Protonix I.V.
Generic: PANTOPRAZOLE SODIUM
Basic Information
Manufacturer
Cardinal Health 107, LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAVENOUS
FDA Set ID
50802e19-72d3-4130-8d14-eb94361b38e7
Indications & Usage
1 INDICATIONS AND USAGE PROTONIX I.V.
is indicated for treatment of: • gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE) for up to 10 days in adults and up to 7 days in pediatric patients 3 months and older.
• pathological hypersecretory conditions including Zollinger-Ellison (ZE) Syndrome in adults.
Limitations of Use The safety and effectiveness of PROTONIX I.V.
for the treatment of upper gastrointestinal bleeding have not been established in adult or pediatric patients.
PROTONIX I.V.
is a proton pump inhibitor (PPI) indicated for treatment of: • gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE) for up to 10 days in adults and up to 7 days in pediatric patients 3 months and older.
( 1 ) • pathological hypersecretion conditions including Zollinger-Ellison (ZE) Syndrome in adults.
( 1 ) Limitations of Use The safety and effectiveness of PROTONIX I.V.
for the treatment of upper gastrointestinal bleeding have not been established in adult or pediatric patients.
( 1 )
is indicated for treatment of: • gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE) for up to 10 days in adults and up to 7 days in pediatric patients 3 months and older.
• pathological hypersecretory conditions including Zollinger-Ellison (ZE) Syndrome in adults.
Limitations of Use The safety and effectiveness of PROTONIX I.V.
for the treatment of upper gastrointestinal bleeding have not been established in adult or pediatric patients.
PROTONIX I.V.
is a proton pump inhibitor (PPI) indicated for treatment of: • gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE) for up to 10 days in adults and up to 7 days in pediatric patients 3 months and older.
( 1 ) • pathological hypersecretion conditions including Zollinger-Ellison (ZE) Syndrome in adults.
( 1 ) Limitations of Use The safety and effectiveness of PROTONIX I.V.
for the treatment of upper gastrointestinal bleeding have not been established in adult or pediatric patients.
( 1 )
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in labeling: • Injection Site Reactions [see Warnings and Precautions (5.2) ] • Potential for Exacerbation of Zinc Deficiency [see Warnings and Precautions (5.3) ] • Acute Tubulointerstitial Nephritis [see Warnings and Precautions (5.4) ] • Clostridioides difficile- Associated Diarrhea [see Warnings and Precautions (5.5) ] • Bone Fracture [see Warnings and Precautions (5.6) ] • Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.7) ] • Cutaneous and Systemic Lupus Erythematosus [see Warnings and Precautions (5.8) ] • Hepatic Effects [see Warnings and Precautions (5.9) ] • Hypomagnesemia and Mineral Metabolism [see Warnings and Precautions (5.10) ] • Fundic Gland Polyps [see Warnings and Precautions (5.11) ] Most common adverse reactions (> 2%) are: headache, diarrhea, nausea, abdominal pain, vomiting, flatulence, dizziness, and arthralgia.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc.
at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience 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.
Gastroesophageal Reflux Disease (GERD) Adults Safety in nine randomized comparative US clinical trials in patients with GERD included 1,473 patients on oral pantoprazole (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 2.
The number of patients treated in comparative studies with PROTONIX I.V.
is limited; however, the adverse reactions seen were similar to those seen in the oral studies.
Thrombophlebitis was the only new adverse reaction identified with PROTONIX I.V.
Table 2: Adverse Reactions Reported in Clinical Trials of Adult Patients with GERD at a Frequency of > 2% Oral 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 4.3 3.5 2.4 Flatulence 3.9 2.9 3.7 Dizziness 3.0 2.9 1.2 Arthralgia 2.8 1.4 1.2 Additional adverse reactions that were reported for oral pantoprazole sodium in US clinical trials with a frequency of ≤2% are listed below by body system: Body as a Whole: allergic reaction, fever, photosensitivity reaction, facial edema, thrombophlebitis (intravenous only) Gastrointestinal: constipation, dry mouth, hepatitis Hematologic: leukopenia (reported in ex-US clinical trials only), thrombocytopenia Metabolic/Nutritional: elevated CPK (creatine phosphokinase), generalized edema, elevated triglycerides, liver function tests abnormal Musculoskeletal: myalgia Nervous: depression, vertigo Skin and Appendages: urticaria, rash, pruritus Special Senses: blurred vision Pediatrics Adverse reactions reported with single and multiple doses of PROTONIX I.V.
in 18 hospitalized pediatric patients 1 to 16 years of age were generally similar to those reported in adults treated with intravenous or oral pantoprazole sodium and in pediatric patients treated with oral pantoprazole sodium in clinical trials.
