pharmacology

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timer Asked: Nov 23rd, 2021

Question Description

i need a person to do two slides for me from a group project i will provide all the other slides and informations needed. the parts that say yemi are my part i need those complete

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Linzess (linaclotide) Julia Bohl (slides: 4, 5, 14, 15), Yemima Abraham Kendall Drury-DeBoer (slides: 2, 8, 11, 12, 13, 14), Haley Schaefer (slides: 3, 6, 7) Minnesota State University, Mankato Drug Class ● IBS agent ● Gastrointestinals ● Guanylate cyclase-C agonist: Increases the enzymes on the lining of the intestines. ● Drugs such as Guanylate cyclase-C agonists end in “IDE” similar to the other drug in the category: plecanatide (RxList, 2021). ● Linzess is used for the abdominal pain with patients suffering from IBS and CIC. ○ This drug helps by retaining water in the intestines, and help pass bowels with little side effects (RxList, 2021). https://www.pmlive.com/pharma_news/china_approves_ironwood_pharmas_ibs_treatment_1275420?SQ_DESIGN_NAME=2 Uses for Linzess ● ● ● Once daily pill that treats the symptoms of: Irritable bowel syndrome with constipation (IBS-C) ○ Constipation ○ Belly pain/bloating ○ Pain/Discomfort Chronic idiopathic constipation (CIC) ○ Constipation (Linaclotide, 2013) Linzess treats these common symptoms FDA regulation ● When was the medication approved? ○ August of 2012 Linzess (linaclotide) was approved by the FDA. ● When does the patent rights on the medication end? ○ Linzess is expected to have a patent expiration date in August of 2031. ● Is there a black box warning with this medication? ○ Yes, there is a black box warning for pediatric patients 17 and younger due to deaths from severe dehydration seen during animal studies. ○ “Contraindicated in patients with a GI obstruction” (Lilley et al., 2020, p. 823) ● Is this drug still in a Clinical III trial? ○ No it is not in a clinical III trail Cost of Medication ● What is the cost of a single dose? ○ ○ ● “The average wholesale price (AWP) is $255 for 30 capsules” (Thomas & Allmond, 2013) The average person on Linzess can pay anywhere between $0-$467 per month for the medication, this all depends on what kind of insurance coverage they have and how much coverage they will provide. ○ The cost of a single dose depends on the price that the patient pays for the medication at the pharmacy Is the medication covered by insurance? ○ Linzess can be covered by a variety of insurances, medicare, and medicaid. “The LINZESS® list price, also known as the wholesale acquisition cost (WAC),1 is $467 per month...Depending on insurance coverage, eligible patients may pay as little as $30 for a 30-day or 90-day prescription* with a LINZESS® savings card” (Abbvie, 2021). Patho of IBS ● ● ● ● Believed factors of IBS include: ○ Visceral Hypersensitivity ○ Altered Bowel Motility ○ Neurotransmitter Imbalance ■ Miscommunication between the gut and the brain results in reflex responses ○ Possible Infection ○ Psychological Disorders ■ Stress and anxiety are known to increase symptoms IBS with diarrhea include rapid motility of bowel movements IBS with constipation usually include abnormal function of pelvic floor muscles and the anal sphincter Inflammation can cause an increase of pain associated with IBS ○ Menstrual cycle can aggravate the gut and cause increase IBS symptoms ○ Food sensitivities will create inflammation causing severe symptoms of IBS (Johns Hopkins Medicine, 2021) Patho of Medication ● ● ● ● ● ● ● Linzess is not a laxative Agonist Stimulates the guanylate cyclase-C (GC-C) receptor (Linaclotide, 2013). ○ Local effect on intestinal epithelial cells When GC-C is activated intracellular and extracellular cyclic guanosine monophosphate concentrations (cGMP) increases (Linaclotide, 2013). ○ Stimulates chloride and bicarbonate (intestinal fluid) ○ Decrease in pain sensing nerves due to