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:

CORTENEMA* 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.

Last updated on RxList: 3/12/2008

CORTENEMA* 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.

The use of CORTENEMA* hydrocortisone retention enema is predicated upon the concomitant use of modem supportive measures such as rational dietary control, sedatives, anldiarrheal 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 practologically. Clinical symptoms usually subside promptly within 3 to 5 days. Improvement in appearance of the mucosa, as seen by sigmoidoscope 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 antidianheal medication, especially early in therapy when the urge to evacuate is great.

CORTENEMA® hydrocortisone 100 mg retention enema, is supplied as disposable single-dose bottles with lubricated rectal applicator tips, in boxes of seven x 60 mL (NDC 62559-1110-7) and boxes of one x 60 mL (NDC 62559-1110-1). Store at controlled room temperature 20° - 25°C (68° - 77°F). [See USP Controlled Room Temperature.]

Manufactured by ANI Pharmaceuticals, Inc. Baltimore, MD 21244. Rev 09/07. FDA Rev date: 2/21/2008

Last updated on RxList: 3/12/2008

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. Opthalmic: Posterior subcapsular cataracts; increased intraocular pressure; glaucoma; exophthalmos. Metabolic: Negative nitrogen balance due to protein catabolism.

No information provided.

Last updated on RxList: 3/12/2008

In severe ulcerative colitis, it is hazardous to delay needed surgery while awaiting response to medical treatment.

Damage to the rectal wall can result from careless or improper insertion of an enema tip.

In patients on corticosteroid therapy subjected to unusual stress, increased dosage of rapidly acting corticosteroids before, during, and after the stressful situation is indicated.

Corticosteroids may mask some signs of infection, and new infections may appear during their use. There may be decreased resistance and inability to localize infection when corticosteroids are used.

Prolonged use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to fungi or viruses.

Usage in pregnancy

Since adequate human reproduction studies have not been done with corticosteroids, the use of these drugs in pregnancy, nursing mothers or women of child-bearing potential requires that the possible benefits of the drug be weighed against the potential hazards to the mother and embryo or fetus. Neonates born of mothers who have received substantial doses of corticosteroid during pregnancy should be carefully observed for signs of hypoadrenalism.

Average and large doses of hydrocortisone or cortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. These effects are less likely to occur with the synthetic derivatives except when used in large doses. Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion.

While on corticosteroid therapy, patients should not be vaccinated against smallpox. Other Immunization procedures should not be undertaken In patients who are on corticosteroids, especially on high dose, because of possible hazards ol neurological complications and a lack of antibody response.

Persons who are on drugs which suppress the immune system are more susceptible to infections than healthy individuals. Chicken pox and measles, for example, can have a more serious or even fatal course in non-immune pediatric patients or adults on corticosteroids. In such pediatric patients or adults who have not had these diseases, particular care should be taken to avoid exposure. How the dose, route and duration of corticosteroid administration affects the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chicken pox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information). If chicken pox develops, treatment with antiviral agents may be considered.

If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary as reactivation of the disease may occur. During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis.

General

CORTENEMA* hydrocortisone retention enema should be used with caution where there is a probability of impending perforation, abscess or other pyogenic infection; fresh intestinal anastomoses; obstruction; or extensive fistulas and sinus tracts. Use with caution in presence of active or latent peptic ulcer; diverticulitis; renal insufficiency; hypertension; osteoporosis; and myasthenia gravis.

Steroid therapy might impair prognosis in surgery by increasing the hazard of infection. If infection is suspected, appropriate antibiotic therapy must be administered, usually in larger than ordinary doses.

Drug-induced secondary adrenocortical insufficiency may occur with prolonged CORTENEMA* therapy. This is minimized by gradual reduction of dosage. This type of relative insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocoru'coid should be administered concurrently.

There is an enhanced effect of corticosteroids on patients with hypothyroidism and in those with cirrhosis.

Corticosteroid should be used cautiously in patients with ocular herpes simplex because of possible corneal perforation.

The lowest possible dose of corticosteroid should be used to control the conditions under treatment, and when reduction in dosage is possible, the reduction should be gradual.

