Description
Generics:
Dexlansoprazole
Dosage Form: Capsule
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 guideline:
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
Route of administration: Orally.
Interaction:
With medicine: Atazanavir, Warfarin, Tacrolimus, Clopidogrel & Methotrexate. With food & others: No data available.
Contraindications:
Dexlansoprazole is contraindicated in patients with known hypersensitivity to any component of the formulation.
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 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 renal
impairment.
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.
Manufactured by: ACME Laboratories Ltd.
