Precautions
Constella (linaclotide) Constella capsules contain the active ingredient linaclotide, which is used for the treatment of moderate to severe irritable bowel syndrome with constipation.
What is linaclotide in Constella capsules?
Treatment of moderate to severe irritable bowel syndrome with constipation in adults. How does it work? Constella capsules contain the active ingredient linaclotide, which is used for the treatment of moderate to severe irritable bowel syndrome with constipation. Linaclotide is not absorbed into the bloodstream.
What is Constella used for?
Linaclotide (marketed under the trade name Linzess in the US and Mexico, and as Constella elsewhere) is a drug used to treat irritable bowel syndrome with constipation and chronic constipation with no known cause.
What is Linzess (linaclotide)?
Constella capsules contain the active ingredient linaclotide, which is used for the treatment of moderate to severe irritable bowel syndrome with constipation. Linaclotide is not absorbed into the bloodstream.
What is the active ingredient in Constella?
How quickly does constella work?
Trial patients experienced results within the first week of dosing, often on the first day, which were sustained over a 12-week treatment period. Improvement of abdominal pain sometimes took a little longer than one week of treatment.
Can you take constella everyday?
The recommended adult starting dose of linaclotide for chronic constipation is 145 µg taken once daily. Some people may be prescribed a dose of 72 µg taken once daily, depending on their response to the starting dose.
What does constella treat?
Constella contains the active substance linaclotide. It is used to treat the symptoms of moderate to severe irritable bowel syndrome (often just called “IBS”) with constipation in adult patients. IBS is a common gut disorder.
How long can you take linaclotide?
Overall, prolonged linaclotide treatment in responding patients should be maintained for between 6 and 12 months. Furthermore, stopping treatment can be considered with the patient's consent, taking into consideration the time needed to achieve a therapeutic effect.
Does constella work right away?
This medication is typically used for the treatment of irritable bowel syndrome. It may also be used to ease constipation. It requires several days to take effect.
What type of laxative is linaclotide?
About linaclotideType of medicineGuanylate cyclase-C receptor agonistUsed forConstipation associated with irritable bowel syndrome in adultsAlso calledConstella®Available asCapsulesSep 16, 2020
Is linaclotide good for IBS?
Linaclotide is an efficacious, well-tolerated treatment option for adults with irritable bowel syndrome with constipation (IBS–C) and chronic idiopathic constipation (CIC). This medication improves both bowel symptoms and abdominal pain and discomfort.
Can you take linaclotide at night?
Consuming Linzess (linaclotide) at night is not recommended. The best time to take Linzess is in the morning (on an empty stomach), half an hour before breakfast. Consumption of Linzess with food may lead to several gastrointestinal side effects, including gas, diarrhoea, and abdominal pain.
Does linaclotide cause diarrhea?
Severe diarrhea was reported in 2% of the LINZESS-treated patients versus less than 1% of the placebo-treated patients, and 5% of LINZESS-treated patients discontinued due to diarrhea vs less than 1% of placebo-treated patients.
Who should not take linaclotide?
Paediatric population Linaclotide should not be used in children and adolescents as it has not been studied in this population. Hence the contraindication of patients aged 0 – 17 years is in effect.
Can you take constella long term?
The CHMP noted that Constella has been shown to have clinically relevant, beneficial effects in patients with IBS with constipation in the long term (for up to six months). It has also been shown to have a beneficial impact on the quality of life of patients.
How long does it take for linaclotide to start working?
When LINZESS is taken daily, constipation relief is typically felt in about 1 week. IBS-C patients may begin to experience relief of belly pain and overall abdominal symptoms* (pain, discomfort, and bloating) in about 1 week, with symptoms typically improving over 12 weeks.
Can you take constella long term?
The CHMP noted that Constella has been shown to have clinically relevant, beneficial effects in patients with IBS with constipation in the long term (for up to six months). It has also been shown to have a beneficial impact on the quality of life of patients.
Is linaclotide good for IBS?
Linaclotide is an efficacious, well-tolerated treatment option for adults with irritable bowel syndrome with constipation (IBS–C) and chronic idiopathic constipation (CIC). This medication improves both bowel symptoms and abdominal pain and discomfort.
Can Linzess cause bowel obstruction?
Linaclotide (applies to Linzess) gastrointestinal obstruction. Major Potential Hazard, High plausibility. The use of linaclotide is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction. Because linaclotide accelerates gastrointestinal transit, it can exacerbate a blockage.
