Pentasa

Name: Pentasa

Uses of Pentasa

Pentasa is a prescription medication used to treat ulcerative colitis (UC). UC is a condition in which part or all of the lining of the colon (also known as the large intestine) is swollen or worn away. It is used to cause the disease to temporarily go away ("induce remission").

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

 

 

Pentasa and Lactation

Tell your doctor if you are breastfeeding or plan to breastfeed. The active ingredient in Pentasa is excreted in human breast milk. The effect of Pentasa on the nursing infant is not known.

 

What should I avoid while taking mesalamine oral?

Ask your doctor before using an antacid, and use only the type your doctor recommends. Some antacids can make it harder for your body to absorb mesalamine.

Precautions While Using Pentasa

It is important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood or urine tests may be needed to check for unwanted effects.

Check with your doctor right away if you have abdominal or stomach pain, bloody diarrhea, cramps, fever, headache, or a rash while you are using this medicine. These may be symptoms of a condition called mesalamine-induced acute intolerance syndrome.

Call your doctor right away if you have difficult breathing or swallowing, a fast heartbeat, itching, rash, or skin redness, or swelling of the face, throat, or tongue. These may be symptoms of an allergic reaction to this medicine.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Do not take antacids (eg, Amphojel®, Maalox®, Mylanta®, Tums®) while you are taking the Apriso™ capsules. Using these medicines together may change the amount of medicine that is released in the body.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Pentasa Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common
  • Abdominal or stomach pain (severe)
  • bloody diarrhea
  • rectal bleeding
Less common
  • Abdominal or stomach cramps (severe)
  • blurred vision
  • dizziness
  • fever
  • full or bloated feeling
  • headache (severe)
  • nervousness
  • pounding in the ears
  • pressure in the stomach
  • skin rash and itching
  • slow or fast heartbeat
  • swelling of the abdominal or stomach area
  • unusual tiredness or weakness
Rare
  • Anxiety
  • back pain (severe)
  • blue or pale skin
  • chest pain, possibly moving to the left arm, neck, or shoulder
  • chills
  • nausea or vomiting
  • yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Abdominal or stomach cramps or pain (mild)
  • diarrhea (mild)
  • headache (mild)
  • runny or stuffy nose
  • sneezing
Less common
  • Acid or sour stomach
  • acne
  • back or joint pain
  • belching
  • difficulty with moving
  • excess air or gas in the stomach or intestines
  • hair loss or thinning of the hair
  • heartburn
  • indigestion
  • loss of appetite
  • muscle pain or stiffness
  • passing gas
  • stomach discomfort or upset

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

What are some other side effects of Pentasa?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Belly pain or heartburn.
  • Headache.
  • Hard stools (constipation).
  • Loose stools (diarrhea).
  • Dizziness.
  • Gas.
  • Runny nose.
  • Stuffy nose.
  • Sore throat.
  • Muscle or joint pain.
  • Back pain.
  • Upset stomach or throwing up.
  • Feeling tired or weak.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Clinical Trials

In two randomized, double-blind, placebo-controlled, dose-response trials (UC-1 and UC-2) of 625 patients with active mild to moderate ulcerative colitis, Pentasa, at an oral dose of 4 g/day given 1 g four times daily, produced consistent improvement in prospectively identified primary efficacy parameters, PGA, Tx F, and SI as shown in the table below.

The 4-g dose of Pentasa also gave consistent improvement in secondary efficacy parameters, namely the frequency of trips to the toilet, stool consistency, rectal bleeding, abdominal/rectal pain, and urgency. The 4-g dose of Pentasa induced remission as assessed by endoscopic and symptomatic endpoints.

In some patients, the 2-g dose of Pentasa was observed to improve efficacy parameters measured. However, the 2-g dose gave inconsistent results in primary efficacy parameters across the two adequate and well-controlled trials.

 

Parameter Evaluated
 Clinical Trial UC-1  Clinical Trial-UC-2
 
PL
(n=90)
  Pentasa  
PL
(n=83)
  Pentasa
  4 g/day
(n=95)
  2 g/day
(n=97)
  4 g/day
(n=85)
  2 g/day
(n=83)
  PGA   36%   59%*   57%*   31%   55%*   41%
  Tx F   22%   9%*   18%   31%   9%*   17%*
  SI -2.5   -5.0*   -4.3*   -1.6   -3.8*   -2.6
  Remission+   12%   26%*   24%*   12%   27%*   12%
  * p<0.05 vs placebo.

PGA: Physician Global Assessment: proportion of patients with complete or marked improvement.

Tx F: Treatment Failure: proportion of patients developing severe or fulminant UC requiring steroid therapy or hospitalization or worsening of the disease at 7 days of therapy, or lack of significant improvement by 14 days of therapy.

SI: Sigmoidoscopic Index: an objective measure of disease activity rated by a standard (15-point) scale that includes mucosal vascular pattern, erythema, friability, granularity/ulcerations, and mucopus: improvement over baseline.

+ Defined as complete resolution of symptoms plus improvement of endoscopic endpoints. To be considered in remission, patients had a "1" score for one of the endoscopic components (mucosal vascular pattern, erythema, granularity, or friability) and "0" for the others.

Pentasa Dosage and Administration

The recommended dosage for the induction of remission and the symptomatic treatment of mildly to moderately active ulcerative colitis is 1g (4 Pentasa 250 mg capsules or 2 Pentasa 500 mg capsules) 4 times a day for a total daily dosage of 4g. Treatment duration in controlled trials was up to 8 weeks.

Pentasa capsules may be swallowed whole, or alternatively, the capsule may be opened and the entire contents sprinkled onto applesauce or yogurt. The entire contents should be consumed immediately. The capsules and capsule contents must not be crushed or chewed.

Safety and efficacy of Pentasa in pediatric patients have not been established.

PRINCIPAL DISPLAY PANEL - 250 mg Capsule Bottle Label

189-81
NDC 54092-189-81

Pentasa®
(mesalamine)

Controlled-Release
Capsules

240 CAPSULES
Rx only

250 mg
Shire

Important information

Call your doctor at once if you have severe stomach pain, cramping, bloody diarrhea (may occur with fever, headache, and skin rash).

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