Pantoprazole Sodium Delayed-release label

Pantoprazole Sodium Delayed-release

Pantoprazole Sodium Delayed-release Recall

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Uses

Pantoprazole Sodium Delayed-Release Tablets 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 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.

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History

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Other Information

The active ingredient in Pantoprazole Sodium Delayed-Release Tablets is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H-benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F2N3NaO4S × 1.5 H2O, with a molecular weight of 432.4. The structural formula is:

Chemical Structure

Pantoprazole sodium sesquihydrate is a white to off-white crystalline powder and is racemic. Pantoprazole sodium has weakly basic and acidic properties. Pantoprazole sodium sesquihydrate is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane.

The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8.

Pantoprazole sodium is supplied as a delayed-release tablet, available in two strengths (20 mg and 40 mg).

Each Pantoprazole Sodium Delayed-Release Tablet contains 45.1 mg or 22.56 mg of pantoprazole sodium sesquihydrate (equivalent to 40 mg or 20 mg pantoprazole sodium, respectively) with the following inactive ingredients: calcium stearate, crospovidone, hypromellose, iron oxide, mannitol, methacrylic acid copolymer, polysorbate 80, povidone, propylene glycol, sodium carbonate, sodium lauryl sulfate, titanium dioxide, and triethyl citrate. Pantoprazole Sodium Delayed-Release Tablets (40 mg and 20 mg) complies with USP dissolution test 2.

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Pantoprazole Sodium Delayed-release Manufacturers

  • Lake Erie Medical Dba Quality Care Products Llc
    Pantoprazole Sodium Delayed-release | Lake Erie Medical Dba Quality Care Products Llc
    No Recall

    Pantoprazole Sodium Delayed-release | Lake Erie Medical Dba Quality Care Products Llc

    Pantoprazole Sodium Delayed-release | Lake Erie Medical Dba Quality Care Products Llc
    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 Indication Dose Frequency * For adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium 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.

  • Contract Pharmacy Services-pa
    Pantoprazole Sodium Delayed-release | Contract Pharmacy Services-pa
    No Recall

    Pantoprazole Sodium Delayed-release | Contract Pharmacy Services-pa

    Pantoprazole Sodium Delayed-release | Contract Pharmacy Services-pa
    Treatment of Erosive Esophagitis

    The recommended adult oral dose is 40 mg given once daily for up to 8 weeks. For those patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium may be considered (see INDICATIONS AND USAGE).

    Maintenance of Healing of Erosive Esophagitis

    The recommended adult oral dose is one pantoprazole sodium 40 mg delayed-release tablet, taken daily (see CLINICAL PHARMACOLOGY, Clinical Studies).

    Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome

    The dosage of pantoprazole sodium in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult starting dose is 40 mg twice daily. 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. Some patients have been treated continuously with pantoprazole sodium for more than 2 years.

    No dosage adjustment is necessary in patients with renal impairment, hepatic impairment, or for elderly patients. Doses higher than 40 mg/day have not been studied in hepatically-impaired patients. No dosage adjustment is necessary in patients undergoing hemodialysis.

    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.

    Patients should be cautioned that pantoprazole sodium delayed-release tablets should not be split, chewed or crushed.

  • Cardinal Health
    Pantoprazole Sodium Delayed-release | Cardinal Health
    No Recall

    Pantoprazole Sodium Delayed-release | Cardinal Health

    Pantoprazole Sodium Delayed-release | Cardinal Health
    Treatment of Erosive Esophagitis

    The recommended adult oral dose is 40 mg given once daily for up to 8 weeks. For those patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium may be considered (see INDICATIONS AND USAGE).

    Maintenance of Healing of Erosive Esophagitis

    The recommended adult oral dose is one pantoprazole sodium 40 mg delayed-release tablet, taken daily (see CLINICAL PHARMACOLOGY, Clinical Studies).

    Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome

    The dosage of pantoprazole sodium in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult starting dose is 40 mg twice daily. 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. Some patients have been treated continuously with pantoprazole sodium for more than 2 years.

    No dosage adjustment is necessary in patients with renal impairment, hepatic impairment, or for elderly patients. Doses higher than 40 mg/day have not been studied in hepatically-impaired patients. No dosage adjustment is necessary in patients undergoing hemodialysis.

    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.

    Patients should be cautioned that pantoprazole sodium delayed-release tablets should not be split, chewed or crushed.

  • Preferred Pharmaceuticals, Inc.
    Pantoprazole Sodium Delayed-release | Pharmacosmetic-diafarm
    No Recall

    Pantoprazole Sodium Delayed-release | Pharmacosmetic-diafarm

    Pantoprazole Sodium Delayed-release | Pharmacosmetic-diafarm

    There is currently no dosage information available for this product. We apologize for any inconvenience.

  • Wyeth Pharmaceuticals Inc., A Subsidiary Of Pfizer Inc.
    Pantoprazole Sodium Delayed-release | Wyeth Pharmaceuticals Inc., A Subsidiary Of Pfizer Inc.
    No Recall

    Pantoprazole Sodium Delayed-release | Wyeth Pharmaceuticals Inc., A Subsidiary Of Pfizer Inc.

    Pantoprazole Sodium Delayed-release | Wyeth Pharmaceuticals Inc., A Subsidiary Of Pfizer Inc.
    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 Indication Dose Frequency * For adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium 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.

  • Cardinal Health
    Pantoprazole Sodium Delayed-release | Cardinal Health
    No Recall

    Pantoprazole Sodium Delayed-release | Cardinal Health

    Pantoprazole Sodium Delayed-release | Cardinal Health
    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 Indication Dose Frequency * For adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium 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.

    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.

  • Aphena Pharma Solutions – Tennessee, Llc
    Pantoprazole Sodium Delayed-release | Aphena Pharma Solutions - Tennessee, Llc
    No Recall

    Pantoprazole Sodium Delayed-release | Aphena Pharma Solutions - Tennessee, Llc

    Pantoprazole Sodium Delayed-release | Aphena Pharma Solutions - Tennessee, Llc
    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 Indication Dose Frequency * For adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium 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. 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.

  • Proficient Rx
    Pantoprazole Sodium Delayed-release | Proficient Rx
    No Recall

    Pantoprazole Sodium Delayed-release | Proficient Rx

    Pantoprazole Sodium Delayed-release | Proficient Rx
    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 Indication Dose Frequency * For adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium 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.

    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.

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