PANTOPRAZOLE SODIUM tablet, delayed release

United States - English - NLM (National Library of Medicine)

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Active ingredient:
PANTOPRAZOLE SODIUM (UNII: 6871619Q5X) (PANTOPRAZOLE - UNII:D8TST4O562)
Available from:
A-S Medication Solutions
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
Pantoprazole sodium  delayed-release tablets are indicated for: 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 (EE). 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. Pantoprazole sodium  delayed-release tablets are 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. Pantoprazole sodium  delayed-release tablets are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison (ZE) Syndrome. - Pantoprazole sodium delayed-release tablets are contra
Product summary:
Product: 50090-5361 NDC: 50090-5361-0 60 TABLET, DELAYED RELEASE in a BOTTLE NDC: 50090-5361-2 30 TABLET, DELAYED RELEASE in a BOTTLE NDC: 50090-5361-1 90 TABLET, DELAYED RELEASE in a BOTTLE
Authorization status:
Abbreviated New Drug Application
Authorization number:
50090-5361-0, 50090-5361-1, 50090-5361-2

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MEDICATION GUIDE

Pantoprazole Sodium Delayed-Release Tablets, USP

(pan toe' pra zole soe' dee um)

What is the most important information I should know about pantoprazole sodium delayed-release

tablets?

You should take pantoprazole sodium delayed-release tablets exactly as prescribed, at the lowest dose

possible and for the shortest time needed.

Pantoprazole sodium delayed-release tablets may help your acid-related symptoms, but you could still

have serious stomach problems. Talk with your doctor.

Pantoprazole sodium delayed-release tablets can cause serious side effects, including:

A type of kidney problem (acute tubulointerstitial nephritis). Some people who take proton pump

inhibitor (PPI) medicines, including pantoprazole sodium delayed-release tablets, may develop a

kidney problem called acute tubulointerstitial nephritis that can happen at any time during

treatment with pantoprazole sodium delayed-release tablets. Call your doctor right away if you

have a decrease in the amount that you urinate or if you have blood in your urine.

Diarrhea caused by an infection (Clostridium difficile) in your intestines. Call your doctor right

away if you have watery stools or stomach pain that does not go away. You may or may not have

a fever.

Bone fractures (hip, wrist, or spine). Bone fractures in the hip, wrist, or spine may happen in

people who take multiple daily doses of PPI medicines and for a long period of time (a year or

longer). Tell your doctor if you have a bone fracture, especially in the hip, wrist, or spine.

Certain types of lupus erythematosus. Lupus erythematosus is an autoimmune disorder (the body’s

immune cells attack other cells or organs in the body). Some people who take PPI medicines,

including pantoprazole sodium delayed-release tablets, may develop certain types of lupus

erythematosus or have worsening of the lupus they already have. Call your doctor right away if

you have new or worsening joint pain or a rash on your cheeks or arms that gets worse in the sun.

Talk to your doctor about your risk of these serious side effects.

Pantoprazole sodium delayed-release tablets can have other serious side effects. See “What are the

possible side effects of pantoprazole sodium delayed-release tablets?”

What are pantoprazole sodium delayed-release tablets?

A prescription medicine called a proton pump inhibitor (PPI) used to reduce the amount of acid in your

stomach.

In adults, pantoprazole sodium delayed-release tablets are used for:

up to 8 weeks for the healing and symptom relief of acid-related damage to the lining of the

esophagus (called erosive esophagitis or EE). Your doctor may prescribe another 8 weeks of

pantoprazole sodium delayed-release tablets in patients whose EE does not heal.

maintaining healing of EE and to help prevent the return of heartburn symptoms caused by GERD.

It is not known if pantoprazole sodium delayed-release tablets are safe and effective when used for

longer than 12 months for this purpose.

the long-term treatment of conditions where your stomach makes too much acid. This includes a

rare condition called Zollinger-Ellison Syndrome.

In children 5 years of age and older, pantoprazole sodium delayed-release tablets are used for:

up to 8 weeks for the healing and symptom relief of EE.

It is not known if pantoprazole sodium delayed-release tablets are safe if used longer than 8 weeks in

children.

Pantoprazole sodium delayed-release tablets are not for use in children under 5 years of age.

It is not known if pantoprazole sodium delayed-release tablets are safe and effective in children for

treatment other than EE.

