Pantoprazole
Generic: PANTOPRAZOLE
Basic Information
Manufacturer
Preferred Pharmaceuticals Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
bb1e79ad-ff52-4696-8743-523f793b29d3
Indications & Usage
1 INDICATIONS AND USAGE Pantoprazole sodium delayed-release tablets are indicated for: Pantoprazole sodium is a proton pump inhibitor (PPI) indicated for the following: 1.
Short-Term Treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD) () 2.
Maintenance of Healing of Erosive Esophagitis () 3.
Pathological Hypersecretory Conditions Including Zollinger-Ellison (ZE) Syndrome () 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 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 (ZE) Syndrome.
Short-Term Treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD) () 2.
Maintenance of Healing of Erosive Esophagitis () 3.
Pathological Hypersecretory Conditions Including Zollinger-Ellison (ZE) Syndrome () 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 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 (ZE) Syndrome.
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in labeling: • Acute Tubulointerstitial Nephritis [see Warnings and Precautions • Clostridium difficile -Associated Diarrhea [see Warnings and Precautions • Bone Fracture [see Warnings and Precautions ] • Severe Cutaneous Adverse Reactions [see Warnings and Precautions • Cutaneous and Systemic Lupus Erythematosus [see Warnings and Precautions ] • Cyanocobalamin (Vitamin B-12) Deficiency [see Warnings and Precautions ] • Hypomagnesemia and Mineral Metabolism [see Warnings and Precautions ] • Fundic Gland Polyps [see Warnings and Precautions ] Most common adverse reactions are: 1.
For adult use (>2%): headache, diarrhea, nausea, abdominal pain, vomiting, flatulence, dizziness, and arthralgia.
() 2.
For pediatric use (>4%): URI, headache, fever, diarrhea, vomiting, rash, and abdominal pain.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Dr. Reddy’s Laboratories, Inc.
at 1-888-375-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience The adverse reaction profiles for pantoprazole sodium 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 US clinical trials in patients with GERD included 1,473 patients on oral pantoprazole sodium (20 mg or 40 mg), 299 patients on an H 2 -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 (n=1473) % Comparators (n=345) % Placebo (n=82) % Headache 12.2 12.8 8.5 Diarrhea 8.8 9.6 4.9 Nausea 7.0 5.2 9.8 Abdominal pain 6.2 4.1 6.1 Vomiting Flatulence 4.3 3.9 3.5 2.9 2.4 3.7 Dizziness 3.0 2.9 1.2 Arthralgia 2.8 1.4 1.2 Additional adverse reactions that were reported for pantoprazole sodium 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 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 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 ( ).
Additional adverse reactions that were reported for pantoprazole sodium 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 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.
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 Immune System Disorders : anaphylaxis (including anaphylactic shock), systemic lupus erythematosus Infections and Infestations : Clostridium difficile associated diarrhea Investigations : weight changes Metabolism and Nutritional Disorders : hypomagnesemia, hypocalcemia, hypokalemia, hyponatremia Musculoskeletal Disorders : rhabdomyolysis, bone fracture Nervous : ageusia, dysgeusia Psychiatric Disorders : hallucination, confusion, insomnia, somnolence Renal and Genitourinary Disorders : acute tubulointerstitial nephritis,erectile dysfunction Skin and Subcutaneous Tissue Disorders : severe dermatologic reactions (some fatal), including erythema multiforme, SJS/TEN, DRESS, AGEP, angioedema (Quincke's edema) and cutaneous lupus erythematosus
For adult use (>2%): headache, diarrhea, nausea, abdominal pain, vomiting, flatulence, dizziness, and arthralgia.
() 2.
For pediatric use (>4%): URI, headache, fever, diarrhea, vomiting, rash, and abdominal pain.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Dr. Reddy’s Laboratories, Inc.
at 1-888-375-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience The adverse reaction profiles for pantoprazole sodium 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 US clinical trials in patients with GERD included 1,473 patients on oral pantoprazole sodium (20 mg or 40 mg), 299 patients on an H 2 -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 (n=1473) % Comparators (n=345) % Placebo (n=82) % Headache 12.2 12.8 8.5 Diarrhea 8.8 9.6 4.9 Nausea 7.0 5.2 9.8 Abdominal pain 6.2 4.1 6.1 Vomiting Flatulence 4.3 3.9 3.5 2.9 2.4 3.7 Dizziness 3.0 2.9 1.2 Arthralgia 2.8 1.4 1.2 Additional adverse reactions that were reported for pantoprazole sodium 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 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 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 ( ).
Additional adverse reactions that were reported for pantoprazole sodium 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 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.
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 Immune System Disorders : anaphylaxis (including anaphylactic shock), systemic lupus erythematosus Infections and Infestations : Clostridium difficile associated diarrhea Investigations : weight changes Metabolism and Nutritional Disorders : hypomagnesemia, hypocalcemia, hypokalemia, hyponatremia Musculoskeletal Disorders : rhabdomyolysis, bone fracture Nervous : ageusia, dysgeusia Psychiatric Disorders : hallucination, confusion, insomnia, somnolence Renal and Genitourinary Disorders : acute tubulointerstitial nephritis,erectile dysfunction Skin and Subcutaneous Tissue Disorders : severe dermatologic reactions (some fatal), including erythema multiforme, SJS/TEN, DRESS, AGEP, angioedema (Quincke's edema) and cutaneous lupus erythematosus