Composition
Dexlazo 30 : Each capsule contains Dexlansoprazole INN 30 mg as enteric coated pellets.

Mechanism of Action
Dexlazo (Dexlansoprazole) is a PPI that suppresses gastric acid secretion by specific inhibition of the (H+/K+)-ATPase in the gastric parietal cell. By acting specifically on the proton pump. Dexlazo (Dexlansoprazole) blocks the final step of acid production.

Pharmacokinetics
The formulation of Dexlazo (Dexlansoprazole) utilizing Dual Delayed Release technology results in 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. No accumulation of Dexlansoprazole occurs after multiple once daily doses of Dexlazo (Dexlansoprazole) 30 mg. After oral administration of Dexlazo (Dexlansoprazole) 30 mg to healthy subjects, mean Cmax and AUC values of Dexlansoprazole increased approximately dose proportionally. Dexlansoprazole is extensively metabolized in the liver and excreted by urine.

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

Dosage and Administration

Important Administration Information
- Dexlazo (Dexlansoprazole) can be taken without regard to food or the timing of food.
- Dexlazo (Dexlansoprazole) should be swallowed whole.
- Alternatively, Dexlazo (Dexlansoprazole) capsules can be administered as follows:
- Open capsule
- Sprinkle intact granules on one tablet spoon
- Swallow immediately. Granules should not be chewed

Missed Dose
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.

Pregnant women and Nursing women
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.

Geriatrics
No dosage adjustment is necessary for elderly patinets.

Pediatrics
Safety and effectiveness of Dexlazo (Dexlansoprazole) in patients below 12 years age have not been established yet.

Renal Impairment
No dosage adjustment is necessary for patients with renal impairment.

Hepatic Impairment
No adjustment of Dexlansoprazole is necessary for patients with mild hepatic impairment. A maximum daily dose of 30 mg for patients with moderate hepatic impairment may be considered.

Contraindication
Dexlazo (Dexlansoprazole) is contraindicated in patients with known hypersensitivity to any component of the formulation.

Side-effects
Diarrhea, abdominal pain, nausea, upper respiratory tract Infection, vomiting & flatulence.

Precautions
Gastric malignancy, Clostridium difficile associated diarrhea, bone fracture, hypomagnesemia, concomitant use of Dexlansoprazole with Methotrexate.

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

Overdose
There have been no reports of significant overdose of Dexlansoprazole, Multiple doses of Dexlansoprazole 120 mg and a single dose of Dexlansoprazole 300 mg did not result in any severe adverse events.

Storage
Do not store above 30C. Keep in a dry place and protect from light. Keep out of reach of children.

Packaging
Dexlazo 30 : Each carton contains 6×10’s, 10×10’s capsules in Alu-Alu blister pack.