What is Augmentan Tropfen für Säuglinge?
Amoxicillin (Augmentan Tropfen für Säuglinge) is an antibiotic in a group of drugs called penicillins. Amoxicillin (Augmentan Tropfen für Säuglinge) fights bacteria in the body.
Clavulanate potassium is a form of Clavulanic Acid (Augmentan Tropfen für Säuglinge), which is similar to penicillin. Clavulanate potassium fights bacteria that is often resistant to penicillins and other antibiotics.
The combination of Amoxicillin (Augmentan Tropfen für Säuglinge) and clavulanate potassium is used to treat many different infections caused by bacteria, such as sinusitis, pneumonia, ear infections, bronchitis, urinary tract infections, and infections of the skin.
Amoxicillin (Augmentan Tropfen für Säuglinge) and clavulanate potassium may also be used for purposes not listed in this medication guide.
Augmentan Tropfen für Säuglinge indications
Augmentan Tropfen für Säuglinge-600 is indicated for the treatment of pediatric patients with recurrent or persistent acute otitis media due to S. pneumoniae (penicillin MICs ≤ 2 mcg/mL), H. influenzae (including β-lactamase–producing strains), or M. catarrhalis (including β-lactamase–producing strains) characterized by the following risk factors:
- antibiotic exposure for acute otitis media within the preceding 3 months, and either of the following:
- age ≤ 2 years
- daycare attendance
NOTE: Acute otitis media due to S. pneumoniae alone can be treated with Amoxicillin (Augmentan Tropfen für Säuglinge). Augmentan Tropfen für Säuglinge-600 is not indicated for the treatment of acute otitis media due to S. pneumoniae with penicillin MIC ≥ 4 mcg/mL.
Therapy may be instituted prior to obtaining the results from bacteriological studies when there is reason to believe the infection may involve both S. pneumoniae (penicillin MIC ≤ 2 mcg/mL) and the β-lactamase–producing organisms listed above.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Augmentan Tropfen für Säuglinge-600 and other antibacterial drugs, Augmentan Tropfen für Säuglinge-600 should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Augmentan Tropfen für Säuglinge description
Each film-coated tablet contains Amoxicillin (Augmentan Tropfen für Säuglinge) trihydrate equivalent to Amoxicillin (Augmentan Tropfen für Säuglinge) 500 mg, and potassium clavulanate equivalent to Clavulanic Acid (Augmentan Tropfen für Säuglinge) 125 mg, respectively.
Each vial contains Amoxicillin (Augmentan Tropfen für Säuglinge) sodium equivalent to Amoxicillin (Augmentan Tropfen für Säuglinge) 1000 mg and clavulanate potassium equivalent to Clavulanic Acid (Augmentan Tropfen für Säuglinge) 200 mg, respectively.
Augmentan Tropfen für Säuglinge tablets also contains the following excipients: Microcrystalline cellulose, sodium starch glycolate, anhydrous colloidal silica, povidone (K30), eudragit E 100, isopropyl alcohol, magnesium stearate, white opadryl 03B58965, PEG400, methylene chloride.
Augmentan Tropfen für Säuglinge is an antibacterial combination consisting of the semi-synthetic antibiotic Amoxicillin (Augmentan Tropfen für Säuglinge) and the β-lactamase inhibitor, clavulanate potassium (the potassium salt of Clavulanic Acid (Augmentan Tropfen für Säuglinge)). Amoxicillin (Augmentan Tropfen für Säuglinge) is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. Its molecular formula is C16H19N305S3H20 and the molecular weight is 419.46. Chemically, Amoxicillin (Augmentan Tropfen für Säuglinge) is (2S, 5R, 6R)-6-[(R)-(-)-2-Amino-2-(p-hydroxyphenyl) acetamido]-3, 3-dimethyl-7-oxo-4-1-azabicyclo[3.2.1] heptane-2-carboxylic acid trihydrate.
Amoxicillin (Augmentan Tropfen für Säuglinge): Clavulanic Acid (Augmentan Tropfen für Säuglinge) is produced by the fermentation of Streptomyces clavuligerus. It is a β-lactam structurally related to the penicillins and possesses the ability to inactivate a wide variety of β-lactamases by blocking the active sites of these enzymes. Clavulanic Acid (Augmentan Tropfen für Säuglinge) is particularly active against the clinically important plasmid-mediated β-lactamases frequently responsible for transferred drug resistance to penicillins and cephalosporins. The clavulanate potassium molecular formula is C8H8KN05 and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)-(2R, 5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate.
