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Indications & Uses
Linzela is indicated for:
Pharmacology
Linaclotide is a peptide taken by mouth that acts as an agonist of guanylate cyclase 2C, and it is used to treat irritable bowel syndrome. Chemically, it is a heterodetic cyclic peptide made up of fourteen amino acids.
Pharmacodynamics: When Linaclotide was taken straight after a high-fat breakfast, stools were looser and passed more often than when it was taken fasting. In clinical trials, Linaclotide was given on an empty stomach, at least 30 minutes before breakfast.
Pharmacokinetics: Very little Linaclotide is absorbed after an oral dose, so the amount reaching the blood is negligible. Plasma concentrations of Linaclotide and its active metabolite were below the limit of quantitation after oral doses of 145 mcg or 290 mcg. Because of this, standard pharmacokinetic parameters such as the area under the curve (AUC), maximum concentration (Cmax) and half-life (t1/2) cannot be calculated. And since plasma concentrations can't be measured at the recommended oral doses, Linaclotide is not expected to spread into tissues to any clinically relevant extent. Linaclotide is metabolized inside the gastrointestinal tract, where it loses its terminal tyrosine moiety and becomes its principal active metabolite. Both Linaclotide and this metabolite are then broken down by proteolysis in the intestinal lumen into smaller peptides and naturally occurring amino acids. In healthy subjects given Linaclotide 290 mcg once daily for seven days, the active peptide recovered in stool samples averaged about 5% when fasted and about 3% when fed, and all of it was the active metabolite.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
For irritable bowel syndrome with constipation (IBS-C), the recommended dose of Linaclotide is one 290 mcg capsule taken by mouth once daily.
For chronic idiopathic constipation (CIC), the recommended dose of Linaclotide is one 145 mcg capsule taken by mouth once daily. A dose of one 72 mcg capsule once daily may be used instead, depending on the person's presentation or how well they tolerate the medicine.
Side Effects
Adverse reactions reported with Linaclotide include diarrhea, abdominal pain, flatulence, upper respiratory infection (URI), headache, viral gastroenteritis, sinusitis, abdominal distension, severe diarrhea, dyspepsia, fecal incontinence, GERD, vomiting and fatigue. The side effects you may notice are diarrhea, stomach or abdominal pain or discomfort, gas, bloating, heartburn, vomiting and headache. Some people get cold symptoms such as a stuffy nose, sneezing or sinus pain. Others have swelling, or a feeling of fullness or pressure in the abdomen (distention).
Cautions & Contraindications
Warnings & Precautions
Linaclotide carries a risk of serious dehydration in children. It is contraindicated in patients less than 6 years of age, and its safety and effectiveness have not been established in patients less than 18 years of age. In neonatal mice (human age equivalent of approximately 0 to 28 days), the medicine increased fluid secretion as a result of GC-C agonism, and the animals died from dehydration within the first 24 hours. Intestinal expression of GC-C is increased in young children, so patients less than 6 years of age may be more likely than those 6 years of age and older to develop severe diarrhea and its potentially serious consequences. Avoid use in pediatric patients 6 years to less than 18 years of age. No deaths were seen in older juvenile mice, but deaths did occur in young juvenile mice, and there are no clinical safety and efficacy data in pediatric patients. For these reasons, use should be avoided in this age group. Diarrhea was the most common adverse reaction in patients treated with Linaclotide in the pooled IBS-C and CIC double-blind placebo-controlled trials. It occurred at a similar rate in the IBS-C and CIC populations. Severe diarrhea was reported in 2% of patients treated with 145 meg and 290 meg, and in <1% of CIC patients treated with 72 meg. In post-marketing experience, some patients developed severe diarrhea together with dizziness, syncope, hypotension and electrolyte abnormalities (hypokalemia and hyponatremia). These patients needed hospitalization or intravenous fluids. If severe diarrhea occurs, suspend dosing and rehydrate the patient.
Contraindications
Linaclotide must not be used in patients less than 6 years of age, because of the risk of serious dehydration. It must also not be used in patients with known or suspected mechanical gastrointestinal obstruction.
Pregnancy & Breastfeeding
Linaclotide falls under Pregnancy Category C. A pregnant woman should take it only if the likely benefit to her justifies the possible risk to the baby.
It isn't known whether linaclotide passes into breast milk. That said, neither linaclotide nor its active metabolite can be measured in the blood plasma after the recommended clinical doses are given.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Overdose
Linaclotide was given to 22 healthy subjects as single 1 doses of 2897 meg. The safety profile in these subjects matched that of the overall Linaclotide-treated population, and diarrhea was the most commonly reported adverse reaction.
⚠️ In an emergency call 999 or go to the nearest hospital emergency department.
Storage
Store Linaclotide between 2°C and 8°C, in a place that stays free of frost. Keep it away from light, and keep it out of the reach of children.
Common questions about Linzela 72 mcg
What is Linzela 72 mcg Capsule?
Linzela 72 mcg Capsule is a medicine that contains Linaclotide. It is made by Nuvista Pharma PLC. It belongs to the Other laxative preparations group of medicines.
What is Linzela used for?
Linzela is used for: Constipation, Irritable Bowel Syndrome.
What are the side effects of Linzela?
Adverse reactions reported with Linaclotide include diarrhea, abdominal pain, flatulence, upper respiratory infection (URI), headache, viral gastroenteritis, sinusitis, abdominal distension, severe diarrhea, dyspepsia, fecal incontinence, GERD, vomiting and fatigue. The side effects you may notice are diarrhea, stomach or abdominal pain or discomfort, gas, bloating, heartburn, vomiting and headache.
Can I take Linzela during pregnancy or while breastfeeding?
Linaclotide falls under Pregnancy Category C. A pregnant woman should take it only if the likely benefit to her justifies the possible risk to the baby. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
What happens if I take too much Linzela?
Linaclotide was given to 22 healthy subjects as single 1 doses of 2897 meg. The safety profile in these subjects matched that of the overall Linaclotide-treated population, and diarrhea was the most commonly reported adverse reaction. In an emergency call 999 or go to the nearest hospital emergency department.
How should I store Linzela?
Store Linaclotide between 2°C and 8°C, in a place that stays free of frost. Keep it away from light, and keep it out of the reach of children.
Is there a cheaper medicine with the same ingredient?
Linzela is already among the lowest-priced brands of Linaclotide at this strength.
Do I need a prescription for Linzela?
Linzela is a prescription (Rx) medicine. Take it as your doctor advises.