Amoxicilline/Acide Clavulanique Biogaran Nourrisson 100 mg/12,5 mg/ml Side effects

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What are the possible side effects of Amoxicilline/Acide Clavulanique Biogaran Nourrisson 100 mg/12,5 mg/ml?

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:

Less serious side effects may include:

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 Amoxicilline/Acide Clavulanique Biogaran Nourrisson 100 mg/12,5 mg/ml in details

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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 (Amoxicilline/Acide Clavulanique Biogaran Nourrisson 100 mg/12,5 mg/ml) is required, consideration should be given to administering the additional Amoxicillin (Amoxicilline/Acide Clavulanique Biogaran Nourrisson 100 mg/12,5 mg/ml) separately.

Hepatitis and cholestatic jaundice have been reported with the combination of Amoxicillin (Amoxicilline/Acide Clavulanique Biogaran Nourrisson 100 mg/12,5 mg/ml) and Clavulanic Acid (Amoxicilline/Acide Clavulanique Biogaran Nourrisson 100 mg/12,5 mg/ml); the Clavulanic Acid (Amoxicilline/Acide Clavulanique Biogaran Nourrisson 100 mg/12,5 mg/ml) component has been implicated. The events associated with Amoxicilline/Acide Clavulanique Biogaran Nourrisson 100 mg/12,5 mg/ml 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 Amoxicilline/Acide Clavulanique Biogaran Nourrisson 100 mg/12,5 mg/ml, the significance of these findings is unknown.

The following adverse reactions have been reported for ampicillin class antibiotics and may occur with Amoxicilline/Acide Clavulanique Biogaran Nourrisson 100 mg/12,5 mg/ml.

Gastrointestinal: Gastritis, stomatitis, glossitis, black hairy tongue, enterocolitis and pseudomembranous colitis. If GI reactions are evident, they may be reduced by taking Amoxicilline/Acide Clavulanique Biogaran Nourrisson 100 mg/12,5 mg/ml at the start of a meal.

Amoxicillin (Amoxicilline/Acide Clavulanique Biogaran Nourrisson 100 mg/12,5 mg/ml) 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, Amoxicilline/Acide Clavulanique Biogaran Nourrisson 100 mg/12,5 mg/ml 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 Amoxicilline/Acide Clavulanique Biogaran Nourrisson 100 mg/12,5 mg/ml. Prolongation of bleeding time and prothrombin time have also been reported less frequently.

Amoxicillin (Amoxicilline/Acide Clavulanique Biogaran Nourrisson 100 mg/12,5 mg/ml) alone or in combination with Clavulanic Acid (Amoxicilline/Acide Clavulanique Biogaran Nourrisson 100 mg/12,5 mg/ml) has been associated with acute hepatic dysfunction. The incidence rate (95% confidence intervals) were 1.7 (1.1-2.7) (Amoxicillin (Amoxicilline/Acide Clavulanique Biogaran Nourrisson 100 mg/12,5 mg/ml)-Clavulanic Acid (Amoxicilline/Acide Clavulanique Biogaran Nourrisson 100 mg/12,5 mg/ml)) and 0.3 (0.2-0.5)/10,000 prescriptions (Amoxicillin (Amoxicilline/Acide Clavulanique Biogaran Nourrisson 100 mg/12,5 mg/ml) 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.

Amoxicilline/Acide Clavulanique Biogaran Nourrisson 100 mg/12,5 mg/ml contraindications

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Hypersensitivity to the Amoxicillin (Amoxicilline/Acide Clavulanique Biogaran Nourrisson 100 mg/12,5 mg/ml)/clavulanate potassium to any of the penicillins or to any of the excipients of Amoxicilline/Acide Clavulanique Biogaran Nourrisson 100 mg/12,5 mg/ml.

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 Amoxicilline/Acide Clavulanique Biogaran Nourrisson 100 mg/12,5 mg/ml.

References

  1. 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).
  2. 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).
  3. 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).

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