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Ospamox powder for oral suspension 250 mg/5 ml bottle 60 ml

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Ospamox powder for oral suspension 250 mg/5 ml bottle 60 ml
Ospamox powder for oral suspension 250 mg/5 ml bottle 60 ml
Ospamox powder for oral suspension 250 mg/5 ml bottle 60 ml
Ospamox powder for oral suspension 250 mg/5 ml bottle 60 ml
Ospamox powder for oral suspension 250 mg/5 ml bottle 60 ml
Ospamox powder for oral suspension 250 mg/5 ml bottle 60 ml
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461.80 грн.
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Active ingredient:Amoxicillin
Adults:Children's release form
ATC code:J ANTIMIBIOTICS FOR SYSTEMIC USE; J01 ANTIBACTERIALS FOR SYSTEMIC USE; J01C BETA-LACTAM ANTIBIOTICS, PENICILLINS; J01C A Broad-spectrum penicillins; J01C A04 Amoxicillin
Country of manufacture:Austria
Diabetics:Can
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Ospamox powder for oral suspension 250 mg/5 ml bottle 60 ml
461.80 грн.
Description

Instructions Ospamox powder for oral suspension 250 mg/5 ml bottle 60 ml

Composition

active ingredient: amoxicillin;

5 ml of suspension contains 250 mg of amoxicillin in the form of amoxicillin trihydrate;

excipients: anhydrous citric acid, sodium benzoate (E 211), aspartame (E 951), talc, anhydrous trisodium citrate, guar gum, precipitated silicon dioxide, powdered lemon flavor, powdered peach-apricot flavor, powdered orange flavor.

Dosage form

Powder for oral suspension.

Main physicochemical properties: white to yellowish powder; white to yellowish suspension.

Pharmacotherapeutic group

Antimicrobials for systemic use. Beta-lactam antibiotics. Broad-spectrum penicillins. Amoxicillin. ATX code J01C A04.

Pharmacological properties

Pharmacodynamics

Mechanism of action

Amoxicillin is a semisynthetic penicillin (beta-lactam antibiotic) that inhibits one or more enzymes (namely, penicillin-binding proteins (PBPs)) in the biosynthetic metabolism of bacterial peptidoglycan, which is an integral structural component of the bacterial cell wall. Inhibition of peptidoglycan synthesis leads to weakening of the cell wall, resulting in cell lysis and death. Amoxicillin is inactive against microorganisms that produce beta-lactamases.

Pharmacokinetics/pharmacodynamics relationship

The time it takes for the antibiotic concentration to reach the minimum inhibitory concentration (T > MIC) is a very important factor for the successful treatment of bacterial infections with amoxicillin.

Resistance mechanisms

The main mechanisms of resistance to amoxicillin are:

inactivation by bacterial beta-lactamases. conversion of PBL, which reduces the affinity of the antibacterial drug for the target structures.

Bacterial impermeability or efflux pump mechanism can cause or contribute to bacterial resistance, particularly in Gram-negative bacteria.

Limit values

MIC breakpoints for amoxicillin established by the European Committee on Antimicrobial Susceptibility Testing (EUCAST), version 5.0.

Microorganisms MIC limit values (mg/l)
Sensitive ≤ Resistant ≥
Enterobacteriaceae 81 8
Staphylococcus spp. Note2 Note2
Enterococcus spp.3 4 8
Streptococci of groups A, B, C and G Note4 Note4
Streptococcus pneumoniae Note5 Note5
Viridans group streptococci 0.5 2
Haemophilus influenzae 26 26
Moraxella catarrhalis Note7 Note7
Neisseria meningitidis 0.125 1
Gram-positive anaerobic bacteria, except Clostridium difficile8 4 8
Gram-negative anaerobic bacteria8 0.5 2
Helicobacter pylori 0.1259 0.1259
Pasteurella multocida 1 1
Limit values not specific to specific species10 2 8

1 Wild-type Enterobacteriaceae are considered susceptible to aminopenicillins. Some countries prefer to classify wild-type isolates of E. coli and P. mirabilis as intermediate. When this is the case, a cut-off value of MIC S ≤0.5 mg/L is used.

