Pantoprazole Sodium

PANTOPRAZOLE SODIUM- pantoprazole sodium tablet, delayed release
Lake Erie Medical DBA Quality Care Products LLC

1 INDICATIONS AND USAGE

Pantoprazole sodium delayed-release tablets, USP are indicated for:

1.1 Short-term Treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD)

Pantoprazole sodium delayed-release tablets are 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 pantoprazole sodium delayed-release tablets 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 delayed-release tablets are 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.

1.3 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome

Pantoprazole sodium delayed-release tablets are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosing Schedule

Pantoprazole sodium is supplied as delayed-release tablets. The recommended dosages are outlined in Table 1.

Table 1: Recommended Dosing Schedule for Pantoprazole Sodium Delayed-release Tablets
*
For adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium delayed-release tablets 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)

≥ 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 the delayed-release tablet dosage form are presented in Table 2.

Table 2: Administration Instructions
*
Patients should be cautioned that pantoprazole sodium delayed-release tablets should not be split, chewed, or crushed.

Formulation

Route

Instructions *

Delayed-release Tablets

Oral

Swallowed whole, with or without food

Pantoprazole Sodium Delayed-release Tablets

Pantoprazole sodium 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 pantoprazole sodium delayed-release tablets.

3 DOSAGE FORMS AND STRENGTHS

Pantoprazole Sodium Delayed-release Tablets

The 20 mg tablets are dark yellow film-coated, oval, unscored tablets imprinted with M P8 in
black ink on one side of the tablet and blank on the other side.
The 40 mg tablets are dark yellow film-coated, oval unscored tablets imprinted with M P9 in black ink on one side of the tablet and blank on the other side.

4 CONTRAINDICATIONS

Pantoprazole sodium delayed-release tablets are 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)].

5 WARNINGS AND PRECAUTIONS

5.1 Concurrent Gastric Malignancy

Symptomatic response to therapy with pantoprazole does not preclude the presence of gastric malignancy.

5.2 Atrophic Gastritis

Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long-term with pantoprazole, particularly in patients who were H. pylori positive.

5.3 Acute Interstitial Nephritis

Acute interstitial nephritis has been observed in patients taking PPIs including pantoprazole. Acute interstitial nephritis may occur at any point during PPI therapy and is generally attributed to an idiopathic hypersensitivity reaction. Discontinue pantoprazole if acute interstitial nephritis develops [see Contraindications (4)].

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