Pramosone (hydrocortisone acetate/pramoxine HCl)

For self-medication for the temporary relief of pain and itching associated with lip or skin irritations in adults and children 2 years of age and older, pramoxine hydrochloride 1% gel, lotion, ointment, or solution is applied topically to the affected area up to 3 or 4 times daily. For use in children younger than 2 years of age, a pediatrician should be consulted.

For self-medication for the temporary relief of pain, soreness, burning, itching, or discomfort caused by hemorrhoids or other anorectal disorders in adults and children 12 years of age and older, pramoxine hydrochloride 1% aerosol foam, cream, ointment, or pledget is applied topically to the affected area up to 4 or 5 times daily or after each bowel movement. The manufacturers state that this dosage should not be exceeded unless directed by a clinician. For use in children younger than 12 years of age, a clinician should be consulted.

For self-medication for the management of anogenital pruritus, pramoxine hydrochloride 1% pledget is applied to the external vaginal area up to 3-4 times daily. For use in children younger than 12 years of age, a clinician should be consulted.

Hydrocortisone and its acetate, buteprate, butyrate, and valerate esters are applied topically. Dermatologic preparations of the drugs are applied 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 externally to the anal area. Some commercially available creams may be applied externally to the anogenital areas. Nonprescription preparations of 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.

Preparations containing pramoxine hydrochloride are applied topically. These preparations may be applied to the lip in the form of an ointment (''lip balm''); to the skin in the form of a gel, lotion, ointment, or solution; to the external vaginal area in the form of pledgets (pads); or to the external anorectal area in the form of an aerosol foam, cream, ointment, or pledgets.

The lotion containing pramoxine hydrochloride should be shaken well prior to use. The aerosol foam should be shaken well and dispersed onto a clean tissue before applying to the affected area. Pledgets should be applied gently by patting or wiping the affected area; pledgets should be used only once and then discarded.

Patients receiving pramoxine-containing preparations for the management of hemorrhoids or other anorectal disorders should be advised to cleanse the affected perianal area with mild soap and warm water and rinsing thoroughly whenever practical; the area then should be dried by patting or blotting with toilet tissue or a soft cloth before application of the drug.

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.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

There is no enhanced messaging for this drug.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

No enhanced messaging available.

No enhanced messaging available.

Women who are pregnant should consult a clinician before initiating therapy with pramoxine-containing preparations.

Women who are breast-feeding should consult a clinician before initiating therapy with pramoxine-containing preparations.

No enhanced messaging available.