure, after which (8-9 hours later) another 3000 mg is prescribed if necessary. For children, 50 mg/kg body weight is prescribed once 1 hour before the surgical procedure. Table for selecting a single dose of the drug Ospamox 125 mg/5 ml depending on body weight Body weight (kg) Daily dose of amoxicillin 40 mg/kg/day 50 mg/kg/day 90 mg/kg/day 2 1.6 ml 2 times a day day or 1 ml 3 times a day 2 ml 2 times a day or 1.3 ml 3 times a day 3.6 ml 2 times a day or 2.4 ml 3 times a day 3 2.4 ml 2 times a day or 1.6 ml 3 times a day 3 ml 2 times a day or 2 ml 3 times a day 5.4 ml 2 times a day or 3.6 ml 3 times a day 4 3.2 ml 2 times a day or 2, 1 ml 3 times a day 4 ml 2 times a day or 2.7 ml 3 times a day 7.2 ml 2 times a day or 4.8 ml 3 times a day 5 4 ml 2 times a day or 2.7 ml 3 times a day 5 ml 2 times a day or 3.3 ml 3 times a day - 6 4.8 ml 2 times a day or 3.2 ml 3 times a day 6 ml 2 times a day or 4 ml 3 times a day day - 7 5.6 ml 2 times a day or 3.7 ml 3 times a day 7 ml 2 times a day or 4.7 ml 3 times a day - 8 6.4 ml 2 times a day or 4.3 ml 3 times a day — — 9 7.2 ml 2 times a day or 4.8 ml 3 times a day — — 10 8 ml 2 times a day or 5.3 ml 3 times a day — — 11 8.8 ml 2 once a day or 5.9 ml 3 times a day — — 12 9.6 ml 2 times a day or 6.4 ml 3 times a day — — 13 10.4 ml 2 times a day or 6.9 ml 3 times per day — — 14 11.4 ml 2 times a day or 7.5 ml 3 times a day — — 15 12 ml 2 times a day or 8 ml 3 times a day — — 16 12.8 ml 2 times a day or 8.5 ml 3 times a day — — 17 13.6 ml 2 times a day or 9.2 ml 3 times a day — — 18 14.4 ml 2 times a day or 9.6 ml 3 times a day — — 19 15.2 ml 2 times a day or 10.1 ml 3 times a day — — 20 16 ml 2 times a day or 10.7 ml 3 times a day — — Table for choosing a single dose of the drug Ospamox 250 mg/5 ml in depending on body weight Body weight (kg) Daily dose of amoxicillin 40 mg/kg/day 50 mg/kg/day 90 mg/kg/day 2 0.8 ml 2 times a day or 0.5 ml 3 times a day 1 ml 2 times a day or 0.7 ml 3 times a day 1.8 ml 2 times a day or 1.2 ml 3 times a day 3 1.2 ml 2 times a day or 0.8 ml 3 times a day 1, 5 ml 2 times a day or 1 ml 3 times a day 2.7 ml 2 times a day or 1.8 ml 3 times a day 4 1.6 ml 2 times a day or 1 ml 3 times a day 2 ml 2 times per day or 1.3 ml 3 times a day 3.6 ml 2 times a day or 2.4 ml 3 times a day 5 2 ml 2 times a day or 1.3 ml 3 times a day 2.5 ml 2 times per day or 1.7 ml 3 times a day 4.5 ml 2 times a day or 3 ml 3 times a day 6 2.4 ml 2 times a day or 1.6 ml 3 times a day 3 ml 2 times a day or 2 ml 3 times a day 5.4 ml 2 times a day or 3.6 ml 3 times a day 7 2.8 ml 2 times a day or 1.9 ml 3 times a day 3.5 ml 2 times a day or 2.3 ml 3 times a day 6.3 ml 2 times a day or 4.2 ml 3 times a day 8 3.2 ml 2 times a day or 2.1 ml 3 times a day 4 ml 2 times a day or 2.7 ml 3 times a day 7.2 ml 2 times a day or 4.8 ml 3 times a day 9 3.6 ml 2 times a day or 2.4 ml 3 times a day 4.5 ml 2 times per day or 3 ml 3 times a day - 10 4 ml 2 times a day or 2.6 ml 3 times a day 5 ml 2 times a day or 3.3 ml 3 times a day - 11 4.4 ml 2 times a day day or 2.9 ml 3 times a day 5.5 ml 2 times a day or 3.7 ml 3 times a day - 12 4.8 ml 2 times a day or 3.2 ml 3 times a day 6 ml 2 times per day or 4 ml 3 times a day - 13 5.2 ml 2 times a day or 3.5 ml 3 times a day 6.5 ml 2 times a day or 4.3 ml 3 times a day - 14 5.6 ml 2 times a day or 3.7 ml 3 times a day 7 ml 2 times a day or 4.7 ml 3 times a day - 15 6 ml 2 times a day or 4 ml 3 times a day 7.5 ml 2 times per day or 5 ml 3 times a day - 16 6.4 ml 2 times a day or 4.2 ml 3 times a day - - 17 6.8 ml 2 times a day or 4.5 ml 3 times a day - - 18 7.2 ml 2 times a day or 4.8 ml 3 times a day — — 19 7.6 ml 2 times a day or 5 ml 3 times a day — — 20 8 ml 2 times a day or 5.3 ml 3 times a day — — 25 10 ml 2 times a day or 6.7 ml 3 times a day — — 30 12 ml 2 times a day or 8 ml 3 times a day — — 35 14 ml 2 times a day or 9, 3 ml 3 times a day - - 40 16 ml 2 times a day or 10.7 ml 3 times a day - - Dosage for patients with renal failure In patients with severe renal failure, recommended doses should be reduced. For patients with renal clearance less