2 Most staphylococci produce penicillinase. They are resistant to amoxicillin. Methicillin-resistant isolates are, with some exceptions, resistant to all beta-lactam agents.

3 Susceptibility to amoxicillin can be inferred from susceptibility to ampicillin

4 The susceptibility of streptococci of groups A, B, C and G to penicillins can be inferred from their susceptibility to benzylpenicillin.

5 Breakpoints apply only to non-meningitic isolates. For isolates with intermediate susceptibility to ampicillins, oral amoxicillin should be avoided. Susceptibility can be inferred from the ampicillin MIC.

6 Breakpoints are established for intravenous administration. It should be noted that beta-lactamase-positive isolates are resistant.

7 It should be noted that organisms that produce beta-lactamase are resistant.

8 Susceptibility to amoxicillin can be inferred from susceptibility to benzylpenicillin.

9 Breakpoints are based on epidemiological cut-off points (ECOFFs) that separate wild-type isolates from isolates with reduced susceptibility.

10 Non-species specific limit values are calculated based on dosages of at least 0.5 g x 3 or 4 doses once daily (1.5 - 2 g/day).

The level of resistance of susceptible microorganisms may vary depending on the region.

In vitro susceptibility of microorganisms to amoxicillin

The following types of microorganisms are sensitive to the drug:

Gram-positive aerobes: Enterococcus faecalis, beta-hemolytic streptococci (groups A, B, C, G) – Listeria monocytogenes

Gram-negative aerobes: Escherichia coli, Haemophilus influenzae, Helicobacter pylori, Proteus mirabilis, Salmonella typhi, Salmonella paratyphi, Shigella spp., Pasteurella multocida, Vibrio cholera. Gram-positive aerobes: Coagulase-negative staphylococci: Staphylococcus aureus1, Streptococcus pneumoniae; Viridans group of streptococci. Almost all S.aureus are resistant to amoxicillin due to the production of penicillinase. In addition, all methicillin-resistant strains are resistant to amoxicillin. Gram-positive anaerobes: Clostridium spp. Gram-negative anaerobes: Fusobacterium spp. Other microorganisms: Borrelia burgdorferi. Microorganisms with natural resistance to the antibiotic2: Gram-positive aerobes: Enterococcus faecium2. 2 natural mediated susceptibility in the absence of an acquired resistance mechanism. Gram-negative aerobes: Acinetobacter spp., Enterobacter spp., Klebsiella spp., Pseudomonas spp. Gram-negative anaerobes: Bacteroides spp. (some strains of Bacteroides fragilis are resistant). Other microorganisms: Chlamydia spp., Mycoplasma spp., Legionella spp.

Pharmacokinetics

Amoxicillin is completely soluble in aqueous solution at physiological pH. It is rapidly and well absorbed after oral administration. The oral bioavailability of amoxicillin is approximately 70%. The maximum concentration of the active substance in the blood plasma is reached after approximately 1 hour.

The results of pharmacokinetic studies in which amoxicillin 250 mg three times daily was administered in the fasted state in a group of healthy volunteers are presented below.

Cmax Tmax* AUC(0-24h) T1/2
(μg/ml) (d) (μg/ml) (d)
3.3 ± 1.12 1.5 (1.0-2.0) 26.7 ± 4.56 1.36 ± 0.56
*Average value (range)

At doses from 250 to 3000 mg, bioavailability (AUC and Cmax parameters) is linearly proportional to dose. Simultaneous food intake does not affect absorption.

Hemodialysis can be used to remove amoxicillin.

