Cortifoam (Page 3 of 3)

OVERDOSAGE

Treatment of acute overdosage is by supportive and symptomatic therapy. For chronic overdosage in the face of severe disease requiring continuous steroid therapy, the dosage of the corticosteroid may be reduced only temporarily, or alternate day treatment may be introduced.

DOSAGE AND ADMINISTRATION

The usual dose is one applicatorful once or twice daily for two or three weeks, and every second day thereafter, administered rectally. Directions for use, below and on the carton, describe how to use the aerosol container and applicator. Satisfactory response usually occurs within five to seven days marked by a decrease in symptoms. Symptomatic improvement in ulcerative proctitis should not be used as the sole criterion for evaluating efficacy. Sigmoidoscopy is also recommended to judge dosage adjustment, duration of therapy, and rate of improvement.

It Should Be Emphasized that Dosage Requirements are Variable and Must Be Individualized on the Basis of the Disease Under Treatment and the Response of the Patient. After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. Situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient’s individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment. In this latter situation it may be necessary to increase the dosage of the corticosteroid for a period of time consistent with the patient’s condition. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.

Directions For Use

(1) Shake foam container vigorously for 5-10 seconds before each use. Do not remove container cap during use of the product.

(2) Hold container upright on a level surface and gently place the tip of the applicator onto the nose of the container cap. CONTAINER MUST BE HELD UPRIGHT TO OBTAIN PROPER FLOW OF MEDICATION.

(3) Pull plunger past the fill line on the applicator barrel.

(4) To fill applicator barrel, press down firmly on cap flanges, hold for 1 – 2 seconds and release. Pause 5 – 10 seconds to allow foam to expand in applicator barrel. Repeat until foam reaches fill line. Remove applicator from container cap. Allow some foam to remain on the applicator tip. A burst of air may come out of container with first pump.

(5) Hold applicator firmly by barrel, making sure thumb and middle finger are positioned securely underneath and resting against barrel wings. Place index finger over the plunger. Gently insert tip into anus. Once in place, push plunger to expel foam, then withdraw applicator.

CAUTION: Do not insert any part of the aerosol container directly into the anus. Apply to anus only with enclosed applicator.

(6) After each use, applicator parts should be pulled apart for thorough cleaning with warm water. The container cap and underlying tip should also be pulled apart and rinsed to help prevent build-up of foam and possible blockage.

HOW SUPPLIED

Cortifoam^® is supplied in an aerosol container with a special rectal applicator. Each applicator delivers approximately 900 mg of foam containing approximately 80 mg of hydrocortisone as 90 mg of hydrocortisone acetate. When used correctly, the aerosol container will deliver a minimum of 14 applications.

NDC 0037-6830-15 15 g

Store at controlled room temperature, 20°-25°C (68°-77°F).

DO NOT REFRIGERATE.

Rx only

Distributed by:
Meda Pharmaceuticals Inc.
Somerset, New Jersey 08873-4120

©2020 Mylan Specialty L.P.

For Medical Inquiries, call toll-free 1-877-848-6608

Cortifoam is a registered trademark of Alaven Pharmaceutical LLC, a Mylan company.

IN-683015-04
141153-0720

PRINCIPAL DISPLAY PANEL — 15 g Label

NDC 0037-6830-15

cortifoam^®
(hydrocortisone acetate 10%)

rectal foam

Rx Only

15 g net wt

DIRECTIONS FOR USE

APPLICATOR		FOAM CONTAINER
1 Shake foam container vigorously for 5 — 10 seconds before each use. Do not remove container cap during use of the product.		2 Hold container upright on a level surface and gently place the tip of the applicator onto the nose of the container cap.
		CONTAINER MUST BE HELD UPRIGHT TO OBTAIN PROPER FLOW OF MEDICATION.
3 Pull plunger past the fill line on the applicator barrel.
4 To fill applicator barrel, press down firmly on cap flanges, hold for 1 – 2 seconds and release. Pause 5 — 10 seconds to allow foam to expand in applicator barrel. Repeat until foam reaches fill line. Remove applicator from container cap. Allow some foam to remain on the applicator tip. A burst of air may come out of container with first pump.
5 Hold applicator firmly by barrel, making sure thumb and middle finger are positioned securely underneath and resting against barrel wings. place index finger over the plunger. Gently insert tip into anus. Once in place, push plunger to expel foam, then withdraw applicator.
6 After each use, applicator parts should be pulled apart for thorough cleaning with warm water. The container cap and underlying tip should also be pulled apart and rinsed to help prevent buildup of foam and possible blockage.

Description: cortifoam^® (hydrocortisone acetate) 10% rectal foam contains hydrocortisone acetate 10% in a base containing propylene glycol, emulsifying wax, polyoxyethylene-10-stearyl ether, cetyl alcohol, methylparaben, propyl-paraben, trolamine, purified water and inert propellants: isobutane and propane.

Dosage: One applicatorful once or twice daily for two or three weeks, and every second day thereafter, administered rectally. See back of carton for full directions for use.

Please see package insert for further information. For rectal use only.

117610-0820 UC-683015-04

Caution: Do not insert any part of the aerosol container directly into the anus. Apply to anus only with the enclosed applicator.

WARNINGS: Contents of the container are under pressure. Do not burn or puncture the aerosol container. Do not store at temperatures above 120°F (49°C).

KEEP OUT OF REACH OF CHILDREN.

Store upright at controlled room temperature 20° — 25°C (68° — 77°F).

DO NOT REFRIGERATE

Distributed by: Meda Pharmaceuticals Inc., Somerset, New Jersey 08873-4120

©2020 Mylan Specialty L.P.

Cortifoam is a registered trademark of Alaven Pharmaceutical LLC, a Mylan company.

CORTIFOAM hydrocortisone acetate aerosol, foam

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0037-6830 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE ACETATE (HYDROCORTISONE) HYDROCORTISONE ACETATE 1500 mg in 15 g

Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL ETHYLENE DISTEARAMIDE STEARETH-10 CETYL ALCOHOL METHYLPARABEN PROPYLPARABEN TROLAMINE WATER ISOBUTANE PROPANE

Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0037-6830-15 1 CANISTER in 1 CARTON contains a CANISTER 1 15 g in 1 CANISTER This package is contained within the CARTON (0037-6830-15)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA017351 06/15/2015

Labeler — Meda Pharmaceuticals Inc. (051229602)

Revised: 08/2020 Meda Pharmaceuticals Inc.