Hevona (minoxidil/fluocinolone acetonide/tretinoin)

Excessive application of tretinoin does not increase the therapeutic effects of the drug and may produce marked inflammatory reactions, including peeling and discomfort.

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.

Fluocinolone acetonide shampoo should be prepared by a pharmacist at the time of dispensing the shampoo; contents of the 12-mg capsule should be mixed with the shampoo base supplied by the manufacturer. The extemporaneously prepared shampoo is stable for 3 months from the time of compounding. The extemporaneously prepared shampoo must be shaken well prior to administration.

Topical fluocinolone acetonide or fluocinonide cream, gel, ointment, and solution are applied sparingly in thin films and rubbed gently into the skin 2-4 times daily depending on the severity of the condition. Occlusive dressings may be used for severe or resistant dermatoses.

For the treatment of atopic dermatitis in adults, fluocinolone acetonide 0.01% topical oil is applied as a thin film 3 times daily.

For the treatment of moderate to severe atopic dermatitis in children 2 years of age or older, a thin film of fluocinolone acetonide 0.01% topical oil may be applied twice daily to affected areas for no longer than 4 weeks. The topical oil should not be applied to the face or diaper area. Application to intertriginous areas also should be avoided because of an increased risk of developing potentially irreversible adverse local effects (e.g., striae, atrophy, telangiectasia).

For the treatment of seborrheic dermatitis of the scalp in adults, no more than 30 mL of fluocinolone acetonide 0.01% shampoo is applied to the scalp once daily, lathered, and allowed to remain on the scalp for about 5 minutes. The hair and scalp are then rinsed thoroughly with water. Fluocinolone acetonide shampoo should not be used with occlusive dressings and patients should be warned that treated areas of the scalp should not be bandaged or otherwise covered or wrapped as to be occlusive, unless directed by a clinician.

For the treatment of psoriasis of the scalp in adults, a thin film of fluocinolone acetonide 0.01% topical oil should be applied to wet or dampened hair and scalp, massaged well, and covered with the manufacturer-supplied shower cap. The oil should be allowed to remain on the scalp overnight or for a minimum of 4 hours following application before being washed off with regular shampoo and rinsed thoroughly with water.

Tretinoin is applied topically to the skin as a cream, gel, or solution. Patients should be instructed carefully in proper use of the drug, including associated precautions. (See Cautions: Precautions and Contraindications and also Drug Interactions.)

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.

Concomitant use of tretinoin with other topical medications (especially those containing keratolytic agents such as sulfur, resorcinol, benzoyl peroxide, or salicylic acid) should be undertaken with caution because of the possibility of interactions. In patients who have used keratolytic agents, sufficient time should elapse for the effects of these drugs to subside before initiating tretinoin therapy. Patients receiving tretinoin therapy should not wash their faces more frequently than 2 or 3 times daily, using a mild, bland soap. Medicated or drying soaps and abrasive soaps and cleansers generally should not be used. Use of topical preparations with high concentrations of alcohol, menthol, spices, or lime such as shaving lotions, astringents, and perfume should be avoided, since they may cause stinging of treated skin, especially during initial therapy. Patients also should avoid the use of irritating cosmetics (e.g., toners, peeling (desquamating) agents), permanent wave solutions, electrolysis, or hair depilatories during topical tretinoin therapy. Non-medicated cosmetics may be used by patients receiving tretinoin therapy, but the areas to be treated should be cleansed thoroughly before tretinoin is applied; medicated cosmetics should not be used.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

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• Dermatosis of the scalp

• Bacterial skin and skin structure infection
• Eczema
• Sunburn

• 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
• Blistering skin
• 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

• Abnormal desquamation
• Dry skin
• Erythema
• Erythema
• Pruritus of skin
• Skin inflammation
• Skin irritation
• Skin photosensitivity
• Stinging of skin

Less Frequent

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

Rare or Very Rare

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

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No enhanced messaging available.

