loratadine, Claritin
Preparation and coating of finely dispersed drugs 4. Loratadine and danazol.

Skapin SD, Matijevic E.

Center for Advanced Materials Processing, Clarkson University, Potsdam, NY 13699-5814, USA.

The preparation of colloidal particles of different morphologies, including spheres, of two drugs, loratadine and danazol, is described. In principle these particles were obtained by precipitation when nonsolvents (water or aqueous surfactant solutions) were added to ethanol solutions of the drug. In addition, procedures were developed that made it possible to use the drug particles thus obtained as cores to be then coated with either silica or aluminum (hydrous) oxide layers. The presence of these inorganic shells was confirmed by electron microscopy, energy dispersive spectroscopy, and electrophoresis.

Online source: www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=14985026&dopt=Abstract loratadine, Claritin



loratadine, Claritin
High-performance liquid chromatographic method for the bioequivalence evaluation of desloratadine fumarate tablets in dogs.

Liu L, Qi M, Wang P, Li H.

School of Pharmacy, Shenyang Pharmaceutical University, Shenyang, PR China.

A simple HPLC method was developed for the determination of desloratadine in dog plasma and was used for evaluating the bioequivalence of desloratadine fumarate tablets and desloratadine tablets in dogs. Chromatographic separation was performed on a Hypersil CN column (150 mm x 5.0 mm, 5 microm) using a mixture of methanol, acetonitrile and phosphate buffer (pH 5.5; 0.01 mol/l) (35:35:30, v/v/v) as mobile phase delivered at a flow rate of 0.8 ml/min. The detection was set at 241 nm. The limit of quantitation was 5.0 ng/ml. The calibration range was from 5.0 to 800.0 ng/ml. Inter- and intra-day precision ranged from 1.8 to 3.8% and from 2.2 to 9.0%, respectively. The recovery of desloratadine from dog plasma ranged from 78.8 to 82.0%. The developed method was applied to the bioequivalence studies of desloratadine fumarate tablets (test preparation) and desloratadine tablets (reference preparation) in five dogs. Pharmacokinetic parameters t(max), C(max), AUC(0-t), AUC(0- infinity ), t(1/2) were determined from plasma concentration-time profiles of both preparations. The analysis of variance (ANOVA) did not show any significant difference between the two preparations and 90% confidence intervals fell within the acceptable range for bioequivalence. Based on these statistical inferences it was concluded that the two preparations exhibited comparable pharmacokinetic profiles and that desloratadine fumarate tablets was bioequivalent to desloratadine tablets.

Online source: www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=15019035&dopt=Abstract loratadine, Claritin



loratadine, Claritin
Evaluation of an association between loratadine and hypospadias--United States, 1997-2001.

Centers for Disease Control and Prevention (CDC).

Hypospadias is a birth defect that affects approximately seven in 1,000 male infants in the United States. In affected infants, the urethral opening is located along the underside of the penis, scrotum, or perineum; the condition usually is corrected by surgery. Hypospadias is classified in order of increasing severity as first, second, or third degree. In 2002, a study in Sweden noted that among male infants born to women who while pregnant had taken loratadine (Claritin), a nonsedating antihistamine commonly used for seasonal allergies, hypospadias prevalence was twice that of the general population. However, insufficient data were available to determine the severity of the hypospadias cases, and the study did not control for confounding variables (e.g., family history of hypospadias or maternal age). In 2003, a prospective study using data from four countries indicated that five of 142 pregnancies in women exposed to loratadine resulted in infants with major malformations, a prevalence consistent with that of the general population; none had hypospadias. To further assess any potential association between loratadine and hypospadias, CDC analyzed data from the National Birth Defects Prevention Study (NBDPS). This report summarizes the results of that analysis, which determined that no increased risk for second- or third-degree hypospadias existed among women who used loratadine in early pregnancy. These results might be useful for women and health-care providers to address concerns about loratadine use and hypospadias.

Online source: www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=15029117&dopt=Abstract loratadine, Claritin



loratadine, Claritin
Evaluation of the utilization patterns of leukotriene modifiers in a large managed care health plan.

Lakomski PG, Chitre M.

