Opiren Capsule (Enteric Coated)

Healing of Erosive Esophagitis: Opiren is indicated for the healing of all grades of erosive esophagitis (EE) for up to 8 weeks.

Maintenance of Healed Erosive Esophagitis: Opiren is indicated to maintain healing of EE and relief of heartburn for up to 6 months.

Symptomatic Non-Erosive Gastroesophageal Reflux Disease: Opiren is indicated for the treatment of heartburn associated with symptomatic non-erosive Gastroesophageal Reflux Disease (GERD) for 4 weeks.

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 C_max and AUC value of Dexlansoprazole increased approximately dose proportionally. Dexlansoprazole is extensively metabolized in the liver and excreated by urine.

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

Dexlansoprazole can be taken without regard to food. It should be swallowed whole.

Alternatively, Dexlansoprazole capsules can be administered as follows:

• Open capsule
• Sprinkle intact granules on one tablespoon
• Swallow immediately.

Granules should not be chewed.

If a capsule is missed at its usual time, it should be taken as soon as possible. But if it is too close to the time of the next dose, only the prescribed dose should be taken at the appointed time. A double dose should not be taken.

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

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

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

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.

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

Use in children & adolescents: Safety and effectiveness of Opiren 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 Opiren is necessary for patients with renal
impairment.

Hepatic impairment: No dose adjustment for Opiren is necessary for patients with mild hepatic impairment. A maximum daily dose of Opiren 30 mg should be considered for patients with moderate hepatic impairment.

There have been no reports of a significant overdose of Opiren. Multiple doses of Opiren 120 mg and a single dose of Opiren 300 mg did not result in death or other severe adverse events.

Proton Pump Inhibitor

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