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The efficacy and safety of a once-daily dose of loratadine 10 mg (5 mg in patients whose body weight was less than or equal to 30 kg) and astemizole 2 mg/10 kg body weight o.d. were compared in a 14-day third-party blind study. Forty-one children (30 boys and 11 girls, aged 6-14 years) with seasonal allergic rhinoconjunctivitis entered the study. The pollen count was monitored throughout the study. A significant improvement (p less than 0.01) in allergy symptoms was observed from the third day for both drugs; there was no significant difference between drugs, although loratadine led to a greater reduction in symptoms. In the astemizole group, the apparently rapid onset of drug action might by explained by reduced pollen exposure. Therapeutic response was excellent/good in 83.3% and 58.8% of the loratadine and astemizole groups, respectively. The results reported by the patients/parents were similar. Nine of the children on astemizole and four children on loratadine complained of side effects; three patients in the astemizole group were withdrawn from treatment because of adverse effects. No abnormal changes in lab values were observed in either group.
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Desloratadine treatment was associated with significant improvements compared with placebo in pruritus scores and in the size of the largest wheals as early as day 1. These improvements continued through to the end of the trial. The mean score for the number of wheals was significantly lower in the desloratadine group than in the placebo group on days 14 and 42 (p < or = 0.016). Overall improvement in CIU (complete, marked, or moderate therapeutic response) was also greater at the end of the study in the desloratadine group compared with placebo (p < 0.001). Adverse events occurred with similar frequency among desloratadine- and placebo-treated patients.
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In healthy volunteers, no increased incidence of QTc values >440 msec or DeltaQTc >/=40 msec were recorded compared to placebo. No dose-related increase in QTc interval was observed. The ECG parameters were not modified by the co-administration of mizolastine with digoxin, diltiazem and erythromycin, when compared to the effect of each co-administered drug alone. In patients, the mean QTc interval changes from baseline did not significantly differ from placebo. In comparative studies vs. loratadine a similar incidence of out of range values was observed with mizolastine and loratadine.
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Patient eyes treated with Patanol were significantly less itchy than those treated with systemic Claritin alone at critical time points 3, 7, and 10 minutes after the onset of action challenge (p < 0.05), and at 3 and 7 minutes after the duration of action challenge (p < 0.05).
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A prospective crossover study.
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To explore the clinical efficacy and the mechanism of acupoint autohemotherapy in the treatment of allergic rhinitis.
To determine the selectivity of the non-sedating antihistamines loratadine and terfenadine and the sedating antihistamine diphenhydramine for peripheral and central histamine H1-receptors, these compounds were examined against intravenous (i.v.) and intracerebroventricular (i.c.v.) histamine-induced bronchoconstriction in anesthetized, spontaneously breathing guinea pigs. Animals were prepared with i.c.v. or i.v. cannulas and instrumented for the measurement of airway resistance (RAW) and dynamic lung compliance (CDyN). Loratadine, terfenadine or diphenhydramine were administered orally 2 h before either i.v. or i.c.v. injection of histamine. Each antihistamine blocked the i.v. histamine bronchospasm with the order of potency loratadine (ED40 = 0.08 mg/kg) greater than terfenadine (ED40 = 0.44 mg/kg) greater than diphenhydramine (ED40 = 5 mg/kg). These drugs also blocked i.c.v. histamine-induced bronchoconstrictions, but loratadine and terfenadine were approximately 10 times less potent against i.c.v. histamine bronchoconstriction than they were against i.v. histamine. In contrast, diphenhydramine was equipotent against i.c.v. and i.v. histamine bronchoconstriction. These results demonstrate that the non-sedating antihistamines loratadine and terfenadine, unlike diphenhydramine, are more effective against peripheral than central H1-receptors, probably because of poor penetration of the blood-brain barrier.
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A sensitive gas-liquid chromatographic (GLC) method was developed for the determination of loratadine, a long-acting tricyclic antihistamine, and its active metabolite, descarboethoxyloratadine, in human plasma. The method involved extraction with organic solvent at neutral and alkaline pH. The organic layer from the neutral pH extraction was evaporated to dryness, reconstituted and injected into the GLC system. On the other hand, to the organic layer from the alkaline pH extraction trifluoroacetic anhydride was added. Following addition of H2O, the mixture was centrifuged and the organic layer was evaporated to dryness, reconstituted and injected onto the GLC system that was equipped with a nitrogen specific detector and a fused-silica capillary column. The linearity for both loratadine and descarboxyloratadine were demonstrated with r > or = 0.998 at concentrations ranging from 0.1 to 30 ng/ml. The results showed that the GLC method was accurate (bias < or = 12%) and precise (coefficient of variation, C.V., < or = 12%) for loratadine and descarboethoxyloratadine. The limit of quantitation was 0.1 ng/ml for loratadine with a C.V. of 9.2% and for descarboethoxyloratadine with a C.V. of 5.3%. The GLC method described has been demonstrated to be useful for the determination of loratadine and descarboethoxyloratadine in plasma samples of pediatric volunteers following oral administration of a single dose of 10 mg of loratadine syrup.
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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.