10/1/2016 IBS - DIARRHEA IBS - DIARRHEA DRUGS FOR IBS-DIARRHEA & PPI THERAPY. Irritable Bowel Syndrome (IBS)

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1 DRUGS FOR IBS-DIARRHEA & PPI THERAPY IBS - DIARRHEA Irritable Bowel Syndrome (IBS) a chronic functional disorder of the gastrointestinal tract characterized by chronic abdominal pain and altered bowel habits in the absence of alarm symptoms IBS - DIARRHEA ROME IV CRITERIA Recurrent ABD pain on average at least 1 day a week, in the last 3 months, associated with 2 or more of the following: S/S started at least 6 months ago Related to defecation a/w change in frequency a/w change in consistency (based on Bristol Scale) 1

2 IBS DIARRHEA Management Education & Reassurance Dietary Modifications i.e FODMAP diet Gluten avoidance Physical activity Adjunctive Pharmacologic Therapy Mixed Mu opioid receptor agonist, Delta opioid receptor antagonist & Kappa opioid receptor agonist ** Controlled Substance IV** Mechanism of Action Reduces peristalsis and acts to decrease ABD pain in IBS-D without constipation side effects 2

3 PHARMACODYNAMICS Protein Binding Metabolism via CYP450 Pathway PHARMACOKINECTICS Peak in 1.5 hours with food and 2 hours without Half life hours Excreted feces DOSING Oral dosing: 100 mg BID in pts with a Gallbladder 75 mg BID without Given with food NO dose adjustment for Renal Disease Child-Pugh class A & B use 75 mg BID Child Pugh class C DO NOT USE SIDE EFFECTS Dizziness, Fatigue, Skin Rash, Increased AST and ALT N/V, ABD pain Contraindications Blockage in gallbladder or Sphincter of Oddi dysfunction ETOH Abuse Hx of Pancreatitis Severe liver problems Pregnancy/Lactation 3

4 DRUG INTERACTIONS Analgesics & Anticholinergics: may increase constipating effects Decrease dose to 75 mg BID in combination with: Hep C drugs, HIV meds, Cyclosporine, Gemfibrozil and Rifampin IBS DIARRHEA Mechanism of Action Non systemically absorbed antibiotics. Approved in 2015 Inhibits of protein synthesis and growth of bacteria 4

5 PHARMACODYNAMICS Binds to Protein Metabolized mainly by CYP3A PHARMACOKINECTICS Half Life elimination in 6 hours Time to peak ~1 hr Primarily excreted in feces DOSING 550 mg PO TID x 2 weeks Recurrence of s/s can be retreated up to 2 times with same dosing regimen Can be given with or without food Renal = no dose adjustments Hepatic= no dose adjustments; use with caution in Child Pugh class C 3 trials showed that Xifaxan 550 mg relieves multiple symptoms commonly associated with IBS-D. 1 After a single course (ie, 2-week treatment) with Xifaxan 550 mg TID in Trial 1 and Trial 2, patients experienced relief of IBS-D symptoms, i.e abdominal pain, and stool consistency, and effects sustained for an average of 3 months. In Trial 3, repeat treatment with Xifaxan 550 mg was effective when symptoms recurred. 5

6 Side Effects/Contraindications Main side effects are Nausea and Elevated ALT XIFAXAN is contraindicated in patients with a hypersensitivity to rifaximin, any of the rifamycin antimicrobial agents, or any of the components in XIFAXAN. Hypersensitivity reactions have included exfoliative dermatitis, angioneurotic edema, and anaphylaxis. Clostridium difficile-associated diarrhea (CDAD) has been reported with use of antibacterial agents, including XIFAXAN, and may range in severity from mild diarrhea to fatal colitis. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Do NOT use in pregnancy IBS - DIARRHEA Xifaxan 550 TID x 2 wk Viberzi 75/100 mg BID PPI THERAPY 6

7 PPI - OBJECTIVES Data to support use of PPI Examine features of 3 specific PPI drugs Identify appropriate Patients for PPI in clinical practice PPI MECHANISM OF ACTION Final step is known as H-K-ATPaseof acid secretion. PPIs inhibit only active parietal cells ALL are the similar in action; DIFFER in pharmacokinetic properties i.e. pka, bioavailability, peak plasma levels and route of excretion 7

8 PPI - PHARMACOKINETICS Dexlansoprazole Esomeprazole Pantoprazole Time to Peak 1 st peak 1-2 hrs 2 nd peak 4-5 hrs hours hours Metabolism & Clearance Metabolized by Liver Excreted in urine and feces SAME Same + via Bile ph Increase N/A PHARMACOKINETICS DIFFERENCES DEXILANT (DEXLANSOPRAZOLE) Can be given AC or PC Dual Peak pattern Inhibits CYP2C19 Pathway Metabolized by CYP3A4 Nexium (ESOMEPRAZOLE) NO adjustment for renal patients Absorption reduced if taken with food IV Formulation Metabolized by CYP2C19 Pathway; increased risk of drug interaction Protonix (PANTOPRAZOLE) Highest plasma concentration levels IV formulation Used in combination with ADR inhibitors 2 step Metabolism pathway has lowest potential for drug interaction WHO NEEDS A PPI?? 8

9 INDICATIONS FOR PPI USE Eradication of H- pylori GERD/ Esophagitis/ Gastritis Peptic Ulcer Disease Treatment & Prevention of Gastric Ulcer associated with NSAIDS Maintenance Therapy Zollinger-Ellison Syndrome Dexlansoprazole Esomeprazole Pantoprazole H Pylori Rx 30 mg PO BID days 40 mg PO daily days 40 mg PO BID days GERD 30 mg PO daily x 4 20 mg daily mg once daily for up weeks weeks to 8 weeks; can repeat Non Erosive 30 mg PO daily x 4 20 mg daily 4-8 NONE Gastritis weeks weeks Erosive Esophagitis 60 mg PO daily up mg daily x 4 IV: 40 mg once daily for to 8wks 6 weeks or 7 to 10 days IV x 10 days Maintenance Not labeled 20 mg PO daily 40 mg once daily Therapy indication NSAID induced NONE mg daily Prophylaxis dosing label Gastric Ulcer 6 months not in U.S. Prophylaxis & treatment of Ulcers due to NSAIDS GU/DU NONE 80 mg bolus then 8 80 mg bolus then 8 Re- bleeding after mg/hr x 72 hours; mg/hr x 72 hours; then 40 Endoscopy then 40 mg PO mg PO P P I D O S I N G Zollinger-Ellison Syndrome NONE 40 mg twice daily Oral: Initial: 40 mg twice daily IV: 80 mg every 12 hours ; adjusted 9

10 PPI Side Effects Common things are. Uncommon things can occur. PPI-Medication Safety Issues Infections Drug Interactions Malabsorption Dementia & Kidney Disease Atrophic Gastritis PPI-Medication Safety Issues Infections: C-diff, Pneumonia (CAP & HCAP) Malabsorption: Mg, Ca (decreasing bone density)leading to Fractures of hip, wrist, & spine Decreased in Vit B12 absorption & Hypergastrinemia (seen with Omeprazole use) 10

11 PPI-Medication Safety Issues Atrophic Gastritis: risk is small Dementia and Kidney Disease: studies ongoing Drug Interactions: May interfere with drugs that need high ph Increases levels of INR in patients on Coumadin, increase levels of patients on Tacrolimus and Methotrexate PPI-Medication Taper WHY To avoid rebound gastric acid hyersecretion WHEN: Pt s with GERD or Dyspepsia start after asymptomatic x 3 months NO taper need s/p treatment for GU/DU Higher dose 40mg daily BIB; dose reduce by 50% every week 11

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