Linzess

Oral Administration

Take on an empty stomach at least 30 minutes before first meal of the day

Swallow capsule whole; do not chew or break apart

Patients who have difficulty swallowing capsules or those with a nasogastric or gastronomy tube, follow instructions below

• 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 entire contents immediately; do not chew beads; do not store applesauce and beads for later use
• Administration in water
  • Pour approximately 1 ounce (30 mL) of bottled water at room-temperature into clean cup
  • Open capsule
  • Sprinkle entire contents (beads) into water
  • Gently swirl beads and water for at least 10 sec
  • Swallow entire mixture of beads and water immediately
  • Add another 1 ounce of water to any beads remaining in cup, swirl for 10 sec, and swallow immediately
  • Do not store the bead-water mixture for future use
  • Note: The drug is coated on surface of the beads and will dissolve off the beads into water; the beads will remain visible and will not dissolve; therefore, it is not necessary to consume all beads to deliver complete dose
• Nasogastric or gastric feeding tube administration in water
  • Open capsule and empty the beads into clean container with 1 ounce (30 mL) of room-temperature bottled water
  • Mix by gently swirling beads for at least 10 sec
  • Draw-up the beads and water mixture to an appropriately sized catheter-tipped syringe and apply rapid and steady pressure (10 mL/10 sec) to dispense the syringe contents into the tube
  • 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

Storage

Store at 25°°C (77F); excursions permitted between 15-30°C (59-86°F)

Keep in the original container; do not subdivide or repackage

Protect from moisture

Do not remove desiccant from the container

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Do not remove the desiccant (drying agent) from the bottle, if one has been provided.

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

• Linzess^®

Linzess is the brand name of the drug linaclotide, which is used to treat bowel problems, such as chronic constipation and irritable bowel syndrome with constipation (IBS-C) in adults.

The drug is in a class of medications called guanylate cyclase-C agonists. It works by increasing fluid in the intestine so that food and waste moves through the bowel quickly.

Linzess also blocks pain signals in the intestines.

The Food and Drug Administration (FDA) approved Linzess in 2012. The drug is manufactured by Ironwood Pharmaceuticals.

Linzess Warnings

Linzess should not be given to children under age 18. The drug caused death in young laboratory mice during clinical testing. There isn't enough information to know whether it could harm young children.

Linzess can help control your symptoms, but it won't cure your condition. Constipation issues may improve in one week, but it may take slightly longer for your stomach pain to get better.

You should keep taking Linzess even if you feel well. Don't stop taking this medicine without first talking to your doctor.

Tell your doctor if you have or have ever had any other medical conditions before taking Linzess. You shouldn't take this drug if you have a blockage in your stomach or intestine.

Pregnancy and Linzess

Linzess is a Pregnancy Category C drug, which means it's not known whether it will harm an unborn baby. You should tell your doctor if you're pregnant or plan to become pregnant while using this medication.

It's also not known whether Linzess passes into breast milk or could harm a breastfeeding baby. Talk to your doctor before breastfeeding while taking this drug.

Linzess is a prescription medicine used in adults to treat irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC).

Linzess belongs to a group of drugs called guanylate cyclase-C (GC-C) agonists, which stimulate the intestines to move food through the body faster.

This medication comes in the form of a capsule and is usually taken once daily, before breakfast.

Common side effects include diarrhea, gas, and stomach-area pain.

• Forest Laboratories, Inc.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Linzess falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

• Take Linzess exactly as your doctor tells you to take it. 
• Take Linzess one time each day on an empty stomach, at least 30 minutes before your first meal of the day. 
• Swallow Linzess capsules whole. Do not break or chew the capsules.
• If you miss a dose, skip the missed dose. Just take the next dose at your regular time. Do not take 2 doses at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The recommended dose of Linzess for the treatment of irritable bowel syndrome with constipation is 290 mcg taken orally once daily.

The recommended dose of Linzess for the treatment of chronic idiopathic constipation is 145 mcg taken orally once daily or 72 mcg orally once daily. The dose will be based on symptoms and how well the medication is tolerated. 

You should not use linaclotide if you are allergic to it, or if you have:

• a blockage in your intestines.

Linaclotide can cause severe dehydration in a child. Linaclotide should not be given to a child younger than 6 years old. Do not give this medicine to any child or teenager without the advice of a doctor.

It is not known whether linaclotide will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether linaclotide passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Linaclotide is used to treat irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC). It works by increasing intestinal fluid secretion, which helps ease the passage of stools and relieve the symptoms of constipation.

This medicine is available only with your doctor's prescription.

Single Linzess doses of 2897 mcg were administered to 22 healthy subjects; the safety profile in these subjects was consistent with that in the overall Linzess-treated population, with diarrhea being the most commonly reported adverse reaction.

You should not use Linzess if you have a blockage in your intestines.

Linzess should not be given to a child younger than 6 years old. Linaclotide can cause severe dehydration in a child.

Take Linzess in the morning on an empty stomach, at least 30 minutes before your first meal. Do not crush, chew, break, or open a capsule. Swallow it whole.

Stop using Linzess and call your doctor at once if you have severe or ongoing diarrhea, severe stomach pain, or black, bloody, or tarry stools.

An interaction is when a substance changes the way a drug works. This can be harmful or prevent the drug from working well. To help prevent interactions, your doctor should manage all of your medications carefully. Be sure to tell your doctor about all medications, vitamins, or herbs you’re taking.

To find out how this drug might interact with something else you’re taking, talk to your doctor or pharmacist.

Alcohol interaction

You should take Linzess on an empty stomach. Take it at least 30 minutes before your first meal of the day. Taking this drug with a high fat meal may cause more diarrhea.

People with blockage in their stomach or intestines

You shouldn’t take this drug if you have a blockage in your stomach or intestines. This medication can make your condition worse and cause severe pain.

Pregnant women

This drug is a category C pregnancy drug. That means two things:

1. Research in animals has shown adverse effects to the fetus when the mother takes the drug.
2. There haven’t been enough studies done in humans to be certain how the drug might affect the fetus.

Talk to your doctor if you’re pregnant or planning to become pregnant. This drug should only be used if the potential benefit justifies the potential risk to the fetus.

For children

It isn’t known if this drug passes into breast milk. If it does, it may cause side effects in a child who is breastfed.

Talk to your doctor if you breastfeed your child. You may need to decide whether to stop breastfeeding or stop taking this medication.

When to call the doctor

This medication hasn’t been studied in children. It shouldn’t be used in people younger than 18 years. It may harm them.

Allergies

Call your doctor right away if you become pregnant while taking this drug.