Apriso

Name: Apriso

Apriso Usage

Take Apriso exactly as prescribed. Do not change the dose or stop taking Apriso without talking to your doctor.

Apriso comes in extended-release capsules and are usually taken once a day in the morning, with or without food.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Apriso at the same time.

Other Requirements

  • Store Apriso at 20° to 25°C (68° to 77°F).
  • Keep this and all medicines out of the reach of children.

Proper Use of mesalamine

This section provides information on the proper use of a number of products that contain mesalamine. It may not be specific to Apriso. Please read with care.

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Do not stop taking this medicine without checking with your doctor first.

Keep taking this medicine for the full time of treatment, even if you begin to feel better after a few days. Do not miss any doses.

You should take the Lialda® tablets with food. All other brands of capsules and tablets can be taken with or without food.

Swallow the capsule or tablet whole. Do not open, break, crush, or chew it before swallowing.

Take the Asacol® HD tablet on an empty stomach, at least 1 hour before or 2 hours after a meal.

If you have trouble swallowing the Delzicol® capsule, carefully open the capsule and take out the 4 tablets. Swallow the tablets whole and make sure all 4 are taken at the same time as one dose. Do not cut, break, crush, or chew them.

The contents of the Pentasa® capsule may be sprinkled on applesauce or yogurt if needed. The mixture must be swallowed right away without chewing.

If you are taking the delayed-release capsule, extended-release capsule, or delayed-release tablet, part of the capsule or tablet may pass into your stool after your body has absorbed the medicine. Contact your doctor if this happens more often than 1 or 2 times.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • 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 in 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.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Store the delayed-release capsules and delayed-release tablets in a tightly-closed container to protect them from moisture.

Precautions While Using Apriso

It is important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood or urine tests may be needed to check for unwanted effects.

Check with your doctor right away if you have abdominal or stomach pain, bloody diarrhea, cramps, fever, headache, or a rash while you are using this medicine. These may be symptoms of a condition called mesalamine-induced acute intolerance syndrome.

Call your doctor right away if you have difficult 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 take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

What do I need to tell my doctor BEFORE I take Apriso?

  • If you have an allergy to mesalamine, salicylates, sulfasalazine, or any other part of Apriso (mesalamine long-acting capsules (apriso)).
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have any of these health problems: Kidney disease or liver disease.
  • If you have had the varicella vaccine in the past 6 weeks.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Apriso with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Dosage Forms and Strengths

Extended-release capsules containing 0.375 g mesalamine.

Contraindications

Apriso is contraindicated in patients with hypersensitivity to salicylates or aminosalicylates or to any of the components of Apriso capsules.

Drug Interactions

Based on in vitro studies, Apriso is not expected to inhibit the metabolism of drugs that are substrates of CYP1A2, CYP2C9, CYP2C19, CYP2D6, or CYP3A4.

Antacids

Because the dissolution of the coating of the granules in Apriso capsules depends on pH, Apriso capsules should not be co-administered with antacids.

Clinical Studies

Ulcerative Colitis

Two similar, randomized, double-blind, placebo-controlled, multi-center studies were conducted in a total of 562 adult patients in remission from ulcerative colitis. The study populations had a mean age of 46 years (11% age 65 years or older), were 53% female, and were primarily white (92%).

Ulcerative colitis disease activity was assessed using a modified Sutherland Disease Activity Index1 (DAI), which is a sum of four subscores based on stool frequency, rectal bleeding, mucosal appearance on endoscopy, and physician’s rating of disease activity.  Each subscore can range from 0 to 3, for a total possible DAI score of 12.

At baseline, approximately 80% of patients had a total DAI score of 0 or 1.0.  Patients were randomized 2:1 to receive either Apriso 1.5 g or placebo once daily in the morning for six months. Patients were assessed at baseline, 1 month, 3 months, and 6 months in the clinic, with endoscopy performed at baseline, at end of study, or if clinical symptoms developed. Relapse was defined as a rectal bleeding subscale score of 1 or more and a mucosal appearance subscale score of 2 or more using the DAI. The analysis of the intent-to-treat population was a comparison of the proportions of patients who remained relapse-free at the end of six months of treatment. For the table below (Table 3) all patients who prematurely withdrew from the study for any reason were counted as relapses.

In both studies, the proportion of patients who remained relapse-free at six months was greater for Apriso than for placebo.

Table 3: Percentage of Patients Relapse-Free* through 6 Months in Apriso Maintenance Studies
  Apriso
1.5 g/day
  % (# no relapse/N)  

Placebo
  % (# no relapse/N)  

Difference
(95% C.I.)


  P-value  
 *Relapse counted as rectal bleeding score ≥ 1 and mucosal appearance score ≥ 2, or premature withdrawal from study.

Study 1 

  68% (143/209)

  51% (49/96)

   17% (5.5, 29.2)  

  <0.001

 Study 2

  71% (117/164)

  59% (55/93)

  12% (0, 24.5)

  0.046

Examination of gender subgroups did not identify difference in response to Apriso among these subgroups. There were too few elderly and too few African-American patients to adequately assess difference in effects in those populations.

The use of Apriso for treating ulcerative colitis beyond six months has not been evaluated in controlled clinical trials.

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Apriso 120 Capsules, Bottle Label

NDC 65649-103-02

Rx only

Apriso®
(mesalamine)
Extended-Release Capsules
0.375 g


120 Capsules

Salix

PHARMACEUTICALS

Apriso 
mesalamine capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65649-103
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MESALAMINE (MESALAMINE) MESALAMINE 375 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE  
MAGNESIUM STEARATE  
CELLULOSE, MICROCRYSTALLINE  
HYPROMELLOSES  
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)  
TALC  
TITANIUM DIOXIDE  
TRIETHYL CITRATE  
ASPARTAME  
ANHYDROUS CITRIC ACID  
POVIDONES  
Product Characteristics
Color BLUE (Light Blue) , BLACK (BLACK) Score no score
Shape CAPSULE (CAPSULE) Size 23mm
Flavor VANILLA (VANILLA) Imprint Code G;M
Contains     
Packaging
# Item Code Package Description
1 NDC:65649-103-02 1 BOTTLE in 1 CARTON
1 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
2 NDC:65649-103-01 1 BOTTLE in 1 CARTON
2 4 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022301 10/31/2008
Labeler - Salix Pharmaceuticals, Inc. (793108036)
Establishment
Name Address ID/FEI Operations
Catalent UK Swindon Zydis Limited 237676320 MANUFACTURE(65649-103)
Revised: 06/2016   Salix Pharmaceuticals, Inc.

Important information

Call your doctor at once if you have severe stomach pain, cramping, bloody diarrhea (may occur with fever, headache, and skin rash).

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