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Trulance
Overview
What is Trulance?
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 CHNOS 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.
What does Trulance look like?
What are the available doses of Trulance?
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.
What should I talk to my health care provider before I take Trulance?
How should I use Trulance?
TRULANCE is indicated in adults for the treatment of:
The recommended dosage of TRULANCE for the treatment of CIC and IBS-C is 3 mg taken orally once daily.
What interacts with Trulance?
Sorry No Records found
What are the warnings of Trulance?
Sorry No Records found
What are the precautions of Trulance?
Sorry No Records found
What are the side effects of Trulance?
Sorry No records found
What should I look out for while using Trulance?
TRULANCE is contraindicated in:
What might happen if I take too much Trulance?
Sorry No Records found
How should I store and handle Trulance?
Storage and HandlingStore in the refrigerator at 2°C to 8°C (36°F to 46°F). Do not leave PEGASYS out of the refrigerator for more than 24 hours. Do not freeze or shake. Protect from light. Vials, prefilled syringes and autoinjectors are for single use only. Discard any unused portion remaining in the vial, prefilled syringe.Storage and HandlingStore in the refrigerator at 2°C to 8°C (36°F to 46°F). Do not leave PEGASYS out of the refrigerator for more than 24 hours. Do not freeze or shake. Protect from light. Vials, prefilled syringes and autoinjectors are for single use only. Discard any unused portion remaining in the vial, prefilled syringe.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: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:
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Plecanatide is a structural analog of human uroguanylin, and similarly to uroguanylin, plecanatide functions as a guanylate cyclase-C (GC-C) agonist. Both plecanatide and its active metabolite bind to GC-C and act locally on the luminal surface of the intestinal epithelium. Activation of GC-C results in an increase in both intracellular and extracellular concentrations of cyclic guanosine monophosphate (cGMP). Elevation of extracellular cGMP has been associated with a decrease in the activity of pain-sensing nerves in animal models of visceral pain. Elevation of intracellular cGMP stimulates secretion of chloride and bicarbonate into the intestinal lumen, mainly through activation of the cystic fibrosis transmembrane conductance regulator (CFTR) ion channel, resulting in increased intestinal fluid and accelerated transit. In animal models, plecanatide has been shown to increase fluid secretion into the gastrointestinal (GI) tract, accelerate intestinal transit, and cause changes in stool consistency.
In an animal model of visceral pain, plecanatide reduced abdominal muscle contractions, a measure of intestinal pain.
Non-Clinical Toxicology
TRULANCE is contraindicated in:The vasodilating effects of nitroglycerin may be additive with those of other vasodilators. Alcohol, in particular, has been found to exhibit additive effects of this variety.
Concomitant use of Nitroglycerin Transdermal Systems with phosphodiesterase inhibitors in any form is contraindicated (see CONTRAINDICATIONS).
Concomitant use of Nitroglycerin Transdermal Systems with riociguat, a soluble guanylate cyclase stimulator, is contraindicated (see CONTRAINDICATIONS).
Marked symptomatic orthostatic hypotension has been reported when calcium channel blockers and organic nitrates were used in combination. Dose adjustments of either class of agents may be necessary.
TRULANCE is contraindicated in patients less than 6 years of age. The safety and effectiveness of TRULANCE in patients less than 18 years of age have not been established. In young juvenile mice (human age equivalent of approximately 1 month to less than 2 years), plecanatide increased fluid-secretion into the intestines as a consequence of stimulation of guanylate cyclase-C (GC-C), resulting in mortality in some mice within the first 24 hours, apparently due to dehydration. Due to increased intestinal expression of GC-C, patients less than 6 years of age may be more likely than patients 6 years of age and older to develop severe diarrhea and its potentially serious consequences.
Avoid the use of TRULANCE in patients 6 years to less than 18 years of age. Although there were no deaths in older juvenile mice, given the deaths in younger mice and the lack of clinical safety and efficacy data in pediatric patients, avoid the use of TRULANCE in patients 6 years to less than 18 years of age .
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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