Hydrocortisone Enema 100mg/60ml (7 Enema Box)

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

HYDROCORTISONE ENEMA - RECTAL

(HYE-droe-KOR-ti-sone)

COMMON BRAND NAME(S): Cortenema

USES: This medication is used to treat the symptoms of a certain intestinal problem called ulcerative colitis. It is not a cure for this condition, but it is usually used with other treatments to manage this problem. Hydrocortisone enemas help to decrease diarrhea and bloody stools by reducing swelling (inflammation) in the rectum and colon. Hydrocortisone belongs to a class of drugs called corticosteroids.

HOW TO USE: Read the directions for use that come with this product. If you have any questions, ask your doctor or pharmacist. Use this product in the rectum as directed by your doctor, usually once nightly before bedtime. The usual length of treatment is 2 to 3 weeks or until symptoms go away (remission). In some cases, remission may take up to 2 or 3 months. The dosage and length of treatment are based on your medical condition and response to treatment. For best results, use after a bowel movement. Shake the bottle thoroughly before use. Lie on your left side with your right knee bent toward the chest. Gently insert the applicator tip into the rectum. Gently but firmly squeeze the bottle so that all of the drug flows into the rectum. Remain lying on your left side for at least 30 minutes. Keep the medicine in your rectum for at least 1 hour and overnight if possible. Use this medication regularly as prescribed to get the most benefit from it. It may take 3 to 5 days to notice an improvement. Do not use more of this product, use it more often, or use it for longer than prescribed. Your condition will not improve any faster, and your risk of side effects may increase. If you have been using this medication for a long time (more than 3 weeks), do not stop using it without consulting your doctor. Some conditions may become worse when this drug is suddenly stopped. Your dose may need to be gradually decreased. Tell your doctor if your condition does not improve after 2 to 3 weeks of treatment or if it worsens.

SIDE EFFECTS: Pain or burning in the rectum, dizziness, menstrual period changes, trouble sleeping, unusual weight gain, increased sweating, acne, or unusual hair growth may occur. If any of these effects persist or worsen, tell 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 headache, swelling ankles/feet, increased thirst/urination, vision problems, puffy face, thinning skin, unusual skin growths, slow wound healing, persistent rectal bleeding, unusual bruising/bleeding, black/tarry stools, vomit that looks like coffee grounds, severe stomach/abdominal pain, severe heartburn, bone pain, easily broken bones, mental/mood changes (such as depression, mood swings, agitation), muscle weakness/pain, irregular heartbeat, signs of infection (such as fever, persistent sore throat, painful urination, worsening redness/irritation near the anus), seizures. A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), 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. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using hydrocortisone, tell your doctor or pharmacist if you are allergic to it; or to other corticosteroids (such as prednisone); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: other stomach/intestinal problems (such as ulcers, blockage, bleeding, infection, recent surgery), infections (such as tuberculosis, fungal infections), certain eye conditions (cataracts, glaucoma, herpes infection of the eye), heart problems (such as congestive heart failure, recent heart attack), high blood pressure, liver disease, kidney disease, thyroid problems (overactive or underactive thyroid disease), diabetes, bone loss (osteoporosis), bleeding or blood clotting problems, mental/mood conditions (such as psychosis, depression), low potassium or calcium blood levels, a certain muscle/nerve disease (myasthenia gravis). This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages to decrease the risk of dizziness and also stomach/intestinal bleeding. Using corticosteroid medications for a long time can make it more difficult for your body to respond to physical stress. Therefore, before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used this medication within the past 12 months. Tell your doctor immediately if you develop unusual/extreme tiredness or weight loss. If you will be using this medication for a long time, carry a warning card or medical ID bracelet that identifies your use of this medication. Do not have immunizations, vaccinations, or skin tests without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose). This drug can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details. 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. This medication may slow down a child's growth if used for a long time. Consult the doctor or pharmacist for more details. See the doctor regularly so your child's height and growth can be checked. During pregnancy, this medication should be used only when clearly needed and not for prolonged periods. Other forms of hydrocortisone (given by mouth or by injection) may harm an unborn baby. Discuss the risks and benefits with your doctor. Infants born to mothers who have been using this medication for an extended time may have low levels of the natural corticosteroid hormone in their bodies and may need more monitoring. Tell your doctor immediately if you notice symptoms such as vomiting, severe diarrhea, or weakness in your newborn. It is unknown if this drug passes into breast milk. However, it is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring. To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval. Some products that may interact with this drug include: aldesleukin, "blood thinners" (such as warfarin), natalizumab, quinolone antibiotics (such as ciprofloxacin, levofloxacin), vaccines. Check all prescription and nonprescription medicine labels carefully since many medications contain pain relievers/fever reducers (including aspirin, salicylates, NSAIDs such as ibuprofen, naproxen) that may increase your risk of bleeding when taken with corticosteroids. However, if your doctor has directed you to take low-dose aspirin for heart attack or stroke prevention (usually at dosages of 81-325 milligrams a day), you should continue taking the aspirin unless your doctor instructs you otherwise. Ask your pharmacist about using those products safely. This document does not contain all possible drug interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.

OVERDOSE: This medicine may be harmful if swallowed. If swallowing or overdose is suspected, contact a poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others. Laboratory and/or medical tests (such as sigmoidoscopy, colonoscopy, adrenal gland function tests) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details. If you use 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 68-77 degrees F (20-25 degrees C). 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 information about enrolling in MedicAlert, call 1-800-854-1166 (US) or 1-800-668-1507 (Canada).

Information last revised June 2012. Copyright(c) 2012 First Databank, Inc.