Posology : מינונים

3   DOSAGE AND ADMINISTRATION
3.1 Recommended Dosage in Adults and adolescents aged 12 to 17 years DEXILANT is available as capsules in 30 mg and 60 mg strengths for adult and adolescents aged 12 to 17 years use. Directions for use in each indication are summarized in Table 1.

Table 1. Recommended DEXILANT Capsules dosage regimen by indication in Adults and adolescents aged 12 to 17 years
Dosage of DEXILANT
Indication                                          Duration
Capsules
Treatment of
One 60 mg capsule once erosive reflux                                     Up to 8 weeks.
daily.
oesophagitis
Maintenance of healed erosive reflux                                     Controlled studies did not oesophagitis     One 30 mg capsule once      extend beyond 6 months in and                  daily.                adults and 16 weeks in maintenance of                                 patients 12 to 17 years of relief of                                              age.
heartburn
Symptomatic non-erosive gastro-      One 30 mg capsule once oesophageal             daily.                       4 weeks.
reflux disease
(GORD)
3.2 Dosage Adjustment in Patients with Hepatic Impairment
For the treatment of erosive reflux oesophagitis
For patients with moderate hepatic impairment (Child-Pugh Class B), the recommended dosage is 30 mg DEXILANT once daily for up to eight weeks.
DEXILANT is not recommended in patients with severe hepatic impairment (Child- Pugh Class C) [see Use in Specific Populations (9.5)].

3.3 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.
• Swallow whole; do not chew.
• For patients who have trouble swallowing capsules, DEXILANT 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.
4. 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 the entire 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 with 10 mL of water, swirl gently, and administer.
4   DOSAGE FORMS AND STRENGTHS
DEXILANT modified-release capsules
• 30 mg: strength is an opaque, blue and gray capsule imprinted with “TAP” and “30”.
• 60 mg: strength is an opaque, blue capsule imprinted with “TAP” and “60”.