Do not take pantoprazole sodium delayed-release tablets if you are:

allergic to pantoprazole sodium, any other PPI medicine, or any of the ingredients in pantoprazole

sodium delayed-release tablets. See the end of this Medication Guide for a complete list of

ingredients.

taking a medicine that contains rilpivirine (EDURANT, COMPLERA, ODEFSEY, JULUCA)

used to treat HIV-1 (Human Immunodeficiency Virus).

Before taking pantoprazole sodium delayed-release tablets, tell your doctor about all of your medical

conditions, including if you:

have low magnesium levels in your blood.

are pregnant or plan to become pregnant. Pantoprazole sodium delayed-release tablets may harm

your unborn baby. Tell your doctor if you become pregnant or think you may be pregnant during

treatment with pantoprazole sodium delayed-release tablets.

are breastfeeding or plan to breastfeed. Pantoprazole sodium can pass into your breast milk. Talk

with your doctor about the best way to feed your baby if you take pantoprazole sodium delayed-

release tablets.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines,

vitamins and herbal supplements. Especially tell your doctor if you take methotrexate (Otrexup, Rasuvo,

Trexall, XATMEP), digoxin (LANOXIN), or a water pill (diuretic).

How should I take pantoprazole sodium delayed-release tablets?

Take pantoprazole sodium delayed-release tablets exactly as prescribed by your doctor.

Do not split, chew, or crush pantoprazole sodium delayed-release tablets.

Swallow pantoprazole sodium delayed-release tablets whole, with or without food.

Tell your doctor if you are not able to swallow your pantoprazole sodium delayed-release

tablet.

You may use antacids while taking pantoprazole sodium delayed-release tablets.

If you miss a dose of pantoprazole sodium delayed-release tablets, take it as soon as possible. If it

is almost time for your next dose, do not take the missed dose. Take the next dose at your regular

time. Do not take 2 doses at the same time.

If you take too much pantoprazole sodium delayed-release tablets, call your doctor or your poison

control center at 1-800-222-1222 right away or go to the nearest emergency room.

What are the possible side effects of pantoprazole sodium delayed-release tablets?

Pantoprazole sodium delayed-release tablets can cause serious side effects, including:

See “What is the most important information I should know about pantoprazole sodium delayed-

release tablets?”

Low vitamin B-12 levels in your body can happen in people who have taken pantoprazole sodium

delayed-release tablets for a long time (more than 3 years). Tell your doctor if you have symptoms

of low vitamin B-12 levels, including shortness of breath, lightheadedness, irregular heartbeat,

muscle weakness, pale skin, feeling tired, mood changes, and tingling or numbness in the arms

and legs.

Low magnesium levels in your body can happen in people who have taken pantoprazole sodium

delayed-release tablets for at least 3 months. Tell your doctor if you have symptoms of low

magnesium levels, including seizures, dizziness, irregular heartbeat, jitteriness, muscle aches or

weakness, and spasms of hands, feet or voice.

Stomach growths (fundic gland polyps). People who take PPI medicines for a long time have an

increased risk of developing a certain type of stomach growths called fundic gland polyps,

especially after taking PPI medicines for more than 1 year.

The most common side effects of pantoprazole sodium delayed-release tablets in adults include:

headache, diarrhea, nausea, stomach-area (abdominal) pain, vomiting, gas, dizziness, and joint pain.

The most common side effects of pantoprazole sodium delayed-release tablets in children include: upper

respiratory infection, headache, fever, diarrhea, vomiting, rash, and stomach-area (abdominal) pain.

These are not all the possible side effects of pantoprazole sodium delayed-release tablets. Call your doctor

for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store pantoprazole sodium delayed-release tablets?

Store pantoprazole sodium delayed-release tablets at room temperature between 68° to 77°F (20° to

25°C).

Keep pantoprazole sodium delayed-release tablets and all medicines out of the reach of children.

General information about the safe and effective use of pantoprazole sodium delayed-release tablets.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not

use pantoprazole sodium delayed-release tablets for a condition for which it was not prescribed. Do not

give pantoprazole sodium delayed-release tablets to other people, even if they have the same symptoms

that you have. It may harm them. You can ask your doctor or pharmacist for information about

pantoprazole sodium delayed-release tablets that is written for health professionals.

What are the ingredients in pantoprazole sodium delayed-release tablets?

Active ingredient: pantoprazole sodium

Inactive ingredients in pantoprazole sodium delayed-release tablets: calcium stearate, crospovidone,

ferric oxide, hydroxypropyl cellulose, hypromellose, mannitol, methacrylic acid and ethyl acrylate

copolymer dispersion, sodium carbonate, and triethyl citrate. The tablets are imprinted with brown ink

containing ammonium hydroxide, iron oxide black, iron oxide red, iron oxide yellow, isopropyl alcohol,

N-butyl alcohol, propylene glycol, and shellac glaze in ethanol.

