Vytone

Drug overview for VYTONE (hydrocortisone acetate/iodoquinol/aloe vera):

Generic name: hydrocortisone acetate/iodoquinol/aloe vera (HYE-droe-KOR-ti-sone/eye-oh-doh-KWIN-ohl)
Drug class: Topical Corticosteroids
Therapeutic class: Dermatological

Hydrocortisone is a corticosteroid secreted by the adrenal cortex. Iodoquinol is a halogenated 8-hydroxyquinoline anti-infective agent.

Although iodoquinol, in a suitable dermatologic vehicle alone or in Hydrocortisone and its acetate, buteprate, butyrate, and valerate esters combination with coal tar, has been used topically in the treatment of share the actions of other topical corticosteroids and are used for the bacterial and fungal infections of the skin, the drug principally is used relief of inflammatory manifestations of corticosteroid-responsive dermatoses, including dermatoses of the anogenital areas. Nonprescription in combination with hydrocortisone for the topical treatment of subacute and chronic dermatoses. There is a lack of substantial evidence that these preparations containing 0.5%

hydrocortisone or hydrocortisone acetate are topical preparations containing iodoquinol are effective for their used for the temporary relief of minor skin irritations, itching, and purported uses. Although iodoquinol previously was used in the treatment of rashes caused by eczema, dermatitis, insect bites, poison ivy, poison oak, diaper rash (diaper dermatitis), use of the drug in children currently is poison sumac, soaps, detergents, cosmetics, or jewelry; for temporary not recommended. (See Cautions.) relief of itchy anal and/or genital areas; and for temporary relief of itching and minor scalp irritation caused by scalp dermatitis.

Hydrocortisone acetate also is used as a paste for adjunctive treatment to Iodoquinol also has been used as a shampoo (no longer commercially available in the US) for the control of seborrheic dermatitis of the scalp. provide temporary relief of symptoms associated with oral inflammatory or However, relapse usually occurs when the medication is discontinued. ulcerative lesions resulting from trauma.

For the use of iodoquinol in intestinal amebiasis and other conditions, see Hydrocortisone also is administered rectally as a retention enema for the 8:30.04 adjunctive treatment of mild or moderate acute ulcerative colitis limited to the rectosigmoid or left colon and, to a lesser extent, in some patients with mild ulcerative colitis of the transverse or descending colon. Hydrocortisone acetate is administered rectally as a suppository or an aerosol foam suspension for the adjunctive treatment of ulcerative colitis of the rectum.

As rectal suppositories, hydrocortisone acetate is used in the treatment of other inflammatory conditions of the anorectum (e.g., inflamed hemorrhoids, postirradiation or factitial proctitis, cryptitis, pruritus ani).

DRUG IMAGES

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The following indications for VYTONE (hydrocortisone acetate/iodoquinol/aloe vera) have been approved by the FDA:

Indications:
None.

Professional Synonyms:
None.

The following dosing information is available for VYTONE (hydrocortisone acetate/iodoquinol/aloe vera):

Dosing
Administration
Dosing Information
Generic

Hydrocortisone and its acetate, buteprate, butyrate, and valerate esters Iodoquinol is applied topically to the skin; contact with the eyes should are applied topically. Dermatologic preparations of the drugs are applied be avoided.

sparingly in thin films and are rubbed gently into the affected area 1-4 times daily. Rectal creams and ointments of the drugs are applied When iodoquinol is used in combination with hydrocortisone for the externally to the anal area. Some commercially available creams may be treatment of subacute and chronic dermatoses, a cream containing iodoquinol 3% is applied topically to the affected area of skin 3 or 4 times daily as applied externally to the anogenital areas.

Nonprescription preparations of directed. the drugs should not be used for self-medication for longer than 7 days; if

the condition worsens or symptoms persist, the drug should be discontinued and a physician consulted. Nonprescription preparations of the drugs should not be used in children younger than 2 years of age unless directed and supervised by a physician.

For dermatoses of the scalp, the hair may be parted and a small amount of lotion applied directly to the affected area and rubbed gently into the scalp. Usual hair care should be maintained, but the lotion should not be washed out immediately after application. Alternatively, for dermatoses of the scalp, hydrocortisone aerosol is applied to the dry scalp after shampooing.

When the aerosol is used for other dermatoses, each 10-cm2 of affected area is sprayed for 1-2 seconds from a distance of about 15 cm 2 or 3 times daily.

