Rx Item-Linzess 72Mcg Cap 30 By Allergan USA

Clinical Information
Gen. Code and Des.
77085 linaclotide ORAL CAPSULE 72 MCG
Strength
72 mcg
Dose Form
CAPSULE
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family

AHFS Class
56920000 GI DRUGS, MISCELLANEOUS
Active Ingredients
14633 linaclotide 851199592
Inactive Ingredients
2549 gelatin 9000708

LINZESS- linaclotide capsule, gelatin coated
Forest Laboratories, Inc.

WARNING: PEDIATRIC RISK

LINZESS is contraindicated in pediatric patients up to 6 years of age; in nonclinical studies, administration of a single, clinically relevant adult oral dose of linaclotide caused deaths due to dehydration in young juvenile mice. Avoid use of LINZESS in pediatric patients 6 through 17 years of age. The safety and efficacy of LINZESS has not been established in pediatric patients under 18 years of age [see Contraindications (4), Warnings and Precautions (5.1), Use in Specific Populations (8.4) and Nonclinical Toxicology (13.2)].

1 INDICATIONS AND USAGE

1.1 Irritable Bowel Syndrome with Constipation (IBS-C)


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

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

2 DOSAGE AND ADMINISTRATION

2.1 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.

2.2 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.

2.3 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:

?Place one teaspoonful of applesauce at room temperature into a clean container.
?Open the capsule.
?Sprinkle entire contents (beads) on applesauce.
?Consume the entire contents immediately. Do not chew the beads. Do not store the applesauce and beads for later use.
?For administration in water:

?Pour approximately 1 ounce (30 mL) of bottled water at room-temperature into a clean cup.
?Open the capsule
?Sprinkle entire contents (beads) into the water
?Gently swirl beads and water for at least 10 seconds.
?Swallow the entire mixture of beads and water immediately.
?Add another 1 ounce of water to any beads remaining in cup, swirl for 10 seconds, and swallow immediately.
?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.

Linzess 72mcg Cap 30 by ALLERG
Linzess 72mcg Cap 30 by ALLERGAN USA

Linzess 72Mcg Cap 30 By Allergan USA
BRAND: LINZESS NDC: 00456-1203-30,456120330 UPC: 3-04561-20330-7,304561203307 Linzess 72mcg Cap 30 by ALLERGAN USA

LINACLOTIDE ORAL CAPSULE
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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Linzess 72mcg Cap 30 by ALLERG
Linzess 72mcg Cap 30 by ALLERGAN USA