Pharmaniaga Co-Amoxiclav Special Precautions

Amoxicillin/clavulanate should be used with caution in patients with evidence of hepatic dysfunction.
Cholestatic jaundice, which may be severe, but is usually reversible, has been reported rarely. Signs and symptoms may not become apparent for up to 6 weeks after treatment has ceased. In patients with moderate or severe renal impairment, dosage should be adjusted. Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on penicillin therapy. These reactions are more likely to occur in individuals with history of penicillin hypersensitivity.
Erythematous rashes have been associated with glandular fever in patients receiving amoxicillin. Prolonged use may also occasionally result in overgrowth of nonsusceptible organisms.
During the administration of high-dose amoxicillin/clavulanate, adequate fluid intake and urinary output should be maintained to minimize the possibility of crystalluria. When present at high concentrations in urine at room temperature, amoxicillin may precipitate in bladder catheters. A regular check on patency should be maintained.
Risk-benefit should be considered when medical problems eg, gastrointestinal disease, especially pseudomembranous colitis and infectious mononucleosis exist. A mobiliform skin rash may occur in a high percentage of patients taking ampicillin.
In patients with moderate or severe renal impairment, tablet dosage should be adjusted (see Dosage & Administration), but not recommended for oral suspension 228 mg/5 mL. The oral suspension contain aspartame and caution should be taken in phenylketonuria conditions.
Use in pregnancy & lactation: Reproduction studies in animals (mice and rats) with orally and parenterally administered amoxicillin/clavulanate have shown no teratogenic effects. There is limited experience in human pregnancy. As with all medicines, use should be avoided in pregnancy, especially during the 1st trimester, unless considered essential by the physician.
Although significant problems in human have not been documented, caution should be exercised when amoxicillin/clavulanate is administered to nursing mothers, because, it may lead to sensitization, diarrhea, candidiasis and skin rash in the infant.