Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)
ANI Pharmaceuticals, Inc.
HYDROCORTISONE
HYDROCORTISONE 100 mg in 60 mL
RECTAL
PRESCRIPTION DRUG
Hydrocortisone Rectal Suspension, USP is indicated as adjunctive therapy in the treatment of ulcerative colitis, especially distal forms, including ulcerative proctitis, ulcerative proctosigmoiditis, and left-sided ulcerative colitis. It has proved useful also in some cases involving the transverse and ascending colons. Systemic fungal infections; and ileocolostomy during the immediate or early post-operative period.
Hydrocortisone Rectal Suspension, USP (Retention)100 mg is supplied as disposable single-dose bottles with lubricated rectal applicator tips, in boxes of seven x 60 mL (NDC 62559-138-07) and boxes of one x 60 mL (NDC 62559-138-11). Store at controlled room temperature 20° - 25°C (68° - 77°F). [See USP Controlled Room Temperature.]
New Drug Application Authorized Generic
ANI Pharmaceuticals, Inc. ---------- PATIENT INSTRUCTIONS How to use the retention enema: Best results are achieved if the bowel is emptied immediately before the enema is given. 1. Preparing the Medication for Administration a Shake the bottle well to make sure that the suspension is homogeneous. b Remove the protective sheath from the applicator tip. Hold the bottle at the neck so as not to cause any of the medication to be discharged. 2. Assuming the Correct Body Position a Best results are obtained by lying on left side with the left leg extended and the right leg flexed forward for balance. b An alternative to lying on the left side is the “knee-chest” position as shown here. 3. Administering the Retention Enema a Gently insert the lubricated applicator tip into the rectum, pointed slightly toward the navel (umbilicus). b Grasp the bottle firmly, then tilt slightly so that the nozzle is aimed toward the back, and squeeze slowly to instill the medication. Steady hand pressure will discharge most of the solution. After administering, withdraw and discard the used unit. c Remain in position for at least 30 minutes to allow thorough distribution of the medication internally. Retain the enema all night, if possible. Manufactured by ANI Pharmaceuticals, Inc. Baudette, MN 56623 9247 Rev 11/11 Revised: 11/2018 Document Id: 73c5cf01-64d5-4ff5-a216-7df62ca45b3b 34391-3 Set id: 40654d12-56e4-4489-be49-19c60ad918ad Version: 4 Effective Time: 20181127 ANI Pharmaceuticals, Inc. Les hele dokumentet
HYDROCORTISONE- HYDROCORTISONE ENEMA ANI PHARMACEUTICALS, INC. ---------- HYDROCORTISONE RECTAL SUSPENSION, USP (RETENTION) 100 MG / 60 ML DISPOSABLE UNIT FOR RECTAL USE ONLY DESCRIPTION Hydrocortisone is a white to practically white, odorless, crystalline powder, very slightly soluble in water. It has the chemical name Pregn-4-ene-3,20-dione,11,17,21-trihydroxy-,(11β)- and the following structural formula: Hydrocortisone Rectal Suspension, USP is a convenient disposable single-dose hydrocortisone enema designed for ease of self-administration. Each disposable unit (60 mL) contains: Hydrocortisone, 100 mg in an aqueous solution containing carbomer 934P, polysorbate 80, purified water, sodium hydroxide and methylparaben, 0.18% as a preservative. CLINICAL PHARMACOLOGY Hydrocortisone is a naturally occurring glucocorticoid (adrenal corticosteroid) similar to its acetate and sodium hemisuccinate derivatives, is partially absorbed following rectal administration. Absorption studies in ulcerative colitis patients have shown up to 50% absorption of hydrocortisone administered as Hydrocortisone Rectal Suspension, USP and up to 30% of hydrocortisone acetate administered in an identical vehicle. Hydrocortisone Rectal Suspension, USP provides the potent anti-inflammatory effect of hydrocortisone. Because this drug is absorbed from the colon, it acts both topically and systemically. Although rectal hydrocortisone, used as recommended for Hydrocortisone Rectal Suspension, USP, has a low incidence of reported adverse reactions, prolonged use presumably may cause systemic reactions associated with oral dosage forms. INDICATIONS AND USAGE Hydrocortisone Rectal Suspension, USP is indicated as adjunctive therapy in the treatment of ulcerative colitis, especially distal forms, including ulcerative proctitis, ulcerative proctosigmoiditis, and left- sided ulcerative colitis. It has proved useful also in some cases involving the transverse and ascending colons. CONTRAINDICATIONS Systemic fungal infections; and ileocolostomy during th Les hele dokumentet