Instructions Ospamox powder for oral suspension 500 mg/5 ml bottle 12 g 60 ml
Composition
active ingredient: amoxicillin;
5 ml of suspension contain 125 mg or 250 mg or 500 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.
Mechanisms of resistance.
The main mechanisms of resistance to amoxicillin are:
inactivation by bacterial beta-lactamases;
conversion of PZB, which reduces the affinity of the antibacterial drug with 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 MIC S cut-off value of ≤ 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 × 3 or 4 doses once daily (1.5 - 2 g/day). |
The level of resistance of susceptible microorganisms may vary depending on the region.
Sensitivity of microorganisms to amoxicillin in vitro.
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.
Intermittent sensitivity (acquired resistance may be a problem).
Gram-positive aerobes: coagulase-negative staphylococci, Staphylococcus aureus1, Streptococcus pneumoniae, Viridans group of streptococci.
1Almost 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 that have natural resistance to antibiotics2.
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.
Absorption. 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) | (hours) | (μg∗h/ml) | (hours) |
| 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. Following intravenous administration, amoxicillin has been found in the gallbladder, abdominal tissue, skin, adipose tissue, muscle tissue, synovial and peritoneal fluids, bile and pus. Amoxicillin does not penetrate the cerebrospinal fluid well. 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 2 times 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.
Gender: Following oral administration of amoxicillin to healthy male and female subjects, there was no significant effect of gender on the pharmacokinetics of amoxicillin.
Renal impairment: Total serum clearance of amoxicillin decreases proportionally with decreasing renal function.
Hepatic impairment: Patients with hepatic impairment 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;
infections of prosthetic joints;
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. Penicillins may reduce the excretion of methotrexate, which may lead to a potential increase in toxicity. Amoxicillin reduces the renal clearance of methotrexate, so serum concentrations should be monitored.
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, a history should be taken regarding the presence/absence 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 hypersensitivity reactions, some of which have been fatal (including anaphylactoid and severe cutaneous adverse reactions), have been reported in patients treated with penicillin. Hypersensitivity reactions may also progress to Kunis syndrome, a serious allergic reaction that may lead to myocardial infarction (see section 4.8). Such reactions are more likely to occur in patients with a history of hypersensitivity to penicillin and in patients with atopic diseases. If an allergic reaction occurs, amoxicillin should be discontinued and appropriate alternative therapy should be initiated. Non-susceptible organisms. Since amoxicillin is not indicated for the treatment of certain types of infections, the drug should only be used 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 4.8). This is especially true for 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 at the beginning of treatment of generalized erythema with fever associated with pustules may be a symptom of acute generalized exanthematous pustulosis. In such cases, treatment should be discontinued and further use of amoxicillin is contraindicated.
Amoxicillin can cause severe skin reactions such as toxic epidermal necrolysis, Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS syndrome). If severe skin reactions occur, amoxicillin should be discontinued and appropriate treatment and/or measures should be taken.
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.
Resistance: Prolonged use of the drug may sometimes cause overgrowth of insensitive microflora. As with other broad-spectrum penicillins, superinfections may occur.
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.
In patients with reduced urine output, crystalluria (including acute kidney injury) has been observed very rarely, mainly with parenteral therapy. Adequate fluid intake and diuresis should be maintained during high doses of amoxicillin to reduce the likelihood of amoxicillin crystalluria. In patients with bladder catheterization, the patency of the catheters should be checked regularly (see sections "Adverse Reactions" and "Overdose").
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.
Drug-induced enterocolitis syndrome (DIES) has been reported, mainly in children receiving amoxicillin (see section 4.8). Drug-induced enterocolitis syndrome is an allergic reaction with the main symptom being prolonged vomiting (1-4 hours after the drug) in the absence of allergic skin or respiratory symptoms. Additional symptoms may include abdominal pain, diarrhoea, hypotension or leukocytosis with neutrophilia. Severe cases have been reported, including progression to shock.
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 maternal plasma. Limited data on the use of amoxicillin during pregnancy indicate no adverse effects on the fetus/newborn. Animal studies have shown no teratogenic effects of amoxicillin. If it is necessary to prescribe amoxicillin during pregnancy, a careful assessment of the potential risk to the fetus and the expected benefit to the woman should be made.
