Generic versus non-generic formulation of extended-release clarithromycin in patients with community-acquired respiratory tract infections: a prospective, randomized, comparative, investigator-blind, multicentre study.

BACKGROUND AND OBJECTIVE: There is a general concern about the use of multisource (generic) antibacterials in the clinical setting with registration based solely on bioequivalence data. In order to address this concern, two modified-release formulations of clarithromycin (i.e. the originator Klacid XL and the generic Klarithran MR) were compared in patients with acute community-acquired respiratory tract infections. METHODS: Patients presenting with tonsillopharyngitis, sinusitis or pneumonia were randomized to receive either of the test drugs provided they clinically qualified for empirical clarithromycin treatment. The study endpoints were clinical and bacteriological cure rates, tolerability and safety. The study was designed to test for non-inferiority with regard to cure rates. RESULTS: The main outcome of this study was that both agents had similar clinical (non-inferior) and bacteriological cure rates and demonstrated no difference in tolerability in patients. The study also demonstrated the clinical efficacy of clarithromycin when used as empirical treatment in patients with respiratory tract infections in community practice (i.e. 95% clinical cure rate). CONCLUSION: The clarithromycin extended-release multisource product (Klarithran MR) does not differ significantly from the originator (Klacid XL) and the clinical cure rate of the generic formulation is non-inferior to that of the originator. The two formulations are tolerated similarly.

Dissipation of quinalphos in kinnow mandarin fruits under subtropical conditions of Punjab, India.

Quinalphos residues were studied separately in the pulp and rind of kinnow mandarin fruits by following a standardized methodology and estimated on gas liquid chromatograph (GC) by employing nitrogen phosphorus detector. Following application of quanilphos (Ekalux 25EC) at 10.0 and 20.0 mL per tree (per 5 L of water) on kinnow mandarin fruits at both these dosages were found to be 0.05 and 0.16 mg/kg, respectively. These initial deposits were found to be less than its maximum residue limit (MRL) of 0.25 mg/kg. The corresponding values in the rind were found to be 0.65 and 1.64 mg/kg, respectively. These residue levels in the rind dissipated below the MRL in 5 and 15 days, respectively. The half-life value for quanilphos in the rind at single and double dosages were found to be 3.2 and 4.0 days, respectively. Low dissipation rate of quanilphos in the rind may be attributed to the fibrous nature of the peel where the insecticide can be adsorbed, high moisture content and oil based nature of the rind. The results clearly show that quanilphos does not penetrate into the pulp of the kinnow mandarin and the fruit is safe for consumption even after one day of the application at both these dosages.

Urethral diverticulum in a female child.

A urethral diverticulum in a female arises from the wall of the urethra and consists mainly of fibrous tissue lined with epithelium. It is uncommon, and usually presents between decades 3 and 5. Most patients present with non-specific, refractory, lower urinary tract symptoms, unrelated to the diverticulum size or number. The diverticulum may also present as a mass at the introitus. We report a case of urethral diverticulum in a female child that presented as an introital mass.