Oxopid (minoxidil/betamethasone dipropionate)

When the dropper applicator is used as directed, the applicator delivers 1 mL of minoxidil topical solution (20 or 50 mg of minoxidil in the 2 or 5% solution, respectively). When the metered-spray or extender-spray applicator is used, delivery of a 1-mL dose requires pumping the spray attachment 6 times (i.e., with approximately 3.3 or 8.3 mg of drug per metered spray with the 2 or 5% solution, respectively). When used as directed, each bottle of minoxidil topical solution should last 25-30 days provided substantial amounts of solution are not lost during applicator changes.

Betamethasone dipropionate and valerate are applied topically. Betamethasone dipropionate preparations and betamethasone valerate preparations should not be used with occlusive dressings and patients should be warned that treated areas of the skin should not be bandaged or otherwise covered or wrapped as to be occlusive, unless directed by a clinician.

Concentrations of the dipropionate and valerate preparations usually are expressed in terms of betamethasone. Concentration of betamethasone valerate foam is expressed in terms of betamethasone valerate.

Topical preparations of betamethasone dipropionate usually are applied sparingly in thin films and are rubbed gently into the affected area once or twice daily. Because betamethasone dipropionate preparations formulated in an optimized (augmented) vehicle are among the most potent topical corticosteroid preparations currently available, the manufacturers state that dosage of betamethasone dipropionate 0.05% ointments, creams, gels, or lotions in optimized (augmented) vehicles should not exceed 45 g, 45 g, 50 g, or 50 mL per week, respectively. Some manufacturers also state that duration of therapy with these optimized preparations should not exceed 2 weeks.

Topical betamethasone 0.1% creams and ointments (as valerate) usually are applied sparingly in thin films and are rubbed gently into the affected area 1-3 times daily. However, once- or twice-daily administration of these preparations often is effective. Topical betamethasone valerate 0.1% solutions are applied sparingly (e.g., a few drops) and are rubbed gently into the affected area twice daily, in the morning and evening. Dosage of the topical solution may be increased in patients with resistant dermatoses. However, dosing frequency should be decreased to once daily following clinical improvement.

For relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the scalp, betamethasone valerate 0.12% foam should be applied twice daily, in the morning and evening. For application to the scalp, the can containing betamethasone valerate foam should be inverted and small amounts of the preparation placed on a saucer or other cool surface. The foam should not be dispensed directly to the hands since the foam will begin to melt immediately upon contact with warm skin. Small amounts of the preparation should be massaged gently into the scalp until the foam disappears and entire scalp area has been treated.

For the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, or tinea corporis caused by Trichophyton mentagrophytes, T. rubrum, or Epidermophyton floccosum, the fixed-combination cream or lotion containing betamethasone 0.05% and clotrimazole 1% should be applied sparingly and rubbed gently into the affected area twice daily, in the morning and evening. If clinical improvement does not occur after 1 week in the treatment of tinea cruris or tinea corporis or after 2 weeks in the treatment of tinea pedis, the diagnosis should be reevaluated. The manufacturer states that dosage of the combination cream or lotion should not exceed 45 g or 45 mL per week, respectively, and duration of therapy with these combination preparations should not exceed 2 weeks in the treatment of tinea cruris or tinea corporis or 4 weeks in the treatment of tinea pedis. Occlusive dressings should not be used with these combination preparations.

For the topical treatment of plaque psoriasis (psoriasis vulgaris) in adults 18 years of age or older, the fixed-combination ointment containing betamethasone 0.05% and calcipotriene 0.005% should be applied and rubbed gently into the affected area until absorbed once daily. The combination ointment should not be applied to greater than 30% of body surface area. The manufacturer states that dosage of the combination ointment should not exceed 100 g per week, and duration of therapy should not exceed 4 consecutive weeks. Occlusive dressings should not be used with the combination preparation, unless directed by a clinician. The fixed-combination ointment should not be applied to the face, axillae, or groin area. The fixed-combination ointment should not be used in patients with erythrodermic, exfoliative, or pustular psoriasis or in patients with preexisting atrophy at the treatment site. Contact with the eyes should be avoided. If irritation occurs, therapy with the fixed-combination ointment should be discontinued and appropriate treatment instituted. Patients should wash their hands after applying the drug. The fixed-combination ointment is not for ophthalmic, oral, or intravaginal use.

