Linzess

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

Swallow capsules whole; do not break apart or chew.

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: White to off-white opaque hard gelatin capsules with grey imprint “FL 145” Bottle of 30: NDC 0456-1201-30

290 mcg Capsules: White to off-white opaque hard gelatin capsules with grey 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, Inc., St. Louis, Missouri, 63045. Marketed by: Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc. , St. Louis, Missouri, 63045. Ironwood Pharmaceuticals, Inc., Cambridge, MA, 02142. Revised: August 2013

Last reviewed on RxList: 8/23/2013
This monograph has been modified to include the generic and brand name in many instances.

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