PANTOPRAZOLE SODIUM

PANTOPRAZOLE SODIUM — pantoprazole sodium granule, delayed release
Sun Pharmaceutical Industries, Inc.

1 INDICATIONS AND USAGE

Pantoprazole sodium for delayed-release oral suspension is indicated for:

1.1 Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD)

Pantoprazole sodium for delayed-release oral suspension 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 pantoprazole sodium for delayed-release oral suspension may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established.

1.2 Maintenance of Healing of Erosive Esophagitis

Pantoprazole sodium for delayed-release oral suspension 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 (ZE) Syndrome


Pantoprazole sodium for delayed-release oral suspension 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

Pantoprazole sodium is supplied as delayed-release granules in packets for preparation of oral suspensions. The recommended dosages are outlined in Table 1.

Table 1: Recommended Dosing Schedule for Pantoprazole Sodium for Delayed-Release Oral Suspension

*
For adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium for delayed-release oral suspension 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.
Indication Dose Frequency
Short-Term Treatment of Erosive Esophagitis Associated With GERD
Adults 40 mg Once daily for up to 8 weeks *
Children (5 years and older) ≥ 40 kg 40 mg Once daily for up to 8 weeks
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 are presented in Table 2.

Table 2: Administration Instructions

Formulation Route Instructions*
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

* Do not split, chew, or crush Pantoprazole Sodium for Delayed-Release Oral Suspension.

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.

Administer pantoprazole sodium 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 pantoprazole sodium for delayed-release oral suspension in liquids other than apple juice, or foods other than applesauce.

Do not divide the 40 mg pantoprazole sodium for delayed-release oral suspension packet to create a 20 mg dosage for pediatric patients who are unable to take the tablet formulation.

Pantoprazole Sodium 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.

Pantoprazole Sodium 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.

Pantoprazole Sodium for Delayed-Release Oral Suspension — Nasogastric (NG) Tube or Gastrostomy Tube Administration

For patients who have a nasogastric tube or gastrostomy tube in place, pantoprazole sodium 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 pantoprazole sodium 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

For Delayed-Release Oral Suspension:

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

4 CONTRAINDICATIONS

  • Pantoprazole sodium for delayed-release oral suspension 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 interstitial nephritis, and urticaria [see Adverse Reactions (6)].
  • Proton pump inhibitors (PPIs), including pantoprazole sodium for delayed-release oral suspension, are contraindicated with rilpivirine-containing products [see Drug Interactions (7)].

5 WARNINGS AND PRECAUTIONS

5.1 Presence of Gastric Malignancy

In adults, symptomatic response to therapy with pantoprazole sodium for delayed-release oral suspension 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.

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