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 adult & for up to 16 wk in patient 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 w/ swallowing difficulties, open cap & sprinkle entire contents in 1 tbsp apple sauce. Swallow immediately, do not chew. Alternatively, mix entire contents w/ water & administer using oral syringe or via a nasogastric tube (≥16 French).
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 hip, wrist, or spine in patients receiving high-dose (multiple daily doses) & long-term (≥1 yr) therapy. Reports of 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). Symptomatic & asymptomatic hypomagnesemia has been reported rarely in patients treated w/ PPIs for at least 3 mth, in most cases after a yr of therapy. 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. Pregnancy & lactation.
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 w/ 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 Cap 30 mg
Packing/Price
14's
Form
Dexilant Cap 60 mg
Packing/Price
14's
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