Antiulcerant

Composition
Nulanso 30 Capsule: Each capsule contains Dexlansoprazole INN 30 mg as enteric coated pellets.
Nulanso 60 Capsule: Each capsule contains Dexlansoprazole INN 60 mg as enteric coated pellets.

Pharmacology
Dexlansoprazole delayed-release capsule is a Proton Pump Inhibitor (PPI) which suppresses gastric acid secretion by specific inhibition of the (H+/K+)-ATPase in the gastric parietal cell. By acting specifically on the proton pump, Dexlansoprazole blocks the final step of acid production. It is the R-enantiomer of lansoprazole (A racemic mixture of the R- and S-enantiomers). Dexlansoprazole is supplied as a Dual Delayed Release (DDR) formulation in a capsule for oral administration. This capsule contains a mixture of two types of enteric coated granules with different pH-dependent dissolution profiles. Dexlansoprazole is extensively metabolized in the liver and excreted by urine.

Indication
Nulanso (Dexlansoprazole) is indicated for:
Healing of all grades of erosive esophagitis for up to 8 weeks in patients 12 years of age and older.
Maintaining healing of erosive esophagitis for up to 4 months in adolescents 12 to 17 years of age and up to 6 months in adults.
Treatment of heartburn associated with symptomatic gastroesophageal reflux disease (GERD) for 4 weeks in patients 12 years of age and older.

Dosage & administration

Indications Dose Frequency
Maintenance of Healed Erosive Esophagitis 30 mg Once daily for up to 6 months in adults and 4 months in adolescents (12 to 17 years)
Symptomatic Gastroesophageal Reflux Disease (GERD) 30 mg Once daily for 4 weeks
Healing of Erosive Esophagitis 60 mg Once daily for up to 8 weeks

*Can be taken without regard to food or the timing of food.

Contra-indication
Dexlansoprazole is contraindicated in patients with known hypersensitivity to any component of the formulation.

Warning and precaution
Gastric malignancy, Clostridium difficile associated Diarrhea, Bone fracture, Hypomagnesemia, and concomitant use of Dexlansoprazole with Methotrexate.

Side effects
Common side effects: Diarrhea, abdominal pain, nausea, vomiting & flatulence.

Use in pregnancy & lactation
Pregnancy Category B. Dexlansoprazole is probably safe for use during pregnancy, although the full risks are currently unknown. It is not known whether Dexlansoprazole is excreted in human milk.

Use in children & adolescents
Safety and effectiveness of Dexlansoprazole in patients below 12 years age have not been established.

Drug interaction
Atazanavir, Warfarin, Tacrolimus, Clopidogrel & Methotrexate.

Overdose
There have been no reports of significant overdose of Dexlansoprazole. Dexlansoprazole is not expected to be removed from the circulation by hemodialysis.

Storage
Keep out of the reach of children. Keep below 300C, protect from light.

Packing
Nulanso 30 capsule: Each box contains 6x10's capsule in blister pack.
Nulanso 60 capsule: Each box contains 3x10's capsule in blister pack.

 

Nulanso 30_Prescribing information

Nulanso 60_Prescribing information