Dexilant Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Thai FDA Category Presentation/Packing

Concise Prescribing Info

Contents

Dexlansoprazole

Indications/Uses

Healing of all grades of erosive esophagitis (EE) for up to 8 wk in patients ≥2 yr. Maintenance of healed EE & relief of heartburn up to 6 mth in adults & 16 wk in patients 12-17 yr. Heartburn associated w/ symptomatic non-erosive GERD for 4 wk in patients ≥12 yr.

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Dosage/Direction for Use

Patients ≥12 yr Healing of EE 60 mg once daily for up to 8 wk. Symptomatic non-erosive GERD 30 mg once daily for 4 wk. Maintenance of healed EE & relief of heartburn Adult 30 mg once daily for up to 6 mth. Patients 12-17 yr 30 mg once daily for up to 16 wk. Moderate hepatic impairment (Child-Pugh Class B) 30 mg once daily for up to 8 wk.

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Overdosage

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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 of applesauce. Swallow immediately w/o chewing. Contents may also be dispersed in 20 mL water & administered immediately via oral syringe/nasogastric tube (≥16 French). Refill syringe w/ 10 mL water twice & administer.

Contraindications

Hypersensitivity. Acute interstitial nephritis w/ other PPIs including lansoprazole. Rilvipirine-containing products.

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Special Precautions

Gastric malignancy. Acute interstitial nephritis. Increased risk of Clostridium difficile-associated diarrhea & osteoporosis-related fractures of hip, wrist or spine. Vit B₁₂ deficiency. Hypomagnesemia. Monitor Mg levels prior to treatment & periodically thereafter. False +ve results in diagnostic investigations for neuroendocrine tumors due to increase in serum chromogranin A levels; secretin stimulative test; urine screening tests for tetrahydrocannabinol. Concomitant use w/ MTX. Cutaneous lupus erythematosus & SLE. Moderate & severe hepatic impairment. Pregnancy & lactation. Childn <12 yr; not recommended for symptomatic non-erosive GERD in ped patients <1 yr.

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Use In Pregnancy & Lactation

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Adverse Reactions

Diarrhea, abdominal pain, nausea, URTI, vomiting, flatulence.

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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 & tacrolimus. Reduced absorption of drugs dependent on gastric pH for absorption (eg, Fe salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole/itraconazole). 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).

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Storage

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Description

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Action

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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).

Thai FDA Category

Presentation/Packing

Form

Dexilant DR cap 30 mg

Packing/Price

4 × 7's

Form

Dexilant DR cap 60 mg

Packing/Price

4 × 7's

Dexilant

dexlansoprazole

Manufacturer:

Takeda

Distributor:

Zuellig Pharma