Midsone-SF ointment

COMPOSITION:
Mometasone Furoate 0.1% &   Salicylic Acid 5% ointment

Each gm of Ointment contains :
Mometasone   Furoate USP 1mg
Salicylic Acid IP               50 mg

In an Ointment base          q.s.

Molecular formula

Mometasone Furoate C27H30CI2O6
Salicylic Acid             C7H6O2

CLINICAL PHARMACOLOGY:

Like other topical corticosteroids, mometasone furoate has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti- inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2. Arachidonic acid binds with cyclo-oxygenase to form highly inflammation prostaglandins, PGE2. Lipocortins inhibits phopholipase A2, and thereby controls the biosynthesis of potent mediators of inflammatory like prostaglandin E2 (PGE2) and leukotrienes, kinins, histamine, liposomal enzymes and the complement system.

Salicylic Acid in MIDSONE –SF is a Keratolytic agent causing desquamation of stratum corneum, thereby ensuring better penetration of Mometasone Furoate. The mechanism of action of topical salicylic acid may include two pathway, both leading to desquamation of corneocytes. Salicylic acid reduces intercellular cohesiveness of the horny cells by dissolving the intercellular cement material. Salicylic acid also reduces the pH of the stratum corneum, thereby increasing hydration and softening.

Topical  corticorticosteroids and keratolytics are both used widely in the management of patients with psoriasis. A combination of two types of agents may provide enhanced relief.  The fixed topical combination of mometasone furoate 0.1% plus salicylic acid 5% has been superior to topical salicylic acid 5% alone in the treatment of psoriasis  wherein

• 5% salicylic acid in MIDSONE –SF exerts a potent and rapid deep keratolytic effect and ultimately an ex foliative action.
• 5% salicylic acid enhances penetration of Mometasone into deeper layers of epidermis.
• 5% salicylic acid in MIDSONE –SF intended for rapid clearing of the toughest psoriatic plaques.

Mometasone furoate 0.1% plus salicylic acid 5% ointment provides more effective treatment of moderate-to-severe psoriasis than does mometasone furoate ointment alone and is safe and well tolerated.
Indications :  Midsone-SF Ointment has been indicated for effective relief in Moderate to Severe Plaque Psoriasis and other severe Hyperkeratoses.

DOSAGE & ADMINISTRATION:

• Before applying Midsone-SF Ointment, soak the affected  area in warm water for 5 minutes.
•  Remove any loosened tissue by rubbing gently with a wash cloth.
•  Dry area thoroughly.
•  Apply a thin film of the Midsone-SF Ointment to the affected area two or three  times a day.

• Apply a thin film of   Midsone-SF Ointment  to the affected skin areas once daily.
• As with other corticosteroids, therapy should be discontinued when control is achieved

CONTRADICTIONS:

Mometasone Furoate is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation.
Salicylic acid ointment is contraindicated in those patients with a history of hypersensitivity

WARNING & PRECAUTIONS:

Midsone-SF Ointment is recommended for external use only. Midsone-SF Ointment  should not be used on irritated skin, on any area that is infected or reddened. Also not recommended  for diabetics, or those with poor blood circulation. Midsone-SF Ointment should not be used on moles, birth marks, warts with hair growing from them, genital warts, or warts on the face or mucous membranes. Do not permit Midsone-SF Ointment to contact eyes (eyelids or skin near the eyes) or mucous membranes. If contact with eyes or mucous membranes occurs, immediately flush with water.

Adverse Reactions
A localized irritant reaction may occur.
Storage Instructions
Store in a cool, dry, dark place