Dexlan-60

Indications of Dexlan Capsule

• Dexlansoprazole is indicated for the healing of all grades of erosive esophagitis (EE) for up to 8 weeks.
• Dexlansoprazole is indicated to maintain healing of EE and relief of heartburn for up to 6 months.
• Dexlansoprazole is indicated for the treatment of heartburn associated with symptomatic non-erosive Gastroesophageal Reflux Disease (GERD) for 4 weeks.

 

Pharmacology of Dexlan Capsule

Dexlansoprazole delayed-release capsule is a proton pump inhibitor (PPI) that inhibits the (H+/K+)-ATPase in the gastric parietal cell, suppressing gastric acid output. Dexlansoprazole works by blocking the final step of acid generation by acting on the proton pump. It's lansoprazole's R-enantiomer (A racemic mixture of the R- and S-enantiomers). Dexlansoprazole is available in capsule form with a Dual Delayed Release (DDR) formulation for oral consumption. This capsule contains a mixture of two types of enteric coated granules with different pH-dependent dissolution profiles. The dual delayed release formulation in dexlansoprazole, 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. After oral administration, the mean Cmax and AUC value of Dexlansoprazole increased approximately dose proportionally. Dexlansoprazole is processed extensively in the liver and excreted in the urine.

 

Dexlan Capsule Dosage

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

 

Administration

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

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

 

Contraindications

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

 

Side-Effects

Common: Diarrhea, abdominal pain, nausea, vomiting & flatulence.

 

Pregnancy & Lactation

There are no adequate and well-controlled studies with Dexlansoprazole in pregnant women. There are no adequate and well-controlled studies with Dexlansoprazole in Lactating mother.

 

Precautions & Warnings

Clostridium difficile Associated Diarrhea, Gastric Malignancy, Bone fracture, Hypomagnesemia, and concomitant use of Dexlansoprazole with 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

The IBN SINA Pharmaceutical Industry Ltd

 

Generic

Dexlansoprazole