Pentasa (Mesalamine)
Pentasa
Mesalamine
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Mesalamine
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Mesalamine
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Prescription Required.

Product of Canada.

Shipped from Canada.

Prescription Required.Product of Canada.Shipped from Canada.

Pentasa (Mesalamine)

What is Pentasa (Mesalamine)?

Pentasa (mesalamine) for oral administration is an extended-release formulation of mesalamine. Mesalamine is an aminosalicylate anti-inflammatory agent used for the induction of remission and treatment of mild to moderate ulcerative colitis in adults.

How does Pentasa work?

The detailed mechanisms of Pentasa are not well understood, but it does show a topical anti-inflammatory effect on epithelial cells in the colon. Arachidonic acid metabolites (e.g., prostaglandins, leukotrienes) are increased in ulcerative colitis patients, and it is postulated that Pentasa reduces inflammation by inhibiting cycloxygenase and reducing prostaglandin production in the colon.

Dosage and How to Use

Pentasa extended-release capsules are available in the following dosages:

  • 250 mg capsules
  • 500 mg capsules

For the induction of remission and treatment of mild to moderate ulcerative colitis in adults, the recommended dosage is 1g (4 x 250 mg capsules or 2 x 500 mg capsules) four times daily (4 grams total daily dosage).

Pentasa capsules can be swallowed whole, or the capsule can be opened to sprinkle the entire contents onto applesauce or yogurt and consumed immediately. The capsule or capsule contents must never be crushed or chewed.

Patients should drink plenty of fluids while treated with Pentasa.

Storage

Store at room temperature (25°C or 77°F). Temperature excursions are permitted between 15°C to 30°C (59°F to 86°F). Keep out of sight and reach of children.

Overdosage

If overdosage with Pentasa occurs, seek medical attention immediately.

In the case of overdosage, signs of salicylate toxicity are possible (nausea, vomiting, abdominal pain, tachypnea, tinnitus, headache, dizziness, or confusion). Severe salicylate toxicity has the potential to cause electrolyte and blood pH imbalances and may lead to organ damage.

There is no specific antidote for Pentasa overdose, but conventional salicylate toxicity treatment may be beneficial. Potential interventions may include gastrointestinal tract decontamination to reduce absorption, followed by correction of fluids and electrolytes.

Side Effects

The possible side effects of Pentasa are:

  • Abdominal pain, vomiting, nausea, diarrhea
  • Gas
  • Fatigue
  • Fever
  • Back pain
  • Muscle and joint pain
  • Dizziness
  • Headache

Rare but serious side effects of Pentasa are:

Serious skin reactions

Stevens-Johnson syndrome (SJS) and toxic epidermal necrosis (TEN) have been reported in patients taking Pentasa. Seek immediate medical attention and stop taking Pentasa if you have one of the following signs of a severe skin reaction: mouth sores, severe skin rash, or any other sign of an allergic reaction.

Kidney problems and kidney stones

Patients taking Pentasa can develop kidney stones and other kidney issues. Contact your doctor if you have any of the following signs of kidney problems: blood in the urine, more frequent urination, or pain in your back, side, or groin. Make sure to drink plenty of fluids while taking Pentasa. Your doctor will be able to give you more information on how much water you should be drinking.

Acute intolerance syndrome

Symptoms can be similar to a flare of inflammatory bowel disease. Contact your doctor immediately if you are experiencing a flare-up of your condition.

Heart problems

This can include myocarditis, pericarditis, shortness of breath, or swelling in the legs and feet

Liver problems, including liver failure

Contact your doctor immediately if you see any of the following signs of liver failure: yellowing of the skin and eyes, dark urine, pale stool, nausea, loss of appetite, or pain in the upper right area of the stomach.

This is not a comprehensive list of side effects. Please ask your doctor or pharmacist for more information. Contact your doctor immediately if you believe you are experiencing a serious side effect.

Warnings & Precautions

Photosensitivity

Use Pentasa with caution in patients with pre-existing skin conditions like dermatitis or eczema due to the risk of more severe photosensitivity reactions. Patients should avoid prolonged sun exposure and use protective clothing and sunscreen when outdoors.

Hepatic impairment

Hepatic failure has been reported in patients with pre-existing liver conditions. Carefully evaluate the risks versus the benefits of treatment with Pentasa in patients with known liver impairment.

