Apriso

1 What is Apriso?

Brand: Apriso, Asacol HD, Delzicol, Lialda

Generic: Mesalamine

Apriso is a non-steroidal anti-inflammatory drug which is generally used to treat and prevent ulcerative colitis (an inflammatory bowel disease). It is considered to be the active moiety of sulfasalazine.

The mechanism of action is uncertain, but may be due to its ability to inhibit local chemical mediators of the inflammatory response especially leukotriene synthesis in the gastrointestinal mucosa.

It works inside the intestine (bowel) to reduce inflammation and other symptoms of the disease. Also, this drug is often used in mild or moderate Crohn’s disease for treatment and prevention of flare-ups.

This medicine is available only with your doctor's prescription. This product is available in the following dosage forms:

  • Capsule, Delayed Release
  • Capsule, Extended Release
  • Tablet, Delayed Release
  • Tablet, Enteric Coated
  • Tablet

2 What to Know Before Using

Before using Apriso, you must know all about the risks and complications associated with it. The suitable drug therapy is usually chosen by a doctor with the active participation of the patient.

There are some important factors such as drug interactions, the presence of any metabolic impairment, history of hypersensitivity reaction, pregnancy, lactation etc. which may alter the desired therapeutic effects of a medicine.

Sometimes the presence of other health disorders affects the beneficial effects of this medicine and even may cause serious toxic effects. If you have had any allergic reactions to any medicine then you must tell your doctor about that.

The use of mesalamine is contraindicated in those who are hypersensitive to this drug or any of the ingredients of the formulation.

Make sure you inform your doctor if you have any other medical problems, especially:

  • Allergy to sulfasalazine (Azulfidine®)—May causes side effects to become worse.
  • Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
  • Liver disease—Use with caution. May make this condition worse.
  • Phenylketonuria (PKU)—The Apriso™ capsule contains aspartame, which may require caution in patients with PKU.

Because of drug-drug interactions, certain medicines should not be used along with this medicine. It is always recommended to consult with your doctor if you are in need of some other medications or even any over-the-counter medicine for another health problem in order to avoid unwanted toxic effects.

It is advised not to use this medicine along with lactulose or other drugs which lower pH. Coated mesalamine may enhance the gastric toxicity of glucocorticoids and hypoglycemic action of sulfonylureas.

The following drug interactions should not be used concurrently:

  • Coumarins
  • Furosemide
  • Methotrexate
  • Mercaptopurine
  • Rifampicin
  • Spironolactone
  • Tamarind
  • Varicella Virus Vaccine
  • Warfarin

Animal reproduction studies have not shown any adverse effect on the fetus and there are no adequate and well-controlled studies in humans. But animal reproduction studies are not always predictive of human response.

Thus, this drug should be used during pregnancy only if clearly needed. Besides, caution should be exercised when used in lactating women because there are no adequate studies in women for determining infant risk when using this medication during breastfeeding.

3 Proper Usage

To use Apriso properly, you must follow all instructions given by your doctor. The dosage schedule and the duration of drug therapy should be individualized and determined based on the physician’s advice.

The therapeutic dose may also vary with the patient’s condition or requirement and the strength of the medicine as well. This medicine comes with patient information.

You should read and follow the instructions carefully before using this medicine; however, the dosage schedule of different dosage forms for different indications are listed below:

For the treatment of ulcerative colitis:

  • For long-acting oral dosage form (delayed-release capsules)
    • Adults—800 milligrams (mg) 3 times a day.
    • Children 5 years and older—Dose is based on body weight and must be determined by your doctor. The dose is usually not more than 2400 mg per day, divided into 2 doses.
    • Children younger than 5 years—Use and dose must be determined by your doctor.
  • For long-acting oral dosage form (delayed-release tablets):
    • Adults-
    • For Asacol® HD: 1600 milligrams (mg) 3 times a day for 6 weeks.
    • For Lialda®: 2.4 to 4.8 grams once a day as a single dose.
    • Children—Use and dose must be determined by your doctor.
  • For long-acting oral dosage form (extended-release capsules):
    • Adults—
    • For Apriso™: 1.5 grams once a day as a single dose in the morning.
    • For Pentasa®: 1 gram 4 times a day.
    • Children—Use and dose must be determined by your doctor.

For prevention of ulcerative colitis:

  • For long-acting oral dosage form (delayed-release capsules):
    • Adults—1600 milligrams (mg) per day, taken in divided doses.
    • Children—Use and dose must be determined by your doctor.
  • For long-acting oral dosage form (delayed-release tablets):
    • Adults—2.4 grams once a day as a single dose.
    • Children—Use and dose must be determined by your doctor.

You should use this medicine following the directions were given by your doctor. If you miss a dose of this medicine, take it as soon as possible. But, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Do not use this drug in larger amounts, more often, or for a longer time than your doctor ordered. Further, it is advised to store the medicine in a closed container at room temperature away from heat, moisture, and direct light.

All kinds of medicines should be kept out of the reach of children. However, outdated medicines should be disposed of by an appropriate way.

4 Precautions to Take

Before using Apriso, there are some precautions you must take. Firstly, regular visits to your doctor are recommended to check that this medicine is working properly or not.

Additionally, the following guidelines should be followed to prevent unwanted complications as well as for the better prognosis of the patients:

Call your doctor right away if you have troubled 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 use any prescription or nonprescription medicine, herbal preparation, or dietary supplement without checking with your doctor.

5 Potential Side Effects

Make sure you meet with your doctor in using DRUG to avoid unwanted potential side effects. Along with the beneficial effects, this medicine may cause some unwanted effects that may not need any medical attention.

These side effects usually go away during the treatment episode as your body adjusts to the medicine. Your healthcare professional may advise you about the ways how to prevent or reduce those unwanted side effects.

Sometimes you may need to consult with the doctor if you notice any of the following toxic effects:

More common:

Less common:

  • Arthralgia
  • Abdominal discomfort
  • Blurred vision
  • Dizziness
  • Fever
  • Full or bloated feeling
  • Hair loss
  • Heartburn
  • Indigestion
  • Loss of appetite
  • Muscle pain or stiffness
  • Nervousness
  • Pounding in the ears
  • Rectal pain
  • Skin rash and itching
  • Slow or fast heartbeat
  • Swelling of the abdominal or stomach area
  • Unusual tiredness or weakness

Rare:

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

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