In animal developmental studies, no effects on embryo-fetal development were observed with oral administration of plecanatide in mice and rabbits during organogenesis at doses much higher than the recommended human dosage. Do not store the mixture for later use. Call your doctor for medical advice about side effects. 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. Severe diarrhea was reported in 1% of TRULANCE-treated patients compared to 0.1% of placebo-treated patients [see WARNINGS AND PRECAUTIONS]. Severe diarrhea was reported in 0.6% of TRULANCE-treated patients compared to 0.3% of placebo-treated patients.
Keep out of the reach of children.Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). This feature requires registration. Remove the polyester coil from the bottle and throw it away after opening the bottle.
Avoid use of TRULANCE in patients 6 years to less than 18 years of age [see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS]. Call your doctor for medical advice about side effects. Plecanatide may also be used for purposes not listed in this medication guide.
What are the possible side effects of TRULANCE? Limited systemic exposure to plecanatide was achieved at the tested dose levels in animals, whereas no detectable exposure occurred in humans. Also tell them if you smoke, drink alcohol, or use illegal drugs. Plecanatide is an amorphous, white to off-white powder. Plecanatide was not tumorigenic in mice at oral doses up to 90 mg/kg/day or in rats at oral doses up to 100 mg/kg/day. Patients should always consult their physician with any questions regarding a medical condition and to obtain medical advice and treatment. Take your medicine at regular intervals. In an animal model of visceral pain, plecanatide reduced abdominal muscle contractions, a measure of intestinal pain. TRULANCE tablets should be swallowed whole. NOTE: This sheet is a summary. Place the TRULANCE tablet in a clean cup with 30 mL of room temperature water. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for TRULANCE and any potential adverse effects on the breastfed infant from TRULANCE or from the underlying maternal condition. Visit the FDA MedWatch website or call 1-800-FDA-1088. Avoid the use of TRULANCE in patients 6 years to less than 18 years of age. The TRULANCE tablet will fall apart in the water. What is the most important information I should know about plecanatide (Trulance)? 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 [see CONTRAINDICATIONS, Diarrhea, Use In Specific Populations].
(TROO lans) Some items may interact with your medicine. Patients also met the IBS-C differentiation criteria for constipation, characterized by a stool pattern such that at least 25% of defecations are hard or lumpy stools and no more than 25% of defecations are loose or watery stool.
The safety data described below reflect data from 1449 adult patients with IBS-C randomized in two double-blind, placebo-controlled clinical trials (Study 3 and Study 4) to receive placebo or 3 mg TRULANCE once daily for 12 weeks. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. Table 2 provides the incidence of adverse reactions reported in at least 2% of IBS-C patients treated with TRULANCE and at an incidence that was greater than in the placebo group. Following completion of the study drug treatment period, patients continued to record data in the daily diary for a 2 week Post-Treatment Period. DESCRIPTION.
Plecanatide and its active metabolite were neither substrates nor inhibitors of the transporters P-glycoprotein (Pgp) or breast cancer resistance protein (BCRP) in vitro.
Wait until your next dose, and take only that dose. The efficacy of TRULANCE for the management of symptoms of IBS-C was established in two 12-week, double-blind, placebo-controlled, randomized, multicenter clinical studies in adult patients (Study 3 and Study 4). Take TRULANCE by mouth, 1 time each day with or without food. Following completion of the study drug treatment period, patients continued to record data in the daily diary for a 2-week Post-Treatment Period. Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. The lowest GoodRx price for the most common version of Trulance is around $438.96, 16% off the average retail price of $525.40. Severe diarrhea was reported to occur within the first day of treatment. Keep TRULANCE in a secure place and in the bottle or blister pack that it comes in.
The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. Over the 12 week treatment period, improvements were observed in stool frequency (number of CSBMs/week and SBMs/week) and/or stool consistency (as measured by the BSFS), and/or in the amount of straining with bowel movements (amount of time pushing or physical effort to pass stool) in the TRULANCE group as compared to placebo.
The TRULANCE tablet will fall apart in the water. If a dose is missed, skip the missed dose and take the next dose at the regular time. To stop TRULANCE and contact their healthcare provider if they experience severe diarrhea [see WARNINGS AND PRECAUTIONS]. Table 3: Efficacy Responder Rates in the Two Placebo-controlled Studies of CIC: at least 9 of 12 weeks and at least 3 of the last 4 weeks (ITT Population).
Use of Trulance should be avoided in patients 6 years to less than 18 years of age. Do not keep the mixture for future use. Keep the tablets in their original bottle or blister pack until you are ready to take one. The TRULANCE tablet will fall apart in the water. Mix by gently swirling the tablet and water mixture for at least 15 seconds. Sign up or log in to your free WellRx account to gain access to this and other tools to help make managing your medications and wellness easier. If you see any part of the tablet left in the cup, add another 1 ounce (30 mL) of water to the cup, swirl for at least 15 seconds and use the same catheter tip syringe to give the mixture through the nasogastric or gastric feeding tube. You may report side effects to FDA at 1-800-FDA-1088. Prescription prices may vary from pharmacy to pharmacy and are subject to change. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Side effects that you should report to your doctor or health care professional as soon as possible: Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome): This list may not describe all possible side effects. Plecanatide was minimally absorbed with negligible systemic availability following oral administration. (plecanatide) Tablets. Certain Medicines For Bowel Problems Or Bladder Incontinence (These Can Cause Constipation), Allergic Reactions Like Skin Rash, Itching Or Hives, Swelling Of The Face, Lips, Or Tongue, Fever Or Chills; Cough; Sore Throat; Pain Or Trouble Passing Urine. How Chronic Constipation Affects Your Body, Constipation: Foods to Eat, Foods to Avoid FAQs, Aluminum foil unit dose blister pack of 30 in a child-resistant pack. NOTE: This medicine is only for you. Do not give TRULANCE to other people, even if they have the same symptoms that you have. This is not a complete list of side effects and others may occur.
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