Augmentan Tropfen für Säuglinge dosage
Tablet: Tablets should be taken immediately before a meal.
General Information: For infections caused by Amoxicillin (Augmentan Tropfen für Säuglinge)-sensitive organisms, the dosage is that approved for Amoxicillin (Augmentan Tropfen für Säuglinge) as the Clavulanic Acid (Augmentan Tropfen für Säuglinge) component does not contribute to the therapeutic effect.
Adults: 1 or 2 Augmentan Tropfen für Säuglinge 375 mg tab 8 hourly or 1 Augmentan Tropfen für Säuglinge 625 mg tab 8 hourly for more severe infections and infections of the respiratory tract.
For Amoxicillin (Augmentan Tropfen für Säuglinge)-resistant organisms, the dosage of Augmentan Tropfen für Säuglinge tablets are as follows:
Since both Augmentan Tropfen für Säuglinge 375 mg and 625 mg contain the same amount of Clavulanic Acid (Augmentan Tropfen für Säuglinge) (125 mg, as the potassium salt), 2 Augmentan Tropfen für Säuglinge 375 mg are not equivalent to 1 Augmentan Tropfen für Säuglinge 625 mg. Therefore, 2 Augmentan Tropfen für Säuglinge 375 mg should not be substituted for 1 Augmentan Tropfen für Säuglinge 625 mg for treatment of more severe infections.
Renal Failure: Both Amoxicillin (Augmentan Tropfen für Säuglinge) and Clavulanic Acid (Augmentan Tropfen für Säuglinge) are excreted by the kidneys and the serum t½ of each increases in patients with renal failure. Therefore, the dose may need to be reduced or the interval extended. The following schedule in the dosage is proposed:
Haemodialysis decreases serum concentrations of both Amoxicillin (Augmentan Tropfen für Säuglinge) and Clavulanic Acid (Augmentan Tropfen für Säuglinge) and an additional dose should be administered at the end of dialysis.
Oral Suspension:
Suspensions should be taken immediately before a meal.Reconstitution: For reconstitution to 30 mL, add water till the mark, invert the bottle and shake well until all the powder is dispersed.
Children: 25-50 mg/kg/day of the 4 parts Amoxicillin (Augmentan Tropfen für Säuglinge), 1 part Clavulanic Acid (Augmentan Tropfen für Säuglinge) preparations (which corresponds to a daily dosage of the equivalent of Amoxicillin (Augmentan Tropfen für Säuglinge) 20-40 mg/kg and Clavulanic Acid (Augmentan Tropfen für Säuglinge) 5-10 mg/kg) to be taken in divided doses every 8 hrs at the start of a meal.
Dosage Guide:
To correspond to a dosage of 25-50 mg/kg/day.
To correspond to a dosage of 50 mg/kg/day.
IV/IM: Augmentan Tropfen für Säuglinge may be administered by the IV routes.
Augmentan Tropfen für Säuglinge is administered by IM or slow IV injection in doses of 500 mg every 8 hrs.
Severe Infections: 1 g every 6 hrs by slow IV injection over 3-4 min or by infusion over 30-60 min.
Children ≤10 years: 50-100 mg/kg body weight daily by injection in divided doses.
Augmentan Tropfen für Säuglinge interactions
See also:
What other drugs will affect Augmentan Tropfen für Säuglinge?
Probenecid decreases the renal excretion of Amoxicillin (Augmentan Tropfen für Säuglinge). Concurrent use with Augmentan Tropfen für Säuglinge may result in increased and prolonged blood levels of Amoxicillin (Augmentan Tropfen für Säuglinge).
The concurrent administration of allopurinol and ampicillin increases the incidence of rashes in patients receiving both drugs as compared to patients receiving ampicillin alone. But it is not known whether this potentiation of ampicillin rash is due to allopurinol or the hyperuricemia present in these patients.
Augmentan Tropfen für Säuglinge should not be co-administrated with disulfiram.
