Antibiotic associated pseudomembranous colitis has been reported with many antibiotics including Cilamox. A toxin produced with Clostridium difficile appears to be the primary cause. The severity of the colitis may range from mild to life threatening. It is important to consider this diagnosis in patients who develop diarrhoea or colitis in association with antibiotic use (this may occur up to several weeks after cessation of antibiotic therapy). Mild cases usually respond to drug discontinuation alone. However, in moderate to severe cases appropriate therapy with a suitable oral antibacterial agent effective against Clostridium difficile should be considered.
Fluids, electrolytes and protein replacement should be provided when indicated.
Drugs which delay peristalsis, e.g. opiates and diphenoxylate with atropine (Lomotil) may prolong and/or worsen the condition and should not be used.
Prolonged Therapy: As with any potent drug, periodic assessment of organ system functions, including renal, hepatic and hematopoietic function is advisable.
Superinfections: Superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur (usually involving Aerobacter, Pseudomonas or Candida), the drug should be discontinued and/or appropriate therapy instituted.
Infectious Mononucleosis: Cilamox, an aminopenicillin, is not the treatment of choice in patients presenting with sore throat or pharyngitis because of the possibility that the underlying cause is infectious mononucleosis in the presence of which there is a high incidence of rash if amoxicillin is used.
Lymphatic Leukaemia: Cilamox should be given with caution to patients with lymphatic leukaemia since they are especially susceptible to ampicillin-induced skin rashes.
Hepatic: Cholestatic hepatitis, which may be severe but is usually reversible, has been reported. Signs and symptoms may not become apparent until several weeks after treatment has ceased. In most cases resolution has occurred with time. However, in extremely rare circumstances, deaths have been reported. These have almost always been cases associated with serious underlying disease or concomitant medications. Hepatic events subsequent to Cilamox have occurred predominantly in adults and elderly patients.
Cilamox should be used with care in patients with evidence of hepatic dysfunction.
Impaired Renal Function: The dosage should be adjusted in patients with moderate or severe renal impairment. In renal impairment the excretion of the antibiotic will be delayed, and depending on the degree of impairment, it may be necessary to reduce the total daily dosage.
Carcinogenesis, Mutagenesis: Long-term carcinogenicity or mutagenicity studies have not been carried out in animals to determine carcinogenic or mutagenic potential of Cilamox.
Use in Labour and Delivery: Oral ampicillin class antibiotics are generally poorly absorbed during labour. Studies in guinea pigs have shown that intravenous administration of ampicillin decreased uterine tone, frequency, height, and duration of contractions. However, it is not known whether the use of Cilamox in humans during labour or delivery has immediate or delayed adverse effects on the foetus, prolongs the duration of labour or increases the likelihood that forceps delivery or other obstetric intervention or resuscitation of the newborn will be necessary.
Use in Pregnancy (Category A): No teratogenic effects were observed in animal studies using oral or parenteral preparations of amoxicillin. Extensive clinical use since 1972 and suitability in human pregnancy has been well documented in clinical studies.
Use in Lactation: Amoxicillin is excreted in breast milk; therefore, caution should be exercised if Cilamox is administered to a breast-feeding mother.