Abstract: Methods for concomitant administration of colchicine together with one or more macrolide antibiotics, e.g., clarithromycin, are disclosed. Such methods reduce the dangers commonly associated with such concomitant administration and provide additional benefits.

Abstract: Stable ultrapure colchicine compositions comprising ultrapure colchicine and a pharmaceutically acceptable excipient are described. The compositions can be tablets. Methods for preparing such compositions and methods of use are also disclosed. Methods of treating gout flares with colchicine compositions are also disclosed.

Abstract: Disclosed herein is a method of using colchicine. In one embodiment, the method comprises administering to a patient colchicine and a substrate of cytochrome P450 1A2 and monitoring the patient during administration of colchicine and the substrate for an adverse event. Also disclosed are articles of manufacture comprising a container containing a dosage form of colchicine and a method of manufacturing a colchicine product.

Abstract: Stable ultrapure colchicine compositions comprising ultrapure colchicine and a pharmaceutically acceptable excipient are described. The compositions can be tablets. Methods for preparing such compositions and methods of use are also disclosed. Methods of treating gout flares with colchicine compositions are also disclosed.

Abstract: Methods for concomitant administration of colchicine together with one or more macrolide antibiotics, e.g., clarithromycin or erythromycin, are disclosed. Such methods reduce the dangers commonly associated with such concomitant administration and provide additional benefits. Methods of notifying health care practitioners and patients regarding appropriate dosing for co-administration of colchicine together with macrolide antibiotics are also provided.

Abstract: Methods for treating gout flares comprising concomitant administration of colchicine together with one or more macrolide antibiotics, e.g., clarithromycin or erythromycin, are disclosed. Such methods reduce the dangers commonly associated with such concomitant administration and provide additional benefits. Methods of notifying health care practitioners and patients regarding appropriate dosing for co-administration of colchicine together with macrolide antibiotics are also provided.

Abstract: A method of using carisoprodol comprises informing a user that administration of carisoprodol in the presence of food decreases the Cmax for carisoprodol compared to administration in the absence of food. In one embodiment, informing comprises providing printed labeling instructions. Also included are articles comprising a carisoprodol formulation and prescribing information, and methods of manufacturing carisoprodol dosage forms. Included are measures intended to increase the safe use of narrow therapeutic medications with carisoprodol.

Abstract: Stable ultrapure colchicine compositions comprising ultrapure colchicine and a pharmaceutically acceptable excipient are described. The compositions can be tablets. Methods for preparing such compositions and methods of use are also disclosed. Methods of treating gout flares with colchicine compositions are also disclosed.

Abstract: Fenofibric acid formulations comprising 105 mg of fenofibric acid are described as well as methods of use thereof. Dosage forms include, for example, immediate-release dosage forms.

Abstract: Stable ultrapure colchicine compositions comprising ultrapure colchicine and a pharmaceutically acceptable excipient are described. The compositions can be tablets. Methods for preparing such compositions and methods of use are also disclosed. Methods of treating gout flares with colchicine compositions are also disclosed.

Abstract: A method of using carisoprodol comprises informing a user that administration of carisoprodol in the presence of food decreases the Cmax for carisoprodol compared to administration in the absence of food. In one embodiment, informing comprises providing printed labeling instructions. Also included are articles comprising a carisoprodol formulation and prescribing information, and methods of manufacturing carisoprodol dosage forms. Included are measures intended to increase the safe use of narrow therapeutic medications with carisoprodol.

Abstract: A method of using carisoprodol, phenytoin or fosphenytoin comprises informing a user that co-administration of carisoprodol with phenytoin or fosphenytoin results in an increase in free phenytoin blood levels, a decrease in total phenytoin levels, or both. In another embodiment, a method of using carisoprodol, phenytoin or fosphenytoin comprises informing a user that when co-administering carisoprodol with phenytoin or fosphenytoin, the level of free phenytoin in a patient serum should be monitored, the level of total phenytoin should be monitored, or both. Also included are methods and articles of manufacture.

