Amocla Special Precautions

It should be administered carefully to the following patients: Patients with severe hepatic dysfunction.
Patients with moderate or severe renal dysfunction (Dose interval should be adjusted for the patients because blood concentration of the drug can be prolonged).
Patients with a previous history of hypersensitivity to penicillins or cephems.
Patients who or whose family have a tendency to show allergic symptoms such as bronchial asthma, rashes, urticaria, etc.
Patients who are mal-nutritioned orally or who are parenterally nutritioned, the elderly patients, and patients with bad systemic condition (vitamin K deficiency may occur).
General precautions: Serious and occasionally fatal hypersensitivity reactions (including anaphylactoid and severe cutaneous adverse reactions) have been reported in patients on penicillin therapy. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity. These reactions may also occur in both oral and parenteral therapy, but more frequently in parenteral therapy. If an allergic reaction occurs, AMOCLA must be discontinued and appropriate alternative therapy instituted. Serious anaphylactic reactions require immediate emergency treatment with adrenaline. Oxygen, intravenous steroids and airway management (including intubation) may also be required.
The long term treatment with AMOCLA may result in overgrowth of nonsusceptible organisms, thus careful observation is required for more than 14 days treatment.
Changes in liver function test have been observed in some patients receiving AMOCLA. The clinical significance of these changes is uncertain, but AMOCLA should be used with caution in patient with evidence of hepatic failure. Serious and usually reversible cholestatic jaundice have been reported rarely. Signs and symptoms may not occur in appearance until six weeks after treatment has ended.
In patients with moderate and severe renal dysfunction dose of AMOCLA should be adjusted following "Dosage & Administration".
Erythematous rashes have been associated with glandular fever in patients receiving amoxicillin, thus use of AMOCLA should be avoided in case that glandular fever is worried.
Use in Pregnancy & Lactation: Animal studies have shown no teratogenic effects; however, safe use of AMOCLA during pregnancy has not been definitely established. Thus, this drug should be used during pregnancy only when the potential benefits justify the possible risks to the fetus. Especially AMOCLA should not be administered during first trimester of pregnancy.
During lactation, trace quantities of penicillin can be excreted in breast milk.