PANTOPRAZOLE SODIUM

PANTOPRAZOLE SODIUM- pantoprazole sodium tablet, delayed release
California Pharmaceuticals LLC

1 INDICATIONS AND USAGE

Pantoprazole sodium delayed-release tablets, USP are 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)

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

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

2 DOSAGE AND ADMINISTRATION

Indication Dose Frequency
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

* Controlled studies did not extend beyond 12 months

See full prescribing information for administration instructions

2.1 Recommended Dosing Schedule

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

Table 1: Recommended Dosing Schedule for Pantoprazole Sodium Delayed-Release Tablets, USP

Indication Dose Frequency
Short-Term Treatment of Erosive Esophagitis Associated Wiith 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 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 pantoprazole sodium delayed-release tablets,
USP 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.

2.2 Administration Instructions

Directions for method of administration are presented in Table 2.

Table 2: Administration Instructions
Formulation Route Instructions*
Delayed-release Tablets Oral Swallow whole, with or with out food
*Patients should be cautioned that pamtoprazole sodium sodium delayed-released tablets, USP should not be split, hewed, or crushed.

3 DOSAGE FORMS AND STRENGTHS

Delayed-release Tablets:

  • 20 mg, light yellow to yellow color, oval shaped, biconvex, delayed-release tablets imprinted “A6” with black ink on one side and plain on the other side.
  • 40 mg, light yellow to yellow color, oval shaped, biconvex, delayed-release tablets imprinted “A37” with black ink on one side and plain on the other side.

4 CONTRAINDICATIONS

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

Pantoprazole sodium delayed-release tablets, USP 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

  • Symptomatic response does not preclude presence of gastric malignancy (5.1)
  • Atrophic gastritis has been noted with long-term therapy (5.2)
  • Acute interstitial nephritis has been observed in patients taking PPIs. (5.3)
  • Cyanocobalamin (vitamin B-12) Deficiency: Daily long-term use (e.g., longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin. (5.4)
  • PPI therapy may be associated with increased risk of Clostridium difficile associated diarrhea. (5.5)
  • 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. (5.6)
  • Hypomagnesemia has been reported rarely with prolonged treatment with PPIs (5.7)

5.1 Concurrent Gastric Malignancy

Symptomatic response to therapy with pantoprazole sodium 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 sodium, 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 sodium. Acute interstitial nephritis may occur at any point during PPI therapy and is generally attributed to an idiopathic hypersensitivity reaction. Discontinue pantoprazole sodium if acute interstitial nephritis develops [see Contraindications (4)].

5.4 Cyanocobalamin (Vitamin B-12) Deficiency

Generally, daily treatment with any acid-suppressing medications over a long period of time (e.g., longer than 3 years) may lead to malabsorption of cyanocobalamin (Vitamin B-12) caused by hypo- or achlorhydria. Rare reports of cyanocobalamin deficiency occurring with acid-suppressing therapy have been reported in the literature. This diagnosis should be considered if clinical symptoms consistent with cyanocobalamin deficiency are observed.

5.5 Clostridium difficile associated diarrhea

Published observational studies suggest that PPI therapy like pantoprazole sodium 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.

5.6 Bone Fracture

Several published observational studies suggest that proton pump inhibitor (PPI) therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine. The risk of fracture was increased in patients who received high-dose, defined as multiple daily doses, and long-term PPI therapy (a year or longer). Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated. Patients at risk for osteoporosis-related fractures should be managed according to established treatment guidelines [see Dosage and Administration (2) and Adverse Reactions (6.2)].

5.7 Hypomagnesemia

Hypomagnesemia, symptomatic and asymptomatic, has been reported rarely in patients treated with PPIs for at least three months, in most cases after a year of therapy. Serious adverse events include tetany, arrhythmias, and seizures. In most patients, treatment of hypomagnesemia required magnesium replacement and discontinuation of the PPI.

For patients expected to be on prolonged treatment or who take PPIs with medications such as digoxin or drugs that may cause hypomagnesemia (e.g., diuretics), health care professionals may consider monitoring magnesium levels prior to initiation of PPI treatment and periodically [see Adverse Reactions (6.2)].

5.8 Tumorigenicity

Due to the chronic nature of GERD, there may be a potential for prolonged administration of pantoprazole sodium. In long-term rodent studies, pantoprazole was carcinogenic and caused rare types of gastrointestinal tumors. The relevance of these findings to tumor development in humans is unknown [see Nonclinical Toxicology (13.1)].

5.9 Interference with Urine Screen for THC

See Drug Interactions (7.5).

5.10 Concomitant use of Pantoprazole Sodium with Methotrexate

Literature suggests that concomitant use of PPIs with methotrexate (primarily at high dose; see methotrexate prescribing information) may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities. In high-dose methotrexate administration, a temporary withdrawal of the PPI may be considered in some patients [see Drug Interactions (7.6)].

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