than 30 ml/min, an increase in the interval between doses or a decrease in subsequent doses is recommended. Adults (including elderly patients) Creatinine clearance (ml/min) Dose Interval between doses > 30 No need for dose adjustment - 10-30 500 mg 12 hours < 10 500 mg 24 hours For hemodialysis: 500 mg of the drug is administered at the end of the procedure. Impaired renal function in children weighing less than 40 kg Creatinine clearance (ml/min) Dose Interval between doses > 30 No need for dose adjustment No need for dose adjustment 10-30 15 mg/kg 12 hours < 10 15 mg/kg 24 h Dosage for patients with hepatic impairment There is no need for dosage adjustment in patients with hepatic impairment. Duration of treatment Treatment should usually be continued for 2-3 days after symptoms disappear. In the case of infection caused by β-hemolytic streptococcus, therapy should continue for at least 6-10 days to achieve complete destruction (eradication) of the microorganism. Method of administration The drug Ospamox is taken orally using a measuring syringe. The measuring syringe is included in the package. The ready-to-use suspension should be taken with a glass of water. Eating does not affect absorption. Use in infants: the recommended dose is given undiluted; milk or tea should be given after administration. To prepare the suspension, pour 56 ml or 55 ml of chilled boiled water (depending on the dosage) to the mark on the bottle, close the bottle and shake thoroughly. After this, the white or slightly yellowish suspension is ready for use. Before each use, shake the bottle thoroughly. Scheme for preparing the suspension for oral administration 125 mg/5 ml and 250 mg/5 ml: Amount of powder Amount of added water (chilled and boiled) Volume of the prepared suspension Volume of the bottle 5.10 g (for a dosage of 125 mg/5 ml) 56 ml 60 ml 87 ±3 ml 6.60 g (for a dosage of 250 mg/5 ml) 55 ml 60 ml 87±3 ml Side effects Often (³ 1% - < 10%) - discomfort in the stomach, nausea, loss of appetite, vomiting, flatulence , diarrhea, diarrhea, enanthems (especially on the oral mucosa), dry mouth, impaired taste perception (as a rule, these effects are characterized by mild severity and often disappear as therapy continues or very quickly after its cessation, reduce the incidence of these complications possible by taking amoxicillin with food) - skin reactions in the form of exanthema, itching, urticaria (typical morbilliform exanthema appears 5-11 days from the start of therapy; immediate development of urticaria indicates an allergic reaction to amoxicillin and requires discontinuation of therapy) Uncommon (³ 0.1% - < 1%) - development of superinfection and colonization of resistant microorganisms or fungi, for example, oral and vaginal candidiasis with prolonged and repeated use of the drug - increase in the level of liver transaminases (transient, moderate) Rarely (³ 0.01 % - <0.1%) - eosinophilia and hemolytic anemia - laryngeal edema, serum sickness, allergic vasculitis, anaphylaxis and anaphylactic shock - CNS reactions, which include hyperkinesis, dizziness and convulsions (convulsions may occur in patients with renal failure, epilepsy, meningitis or in patients receiving high doses of the drug) - superficial discoloration of teeth (as a rule, discoloration is removed by brushing the teeth) - hepatitis and cholestatic jaundice - angioedema (Quincke's edema), exudative multiforme - erythema, acute generalized pustular rashes, syndrome Lyell's syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous and exfoliative dermatitis - acute interstitial nephritis, crystalluria - drug fever Very rare (£ 0.01%) - leukopenia, neutropenia, granulocytopenia, pancytopenia, anemia, - myelosuppression, agranulocytosis, prolongation bleeding time and prothrombin time (all changes were reversible upon cessation of therapy) - with the development of severe persistent diarrhea, it is necessary to take into account - the likelihood of pseudomembranous colitis (in most cases caused by Clostridium difficile) - black staining of the tongue Contraindications - hypersensitivity to penicillin; the possibility of cross-allergy to other β-lactam antibiotics, such as cephalosporins - combined use with drugs that suppress intestinal motility - history of allergic reactions, hay fever, bronchial asthma - patients with infectious mononucleosis and malignant diseases of the lymph glands (lymphosarcoma, lymphocytic leukemia) - phenylketonuria (Felling's disease) - a history of gastrointestinal tract diseases (especially colitis associated with the use of antibiotics) Drug interactions Combined use is not recommended: ALLOPURINOL COMBINED USE WITH ALLOPURINOL MAY LEAD TO THE DEVELOPMENT OF ALLERGIC SKIN REACTIONS. DIGOXIN IT IS POSSIBLE TO INCREASE THE ABSORPTION OF DIGOXIN DURING OSPAMOX THERAPY. DOSE ADJUSTMENT REQUIRED FOR DIGOXIN. ANTICOAGULANTS COMBINED USE OF AMOXICILLIN AND ANTICOAGULANTS MAY INCREASE THE CHANCE OF BLEEDING DUE TO ELONGATION OF PROTHROMBIN TIME. DOSE CORRECTION FOR ANTICOAGULANTS IS REQUIRED. WHEN PRESCRIBING ANTICOAGULANTS TOGETHER WITH AMOXICILLIN, MONITORING OF BLOOD CLOTTING INDICATORS IS REQUIRED. METHOTREXATE COMBINED USE OF METHOTREXATE AND AMOXICILLIN MAY INCREASE THE TOXICITY OF METHOTREXATE, POSSIBLY AS A RESULT OF COMPETITIVE INHIBITION OF TUBULAR RENAL SECRETION OF METHOTREXATE BY AMOXICILLIN. WHEN PRESCRIBING METHOTREXATE TOGETHER WITH AMOXICILLIN, MONITORING THE CONCENTRATION OF METHOTREXATE IN THE BLOOD SERUM IS REQUIRED. AMOXICILLIN DECREASES THE CLEARANCE OF METHOTREXATE. With caution, amoxicillin with the following drugs, oral hormonal contraceptives, the use of amoxicillin can lead to a transient decrease in the concentration of estrogen and progesterone in the blood, and reduce the effectiveness of contraceptives. In this regard, it is recommended to additionally use other non -hormonal methods of contraception during treatment. Other interactions enhanced diuresis leads to a decrease in blood concentration due to an increase in amoxicillin elimination, when determining the presence of glucose in the urine against the background of amoxicillin, use enzymatic glucose oxidaic methods. When using chemical methods, a high concentration of amoxicillin in the urine can cause false and positive results of the study. Amoxicillin can reduce the amount of estriol in the urine in pregnant women. At high concentrations, amoxicillin can reduce the results of glucose levels in blood serum. When using colorimetric methods, amoxicillin can interfere with the definition of protein. It is important to verify special instructions before the start of amoxicillin therapy in the absence of hypersensitivity to penicillins and cephalosporins that can cause a cross allergic reaction (10%-15%). There are reports of the development of severe, sometimes with fatal outcome, hypersensitivity reactions (anaphylactoid) against the background of penicillin therapy. These reactions are more often observed in people who have a history of hypersensitivity to beta-lactam antibacterial agents. Caution should be observed in the treatment of children, including premature and newborn: it is necessary to control the functions of the kidneys, liver and the condition of the hematopoietic system. In patients with renal failure, the excretion of amoxicillin will slowly and, depending on the degree of violation, it may be necessary to reduce the total daily dose. Long -term use of amoxicillin in some cases can lead to an increase in bacteria and fungi insensitive to it. In this regard, patients should carefully monitor the development of superinfection. Messages about anaphylactic shock and other severe manifest allergic reactions after oral administration of amoxicillin are very rare. In the event of such a reaction, it is necessary to conduct a complex of emergency measures: intravenous administration of adrenaline, then antihistamines, compensation for the volume of circulating blood and the administration of glucocorticoids. The presence of amoxicillin in the urine in a high concentration can cause precipitation of the drug in the urinary catheter, so the catheters must be