Friday, November 4, 2011

About Asacol (mesalamine)

Asacol (mesalamine) helps relieve ulcerative colitis symptoms including number of bowel movements Tazalis and rectal bleeding as early as 3 weeks.* Asacol is the only sulfa-free 5-ASA medication indicated for both treatment of mild to moderate flare-ups of ulcerative colitis and maintenance of remission of ulcerative colitis. 

Asacol (mesalamine) is Proven to Help Treat Flare-Ups

Asacol (mesalamine) has been proven to help treat mild to moderate flare-ups of ulcerative colitis. 

In six-week clinical studies of flare-ups, Asacol helped many patients reduce their symptoms of ulcerative colitis, including number of bowel movements and rectal bleeding, for some as early as 3 weeks.* 

Asacol is the #1 most dispensed oral 5-ASA medication. † In 2007 Asacol celebrated its 15th year as a therapy for UC. 



Asacol (mesalamine) is Proven to Help Maintain Remission

In a six-month study, patients taking Asacol (mesalamine) at a maintenance dose were more likely to remain in remission as compared to those taking a placebo (sugar pill). 

Ulcerative colitis rarely goes into permanent remission. 

Lowest Average Out-of-Pocket Cost

Asacol offers the lowest average out-of-pocket cost versus other oral brand name mesalamine products.‡ 


*Individual results may vary. 

† This information is an estimate derived from the use of information under license from IMS National Prescription Data for the 12 month period ending July 2008. IMS expressly reserves all rights, including rights of copying, distribution and republication. This statement does not imply superior efficacy or safety.

‡ SDI's Vector One®: Payer, for the 6 month period ending August 2008. Out-of-pocket cost is the portion of the prescription cost that the patient is required to pay. These data include patients who pay the entire cost of their prescription and those who receive coverage via private insurance, Medicaid, or Medicare. VA and mail order co-pays are not included. Lower out of pocket costs to patients do not necessarily reflect a cost savings to providers. Products that are subject of a price comparison are not known to have comparable efficacy and safety. 


Asacol is proven to help improve ulcerative colitis symptoms of rectal bleeding and increased stool frequency and can help begin repairing the lining of your colon.* The Asacol patented delivery system gets medicine where it is needed most.
  • Once swallowed, a special outer coating allows the tablet to travel through the stomach until it reaches the end of the small intestine and the beginning of the colon.
  • At the beginning of the colon, the tablet releases the active ingredient, mesalamine, to work throughout the colon.
  • The active ingredient acts throughout the colon to help reduce inflammation of the inner lining of the colon and rectum.
When taking Asacol, be sure to swallow your tablets whole – do not break or chew them. Chewing breaks the special outer coating. In clinical studies, a small percentage of people (2-3%) reported passage in the stool of what appeared to be whole tablets, fragments of tablets or tablet shells. If this occurs repeatedly, contact your doctor. 

Who Should Not Take Asacol

You should not take Asacol if you are allergic to Asacol or to salicylates such as aspirin. Tell your doctor if you have kidney problems or a history of kidney disease. It is recommended that all people have their kidney function tested prior to starting Asacol tablets and periodically while on Asacol therapy. Serious side effects may occur. 

If you have questions about taking Asacol, please talk to your doctor and see the accompanying product information.

* As demonstrated by endoscopy in clinical studies. 



Important Precautions

There are some important precautions you should be aware of regarding Asacol therapy, including:
  • It is recommended that all people have their kidney function tested prior to starting Asacol and periodically while on Asacol therapy.
  • If you have a history of kidney impairment or kidney disease, you should tell your doctor before starting Asacol.
  • If you are pregnant, become pregnant or are a nursing mother, talk with your doctor before taking Asacol.
  • Some people who have had a reaction to sulfasalazine may have a similar reaction to Asacol or other products that contain mesalamine. Such a reaction may include worsening of colitis symptoms (i.e., cramping, abdominal pain, and bloody diarrhea) and occasionally fever, headache, general discomfort, itching, rash, and conjunctivitis (an inflammation of part of the eye).
  • There was a worsening of the symptoms of colitis as reported in 3% of Asacol-treated people in clinical trials.
  • If you have pyloric stenosis (a narrowing of the outlet from the stomach), you should tell your doctor before using Asacol.

Asacol Adverse Effects

Asacol is generally well tolerated.

In studies of flare-ups, some people taking Asacol reported headache, abdominal pain, general pain, rash, upset stomach and worsening of colitis symptoms. In a six-month maintenance study, some people reported headache, runny nose, general pain, sore throat, infection, and nervousness. 

Talk with your doctor if you have questions about side effects or Asacol. It's also important to visit your doctor periodically to monitor your condition and discuss your treatment plan. 

Asacol


What is the most important information I should know about Asacol (Mesalamine)?

You should not use this medication if you are allergic to mesalamine or to aspirin or other salicylates (such as Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others).
Before you take mesalamine, tell your doctor if you have kidney or liver disease, a stomach condition called pyloric stenosis, a heart condition such as congestive heart failure, or a history of allergy to sulfasalazine (Azulfidine).
Do not crush, break, or chew a mesalamine tablet or capsule. Swallow the pill whole. It is specially formulated to release the medicine after it has passed through your stomach into your intestines.
Call your doctor if you find undissolved tablets in your stool.
Stop using mesalamine and call your doctor at once if you have Viagora severe stomach pain, cramping, fever, headache, and bloody diarrhea.

What should I discuss with my healthcare provider before taking Asacol (Mesalamine)?

You should not use this medication if you are allergic to mesalamine or to aspirin or other salicylates (such as Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others).
To make sure you can safely take mesalamine, tell your doctor if you have any of these other conditions:
  • a stomach condition called pyloric stenosis
  • a history of allergy to sulfasalazine (Azulfidine)
  • a heart condition such as congestive heart failure
  • kidney disease; or
  • liver disease
FDA pregnancy category C. It is not known whether mesalamine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.
Mesalamine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

What are the possible side effects of Asacol (Mesalamine)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop taking mesalamine and call your doctor at once if you have a serious side effect such as:
  • severe stomach pain, cramping, fever, headache, and bloody diarrhea
Less serious side effects may include:
  • mild nausea, vomiting, stomach cramps, diarrhea, gas
  • fever, sore throat, or other flu symptoms
  • constipation
  • headache or dizziness
  • tired feeling; or
  • skin rash
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs affect Asacol (Mesalamine)?

Tell your doctor about all other medicines you use, especially:
  • azathioprine (Imuran) or mercaptopurine (Purinethol)
  • pentamidine (Nebupent, Pentam)
  • tacrolimus (Prograf)
  • amphotericin B (Fungizone, AmBisome, Amphotec, Abelcet)
  • antibiotics such as capreomycin (Capastat), rifampin (Rifadin, Rimactane, Rifater), vancomycin (Vancocin, Vancoled)
  • antiviral medicines such as acyclovir (Zovirax), adefovir (Hepsera), cidofovir (Vistide), or foscarnet (Foscavir)
  • cancer medicine such as aldesleukin (Proleukin), carmustine (BiCNU, Gliadel), cisplatin (Platinol), ifosfamide (Ifex), oxaliplatin (Eloxatin), streptozocin (Zanosar), or tretinoin (Vesanoid); or
  • aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as ibuprofen (Advil, Motrin), diclofenac (Voltaren), etodolac (Lodine), indomethacin, nabumetone (Relafen), naproxen (Aleve, Naprosyn), piroxicam (Feldene), and others
This list is not complete and other drugs may interact with mesalamine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.