How long does it take for Linzess to work for constipation?
When LINZESS is taken daily, constipation relief is typically felt in about 1 week. IBS-C patients may begin to experience relief of belly pain and overall abdominal symptoms* (pain, discomfort, and bloating) in about 1 week, with symptoms typically improving over 12 weeks.
Before Taking This Medicine
You should not use linaclotide if you are allergic to it, or if you have: 1. a blockage in your intestines.Linaclotide can cause severe dehydration...
How Should I Take Linaclotide?
Follow the directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.Take linacl...
What Happens If I Miss A Dose?
Skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.
Linaclotide Dosing Information
Usual Adult Dose for Irritable Bowel Syndrome:290 mcg orally once a dayComments:-Take on an empty stomach, at least 30 minutes prior to the first m...
What Other Drugs Will Affect Linaclotide?
Other drugs may interact with linaclotide, including prescription, over-the-counter, vitamin, and herbal products. Tell your doctor about all medic...
What is linaclotide used for?
Linaclotide is used to treat chronic constipation, or chronic irritable bowel syndrome ( IBS) in people who have had constipation as the main symptom. Linaclotide may also be used for purposes not listed in this medication guide.
How should I take linaclotide?
Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
What should I avoid while taking linaclotide?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
What other drugs will affect linaclotide?
Other drugs may affect linaclotide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.
Can you give linaclotide through a NG tube?
If needed, medicine from the linaclotide capsule may be given through a nasogastric (NG) or gastro nomy tube.
Can a 6-year-old take linaclotide?
Linaclotide should not be given to a child younger than 6 years old. Linaclotide can cause severe diarrhea and fatal dehydration in a child. Do not give linaclotide to any child or teenager without the advice of a doctor.
Can you take linaclotide if you are allergic to it?
Before taking this medicine. You should not use linaclotide if you are allergic to it, or if you have: a blockage in your intestines ( bowel obstruction ).
What is the active ingredient in Constella capsules?
Constella capsules contain the active ingredient linaclotide, which is used for the treatment of moderate to severe irritable bowel syndrome with constipation.
Can Constella cause diarrhoea?
There may be an increased risk of getting diarrhoea if you take the following medicines with Constella:
Is linaclotide available in the UK?
There are currently no other medicines available in the UK that contain linaclotide as the active ingredient.
Does Constella help with constipation?
The symptoms of irritable bowel syndrome vary from person to person. Constella is only used for IBS with constipation that is causing symptoms such as abdominal pain and bloating.
What is linaclotide used for?
(what is this?) (verify) Linaclotide, (sold under the brand name Linzess in the US and Mexico, and as Constella elsewhere) is a drug used to treat irritable bowel syndrome with constipation and chronic constipation with no known cause.
Where was linaclotide discovered?
The drug was discovered at Microbia, Inc, which had been spun out of the Whitehead Institute in 1998 by postdocs from the lab of Gerald Fink to commercialize the lab's know-how and inventions related to microbial pathogens and biology. In 2002 the company hired Mark Currie who had worked at the Searle division of Monsanto and then had gone to Sepracor. Currie directed the efforts that led to the discovery of linaclotide, which was based on an enterotoxin produced by some strains of Escherichia coli that cause traveler’s diarrhea. The company started Phase I trials in 2004.
What are the three bonds in linaclotide?
However, the actual structure of linaclotide is not fully specified without the three disulfide (R-S-S-R) bonds it contains, which are between Cys 1 and Cys 6, between Cys 2 and Cys 10, and between Cys 5 and Cys 13 ; these are shown in exaggerated fashion in the line-angle graphic showing the chemical bonds within and between each amino acid (and their stereochemistries, see the infobox, above right), and are represented using a one-letter abbreviations in the following additional schematic:
How old do you have to be to take linaclotide?
The US label has a black box warning to not use linaclotide in children less than 6 years old and to avoid in people from 6 to 18 years old, due to the risk of serious dehydration.
Where is the phenolic ring of terminal tyrosine?
The phenolic ring of terminal tyrosine (Y) is in the lower left corner. Exaggerated bond lengths emphasize 3 disulfide (-S—S-) bonds between 6 cysteines (C's). Linaclotide, (sold under the brand name Linzess in the US and Mexico, and as Constella elsewhere) is a drug used to treat irritable bowel syndrome with constipation ...