Excellus Health Plan, Inc., 344 South Warren St., Syracuse, NY 13202, USA. paul.lakomski flrx.com

OBJECTIVE: To assess the utilization of leukotriene modifiers (LM) relative to national guidelines and to investigate possible emergency room utilization differences for LMs as monotherapy versus inhaled corticosteroid (ICS) monotherapy or combination ICS and LM therapy. METHODS: The utilization of leukotriene modifiers (montelukast sodium, zafirlukast, and zileuton), concurrent inhaled steroids (beclomethasone, budesonide, flunisolide, fluticasone, and triamcinolone), beta-agonists (albuterol, bitolterol, formoterol, isoetharine, levalbuterol, metaproterenol, pirbuterol, salmeterol, and terbutaline) and low-sedating antihistamines ([LSAs] cetirizine, desloratadine, fexofenadine, and loratadine) were assessed from the drug claims database of a large health insurer for dates of service for the 12-month period from September 1, 2001, through August 31, 2002. New-start LM patients were identified as having no previous LM drug claim within a 180-day look-back period from the first date of fill for the LM. Claims were stratified into age cohorts of.under 16 years. and.16 years and older. Emergency room (ER) claims for patients utilizing LMs, ICSs, and patients on both LM and ICS were retrieved for analysis from the medical claims database for the same 12-month study period. RESULTS: More than 89% of new LM starts had no history of an ICS in the claims database. Overall, 61% of all (new and existing) LM patients did not have a claim for an ICS in their drug claims profile during the study period. An estimated 25% of LM utilization was not for asthma. No differences in ER utilization were found between ICS users and LM users; however, the ER utilization rate (0.090 ER visits per patient per year) was lower with combination therapy compared with monotherapy with ICS (0.110 ER visits per patient per year, P = 0.001) or LM (0.119 emergency room visits per patient per year, P<0.001). CONCLUSIONS: The majority of LM use in this health plan was initial monotherapy, contrary to national treatment guidelines for asthma. At the time of the study, the apparent off-label use of LM for allergic rhinitis was significant for this health plan.

Online source: www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=15032560&dopt=Abstract loratadine, Claritin



loratadine, Claritin
Nociceptive and edematogenic responses elicited by a crude bristle extract of Lonomia obliqua caterpillars.

de Castro Bastos L, Veiga AB, Guimaraes JA, Tonussi CR.

Department of Pharmacology, Federal University of Santa Catarina, P.O. Box 476, Florianopolis, SC 88040-900, Brazil.

Lyophilized Lonomia obliqua crude bristle extract (LOCBE) diluted in physiological saline (15, 35 and 50 microg of protein/paw) was injected in the plantar surface of the hind paw of the rat, causing a nociceptive response which lasted from 30 to a maximum of 50 min, peaking in the first 5 min. The animals also presented hematuria and nasal bleeding. Nociception was inhibited by indomethacin pretreatment (2.5 mg/kg, i.p., 60 min before), but not by guanethidine (30 mg/kg/day, s.c., for 3 days) or loratadine (5 mg/kg, p.o., 60 min before). LOCBE injection also produced paw edema peaking 1 h after injection and lasting for 6 h. Loratadine pretreatment, but neither guanethidine nor indomethacin, reduced edema. After the period of overt nociception, a nociceptive aftersensation response could be evoked up to 6 h after by immersing the paw into cold water (15 degrees C) for 10 s. Capsaicin (1.6 microg), formalin (0.5%) or prostaglandin E(2) (500 ng) did not produce the same aftersensation phenomenon. These results suggest that LOCBE-induced nociception is largely facilitated by prostaglandin production, and edematogenic response seems to be facilitated by prostanoids and histamine. Finally, LOCBE induced a state of sensitization to cold, which seemed to be specific as it was not caused by other noxious chemicals.

Online source: www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=15033325&dopt=Abstract loratadine, Claritin



loratadine, Claritin
Assessing patient satisfaction with desloratadine after conversion from loratadine, fexofenadine, or cetirizine.

Glass D, Harper A.

Harris Interactive Healthcare Division, New York City, New York 10003, USA. dglass harrisinteractive.com

A number of prescription and nonprescription nonsedating antihistamines are available for the treatment of allergic rhinitis. From a managed care perspective, determining the extent to which a medication conversion to desloratadine from loratadine, fexofenadine, or cetirizine results in maintained or increased patient satisfaction with allergy care would be informative for formulary decision makers and other budget holders. To that end, a survey was undertaken of patient medication assessments after a switch in antihistamines. On average, patients who converted to desloratadine from loratadine, fexofenadine, or cetirizine reported increased satisfaction with desloratadine treatment.

Online source: www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=15038691&dopt=Abstract loratadine, Claritin