February 13, 2016
Recommended Topic Related To:

Linzess

"The U.S. Food and Drug Administration today approved Viberzi (eluxadoline) and Xifaxan (rifaximin), two new treatments, manufactured by two different companies, for irritable bowel syndrome with diarrhea (IBS-D) in adult men and women.

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Linzess




Indications
Dosage
How Supplied

INDICATIONS

Irritable Bowel Syndrome With Constipation (IBS-C)

LINZESS (linaclotide) is indicated in adults for the treatment of irritable bowel syndrome with constipation (IBS-C).

Chronic Idiopathic Constipation (CIC)

LINZESS is indicated in adults for the treatment of chronic idiopathic constipation (CIC).

DOSAGE AND ADMINISTRATION

Irritable Bowel Syndrome With Constipation (IBS-C)

The recommended dose of LINZESS is 290 mcg taken orally once daily on an empty stomach, at least 30 minutes prior to the first meal of the day.

Chronic Idiopathic Constipation (CIC)

The recommended dose of LINZESS is 145 mcg taken orally once daily on an empty stomach, at least 30 minutes prior to the first meal of the day.

Important Administration Instructions

Do not crush or chew capsule or capsule contents. Swallow LINZESS capsule whole, or for adult patients with swallowing difficulties, follow the instructions below for administration with applesauce or water. Sprinkling of LINZESS beads on other soft foods or in other liquids has not been tested.

For administration in applesauce:

  1. Place one teaspoonful of applesauce at room temperature into a clean container.
  2. Open the capsule.
  3. Sprinkle entire contents (beads) on applesauce.
  4. Consume the entire contents immediately. Do not chew the beads. Do not store the applesauce and beads for later use.

For administration in water:

  1. Pour approximately 1 ounce (30 mL) of bottled water at room-temperature into a clean cup.
  2. Open the capsule
  3. Sprinkle entire contents (beads) into the water
  4. Gently swirl beads and water for at least 10 seconds.
  5. Swallow the entire mixture of beads and water immediately.
  6. Add another 1 ounce of water to any beads remaining in cup, swirl for 10 seconds, and swallow immediately.
  7. Do not store the bead-water mixture for future use.

Note: The drug is coated on the surface of the beads and will dissolve off the beads into the water. The beads will remain visible and will not dissolve. Therefore, it is not necessary to consume all the beads to deliver the complete dose.

For nasogastric or gastric feeding tube administration in water:

  1. Open the capsule and empty the beads into a clean container with 1 ounce (30 mL) of room-temperature bottled water.
  2. Mix by gently swirling beads for at least 10 seconds
  3. Draw-up the beads and water mixture to an appropriately sized catheter-tipped syringe and apply rapid and steady pressure (10 mL/10 seconds) to dispense the syringe contents into the tube.
  4. After administering the bead-water mixture, flush nasogastric/gastric tube with a minimum of 10 mL of water.

Note: It is not necessary to flush all the beads through to deliver the complete dose.

After dosing of linaclotide in either applesauce or water, the first meal of the day can be consumed 30 minutes later.

HOW SUPPLIED

Dosage Forms And Strengths

  • 145 mcg capsules are white to off-white opaque with gray imprint “FL 145”
  • 290 mcg capsules are white to off-white opaque with gray imprint “FL 290”

Storage And Handling

145 mcg Capsules: W hite to off-white opaque hard gelatin capsules with gray imprint “FL 145” Bottle of 30: NDC 0456-1201-30

290 mcg Capsules: W hite to off-white opaque hard gelatin capsules with gray imprint “FL 290” Bottle of 30: NDC 0456-1202-30

Storage

Store at 25°C (77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].

Keep LINZESS in the original container. Do not subdivide or repackage. Protect from moisture. Do not remove desiccant from the container. Keep bottles tightly closed in a dry place.

Distributed by: Forest Pharmaceuticals, Inc. Subsidiary of Forest Laboratories, LLC Cincinnati, OH 45209. Marketed by: Forest Pharmaceuticals, Inc. Subsidiary of Forest Laboratories, LLC, Cincinnati, OH 45209. Ironwood Pharmaceuticals, Inc. Cambridge, MA, 02142. Revised: November 2015

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 12/7/2015

Indications
Dosage
How Supplied

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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