a fairly large [2%),:<2%), cardiac arrhythmia (> <2%), chest pain (> <2%), deep vein thrombosis (> <2%), edema (> <2%; including oral, facial, and pharyngeal), hypertension (> <2%), palpitations (> <2%), tachycardia (> <2%) Central nervous system: Headache (> <2%; adolescents: 5%), abnormal dreams (> <2%), anxiety (> <2%), chills (> <2%), depression (> <2%), dizziness (> <2%), falling (> <2%), feeling abnormal (> <2%), insomnia (> <2%), memory impairment (> <2%), migraine (> <2%), myocardial infarction (> <2%), pain (> <2%), painful defecation (> <2%), paresthesia (oral:> <2%), procedural pain (> <2%), psychomotor agitation (> <2%), seizure (> <2%), trigeminal neuralgia (> <2%), vertigo (> <2%) Dermatologic: Acne vulgaris (> <2%), dermatitis (> <2%), erythema (> <2%), pruritus (> <2%), skin lesion (> <2%), skin rash (> <2%), sunburn (> <2%), urticaria (> <2%) Endocrine & metabolic: Change in libido (> <2%), goiter (> <2%), hot flash (> <2%), hypercalcemia (> <2%), hypermenorrhea (> <2%), hypokalemia (> <2%), increased gastrin (> <2%), increased serum glucose (> <2%), increased serum potassium (> <2%), increased serum total protein (> <2%), menstrual disease (> <2%), weight gain (> <2%) Gastrointestinal: Abdominal pain (adolescents: 5%), diarrhea (adolescents and adults: 5%), flatulence (1% to 3%), abdominal distress (> <2%), abdominal tenderness (> <2%), abnormal bowel sounds (> <2%), abnormal stools (> <2%), anorectal pain (> <2%), Barrett esophagus (> <2%), bezoar formation (> <2%), biliary colic (> <2%), change in appetite (> <2%), cholelithiasis (> <2%), colitis (microscopic;> <2%), colonic polyps (> <2%), constipation (> <2%), delayed gastric emptying (> <2%), duodenitis (> <2%), dysgeusia (> <2%), dyspepsia (> <2%), dysphagia (> <2%), enteritis (> <2%), eructation (> <2%), esophagitis (> <2%), gastric polyp (> <2%), gastritis (> <2%), gastroenteritis (> <2%), gastroesophageal reflux disease (> <2%), gastrointestinal disease (> <2%), gastrointestinal hypermotility (> <2%), gastrointestinal perforation (> <2%), gastrointestinal ulcer (> <2%), halitosis (> <2%), hematemesis (> <2%), hematochezia (> <2%), hemorrhoids (> <2%), hiccups (> <2%), irritable bowel syndrome (> <2%), mucosal inflammation (> <2%), mucus stools (> <2%), oral bullae (> <2%), oral herpes (> <2%), proctitis (> <2%), retching (> <2%), sore throat (> <2%), vomiting (2%), xerostomia (> <2%) Genitourinary: Dysmenorrhea (> <2%), dyspareunia (> <2%), dysuria (> <2%), urinary urgency (> <2%), vulvovaginal infection (> <2%) Hematologic & oncologic: Anemia (> <2%), decreased platelet count (> <2%), lymphadenopathy (> <2%), rectal hemorrhage (> <2%) Hepatic: Abnormal hepatic function tests (> <2%), decreased serum bilirubin (> <2%), hepatomegaly (> <2%), increased serum alkaline phosphatase (> <2%), increased serum ALT (> <2%), increased serum AST (> <2%), increased serum bilirubin (> <2%) Hypersensitivity: Hypersensitivity reaction (> <2%) Infection: Candidiasis (> <2%), influenza (> <2%), viral infection (> <2%) Neuromuscular & skeletal: Arthralgia (> <2%), arthritis (> <2%), bone fracture (> <2%), joint sprain (> <2%), muscle cramps (> <2%), musculoskeletal pain (> <2%), myalgia (> <2%), tremor (> <2%), weakness (> <2%) Ophthalmic: Eye irritation (> <2%), swelling of eye (> <2%) Otic: Otalgia (> <2%), tinnitus (> <2%) Renal: Increased serum creatinine (> <2%) Respiratory: Nasopharyngitis (adults:> <2%; adolescents: 5%), oropharyngeal pain (adolescents: 5%), upper respiratory tract infection (2% to 3%), aspiration (> <2%), asthma (> <2%), bronchitis (> <2%), cough (> <2%), dyspnea (> <2%), hyperventilation (> <2%), pharyngitis (> <2%), respiratory congestion (> <2%), sinusitis (> <2%) Miscellaneous: Fever (> <2%), inflammation (> <2%), nodule (> <2%)> <1%, postmarketing, and/or case reports: Acute renal failure, anaphylactic shock, autoimmune hemolytic anemia, blurred vision, cerebrovascular accident, chronic renal insufficiency (Lazarus 2016), Clostridium difficile -associated diarrhea, constriction of the pharynx, deafness, exfoliative dermatitis, hepatitis, hepatotoxicity (idiosyncratic) (Chalasani 2014), hypersensitivity angiitis, hypomagnesemia, hyponatremia, immune thrombocytopenia, pancreatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, transient ischemic attacks Warnings/Precautions Concerns related to adverse effects: Carcinoma: No occurrences of enterochromaffin-like (ECL) cell carcinoids, dysplasia, or neoplasia (such as those seen in studies of rodents exposed to lansoprazole) have been reported in humans. Clostridium difficile -associated diarrhea (CDAD): Use of proton pump inhibitors (PPIs) may increase risk of CDAD, especially in hospitalized patients; consider CDAD diagnosis in patients with persistent diarrhea that does not improve. Use the lowest dose and shortest duration of PPI therapy appropriate for the condition being treated. Cutaneous and systemic lupus erythematosus: Has been reported as new onset or exacerbation of existing autoimmune disease; most cases were cutaneous lupus erythematosus (CLE), most commonly, subacute CLE (occurring within weeks to years after continuous therapy). Systemic lupus erythematosus (SLE) is less common (typically occurs within days to years after initiating treatment) and occurred primarily in young adults up to elderly patients. Discontinue therapy if signs or symptoms of CLE or SLE occur and refer to specialist for evaluation; most patients improve 4 to 12 weeks after discontinuation of dexlansoprazole. Fractures: Increased incidence of