Apriso

Apriso

What is Apriso?

Apriso is used to treat mild to moderate ulcerative colitis in patients 18 years of age and older.

Apriso is used to prevent symptoms of ulcerative colitis from coming back.

Warnings

Stop using Apriso and call your doctor immediately if you have severe stomach pain, stomach cramps, or bloody diarrhea (may occur along with fever, headache, and rash).

Before you take this medicine

You should not use Apriso if you are allergic to mesalamine, aspirin, sulfasalazine, or salicylates (such as Disalcid, Doans Pills, Dolobid, Kaopectate, Nuprin Backache, Pepto-Bismol, Tricosal, Trilisate, and others).

To make sure Apriso is safe for you, tell your doctor if you have ever had:

• a kidney stone or kidney disease;

• liver disease;

• a blockage in your stomach or intestines (e.g. pyloric stenosis); or

• a skin condition such as eczema.

Apriso capsules contain phenylalanine. Tell your doctor if you have phenylketonuria (PKU).

Tell your doctor if you are pregnant or planning to become pregnant. It is not known whether mesalamine will harm an unborn child. However, untreated or uncontrolled ulcerative colitis during pregnancy can lead to complications such as low birth weight or premature birth. The benefits of treating ulcerative colitis may outweigh any risks to the baby.

Breastfeeding may not be safe while using this medication. Ask your doctor about any risks. If you are breastfeeding, tell your doctor if you notice diarrhea in your breastfed baby.

Do not give this medicine to a child.Apriso is not approved for use in people under 18 years of age.

How should I take Apriso?

Take Apriso exactly as your doctor has told you. Follow all instructions on your prescription label and read any medication guides or instructions for use.

This medicine may affect the results of certain medical tests. Tell any doctor who treats you that you are using mesalamine.

You can take Apriso with or without meals.

Drink plenty of fluids to prevent kidney stones.

Swallow the capsule whole and do not open, chew, or break it.Tell your doctor if you have problems swallowing the capsule.

Call your doctor if your ulcerative colitis symptoms don't improve or get worse.

This medicine may affect the results of certain medical tests. Tell any doctor who treats you that you are using Apriso.

Frequent blood tests may be needed to check your blood cells or kidney function.

Store at room temperature, protected from moisture and heat.

Dosage information

Usual Adult Dose for Ulcerative Colitis – Maintenance Dose:

Apriso 375 mg extended-release capsules: 1.5 g (4 capsules) taken orally once daily in the morning

Comments:
Do not administer Apriso 375 mg extended-release capsules at the same time as antacids.

Uses: Maintaining remission of ulcerative colitis in adults.

What happens if I miss a dose?

Take the medicine as soon as possible, but skip the missed dose if it is almost time for the next dose. Do not take two doses at the same time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help hotline at 1-800-222-1222.

What should I avoid while taking Apriso?

If you have a skin condition such as eczema, mesalamine may cause you to sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when outdoors.

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

Apriso side effects

If necessary, get emergency medical helpSigns of an allergic reaction to Apriso:hives; difficulty breathing; Swelling of your face, lips, tongue, or throat.

Stop using Apriso and call your doctor immediately if you have:

• severe stomach pain, stomach cramps, bloody diarrhea;

• fever, headache, general malaise;

• rash, itching, eye redness;

• bloody or tarry stools, coughing up blood, or vomit that looks like coffee grounds;

• low white blood cell count- Fever, chills, mouth sores, sore skin, sore throat, cough, dizziness, difficulty breathing;

• Signs of a kidney stone- severe pain in the side and back, frequent urge to urinate, foul-smelling urine, dark or cloudy urine;

• Kidney problems– increased or decreased urination, swelling, weight gain; or

• Liver problems- Loss of appetite, pain in the upper abdomen, tiredness, easy bruising or bleeding, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Low white blood cell counts may be more likely in older adults.

Common side effects of Apriso may include:

• Belching, constipation, nausea, vomiting, stomach pain, diarrhea, flatulence;

• Dizziness;

• Cold symptoms such as stuffy nose, sneezing, sore throat;

• back pain;

• Headache;

• rash; or

• abnormal liver function tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You can report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Apriso?

Apriso can harm your kidneys, especially if you also take certain medicines for infections, cancer, osteoporosis, organ transplant rejection, intestinal disease, high blood pressure, or pain or arthritis (including Advil, Motrin, and Aleve).

Tell your doctor about all other medicines you are taking, especially:

• Azathioprine or 6-mercaptopurine.

This list is not complete. Other medications can interact with mesalamine, including prescription and over-the-counter medications, vitamins, and herbal products. Not all possible drug interactions are listed here.

References

1. Apriso-Produktetikett

More information

Remember to keep this and all other medicines out of the reach of children, never share your medicines with others, and only use Apriso for the prescribed indication.