Prolongation of bleeding time and prothrombin time have been reported in some patients receiving Augmentan Tropfen für Säuglinge. Thus, Augmentan Tropfen für Säuglinge should be used with care in patients on anticoagulation therapy.
Augmentan Tropfen für Säuglinge may reduce the effect of oral contraceptives and the caution should be given to patients.
Laboratory Test Interactions: Augmentan Tropfen für Säuglinge results in high urine concentration. High urine concentration of ampicillin may result in false-positive reactions when testing for the presence of glucose in urine using Clinitest, Benedict or Fehling's solution.
Augmentan Tropfen für Säuglinge side effects
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What are the possible side effects of Augmentan Tropfen für Säuglinge?
The most frequently reported adverse effects were diarrhoea, nausea, vomiting, abdominal pain, skin rashes, urticaria and erythema multiforme, vaginitis, abnormal taste, headache, dizziness, tiredness and hot flushes. The incidence and severity of adverse effects, particularly nausea and diarrhoea, increased with the higher recommended dose and can be minimised by administering the agent at the start of a meal. In addition, as these symptoms are especially related to the potassium clavulanate component, where these GI symptoms occur and a higher concentration of Amoxicillin (Augmentan Tropfen für Säuglinge) is required, consideration should be given to administering the additional Amoxicillin (Augmentan Tropfen für Säuglinge) separately.
Hepatitis and cholestatic jaundice have been reported with the combination of Amoxicillin (Augmentan Tropfen für Säuglinge) and Clavulanic Acid (Augmentan Tropfen für Säuglinge); the Clavulanic Acid (Augmentan Tropfen für Säuglinge) component has been implicated. The events associated with Augmentan Tropfen für Säuglinge may be severe and occur predominantly in adult or elderly patients. Signs and symptoms usually occur during or shortly after treatment, but in some cases may not become apparent until several weeks after treatment has ceased. The hepatic events are usually reversible. However, in extremely rare circumstances, death has been reported. These have almost always been cases associated with serious underlying disease or concomitant medication.
A moderate rise in aspartate transaminase and/or alanine transaminase has been noted in patients treated with Augmentan Tropfen für Säuglinge, the significance of these findings is unknown.
The following adverse reactions have been reported for ampicillin class antibiotics and may occur with Augmentan Tropfen für Säuglinge.
Gastrointestinal: Gastritis, stomatitis, glossitis, black hairy tongue, enterocolitis and pseudomembranous colitis. If GI reactions are evident, they may be reduced by taking Augmentan Tropfen für Säuglinge at the start of a meal.
Amoxicillin (Augmentan Tropfen für Säuglinge) causes hypersensitivity reactions similar to those induced by penicillin G and ampicillin, including rashes and fever. The incidence of these reaction is probably no higher than with other penicillins. Sensitivity reactions are more likely to occur in individuals who have previously demonstrated hypersensitivity to penicillins and in those with a history of allergy, asthma, hay fever or uticaria. Hypersensitivity reactions include skin rashes, urticaria, erythema multiforme, rare cases of Stevens-Johnson syndrome and less frequently exfoliative dermatitis and toxic epidermal necrolysis have been reported. Whenever such reactions occur, Augmentan Tropfen für Säuglinge should be discontinued. Serious and occasional fatal hypersensitivity (anaphylactic) reactions and angioneurotic oedema can occur with oral penicillin.
Haematopoietic and Lymphatic: Anaemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leucopenia and agranulocytosis have been reported during therapy with penicillins. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena. A slight thrombocytosis was noted in patients treated with Augmentan Tropfen für Säuglinge. Prolongation of bleeding time and prothrombin time have also been reported less frequently.
Amoxicillin (Augmentan Tropfen für Säuglinge) alone or in combination with Clavulanic Acid (Augmentan Tropfen für Säuglinge) has been associated with acute hepatic dysfunction. The incidence rate (95% confidence intervals) were 1.7 (1.1-2.7) (Amoxicillin (Augmentan Tropfen für Säuglinge)-Clavulanic Acid (Augmentan Tropfen für Säuglinge)) and 0.3 (0.2-0.5)/10,000 prescriptions (Amoxicillin (Augmentan Tropfen für Säuglinge) alone). Risks were increased in patients receiving >1 course and in older recipients.
