MESALAMINE (5-AMINOSALICYLIC ACID) DELAYED-RELEASE TABLET - ORAL
Common Brand Name(s): Asacol
Phonetic Pronunciation: (mess-AL-uh-meen)
Information last revised May 2010
What does MESALAMINE DEL REL TAB-ORAL look like?
Asacol 400 mg Tab
Asacol HD 800 mg Tab
Uses:
This medication is used to treat ulcerative colitis, a type of bowel disease. It does not cure ulcerative colitis, but it may decrease symptoms such as stomach pain, diarrhea, and rectal bleeding caused by irritation/swelling in the colon/rectum. Mesalamine is an aminosalicylate anti-inflammatory drug. It is believed to work by keeping your body from making certain natural chemicals that may cause pain and swelling.
Missed Dose
If you miss a dose, take 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.
How To Use
Take this medication by mouth with or without food, usually 3 times daily or as directed by your doctor. Dosage is based on your medical condition and response to treatment. Different brands of this medication deliver different amounts of medication. Do not switch brands without your doctor's permission and directions. Swallow this medication whole. Do not crush, chew, or break the tablets. Doing so can keep the drug from being released properly into the colon. Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same times each day. Tell your doctor if your condition persists or worsens.
Drug Interactions
Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: drugs that may harm your kidneys (e.g., NSAIDs such as ibuprofen, indomethacin), methotrexate. 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.
Notes
Do not share this medication with others. Laboratory and/or medical tests (e.g., kidney and liver function tests, sigmoidoscopy, complete blood count) may be performed regularly to monitor your progress or check for side effects. Consult your doctor for more details.
Overdose
If 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. Canada residents can call a provincial poison control center. Symptoms of overdose may include: ringing ears, severe dizziness, sweating, rapid breathing.
Precautions
Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or to other medications that are broken down into mesalamine (e.g., sulfasalazine, olsalazine); or to salicylates (e.g., aspirin); 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: kidney problems, liver problems, asthma, abnormal emptying of stomach contents into the intestine (pyloric stenosis), pancreas problems (pancreatitis), inflammation of the sac around the heart (pericarditis). 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. This medication may cause stomach bleeding. Daily use of alcohol may increase your risk for stomach bleeding, especially when combined with this medication. Consult your doctor or pharmacist for more information. Caution is advised when using this drug in older adults because they may be more sensitive to its effects, especially kidney problems and effects on the blood (e.g., blood dyscrasias). This medication is similar to aspirin. Children and teenagers should not take aspirin or aspirin-related medications (e.g., salicylates) if they have chickenpox, flu, or any undiagnosed illness, or if they have just been given a live virus vaccine (e.g., varicella vaccine), without first consulting a doctor about Reye's syndrome, a rare but serious illness. Rarely, this medication may affect a man's fertility. If your partner has trouble becoming pregnant while you are using this medication, consult your doctor for fertility testing. This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. This medication passes into breast milk and may have undesirable effects on a nursing infant. Discuss the risks and benefits with your doctor before breast-feeding.
Storage
Store the US product at room temperature between 68-77 degrees F (20-25 degrees C). Store the Canadian product at room temperature between 59-86 degrees F (15-30 degrees C). Protect this product 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.
Side Effects
Flu-like symptoms, vomiting, nausea, dizziness, weakness, headache, constipation, abdominal/back pain, upset stomach, diarrhea, or gas may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. You may sometimes see whole or partial tablets in your stool. If this occurs frequently, tell your doctor. You may not be absorbing enough of the medication. Remember that your doctor has prescribed this medication because the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Infrequently, this medication may make your symptoms worse rather than better (acute intolerance syndrome or sensitivity reaction). Tell your doctor immediately if you experience any of these unlikely but serious side effects: worsening stomach pain/cramping, worsening bloody diarrhea, fever, headache. Tell your doctor immediately if any of these unlikely but serious side effects occur: tingling hands/feet, painful straining during a bowel movement. Tell your doctor immediately if any of these rare but very serious side effects occur: dark urine, persistent nausea/vomiting, severe stomach/abdominal pain, yellowing eyes/skin, signs of infection (e.g., fever with persistent sore throat), easy bruising/bleeding, chest pain, shortness of breath, change in the amount of urine. 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.
Other Uses
This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional. This medication may also be used to treat Crohn's disease.
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.
The information contained in the First DataBank databases is intended to supplement the knowledge of physicians, pharmacists, and other healthcare professionals regarding drug therapy problems and patient counselling information. This information is advisory only and is not intended to replace sound clinical judgment in the delivery of healthcare services. First DataBank disclaims all warranties, whether expressed or implied, including any warranty as to the quality, accuracy, and suitability of this information for any purpose.
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