Renal impairment

Kidney stones and other kidney problems have been reported in patients taking Pentasa. Use caution in patients with renal impairment and ensure adequate hydration during treatment.

Drug Interactions & Other Interactions

Nephrotoxic agents, including non-steroidal anti-inflammatory drugs (NSAIDs)

Using mesalamine with nephrotoxic agents (e.g., NSAIDs) may increase the risk of nephrotoxicity. Monitor patients for changes in renal function if taking NSAIDs and mesalamine concurrently.

Azathioprine or 6-mercaptopurine

Using mesalamine with any drugs known to cause myelotoxicity (e.g., azathioprine and 6-mercaptopurine) may increase the risk for blood disorders, bone marrow failure, and associated complications. Carefully monitor blood tests if concurrent mesalamine and azathioprine or 6-mercaptopurine use is necessary.

Contraindications

Pentasa is contraindicated in patients with hypersensitivity to mesalamine, aminosalicylates, salicylates, or any component of the formulation.

Frequently Asked Questions

Pentasa, also known as mesalamine, is an oral aminosalicylate anti-inflammatory agent used to induce remission or treat mild to moderate ulcerative colitis.

The exact mechanism is not well understood, but it has a topical anti-inflammatory effect on the cells of the colon. It is proposed that it inhibits an enzyme called cyclooxygenase and reduces the number of inflammatory mediators.

Pentasa should be taken as 1 g (4 x 250 mg capsules or 2 x 500 mg capsules) 4 times daily for a total daily dose of 4 g. Do not crush or chew the capsules and make sure to drink plenty of water throughout the day.

Capsules can be swallowed whole, or the capsule can be opened to sprinkle the entire contents onto applesauce or yogurt and consumed immediately. The capsule or capsule contents cannot be crushed or chewed.

If you miss a dose, skip the missed dose, and continue with the next dose at the scheduled time. Do not double up on the next dose to make up for the missed dose.

If you or someone you know have ingested too much Pentasa, please contact your doctor or seek immediate healthcare attention, even if no symptoms are present.

The active ingredient in Pentasa is mesalamine. Other inactive ingredients include acetylated monoglyceride, castor oil, colloidal silicon dioxide, ethylcellulose, hydroxypropyl methylcellulose, starch, stearic acid, sugar, talc, and white wax.

This medication should be stored between a temperature of 15°C to 30°C (59°F to 86°F).

Please speak with your doctor immediately if you are pregnant or plan on becoming pregnant. Pentasa has not been shown to have adverse reactions for the mother or child during pregnancy. However, Pentasa should only be used in pregnancy if the benefits outweigh the potential risks.

You should not take Pentasa if you are breastfeeding or plan on breastfeeding. Pentasa does pass into breast milk and may affect your child.

Pentasa is not recommended for use in children because safety has not been established.

Some of the more common side effects of Pentasa are:

  • Abdominal pain, vomiting, nausea, diarrhea
  • Gas
  • Fatigue
  • Fever
  • Back pain
  • Muscle and joint pain
  • Dizziness
  • Headache

This is not a complete list of all possible side effects. Please talk to your doctor or pharmacist for more information.

Serious side effects can occur with Pentasa. Call your doctor right away if you have any of the following signs or symptoms:

  • Signs of a severe skin reaction: mouth sores, severe skin rash, or any other sign of an allergic reaction
  • Signs of kidney problems: blood in the urine, more frequent urination, or pain in your back, side, or groin
  • Symptoms similar to a flare-up of inflammatory bowel disease
  • Signs of heart problems: shortness of breath or swelling in the legs and feet
  • Signs of liver problems: yellowing of skin and eyes, dark urine, pale stool, nausea, loss of appetite, or pain in the upper right area of the stomach

You should not take Pentasa if you have a history of hypersensitivity reactions to mesalamine, aminosalicylates, salicylates, or any component of the formulation.

  • If you are allergic to mesalamine or any other part of this drug. Also, inform your doctor of any other drug, food, or substance allergies you have
  • If you have kidney, liver, or heart problems
  • If you have a history of a skin condition
  • About all of the prescription or over-the-counter drugs, supplements, vitamins, and natural remedies that you are taking

Pentasa can cause some sensitivity to sunlight. It is recommended to avoid long periods of time in the sun and use protective clothing and sunscreen when outdoors.

Pentasa can be taken with or without food.