Psychic derangement may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression, to frank psychotic manifestations. Also, existing emotional instability or psychotic tendencies may be aggravated by corticosteroids. Aspirin should be used cautiously In conjunction with corticosteroids in hypoprothrombinemia

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Growth and development of pediatric patients on prolonged corticosteroid therapy should be carefully observed.

Information for Patients

Persons who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chicken pox or measles. Patients should also be advised that if they are exposed, medical advice should be sought without delay.

Last updated on RxList: 3/12/2008

No information provided.

Systemic fungal infections; and ileocolostomy during the immediate or early post- operative period.

Last updated on RxList: 3/12/2008

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.

Last updated on RxList: 3/12/2008

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
   1. Shake the bottle well to make sure that the suspension is homogeneous.
   2. 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
   1. Best results are obtained by lying on left side with the left leg extended and the right leg flexed forward for balance.
   2. An alternative to lying on the left side is the "knee-chest" position as shown here.

3. Administering the Retention Enema
   1. Gently insert the lubricated applicator tip into the rectum, pointed slightly toward the navel (umbilicus).
   2. 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.
   3. Remain in position for at least 30 minutes to allow thorough distribution of the medication internally. Retain the enema all night, if possible.

Last updated on RxList: 3/12/2008

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

HYDROCORTISONE ENEMA - RECTAL

(HYE-droe-KOR-ti-sone)

COMMON BRAND NAME(S): Cortenema

WARNING: This medication is similar to certain natural substances made by your body (adrenal gland hormones). If you have been taking this medication for a long time, your body may not make enough natural hormones while you are under physical stress (e.g., due to infection, surgery, severe injury). Your dose may need to be adjusted. If you have stopped taking this drug within the past 12 months, you may need to start taking it again if your body is under physical stress. Consult your doctor for more details.

This medication may mask signs of infection or put you at greater risk of developing very serious infections. Report any signs of infection (e.g., persistent sore throat/fever, coughing up yellow/green phlegm, pain during urination, muscle aches) to your doctor.

USES: This medication is used with other treatments for certain problems with the intestines (ulcerative colitis). Using this medication as an enema allows it to work directly on the affected area as well as throughout the body. It does not cure this problem, but it may relieve pain and decrease the amount of diarrhea and bloody stools caused by swelling (inflammation). Hydrocortisone is an anti-inflammatory drug (corticosteroid hormone). It works by decreasing the body's natural defense response and decreasing inflammation.

HOW TO USE: Use this drug in the rectum, usually once daily in the evening or as directed by your doctor. The dosage and duration of therapy are based on your medical condition and response to therapy.

For best results, use after a bowel movement. Unwrap the bottle and shake well. Lie on your left side with the left knee bent toward the chest. Gently insert the nozzle into the rectum. Gently but firmly squeeze the bottle so that all of the drug flows into the rectum. Continue lying on your left side for at least 30 minutes. Keep the medicine in your rectum for at least one hour and overnight if possible.

Use this medication regularly in order to get the most benefit from it. It may take 3-5 days to notice improvement of your symptoms.

Do not use more of this product, use it more often, or keep using it for longer than prescribed by your doctor. If you have been using this medication for a long time, do not suddenly stop it without your doctor's approval. Some conditions may become worse when this drug is suddenly stopped. Your dose may need to be gradually decreased to reduce symptoms such as extreme tiredness, weakness, weight loss, or nausea.

Inform your doctor if your condition persists or worsens after 2 weeks of treatment.