Is linaclotide used for constipation?
Linaclotide is used to treat irritable bowel syndrome with constipation and chronic constipation with no known cause. It has not been tested in pregnant women and it is unknown if it is excreted in breast milk.
Is linaclotide a solid supported synthesis?
The study also reported that solution-phase oxidation (disulfide formation) was advisable over solid-supported synthesis for linaclotide, and that the Cys 1 –Cys 6 disulfide bridge was the most favored energetically.
How does this medication work? What will it do for me?
Linaclotide belongs to the class of medications called guanylate cyclase-C agonists.
What form (s) does this medication come in?
72 µg Each white-to-off-white, opaque, hard gelatin capsule, imprinted "FL 72" in grey and filled with linaclotide-coated beads, contains 72 µg of linaclotide.
How should I use this medication?
The recommended adult dose of linaclotide to treat symptoms of irritable bowel syndrome with constipation is 290 µg taken once a day.
What side effects are possible with this medication?
Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.
Are there any other precautions or warnings for this medication?
Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
What other drugs could interact with this medication?
Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.
What is Constella used for?
What Constella is used for#N#Constella contains the active substance linaclotide and is used to treat the symptoms of moderate to severe irritable bowel syndrome (often called IBS) with constipation in adult patients.
How many capsules are in a pack of Constella?
Constella is available in packs containing 10, 28, or 90 capsules and in a multi-pack of 112 capsules divided into 4 cartons with 28 capsules in each. Not all pack sizes may be marketed.
What happens if you take too much Constella?
The most likely effect of taking too much Constella is diarrhea. Contact your doctor or pharmacist if you have used too much of this medicine.
How old do you have to be to take Constella?
Do not give this medicine to children and adolescents under 18 years of age, as the safety and efficacy of Constella for this age group have not been established.
Does Constella cause diarrhea?
Constella causes more frequent bowel movements and diarrhea (loose stools) when taken with food compared to when taken on an empty stomach (see section 3).
Can Constella be discontinued?
Preferably discuss with a doctor before ending treatment. However, treatment with Constella can be safely discontinued at any time.
Does Constella affect your ability to drive?
Constella does not affect your ability to drive or use machines.
What is Constella used for?
Constella contains the active substance linaclotide. It is used to treat the symptoms of moderate to severe irritable bowel syndrome (often just called “IBS”) with constipation in adult patients.
How old do you have to be to take Constella?
Do not give this medicine to children and adolescents under the age of 18 years because the safety and efficacy of Constella in this age group has not been established.
What happens if you take too much Constella?
The most likely effect of taking too much Constella is diarrhoea. Contact your doctor or pharmacist if you have taken too much of this medicine.
How much linaclotide should I take?
The recommended dose is one capsule (i.e. 290 micrograms of linaclotide) taken orally once a day. The capsule should be taken at least 30 minutes before a meal.
Does Constella help with bloating?
Constella, Linaclotide 290mcg, acts locally in your gut, helping you to feel less pain and less bloated, and to restore the normal functioning of your bowels. It is not absorbed into the body, but attaches to receptor called guanylate cyclase C on the surface of your gut. By attaching to this receptor, it blocks the sensation of pain and allows liquid to enter from the body into the gut, thereby loosening the stools and increasing your bowel movements.
Can Constella be stopped?
It is preferable to discuss stopping treatment with your doctor before actually doing so. However, treatment with Constella can be safely stopped at any time.
Can you take Constella while breast feeding?
If you are breast-feeding, do not take Constella unless your doctor advises to do so.
What it is used for
CONSTELLA is indicated in adults for the treatment of: irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) when dietary fibre, laxatives and stool softeners have not been sufficient and with adequate constipation minimisation dietary support.
How to take it
The way to take this medicine is: Oral. This medicine is taken by mouth.
Visual appearance
White to off-white opaque body and cap, size '2' hard capsules with "FL 290" printed in grey ink on the cap
Reporting side effects
This medicine is under additional monitoring as it is new or being used in a different way. You can help identify new safety information by reporting any side effects you may get.
How well does linzess work?
Linzess - How well does it work? In the clinical trials for this medication, IBS patients fared better -- 7 percent to 25 percent better -- when taking Linzess than when taking dummy pills (placebos).
What is Linzess?
