Desoximetasone Ointment

Desoximetasone Ointment USP, 0.25% contains the active synthetic corticosteroid desoximetasone.

The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents.

Each gram of Desoximetasone Ointment USP, 0.25% contains 2.5 mg of desoximetasone USP in an ointment base consisting of medium-chain triglycerides and white petrolatum.

The chemical name of desoximetasone is Pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 21-dihydroxy- 16-methyl-,(11ß,16α)-.

Desoximetasone has the molecular formula C22H29FO4 and a molecular weight of 376.47. The CAS Registry Number is 382-67-2.

The structural formula is:

Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions.

The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.

Pharmacokinetics

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.

Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses.

Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

Pharmacokinetic studies in men with Desoximetasone Ointment, 0.25% with tagged desoximetasone showed no detectable level (limit of sensitivity: 0.003 mcg/mL) in 1 subject and 0.004 and 0.006 mcg/mL in the remaining 2 subjects in the blood when it was applied topically on the back followed by occlusion for 24 hours. The extent of absorption for the ointment was 7% based on radioactivity recovered from urine and feces. Seven days after application, no further radioactivity was detected in urine or feces. Studies with other similarly structured steroids have shown that predominant metabolite reaction occurs through conjugation to form the glucuronide and sulfate ester.

Desoximetasone Ointment, 0.25% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects [see PRECAUTIONS].

Desoximetasone Ointment USP, 0.25% is supplied as follows:

15 gram tubes   NDC 68180-946-01

30 gram tubes   NDC 68180-946-02

60 gram tubes   NDC 68180-946-04

100 gram tubes NDC 68180-946-06

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Manufactured for:

Lupin Pharmaceuticals, Inc.

Baltimore, Maryland 21202

United States

Manufactured by:

Lupin Limited

Pithampur (M.P.) – 454 775

India

February 2017                                                                                                 ID#: 250566

Desoximetasone Ointment USP, 0.25%

60 g Tube label

NDC 68180-946-04

Rx only

FOR TOPICAL USE ONLY. NOT FOR ORAL, OPHTHALMIC, OR INTRAVAGINAL USE.

Keep this and all medications out of the reach of children.

Desoximetasone Ointment USP, 0.25%

60 g Carton label

NDC 68180-946-04

Rx only

FOR TOPICAL USE ONLY. NOT FOR ORAL, OPHTHALMIC, OR INTRAVAGINAL USE.

Keep this and all medications out of the reach of children.