Pantoprazole Sodium

PANTOPRAZOLE SODIUM- pantoprazole sodium tablet, delayed release
RedPharm Drug, Inc.

These highlights do not include all the information needed to use pantoprazole sodium delayed-release tablets safely and effectively. See full prescribing information for pantoprazole sodium delayed-release tablets.
PANTOPRAZOLE sodium delayed-release tablets, for oral use
Initial U.S. Approval: 2000

RECENT MAJOR CHANGES

Warnings and Precautions, Atrophic Gastric removed (5.2) 10/2016

Warnings and Precautions, Cutaneous and Systemic Lupus Erythematosus (5.5) 10/2016

INDICATIONS AND USAGE

Pantoprazole is a proton pump inhibitor 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 Syndrome (1.3)

DOSAGE AND ADMINISTRATION

Indication Dose Frequency

*
Controlled studies did not extend beyond 12 months

Short-Term Treatment of Erosive Esophagitis Associated With GERD (2.1)
Adults 40 mg Once Daily for up to 8 wks
Children (5 years and older)
≥ 15 kg to < 40 kg 20 mg Once Daily for up to 8 wks
≥ 40 kg 40 mg
Maintenance of Healing of Erosive Esophagitis (2.1)
Adults 40 mg Once Daily*
Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome (2.1)
Adults 40 mg Twice Daily

See full prescribing information for administration instructions

DOSAGE FORMS AND STRENGTHS

Delayed-Release Tablets, 20 mg and 40 mg (3)

CONTRAINDICATIONS

Known hypersensitivity to any component of the formulation or to substituted benzimidazoles (4)

WARNINGS AND PRECAUTIONS

In adults, symptomatic response does not preclude presence of gastric malignancy. Consider additional follow-up and diagnostic testing. (5.1)

Acute interstitial nephritis has been observed in patients taking PPIs. (5.2)

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 Pantoprazole 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 has been reported rarely with prolonged treatment with PPIs (5.7)

ADVERSE REACTIONS

The most frequently occurring adverse reactions are as follows:

For adult use (>2%) are headache, diarrhea, nausea, abdominal pain, vomiting, flatulence, dizziness, and arthralgia. (6)
For pediatric use (>4%) are URI, headache, fever, diarrhea, vomiting, rash, and abdominal pain. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Lannett Company, Inc. at 1-844-834-0530 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

DRUG INTERACTIONS

Do not co-administer with atazanavir or nelfinavir (7.1)
Concomitant warfarin use may require monitoring (7.2)
May interfere with the absorption of drugs where gastric pH is important for bioavailability (e.g. ketoconazole, ampicillin esters, atazanavir, iron salts, erlotinib and mycophenolate mofetil) (7.4)
May produce false-positive urine screen for THC (7.5)
Methotrexate: Pantoprazole may increase serum level of methotrexate (7.6)

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 11/2016

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE
1.1 Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD)
1.2 Maintenance of Healing of Erosive Esophagitis
1.3 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosing Schedule
2.2 Administration Instructions
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Presence of Gastric Malignancy
5.2 Acute Interstitial Nephritis
5.3 Clostridium difficile-Associated Diarrhea
5.4 Bone Fracture
5.5 Cutaneous and Systemic Lupus Erythematosus
5.6 Cyanocobalamin (Vitamin B-12) Deficiency
5.7 Hypomagnesemia
5.8 Tumorigenicity
5.9 Interference with Urine Screen for THC
5.10 Concomitant Use of Pantoprazole with Methotrexate
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Postmarketing Experience
7 DRUG INTERACTIONS
7.1 Interference with Antiretroviral Therapy
7.2 Coumarin Anticoagulants
7.3 Clopidogrel
7.4 Drugs for Which Gastric pH Can Affect Bioavailability
7.5 False Positive Urine Tests for THC
7.6 Methotrexate
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Gender
8.7 Patients with Hepatic Impairment
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
12.4 Pharmacogenomics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
13.2 Animal Toxicology and/or Pharmacology
14 CLINICAL STUDIES
14.1 Erosive Esophagitis (EE) Associated with Gastroesophageal Reflux Disease (GERD)
14.2 Long-Term Maintenance of Healing of Erosive Esophagitis
14.3 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION

*
Sections or subsections omitted from the full prescribing information are not listed.

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 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 Pantoprazole 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 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.

1.3 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome

Pantoprazole is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosing Schedule

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

Table 1: Recommended Dosing Schedule for Pantoprazole
Indication Dose Frequency

*
For adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of Pantoprazole 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*

*
Patients should be cautioned that Pantoprazole Sodium Delayed-Release Tablets should not be split, chewed, or crushed.

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.