For more information, call Aurobindo Pharma USA, Inc. at 1-866-850-2876.

The brands listed are trademarks of their respective owners and are not trademarks of Aurobindo Pharma

Limited.

Dispense with Medication Guide available at: www.aurobindousa.com/medication-guides

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Distributed by:

Aurobindo Pharma USA, Inc.

279 Princeton-Hightstown Road

East Windsor, NJ 08520

Manufactured by:

Aurobindo Pharma Limited

Hyderabad-500 038, India

Revised: 12/2020

Revised: 3/2021

Document Id: e80af29b-c5cb-4fc4-b921-7a76623ef75c

34391-3

Set id: 517d6b02-0e68-4d6b-98b3-eac0be457e6b

Version: 5

Effective Time: 20210302

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PANTOPRAZOLE SODIUM - pantoprazole sodium tablet, delayed release

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HIGHLIGHTS OF PRESCRIBING INFORMATION

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, Acute Tubulointerstitial Nephritis (5.2) 11/2020

INDICATIONS AND USAGE

Pantoprazole sodium delayed-release tablets are a proton pump inhibitor (PPI) 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 (ZE) Syndrome (1.3)

DOSAGE AND ADMINISTRATION

* Controlled studies did not extend beyond 12 months

See full prescribing information for administration instructions

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

DOSAGE FORMS AND STRENGTHS

Delayed-Release Tablets: 20 mg and 40 mg pantoprazole (3)

CONTRAINDICATIONS

Patients with known hypersensitivity to any component of the formulation or to substituted

benzimidazoles (4)

Patients receiving rilpivirine-containing products (4,7)

WARNINGS AND PRECAUTIONS

Gastric Malignancy: In adults, symptomatic response does not preclude presence of gastric

malignancy. Consider additional follow-up and diagnostic testing. (5.1)

Acute Tubulointerstitial Nephritis: Discontinue treatment and evaluate patients. (5.2)

Clostridium difficile-Associated Diarrhea: 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 sodium delayed-release tablets and refer to specialist for

existing disease; discontinue pantoprazole sodium delayed-release tablets 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: Reported rarely with prolonged treatment with PPIs. (5.7)

Fundic Gland Polyps: Risk increases with long-term use, especially beyond one year. Use the shortest

duration of therapy. (5.9)

ADVERSE REACTIONS

Most common adverse reactions are:

For adult use (>2%): headache, diarrhea, nausea, abdominal pain, vomiting, flatulence, dizziness, and

arthralgia. (6.1)

For pediatric use (>4%): URI, headache, fever, diarrhea, vomiting, rash, and abdominal pain. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-

850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

See full prescribing information for a list of clinically important drug interactions (7)

USE IN SPECIFIC POPULATIONS

Pregnancy: Based on animal data, may cause fetal harm. (8.1)

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 3/2021

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 (ZE) 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 Tubulointerstitial 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 Fundic Gland Polyps

5.10 Interference with Investigations for Neuroendocrine Tumors

5.11 Interference with Urine Screen for THC

5.12 Concomitant Use of Pantoprazole Sodium Delayed-Release Tablets with

Methotrexate

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Postmarketing Experience

7 DRUG INTERACTIONS

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Lactation

8.4 Pediatric Use

8.5 Geriatric Use

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

12.5 Pharmacogenomics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

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

FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE

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 (EE). 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

EE and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult

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

patients with GERD. Controlled studies did not extend beyond 12 months.

1.3 Pathological Hypersecretory Conditions Including Zollinger-Ellison (ZE)

Syndrome

Pantoprazole sodium delayed-release tablets are 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 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.

** 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

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 of pantoprazole sodium delayed-release tablets

are presented in Table 2.

Table 2: Administration Instructions

* Do not split, chew, or crush pantoprazole sodium delayed-release

tablets.

Formulation

Route

Instructions*

Delayed-Release

Tablets

Oral

Swallowed whole, with or without

food

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.

Swallow pantoprazole sodium delayed-release tablets whole, with or without food in the

stomach. For patients 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

20 mg pantoprazole, yellow colored, oval shaped, biconvex, enteric-coated tablets

imprinted with ‘I’ and ‘51’ with brown ink on one side and plain on other side.

