Larazotide Dosing Calculator

Dose

0.5 mg

Frequency

Three times daily (before meals)

Duration

8-12 weeks

Route

Oral

Mirrors the Phase 2b clinical trial dose that showed statistical significance; taken 15 minutes before meals

Dose

0.25 mg

Frequency

Three times daily

Duration

Ongoing

Route

Oral

Lower dose for ongoing gut permeability support; used by those with celiac disease on gluten-free diets

Dose

0.5-1 mg

Frequency

Three times daily

Duration

4-8 weeks

Route

Oral

Used beyond celiac disease for general intestinal permeability concerns; community extension of clinical indications

Dose

0.25 mg and 0.5 mg oral capsules three times daily in patients on a gluten-free diet with persistent symptoms.

Frequency

Three times daily

Duration

24-week treatment period

Phase 3 trial was discontinued after interim analysis of 525 patients showed insufficient treatment effect to justify continuation.

How much bacteriostatic water should I add to a 5 mg vial of Larazotide?

The community standard is 2 mL of bacteriostatic water for a 5 mg Larazotide vial. That gives a concentration of 2.50 mg/mL, so a 500 mcg dose is 20 units on a U-100 insulin syringe. Adding 1 mL instead doubles the concentration to 5.00 mg/mL and halves the draw to 10 units. Less water = smaller injection volume but harder to measure precisely.

How many syringe units is a 500 mcg dose of Larazotide?

On a standard U-100 insulin syringe, a 500 mcg dose of Larazotide is 20 units when the 5 mg vial is reconstituted with 2 mL of bacteriostatic water (2.50 mg/mL). If you use 1 mL of bac water instead, draw 10 units (5.00 mg/mL).

What is the standard Larazotide dose?

Clinical protocols for Larazotide typically use 0.5 mg–1 mg once daily via subcutaneous injection. 500 mcg is a common starting dose. The 0.5 mg TID dose was the only dose to reach statistical significance versus placebo. The inverted dose-response (lower dose more effective) may reflect receptor occupancy dynamics at the gut surface.

How long does a vial of Larazotide last at 500 mcg once daily?

A 5 mg vial of Larazotide contains roughly 10 doses at 500 mcg per injection. At once daily dosing, that is approximately 10 days (about 1 weeks) of supply per vial. Reconstituted Larazotide should generally be used within 28 days when refrigerated.

Where do you inject Larazotide?

Larazotide is typically injected subcutaneously. Common sites reported in the literature and by users include: Not applicable -- larazotide is an oral capsule formulation. Rotate sites with each injection to reduce localized irritation.

Can I use sterile water instead of bacteriostatic water for Larazotide?

Bacteriostatic water (containing 0.9% benzyl alcohol as a preservative) is strongly preferred for multi-dose vials like Larazotide because it inhibits microbial growth and lets a single vial be used over multiple weeks. Sterile water has no preservative and should generally be reserved for single-use preparations only.