Why is this medication prescribed?

Apriso (Generic Mesalamine) is prescribed primarily for the treatment and maintenance of remission in patients with ulcerative colitis, a chronic inflammatory condition of the colon and rectum. Mesalamine is an anti-inflammatory drug that works by reducing inflammation in the colon and rectum, which helps alleviate symptoms such as diarrhea, rectal bleeding, and stomach pain.

How should this medicine be used?

How Apriso Should Be Used:

• Dosage: The typical dosage for maintaining remission in adults with ulcerative colitis is 1.5 grams (four capsules) taken once daily in the morning. Dosage and duration may vary depending on the specific condition and the patient’s response to treatment.
• Administration: Swallow the capsules whole with a full glass of water. Do not crush, chew, or break them, as this may affect the release of the medication in the colon. Take Apriso at the same time each day to maintain an even level of the medication in your body.
• Food Considerations: Apriso can be taken with or without food, but you should avoid consuming antacids while taking this medication, as they can interfere with its effectiveness.
• Duration: Use Apriso for the entire prescribed duration, even if you start feeling better. Stopping the medication too soon may result in a flare-up of symptoms.
• Missed Dose: If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose; do not double up to make up for the missed one.
• Hydration: Drink plenty of fluids while using Apriso to help prevent kidney stones, a potential side effect of mesalamine.

Always follow your healthcare provider’s instructions and the information provided with the medication for the best results and to manage any potential side effects.

Other uses for this medicine

While Apriso is primarily prescribed for maintaining remission in ulcerative colitis, it may also be used off-label for other conditions, including:

• Crohn’s Disease: Mesalamine can sometimes be used to treat mild to moderate cases of Crohn’s disease, another form of inflammatory bowel disease (IBD), particularly when it affects the colon.
• Proctitis and Proctosigmoiditis: Mesalamine may be used to treat inflammation limited to the rectum (proctitis) or the rectum and the lower end of the colon (proctosigmoiditis).

What special precautions should I follow?

Special Precautions to Follow When Using Apriso:

• Allergies: Inform your doctor if you are allergic to mesalamine, salicylates (e.g., aspirin), or any other medications. Also, disclose if you have allergies to dyes, preservatives, or other substances.
• Medical History: Share your medical history with your doctor, especially if you have:
  • Kidney or liver disease.
  • Heart disease.
  • Gastrointestinal blockage or strictures.
  • Pyloric stenosis (narrowing of the stomach opening).
  • Any condition that affects your ability to swallow or digest capsules.
• Pregnancy and Breastfeeding: Discuss with your doctor if you are pregnant, planning to become pregnant, or breastfeeding. The medication may pass into breast milk, so it’s important to weigh the risks and benefits.
• Kidney Function: Mesalamine can affect kidney function. Regular kidney function tests may be needed while using this medication. Stay hydrated to help prevent kidney stones.
• Liver Function: Mesalamine may cause liver problems in some cases. If you have liver disease, your doctor may monitor your liver function during treatment.
• Blood Disorders: Mesalamine can cause blood disorders, such as anemia. Report any unusual bleeding, bruising, or signs of infection to your healthcare provider immediately.
• Use of Antacids: Avoid taking antacids while using Apriso, as they can affect the release and absorption of the medication.
• Sun Exposure: Apriso may make your skin more sensitive to sunlight. Use sunscreen and wear protective clothing when outdoors.
• Medication Interactions: Provide a full list of all medications, supplements, or herbal products you are taking, as mesalamine can interact with other drugs, such as nonsteroidal anti-inflammatory drugs (NSAIDs) or certain blood thinners.

By following these precautions and maintaining open communication with your healthcare provider, you can help ensure that Apriso remains a safe and effective option for you.

What special dietary instructions should I follow?

• Normal Diet: In general, no specific dietary restrictions are required while taking Apriso. You can continue with your usual diet unless your doctor advises otherwise.
• Avoid Antacids: Do not consume antacids, as they can interfere with the medication’s effectiveness.
• Stay Hydrated: Drink plenty of water throughout the day to help prevent kidney stones and ensure proper kidney function.

What should I do if I forget a dose?

