Cortenema

• ANI Pharmaceuticals, Inc.

• ANIP Acquisition Company

• Solvay Pharmaceuticals, Inc.

Hydrocortisone is a steroid medicine that reduces inflammation in the body.

The information in this medication guide is specific to hydrocortisone rectal foam or enema.

Hydrocortisone rectal is used to treat hemorrhoids and itching or swelling of the rectal area caused by hemorrhoids or other inflammatory conditions of the rectum or anus.

Hydrocortisone rectal is also used together with other medications to treat ulcerative colitis, proctitis, and other inflammatory conditions of the lower intestines and rectal area.

Hydrocortisone rectal may also be used for purposes not listed in this medication guide.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Burning.
• Pain.
• Rectal irritation.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• Store at room temperature. Do not freeze.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Cortenema or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Cortenema. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

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 Cortenema® and up to 30% of hydrocortisone acetate administered in an identical vehicle.

Cortenema® 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 Cortenema®, has a low incidence of reported adverse reactions, prolonged use presumably may cause systemic reactions associated with oral dosage forms.

Local pain or burning, and rectal bleeding attributed to Cortenema® have been reported rarely. Apparent exacerbations or sensitivity reactions also occur rarely. The following adverse reactions should be kept in mind whenever corticosteroids are given by rectal administration.
 

Fluid and Electrolyte Disturbances: Sodium retention; fluid retention; congestive heart failure in susceptible patients; potassium loss; hypokalemic alkalosis; hypertension. Musculoskeletal: Muscle weakness; steroid myopathy; loss of muscle mass; osteoporosis; vertebral compression fractures; asceptic necrosis of femoral and humeral heads; pathologic fracture of long bones. Gastrointestinal: Peptic ulcer with possible perforation and hemorrhage; pancreatitis; abdominal distention; ulcerative esophagitis. Dermatologic: Impaired wound healing; thin fragile skin; petechiae and ecchymoses; facial erythema; increased sweating; may suppress reactions to skin tests. Neurological: Convulsions; increased intracranial pressure with papilledema (pseudo-tumor cerebri) usually after treatment; vertigo; headache. Endocrine: Menstrual irregularities; development of Cushingoid state; suppression of growth in pediatric patients; secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, as in trauma, surgery or illness, decreased carbohydrate tolerance; manifestations of latent diabetes requirements for insulin or oral hypoglycemic agents in diabetics. Ophthalmic: Posterior subcapsular cataracts; increased intraocular pressure; glaucoma; exophthalmos. Metabolic: Negative nitrogen balance due to protein catabolism.

The use of Cortenema® hydrocortisone retention enema is predicated upon the concomitant use of modern supportive measures such as rational dietary control, sedatives, antidiarrheal agents, antibacterial therapy, blood replacement if necessary, etc.

The usual course of therapy is one Cortenema® nightly for 21 days, or until the patient comes into remission both clinically and proctologically. Clinical symptoms usually subside promptly within 3 to 5 days. Improvement in the appearance of the mucosa, as seen by sigmoidoscopic examination, may lag somewhat behind clinical improvement. Difficult cases may require as long as 2 or 3 months of Cortenema® treatment. Where the course of therapy extends beyond 21 days, Cortenema® should be discontinued gradually by reducing administration to every other night for 2 or 3 weeks.

If clinical or proctologic improvement fails to occur within 2 or 3 weeks after starting Cortenema®, discontinue its use.

Symptomatic improvement, evidenced by decreased diarrhea and bleeding; weight gain; improved appetite; lessened fever; and decrease in leukocytosis, may be misleading and should not be used as the sole criterion in judging efficacy. Sigmoidoscopic examination and X-ray visualization are essential for adequate monitoring of ulcerative colitis. Biopsy is useful for differential diagnosis.

Patient instructions for administering Cortenema® are enclosed in each box. It is recommended that the patient lie on their left side during administration and for 30 minutes thereafter, so that the fluid will distribute throughout the left colon. Every effort should be made to retain the enema for at least an hour and preferably, all night. This may be facilitated by prior sedation and/or antidiarrheal medication, especially early in therapy when the urge to evacuate is great.

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

9156 Rev 11/11

Carton Label

NDC 62559-111-11

UNIT DOSE 1 x 60 mL

THIS END UP

Cortenema®

hydrocortisone retention enema

100 mg/60 mL

USUAL DOSE: One 60 mL enema daily before retiring.

See enclosed directions for use. See package insert for additional prescribing information.

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.

FOR RECTAL USE ONLY.

SHAKE WELL BEFORE USE.

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

(See USP Controlled Temperature.)

Rx only

ANI Pharmaceuticals, Inc.

Baudette, MN 56623