Distribution: Approximately 18% of amoxicillin is bound to plasma proteins and the apparent volume of distribution is approximately 0.3-0.4 L/kg. After intravenous administration, amoxicillin has been found in the gallbladder, abdominal tissue, skin, adipose tissue, muscle tissue, synovial and peritoneal fluids, bile and pus. Amoxicillin penetrates poorly into the cerebrospinal fluid. Animal studies have shown no evidence of significant retention of substances derived from any component of the drug in body tissues.

Amoxicillin, like most penicillins, can pass into breast milk. Amoxicillin has been shown to cross the placental barrier.

Biotransformation: Amoxicillin is partially excreted in the urine as inactive penicillic acid in amounts equivalent to 10-25% of the initial dose.

Excretion. Amoxicillin is excreted primarily by the kidneys. In healthy volunteers, the mean elimination half-life of amoxicillin is approximately one hour and the mean total clearance is approximately 25 l/h. Approximately 60-70% of the administered dose is excreted unchanged in the urine within the first 6 hours after a single dose of 250 mg or 500 mg of amoxicillin. Various studies have shown that urinary excretion is 50-85% for amoxicillin over a 24-hour period. Concomitant use of probenecid slows the elimination of amoxicillin.

Age

The half-life of amoxicillin is identical for children aged 3 months to 2 years, older children and adults. For children (including premature infants) in the first week of life, the dosing interval should not exceed twice a day due to the immaturity of the renal excretion pathway. Since elderly patients are more prone to decreased renal function, dosage should be selected with caution, and monitoring of renal function is also recommended.

Sex

Following oral administration of amoxicillin to healthy male and female subjects, no significant effect of gender on the pharmacokinetics of amoxicillin was observed.

Kidney dysfunction

Total serum clearance of amoxicillin decreases proportionally with decreasing renal function.

Liver dysfunction

Patients with impaired liver function should take the drug with caution. Liver function should be monitored regularly.

Indication

Amoxicillin is indicated for the treatment of the following infections:

acute bacterial sinusitis; acute otitis media; acute streptococcal tonsillitis and pharyngitis; exacerbation of chronic bronchitis; community-acquired pneumonia; acute cystitis; asymptomatic bacteriuria during pregnancy; acute pyelonephritis; typhoid and paratyphoid fever; dental abscesses with widespread cellulitis; prosthetic joint infections; eradication of Helicobacter pylori (as part of combination therapy); Lyme disease.

The drug is used for the treatment and prevention of endocarditis.

Contraindication

Hypersensitivity to amoxicillin, other penicillins or excipients of the drug. History of severe hypersensitivity reactions (including anaphylaxis) to beta-lactam antibiotics (including cephalosporins, carbapenems or monobactams).

Interaction with other medicinal products and other types of interactions

Allopurinol: Concomitant use with amoxicillin may increase the risk of allergic skin reactions.

Tetracyclines. Tetracyclines and other drugs that have a bacteriostatic effect (macrolides, chloramphenicol) can neutralize the bactericidal effect of amoxicillin.

Parallel use of aminoglycosides is possible (synergistic effect).

Oral anticoagulants. Oral anticoagulants and penicillin antibiotics are widely used in practice; no interactions have been reported. However, isolated cases of increased international normalized ratio (INR) have been described in patients receiving amoxicillin and acenocoumarol or warfarin concomitantly. If such use is necessary, prothrombin time or INR should be closely monitored. In addition, dose adjustment of oral anticoagulants may be necessary.

Methotrexate. The use of amoxicillin with methotrexate leads to an increase in the toxic effect of the latter. Amoxicillin reduces the renal clearance of methotrexate, so its serum concentration should be checked.

Digoxin. The absorption of digoxin increases, so its dose should be adjusted.

Amoxicillin should be used with caution in combination with oral hormonal contraceptives, as plasma levels of estrogen and progesterone may be temporarily decreased, which may reduce the effectiveness of hormonal contraceptives. Therefore, the use of additional non-hormonal contraceptives is recommended.

Other types of interactions.

