Country: Bandaríkin
Tungumál: enska
Heimild: NLM (National Library of Medicine)
Hydrocortisone Acetate (UNII: 3X7931PO74) (Hydrocortisone - UNII:WI4X0X7BPJ), Pramoxine Hydrochloride (UNII: 88AYB867L5) (Pramoxine - UNII:068X84E056)
Pageview Pharmaceuticals
RECTAL
PRESCRIPTION DRUG
Hydrocortisone acetate and pramoxine hydrochloride suppositories are indicated for use in inflamed hemorrhoids, post-irradiation (factitial) proctitis; as an adjunct in the treatment of chronic ulcerative colitis; cryptitis; and other inflammatory conditions of anorectum and pruritus ani. Hydrocortisone acetate and pramoxine hydrochloride suppositories are contraindicated in those patients having a history of hypersensitivity to hydrocortisone acetate or any of the components. Drug abuse and dependence have not been reported in patients treated with hydrocortisone acetate suppositories. If signs and symptoms of systemic overdosage occur, discontinue use.
Hydrocortisone acetate 25mg and Pramoxine Hydrochloride 18 mg Suppositories are off-white, smooth surfaced and bullet shaped with one pointed end. Box of 12 suppositories, NDC 73028-401-12 Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Excursions permitted to 15°-30°C (59°-86°F). Store away from heat. Protect from freezing. Avoid contact with eyes. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately. PHARMACIST: This product is not an Orange Book rated product, therefore all prescriptions using this product shall be subject to state and federal statutes as applicable. This product has not been subjected to FDA therapeutic or other equivalency testing. There are no claims of bioequivalence or therapeutic equivalence. Each person recommending a prescription substitution using this product shall make such recommendation based on his/her professional knowledge and opinion, upon evaluating the active ingredients, inactive ingredients, excipients and chemical information contained within the enclosed prescribing information.
unapproved drug other
HYDROCORTISONE ACETATE PRAMOXINE HYDROCHLORIDE- HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE SUPPOSITORY PAGEVIEW PHARMACEUTICALS _Disclaimer: This drug has not been found by FDA to be safe and effective, and this_ _labeling has not been approved by FDA. For further information about unapproved_ _drugs, click here._ ---------- HYDROCORTISONE ACETATE 25 MG AND PRAMOXINE HYDROCHLORIDE 18 MG SUPPOSITORIES For Rectal Administration Rx Only DESCRIPTION Hydrocortisone acetate is a corticosteroid designed chemically as pregn-4-ene 3, 20- dione, 21-(acetyloxy)-11, 17-dihydroxy–(11b) with the following structural formula: Pramoxine Hydrochloride is a topical anesthetic agent designed chemically as 4-(3- (butoxyphenoxy)propyl)morpholine hydrochoride with the following structural formula: Each suppository for rectal administration contains hydrocortisone acetate, USP 25 mg and pramoxine hydrochloride, USP 18 mg in a specially blended hydrogenated vegetable base. CLINICAL PHARMACOLOGY In normal subjects, about 26% of hydrocortisone acetate is absorbed when the suppository is applied to the rectum. Absorption of hydrocortisone acetate may vary across abraded or inflamed surfaces. Topical steroids are primarily effective because of their anti-inflammatory, anti-pruritic and vasoconstrictive action. Pramoxine hydrochloride is a topical anesthetic agent which provides temporary relief from itching and pain. It acts by stabilizing the neuronal membrane of nerve endings with which it comes into contact. INDICATIONS AND USAGE Hydrocortisone acetate and pramoxine hydrochloride suppositories are indicated for use in inflamed hemorrhoids, post-irradiation (factitial) proctitis; as an adjunct in the treatment of chronic ulcerative colitis; cryptitis; and other inflammatory conditions of anorectum and pruritus ani. CONTRAINDICATIONS Hydrocortisone acetate and pramoxine hydrochloride suppositories are contraindicated in those patients having a history of hypersensitivity to hydrocortisone acetate or any of the components. PRECAUT Lestu allt skjalið