SIDE EFFECTS: Pain/discomfort in the rectal area, headache, dizziness, menstrual period changes (e.g., delayed/irregular/absent periods), trouble sleeping, increased sweating, acne, increased appetite, or unusual weight gain may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: persistent rectal bleeding, dizziness, fainting, tingling/numbness in the arms/legs, easy bruising/bleeding, black stools, vomit that looks like coffee grounds, severe stomach/abdominal pain, bone/joint pain, fast/pounding/irregular heartbeat, slight to moderate weight gain, swelling of the ankles/feet, puffy face, unusual hair growth, difficult breathing, mental/mood changes (e.g., depression, mood swings, agitation), muscle weakness/pain, thinning skin, slow wound healing, increased thirst/urination, signs of infection (e.g., fever, persistent sore throat, frequent/painful urination, eye pain/discharge), vision changes, seizures, back pain, unusual skin growths.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using hydrocortisone enema, tell your doctor or pharmacist if you are allergic to hydrocortisone; or to other corticosteroids (e.g., prednisone); or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain problems in the intestines (blockage, infections including abscesses or peritonitis), recent intestinal surgeries, untreated active fungal infections.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: certain eye diseases (cataracts, glaucoma, herpes of the eye), certain heart problems (e.g., congestive heart failure), high blood pressure, severe liver disease (cirrhosis), kidney disease, underactive thyroid gland (hypothyroidism), diabetes, stomach/intestinal problems (e.g., diverticulitis, ulcer), brittle bones (osteoporosis), current infections (e.g., tuberculosis, positive tuberculosis test, other herpes), bleeding problems, history of blood clots, certain mental/mood conditions (e.g., psychosis, anxiety, depression), low salts in the blood (e.g., low potassium/calcium).

This drug may make you dizzy; use caution while engaging in activities requiring alertness such as driving or using machinery. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist that you are using this medication or have taken it within the last 12 months.

Do not have immunizations, vaccinations or skin tests unless specifically directed by your doctor. Avoid contact with people who have recently received oral polio vaccine.

Avoid exposure to chickenpox or measles infection while taking this medication. If you are exposed to these infections, seek immediate medical attention.

If you have diabetes, this drug may make it harder to control your blood sugar. Check your blood sugar levels regularly as directed by your doctor. Tell your doctor immediately if you have symptoms of high blood sugar such as increased thirst/urination. Your anti-diabetic medication or diet may need to be adjusted.

If you have a history of ulcers or take large doses of aspirin or other arthritis medication, limit alcoholic beverages while taking this medication to decrease the risk of stomach/intestinal bleeding.

Caution is advised when using this drug for a long time in children. This medication may temporarily slow down a child's growth rate. Monitor your child's height and growth rate regularly. Consult your doctor for more details.

This medication should be used only when clearly needed during pregnancy. There have been rare reports of harm to the unborn baby. Discuss the risks and benefits of taking this medication with your doctor. Infants born to mothers who have been using this medication for an extended period of time may have hormone problems. Tell your doctor immediately if you notice symptoms such as persistent nausea/vomiting, severe diarrhea, or weakness in your newborn.

This medication passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.

This drug should not be used with the following medications because very serious interactions may occur: live virus vaccines, mifepristone, natalizumab.

If you are currently using any of these medications, tell your doctor or pharmacist before starting hydrocortisone.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: aldesleukin, large doses of aspirin and aspirin-like drugs (salicylates), nonsteroidal anti-inflammatory drugs (NSAIDs such as indomethacin, ibuprofen), birth control pills, estrogen hormone replacement, blood thinners (e.g., warfarin), bupropion, drugs for diabetes, herbal products (e.g., licorice), isoniazid, drugs affecting liver enzymes that remove hydrocortisone from your body (such as ephedrine, erythromycin, azole antifungals including ketoconazole, barbiturates including phenobarbital, rifamycins including rifampin, certain anti-seizure medications including phenytoin), drugs that may cause potassium loss (e.g., amphotericin B, water pills such as hydrochlorothiazide or furosemide), quinolone antibiotics (e.g., ciprofloxacin, levofloxacin).

Check all prescription and nonprescription medicine labels carefully since many contain pain relievers/fever reducers (NSAIDs such as aspirin, ibuprofen, naproxen) which may increase the risk of stomach bleeding. Low-dose aspirin, as prescribed by your doctor for specific medical reasons such as heart attack or stroke prevention (usually at dosages of 81-325 milligrams per day), should be continued. Consult your doctor or pharmacist for more details.

This product may interfere with certain lab tests. Make sure laboratory personnel and all your doctors know you use this drug.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: This medication may be harmful if swallowed. If swallowing/overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly.

NOTES: Do not share this medication with others.

Laboratory and/or medical tests (e.g., sigmoidoscopy, X-rays) should be performed regularly to monitor your progress. Consult your doctor for more details.

If you take this medication for a long time, wear or carry identification stating that you are using it.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.