Forced diuresis leads to a decrease in the concentration of amoxicillin in the blood plasma due to an increase in its elimination.

The occurrence of diarrhea may lead to a decrease in the absorption of other drugs and adversely affect their effectiveness.

Elevated levels of amoxicillin in blood plasma and urine may interfere with the results of some laboratory tests. False-positive results are commonly observed with chemical methods.

When determining glucose in urine, it is recommended to use the enzymatic glucose oxidase method.

The presence of amoxicillin may affect the results of estriol quantification in pregnant women.

At high concentrations, amoxicillin may reduce serum glycemia. Amoxicillin may interfere with colorimetric protein determination.

Application features

Hypersensitivity. Before initiating treatment with amoxicillin, inquiry should be made regarding the presence/absence of a history of hypersensitivity reactions to penicillins, cephalosporins or other beta-lactam antibacterial agents and allergens. Cross-hypersensitivity (10-15%) between penicillins and cephalosporins is possible.

Serious and sometimes fatal cases of hypersensitivity (including anaphylactoid reactions and severe cutaneous adverse reactions) have been reported in patients receiving penicillin therapy. Such reactions are more likely to occur in patients with a history of hypersensitivity to penicillins or hypersensitivity to various allergens. If an allergic reaction occurs, amoxicillin therapy should be discontinued and appropriate treatment instituted.

Non-susceptible organisms: Since amoxicillin is not indicated for the treatment of certain types of infections, the drug should be used only when the pathogenic microorganism is identified or when there is reason to believe that the infectious agent is likely to be susceptible to amoxicillin (see section 5.1). This is particularly true in patients with genitourinary tract infections and severe ear, nose and throat infections.

Convulsions: Convulsions may occur in patients with impaired renal function, as well as in those receiving high doses of the drug or with a predisposition to seizures (e.g., history of epileptic seizures, treated epilepsy, meningitis) (see section "Adverse reactions").

Renal impairment: In patients with renal impairment, the dose of amoxicillin should be adjusted depending on the degree of renal impairment.

Skin reactions: The appearance of generalized erythema with fever associated with pustules at the beginning of treatment may be a symptom of acute generalized exanthematous pustulosis. In such cases, treatment should be discontinued and further use of amoxicillin is contraindicated.

Amoxicillin should be avoided in suspected infectious mononucleosis, as the occurrence of a choreoid rash in this case may be associated with hypersensitivity to penicillins. Amoxicillin is not recommended for the treatment of patients with viral infections, acute lymphoblastic leukemia due to an increased risk of erythematous skin rashes.

Jarisch-Herxheimer reaction. During the treatment of Lyme disease, a Jarisch-Herxheimer reaction may occur (see section "Adverse reactions"), which occurs as a result of the bactericidal effect of amoxicillin on the causative agent of Lyme disease, the spirochete Borrelia burgdorferi.

Antibiotic-associated colitis, ranging from mild to life-threatening, has been reported with the use of nearly all antibacterial agents, including amoxicillin. If severe diarrhea consistent with pseudomembranous colitis (mostly caused by Clostridium difficile) occurs, discontinuation of the drug and appropriate supportive measures should be considered. Antiperistaltic agents are contraindicated. Appropriate supportive measures should also be taken in the event of hemorrhagic colitis or hypersensitivity reactions.

Patients with severe gastrointestinal disorders accompanied by diarrhea and vomiting should not use the drug due to the risk of reduced absorption.

Long-term therapy: During long-term treatment, it is recommended to periodically evaluate the functions of body systems, including the urinary, hepatobiliary and hematopoietic systems. Elevated liver enzymes and changes in blood counts have been reported.

Anticoagulants: Prolongation of prothrombin time has been reported very rarely in patients receiving amoxicillin. When co-administered with anticoagulants, appropriate monitoring should be carried out and the dose of the latter adjusted if necessary.