osteoporosis-related bone fractures of the hip, spine, or wrist may occur with PPI therapy. Patients on high-dose (multiple daily doses) or long-term therapy ( 1 year) should be monitored. Use the lowest effective dose for the shortest duration of time, use vitamin D and calcium supplementation, and follow appropriate guidelines to reduce risk of fractures in patients at risk. Hypomagnesemia: Reported rarely, usually with prolonged PPI use of 3 months (most cases> 1 year of therapy). May be symptomatic or asymptomatic; severe cases may cause tetany, seizures, and cardiac arrhythmias. Consider obtaining serum magnesium concentrations prior to beginning long-term therapy, especially if taking concomitant digoxin, diuretics, or other drugs known to cause hypomagnesemia; and periodically thereafter. Hypomagnesemia may be corrected by magnesium supplementation, although discontinuation of dexlansoprazole may be necessary; magnesium levels typically return to normal within 1 week of stopping. Interstitial nephritis: Acute interstitial nephritis has been observed in patients taking PPIs; may occur at any time during therapy and is generally due to an idiopathic hypersensitivity reaction. Discontinue if acute interstitial nephritis develops. Vitamin B 12 deficiency: Prolonged treatment ( 2 years) may lead to vitamin B 12 malabsorption and subsequent vitamin B 12 deficiency. The magnitude of the deficiency is dose related and the association is stronger in females and those younger in age ( <30 years); prevalence is decreased after discontinuation of therapy (Lam 2013). Disease-related concerns: Gastric malignancy: Relief of symptoms does not preclude the presence of a gastric malignancy. Gastrointestinal infection (eg, Salmonella, Campylobacter ): Use of PPIs may increase risk of these infections. Hepatic impairment: Patients with moderate hepatic impairment (Child-Pugh class B) may require dosage reductions; use is not recommended in patients with severe hepatic impairment (Child-Pugh class C). Concurrent drug therapy issues: Clopidogrel: PPIs may diminish the therapeutic effect of clopidogrel, thought to be due to reduced formation of the active metabolite of clopidogrel. The manufacturer of clopidogrel recommends either avoidance of both omeprazole (even when scheduled 12 hours apart) and esomeprazole or use of a PPI with comparatively less effect on the active metabolite of clopidogrel (eg, pantoprazole). Although lansoprazole exhibits the most potent CYP2C19 inhibition in vitro (Li 2004; Ogilvie 2011), an in vivo study of extensive CYP2C19 metabolizers showed less reduction of the active metabolite of clopidogrel when administered with lansoprazole/dexlansoprazole compared to esomeprazole/omeprazole (Frelinger 2012). In contrast to these warnings, others have recommended the continued use of PPIs, regardless of the degree of inhibition, in patients with a history of GI bleeding or multiple risk factors for GI bleeding who are also receiving clopidogrel since no evidence has established clinically meaningful differences in outcome; however, a clinically significant interaction cannot be excluded in those who are poor metabolizers of clopidogrel (Abraham 2010; Levine 2011). The manufacturer of dexlansoprazole states that no dosage adjustment is necessary for clopidogrel when used concurrently with approved doses. Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information. Other warnings/precautions: Laboratory test interference: Serum chromogranin A (CgA) levels increase secondary to drug-induced decreases in gastric acid; may cause false-positive results in diagnostic investigations for neuroendocrine tumors. Temporarily stop dexlansoprazole treatment at least 14 days before CgA test; if CgA level is high, repeat test to confirm. Use same commercial laboratory for testing to prevent variable results. Monitoring Parameters Magnesium levels (prior to initiation of therapy and periodically thereafter) in patients on long-term treatment or those taking digoxin, diuretics, or other drugs that cause hypomagnesemia. Pregnancy Considerations Adverse events have not been observed in animal reproduction studies. Dexlansoprazole is the R-enantiomer of lansoprazole. Information related to dexlansoprazole in pregnancy has not been located. Refer to the lansoprazole monograph for additional information. When treating GERD in pregnancy, PPIs may be used when clinically indicated (Katz 2013). 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 abdominal pain, nausea, vomiting, flatulence, diarrhea, or signs of common cold. Have patient report immediately to prescriber signs of low magnesium (mood changes; muscle pain or weakness; muscle cramps or spasms; seizures; tremors; lack of appetite; severe nausea or vomiting; or an abnormal heartbeat), signs of kidney problems (urinary retention, hematuria, change in amount of urine passed, or weight gain), signs of lupus (rash on the cheeks or other body parts, sunburn easy, muscle or joint pain, angina or shortness of breath, or swelling in the arms or legs), dizziness, passing out, tachycardia, bone pain, signs of Clostridium difficile ( C. diff )-associated diarrhea (abdominal pain or cramps, severe diarrhea or watery stools, or bloody stools), or signs of Stevens-Johnson syndrome/toxic epidermal necrolysis (red, swollen, blistered, or peeling skin [with or without fever]; red or irritated eyes; or sores in mouth, throat, nose, or eyes) (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. 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