Dexilant Capsules (Hard Gelatin) / Modified Release
Dexlansoprazole
60mg
TAKEDA PHARMACEUTICALS U.S.A., INC.
| Pack size | 28's (7's Blister x 4) |
|---|---|
| Dispensing mode | POM |
| Source | USA |
| Agent | Modern Pharmaceutical Co. |
| Retail Price | 200.50 AED |
Available as:
Indications
Dexilant Capsules (Hard Gelatin) / Modified Release is used for:
Oesophagitis, Gastro-oesophageal reflux disease (GERD)
Adult Dose
Erosive Esophagitis
Capsule: Indicated for healing of all grades of erosive esophagitis (EE) and maintaining healing of EE
DR: Indicated for maintaining healing of EE
Healing (capsule): 60 mg PO qDay for up to 8 weeks
Maintenance (capsule or DR): 30 mg PO qDay for up to 6 months
Gastroesophageal Reflux Disease
Indicated for treating heartburn associated with symptomatic nonerosive GERD
Capsule or DR: 30 mg PO qDay for 4 weeks
Hepatic impairment
Milde (Child-Pugh A): Dose adjustment not necessary
Moderate (Child-Pugh B): Not to exceed 30 mg/day
Severe (Child-Pugh C): Not recommended
Child Dose
<12 years
Safety and efficacy not established
>12 years
Erosive Esophagitis
Capsule: Indicated for healing of all grades of erosive esophagitis (EE) and maintaining healing of EE
DR: Indicated for maintaining healing of EE
Healing (capsule): 60 mg PO qDay for up to 8 weeks
Maintenance (capsule or DR): 30 mg PO qDay for up to 6 months
Gastroesophageal Reflux Disease
Indicated for treating heartburn associated with symptomatic nonerosive GERD
Capsule or DR: 30 mg PO qDay for 4 weeks
Renal Dose
Administration
Capsule: May take with or without food
DR: Take at least 30 minutes before a meal
Contra Indications
Hypersensitivity.
Precautions
Hepatic impairment. Gastric malignancy should be ruled out. Pregnancy and lactation.
Lactation
Risk Summary
There is no information regarding presence of dexlansoprazole in human milk, effects on breastfed infant, or on milk production; however, lansoprazole and its metabolites are present in rat milk; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and potential adverse effects on breastfed child from therapy or from the underlying maternal condition
Pregnancy-Lactation
Pregnancy
There are no studies with dexlansoprazole use in pregnant women to inform a drug-associated risk; dexlansoprazole is R-enantiomer of lansoprazole, and published observational studies of lansoprazole use during pregnancy did not demonstrate an association of adverse pregnancy-related outcomes with lansoprazole
In animal reproduction studies, oral administration of lansoprazole to rats during organogenesis through lactation at 1.8 times the maximum recommended human dexlansoprazole dose; produced reductions in the offspring in femur weight, femur length, crown-rump length and growth plate thickness (males only) on postnatal day 21; these effects were associated with reduction in body weight gain; advise pregnant women of potential risk to fetus
Lactation
There is no information regarding presence of dexlansoprazole in human milk, effects on breastfed infant, or on milk production; however, lansoprazole and its metabolites are present in rat milk; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and potential adverse effects on breastfed child from therapy or from the underlying maternal condition
Interactions
Increased risk of hypomagnesaemia w/ diuretics and digoxin. May decrease plasma concentration of erlotinib, dasatinib and lapatinib. May decrease the bioavailability of itraconazole and ketoconazole. May increase plasma concentration of cilostazol and methotrexate. Reduced bioavailability w/ antacids and sucralfate.
Potentially Fatal: May decrease serum levels and pharmacological effects of rilpivirine and atazanavir.
Adverse Effects
Side effects of Dexlansoprazole :
1-10%
Diarrhea (5%), Abdominal pain (4%), Nausea (3%), URI (2-3%), Vomiting (1-2%), Flatulence (1%)
<1% (Selected)
Arrhythmia, Bradycardia, Barrett's esophagus, DVT, Dyspnea, Hepatomegaly, Hypertension, Paresthesia, Rectal hemorrhage, Vulvovaginal infection
Mechanism of Action
R-enantiomer of lansoprazole; PPI; binds to H+/K+-exchanging ATPase (proton pump) in gastric parietal cells, resulting in blockage of acid secretion.Dual release formulation.
Note
Dexilant 60mg Capsules (Hard Gelatin) / Modified Release manufactured by TAKEDA PHARMACEUTICALS U.S.A., INC.. Its generic name is Dexlansoprazole. Dexilant is availble in United Arab Emirates.
Farmaco UAE drug index information on Dexilant Capsules (Hard Gelatin) / Modified Release is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.