Crystalluria. Crystalluria has been observed very rarely in patients with reduced diuresis, mainly with parenteral therapy. When using high doses of the drug, it is necessary to drink sufficient fluids to prevent amoxicillin-associated crystalluria. The presence of high concentrations of amoxicillin in the urine may cause precipitation in the urinary catheter, so it should be visually inspected at regular intervals.

In premature infants and in the neonatal period, kidney, liver, and blood function should be monitored.

When using amoxicillin as part of combination therapy for the eradication of Helicobacter pylori, the instructions for medical use of other medicines for combination therapy should be consulted.

The suspension should be used with extreme caution in patients with phenylketonuria, as the drug contains aspartame (E 951).

Ospamox contains sodium benzoate (E 211) and sodium citrate, which must be taken into account when prescribing the drug to patients on a sodium-restricted diet.

Ability to influence reaction speed when driving vehicles or other mechanisms

Studies on the effects on the ability to drive and use machines have not been conducted. However, some adverse reactions (e.g. allergic reactions, dizziness, convulsions) may affect the ability to drive or use machines.

Use during pregnancy or breastfeeding

Amoxicillin crosses the placental barrier; its concentration in the fetal plasma is approximately 25-30% of the concentration in the pregnant woman's plasma. Limited data on the use of amoxicillin during pregnancy indicate the absence of undesirable effects on the fetus/newborn. Animal studies have shown the absence of teratogenic effects of amoxicillin. If it is necessary to prescribe amoxicillin during pregnancy, a careful assessment of the ratio of the potential risk to the fetus and the expected benefit to the woman should be carried out.

Amoxicillin is excreted in small amounts in breast milk, so the risk of hypersensitivity in the child during breastfeeding cannot be excluded. The use of the drug during this period is possible only if the expected benefit to the woman outweighs the potential risk to the child. Breastfeeding should be discontinued if the newborn develops gastrointestinal disorders (diarrhea), candidiasis or skin rashes.

Fertility: There are no data on the effects of amoxicillin on fertility in humans. Animal reproductive toxicity studies have shown no effect on fertility.

Method of administration and doses

Doses

To calculate the dose of Ospamox required for individual treatment of infections, the following must be taken into account:

expected pathogens and their likely antimicrobial susceptibility; severity and location of the infection; age, weight, and renal status of the patient, as shown below.

The duration of treatment is determined by the type of infection and after discussion with the patient. In general, the duration of treatment should be as short as possible. Some types of infections require longer treatment (see section "Special instructions" for prolonged therapy).

Adults and adolescents (≥ 40 kg)

Indication* Dose*
Acute bacterial sinusitis 250-500 mg every 8 hours or 750 – 1000 mg every 12 hours

Asymptomatic bacteriuria during pregnancy

Acute pyelonephritis

Dental abscesses with extended cellulitis

For severe infections 750-1000 mg every 8 hours
Acute cystitis For acute cystitis, treatment may be prescribed at 3000 mg twice daily for 1 day.
Acute otitis media 500 mg every 8 hours, 750-1000 mg every 12 hours

Acute tonsillitis and pharyngitis caused by streptococci

Exacerbation of chronic bronchitis

For severe infections, 750-1000 mg every 8 hours for 10 days
Community-acquired pneumonia 500-1000 mg every 8 hours
Typhoid and paratyphoid fever 500-2000 mg every 8 hours
Infections of prosthetic joints 500-1000 mg every 8 hours
Prevention of endocarditis Single dose of 2000 mg orally, 30-60 minutes before the procedure

Helicobacter pylori eradication

(as part of combination therapy)

750-1000 mg daily in combination with a proton pump inhibitor (e.g., omeprazole, lansoprazole) and another antibiotic (e.g., clarithromycin, metronidazole) for 7 days
Lyme disease (see section "Special instructions")

Initial stage: 500-1000 mg every 8 hours up to a maximum dose of 4000 mg/day in divided doses for 14 days (10-21 days)

Late stage (systemic lesions): 500-2000 mg every 8 hours to a maximum dose of 6000 mg/day in several doses for 10-30 days

* Official guidelines on appropriate treatment for each indication should be considered

Children weighing <40 kg

Children can take amoxicillin in the form of an oral suspension prepared from Ospamox oral suspension powder or Ospamox DT dispersible tablets, if treatment regimens can be provided using the appropriate dosage forms. Amoxicillin in the form of a suspension is prescribed to children under 6 months of age. Children weighing more than 40 kg should be given adult doses.

