Protonix Delayed-Release: Package Insert and Label Information

PROTONIX DELAYED-RELEASE- pantoprazole sodium tablet, delayed release
RedPharm Drug, Inc.

1 INDICATIONS AND USAGE

PROTONIX is a proton pump inhibitor (PPI) indicated for the following:

Short-Term Treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD) ( 1.1)
Maintenance of Healing of Erosive Esophagitis ( 1.2)
Pathological Hypersecretory Conditions Including Zollinger-Ellison (ZE) Syndrome ( 1.3)

PROTONIX For Delayed-Release Oral Suspension and PROTONIX Delayed-Release Tablets are indicated for:

1.1 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 (EE). 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.

1.2 Maintenance of Healing of Erosive Esophagitis

PROTONIX is indicated for maintenance of healing of EE and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with GERD. Controlled studies did not extend beyond 12 months.

1.3 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome

PROTONIX is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison (ZE) Syndrome.

2 DOSAGE AND ADMINISTRATION

2.1 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

Table 1: Recommended Dosing Schedule for PROTONIX
Indication Dose Frequency

*
For adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of PROTONIX may be considered.

Controlled studies did not extend beyond 12 months

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.

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‡

2.2 Administration Instructions

Directions for method of administration for each dosage form are presented in Table 2.

Table 2: Administration Instructions
Formulation Route Instructions*

*
Do not split, chew, or crush PROTONIX Delayed-Release Tablets and PROTONIX For Delayed-Release Oral Suspension.

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

Take a missed dose as soon as possible. If it is almost time for the next dose, skip the missed dose and take the next dose at the regular scheduled time. Do not take 2 doses at the same time.

PROTONIX Delayed-Release Tablets

Swallow PROTONIX Delayed-Release Tablets whole, with or without food in the stomach. For patients 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

Administer PROTONIX For Delayed-Release Oral Suspension 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.

2.1 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
Indication Dose Frequency
*
For adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of PROTONIX may be considered.
Controlled studies did not extend beyond 12 months
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.
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

2.2 Administration Instructions

Directions for method of administration for each dosage form are presented in Table 2.

Table 2: Administration Instructions
Formulation Route Instructions *
*
Do not split, chew, or crush PROTONIX Delayed-Release Tablets and PROTONIX For Delayed-Release Oral Suspension.
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

Take a missed dose as soon as possible. If it is almost time for the next dose, skip the missed dose and take the next dose at the regular scheduled time. Do not take 2 doses at the same time.

PROTONIX Delayed-Release Tablets

Swallow PROTONIX Delayed-Release Tablets whole, with or without food in the stomach. For patients 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

Administer PROTONIX For Delayed-Release Oral Suspension 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.

3 DOSAGE FORMS AND STRENGTHS

Delayed-Release Tablets:

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

For Delayed-Release Oral Suspension:

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

4 CONTRAINDICATIONS

  • PROTONIX is contraindicated in patients with known hypersensitivity to any component of the formulation or any substituted benzimidazole. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis, and urticaria [see Warnings and Precautions (5.2), Adverse Reactions (6)] .
  • Proton pump inhibitors (PPIs), including PROTONIX, are contraindicated in patients receiving rilpivirine-containing products [see Drug Interactions (7)] .

  • Patients with known hypersensitivity to any component of the formulation or to substituted benzimidazoles ( 4)
  • Patients receiving rilpivirine-containing products ( 4, 7)

5 WARNINGS AND PRECAUTIONS

  • Gastric Malignancy: In adults, symptomatic response does not preclude presence of gastric malignancy. Consider additional follow-up and diagnostic testing. ( 5.1)
  • Acute Tubulointerstitial Nephritis: Discontinue treatment and evaluate patients. ( 5.2)
  • Clostridium difficile- Associated Diarrhea : PPI therapy may be associated with increased risk of Clostridium difficile- associated diarrhea. ( 5.3)
  • Bone Fracture: Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine. ( 5.4)
  • Cutaneous and Systemic Lupus Erythematosus: Mostly cutaneous; new onset or exacerbation of existing disease; discontinue PROTONIX and refer to specialist for evaluation. ( 5.5)
  • Cyanocobalamin (Vitamin B-12) Deficiency: Daily long-term use (e.g., longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin. ( 5.6)
  • Hypomagnesemia: Reported rarely with prolonged treatment with PPIs. ( 5.7)
  • Fundic Gland Polyps: Risk increases with long-term use, especially beyond one year. Use the shortest duration of therapy. ( 5.9)

5.1 Presence of Gastric Malignancy

In adults, symptomatic response to therapy with PROTONIX does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing in adult patients who have a suboptimal response or an early symptomatic relapse after completing treatment with a PPI. In older patients, also consider an endoscopy.

5.2 Acute Tubulointerstitial Nephritis

Acute tubulointerstitial nephritis (TIN) has been observed in patients taking PPIs and may occur at any point during PPI therapy. Patients may present with varying signs and symptoms from symptomatic hypersensitivity reactions to non-specific symptoms of decreased renal function (e.g., malaise, nausea, anorexia). In reported case series, some patients were diagnosed on biopsy and in the absence of extra-renal manifestations (e.g., fever, rash or arthralgia). Discontinue PROTONIX and evaluate patients with suspected acute TIN [see Contraindications (4)].

5.3 Clostridium difficile- Associated Diarrhea

Published observational studies suggest that PPI therapy like PROTONIX may be associated with an increased risk of Clostridium difficile associated diarrhea, especially in hospitalized patients. This diagnosis should be considered for diarrhea that does not improve [see Adverse Reactions (6.2)] .

Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.

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