Abstract: Stable ultrapure colchicine compositions comprising ultrapure colchicine and a pharmaceutically acceptable excipient are described. The compositions can be tablets. Methods for preparing such compositions and methods of use are also disclosed. Methods of treating gout flares with colchicine compositions are also disclosed.

Abstract: Stable fenofibrate suspensions are disclosed herein. A fenofibrate composition includes fenofibrate nanoparticles having an average particle size of less than 500 nm, and a particle sequestrant, wherein the average particle size of the nanoparticulate suspension changes by less than 50% after standing at room temperature for 21 or more days.

Abstract: Disclosed are oral dosage forms comprising an effective amount of mesalamine, wherein the dosage form has a dissolution profile such that greater than 5 wt % of the total weight of the mesalamine in the dosage form is released during a pH 6.0 portion of a dissolution test, the dissolution test comprising stirring in a pH 6.0 solution for 1 hour, followed by stirring in a pH 7.2 solution for an additional hour. In some embodiments, the dosage form releases less than all of the mesalamine to the right side of the colon. Release of less than all of the mesalamine dosage form to the right side of the colon may be determined by the in vitro dissolution profile of the dosage form.

Abstract: Disclosed herein are methods of using metaxalone. In one embodiment, the method comprises determining that a patient in need metaxalone therapy is taking a substance that is a n inhibitor or an inducer of a cytochrome p450 isozyme, wherein the cytochrome P450 is CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, or CYP3A4, and adjusting administration to the patient of metaxalone or the substance to avoid an adverse event associated with metaxalone. In another embodiment, the method comprises informing a user that metaxalone ais metabolized by a cytochrome p450 isozyme, wherein the cytochrome P450 is CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, or CYP3A4. Also included are articles of manufacture comprising a container containing a dosage form of metaxalone, wherein the container is associated with published material informing that metaxalone affects activity of a cytochrome p450 isozyme. Also disclosed are a method of treatment and a method of manufacturing a metaxalone product.

Abstract: A method of using carisoprodol comprises informing a user that co-administration of carisoprodol with steady-state phenyloin results in an increase in free phenyloin blood levels, a decrease in total phenyloin blood levels, or both. In another embodiment, a method of using carisoprodol comprises informing a user that when co-administering carisoprodol with steady-state phenyloin, the level of free phenyloin in a patient serum should be monitored, the level of total phenyloin should be monitored, or both. Also included are methods and articles of manufacture.

Abstract: The present invention provides stable formulations of ACE inhibitors, especially enalapril maleate, that can be manufactured in a time efficient, cost effective manner. Such formulations can be prepared simply and on a large industrial scale. The present invention also provides methods for the preparation of stable formulations of ACE inhibitors, especially enalapril maleate.

Abstract: Active agent compositions comprising active agent particles having an effective average particle size of less than 2000 nm, wherein the compositions comprise a particle sequestrant are disclosed. Compositions having an effective average particle size of less than 2000 nm, wherein the compositions comprise no added surfactants, phospholipids, or combinations thereof, are also disclosed.

Abstract: Alfuzosin compositions comprising alfuzosin and a release-retarding matrix comprising about 40 to about 80% (by weight) hydroxypropyl methyl cellulose with a maximum apparent viscosity of about 5600 cP, wherein the compositions are bioequivalent to the reference dosage form of NDA #021287 are disclosed. Alfuzosin compositions comprising alfuzosin and a release-retarding matrix comprising about 40 to about 80% (by weight) hydroxypropyl methyl cellulose (HPMC) with a maximum apparent viscosity of about 5600 cP, wherein the dissolution profile of the compositions are substantially identical to the dissolution profile of the reference dosage form of NDA #021287 are also disclosed. Methods of making and using the alfuzosin compositions are also disclosed.