DELANIX 60 mg

Description

Indications

Delanix is indicated for the treatment of the following conditions:

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

2. Maintenance of Healed Erosive Esophagitis: To maintain healing of EE and provide relief from heartburn for up to 6 months.

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

Take this medication only as directed by a registered physician.

Pharmacology

Dexlansoprazole is a Proton Pump Inhibitor (PPI) that inhibits gastric acid secretion by blocking the (H+/K+)-ATPase enzyme in the gastric parietal cells, which is the final step in acid production. It is the R-enantiomer of lansoprazole and is formulated as a Dual Delayed Release (DDR) capsule. This unique formulation includes two types of enteric-coated granules with distinct pH-dependent dissolution profiles, resulting in a plasma concentration-time profile with two distinct peaks: the first within 1-2 hours and the second within 4-5 hours after administration.

Dexlansoprazole is extensively metabolized in the liver and primarily excreted through urine.

Dosage

Dexlansoprazole dosing recommendations:

• Healing of Erosive Esophagitis: 60 mg once daily for up to 8 weeks.

• Maintenance of Healed Erosive Esophagitis and Relief of Heartburn: 30 mg once daily.

• Symptomatic Non-Erosive GERD: 30 mg once daily for 4 weeks.

Dexlansoprazole MUPS dosing recommendations:

• Maintenance of Healed Erosive Esophagitis and Relief of Heartburn: One 30 mg tablet once daily for 6 months (adults) or 16 weeks (patients aged 12-17).

• Symptomatic Non-Erosive GERD: One 30 mg tablet once daily for 4 weeks.

Take this medication only as directed by a registered physician.

Administration

Dexlansoprazole can be taken with or without food. The capsules should be swallowed whole.

If needed, capsules may be administered as follows:

1. Open the capsule.

2. Sprinkle the granules on one tablespoon of soft food or liquid.

3. Swallow immediately without chewing the granules.

Missed Dose: If a dose is missed, take it as soon as possible. However, if the next scheduled dose is near, skip the missed dose and continue with the regular dosing schedule. Do not take a double dose.

Interaction

• With Medications: Interactions may occur with atazanavir, warfarin, tacrolimus, clopidogrel, and methotrexate.

• With Food and Others: No data available.

Contraindications

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

Side Effects

Common side effects include:

• Diarrhea

• Abdominal pain

• Nausea

• Vomiting

• Flatulence

Pregnancy & Lactation

• Pregnancy: Category B. There are no adequate or well-controlled studies in pregnant women. Dexlansoprazole should only be used during pregnancy if clearly needed.

• Lactation: There are no sufficient studies in lactating mothers. Use with caution and only if the potential benefits outweigh the risks.

Precautions & Warnings

Use with caution in the following conditions:

• Gastric malignancy

• Clostridium difficile-associated diarrhea

• Bone fractures

• Hypomagnesemia

• Concomitant use with methotrexate

Use in Special Populations

• Pediatric Use: Safety and efficacy have not been established in patients under 12 years.

• Geriatric Use: No dose adjustments are necessary.

• Renal Impairment: No dose adjustments are required.

• Hepatic Impairment: No dose adjustment is required for mild hepatic impairment. A maximum daily dose of 30 mg should be considered for moderate hepatic impairment.

Overdose Effects

There have been no significant reports of Dexlansoprazole overdose. Studies show that doses up to 120 mg (multiple) or 300 mg (single) did not result in death or severe adverse events.

Therapeutic Class

Proton Pump Inhibitors

Storage Conditions

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