periodically checked. When using amoxicillin in high doses in order to minimize the risk of amoxicillin crystaluria, it is important to monitor the adequacy of the consumption and excretion of fluid. Ospamox should not be used to treat bacterial infections in patients with viral infections, acute lymphoblastic leukemia or infectious mononucleosis (due to the increased risk of erythematous rash on the skin). As with other antibacterial agents, when using high doses of amoxicillin, it is necessary to regularly monitor blood indicators. Patients need careful observation and, if necessary, other therapeutic procedures (artificial respiration, oxygen). Ospamox should be used with caution in patients with allergic diathesis, asthma, halflelinosis and diseases of the gastrointestinal tract (especially colitis associated with the use of antibiotics). In the presence of severe disorders from the gastrointestinal tract with diarrhea and vomiting, Ospamox should not be used, since these conditions may reduce its absorption. Such patients are recommended by the prescription of the parenteral form of amoxicillin. Ospamox contains aspartam (E951), and it should be caused with caution to patients suffering from phenylketonuria. When regulating nutrition in patients with phenylketonuria homozygous ones, it is necessary to take into account the amount of phenylalanine coming with aspartam. Pregnancy and the period of lactation of Ospamox are used during pregnancy with caution. When used, the principle must be observed - the estimated benefit for the mother should exceed the potential risk to the fetus. Ospamox can be used during lactation. Ospamox penetrates into breast milk and in rare cases can lead to the development of diarrhea and/or fungal colonization of mucous membranes in newborns. It is also necessary to take into account the possibility of sensitizing the newborn to beta-lactam antibacterial agents. When used during lactation, it is recommended to interrupt breastfeeding for treatment period. Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms do not affect the ability to drive a vehicle or other potentially dangerous mechanisms. An overdose of amoxicillin usually does not cause acute toxic effects, even with randomly taking high doses. Symptoms: an overdose can be manifested by symptoms of gastrointestinal disorders, a violation of the water-electrolyte balance. In patients with severe renal failure, an overdose of large doses of amoxicillin may be accompanied by signs of nephrotoxicity and crystalluria. Treatment: there is no specific antidote of amoxicillin. Therapy includes the introduction of activated coal (indications for washing the stomach, as a rule, are not) or symptomatic measures. Particular attention should be paid to the water-electrolyte balance. It is possible to use hemodialysis. The output and packaging form of 5.10 g (for a dosage of 125 mg/5 ml) or 6.60 g (for a dosage of 250 mg/5 ml) powder in the bottles of brown glass with a capacity of 87 ± 3 ml with a membrane seal and a twisting lid with protection against children. 1 bottle along with a measured syringe of polypropylene/polyethylene with an adapter and instructions for medical use in the state and Russian languages are placed in a pack of cardboard. Storage conditions are stored at a temperature of not higher than 25 ° C. Store the prepared suspension at a temperature of 2 ° C to 8 ° C (in the refrigerator) for no more than 14 days. KEEP OUT OF THE REACH OF CHILDREN! SHELF LIFE: 3 YEARS DO NOT USE AFTER EXPIRATION. Conditions for the vacation from pharmacies according to the prescription manufacturer/Packer/Owner of the registration certificate of Sandoz GMBH, Austria Biochemiestrasse 10 6250 Kundl, Austria, the organization address of the Organization of Kazakhstan claims from consumers on the quality of products (goods) responsible for post -storage monitoring of the safety of the drug JSC "Sandoz Farmasyutikals D.D." In the Republic of Kazakhstan, Almaty, st. Lugansk 96, phone number, E-mail fax 8 800 080 0066-Free call number in Kazakhstan