the increase of extracellular cGMP Half-life cannot be calculated (Mechanism of Action, 2021) Works throughout the upper and lower GI tract (Mechanism of Action, 2021) Works to: ○ Increase GI motility ○ Reduce visceral hypersensitivity Pharmacogenomics ● Is there a pharmacogenomics link? ○ ● There is no pharmacogenomics link to Linzess (Center for Drug Evaluation and Research, n.d.). There are many cytochrome pathways? ○ “Linaclotide does not affect cytochrome P450 or P-glycoprotein and should have no effect on drugs eliminated through either of these pathways” (Cada, D. J., Levien, T. L., & Baker, D. E., 2013). Dosing Nursing Interventions pt. 1 (Yemi) ● List all the routes and general dosing parameters Dosing Nursing Interventions pt. 2 (Yemi) ● Identify all the nursing interventions need ( is. beta blocker- monitor BP and HR before giving, or ie. enoxoparin - monitor the skin site, document the site of injection and why you rotate the injection site, how often do you monitor labs, how long is this medication given) Dietary Supplement ● Are there any supplements or diet maintenance that can interact with this medication? ○ It should be noted that linaclotide should be taken 30 minutes before the first meal of the day to avoid an upset stomach. ○ Minor drug interactions with linzess are the following: MiraLAX, omeprazole, pantoprazole, Vitamin D3 ○ Major drug interactions: levothyroxine ○ Linaclotide does not have that many drug interactions and the ones it does have are simple interactions. ○ It is also often advised to be eating a diet high in fiber, fruits and veggies to help with an upset stomach, these also help with passing stools. ○ Drinking 6-8 glasses a day is recommended for this drug, staying hydrated to keep from losing too much fluid from diarrheal symptoms of the drug and also the condition of IBS. (Linzess and Vitamin D3 Interactions, n.d.) Compare Effectiveness pt. 1 (Thomas, R. H., & Allmond, K., 2013) ● The individuals in this study were a majority women (87%–92%) and also Caucasian (73%–79%) (para. 20). ● 87-88% of patients reported less pain on a 0-10 point scale after linaclotide drug therapy (mean scores, 5.6–5.7 and 5.5–5.6 (para 22). ● 76% of patients reported a stop of spontaneous bowel movements of 0.2 a week (para. 22). ● “Despite the cost of linaclotide, its efficacy and safety, in conjunction with the dearth of other treatments for IBS–C and CIC, make it an important emerging therapeutic option for patients with IBS–C or CIC” (Thomas, R. H., & Allmond, K., 2013, para. 71). ● The study does state that a significant improvements in abdominal pain, discomfort and bloating was noted while taking Linaclotide. Thomas, R. H., & Allmond, K. (2013). Linaclotide (Linzess) for Irritable Bowel syndrome With Constipation and For Chronic Idiopathic Constipation. P & T : a peer-reviewed journal for formulary management, 38(3), 154–160. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3638410/ Compare Effectiveness pt. 2 (Lacy. B.E., Levenick, J.M., & Crowell, M.D. 2012) ● 310 patients (92% women; 84% white; mean age, 47.3 years), little diversity was used to research the effects on other races (Lacy. B.E., Levenick, J.M., & Crowell, M.D. 2012, para. 16). ● The study proved that linaclotide improved straining, stool consistency and abdominal pain after taking linaclotide. “Constipation severity, IBS severity, and global relief of IBS were all significantly improved with ○ linaclotide” (Lacy. B.E., Levenick, J.M., & Crowell, M.D. 2012, para. 14). ● All patients, after the cessation of taking linaclotide, stated their pain returned to their regular pain levels of IBS. Lacy, B. E., Levenick, J. M., & Crowell, M. D. (2012). Linaclotide: a novel therapy for chronic constipation and constipation-predominant irritable bowel syndrome. Gastroenterology & hepatology, 8(10), 653–660. