Delanix 60

Indications of Delanix Capsule

Healing of erosive esophagitis: Dexlansoprazole is suitable for the treatment of all grades of erosive esophagitis (EE) for up to 8 weeks.

Maintenance of healing of erosive esophagitis: Dexlansoprazole is used to maintain healing of EE and relieve heartburn for up to 6 months.

Symptomatic non-erosive gastroesophageal reflux disease: Dexlansoprazole is indicated for the treatment of heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD) for a period of 4 weeks.

 

Pharmacology of Delanix Capsule

Dexlansoprazole sustained-release capsule is a proton pump inhibitor (PPI), which inhibits gastric acid secretion by specifically inhibiting (H + / K +) ATPase in gastric parietal cells. By acting exclusively on the proton pump, dexlansoprazole prevents the last step of acid production. It is the enantiomer of lansoprazole (a racemic mixture of R and the enantiomer). Dexlansoprazole is provided as a dual delayed release (DDR) formulation in an oral capsule. The capsule contains a mixture of two types of enteric-coated granules, which have different pH-dependent dissolution profiles. The dual delayed-release formulation in dexlansoprazole has two different peak plasma concentration time profiles; the first peak appears 1 to 2 hours after administration, followed by the second peak within 4 to 5 hours. After oral administration, the mean Cmax and AUC values ​​of dexlansoprazole increase approximately in proportion to the dose. Dexlansoprazole is extensively metabolized in the liver and excreted in the urine.

 

Delanix Capsule Dosage & Administration

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 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.

 

Interactions

Drugs used: atazanavir, warfarin, tacrolimus, clopidogrel and methotrexate. With food and others: no data available.

 

Contraindications

Patients who are known to be allergic to any component of the preparation should not use dexlansoprazole.

 

Side Effects

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

 

Pregnancy

Pregnancy category B. There are no adequate and well-controlled studies on the use of dexlansoprazole in pregnant women. There are no adequate and well-controlled studies on the use of dexlansoprazole in breastfeeding mothers.

 

Precautions

Gastric neoplasms, Clostridium difficile-related diarrhea, fractures, hypomagnesemia, and simultaneous use of dexlansoprazole and methotrexate.

 

Therapeutic Class

Proton Pump Inhibitor

 

Storage Conditions

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

 

Pharmaceutical Name

Incepta Pharmaceuticals Ltd

 

Generic

Dexlansoprazole