Linaclotide: Dosing Protocols
Dosing guidelines, reconstitution, and administration information
๐TL;DR
- โข2 dosing protocols documented
- โขReconstitution instructions included
- โขStorage: Store at 25 degrees C (77 degrees F); excursions permitted to 15-30 degrees C. Keep in original container to protect from moisture. Do not remove desiccant from the bottle. Keep bottle tightly closed.
Protocol Quick-Reference
IBS-C (290 mcg) and chronic idiopathic constipation (145 mcg or 72 mcg)
Dosing
Amount
290 mcg (IBS-C) or 145/72 mcg (CIC)
Frequency
Once daily
Duration
Ongoing
Administration
Route
OralSchedule
Once daily oral capsule
Timing
On empty stomach at least 30 minutes before first meal
Cycle
Duration
Ongoing
Repeatable
Yes
Preparation & Storage
โ Ready-to-use โ no reconstitution required
Storage: Store at room temperature (25 degrees C). Keep in original container with desiccant. Protect from moisture.
๐ก Key Considerations
- โContraindicated in children under 2 years of age
- โAvoid use in children 2-17 years of age
- โTake on empty stomach at least 30 minutes before first meal for optimal effect
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| Purpose | Dose | Frequency | Duration | Notes |
|---|---|---|---|---|
| Irritable Bowel Syndrome with Constipation (IBS-C) | 290 mcg orally once daily on an empty stomach, at least 30 minutes before the first meal of the day. | Once daily oral capsule | Ongoing as needed for symptom management | Swallow capsule whole; do not break or chew. May also be opened and sprinkled on applesauce or administered via nasogastric tube in water. Take consistently at least 30 minutes before first meal. |
| Chronic Idiopathic Constipation (CIC) | 145 mcg orally once daily on an empty stomach. A 72 mcg dose is also available for patients who have difficulty tolerating the 145 mcg dose. | Once daily oral capsule | Ongoing as needed for symptom management | 72 mcg dose approved for CIC patients who cannot tolerate 145 mcg. Both doses should be taken on an empty stomach at least 30 minutes before first meal. |
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๐Reconstitution Instructions
Linaclotide is supplied as oral capsules. No reconstitution required. Capsules may be opened and contents sprinkled on applesauce or mixed with water for nasogastric tube administration.
๐งStorage Requirements
Store at 25 degrees C (77 degrees F); excursions permitted to 15-30 degrees C. Keep in original container to protect from moisture. Do not remove desiccant from the bottle. Keep bottle tightly closed.
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Before You Begin
Review safety warnings and contraindications before starting any protocol.
Prescribing Information#
Linaclotide (Linzess/Constella) is an FDA-approved prescription medication for the treatment of IBS-C and CIC in adults. All dosing information is based on FDA-approved prescribing information. Linaclotide must be prescribed by a qualified healthcare provider.
Indication-Specific Dosing#
IBS-C (Irritable Bowel Syndrome with Constipation)#
The approved dose for IBS-C is 290 mcg once daily. This dose was used in the pivotal phase 3 IBS-C trials and provides both the secretory effect (improved constipation symptoms) and the analgesic effect (reduced abdominal pain and discomfort).
CIC (Chronic Idiopathic Constipation)#
The primary approved dose for CIC is 145 mcg once daily. A lower 72 mcg dose is also approved for patients who have difficulty tolerating the 145 mcg dose. Both doses were evaluated in phase 3 CIC trials.
| Indication | Dose | Key Endpoint |
|---|---|---|
| IBS-C | 290 mcg daily | Bowel symptoms + abdominal pain |
| CIC | 145 mcg daily | Bowel symptoms (CSBM) |
| CIC (lower dose) | 72 mcg daily | For tolerability concerns |
Administration Instructions#
Oral Capsule#
- Timing: Take once daily on an empty stomach, at least 30 minutes before the first meal of the day. Food decreases the bioactivity of linaclotide in the gut.
