DRT 60 mg

INDICATIONS

Healing of Erosive Esophagitis: Dexlansoprazole is indicated for the healing of all grades of erosive esophagitis (EE) for up to 8 weeks.Maintenance of Healed Erosive Esophagitis: Dexlansoprazole is indicated to maintain healing of EE and relief of heartburn for up to 6 months.Symptomatic Non-Erosive Gastroesophageal Reflux Disease: Dexlansoprazole is indicated for the treatment of heartburn associated with symptomatic non-erosive Gastroesophageal Reflux Disease (GERD) for 4 weeks.

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. The dual delayed release formulation in dexlansoprazole, plasma concentration-time profile with two distinct peaks; the first peak occurs 1 to 2 hours after administration, followed by a second peak within 4 to 5 hours. After oral administration, mean Cmax and AUC value of Dexlansoprazole increased approximately dose proportionally. Dexlansoprazole is extensively metabolized in the liver and excreated by urine.

DOSAGE

Dexlansoprazole dosing recommendations-

Maintenance of Healed erosive esophagitis and relief of heartburn: 30 mg Once daily
Symptomatic Non-Erosive GERD: 30 mg Once daily for 4 weeks
Healing of erosive esophagitis: 60 mg Once daily for up to 8 weeks

Dexlansoprazole MUPS dosing recommendations-

Maintenance of healed erosive esophagitis and relief of heartburn: One 30 mg tablet once daily for 6 months in adults and 16 weeks in patients 12 to 17 years of age
Symptomatic Non-Erosive GERD: One 30 mg tablet once daily for 4 weeks

INTERACTION

With medicine: Atazanavir, Warfarin, Tacrolimus, Clopidogrel & Methotrexate. With food & others: No data available.

SIDE EFFECTS

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

PREGNANCY & LACTATION

Pregnancy Category B. There is no adequate and well-controlled studies with Dexlansoprazole in pregnant women. There is no adequate and well-controlled studies with Dexlansoprazole in Lactating mother.

PRECAUTIONS & WARNINGS

Gastric Malignancy, Clostridium difficile Associated Diarrhea, Bone fracture, Hypomagnesemia, and concomitant use of Dexlansoprazole with Methotrexate.

USE IN SPECIAL POPULATIONS

Use in children & adolescents: Safety and effectiveness of Dexlansoprazole in patients below 12 years age have not been established.Geriatric use: No dose adjustment is necessary for elderly patients.Renal impairment: No dose adjustment of Dexlansoprazole is necessary for patients with renalimpairment.Hepatic impairment: No dose adjustment for Dexlansoprazole is necessary for patients with mild hepatic impairment. A maximum daily dose of Dexlansoprazole 30 mg should be considered for patients with moderate hepatic impairment.

THERAPEUTIC CLASS

Proton Pump Inhibitor

STORAGE CONDITIONS

Store below 30°C temperature & in a dry place, protected from light. Keep all medicines out of reach of children.