• Take as Soon as You Remember: If you miss a dose, take it as soon as you remember.
• Skip If Close to Next Dose: If it is almost time for your next scheduled dose, skip the missed dose. Do not take two doses at the same time to make up for the missed one.

What side effects can this medication cause?

Apriso can cause a range of side effects, from mild to severe. It is important to monitor for any unusual symptoms and consult your healthcare provider if they occur.

Common Side Effects

• Headache: A common side effect that usually diminishes as your body adjusts to the medication.
• Nausea: Mild stomach discomfort or nausea may occur.
• Diarrhea or Constipation: Some people may experience changes in bowel movements, including diarrhea or constipation.
• Abdominal Pain or Cramps: Mild to moderate stomach pain or cramping can occur.
• Gas or Bloating: Some individuals may feel gassy or bloated while taking Apriso.
• Dizziness or Fatigue: You may feel dizzy or unusually tired.
• Joint Pain: Some patients report joint pain or aches.
• Back Pain: Mild back pain might occur in some cases.
• Mild Rash or Itching: Skin irritation or rashes can occasionally develop.

Serious Side Effects: Seek medical attention immediately if you experience any of the following:

• Severe Abdominal Pain: Persistent or severe stomach pain, especially if accompanied by bloody diarrhea.
• Allergic Reactions: Symptoms may include rash, itching, swelling (especially of the face, tongue, or throat), severe dizziness, or difficulty breathing.
• Kidney Problems: Symptoms like a change in urine amount, dark or bloody urine, or pain in the lower back or sides.
• Liver Problems: Signs may include yellowing of the skin or eyes (jaundice), dark urine, persistent nausea, or severe fatigue.
• Heart Problems: Chest pain, shortness of breath, or rapid/irregular heartbeat.
• Severe Skin Reactions: Blistering or peeling skin, severe rash, or hives.
• Blood Disorders: Symptoms can include unusual bleeding or bruising, severe fatigue, or frequent infections.
• Pancreatitis: Severe upper stomach pain that may radiate to the back, accompanied by nausea and vomiting.
• Worsening of Colitis Symptoms: Increased diarrhea, pain, or rectal bleeding.

If you experience mild side effects like headache or nausea, monitor your symptoms. They may subside as your body adjusts to the medication. Discuss with your healthcare provider if they persist or worsen.

Stop taking Apriso and seek immediate medical attention if you experience any severe or allergic reactions.

What should I know about storage and disposal of this medication?

Storage and Disposal of Apriso:

• Storage:
  • Store Apriso at room temperature, between 20°C to 25°C (68°F to 77°F).
  • Keep it in a dry place, away from moisture, heat, and direct light. Avoid storing in the bathroom.
  • Keep Apriso in its original container, tightly closed, and out of reach of children.
• Disposal:
  • Do not flush Apriso down the toilet or pour it into a drain unless instructed to do so.
  • Dispose of the medication through a medicine take-back program if available. If no take-back programs are accessible, consult your pharmacist or local waste disposal company for guidelines on properly discarding the medication.

In case of emergency/overdose

• Symptoms of Overdose: Symptoms may include severe headache, confusion, vomiting, nausea, difficulty breathing, ringing in the ears, dizziness, or severe abdominal pain.
• Call Emergency Services: If someone has overdosed and is experiencing severe symptoms such as difficulty breathing or loss of consciousness, call emergency services immediately.
• Poison Control Center: You can also contact your local poison control center at 1-800-222-1222 (in the U.S.) for further guidance.

What other information should I know?

• Keep a Medication List: Maintain an updated list of all prescription and over-the-counter medications, supplements, and herbal products you are taking. Share this list with your healthcare provider and pharmacist.
• Do Not Share Medication: Apriso should be used only by the person for whom it is prescribed. Do not share it with others, even if they have similar symptoms.
• Monitor Health Regularly: Regular follow-up appointments with your healthcare provider are important to monitor your progress, adjust dosage, and check for any side effects or complications.
• Interactions: Be aware of potential interactions with other medications or supplements. Always inform your healthcare provider of any new medications you are taking.
• Missed Dose: If you miss a dose, take it as soon as you remember unless it is close to the time for your next dose. Do not double the dose to catch up.

Always follow your healthcare provider’s advice and read the information provided with Apriso for comprehensive guidance on its use, storage, and disposal.