ABSTRACT
Background: Co-amoxiclav which is a combination of Amoxicillin and Calvulanic acid is one of the most commonly prescribed antibiotics so there was need to study the side effects of this drug
Objectives: This study was done to enlist the adverse reactions especially the gastroinstestinal and hepatotoxic adverse reactions in patients who were prescribed co-amoxiclav
Patients and Methods: This cross-sectional study was conducted on 200 patients, both indoors and out-doors in the Department of Medicine of Khyber Teaching Hospital [KTH], Lady Reading Hospital [LRH] and Hayatabad Medical Complex Peshawar, in months of August-October of 2013. The individuals included in the study were those treated as inpatient or outpatient with the diagnoses of uncomplicated UTIs, RTIs including Sinusitis and Pneumonia and the Skin infection. Those who were below the age of 18 years, requiring more than one antibiotic, having previously known chronic disease especially the liver disease or on any long-term medications, alcoholics and pregnant ladies were excluded from the study. A detailed questionnaire mentioning the age, sex and ethnicity of the patients, indications for the use of co-amoxiclav, duration of the treatment, base line LFTs including Bilirubin, SGPT and Alkaline Phosphatase and use of any concomitant drugs was devised. The patients were asked for follow up at weekly intervals for eight weeks after the course of treatment and assessed clinically and biochemically and LFTs recorded. This study which was approved by the Ethics Committee of our hospital was self-funded by the authors and informed consent was taken from every patient. The data was processed using SPSS version 16
Results: Amoxicillin- Calvulanate combination was seen to be well tolerated by most of the patients in our study subjects and adverse reaction were noted only in 36 [18%] of the patients. The commonest side effect was diarrhea seen in 24 [12%] of the patients which was more severe in patients getting higher doses and for more than a week. Side effects were commonly seen in old patients 16 [8%] and in chronic smokers. Hepatotoxic side effects were seen in 6 [3%] of the participants mainly cholestatic type of derangement on LFTs was seen and the toxicity was Mild i.e. Grade 1 in five of them as per National Institute of Cancer's, "Common Toxicity Criteria for Adverse Events, version 4.0 [CTCAEv4]" while one developed Grade 2 Hepatocellular type of Liver injury secondary to Co-Amoxiclav. Only 2% of the patients were discontinued with the drug when they developed signs and symptoms of allergy on the 1[st] day of treatment while Oral candidiasis was seen in only 1% of the study subjects
Conclusion: Gastrointestinal and hepatic side effects are uncommon with Co-Amoxiclav and the commonest adverse reaction is diarrhea. Clinically obvious jaundice along with biochemically deranged LFTs is pretty remote possibility and can be reverted on stopping the drug and commencing the supportive treatment