Ranitidine

Ranitidine-induced Thrombocytopenia in a Neonate - A Case Report and Review of Literature.[Pubmed:30837818]

J Pediatr Pharmacol Ther. 2019 Jan-Feb;24(1):66-71.

Thrombocytopenia (platelet count <150 x 10(9)/L) regularly occurs in newborns but is especially observed in critically ill neonates. We describe the case of a small for gestational age (SGA) neonate, who showed an unexpected, severe thrombocytopenia (8 x 10(9)/L) at day 5 of life. The thrombocytopenia recovered completely after cessation of Ranitidine (0.5 mg/kg/6 hr), which was started in a context of feeding difficulties. Other causes of neonatal thrombocytopenia were ruled out. Besides a brief report on a cimetidine-induced thrombocytopenia over 25 years ago, no other neonatal or pediatric cases of H2 antagonist-induced thrombocytopenia have been reported to date, although being widely used in routine care. Moreover, several adult cases have been published. In general, neonatal thrombocytopenia, although one of the most frequent hematological conditions in newborns, is only rarely attributed to an adverse drug reaction. Clinicians should be aware of the risks for adverse reactions, especially in routinely used drugs and in critically ill patients.

Physical Compatibility and Chemical Stability of Injectable and Oral Ranitidine Solutions.[Pubmed:30718932]

Hosp Pharm. 2019 Feb;54(1):32-36.

Objectives: The physical compatibility and chemical stability of Ranitidine hydrochloride injectable solutions and oral syrup were studied to define beyond-use dates (BUDs). Methods: Ranitidine hydrochloride injectable solutions of 25 mg/mL packaged in glass vials and 5 mg/mL in polypropylene (PP) syringes were prepared in triplicate. Samples were refrigerated and protected from light (PFL) or stored at 25 degrees C and either exposed to light (ETL) or PFL. Ranitidine hydrochloride oral syrup 15 mg/mL in unit-dose amber PP syringes were prepared in triplicate and then kept at 25 degrees C. Samples were collected at days 0, 7, 14, 28, 56, and 91. Additional samples were collected at 6 months and at 6, 9, and 12 months for the 25 mg/mL solution and oral syrup, respectively. Physical parameters of pH, clarity, and color were obtained at each collection time. A validated stability-indicating high-performance liquid chromatography (HPLC) method was used to determine the chemical stability. Results: Formulations had no significant change in pH or clarity. Although some samples yellowed, this was not associated with a decrease in concentration. The 25 mg/mL solution remained above 98.6% for 6 months, whereas the 5 mg/mL solution remained above 93.5% for 91 days under all storage conditions. At 25 degrees C, the oral syrup retained greater than 98.8% for 12 months. Conclusions: The Ranitidine hydrochloride injectable solutions were stable for 6 months and 91 days under the 3 storage conditions, respectively, for the 25 mg/mL solution in glass vials and 5 mg/mL solution in PP syringes. The 15 mg/mL oral syrup in unit-dose amber PP syringes was stable for 12 months at 25 degrees C and PFL.