HYDROCORTISONE enema

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)

Available from:

ANI Pharmaceuticals, Inc.

INN (International Name):

HYDROCORTISONE

Composition:

HYDROCORTISONE 100 mg in 60 mL

Administration route:

RECTAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

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.]

Authorization status:

New Drug Application Authorized Generic

Patient Information leaflet

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.

Summary of Product characteristics

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