Central Nervous System: Reversible hyperactivity, agitation, anxiety, insomnia, confusion, behavioural changes and/or dizziness have also been reported. Depression, seizures or hallucinations.
Augmentan Tropfen für Säuglinge contraindications
Hypersensitivity to the Amoxicillin (Augmentan Tropfen für Säuglinge)/clavulanate potassium to any of the penicillins or to any of the excipients of Augmentan Tropfen für Säuglinge.
History of a severe immediate hypersensitivity reaction (eg, anaphylaxis) to another β-lactam agent (eg, a cephalosporin, carbapenem or monobactam).
History of cholestatic jaundice/hepatic dysfunction due to Augmentan Tropfen für Säuglinge.
Active ingredient matches for Augmentan Tropfen für Säuglinge:
Amoxicillin/Clavulanic Acid in Germany.
List of Augmentan Tropfen für Säuglinge substitutes (brand and generic names) | Sort by popularity |
Unit description / dosage (Manufacturer) | Price, USD |
Augmentan i.v. pro infantibus (Germany) | |
Augmentin 1 g/125 mg (France) | |
Augmentin 1 g/200 mg (France) | |
Augmentin 1,000 | |
Augmentin 1,2 iu (Turkey) | |
Augmentin 1.1g Kind (Switzerland) | |
Augmentin 1.2g (Switzerland) | |
Augmentin 1000 mg/100 mg (Austria) | |
Augmentin 1000 mg/200 mg (Hungary) | |
Augmentin 125 mg/31.25 mg/5 ml (Bulgaria, Hungary) | |
Augmentin 125/31 SF (United Kingdom) | |
Augmentin 125mg (United States) | |
Augmentin 125mg/5ml (Israel) | |
Augmentin 12h | |
Suspension; Oral; Amoxicillin Trihydrate 200 mg; Clavulanic Acid / Clavulanate Potassium 28.5 mg / 5 ml | |
Suspension; Oral; Amoxicillin Trihydrate 400 mg; Clavulanic Acid / Clavulanate Potassium 57 mg / 5 ml | |
Tablet; Oral; Amoxicillin Trihydrate 875 mg; Clavulanic Acid / Clavulanate Potassium 125 mg | |
Augmentin 1g (Israel, Switzerland) | |
Augmentin 2 g/200 mg (Austria, France) | |
Augmentin 2.2g (Switzerland) | |
Augmentin 228 | |
Augmentin 250 mg/125 mg (Bulgaria, Hungary) | |
Augmentin 250 mg/62.5 mg/5 ml (Bulgaria, Hungary) | |
Augmentin 250/62 SF (United Kingdom) | |
Augmentin 250mg (Israel, United States) | |
Augmentin 250mg/5ml (Israel) | |
Augmentin 312 Mg | |
Augmentin 375 | |
Augmentin 375 Tablet (Glaxo SmithKline Pharmaceuticals Ltd) | $ 0.28 |
Augmentin 375mg (United Kingdom) | |
Augmentin 400 mg/57 mg (Turkey) | |
Augmentin 400/57 (United Kingdom) | |
Augmentin 400mg/5ml (Israel) | |
Augmentin 457 | |
Augmentin 500 mg/100 mg (Hungary) | |
Augmentin 500 mg/125 mg (Austria, Bulgaria, Hungary) | |
Augmentin 500 mg/50 mg (Austria, France) | |
Augmentin 500 mg/62,5 mg (France) | |
Augmentin 500mg (Israel) | |
Augmentin 550mg Kind (Switzerland) | |
Augmentin 625 | |
Augmentin 625 Duo Tablet (Glaxo SmithKline Pharmaceuticals Ltd) | $ 0.21 |
Augmentin 625 Mg | |
Augmentin 625mg (Switzerland, United Kingdom) | |
Augmentin 875 mg/125 mg (Austria, Bulgaria) | |
See 7042 substitutes for Augmentan Tropfen für Säuglinge |
References
- DailyMed. "AMOXICILLIN; CLAVULANATE POTASSIUM: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- PubChem. "CLAVULANIC ACID". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
- PubChem. "amoxicillin". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology