on the other hand Crofelemer Overview Side Effects Dosage Professional Pregnancy More User Reviews Support Group Q & A Pronunciation (kroe FEL e mer) Index Terms Croton lechleri Provir SP-303 Slideshow Seasoned Pro: Be Mindful of These Winter Health Hazards Dosage Forms Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product Tablet Delayed Release, Oral: Fulyzaq: 125 mg [DSC] [contains methylparaben, propylparaben] Mytesi: 125 mg [contains methylparaben, propylparaben] Brand Names: U.S. Fulyzaq [DSC] Mytesi Pharmacologic Category Antidiarrheal Pharmacology Inhibits cyclic adenosine monophosphate (cAMP)-stimulated cystic fibrosis transmembrane conductance regulator (CFTR) chloride ion channel and calcium activated chloride ion channels at the enterocyte luminal membrane. This regulates fluid secretion and water loss (high volume) due to diarrhea, normalizing chloride ion and water flow in the GI tract. Absorption Minimal systemic absorption Use: Labeled Indications Symptomatic relief of noninfectious diarrhea in patients with HIV/AIDS on antiretroviral therapy Contraindications There are no contraindications listed in the manufacturer s labeling. Dosing: Adult Diarrhea, noninfectious (associated with antiretroviral therapy for HIV/AIDS): Oral: 125 mg twice daily Dosing: Renal Impairment No dosage adjustment provided in the manufacturer s labeling. Dosing: Hepatic Impairment No dosage adjustment provided in the manufacturer s labeling. Administration May be administered orally with or without food. Swallow whole; do not crush or chew. Dietary Considerations May be taken with or without food. Storage Store at 20 C to 25 C (68 F to 77 F); excursions permitted to 15 C to 30 C (59 F to 86 F). Drug Interactions There are no known significant interactions. Adverse Reactions 1% to 10%: Central nervous system: Anxiety (2%), depression (1% to 2%), dizziness (1% to 2%) Dermatologic: Acne vulgaris (1% to 2%), dermatitis (1% to 2%) Gastrointestinal: Flatulence (3%), nausea (3%), abdominal distention (2%), giardiasis (2%), hemorrhoids (2%), abdominal pain (1% to 2%), constipation (1% to 2%), dyspepsia (1% to 2%), gastroenteritis (1% to 2%), xerostomia (1% to 2%) Genitourinary: Urinary tract infection (2%), pollakiuria (1% to 2%) Hematologic & oncologic: Leukopenia (1% to 2%) Hepatic: Hyperbilirubinemia (1% to 3%), increased serum ALT (2%), increased serum AST (1% to 2%) Hypersensitivity: Seasonal allergy (1% to 2%) Infection: Herpes zoster (1% to 2%) Neuromuscular & skeletal: Arthralgia (3%), back pain (3%), musculoskeletal pain (2%), limb pain (1% to 2%) Renal: Nephrolithiasis (1% to 2%) Respiratory: Upper respiratory tract infection (6%), bronchitis (4%), cough (4%), nasopharyngitis (2%), sinusitis (1% to 2%) Warnings/Precautions Disease-related concerns: HIV/AIDS: CD4 cell count and viral load do not have a clinical impact on crofelemer treatment; no adjustments are necessary based on CD4 cell count or viral load. Infectious diarrhea: Crofelemer is not indicated for infectious diarrhea; there is a risk of inadequate or delayed treatment if used when infectious diarrhea is present. Rule out infectious causes for diarrhea prior to initiating treatment. Pregnancy Risk Factor C Pregnancy Considerations Adverse events were observed in some animal reproduction studies; however, maternal toxicity was also present. Systemic absorption following oral administration is limited. Patient Education Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?) Patient may experience flatulence, cough, pharyngitis, rhinitis, or rhinorrhea (HCAHPS). Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions. Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients. Next Pregnancy Warnings Print this page Add to My Med List More about crofelemer Side Effects During Pregnancy Dosage Information Support Group En Español 0 Reviews Add your own review/rating Drug class: antidiarrheals Consumer resources Crofelemer Crofelemer (Advanced Reading) Professional resources Crofelemer (AHFS Monograph) Other brands: Fulyzaq , Mytesi Related treatment guides Diarrhea Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Crofelemer Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first! Drug Class Antidiarrheals Related Drugs antidiarrheals loperamide , Lomotil , Imodium , Acidophilus , atropine / diphenoxylate , Florastor Diarrhea loperamide , Lomotil , Imodium , Acidophilus , atropine / diphenoxylate , neomycin , Florastor , lactobacillus acidophilus , Pepto-Bismol , bismuth subsalicylate , Florajen , saccharomyces boulardii lyo , Imodium A-D , Kaopectate , Anti-Diarrheal , Pedialyte , opium , Bacid (LAC) , Bismatrol , attapulgite , Flora-Q , RisaQuad , More... prospective customers
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