Indications and Dosing

PROTONIX is the brand you recognize, from the company you know—only from Pfizer.

PROTONIX for delayed-release oral suspension and PROTONIX delayed-release tablets are indicated for:

Short-term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD)1

  • PROTONIX is indicated in adults and pediatric patients 5 years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis
  • For those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of PROTONIX may be considered
  • Safety of treatment beyond 8 weeks in pediatric patients has not been established
Recommended Dosing Schedule for Short-term Treatment of Erosive Esophagitis Associated With GERD
  Dose Frequency
Adults 40 mg Once daily for up to 8 weeks
Children (5 years and older) ≥15 kg to <40 kg 20 mg Once daily for up to 8 weeks
≥40 kg 40 mg Once daily for up to 8 weeks
  • For adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of PROTONIX may be considered.

Maintenance of Healing of Erosive Esophagitis1

  • PROTONIX is indicated for maintenance of healing of erosive esophagitis and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with GERD
  • Controlled studies did not extend beyond 12 months
Recommended Dosing Schedule for Maintenance of Healing of Erosive Esophagitis
 
Dose
Frequency
Adults
40 mg
Once daily
  • Controlled studies did not extend beyond 12 months.

Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome1

  • PROTONIX is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.
Recommended Dosing Schedule for Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
 
Dose
Frequency
Adults
40 mg
Twice daily§
  • §Dosage regimens should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 240 mg daily have been administered.
 

ADMINISTRATION INSTRUCTIONS1

PROTONIX is supplied as delayed-release granules in packets for preparation of oral suspensions or as delayed-release tablets.

Directions for method of administration for each dosage form are presented in the table below.

Administration Instructions
Formulation
Route
Instructions||
Delayed-Release Tablets
Oral
Swallowed whole, with or without food
For Delayed-Release Oral Suspension
Oral
Administered in 1 teaspoonful of applesauce or apple juice approximately 30 minutes prior to a meal
For Delayed-Release Oral Suspension
Nasogastric tube
See instructions below
  • ||Patients should be cautioned that PROTONIX Delayed-Release Tablets and PROTONIX For Delayed-Release Oral Suspension should not be split, chewed, or crushed.

PROTONIX Delayed-Release Tablets

PROTONIX Delayed-Release Tablets should be swallowed whole, with or without food in the stomach. If patients are unable to swallow a 40-mg tablet, two 20-mg tablets may be taken. Concomitant administration of antacids does not affect the absorption of PROTONIX Delayed-Release Tablets.

PROTONIX For Delayed-Release Oral Suspension

PROTONIX For Delayed-Release Oral Suspension should only be administered approximately 30 minutes prior to a meal via oral administration in apple juice or applesauce or nasogastric tube in apple juice only. Because proper pH is necessary for stability, do not administer PROTONIX For Delayed-Release Oral Suspension in liquids other than apple juice, or foods other than applesauce.

Do not divide the 40-mg PROTONIX For Delayed-Release Oral Suspension packet to create a 20-mg dosage for pediatric patients who are unable to take the tablet formulation.

PROTONIX For Delayed-Release Oral Suspension—Oral Administration in Applesauce

1.

Open packet

2.

Sprinkle granules on one teaspoonful of applesauce. DO NOT USE OTHER FOODS OR CRUSH OR CHEW THE GRANULES

3.

Take within 10 minutes of preparation

4.

Take sips of water to make sure granules are washed down into the stomach. Repeat water sips as necessary

PROTONIX For Delayed-Release Oral Suspension—Oral Administration in Apple Juice

1.

Open packet

2.

Empty granules into a small cup or teaspoon containing one teaspoon of apple juice

3.

Stir for 5 seconds (granules will not dissolve) and swallow immediately

4.

To make sure that the entire dose is taken, rinse the container once or twice with apple juice to remove any remaining granules. Swallow immediately

PROTONIX For Delayed-Release Oral Suspension—Nasogastric (NG) Tube or Gastrostomy Tube Administration

For patients who have a nasogastric tube or gastrostomy tube in place, PROTONIX For Delayed-Release Oral Suspension can be given as follows:

1.

Remove the plunger from the barrel of a 2-ounce (60 mL) catheter-tip syringe. Discard the plunger

2.

Connect the catheter tip of the syringe to a 16 French (or larger) tube

3.

Hold the syringe attached to the tubing as high as possible while giving PROTONIX For Delayed-Release Oral Suspension to prevent any bending of the tubing

4.

Empty the contents of the packet into the barrel of the syringe

5.

Add 10 mL (2 teaspoonfuls) of apple juice and gently tap and/or shake the barrel of the syringe to help rinse the syringe and tube. Repeat at least twice more using the same amount of apple juice (10 mL or 2 teaspoonfuls) each time. No granules should remain in the syringe

3 Dosage Forms and Strengths

Delayed-Release Tablets:

  • 40 mg, yellow oval biconvex tablets imprinted with PROTONIX (brown ink) on one side
  • 20 mg, yellow oval biconvex tablets imprinted with P20 (brown ink) on one side

For Delayed-Release Oral Suspension:

  • 40 mg, pale yellowish to dark brownish, enteric-coated granules in a unit dose packet