Regler® 30: Each capsule contains 30 mg of Dexlansoprazole INN as enteric-coated pellets.

Regler® 60: Each capsule contains 60 mg of Dexlansoprazole INN as enteric-coated pellets.

Regler® (Dexlansoprazole) delayed-release capsule is a Proton Pump Inhibitor (PPI) that inhibits gastric acid secretion. It is the R-enantiomer of lansoprazole (a racemic mixture of R- and S-enantiomers). The capsules are supplied as a Dual Delayed Release (DDR) formulation for oral administration, containing a mixture of two types of enteric-coated granules with distinct pH-dependent dissolution profiles.

Regler® (Dexlansoprazole) suppresses gastric acid secretion by specifically inhibiting the (H+/K+)-ATPase enzyme in gastric parietal cells. By targeting the proton pump, it effectively blocks the final step of acid production.

The Dual Delayed Release technology results in a plasma concentration-time profile with two distinct peaks:

The first peak occurs 1–2 hours after administration.

The second peak occurs within 4–5 hours.

No accumulation of Dexlansoprazole occurs after multiple once-daily doses of 30 mg or 60 mg. After oral administration, mean Cmax and AUC values increase approximately dose-proportionally. Dexlansoprazole is extensively metabolized in the liver and primarily excreted in urine.

Healing of Erosive Esophagitis (EE): Indicated for healing all grades of EE for up to 8 weeks.

Maintenance of Healed EE: Indicated for maintaining healing and relieving heartburn for up to 6 months.

Symptomatic Non-Erosive GERD: Indicated for the treatment of heartburn associated with symptomatic GERD for 4 weeks.

Important Administration Information

Regler® (Dexlansoprazole) can be taken without regard to food.

Swallow the capsule whole.

Alternatively, the capsule can be opened, and the granules sprinkled on one tablespoon of food. Swallow immediately without chewing.

If a dose is missed, take it as soon as possible. If it is almost time for the next dose, skip the missed dose. Do not take a double dose.

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

Common side effects include:

Diarrhea

Abdominal pain

Nausea

Upper respiratory tract infection

Vomiting

Flatulence

Precautions

Use with caution in patients with:

Gastric malignancy

Clostridium difficile-associated diarrhea

Bone fractures

Hypomagnesemia

Concurrent use of Dexlansoprazole with methotrexate

Drug Interactions

Potential interactions with:

Atazanavir

Warfarin

Tacrolimus

Clopidogrel

Methotrexate

Overdose

There have been no reports of significant overdose. Doses up to 120 mg multiple times and a single dose of 300 mg did not cause severe adverse events.

Store below 30°C in a dry place. Protect from light and moisture.

Keep out of reach of children.