What are the possible side effects of Augmentan Tropfen für Säuglinge?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using this medicine and call your doctor at once if you have a serious side effect such as:
- diarrhea that is watery or has blood in it;
- pale or yellowed skin, dark colored urine, fever, confusion or weakness;
- easy bruising or bleeding;
- skin rash, bruising, severe tingling, numbness, pain, muscle weakness;
- agitation, confusion, unusual thoughts or behavior, seizure (convulsions);
- nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
- severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.
Less serious side effects may include:
- mild diarrhea, gas, stomach pain;
- nausea or vomiting;
- headache;
- skin rash or itching;
- white patches in your mouth or throat; or
- vaginal yeast infection (itching or discharge).
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Side effects of Augmentan Tropfen für Säuglinge in details
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.
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).
- European Chemicals Agency - ECHA. "Amoxicillin: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).
- European Chemicals Agency - ECHA. "clavulanic acid: The European Chemicals Agency (ECHA) is an agency of the European Union which is the driving force among regulatory authorities in implementing the EU's groundbreaking chemicals legislation for the benefit of human health and the environment as well as for innovation and competitiveness.". https://echa.europa.eu/ (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Augmentan Tropfen für Säuglinge are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Augmentan Tropfen für Säuglinge. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
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Information checked by Dr. Sachin Kumar, MD Pharmacology
