Dexilant

Dexilant

dexlansoprazole

Manufacturer:

Takeda

Distributor:

Zuellig
Concise Prescribing Info
Contents
Dexlansoprazole
Indications/Uses
Healing of all grades of erosive esophagitis (EE) for up to 8 wk in patients ≥12 yr. Maintain healing of EE & relief of heartburn for up to 6 mth in adults & 16 wk in patients 12-17 yr. Treatment of heartburn associated w/ symptomatic non-erosive GERD for 4 wk in patients ≥12 yr.
Dosage/Direction for Use
Patient ≥12 yr Healing of EE 60 mg once daily up to 8 wk. Maintenance of healed EE & relief of heartburn 30 mg once daily for 6 mth in adult & 16 wk in childn 12-17 yr. Symptomatic non-erosive GERD 30 mg once daily for 4 wk. Patient w/ moderate hepatic impairment (Child-Pugh class B) 30 mg once daily up to 8 wk.
Administration
May be taken with or without food: Swallow whole, do not chew. For patients w/ swallowing difficulties, open cap & sprinkle contents in 1 tbsp applesauce. Swallow immediately, do not chew. Alternatively, empty contents in 20 mL water & administer using oral syringe or via a nasogastric tube (≥16 French).
Contraindications
Hypersensitivity. Concomitant use w/ rilpivirine-containing products.
Special Precautions
Symptomatic response to therapy does not preclude presence of gastric malignancy; consider additional follow-up & diagnostic testing in adults who have suboptimal response or early symptomatic relapse after completing treatment w/ PPI. Discontinue treatment at 1st signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity. May be associated w/ increased risk of Clostridium difficile-associated diarrhea, especially in hospitalized patients; osteoporosis-related fractures of hip, wrist or spine; fundic gland polyps that increases w/ long-term use especially >1 yr. Risk of acute tubulointerstitial nephritis. Reports of cutaneous lupus erythematosus & SLE; rarely, symptomatic & asymptomatic hypomagnesemia. Daily treatment over long period of time (eg, >3 yr) may lead to malabsorption of cyanocobalamin (vit B12) caused by hypo- or achlorhydria. Temporarily stop treatment at least 14 days before assessing chromogranin A (CgA) levels (in diagnostic investigations for neuroendocrine tumors) & consider repeating test if initial CgA levels are high. Concomitant use w/ MTX. Patients w/ moderate hepatic impairment. Not recommended in severe hepatic impairment. Pregnancy & lactation. Safety & effectiveness have not been established in ped patients <12 yr. Not recommended in ped patients <2 yr & for treatment of symptomatic GERD in ped patients 1 mth to <1 yr. Elderly.
Adverse Reactions
Diarrhea, abdominal pain, nausea, URTI, vomiting & flatulence.
Drug Interactions
Decreased exposure of some antiretroviral drugs eg, rilpivirine, atazanavir & nelfinavir. Increased exposure of other antiretroviral drugs eg, saquinavir. Increased INR & prothrombin time w/ warfarin. May elevate & prolong serum conc of MTX &/or its metabolite hydroxymethotrexate, possibly leading to toxicities. Potential for increased exposure of digoxin. Reduced absorption of drugs dependent on gastric pH for absorption (eg, Fe salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole/itraconazole). Potentially increased exposure of tacrolimus especially in transplant patients. False +ve results in diagnostic investigations for neuroendocrine tumors. False suggestion of gastrinoma in secretin simulation test due to hyper-response in gastrin secretion. False +ve urine screening tests for tetrahydrocannabinol. Decreased exposure w/ strong CYP2C19 or CYP3A4 inducers. Increased exposure w/ strong CYP2C19 or CYP3A4 inhibitors.
MIMS Class
Antacids, Antireflux Agents & Antiulcerants
ATC Classification
A02BC06 - dexlansoprazole ; Belongs to the class of proton pump inhibitors. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).
Presentation/Packing
Form
Dexilant DR cap 30 mg
Packing/Price
28's
Form
Dexilant DR cap 60 mg
Packing/Price
28's