Ospamox®

Before starting amoxicillin therapy, the patient should be interviewed in detail regarding previous hypersensitivity reactions to penicillins, cephalosporins and other beta-lactams.

In patients who are hypersensitive to penicillins, cross-allergic reactions with cephalosporin antibiotics are possible. Serious hypersensitivity reactions (including anaphylactoid and severe cutaneous adverse reactions), sometimes fatal, have been reported in patients receiving penicillin therapy. The development of these reactions is more likely in persons with a history of hypersensitivity to penicillin, as well as in persons with atopy. If an allergic reaction occurs, discontinue amoxicillin therapy and institute appropriate alternative treatment.

There have been rare cases of hypersensitivity reactions such as allergic acute coronary syndrome (Kounis syndrome), in the event of which, when taken together with amoxicillin, appropriate treatment is required.

During treatment, it is necessary to monitor the state of function of the hematopoietic organs, liver and kidneys.

Increased activity of liver enzymes and changes in the number of blood cells were reported.

With long-term use, cases of superinfection and candidiasis (especially vulvovaginal candidiasis) may develop.

When taking almost all antibacterial drugs, it is possible to develop antibiotic-associated colitis up to a life-threatening condition. This should be taken into account if diarrhea occurs during antibiotic therapy or after its completion. If antibiotic-associated colitis develops, drug therapy should be stopped immediately and the attending physician should be consulted to prescribe appropriate treatment.

The use of drugs that inhibit intestinal motility is contraindicated.

The occurrence of generalized erythema with fever accompanied by pustules at the beginning of therapy may be a symptom of acute generalized exanthematous pustulosis (AGEP). This adverse drug reaction requires discontinuation of treatment with amoxicillin and is a contraindication for its further use in any situation.

The use of amoxicillin should be avoided if the patient is suspected of developing infectious mononucleosis, since its use during treatment of this disease can lead to the appearance of a measles-like rash. The Jarisch-Herxheimer reaction has been observed following the use of amoxicillin in patients with Lyme disease. Its direct cause is the bactericidal activity of amoxicillin against the bacteria that cause Lyme disease, the spirochete Borrelia burgdorferi.

Patients should be reassured that this reaction is a common and usually self-limiting consequence of antibiotic use in patients with Lyme disease.

Treatment must continue for 48-72 hours after the disappearance of clinical signs of the disease.

Convulsions may occur in patients with impaired renal function or in patients receiving high doses of the drug or with predisposing factors (for example, a history of seizures, treatment for epilepsy, or meningitis).

In case of renal failure, it is necessary to adjust the dosage regimen depending on the degree of renal failure.

In patients with reduced diuresis, crystalluria was very rarely observed, mainly during parenteral therapy. When using high doses of amoxicillin, it is recommended to maintain adequate fluid intake and diuresis to reduce the possibility of drug-associated crystalluria. In patients with a catheterized bladder, catheter patency should be checked regularly.

There is a possibility that increased concentrations of amoxicillin in serum and urine may influence the results of some laboratory tests. When using chemical methods, high concentrations of amoxicillin in the urine may cause false-positive test results.

To determine the presence of glucose in urine during treatment with amoxicillin, it is recommended to use enzymatic glucose oxidase methods.

The use of amoxicillin may distort the results of the quantitative determination of estriol in pregnant women.

When treating premature infants and during the neonatal period, caution should be exercised: it is necessary to monitor renal, liver and hematological functions.

The drug should be used with caution in the elderly, pregnant women, and during lactation.

When using amoxicillin to treat Helicobacter pylori

, you should take into account the information specified in the text of the instructions for medical use of other concomitantly used drugs.

This drug contains sodium benzoate and sodium citrate, which is important for patients on a sodium-restricted diet. The sodium content in the maximum daily dose does not exceed 200 mg. Sodium benzoate is a mild irritant to the skin, mucous membranes and eyes and may increase the risk of jaundice in newborns.

Special precautions when disposing of unused drug

There is no need for special precautions when disposing of unused drug.