Linzess (the generic name is linaclotide) is a drug manufactured by Forest Laboratories and Ironwood Pharmaceuticals, and available by prescription only in the US. Linzess is a guanylate cyclase-C agonist. Linzess and its active metabolite bind to GCC and act locally on the luminal surface of the intestinal epithelium.
How much does Linzess cost?
In the US, estimates are that Linzess tablets will sell for somewhere in the range of $6 - $7 each. The drug is expected to generate $2 billion in annual sales for Forest.
How old do you have to be to give Linzess?
Do not give Linzess to children under 6 years of age.
When did Linzess get FDA approval?
As Linzess received US FDA approval in August 2012, the medication has not been on the market long enough to determine safety or effectiveness for long term use for IBS-Constipation. Clinical studies to determine the impact of age and gender on the actions of Linzess have not been conducted. As of November 2012, Linzess, to be known in Europe by ...
What to do if you have diarrhea while taking Linzess?
If you experience any side effects while taking Linzess, call your doctor. If you experience new or worsening abdominal pain not typical of your IBS, or severe diarrhea, call your doctor.
Is linzess safe for diarrhea?
Live. •. Linzess is NOT for diarrhea-predominant Irritable Bowel Syndrome. Linzess is NOT be used in patients 17 years of age and younger. It may harm them. Linzess is NOT to be used in patients with known or suspected mechanical gastrointestinal obstruction. As Linzess received US FDA approval in August 2012, the medication has not been on ...
How Does It Work?
Linaclotide is used to treat certain types of bowel problems (irritable bowel syndrome with constipation, chronic idiopathic constipation). It works by increasing fluid in your intestines and helping speed up movement of food through the gut. Linaclotide may improve stool texture and lessen symptoms such as bloating, abdominal pain/discomfort, straining, and feelings of incomplete bowel movements.
May Treat: Chronic idiopathic constipation · Constipation predominant irritable bowel syndrome
Brand Names: Linzess
Drug Class: Chronic Idiopathic Const. Agents - Guanylate Cyclase-C (GC-C) Agonists · IBS Agent - Guanylate Cyclase-C (GC-C) Agonists
Availability: Prescription Required
Pregnancy: Consult a doctor before using
Lactation: Consult a doctor before using
- Before use, important to read the Medication Guide
- Do not use in kids less than 2.
- Take 30 min before break- fast on an empty stomach.
- Before use, important to read the Medication Guide
- Do not use in kids less than 2.
- Take 30 min before break- fast on an empty stomach.
- May open capsule and pour contents in water.
- May open capsule. Mix into cool applesauce & swallow
- Report severe diarrhea or abdominal pain to Dr.
- Tell doctor if not able to pass stool at all.
- Tell doctor your complete medical history
How Do I Take It?
Warning!
Use with Caution in
Not to Be Used in
Pregnancy and Breastfeeding
- The usual dose is one Constella capsule taken once a day with a drink of water.
- The capsule should be taken on an empty stomach, at least 30 minutes before a meal. Taking the capsule with food is more likely to cause loose and more frequent stools (diarrhoea – see warning below).
- If you forget to take a dose don’t worry, just leave out the forgotten dose and take your next d…
- The usual dose is one Constella capsule taken once a day with a drink of water.
- The capsule should be taken on an empty stomach, at least 30 minutes before a meal. Taking the capsule with food is more likely to cause loose and more frequent stools (diarrhoea – see warning below).
- If you forget to take a dose don’t worry, just leave out the forgotten dose and take your next dose as usual. Do not take a double dose to make up for a missed dose.
- If you have taken this medicine once a day for four weeks and it does not seem to be helping your symptoms, it is important that you let your doctor know.
Side Effects
- This medicine can cause diarrhoea. You should tell your doctor if you experience severe diarrhoea or diarrhoea lasting longer than a week. If you get diarrhoea make sure you drink plenty of fluids...
- Bottles of Constella capsules contain a dessicant (silica gel) that stops the capsules absorbing moisture. It is important to keep your Constella capsules in this bottle and keep it tightly clos…
- This medicine can cause diarrhoea. You should tell your doctor if you experience severe diarrhoea or diarrhoea lasting longer than a week. If you get diarrhoea make sure you drink plenty of fluids...
- Bottles of Constella capsules contain a dessicant (silica gel) that stops the capsules absorbing moisture. It is important to keep your Constella capsules in this bottle and keep it tightly closed...
