Usual Adult Dose for Erosive Esophagitis

Healing of Erosive Esophagitis (EE): 60 mg orally once a day

• Duration of therapy: Up to 8 weeks

Maintenance dose: 30 mg orally once a day

• Duration of therapy: Up to 6 months

Comments:

• Patients may be given maintenance doses for the relief of heartburn.
• Controlled studies for maintenance therapy did not extend beyond 6 months.

Uses:

• Healing of all grades of EE
• Maintenance of healed EE
• Relief of heartburn

Usual Adult Dose for Gastroesophageal Reflux Disease

30 mg orally once a day

• Duration of therapy: 4 weeks

Use: Treatment of heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD)

Usual Pediatric Dose for Erosive Esophagitis

12 years and older:
Healing of EE: 60 mg orally once a day

• Duration of therapy: Up to 8 weeks

Maintenance dose: 30 mg orally once a day

• Duration of therapy: Up to 6 months

Comments:

• Patients may be given maintenance doses for the relief of heartburn.
• Controlled studies of maintenance therapy did not extend beyond 16 weeks.

Uses:

• Healing of all grades of EE
• Maintenance of healed EE
• Relief of heartburn

Usual Pediatric Dose for Gastroesophageal Reflux Disease

12 years and older: 30 mg orally once a day

• Duration of therapy: 4 weeks

Use: Treatment of heartburn associated with symptomatic non-erosive GERD

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

Mild liver dysfunction (Child-Pugh A): No adjustment recommended.
Moderate liver dysfunction (Child-Pugh B): 30 mg orally once a day for up to 8 weeks
Severe liver dysfunction (Child-Pugh C): Not recommended.

Precautions

CONTRAINDICATIONS:

• Hypersensitivity to the active component or any of the ingredients
• Use with rilpivirine-containing products

Safety and efficacy have not been established in patients younger than 12 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• This drug can be taken without regard to food.
• This drug should not be chewed; it should be swallowed whole.
• For patients that have difficulty swallowing capsules, the contents of a capsule can be sprinkled on applesauce, or dissolved in 20 mL of water and withdrawn into an oral syringe. Administer immediately into the mouth. Refill the syringe with 10 mL of water, swirl gently and administer. Repeat this step one more time.

Administration with water via a nasogastric tube:

• Open the capsule and dissolve the content in 20 mL of water.
• Withdraw the entire mixture into a catheter-tip syringe, swirl the syringe gently in order to keep the granules from settling, and immediately inject the mixture through the nasogastric tube into the stomach.
• Do not save the water and granule mixture for later use.
• Refill the syringe with 10 mL of water, swirl gently, and flush the tube.
• Refill the syringe again with 10 mL of water, swirl gently, and administer.

General:

• Two, 30 mg tablets are not interchangeable with one, 60 mg tablet.

Patient advice:

• Report immediately and seek care if diarrhea does not improve. This may be a sign of Clostridium difficile associated diarrhea.
• Report immediately and seek care for any cardiovascular or neurological symptoms including palpitations, dizziness, seizures, and tetany as these may be signs of hypomagnesemia.
• Advise patients to speak to their physician or health care professional if they are pregnant, intend to become pregnant, or are breastfeeding.