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Dexilant特胃能

Dexilant

dexlansoprazole

Manufacturer:

Takeda

Distributor:

Zuellig
/
Firma Chun Cheong
Concise Prescribing Info
Contents
Dexlansoprazole
Indications/Uses
Healing of all grades of erosive esophagitis. Maintenance of healed erosive esophagitis & relief of heartburn. Treatment of heartburn associated w/ symptomatic non-erosive GERD.
Dosage/Direction for Use
Patient ≥12 yr Healing of erosive esophagitis 60 mg once daily for up to 8 wk. Maintenance of healed erosive esophagitis & relief of heartburn 30 mg once daily for up to 6 mth in adults & 16 wk in patients 12-17 yr. Symptomatic non-erosive GERD 30 mg once daily for 4 wk. Patient w/ moderate hepatic impairment (Child-Pugh class B) Healing of erosive esophagitis 30 mg once daily for up to 8 wk.
Administration
May be taken with or without food: Swallow whole. For patients who have trouble swallowing, open cap & sprinkle granules on 1 tbsp of applesauce, then swallow immediately w/o chewing. Alternatively, open cap & mix granules w/ water, then administer via oral syringe or nasogastric tube.
Contraindications
Hypersensitivity. Rilpivirine-containing products.
Special Precautions
Symptomatic response to therapy does not preclude the presence of gastric malignancy in adults. Risk of acute tubulointerstitial nephritis. Increased risk of GI infections & Clostridium difficile-associated diarrhea. Increased risk for osteoporosis-related fractures of the hip, wrist or spine in patients who received high-dose (multiple daily doses) & long-term (≥1 yr) therapy. Reports of severe cutaneous adverse reactions, including SJS, TEN, DRESS, & acute generalized exanthematous pustulosis; cutaneous lupus erythematosus & SLE. Daily treatment w/ any acid-suppressing medications over a long period of time (eg, >3 yr) may lead to malabsorption of cyanocobalamin (vit B12). Consider monitoring Mg & Ca levels prior to treatment initiation & periodically while on treatment in patients w/ pre-existing risk of hypocalcemia (eg, hypoparathyroidism). Increased risk of fundic gland polyps that increases w/ long-term use (especially >1 yr). Interactions w/ investigations for neuroendocrine tumors. Concomitant use w/ high-dose MTX. Not recommended in patients w/ severe hepatic impairment (Child-Pugh class C); in ped patients <2 yr; for treatment of symptomatic GERD in ped patients 1 mth to <1 yr of age. Safety & effectiveness have not been established in ped patients <12 yr. Advise pregnant women of potential risk to fetus. Consider benefits of breastfeeding along w/ mother's clinical need for treatment & any potential adverse effects on breastfed child.
Adverse Reactions
Diarrhea, abdominal pain. Adult: Nausea, URTI, vomiting, flatulence. Ped: Headache, nasopharyngitis, oropharyngeal pain.
Drug Interactions
Decreased exposure of rilpivirine, atazanavir, & nelfinavir. Increased exposure of saquinavir. Increased INR & prothrombin time in patients concomitantly receiving warfarin. Elevated & prolonged serum conc of MTX &/or its metabolite hydroxymethotrexate. 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 who are intermediate or poor CYP2C19 metabolizers. Decreased exposure w/ strong CYP2C19 or CYP3A4 inducers (eg, St. John's wort, rifampin, ritonavir-containing products). Increased exposure w/ strong CYP2C19 or CYP3A4 inhibitors (eg, voriconazole). Increased serum chromogranin A levels (secondary to PPI-induced decreases in gastric acidity) may cause false +ve results in diagnostic investigations for neuroendocrine tumors. Hyper-response in gastrin secretion in response to secretin stimulation test, falsely suggesting gastrinoma. False +ve urine screening tests for tetrahydrocannabinol.
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
14's
Form
Dexilant DR cap 60 mg
Packing/Price
14's
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