Dexilant

Dexilant

dexlansoprazole

Manufacturer:

Takeda

Distributor:

Takeda
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.
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. Symptomatic non-erosive GERD 30 mg once daily for 4 wk. Moderate hepatic impairment 30 mg once daily up to 8 wk.
Administration
May be taken with or without food: Swallow whole. 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. Anaphylaxis & acute interstitial nephritis. Concomitant use w/ rilpivirine-containing products.
Special Precautions
Gastric malignancy. Discontinue use if acute interstitial nephritis develops; signs or symptoms of cutaneous or SLE are noted. Cyanocobalamin deficiency. Clostridium difficile-associated diarrhea. High doses & long-term therapy may result to bone fractures. Hypomagnesemia. Monitor Mg levels prior to treatment & periodically thereafter for patients on prolonged treatment or medications eg, digoxin or drugs that cause hypomagnesemia (eg, diuretics). Concomitant use w/ methotrexate. May cause false +ve results in diagnostic investigations for neuroendocrine tumors; temporarily stop treatment at least 14 days before assessing serum chromogranin A levels & repeat test if initial levels are high. Discontinue use if signs & symptoms of cutaneous or SLE occurs. Fundic gland polyps. False +ve results in secretin stimulation test & urine tests for tetrahydrocannabinol. Not recommended in severe hepatic impairment. Pregnancy & lactation. Not recommended in childn <12 yr.
Adverse Reactions
Diarrhea, abdominal pain, nausea, upper resp tract infection, 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 methotrexate &/or its metabolite, 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. Decreased exposure w/ strong CYP2C19 or CYP3A4 inducers. Increased exposure w/ strong CYP2C19 or CYP3A4 inhibitors.
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 (P2,051.64/box)
Form
Dexilant DR cap 60 mg
Packing/Price
28's (P2,567.32/box)
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