LINZESS- linaclotide capsule, gelatin coated

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

LINACLOTIDE (UNII: N0TXR0XR5X) (LINACLOTIDE - UNII:N0TXR0XR5X)

Disponível em:

Allergan, Inc.

DCI (Denominação Comum Internacional):

linaclotide

Composição:

linaclotide 145 ug

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

LINZESS is indicated for the treatment of: • irritable bowel syndrome with constipation (IBS-C) in adults • chronic idiopathic constipation (CIC) in adults • functional constipation (FC) in pediatric patients 6 to 17 years of age LINZESS is contraindicated in: - Patients less than 2 years of age due to the risk of serious dehydration [see Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.4 )] . - Patients with known or suspected mechanical gastrointestinal obstruction.  Risk Summary Linaclotide and its active metabolite are negligibly absorbed systemically following oral administration [see Clinical Pharmacology ( 12.3 )] , and maternal use is not expected to result in fetal exposure to the drug. The available data on LINZESS use in pregnant women are not sufficient to inform any drug-associated risk for major birth defects and miscarriage. In animal developmental studies, no effects on embryo-fetal development were observed with oral administration of linaclotide in rats and rabbits during o

Resumo do produto:

How Supplied 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.

Status de autorização:

New Drug Application

Folheto informativo - Bula

Allergan, Inc.
----------
MEDICATION GUIDE
LINZESS® (lin-ZESS)
(linaclotide)
capsules, for oral use
What is the most important information I should know about LINZESS?
•
Do not give LINZESS to children who are less than 2 years of age. It
may harm them.
See the section “What are the possible side effects of LINZESS?”
for more information about side
effects.
What is LINZESS?
LINZESS is a prescription medicine used to treat:
•
irritable bowel syndrome with constipation (IBS-C) in adults.
•
a type of constipation called chronic idiopathic constipation (CIC) in
adults. “Idiopathic” means
the cause of the constipation is unknown.
•
functional constipation in children and adolescents 6 to 17 years of
age.
It is not known if LINZESS is safe and effective in children with
functional constipation less than 6 years
of age or in children with IBS-C less than 18 years of age.
Who should not take LINZESS?
•
Do not give LINZESS to children who are less than 2 years of age.
LINZESS can cause severe
diarrhea and your child could get severe dehydration (loss of a large
amount of body water and
salt).
•
Do not take LINZESS if a doctor has told you that you have a bowel
blockage (intestinal
obstruction).
Before you take LINZESS, tell your doctor about all of your medical
conditions, including if you:
•
are pregnant or plan to become pregnant. It is not known if LINZESS
will harm your unborn
baby.
•
are breastfeeding or plan to breastfeed. You and your doctor should
decide if you will take
LINZESS and breastfeed.
Tell your doctor about all the medicines you take, including
prescription and over-the-counter medicines,
vitamins and herbal supplements.
How should I take LINZESS?
•
Take LINZESS exactly as your doctor tells you to take it.
•
Take LINZESS 1 time each day on an empty stomach, at least 30 minutes
before a meal, at
approximately the same time each day. You should also wait 30 minutes
before eating a meal if
you take LINZESS with applesauce or mixed with water.
•
If you miss a dose, skip the mis

Características técnicas

LINZESS- LINACLOTIDE CAPSULE, GELATIN COATED
ALLERGAN, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LINZESS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LINZESS.
LINZESS (LINACLOTIDE) CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 2012
WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS LESS THAN 2
YEARS OF AGE
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
LINZESS IS CONTRAINDICATED IN PATIENTS LESS THAN 2 YEARS OF AGE; IN
NEONATAL MICE,
LINACLOTIDE CAUSED DEATHS DUE TO DEHYDRATION. (4, 5.1, 8.4)
RECENT MAJOR CHANGES
Indications and Usage, Functional Constipation (1)
6/2023
Dosage and Administration, Functional Constipation (2.1)6/2023
Dosage and Administration (2.2)
6/2023
Warnings and Precautions (5.2)
6/2023
INDICATIONS AND USAGE
LINZESS is a guanylate cyclase-C agonist indicated for treatment of:
Irritable bowel syndrome with constipation (IBS-C) in adults. (1)
Chronic idiopathic constipation (CIC) in adults. (1)
Functional constipation (FC) in pediatric patients 6 to 17 years of
age. (1)
DOSAGE AND ADMINISTRATION
The recommended dosage in adults is:
IBS-C: 290 mcg orally once daily. (2.1)
CIC: 145 mcg orally once daily or 72 mcg orally once daily based on
individual presentation or
tolerability. (2.1)
The recommended dosage in pediatric patients 6 to 17 years is:
FC: 72 mcg orally once daily. (2.1)
Administration Instructions (2.2):
Take on empty stomach at least 30 minutes prior to a meal at
approximately the same time each day.
Do not crush or chew LINZESS capsule or capsule contents.
For patients who have difficulty swallowing capsules whole or those
with a nasogastric or gastrostomy
tube, see full prescribing information for instructions for opening
the capsule and administering with
applesauce or water.
DOSAGE FORMS AND STRENGTHS
Capsules: 72 mcg, 145 mcg and 290 mcg (3)
CONTRAINDICATIONS
Patients less than 2 years of age. (4, 5.1, 8.4)
Patients with known or suspected mechanical gastrointes