40 mg pantoprazole, yellow colored, oval shaped, biconvex, enteric-coated tablets

imprinted with ‘I’ and ‘52’ with brown ink on one side and plain on 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 tubulointerstitial nephritis, and urticaria

[see Warnings and Precautions (5.2), Adverse Reactions (6)].

Proton pump inhibitors (PPIs), including pantoprazole sodium delayed-release tablets,

are contraindicated in patients receiving 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 delayed-release

tablets 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.

5.2 Acute Tubulointerstitial Nephritis

Acute tubulointerstitial nephritis (TIN) has been observed in patients taking PPIs and may

occur at any point during PPI therapy. Patients may present with varying signs and

symptoms from symptomatic hypersensitivity reactions to non-specific symptoms of

decreased renal function (e.g., malaise, nausea, anorexia). In reported case series,

some patients were diagnosed on biopsy and in the absence of extra-renal

manifestations (e.g., fever, rash or arthralgia). Discontinue pantoprazole sodium

delayed-release tablets and evaluate patients with suspected acute TIN [see

Contraindications (4)].

5.3 Clostridium difficile-Associated Diarrhea

Published observational studies suggest that PPI therapy like pantoprazole sodium

delayed-release tablets 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.

5.4 Bone Fracture

Several published observational studies suggest that 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), Adverse Reactions

(6.2)].

5.5 Cutaneous and Systemic Lupus Erythematosus

Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have

been reported in patients taking PPIs, including pantoprazole sodium. These events have

occurred as both new onset and an exacerbation of existing autoimmune disease. The

majority of PPI-induced lupus erythematous cases were CLE.

The most common form of CLE reported in patients treated with PPIs was subacute CLE

(SCLE) and occurred within weeks to years after continuous drug therapy in patients

ranging from infants to the elderly. Generally, histological findings were observed

without organ involvement.

Systemic lupus erythematosus (SLE) is less commonly reported than CLE in patients

receiving PPIs. PPI associated SLE is usually milder than non-drug induced SLE. Onset of

SLE typically occurred within days to years after initiating treatment primarily in patients

ranging from young adults to the elderly. The majority of patients presented with rash;

however, arthralgia and cytopenia were also reported.

Avoid administration of PPIs for longer than medically indicated. If signs or symptoms

consistent with CLE or SLE are noted in patients receiving pantoprazole sodium delayed-

release tablets, discontinue the drug and refer the patient to the appropriate specialist

for evaluation. Most patients improve with discontinuation of the PPI alone in 4 to 12

weeks. Serological testing (e.g. ANA) may be positive and elevated serological test

results may take longer to resolve than clinical manifestations.

5.6 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.

5.7 Hypomagnesemia

Hypomagnesemia, symptomatic and asymptomatic, has been reported rarely in patients

treated with PPIs for at least three months, and 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 delayed-release tablets. 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 Fundic Gland Polyps

PPI use is associated with an increased risk of fundic gland polyps that increases with

long-term use, especially beyond one year. Most PPI users who developed fundic gland

polyps were asymptomatic and fundic gland polyps were identified incidentally on

endoscopy. Use the shortest duration of PPI therapy appropriate to the condition being

treated.

5.10 Interference with Investigations for Neuroendocrine Tumors

Serum chromogranin A (CgA) levels increase secondary to drug-induced decreases in

gastric acidity. The increased CgA level may cause false positive results in diagnostic

investigations for neuroendocrine tumors. Healthcare providers should temporarily stop

pantoprazole sodium delayed-release tablets treatment at least 14 days before

assessing CgA levels and consider repeating the test if initial CgA levels are high. If serial

tests are performed (e.g. for monitoring), the same commercial laboratory should be

used for testing, as reference ranges between tests may vary [see Clinical

Pharmacology (12.2)].

5.11 Interference with Urine Screen for THC

There have been reports of false-positive urine screening tests for tetrahydrocannabinol

(THC) in patients receiving PPIs, including pantoprazole sodium delayed-release tablets

[see Drug Interactions (7)].

5.12 Concomitant Use of Pantoprazole Sodium Delayed-Release Tablets 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 ADVERSE REACTIONS

The following serious adverse reactions are described below and elsewhere in labeling:

Acute Tubulointerstitial Nephritis [see Warnings and Precautions (5.2)]

Clostridium difficile-Associated Diarrhea [see Warnings and Precautions (5.3)]

Bone Fracture [see Warnings and Precautions (5.4)]

Cutaneous and Systemic Lupus Erythematosus [see Warnings and Precautions (5.5)]

Cyanocobalamin (Vitamin B-12) Deficiency [see Warnings and Precautions (5.6)]

Hypomagnesemia [see Warnings and Precautions (5.7)]

Fundic Gland Polyps [see Warnings and Precautions (5.9)]

6.1 Clinical Trials Experience

The adverse reaction profiles for pantoprazole sodium for delayed-release oral

suspension and pantoprazole sodium delayed-release tablets are similar.

