Jdp Therapeutics, Inc.

Mutual Pharmaceutical Company, Inc.

Jie Du

Richard H Roberts

Matthew William Davis

Described herein is a method of administering injectable cetirizine or levocetirizine to treat acute urticaria, with or without concomitant angioedema, without life-threatening airway swelling by intravenously injecting a human patient within minutes to hours of developing acute urticaria in an emergency department or clinic with a therapeutically effective amount of an injectable cetirizine or levocetirizine composition. In the method, the injectable cetirizine or levocetirizine is the only treatment administered in the emergency department or clinic. The method can include determining, by the patient, a patient rated pruritus severity score at a 1 hour assessment, and optionally at a 2 hours assessment, and a physician discharging the human patient after 1.7±0.9 hours in the emergency department or clinic, wherein the human patient has a patient rated pruritus severity score reduction of at least 1 unit and baseline sedation at the time of discharge.

Dosing regimen for injectable cetirizine

Described herein is a method of administering injectable cetirizine or levocetirizine including intravenously injecting a mammal in need thereof with a therapeutically effective amount of an injectable cetirizine or levocetirizine composition, wherein the mammal receives a maximum daily dose of the cetirizine or levocetirizine that is no more than 15 times a maximum recommended daily clinical dose for the mammal.

Disclosed are injectable formulations of cetirizine for treating acute allergic reactions and methods for treating acute allergic reactions. In particular, an intravenous injectable is disclosed as are methods of treating acute allergic reactions.

Non-sedating antihistamine injection formulations and methods of use thereof

Described herein are automatic injectors suitable for administration of a non-sedating antihistamine, and methods of using the automatic injectors. A specific non-sedating antihistamine is cetirizine. The automatic injectors are useful in treating acute urticaria or angioedema associated with an acute allergic reaction including anaphylaxis.

Described herein are injectable compositions containing non-sedating or second and third generation antihistamines such as cetirizine/levocetirizine and methods of use thereof. Specifically, methods of treating acute allergic reactions including anaphylaxis with the compositions are disclosed. In certain embodiments, the injectable compositions are bioequivalent to currently marketed oral dosage forms. In other embodiments, the non-sedating or second and third generation antihistamine injectable formulations are therapeutically equivalent to diphenhydramine injectable formulations and/or are more effective than placebo. In other embodiments, a non-sedating antihistamine injectable composition is delivered by an autoinjector.

Described herein are injectable compositions containing non-sedating or second and third generation antihistamines such as cetirizine/levocetirizine and methods of use thereof. Specifically, methods of treating acute urticaria or angioedema associated with an acute allergic reaction are disclosed. In certain embodiments, the injectable compositions are bioequivalent to currently marketed oral dosage forms with the same number of mg of cetirizine.

Disclosed are injectable formulations of cetirizine for treating acute allergic reactions and methods for treating acute allergic reactions. In particular, an intravenous injectable is disclosed as are methods of treating acute allergic reactions therewith.

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 is 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.

Metaxalone products, method of manufacture, and method of use

A method of using carisoprodol comprises informing a user that administration of carisoprodol in the presence of food decreases the Cfor 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.

Carisoprodol articles and methods

Disclosed herein is a method of using metaxalone. In one embodiment, the method comprises obtaining metaxalone from a container providing information that metaxalone affects the activity of a cytochrome p450 isozyme. In another embodiment, the method comprises informing a user that metaxalone affects the activity of a cytochrome p450 isozyme. 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.

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Lansdale, PA, United States of America

Jie Du