Additionally, upper respiratory tract infections in pediatric patients less than 16 years of age and otitis media in pediatric patients less than 1 year of age were reported with oral pantoprazole sodium.
Zollinger-Ellison (ZE) Syndrome In clinical studies of ZE Syndrome, adverse reactions reported in 35 patients administered PROTONIX I.V.
doses of 80 mg to 240 mg per 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 post approval use of pantoprazole sodium products.
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: General disorders and administration conditions: asthenia, fatigue, malaise Immune system disorders: anaphylaxis (including anaphylactic shock), systemic lupus erythematosus Investigations: weight changes 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 Musculoskeletal disorders: rhabdomyolysis, bone fracture Renal and genitourinary disorders: acute tubulointerstitial nephritis, erectile dysfunction Hepatobiliary disorders: hepatocellular damage leading to jaundice and hepatic failure Psychiatric disorder: hallucinations, confusion, insomnia, somnolence Metabolism and nutritional disorders: hyponatremia, hypomagnesemia, hypocalcemia, hypokalemia, hyponatremia Infections and infestations: Clostridioides difficile -associated diarrhea Hematologic: pancytopenia, agranulocytosis Nervous: ageusia, dysgeusia Gastrointestinal disorders: fundic gland polyps
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc.
at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience 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.
Gastroesophageal Reflux Disease (GERD) Adults Safety in nine randomized comparative US clinical trials in patients with GERD included 1,473 patients on oral pantoprazole (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 2.
The number of patients treated in comparative studies with PROTONIX I.V.
is limited; however, the adverse reactions seen were similar to those seen in the oral studies.
Thrombophlebitis was the only new adverse reaction identified with PROTONIX I.V.
Table 2: Adverse Reactions Reported in Clinical Trials of Adult Patients with GERD at a Frequency of > 2% Oral 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 4.3 3.5 2.4 Flatulence 3.9 2.9 3.7 Dizziness 3.0 2.9 1.2 Arthralgia 2.8 1.4 1.2 Additional adverse reactions that were reported for oral pantoprazole sodium in US clinical trials with a frequency of ≤2% are listed below by body system: Body as a Whole: allergic reaction, fever, photosensitivity reaction, facial edema, thrombophlebitis (intravenous only) Gastrointestinal: constipation, dry mouth, hepatitis Hematologic: leukopenia (reported in ex-US clinical trials only), thrombocytopenia Metabolic/Nutritional: elevated CPK (creatine phosphokinase), generalized edema, elevated triglycerides, liver function tests abnormal Musculoskeletal: myalgia Nervous: depression, vertigo Skin and Appendages: urticaria, rash, pruritus Special Senses: blurred vision Pediatrics Adverse reactions reported with single and multiple doses of PROTONIX I.V.
in 18 hospitalized pediatric patients 1 to 16 years of age were generally similar to those reported in adults treated with intravenous or oral pantoprazole sodium and in pediatric patients treated with oral pantoprazole sodium in clinical trials.
Additionally, upper respiratory tract infections in pediatric patients less than 16 years of age and otitis media in pediatric patients less than 1 year of age were reported with oral pantoprazole sodium.
Zollinger-Ellison (ZE) Syndrome In clinical studies of ZE Syndrome, adverse reactions reported in 35 patients administered PROTONIX I.V.
doses of 80 mg to 240 mg per 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 post approval use of pantoprazole sodium products.
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: General disorders and administration conditions: asthenia, fatigue, malaise Immune system disorders: anaphylaxis (including anaphylactic shock), systemic lupus erythematosus Investigations: weight changes 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 Musculoskeletal disorders: rhabdomyolysis, bone fracture Renal and genitourinary disorders: acute tubulointerstitial nephritis, erectile dysfunction Hepatobiliary disorders: hepatocellular damage leading to jaundice and hepatic failure Psychiatric disorder: hallucinations, confusion, insomnia, somnolence Metabolism and nutritional disorders: hyponatremia, hypomagnesemia, hypocalcemia, hypokalemia, hyponatremia Infections and infestations: Clostridioides difficile -associated diarrhea Hematologic: pancytopenia, agranulocytosis Nervous: ageusia, dysgeusia Gastrointestinal disorders: fundic gland polyps