Because clinical trials are conducted under widely varying conditions, adverse reaction

rates observed in the clinical trials of a drug cannot be directly compared to rates in the

clinical trials of another drug and may not reflect the rates observed in clinical practice.

Adults

Safety in nine randomized comparative U.S. clinical trials in patients with GERD included

1,473 patients on oral pantoprazole sodium delayed-release tablets (20 mg or 40 mg),

299 patients on an H -receptor antagonist, 46 patients on another PPI, and 82 patients

on placebo. The most frequently occurring adverse reactions are listed in Table 3.

Table 3: Adverse Reactions Reported in Clinical

Trials of Adult Patients with GERD at a Frequency of

>2%

Pantoprazole

Sodium

Delayed-Release

Tablets

(n=1473)

%

Comparators

(n=345)

%

Placebo

(n=82)

%

Headache

12.2

12.8

Diarrhea

Nausea

Abdominal

pain

Vomiting

Flatulence

Dizziness

Arthralgia

Additional adverse reactions that were reported for pantoprazole sodium delayed-

release tablets in clinical trials with a frequency of ≤2% are listed below by body system:

Body as a Whole: allergic reaction, pyrexia, photosensitivity reaction, facial edema

Gastrointestinal: constipation, dry mouth, hepatitis

Hematologic: leukopenia, thrombocytopenia

Metabolic/Nutritional: elevated CK (creatine kinase), generalized edema, elevated

triglycerides, liver enzymes elevated

Musculoskeletal: myalgia

Nervous: depression, vertigo

Skin and Appendages: urticaria, rash, pruritus

Special Senses: blurred vision

Pediatric Patients

Safety of pantoprazole sodium delayed-release tablets in the treatment of EE associated

with GERD was evaluated in pediatric patients ages 1 year through 16 years in three

clinical trials. Safety trials involved pediatric patients with EE; however, as EE is

uncommon in the pediatric population, 249 pediatric patients with endoscopically-proven

or symptomatic GERD were also evaluated. All adult adverse reactions to pantoprazole

sodium delayed-release tablets are considered relevant to pediatric patients. In patients

ages 1 year through 16 years, the most commonly reported (>4%) adverse reactions

include: URI, headache, fever, diarrhea, vomiting, rash, and abdominal pain.

For safety information in patients less than 1 year of age see Use in Specific Populations

(8.4).

Additional adverse reactions that were reported for pantoprazole sodium delayed-

release tablets in pediatric patients in clinical trials with a frequency of ≤4% are listed

below by body system:

Body as a Whole: allergic reaction, facial edema

Gastrointestinal: constipation, flatulence, nausea

Metabolic/Nutritional: elevated triglycerides, elevated liver enzymes, elevated CK (creatine

kinase)

Musculoskeletal: arthralgia, myalgia

Nervous: dizziness, vertigo

Skin and Appendages: urticaria

The following adverse reactions seen in adults in clinical trials were not reported in

pediatric patients in clinical trials, but are considered relevant to pediatric patients:

photosensitivity reaction, dry mouth, hepatitis, thrombocytopenia, generalized edema,

depression, pruritus, leukopenia, and blurred vision.

Zollinger-Ellison (ZE) Syndrome

In clinical studies of ZE Syndrome, adverse reactions reported in 35 patients taking

pantoprazole sodium delayed-release tablets 80 mg/day to 240 mg/day for up to 2

years were similar to those reported in adult patients with GERD.

6.2 Postmarketing Experience

The following adverse reactions have been identified during postapproval use of

pantoprazole sodium delayed-release tablets. Because these reactions are reported

voluntarily from a population of uncertain size, it is not always possible to reliably

estimate their frequency or establish a causal relationship to drug exposure.

These adverse reactions are listed below by body system:

Gastrointestinal Disorders: fundic gland polyps

General Disorders and Administration Conditions: asthenia, fatigue, malaise

Hematologic: pancytopenia, agranulocytosis

Hepatobiliary Disorders: hepatocellular damage leading to jaundice and hepatic failure

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