Haematological Modulations by Fixed Dose Combination (FDC) of Tramadol Hydrochloride/Paracetamol (THP)

Analgesics as fixed-dose combination are very useful for fast pain relief. Overdose or chronic use of analgesics, especially fixed doses form, develop mild to severe adverse effects and sometimes damage various organs like the liver, kidney and brain. Tramadol hydrochloride/paracetamol (THP) is a fixed-dose combination (37.5 mg of Tramadol hydrochloride and 325 mg of paracetamol) extensively used for the treatment of moderate to severe pain. Administration of THP upon animal model severely disturbed hepatic and renal biochemical parameters, which leads to altering normal cellular homeostasis. In this context, our recent study established that the application of Tramadol hydrochloride/paracetamol produced deleterious effects on haematological parameters in the experimental murine model. 1.12 g/300 ml and 1.68 g/300 ml chronic administration of Tramadol hydrochloride/paracetamol (THP) decrease the packed cell volume (PCV), haemoglobin (Hb), mean cell volume (MCV), means cell haemoglobin (MCH) and increase the mean corpuscular haemoglobin concentration (MCHC) and white blood cell (WBC) in an experimental animal model. Other haematological parameters likes red blood corpuscle (RBC), reticulocyte (RT), haematocrit (HCT) did not show any significant changes upon animals. Increased MCHC inhibits the oxidation process and energy balance, whereas elevated WBC levels indicate immune system damage. Decreased haemoglobin and PCV indicate that Tramadol hydrochloride/paracetamol (THP) is an indirect cause of anaemia. It may be concluded that prolonged or chronic administration of THP may cause severe thrombocytopenia, leading to the failure of the immune system, anemia, and a very low erythrocyte count. These side effects increase according to the dosage and duration of the treatment. So clinicians, patients and pharmacists should be aware of the deleterious effects of Tramadol hydrochloride/paracetamol (THP) on haematological parameters when using this combination.