Delanix 30 mg

Description

Indications

• Healing of Erosive Esophagitis: Delanix is used to heal all grades of erosive esophagitis (EE) for a duration of up to 8 weeks.

• Maintenance of Healed Erosive Esophagitis: Delanix helps maintain the healing of EE and provides relief from heartburn for up to 6 months.

• Symptomatic Non-Erosive Gastroesophageal Reflux Disease (GERD): Delanix is effective in treating heartburn associated with symptomatic non-erosive GERD for a period of 4 weeks.

Use the medication as per the advice of a registered medical practitioner.

Pharmacology

Dexlansoprazole is a delayed-release Proton Pump Inhibitor (PPI) that works by suppressing gastric acid secretion through the specific inhibition of the (H+/K+)-ATPase in the gastric parietal cells. This action targets the proton pump, effectively blocking the final stage of acid production. Dexlansoprazole is the R-enantiomer of lansoprazole and is provided as a Dual Delayed Release (DDR) formulation in a capsule for oral consumption. The capsule contains two types of enteric-coated granules that dissolve at different pH levels.

The DDR formulation of dexlansoprazole produces a plasma concentration-time profile with two distinct peaks. The first peak occurs 1 to 2 hours after administration, and the second peak appears within 4 to 5 hours. After oral administration, both Cmax and AUC values increase proportionally with the dosage. Dexlansoprazole is extensively metabolized in the liver and excreted in the urine.

Dosage

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

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

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

For Dexlansoprazole MUPS (Multiple Unit Pellet System):

• For Maintenance of Healed Erosive Esophagitis and Relief of Heartburn: One 30 mg tablet once daily for 6 months in adults and 16 weeks for patients aged 12 to 17 years.

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

Use the medication as per the advice of a registered medical practitioner.

Administration

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

Alternatively, the contents of the capsule may be sprinkled on a tablespoon of food and swallowed immediately. Do not chew the granules.

If a dose is missed, it should be taken as soon as possible unless it is close to the time for the next dose. In that case, take only the prescribed dose and avoid doubling the dose.

Use the medication as per the advice of a registered medical practitioner.

Interactions

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

Contraindications

Dexlansoprazole is contraindicated in individuals with known hypersensitivity to any ingredient in the formulation.

Side Effects

Common side effects may include diarrhea, abdominal pain, nausea, vomiting, and flatulence.

Pregnancy & Lactation

Dexlansoprazole is categorized as Pregnancy Category B. There are no well-controlled studies in pregnant women or lactating mothers. Therefore, it should be used during pregnancy or breastfeeding only if the potential benefits justify the potential risks.

Precautions & Warnings

Caution is advised for patients with:

• Gastric malignancy
• Clostridium difficile-associated diarrhea
• Bone fractures
• Hypomagnesemia
• Concomitant use with Methotrexate.

Use in Special Populations

• Children and Adolescents: The safety and effectiveness of Delanix have not been established for patients under 12 years of age.

• Geriatric Use: No dosage adjustments are needed for elderly patients.

• Renal Impairment: No dose adjustment is required for patients with renal impairment.

• Hepatic Impairment: For patients with mild hepatic impairment, no dosage adjustment is required. However, for patients with moderate hepatic impairment, the maximum daily dose should not exceed 30 mg.

Overdose Effects

No significant overdose reports have been observed. Doses up to 120 mg have not caused fatal outcomes or severe adverse effects.

Therapeutic Class

Proton Pump Inhibitor

Storage Conditions

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