For the topical treatment of moderate to severe plaque psoriasis (psoriasis vulgaris) of the scalp in adults 18 years of age or older, the fixed-combination suspension containing betamethasone 0.05% and calcipotriene 0.005% should be applied to the affected area(s) on the scalp once daily for 2 weeks or until cleared. The manufacturer states that dosage of the combination suspension should not exceed 100 g per week, and duration of therapy should not exceed 8 weeks. Occlusive dressings should not be used with the combination preparation, unless directed by a clinician. The combination suspension should not be applied to the face, axillae, or groin area. In addition, the suspension should not be used in patients with erythrodermic, exfoliative, or pustular psoriasis or in patients with preexisting atrophy at the treatment site. Contact with the eyes should be avoided; eye irritation may occur. The bottle containing the suspension should be shaken prior to each use; patients should wash their hands after applying the drug. The fixed-combination suspension is not for ophthalmic, oral, or intravaginal use.

Because calcipotriene may increase the effect of ultraviolet radiation to induce skin tumors, patients who apply the fixed-combination ointment or suspension to exposed areas of the body should avoid exposure to natural or artificial (e.g., sunlamps, tanning booths) sunlight and limit or avoid phototherapy.

Minoxidil solution is applied topically to the scalp. Twice-daily application appears to be necessary for optimum results. Individuals receiving topical minoxidil therapy should be carefully instructed regarding proper use of the solution. To obtain optimum results, these individuals should be given a copy of the instructions provided by the manufacturers.

Topical minoxidil solution is applied to the total affected areas of the scalp using one of the applicators provided by the manufacturers (i.e., metered-spray applicator, extender spray applicator, dropper applicator). The manufacturers' patient information should be consulted for specific methods of application. Individuals being treated for androgenetic alopecia should be advised that because of the risk of adverse systemic effects, the topical preparation is intended for application to the scalp only and should not be applied to other areas of the body.

Prior to application of minoxidil topical solution, the hair and scalp should be dry. Individuals applying minoxidil topical solution with their fingertips should be instructed to wash their hands thoroughly afterward. When the metered-spray or extender-spray applicator is used, inhalation of the spray mist should be avoided.

No dosing information is available for this tab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

There is no enhanced messaging for this drug.

• Dermatosis of the scalp

• Bacterial skin and skin structure infection

• Hypothalamic-pituitary insufficiency

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Less Frequent

• Dermatitis due to topical drug
• Folliculitis
• Pruritus of skin
• Purpura
• Skin and skin structure infection
• Skin atrophy
• Skin rash
• Urticaria

Rare or Very Rare

• Abnormal sexual function
• Adrenocortical insufficiency
• Alopecia
• Angioedema
• Body fluid retention
• Bullous dermatitis
• Cardiac arrhythmia
• Cataracts
• Central serous chorioretinopathy
• Chest pain
• Dizziness
• Eczema
• Edema
• Folliculitis
• Glaucoma
• Growth failure
• Head sensation disturbance
• Headache disorder
• Hypotension
• Hypothalamic-pituitary insufficiency
• Intracranial hypertension
• Neuralgia
• Ocular hypertension
• Reduced visual acuity
• Skin hypopigmentation
• Skin striae
• Skin ulcer
• Tachycardia
• Urticaria
• Visual changes

More Frequent

• Erythema
• Stinging of skin

Less Frequent

• Acute pain at drug application site
• Blurred vision
• Dry skin
• Erythema
• Headache disorder
• Paresthesia
• Pruritus of skin
• Skin rash
• Telangiectasia
• Treatment site sequelae

Rare or Very Rare

• Acneiform eruption
• Alopecia
• Blistering skin
• Contact dermatitis
• Dry skin
• Dyschromia
• Glycosuria
• Hirsutism
• Hypercortisolism
• Hyperesthesia
• Hyperglycemia
• Miliaria
• Perioral dermatitis
• Skin irritation
• Vasodilation of blood vessels

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No enhanced messaging available.

Although there are no adequate and controlled studies to date in humans receiving oral or topical minoxidil, orally administered minoxidil has been associated with evidence of increased fetal resorption in rabbits, but not rats, when given at dosages 5 times the maximum recommended human oral antihypertensive dosage. There was no evidence of teratogenic effects of orally administered minoxidil in rats or rabbits. There was no evidence of teratogenic effects in rats receiving subcutaneous minoxidil dosages of 80 mg/kg daily (about 2000 times the maximal systemic human exposure achieved with daily administration of topical minoxidil); however, maternal toxicity was observed with this dosage. Evidence of developmental toxicity was observed in rats receiving subcutaneous dosages exceeding 80 mg/kg daily. For additional information on the potential risks of oral minoxidil therapy during pregnancy, see Cautions: Pregnancy, Fertility, and Lactation, in Minoxidil 24:08.20. The effects of the drug on labor and delivery are not known.

Minoxidil is distributed into milk after oral administration. Because of the potential for serious adverse effects in nursing infants if topically applied drug were absorbed percutaneously and distributed into breast milk, the manufacturer recommends that minoxidil topical solution not be administered to nursing women.

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