ABSTRACT
STUDY OBJECTIVES: To evaluate the safety and potential pharmacokinetic interaction between indinavir and clarithromycin. STUDY METHODS: In a randomized, three-period, crossover fashion, 12 healthy adults received the following for 1 week: 800 mg oral indinavir sulfate every 8 hours with placebo, 500 mg oral clarithromycin every 12 hours with placebo, and indinavir sulfate with clarithromycin. Plasma indinavir, clarithromycin, and 14-hydroxyclarithromycin concentrations were determined after the last dose in each treatment period. RESULTS: Administration of indinavir sulfate with clarithromycin caused a statistically significant increase in four pharmacokinetic parameters: a 58% increase in plasma indinavir concentrations at 8 hours (P = .029), a 47% increase in values for clarithromycin area under the plasma concentration versus time curve from time zero to the last measured concentration [AUC(0-12h); P = .0002], and 49% and 48% decreases in 14-hydroxyclarithromycin AUC(0-12h) and maximum plasma concentration (Cmax) values, respectively (P = .0001 and P = .0001). These effects are not considered to be clinically significant in view of the insignificant effects on the values for indinavir area under the plasma concentration versus time curve from time zero to the last measured concentration [AUC(0-8h)] and Cmax, as well as the safety profile of clarithromycin. CONCLUSIONS: The combination of indinavir sulfate and clarithromycin is generally well tolerated and can be coadministered without dose adjustment.
Subject(s)
Anti-Bacterial Agents/pharmacokinetics , Clarithromycin/pharmacokinetics , HIV Protease Inhibitors/pharmacokinetics , Indinavir/pharmacokinetics , Administration, Oral , Adult , Anti-Bacterial Agents/blood , Area Under Curve , Calcium/urine , Chromatography, High Pressure Liquid , Clarithromycin/analogs & derivatives , Clarithromycin/blood , Cross-Over Studies , Drug Interactions , HIV Protease Inhibitors/blood , Humans , Indinavir/blood , Male , Uric Acid/urineABSTRACT
This study evaluates the safety and potential pharmacokinetic interaction between indinavir and trimethoprim/sulfamethoxazole (TMP/SMZ). In a randomized, three-period crossover fashion, 12 healthy adults received 1 week of indinavir sulfate 400 mg orally every 6 hours with placebo, TMP 160 mg/SMZ 800 mg orally every 12 hours with placebo, and indinavir sulfate with TMP/SMZ. Plasma indinavir, SMZ, and TMP concentrations were determined after the last dose of each treatment period. Concomitant administration resulted in a 17% decrease in geometric mean trough plasma indinavir concentrations (p = 0.032), an 18% increase in geometric mean AUC0-12 h and Cmax TMP values (p = 0.031 and 0.030, respectively), and a 5% increase in geometric mean AUC0-12 h SMZ values (p = 0.039). None of these effects was considered clinically significant. The combination of indinavir sulfate and TMP/SMZ is generally well tolerated, with no clinically significant pharmacokinetic interaction being noted.
Subject(s)
Anti-Infective Agents/pharmacokinetics , HIV Protease Inhibitors/pharmacokinetics , Indinavir/pharmacokinetics , Trimethoprim, Sulfamethoxazole Drug Combination/pharmacokinetics , Abdominal Pain/chemically induced , Administration, Oral , Adolescent , Adult , Anti-Infective Agents/adverse effects , Area Under Curve , Bilirubin/blood , Cross-Over Studies , Diarrhea/chemically induced , Drug Interactions , Female , HIV Protease Inhibitors/adverse effects , Headache/chemically induced , Humans , Indinavir/adverse effects , Indinavir/blood , Male , Middle Aged , Trimethoprim, Sulfamethoxazole Drug Combination/adverse effects , Trimethoprim, Sulfamethoxazole Drug Combination/bloodABSTRACT
Deficiency of the tears or obstruction to the free flow of tears predispose to infections of the lacrimal system. The relevant anatomy of the lacrimal system and the pathologic conditions leading to obstruction are outlined. The clinical manifestations of infections of the lacrimal gland, the canaliculus, and the lacrimal sac are described, and the basis for medical and surgical treatment is discussed.
Subject(s)
Dacryocystitis/microbiology , Eye Infections , Dacryocystitis/drug therapy , Eye Infections/diagnosis , Eye Infections/drug therapy , HumansABSTRACT
Parvovirus B19 is a recently described pathogen, associated with an increasing spectrum of clinical manifestations. We present the first reported case, to our knowledge, of parvovirus B19-associated hemophagocytic syndrome, in which the diagnosis of parvovirus infection was documented by the presence of B19-specific IgM and IgG antibodies. Pancytopenia resolved immediately following splenectomy and the patient recovered completely.