Recommended dosage:

Indications+ Dose+
Acute bacterial sinusitis

20-90 mg/kg/day in divided doses*

(do not exceed the dose of 3 g/day).

Acute otitis media
Community-acquired pneumonia
Acute cystitis
Acute pyelonephritis
Dental abscesses with extended cellulitis
Acute tonsillitis and pharyngitis caused by streptococci

40-90 mg/kg/day in divided doses*

(do not exceed dose of 3 g/day)

Typhoid and paratyphoid fever 100 mg/kg/day in divided doses
Prevention of endocarditis Single dose of 50 mg/kg orally, 30-60 minutes before the procedure
Lyme disease (see section "Special warnings and precautions for use")

Initial stage: 25-50 mg/kg/day in three divided doses for 10-21 days.

Late stage (systemic lesions): 100 mg/kg/day in several doses for 10-30 days.

+ Official guidelines on appropriate treatment for each indication should be considered
*taking the drug twice a day should only be considered in cases of high doses

Elderly patients

No dose adjustment is necessary.

Patients with renal impairment.

Creatinine clearance, (ml/min) Adults and children ≥40 kg Children <40 kg#
More than 30 Does not require dose adjustment Does not require dose adjustment
10-30 Maximum 500 mg 2 times a day

15 mg/kg 2 times a day

(maximum 500 mg 2 times a day)

Less than 10 Maximum 500 mg per day

15 mg/kg once daily

(maximum 500 mg per day)

#In most cases, parenteral therapy is preferred.

Patients receiving hemodialysis:

Amoxicillin can be removed from the circulation by hemodialysis.

Hemodialysis
Adults and children ≥40 kg

15 mg/kg/day single daily dose.

An additional 15 mg/kg should be administered before hemodialysis. To restore therapeutic blood levels, 15 mg/kg should be administered after hemodialysis.

Patients receiving peritoneal dialysis:

The maximum daily dose is 500 mg of amoxicillin.

Patients with liver dysfunction.

The dose should be carefully selected. Liver function should be checked at regular intervals (see sections "Special warnings and precautions for use" and "Adverse reactions").

Method of application

Ospamox is intended for internal use.

Taking Ospamox does not depend on food.

Treatment with recommended doses of intravenous formulations can be initiated parenterally and continued with oral formulations.

Preparation of suspension. Shake the bottle to separate the powder from the walls and bottom. Add drinking water in two portions (first to 2/3, and then to the circular mark on the bottle in the form of a recess in the glass), shaking the bottle each time. SHAKE WELL BEFORE EACH ADMINISTRATION.

To measure the suspension, a dosing syringe with an adapter or a 5 ml measuring spoon with 1.25 ml and 2.5 ml markings is included.

Method of administration. Food intake does not affect the absorption of amoxicillin. The prepared suspension should be taken undiluted with water.

Children

The drug is prescribed to children from birth (see the section "Method of administration and dosage").

Overdose

Symptoms: digestive tract dysfunction – nausea, vomiting, diarrhea, which may result in a violation of water and electrolyte balance.

Cases of crystalluria, sometimes leading to renal failure, have been reported.

Treatment: induce vomiting or gastric lavage, then administer activated charcoal and an osmotic laxative. Maintain fluid and electrolyte balance. Amoxicillin can be removed from the bloodstream by hemodialysis. No specific antidote is known.

Adverse reactions

The most common adverse reactions are diarrhea, nausea, and skin rashes.

