Mesalazine

Uses

Mesalazine is part of a class of drugs known as aminosalicylates. Aminosalicylates work by reducing inflammation in the lining of the intestines. This is useful for the maintenance treatment of inflammatory bowel disease.

Mesalazine is mainly indicated to treat the following conditions:

• Ulcerative colitis
• Crohn’s disease

How should I take mesalazine?

Mesalazine is available as an oral tablet, granules, and rectal suppository. The oral tablet and granules should be taken by mouth without chewing, crushing, or dissolving it in water. Drink a glass of water after swallowing the medication. The tablets should be taken on an empty stomach, one hour before meals.

The rectal suppository should be stored at controlled room temperature or in the refrigerator until it is ready to be used. Laying on your side with one leg bent or standing with one leg on a chair can make it easier to insert the suppository. Insert the suppository with the tapered end first. Straighten your legs and sit or lie still for 15 to 20 minutes to allow the medication to dissolve.

How do I store mesalazine?

This drug should be stored at room temperature (20-25°C) and be protected from light and moisture. Rectal suppositories may be stored in the refrigerator to prevent melting. Do not store it in the freezer.

Always check the label before using this product. Do not use if the printed expiration date has passed, the product seal has been broken, or the product has changed in color, odor, or consistency. For safety, keep out of the reach of children and pets.

Do not dispose of this product by pouring it down the drain, toilet, or into the environment. Ask your pharmacist regarding the proper way and location of disposal.

Precautions & Warnings

Before using this medication, inform your doctor if:

• You have ever had an allergic reaction to mesalazine or other salicylates (e.g. aspirin).
• You have a history of allergy to other medications, food, or other substances.
• You are taking other medications.
• You have underlying health conditions (e.g. asthma, phenylketonuria, kidney, or liver impairment)

Is it safe during pregnancy or breastfeeding?

Mesalazine is a pregnancy category B drug, so it is considered generally safe to use during pregnancy. This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, as determined by your doctor.

This drug may be excreted in breast milk. This drug should be used while breastfeeding only if the potential benefit justifies the potential risk to the child, as determined by your doctor.

Side Effects

All drugs have the potential to elicit side effects even with normal use. Many side effects are dose-related and will resolve when it is adjusted or at the end of therapy.

Potential side effects while using this drug include:

• Headache
• Indigestion
• Nausea
• Diarrhea
• Rash
• Itchiness
• Fever

Seek medical attention immediately if you experience any of these serious, potentially fatal drug reactions:

• Liver impairment
• Renal impairment
• Lung injury
• Pancreatic injury
• Induced pericarditis
• Blood dyscrasias
  • Bruising
  • Nosebleeds

You may experience some, none, or other side effects not mentioned above. If you have any concerns about a side effect or it becomes bothersome, consult your doctor or pharmacist.

Interactions

This drug may interact with other medications. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs, and herbal products) and inform your doctor and pharmacist.

Known drugs and their interactions with mesalazine include:

• Anticoagulants
  • Increased risk of bleeding
• NSAIDs
  • Increased risk of liver and kidney injury
• Glucocorticoid steroids
  • Increased risk of
• Sulfonylureas
  • Increased risk of bleeding and hypersensitivity
• Methotrexate
• Probenecid
  • Increased risk of toxicity
• Diuretics
  • Increased risk of kidney injury
• Digoxin
  • May decrease gastrointestinal absorption of digoxin
• Rifampicin
  • May decrease the
• Azathioprine

• Increased risk of blood dyscrasias

If you experience an adverse drug interaction, stop taking this drug and continue taking your other medication. Inform your doctor immediately to reevaluate your treatment plan. Your dose may need to be adjusted, substituted with another drug, or discontinue using the drug.

Does food or alcohol interact with mesalazine?

The absorption of mesalazine is affected by food intake. It is best to take it on an empty stomach. This drug should not be taken with alcohol as it may increase the risk of gastrointestinal discomfort, bleeding, and hepatotoxicity.

Inform your doctor or pharmacist if you have any concerns regarding food-drug interactions.

What health conditions may interact with mesalazine?

This drug should be taken with caution if you have any of the following conditions or risk factors:

• Asthma
• Renal impairment
• Hepatic impairment
• Active peptic ulceration
• Personal or family history of myocarditis or pericarditis

Inform your doctor or pharmacist if you have any concerns regarding specific health conditions.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult your doctor or pharmacist before using mesalazine.

What is the dose of mesalazine for an adult?

For treating ulcerative colitis

• Pentasa:
  • Tablet: Take up to 4 g per day in divided doses.
  • Maintenance: Take up to 2 g per day in divided doses.
• Salofalk:
  • Tablet: Take 1 tablet 3 times a day, 1 hour before meals.
  • For maintenance during remission: tTke 0.5 g 3 times a day, 1 hour before meals.
  • Granules: Take 1 to 2 sachets once a day.

For treating Crohn’s disease

• Pentasa:
  • Tablet: Take up to 4 g per day in divided doses.
  • Maintenance: Take 15 to 30 mg/kg/day in divided doses. Maximum dose of 4 g per day.

For treating ulcerative proctitis

• Pentasa:
  • Suppository: Administer 1 suppository one to two times per day.

What is the dose of mesalazine for a child?

For treating ulcerative colitis

• Pentasa:
  • Tablet: Take up to 20 to 30 mg/kg/day in divided doses. Maximum dose of 4 g/day.

For treating Crohn’s disease

• Pentasa:
  • Tablet: Take up to 20 to 30 mg/kg/day. Maximum dose of 4 g/day.

How is mesalazine available?

This drug is available in the following brands, dosage forms, and strengths:

• Pentasa tablet 500 mg, 1 g
• Pentasa suppository 1 g
• Salofalk enteric-coated tablet 500 mg
• Salofalk gastro-resistant PR granules 1.5 g sachet

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of this drug, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.