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). Betamethasone 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. Dosage is based on your medical condition and response to treatment.

For best results, use after a bowel movement. Lie on your left side with the left knee bent toward the chest. Gently insert the opening of the enema bag into the rectum. Gently but firmly squeeze the bag 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 1 hour and overnight if possible.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time each day.

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.

Tell your doctor if your condition persists or worsens.

Side Effects

See also Precautions section.

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

Remember that this medication has been prescribed because your doctor 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 right away if any of these unlikely but serious side effects occur:

• persistent rectal bleeding
• painful swallowing
• symptoms of stomach/intestinal bleeding (such as stomach/abdominal pain, black/tarry stools, vomit that looks like coffee grounds)
• irregular heartbeat
• swelling ankles/feet
• swollen belly
• puffy face
• bone/back pain
• easy bruising
• skin thinning
• increased thirst/urination
• unusual hair growth
• muscle pain/weakness/shrinking
• vision changes
• mental/mood changes (such as depression, mood swings, agitation)
• 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 or at www.fda.gov/medwatch.

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 betamethasone, tell your doctor or pharmacist if you are allergic to it; or to other corticosteroids (such as hydrocortisone, 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have:

• recent intestinal surgeries
• certain problems in the intestines (blockage, abscesses, peritonitis)
• untreated current fungal infections

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• kidney disease
• liver disease
• certain heart problems (such as congestive heart failure)
• high blood pressure
• diabetes
• underactive thyroid (hypothyroidism)
• brittle bones (osteoporosis)
• eye diseases (such as cataracts, glaucoma, herpes of the eye)
• stomach/intestinal problems (such as diverticulitis, ulcer)
• current infections (such as tuberculosis, positive tuberculosis test, herpes)
• certain muscle/nerve problem (myasthenia gravis)
• mental/mood conditions (such as psychosis, anxiety, depression)
• seizures
• low salts in the blood (such as low potassium, calcium)

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

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

Tell your health care professional that you are using betamethasone before having any immunizations, vaccinations, or skin tests. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

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

Avoid exposure to chickenpox or measles infection while taking this medication unless you have previously had these infections (such as in childhood). If you are exposed to either of these infections and you have not previously had them, seek immediate medical attention.

If you have diabetes, this drug may affect your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

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.

Using corticosteroid medications for a long time can make it more difficult for your body to respond to physical stress. 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 right away 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.

Older adults may be more sensitive to the side effects of this drug, especially high blood sugar, high blood pressure, bone loss/pain, stomach/intestinal bleeding, and mental/mood changes (such as confusion).

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. There have been rare reports of harm to the unborn baby. Infants born to mothers who have been using this medication for an extended period of time may have hormone problems. Discuss the risks and benefits with your doctor. Tell your doctor right away if you notice symptoms such as nausea/vomiting that doesn't stop, severe diarrhea, or weakness in your newborn.

It is unknown if this drug passes into breast milk. Similar medications pass into breast milk. Consult your doctor before breast-feeding.

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug are:

• aldesleukin
• amphotericin B
• large doses of aspirin and aspirin-like drugs (salicylates)
• "blood thinners" (such as warfarin)
• estrogens (such as hormone replacement, birth control pills)
• herbal products (such as licorice)
• drugs for myasthenia gravis (such as neostigmine, pyridostigmine)
• nonsteroidal anti-inflammatory drugs (NSAIDs such as indomethacin, ibuprofen)
• drugs affecting liver enzymes that remove betamethasone from your body (ephedrine, azole antifungals including ketoconazole, barbiturates including phenobarbital, rifamycins including rifampin, certain anti-seizure medications including phenytoin)

Check all prescription and nonprescription medicine labels carefully since many contain pain relievers/fever reducers (NSAIDs such as aspirin, ibuprofen, naproxen) that 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 81-162 milligrams a day), should be continued. Consult your doctor or pharmacist for more details.

Overdose

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 9-1-1. Otherwise, call a poison control center right away. US residents can call their local poison control center 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, X-rays) should be performed regularly to monitor your progress. Consult your doctor for more details.

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. Use your next dose at the regular time. Do not double the dose to catch up.

Storage

Store at room temperature 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.