X Lan Capsule
Dexlansoprazole
60 mg
Somatec Pharmaceuticals Ltd.
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| Retail Price | 16.00 AED |
Available as:
Indications
X Lan Capsule is used for:
Oesophagitis, Gastro-oesophageal reflux disease (GERD)
Adult Dose
Erosive Esophagitis
Capsule: Indicated for the healing of all grades of erosive esophagitis (EE) and maintaining the healing of EE
DR: Indicated for maintaining the healing of EE
Healing (capsule): 60 mg PO Once daily for up to 8 weeks
Maintenance (capsule or DR): 30 mg PO Once daily for up to 6 months
Gastroesophageal Reflux Disease
Indicated for treating heartburn associated with symptomatic nonerosive GERD
Capsule or DR: 30 mg PO Once daily for 4 weeks
Child Dose
<12 years
Safety and efficacy not established
>12 years
Erosive Esophagitis
Capsule: Indicated for the healing of all grades of erosive esophagitis (EE) and maintaining the healing of EE
DR: Indicated for maintaining the healing of EE
Healing (capsule): 60 mg PO Once daily for up to 8 weeks
Maintenance (capsule or DR): 30 mg PO Once daily for up to 6 months
Gastroesophageal Reflux Disease
Indicated for treating heartburn associated with symptomatic nonerosive GERD
Capsule or DR: 30 mg PO Once daily 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 reactions, including anaphylaxis and acute interstitial nephritis reported
PPIs are contraindicated with rilpivirine-containing products
Precautions
Gastric Malignancy: In adults, symptomatic response with Dexlansoprazole does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing.
Acute Tubulointerstitial Nephritis: Discontinue treatment and evaluate patients.
Clostridium difficile-Associated Diarrhea: PPI therapy may be associated with increased risk.
Bone Fracture: Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine.
Cutaneous and Systemic Lupus Erythematosus: Mostly cutaneous; new onset or exacerbation of existing disease; discontinue Dexlansoprazole and refer to specialist for evaluation.
Cyanocobalamin (Vitamin B12) Deficiency: Daily long-term use (e.g., longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin.
Hypomagnesemia: Reported rarely with prolonged treatment with PPIs.
Interactions with Investigations for Neuroendocrine Tumors:
Increases in intragastric pH may result in hypergastrinemia and enterochromaffin-like cell hyperplasia and increased chromogranin
A levels which may interfere with diagnostic investigations for neuroendocrine tumors.
Interaction with Methotrexate: Concomitant use with PPIs may elevate and/or prolong serum concentrations of methotrexate and/or its metabolite, possibly leading to toxicity. With high-dose methotrexate administration, consider a temporary withdrawal of Dexlansoprazole.
Fundic Gland Polyps: Risk increases with long-term use, especially beyond 1 year. Use the shortest duration of therapy.
Risk of Heart Valve Thickening in Pediatric Patients Less than Two Years of Age: Dexlansoprazole is not recommended in pediatric patients less than 2 years of age.
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.
Contraindicated (2)
nelfinavir
rilpivirine
Serious (29)
acalabrutinib
apalutamide
atazanavir
dacomitinib
dasatinib
defactinib
digoxin
enzalutamide
erlotinib
fedratinib
fexinidazole
idelalisib
infigratinib (DSC)
itraconazole
ketoconazole
levoketoconazole
lonafarnib
mesalamine
neratinib
nilotinib
pazopanib
pexidartinib
phenobarbital
rifapentine
secretin
sofosbuvir/velpatasvir
sotorasib
sparsentan
tucatinib
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
X Lan 60 mg Capsule manufactured by Somatec Pharmaceuticals Ltd.. Its generic name is Dexlansoprazole. X Lan is availble in Bangladesh.
Farmaco BD drug index information on X Lan Capsule is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.