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.
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.
Method of administration and doses
Doses.
When calculating the individual dose of Ospamox for the treatment of infections, it is necessary to take into account:
expected pathogens and their likely susceptibility to antimicrobial agents;
severity and localization of the infectious process;
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 For severe infections, 750–1000 mg every 8 hours For acute cystitis, 3000 mg twice daily for 1 day may be prescribed. |
| Asymptomatic bacteriuria during pregnancy |
| Acute pyelonephritis |
| Dental abscesses with widespread cellulitis |
| Acute cystitis |
| Acute otitis media | 500 mg every 8 hours, 750–1000 mg every 12 hours For severe infections, 750–1000 mg every 8 hours for 10 days |
| Acute tonsillitis and pharyngitis caused by streptococci |
| Exacerbation of chronic bronchitis |
| 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 2 times a day 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 warnings and precautions for use") | 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 divided doses for 10–30 days |
| * Appropriate treatment guidelines for each indication should be considered. |
Children weighing < 40 kg
Children can take amoxicillin in the form of an oral suspension prepared from the powder for oral suspension Ospamox or dispersible tablets Ospamox DT (if possible, treatment regimens using the appropriate dosage forms are provided). Amoxicillin in the form of a suspension is prescribed for children up to 6 months. Children weighing more than 40 kg should be prescribed 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 3 g/day) |
| Typhoid and paratyphoid fever | 100 mg/kg/day in 3 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 3 divided doses for 10–21 days Late stage (systemic lesions): 100 mg/kg/day in 3 divided doses for 10–30 days |
| + Official guidelines on appropriate treatment for each indication should be considered. |
| *Taking the drug twice daily should only be considered when prescribing high doses. |
Elderly patients: No dose adjustment is required.
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.
Adults and children ≥ 40 kg | Hemodialysis |
15 mg/kg/day single daily dose. An additional 15 mg/kg should be administered before hemodialysis. To restore therapeutic levels of the drug in the blood, 15 mg/kg should be taken 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.
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.
The finished suspension should be taken undiluted with water.
Children.
The medicine 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.
Amoxicillin crystalluria has been observed, in some cases leading to renal failure (see section "Special warnings and precautions for use").
Convulsions may occur in patients with impaired renal function or those who have received high doses of amoxicillin (see sections "Special warnings and precautions for use" and "Adverse reactions").
Treatment: induce vomiting or gastric lavage, then take 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.
Side effects
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. Frequency unknown - drug-induced enterocolitis syndrome (DIES).
From the 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), frequency unknown - aseptic meningitis.
From the side of the cardiovascular system: frequency unknown - Kunis syndrome.
On the part of the hepatobiliary system: rare - hepatitis, cholestatic jaundice, moderate and short-term increase in the level of liver enzymes (aspartate aminotransferase, alanine aminotransferase).
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).
Sudden onset of urticaria indicates an allergic reaction to amoxicillin and requires immediate discontinuation of therapy. Frequency unknown - linear immunoglobulin A (IgA) disease.
Renal and urinary disorders: rare - acute interstitial nephritis, frequency unknown - crystalluria (including acute kidney injury).
Others: isolated - fever.
Expiration date
3 years.
Storage conditions
Store at a temperature not exceeding 25 °C in the original packaging.
Keep out of reach of children.
Use the prepared suspension within 14 days;
Store the prepared suspension in a refrigerator (2–8 °C).
Packaging
6.6 g or 11 g of powder in a vial for 60 ml or 100 ml of suspension (250 mg/5 ml), 1 vial complete with a dosing syringe with an adapter in a cardboard box;
12 g or 20 g of powder in a vial for 60 ml or 100 ml of suspension (500 mg/5 ml), respectively; 1 vial together with a measuring spoon in a cardboard box.
Vacation category
According to the recipe.
Producer
Sandoz GmbH - Production site Anti-infectives and Chemical Operations Kundl (AIHO Kundl).
Address
Biochemiststrasse 10, 6250 Kundl, Austria.