How Can This Medicine Affect Other Medicines?
- Elderly people.
- People with heart disease or high blood pressure.
- Diabetes.
Other Medicines containing The Same Active Ingredient
- People with a blockage or obstruction in the gut.
- Inflammatory bowel disease such as Crohn's disease or ulcerative colitis.
- Pregnancy.
- Breastfeeding.
Overview
- Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine. 1. There is little information available about the safety of …
Medical use
- Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.
Adverse effects
- It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to make sure that the combination is safe. This medicine can cause diarrhoea, w…
Pharmacology
- There are currently no other medicines available in the UK that contain linaclotide as the active ingredient. Last updated 19.05.2020
Chemistry
Linaclotide, (sold under the brand name Linzess in the US and Mexico, and as Constella elsewhere) is a drug used to treat irritable bowel syndrome with constipation and chronic constipation with no known cause. It has a black box warning about the risk of serious dehydration in children in the US; the most common adverse effects in others are gastrointestinal.
History
Linaclotide is used to treat irritable bowel syndrome with constipation and chronic constipation with no known cause.
It has not been tested in pregnant women and it is unknown if it is excreted in breast milk.
How Does This Medication Work? What Will It Do For Me?
The US label has a black box warning to not use linaclotide in children less than 6 years old and to avoid in people from 6 to 18 years old, due to the risk of serious dehydration.
More than 10% of people taking linaclotide have diarrhea. Between 1% and 10% of people have decreased appetite, dehydration, low potassium, dizziness when standing up too quickly, nausea, vomiting, urgent need to defecate, fecal incontinence, and bleeding in their colon, rectum, and an…
What Form(S) Does This Medication Come in?
Systemic absorption of the globular tetradecapeptide is minimal.
Linaclotide, like the endogenous guanylin and uroguanylin it mimics, is an agonist that activates the cell surface receptor of guanylate cyclase 2C (GC-C). The medication binds to the surface of the intestinal epithelial cells. Linaclotide is minimally absorbed and it is undetectable in the systemic circulation at therapeutic doses. Activation of GC-C increases cyclic guanosine monophosphate (…
How Should I Use This medication?
Linaclotide is a hybrid peptide design of the E.coli heat-stable enterotoxin (STa) and the endogenous peptide hormones endogenous guanylin and uroguanylin. It is a synthetic tetradecapeptide (14 amino acid peptide) with the sequence CCEYCCNPACTGCY by one-letter abbreviation, or by three-letter abbreviation:
H–Cys –Cys –Glu –Tyr –Cys –Cys –Asn –Pro –Ala –Cys –Thr –Gly –Cys –Tyr –…
Who Should Not Take This medication?
The drug was discovered at Microbia, Inc, which had been spun out of the Whitehead Institute in 1998 by postdocs from the lab of Gerald Fink to commercialize the lab's know-how and inventions related to microbial pathogens and biology. In 2002 the company hired Mark Currie who had worked at the Searle division of Monsanto and then had gone to Sepracor. Currie directed the efforts that led to the discovery of linaclotide, which was based on an enterotoxin produced by some str…
What Side Effects Are Possible with This medication?
- Linaclotide belongs to the class of medications called guanylate cyclase-C agonists. It is used to treat irritable bowel syndrome with constipation (IBS-C) and to treatchronic (long-term) constipation.Linaclotide works by increasing fluid in the digestive tract. This causes softening of the stools, increased speed of food and waste travelling throu...
Are There Any Other Precautions Or Warnings For This medication?
- 72 µg Each white-to-off-white, opaque, hard gelatin capsule, imprinted "FL 72" in grey and filled with linaclotide-coated beads, contains 72 µg of linaclotide. Nonmedicinal ingredients:calcium chloride dihydrate, gelatin, hypromellose, iron oxide black, iron oxide yellow, microcrystalline cellulose, polyvinyl alcohol, shellac glaze, talc, and titanium dioxide. 145 µg Each white-to-off-wh…
What Other Drugs Could Interact with This medication?
- The recommended adult dose of linaclotide to treat symptoms of irritable bowel syndrome with constipation is 290 µg taken once a day. The recommended adult starting dose of linaclotide for chronic constipation is145 µg taken once daily. Some people may be prescribed a dose of 72 µg taken once daily, depending on their response to the starting dose. This medication should be ta…