Inhibtol 30mg D.R.

Composition

• Dexalansoprazole 30mg

Dosage form

• Delayed release hard gelatin Capsules

Therapeutic Indication

• Healing of Erosive Esophagitis Inhibitol is indicated in patients 12 years of age and older for healing of all grades of erosive esophagitis (EE) for up to eight weeks.

• Maintenance of Healed Erosive Esophagitis and Relief of Heartburn Inhibitol is indicated in patients 12 years of age and older to maintain healing of EE and relief of heartburn for up to six months in adults and 16 weeks in patients 12 to 17 years of age

• Treatment of Symptomatic Non-Erosive Gastroesophageal Reflux Disease Inhibitol is indicated in patients 12 years of age and older for the treatment of heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD) for four weeks.

Dosage and route of administration
Dosage:

• Recommended Inhibitol Capsules Dosage Regimen by Indication in Patients 12 Years of Age and Older
• Healing of EE: One 60 mg capsule once daily. Up to 8 weeks.
• Maintenance of Healed EE and Relief of Heartburn : One 30 mg capsule once daily. Controlled studies did not extend beyond 6 months in adults and 16 weeks in patients 12 to 17 years of age.

Symptomatic Non- Erosive GERD : One 30 mg capsule once daily. 4 weeks.

• Method of administration
  -Important Administration Information :
  
  
  
• Take without regard to food
• Missed doses: If a dose is missed, administer   as soon as possible. However, if the next scheduled dose is due, do not    take   the missed  dose, and take the next dose on time. Do not take two doses at one time to make up for a missed dose.
• For patients who have trouble swallowing capsules, Inhibitol capsules can be opened and administered with applesauce as follows ;
  1-Place    one tablespoonful of applesauce into a clean container.
  2-Open capsule.
  3-Sprinkle intact granules on applesauce. Swallow applesauce and granules immediately.  Do not chew granules. Do not save the applesauce and granules for later use.
  
• Alternatively,  the capsule can be administered with water via oral syringe or nasogastric (NG) tube.

• Administration with Water in an Oral Syringe
  1-Open the capsule and empty the granules into a clean container with 20 mL of water.
  2-Withdraw theentire mixture into a syringe.
  3-Gently swirl the syringe in order to keep granules from settling.
  4-Administer the mixture immediately  into the mouth. Do not save the water and granule mixture for later use
  5-Refill the syringe with 10 mL of water, swirl gently, and administer.
  6-Refill the syringe again with 10 mL of water, swirl gently, and administer
  

• Administration with Water via a NG Tube (≥16 French):
  1-Open the capsule and empty the granules into a clean container with 20 mL of water.
  2-Withdraw the entire mixture into a catheter-tip syringe.
  3-Swirl the catheter- tip syringe gently in order to keep the granules from settling,and immediately inject the mixture through the NG tube into the stomach. Do not save the water and granule mixture for later use.
  4-Refill   the catheter-tip syringe with 10 mL of water,  swirl gently, and flush the tube.
  5-Refill the catheter-tip syringe again with10 mL of water, swirl gently, and administer.
  

Package

• Carton box
  containing 1,2,3 (AL/transparent PVC) strips, each of
  7 hard gelatin
•  inner leaflet
• capsules