Veterinary Pharmaceutical Dosage Forms: A Technical Note

Research Article

Austin Therapeutics. 2014;1(1): 3.

Veterinary Pharmaceutical Dosage Forms: A Technical Note

Ramteke KH*, Joshi SA, Dighe PA and Kharat AR

1Department of Industrial Pharmacy, Wroclaw Medical University, Poland

2Department of Pediatric Infectious Diseases, Wroclaw Medical University, Poland

3Pharmacovigilance Department, PPF HASCO-LEK S.A. Wroclaw, Poland

*Corresponding author: Ernest Kuchar, Department of Pediatric Infectious Diseases, Wroclaw Medical University 44 Bujwida Street, 50-345 Wroclaw, Poland

Received: September 04, 2014; Accepted: October 07, 2014; Published: October 07, 2014

Abstract

Spontaneous (passive) reports of adverse drug reactions are very important in drug safety monitoring.

Aim of the Study: Analysis of the adverse events of oral loratadine marketed in Poland.

Methods and Material: We contacted all manufactures marketing loratadine in Poland (Hasco-LekS.A.Galena, US Pharmacia, Sandoz, MSD Polska) and analysed spontaneous reports on the adverse effects of oral loratadine reported in 2008-2013.

Results: There were five spontaneous reports concerning these medications registered in the period analyzed. Polish total loratadine market at that time was estimated at 3.2-5.3 million packs per year.

Conclusion: Oral loratadine is a safe medication rarely causing adverse effects. Single adverse events were reported in 6-year observation period when 26.7 million of medication units were distributed in Poland. The existing monitoring system of adverse effects in Poland may not be sensitive enough to detect all adverse effects.

Keywords: Pharmacoepidemiology; Drug safety; Phamacovigilance

Introduction

An azatadine-derivative, loratadine is a second-generation competitive histamine H1 receptor antagonist widely used in the treatment of allergic rhinitis and urticaria as a longacting antihistamine drug. Unlike most classic first-generation antihistamines, it lacks central nervous system depressing effects such as drowsiness [1].

Patented in 1981, loratadine was introduced to the pharmaceutical market in 1988 in Belgium, and in 1993 in the USA by Schering- Plough as Claritin and is now available in 114 countries, as an overthe- counter medication in 33 of them [2].

The drug is effective in the management of allergic rhinitis and allergic skin reactions such as urticaria and itching sensations [3]. Loratadine is one of the most common antihistamines worldwide, which is demonstrated by the large number of loratadine-containing medications registered worldwide. There are five manufacturers of loratadine in Poland: HASCO-LEK S.A., the manufacturer of Loratan soft capsules containing 10mg of the active substance and syrup with loratadine concentration of 5mg/5 ml., Galena, the manufacturer of Loratadyna Galena 10 mg tablets and Loratadyna Pylox 10 mg tablets, US Pharmacia, the manufacturer of Aleric Lora 10 mg tablets, Sandoz, the manufacturer of Flonidan 10 mg tablets, Flonidan Control 10 mg tablets and Flonidan suspension (1mg/ml) and MSD Polska marketing Claritine 10 mg tablets, Claritine Alergy 10 mg tablets and Claritine Alergy syrup (1mg/ml).

Citation: Karlowicz-Bodalska K, Han S, Miskiewicz K, Kutycka E and Kuchar E. Adverse Events of Oral Loratadine Spontaneously Reported to Manufacturers in Poland in 6-Year Period. Austin Therapeutics. 2014;1(1): 3. ISSN:2472-3673