Retinoids (e.g., isotretinoin) have been reported to cause serious fetal harm when administered to pregnant women. (See Cautions: Pregnancy, Fertility, and Lactation, in Isotretinoin 84:36.) Oral tretinoin has been shown to be teratogenic in rats, mice, rabbits, hamsters, and subhuman primates. Tretinoin was teratogenic in Wistar rats when given orally or topically in dosages exceeding 1 mg/kg daily (8 times the maximum human systemic dosage normalized for total body surface area). In the cynomolgus monkey, which metabolically is closer to humans for tretinoin than other species examined, fetal malformations were reported at oral dosages of 10 mg/kg daily or greater, but none were observed at 5 mg/kg daily (83 times the maximum human systemic dosage normalized for total body surface area), although increased skeletal variations were observed at all dosages. Dose-related increased embryolethality and abortion also were reported. Similar results also have been reported in pigtail macaques.

Topical tretinoin in animal teratogenicity tests has generated equivocal results. There is evidence for teratogenicity (shortened or kinked tail) of topical tretinoin in Wistar rats at dosages exceeding 1 mg/kg daily (8 times the maximum human systemic dosage normalized for total body surface area). Bone anomalies (short (13%) or bent (6%) humerus, incompletely ossified os parietal (14%)) also have been reported in rats when tretinoin 10 mg/kg daily was applied dermally. Topical tretinoin cream was associated with an increased incidence of cleft palate and hydrocephaly in rabbits when administered in a dosage 91 times the topical human dosage (based on topical application of 1 g of 0.1% tretinoin cream in a 50-kg adult). In New Zealand white rabbits treated with topical tretinoin at dosages 80 times the recommended human topical clinical dosage, an increased incidence of domed head and hydrocephaly was noted in some of the fetuses, typical of retinoid-induced fetal malformations in this species; no abnormalities were observed at dosages 3 times the maximum human systemic dosage of tretinoin after topical administration of 0.1% tretinoin gel (microsphere formulation), normalized for total body surface area. In addition, topical tretinoin in formulations other than the gel (microsphere formulation) was not teratogenic when given in dosages of 42 or 27 times the maximum human systemic topical dosage in rats or rabbits, respectively. However, delayed ossification of several bones, occurred in rabbits and a dose-dependent incease in supernumerary ribs was observed in rats at these topical dosages.

Oral tretinoin was fetotoxic in rats at dosages 21 times the maximum human systemic dosage normalized for total body surface area, resulting in skeletal variations and increased intrauterine death in rats. Topical tretinoin has been shown to be fetotoxic in rabbits when administered in dosages 8 times the maximum human systemic dosage applied topically and normalized for total body surface area), resulting in fetal resorption and variations in ossification.

When given subcutaneously to rabbits, tretinoin was teratogenic at a dosage of 2 mg/kg daily but not at 1 mg/kg daily. These dosages are approximately 400 and 200 times, respectively, the human topical dosage of tretinoin cream (based on topical application of 1 g of 0.025% tretinoin cream in a 50-kg adult).

With widespread use of any drug, a small number of birth defect reports associated with the administration of the drug would be expected by chance alone. During 2 decades of clinical use of one formulation of topical tretinoin (Retin-A(R)), 30 cases of temporally associated congenital malformations have been reported. Although no definite pattern of teratogenicity and no causal associations have been established from these cases, 5 of the reports described the rare birth defect category holoprosencephaly (defects associated with incomplete midline development of the forebrain). The relevance of these spontaneous reports in terms of risk to the fetus is unknown.

To date, there have been no adequate and well-controlled studies performed in pregnant women, and the teratogenic blood level of tretinoin is not known. The manufacturer of some topical tretinoin preparations (e.g., Retin-A(R)) state that topical tretinoin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, while manufacturers of other tretinoin formulations (e.g., Avita(R) cream, Renova(R) emollient cream) state that these products should not be used during pregnancy.

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.

It is not known whether topically applied tretinoin is excreted in human milk. Caution should be exercised when topical tretinoin is administered to a nursing woman.

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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