"The U.S. Food and Drug Administration today approved the first generic versions of Aciphex (rabeprazole sodium) delayed-release tablets, used to treat gastroesophageal reflux disease (GERD) in adults and adolescents (ages 12 and up).
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)
PROTONIX is indicated in adults and pediatric patients five 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.
Maintenance Of Healing Of Erosive Esophagitis
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.
Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
PROTONIX is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.
DOSAGE AND ADMINISTRATION
Recommended Dosing Schedule
PROTONIX is supplied as delayed-release granules in packets for preparation of oral suspensions or as delayed-release tablets. The recommended dosages are outlined in Table 1.
Table 1: Recommended Dosing Schedule for PROTONIX
|Short-Term Treatment of Erosive Esophagitis Associated With GERD|
|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|
|Maintenance of Healing of Erosive Esophagitis|
|Adults||40 mg||Once daily***|
|Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome|
|Adults||40 mg||Twice daily**|
|* For adult patients who have not healed after 8 weeks of
treatment, an additional 8-week course of PROTONIX may be considered.
** 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.
*** Controlled studies did not extend beyond 12 months
Directions for method of administration for each dosage form are presented in Table 2.
Table 2: Administration 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
- Open packet.
- Sprinkle granules on one teaspoonful of applesauce. DO NOT USE OTHER FOODS OR CRUSH OR CHEW THE GRANULES.
- Take within 10 minutes of preparation.
- 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
- Open packet.
- Empty granules into a small cup or teaspoon containing one teaspoon of apple juice.
- Stir for 5 seconds (granules will not dissolve) and swallow immediately.
- 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:
- Remove the plunger from the barrel of a 2 ounce (60 mL) catheter-tip syringe. Discard the plunger.
- Connect the catheter tip of the syringe to a 16 French (or larger) tube.
- 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.
- Empty the contents of the packet into the barrel of the syringe.
- 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.
Dosage Forms And Strengths
- 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
Storage And Handling
PROTONIX (pantoprazole sodium) Delayed-Release Tablets are supplied as 40 mg yellow, oval biconvex delayed-release tablets imprinted with PROTONIX (brown ink) on one side and are available as follows:
NDC 0008-0841-81, bottles of 90
NDC 0008-0841-99, carton of 10 Redipak® blister strips of 10 tablets each
PROTONIX (pantoprazole sodium) Delayed-Release Tablets are supplied as 20 mg yellow oval biconvex delayed-release tablets imprinted with P20 (brown ink) on one side and are available as follows:
NDC 0008-0843-81, bottles of 90
PROTONIX (pantoprazole sodium) For Delayed-Release Oral Suspension 40 mg contains pale yellowish to dark brownish, enteric-coated granules in a 40 mg unit-dose packet and are available as follows:
NDC 0008-0844-02, unit-dose carton of 30
Store PROTONIX For Delayed-Release Oral Suspension and PROTONIX Delayed-Release Tablets at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Distributed by : Wyeth Pharmaceuticals Inc, A subsidiary of Pfizer Inc., Philadelphia, PA 19101. under license from Takeda GmbH D78467 Konstanz, Germany. Revised: December 2014
Last reviewed on RxList: 1/12/2015
This monograph has been modified to include the generic and brand name in many instances.
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