Criteria for assessing the frequency of adverse reactions: common (≥ 1/100, < 1/10), uncommon (≥ 1/1000, < 1/100), rare (≥ 1/10,000, < 1/1000), frequency unknown (frequency cannot be estimated due to lack of data).

Infections and infestations: rare - prolonged or repeated use of the drug may lead to the development of superinfections and overgrowth of non-susceptible microorganisms or yeasts, causing candidiasis of the skin and mucous membranes.

From the blood and lymphatic system: rare - eosinophilia, hemolytic anemia; rare - leukopenia, severe neutropenia, agranulocytosis, thrombocytopenia, pancytopenia, myelosuppression, granulocytopenia, increased bleeding time and prothrombin index. These manifestations are reversible upon discontinuation of treatment.

Immune system disorders: Rare: severe allergic reactions, including angioedema (Quincke's edema), anaphylaxis, serum sickness, allergic vasculitis, laryngeal edema, anaphylactic shock; frequency unknown: Jarisch-Herxheimer reaction.

On the part of the digestive tract: frequent - diarrhea, nausea, vomiting, flatulence, stomach pain, soft stools, itching in the anus, loss of appetite, enanthema (especially in the mouth), dry mouth, taste disturbance; rare - discoloration of the surface of the teeth (especially in children when taking the suspension). Proper oral hygiene procedures can prevent tooth discoloration, since such plaque is mostly removed when brushing the teeth; rare - antibiotic-associated colitis (including pseudomembranous and hemorrhagic colitis), intestinal candidiasis, black tongue color. These side effects are mostly not serious and disappear either during treatment or immediately after the end of therapy. The occurrence of such effects can be prevented if amoxicillin is taken with food.

Nervous system: rare - hyperkinesia, hyperactivity, dizziness, convulsions (in patients with epilepsy and meningitis, in case of impaired renal function, when using high doses of amoxicillin), aseptic meningitis.

From the hepatobiliary system: rare - hepatitis, cholestatic jaundice, moderate and short-term increase in liver enzymes (AST, ALT).

Skin and subcutaneous tissue disorders: common: skin rash, urticaria, pruritus; rare: erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous and exfoliative dermatitis, acute generalized exanthematous pustulosis, Lyell's syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome).

The sudden onset of urticaria indicates an allergic reaction to amoxicillin and requires immediate discontinuation of therapy.

From the kidneys and urinary system: rare - acute interstitial nephritis, crystalluria.

Others: isolated - fever.

Expiration date

3 years.

Storage conditions

Store at a temperature not exceeding 25 °C in the original packaging. Keep out of the reach of children.

Use the prepared suspension within 14 days; store the prepared suspension in a refrigerator (2-8°C).

Packaging

6.6 g of powder in a vial, respectively for 60 ml of suspension (250 mg/5 ml); 1 vial complete with a dosing syringe with adapter in a cardboard box.

Vacation category

According to the recipe.

Producer

Sandoz GmbH – TechOps.

Location of the manufacturer and its business address

Biochemiststrasse 10, 6250 Kundl, Austria.

Specifications
Characteristics
Active ingredient
Amoxicillin
Adults
Children's release form
ATC code
J ANTIMIBIOTICS FOR SYSTEMIC USE; J01 ANTIBACTERIALS FOR SYSTEMIC USE; J01C BETA-LACTAM ANTIBIOTICS, PENICILLINS; J01C A Broad-spectrum penicillins; J01C A04 Amoxicillin
Country of manufacture
Austria
Diabetics
Can
Dosage
50 mg/ml
Drivers
With caution
For allergies
With caution
For children
From birth to 12 years old
Form
Dry suspensions, syrups, drops
Method of application
Inside, liquid
Nursing
It is impossible.
Pregnant
It is impossible.
Producer
Sandoz
Quantity per package
60 ml
Series/Line
For children
Trade name
Ospamox
Vacation conditions
By prescription
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