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3969007/ Adverse Effects of Medication ● Diarrhea ○ Due to the increased secretion of chloride and bicarbonate in the intestines. These two compounds increase intestinal secretions easing the passing of stool. ○ Other factor is that Linzess decreases the amount of time it takes for food to travel through digestive tract ○ Avoiding dairy, stress, drinking lots of water, eat lot of bland foods and avoiding spicy foods help with diarrhea. ● Abdominal Pain ○ ● Generally caused from the increased compounds leading to diarrhea Flatulence ○ Caused by the incorrect breakdown of carbs that isn't absorbed by the small intestine and quickly break down in the large intestine, producing gas. ○ Adjusting the diet to ingesting less carbs helps with decreasing flatulence in IBS, but will not always fix it (Halser, 2006). Education of Client ● What will you teach the client about what to monitor? ○ If they experience diarrhea during the first 2 weeks of Linzess treatment to contact their doctor immediately. ○ Be cautious of becoming pregnant while on Linzess ○ Watch for possible hypersensitivity to medication ○ Do not use if pregnant and watch for possible pregnancies if sexually active ○ Do not use for a GI obstruction ○ Watch for bloody, black stools and unfamiliar tightness in abdomen ● What lab values will be linked to this medication? ○ “No clinically significant differences in laboratory values or vital signs were noted between the linaclotide and placebo groups” (Thomas & Allmond, 2013) References 20, S. C. T., A., Team, S. C., & Team, S. C. (2021). A guide to linzess side effects. https://www.singlecare.com/blog/linzess-side-effects/. Abbvie . (2021). Allergan pricing: Linzess (linaclotide). Allergan Pricing | LINZESS (linaclotide). Retrieved November 22, 2021, from https://www.allerganpricing.com/Linzess?guid=Linzess_DTC_Pricing. Cada, D. J., Levien, T. L., & Baker, D. E. (2013). Linaclotide. Hospital pharmacy, 48(2), 143–152. https://doi.org/10.1310/hpj4802-143.test Center for Drug Evaluation and Research. (n.d.). Table of substrates, inhibitors and inducers. U.S. Food and Drug Administration. https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers#table1-2. Hasler W. L. (2006). Gas and Bloating. Gastroenterology & hepatology, 2(9), 654–662. Johns Hopkins Medicine. (2021). https://www.hopkinsmedicine.org/gastroenterology_hepatology/_pdfs/small_large_intestine/irritable_bowel_byndrome_ibs.pdf Lacy, B. E., Levenick, J. M., & Crowell, M. D. (2012). Linaclotide: a novel therapy for chronic constipation and constipation-predominant irritable bowel syndrome. Gastroenterology & hepatology, 8(10), 653–660.https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3969007/ References Lilley, L. L., Collins, S. R., & Snyder, J. S. (2020). Drugs for irritable bowel syndrome . In Pharmacology and the nursing process. Elsevier. Talk with a doctor online* in just a few steps. Help Relieve Symptoms of IBS-C & CIC | LINZESS (linaclotide). https://www.linzess.com/why-linzess/how-linzess-can-help?guid=sem_goo_43700062627792097&gclid=CjwKCAiAnO2MBhApEiwA8q0HYcMj8P8C4Uv8JiToLr-1u ZiqAYoVIweqEyXI-3kkHcJyv8Y3BzVRohoCTXYQAvD_BwE&gclsrc=aw.ds. Linaclotide: Uses, Interactions. (2013). Mechanism of Action. DrugBank Online DrugBank. https://go.drugbank.com/drugs/DB08890 Linzess and Vitamin D3 Interactions. (n.d) Drugs.com. . https://www.drugs.com/drug-interactions/linzess-with-vitamin-d3-3413-15864-646-5790.html. Mechanism of Action (2021). LINZESS® (linaclotide) | For HCPs. https://www.linzesshcp.com/MOA RxList. (2020). Linzess (Linaclotide capsules): Uses, dosage, side effects, interactions, warning. https://www.rxlist.com/linzess-drug.htm. Thomas, R. H., & Allmond, K. (2013). Linaclotide (Linzess) for Irritable Bowel syndrome With Constipation and For Chronic Idiopathic Constipation. P & T : a peer-reviewed journal for formulary management, 38(3), 154–160. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3638410/
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