Occlusive dressings may be used for severe or resistant dermatoses.

For use in the mouth, a small amount of 0.5% hydrocortisone acetate paste is pressed to the lesion without rubbing until a thin film develops. The paste is applied 2 or 3 times daily after meals and at bedtime.

If substantial regeneration or repair of the oral tissues does not occur after 7 days of treatment, further investigation of the etiology of the oral lesions should be undertaken.

Hydrocortisone is administered rectally as a retention enema, and hydrocortisone acetate is given rectally as a suppository or an aerosol foam suspension according to the manufacturers' instructions. Patients should be advised that hydrocortisone acetate suppositories may stain fabric so that they can take appropriate precautionary measures. For the adjunctive treatment of ulcerative colitis, 100 mg of hydrocortisone is administered nightly as a retention enema.

The patient should lie on his left side during and for 30 minutes after administration of the retention enema so that the drug will distribute throughout the left colon; the enema should be retained for at least 1 hour and preferably all night. Some clinicians administer 100 mg as a retention enema twice daily followed by 100 mg nightly when improvement occurs. The drug is usually given for 21 days or until clinical and proctologic remissions are achieved.

Clinical symptoms may improve in 3-5 days, followed by proctologic improvement; in some cases, 2-3 months of therapy may be required to attain a proctologic remission. Therapy with hydrocortisone retention enema should be discontinued if clinical or proctologic improvement does not occur within 2-3 weeks. Following treatment for longer than 21 days, therapy with hydrocortisone enema should be withdrawn gradually by giving the drug every other night for 2-3 weeks and then discontinuing it.

In patients with ulcerative proctitis of the distal rectum who cannot retain corticosteroid enemas, 90 mg of hydrocortisone acetate (1 applicatorful of a 10% aerosol foam suspension) may be given rectally 1 or 2 times daily for 2-3 weeks and then, if necessary, every other day until clinical and proctologic improvements occur; symptoms may improve within 5-7 days. For the adjunctive treatment of ulcerative colitis of the rectum and other inflammatory conditions of the anorectum, 25 mg of hydrocortisone acetate as a suppository may be administered rectally in the morning and at night for 2 weeks; in severe proctitis, 25 mg may be given 3 times daily or 50 mg may be given twice daily. For the adjunctive treatment of postirradiation or factitial proctitis, therapy is generally continued for 6-8 weeks or less if an adequate response is attained. Alternatively, for the symptomatic treatment of internal hemorrhoids and the adjunctive treatment of other inflammatory conditions of the anorectum, 10 mg of hydrocortisone acetate as a suppository may be administered rectally in the morning and at night for 2-6 days.

No enhanced Administration information available for this drug.

No dosing information available.

No generic dosing information available.

Moderate List
Hypothalamic-pituitary insufficiency

The following adverse reaction information is available for VYTONE (hydrocortisone acetate/iodoquinol/aloe vera):

Overview
Severe
Less Severe

Adverse reaction overview.

No enhanced Common Adverse Effects information available for this drug.

There are 15 severe adverse reactions.

More Frequent	Less Frequent
None.	Folliculitis Purpura Skin and skin structure infection Skin atrophy

Rare/Very Rare
Adrenocortical insufficiency Bullous dermatitis Cataracts Central serous chorioretinopathy Glaucoma Hypothalamic-pituitary insufficiency Ocular hypertension Skin hypopigmentation Skin striae Skin ulcer Urticaria

There are 25 less severe adverse reactions.

More Frequent	Less Frequent
Erythema Stinging of skin	Acute pain at drug application site Blurred vision Headache disorder Paresthesia Pruritus of skin Skin irritation Skin rash Telangiectasia Treatment site sequelae

Rare/Very Rare
Acneiform eruption Alopecia Blistering skin Contact dermatitis Dry skin Dyschromia Glycosuria Hirsutism Hypercortisolism Hyperesthesia Hyperglycemia Miliaria Perioral dermatitis Skin irritation

The following precautions are available for VYTONE (hydrocortisone acetate/iodoquinol/aloe vera):

Pediatric
Pregnant
Lactation
Geriatric

No enhanced Pediatric Use information available for this drug.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None

No enhanced Pregnancy information available for this drug.

No enhanced Lactation information available for this drug.

No enhanced Geriatric Use information available for this drug.