- Swallow whole: Do not break, crush, or chew the capsule.
- Alternative administration: Capsule may be opened and contents sprinkled on room-temperature applesauce, consumed immediately without chewing. May also be administered via nasogastric or gastric tube mixed in water.
- Consistency: Take at approximately the same time each day.
Missed Doses#
If a dose is missed, skip the missed dose and take the next dose at the regular time. Do not take two doses on the same day.
Storage Requirements#
- Store at room temperature, 25 degrees C (77 degrees F)
- Excursions permitted to 15-30 degrees C (59-86 degrees F)
- Keep in original bottle with desiccant to protect from moisture
- Keep bottle tightly closed
- Do not subdivide or transfer capsules to other containers
Special Populations#
Renal Impairment#
No dose adjustment required. Linaclotide has negligible systemic absorption and is not cleared renally.
Hepatic Impairment#
No dose adjustment required. Linaclotide is not metabolized hepatically.
Pediatric#
Contraindicated in children under 2 years of age due to risk of serious dehydration (deaths observed in neonatal mice). Should be avoided in children ages 2-17 (safety not established).
Elderly#
No dose adjustment required.
Pregnancy#
Limited data. Animal studies at high doses showed no teratogenicity, consistent with minimal systemic absorption. Use if potential benefit justifies potential risk.
Dosing Context#
Linaclotide belongs to the Healing category of research peptides. Dosing protocols for Linaclotide are derived from available clinical trial data. These protocols are provided for research reference only and do not constitute medical advice. Actual dosing decisions should be made by qualified healthcare providers based on individual patient factors.
Research Protocols#
The following dosing protocols have been documented in clinical research for Linaclotide:
Irritable Bowel Syndrome with Constipation (IBS-C)#
Dose: 290 mcg orally once daily on an empty stomach, at least 30 minutes before the first meal of the day.
Frequency: Once daily oral capsule
Duration: Ongoing as needed for symptom management
Swallow capsule whole; do not break or chew. May also be opened and sprinkled on applesauce or administered via nasogastric tube in water. Take consistently at least 30 minutes before first meal.
Chronic Idiopathic Constipation (CIC)#
Dose: 145 mcg orally once daily on an empty stomach. A 72 mcg dose is also available for patients who have difficulty tolerating the 145 mcg dose.
Frequency: Once daily oral capsule
Duration: Ongoing as needed for symptom management
72 mcg dose approved for CIC patients who cannot tolerate 145 mcg. Both doses should be taken on an empty stomach at least 30 minutes before first meal.
Protocol Quick Reference#
Primary Use: IBS-C (290 mcg) and chronic idiopathic constipation (145 mcg or 72 mcg)
Dosing Summary: 290 mcg (IBS-C) or 145/72 mcg (CIC) administered Once daily for Ongoing.
Route of Administration: oral (Once daily oral capsule).
Timing Notes: On empty stomach at least 30 minutes before first meal
Cycle Duration: Ongoing.
Storage: Store at room temperature (25 degrees C). Keep in original container with desiccant. Protect from moisture.
Additional Considerations#
- Contraindicated in children under 2 years of age
- Avoid use in children 2-17 years of age
- Take on empty stomach at least 30 minutes before first meal for optimal effect
Reconstitution and Preparation#
Linaclotide is supplied as oral capsules. No reconstitution required. Capsules may be opened and contents sprinkled on applesauce or mixed with water for nasogastric tube administration.
Storage Requirements#
Store at 25 degrees C (77 degrees F); excursions permitted to 15-30 degrees C. Keep in original container to protect from moisture. Do not remove desiccant from the bottle. Keep bottle tightly closed.
Related Reading#
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Medical Disclaimer
This website is for educational and informational purposes only. The information provided is not intended to diagnose, treat, cure, or prevent any disease. Always consult with a qualified healthcare professional before using any peptide or supplement.