Source: FDA, National Drug Code (US) Revision Year: 2020
TRULANCE (plecanatide) is a guanylate cyclase-C (GC-C) agonist. Plecanatide is a 16 amino acid peptide with the following chemical name: L-Leucine, L-asparaginyl-L-α-aspartyl-L-α-glutamyl-L-cysteinyl-L-α-glutamyl-L-leucyl-L-cysteinyl-L-valyl-L-asparaginyl-L-valyl-L-alanyl-L-cysteinyl-L-threonylglycyl-L-cysteinyl-, cyclic (4→12),(7→15)-bis(disulfide).
The molecular formula of plecanatide is C65H104N18O26S4 and the molecular weight is 1682 Daltons.
The amino acid sequence for plecanatide is shown below:
The solid lines linking cysteines illustrate disulfide bridges.
Plecanatide is an amorphous, white to off-white powder. It is soluble in water. TRULANCE tablets are supplied as 3 mg tablets for oral administration. The inactive ingredients are magnesium stearate and microcrystalline cellulose.
| Dosage Forms and Strengths |
|---|
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TRULANCE Tablets: 3 mg: white to off-white, plain, round tablet debossed with “SP” on one side and “3” for 3 mg on the other side. |
| How Supplied | ||||||
|---|---|---|---|---|---|---|
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TRULANCE tablets are packaged in an aluminum foil unit dose blister pack of 30 in a child-resistant pack or in a white, opaque, high-density polyethylene round bottle with a screw-top polypropylene child-resistant cap and heat-activated induction seal. Each bottle container-closure system also contains a desiccant and a polyester coil. TRULANCE 3 mg tablets are white to off-white, plain and round, debossed with “SP” on one side and “3” for 3 mg on the other side and supplied as:
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| Drug | Countries | |
|---|---|---|
| TRULANCE | United States |
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