Omeprazole
Generic: OMEPRAZOLE
Basic Information
Manufacturer
Sandoz Inc
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
5a09ce48-7139-4fc7-9b6e-439459c8e866
Indications & Usage
1 INDICATIONS AND USAGE Omeprazole delayed-release capsules are a proton pump inhibitor (PPI) indicated for the: • Treatment of active duodenal ulcer in adults ( 1.1 ) • Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults ( 1.2 ) • Treatment of active benign gastric ulcer in adults ( 1.3 ) • Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 2 years of age and older ( 1.4 ) • Treatment of erosive esophagitis (EE) due to acid-mediated GERD in patients 2 years of age and older ( 1.5 ) • Maintenance of healing of EE due to acid-mediated GERD in patients 2 years of age and older ( 1.6 ) • Pathologic hypersecretory conditions in adults ( 1.7 ) 1.1 Treatment of Active Duodenal Ulcer Omeprazole delayed-release capsules are indicated for short-term treatment of active duodenal ulcer in adults.
Most patients heal within four weeks.
Some patients may require an additional four weeks of therapy.
1.2 Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Eradication of H.
pylori has been shown to reduce the risk of duodenal ulcer recurrence.
Triple Therapy Omeprazole delayed-release capsules in combination with clarithromycin and amoxicillin, are indicated for treatment of patients with H.
pylori infection and duodenal ulcer disease (active or up to 1-year history) to eradicate H.
pylori in adults.
Dual Therapy Omeprazole delayed-release capsules in combination with clarithromycin are indicated for treatment of patients with H.
pylori infection and duodenal ulcer disease to eradicate H.
pylori in adults.
Among patients who fail therapy, omeprazole delayed-release capsules with clarithromycin are more likely to be associated with the development of clarithromycin resistance as compared with triple therapy.
In patients who fail therapy, susceptibility testing should be done.
If resistance to clarithromycin is demonstrated or susceptibility testing is not possible, alternative antimicrobial therapy should be instituted [see Clinical Pharmacology ( 12.4 ) and the clarithromycin prescribing information, Microbiology section] .
1.3 Treatment of Active Benign Gastric Ulcer Omeprazole delayed-release capsules are indicated for short-term treatment (4 to 8 weeks) of active benign gastric ulcer in adults.
1.4 Treatment of Symptomatic Gastroesophageal Reflux Disease (GERD) Omeprazole delayed-release capsules are indicated for the treatment of heartburn and other symptoms associated with GERD for up to 4 weeks in patients 2 years of age and older.
1.5 Treatment of Erosive Esophagitis (EE) Due to Acid-Mediated GERD Omeprazole delayed-release capsules are indicated for the short-term treatment (4 to 8 weeks) of EE due to acid-mediated GERD that has been diagnosed by endoscopy in patients 2 years of age and older.
The efficacy of omeprazole delayed-release capsules are used for longer than 8 weeks in patients with EE has not been established.
If a patient does not respond to 8 weeks of treatment, an additional 4 weeks of treatment may be given.
If there is recurrence of EE or GERD symptoms (e.g., heartburn), additional 4 to 8 week courses of omeprazole delayed-release capsules may be considered.
1.6 Maintenance of Healing of EE Due to Acid-Mediated GERD Omeprazole delayed-release capsules are indicated for the maintenance healing of EE due to acid-mediated GERD in patients 2 years of age and older.
Controlled studies do not extend beyond 12 months.
1.7 Pathological Hypersecretory Conditions Omeprazole delayed-release capsules are indicated for the long-term treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine adenomas and systemic mastocytosis) in adults.
Most patients heal within four weeks.
Some patients may require an additional four weeks of therapy.
1.2 Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Eradication of H.
pylori has been shown to reduce the risk of duodenal ulcer recurrence.
Triple Therapy Omeprazole delayed-release capsules in combination with clarithromycin and amoxicillin, are indicated for treatment of patients with H.
pylori infection and duodenal ulcer disease (active or up to 1-year history) to eradicate H.
pylori in adults.
Dual Therapy Omeprazole delayed-release capsules in combination with clarithromycin are indicated for treatment of patients with H.
pylori infection and duodenal ulcer disease to eradicate H.
pylori in adults.
Among patients who fail therapy, omeprazole delayed-release capsules with clarithromycin are more likely to be associated with the development of clarithromycin resistance as compared with triple therapy.
In patients who fail therapy, susceptibility testing should be done.
If resistance to clarithromycin is demonstrated or susceptibility testing is not possible, alternative antimicrobial therapy should be instituted [see Clinical Pharmacology ( 12.4 ) and the clarithromycin prescribing information, Microbiology section] .
1.3 Treatment of Active Benign Gastric Ulcer Omeprazole delayed-release capsules are indicated for short-term treatment (4 to 8 weeks) of active benign gastric ulcer in adults.
1.4 Treatment of Symptomatic Gastroesophageal Reflux Disease (GERD) Omeprazole delayed-release capsules are indicated for the treatment of heartburn and other symptoms associated with GERD for up to 4 weeks in patients 2 years of age and older.
1.5 Treatment of Erosive Esophagitis (EE) Due to Acid-Mediated GERD Omeprazole delayed-release capsules are indicated for the short-term treatment (4 to 8 weeks) of EE due to acid-mediated GERD that has been diagnosed by endoscopy in patients 2 years of age and older.
The efficacy of omeprazole delayed-release capsules are used for longer than 8 weeks in patients with EE has not been established.
If a patient does not respond to 8 weeks of treatment, an additional 4 weeks of treatment may be given.
If there is recurrence of EE or GERD symptoms (e.g., heartburn), additional 4 to 8 week courses of omeprazole delayed-release capsules may be considered.
1.6 Maintenance of Healing of EE Due to Acid-Mediated GERD Omeprazole delayed-release capsules are indicated for the maintenance healing of EE due to acid-mediated GERD in patients 2 years of age and older.
Controlled studies do not extend beyond 12 months.
1.7 Pathological Hypersecretory Conditions Omeprazole delayed-release capsules are indicated for the long-term treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine adenomas and systemic mastocytosis) in adults.
Adverse Reactions
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 ( 5.6 )] • Cyanocobalamin (Vitamin B-12) Deficiency [see Warnings and Precautions ( 5.8 )] • Hypomagnesemia and Mineral Metabolism [see Warnings and Precautions ( 5.9 )] • Fundic Gland Polyps [see Warnings and Precautions ( 5.13 )] Adults: Most common adverse reactions in adults (incidence ≥2%) are: • Headache, abdominal pain, nausea, diarrhea, vomiting, and flatulence.
( 6 ) Pediatric patients (2 to 16 years of age): • Safety profile similar to that in adults, except that respiratory system events and fever were the most frequently reported reactions in pediatric studies.
( 8.4 ) To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc.
at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience with Omeprazole Monotherapy 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 practice.
The safety data described below reflects exposure to omeprazole delayed-release capsules in 3,096 patients from worldwide clinical trials (465 patients from US studies and 2,631 patients from international studies).
Indications clinically studied in US trials included duodenal ulcer, resistant ulcer, and Zollinger-Ellison syndrome.
The international clinical trials were double blind and open-label in design.
The most common adverse reactions reported (i.e., with an incidence rate ≥2%) from omeprazole-treated patients enrolled in these studies included headache (7%), abdominal pain (5%), nausea (4%), diarrhea (4%), vomiting (3%), and flatulence (3%).
Additional adverse reactions that were reported with an incidence ≥1% included acid regurgitation (2%), upper respiratory infection (2%), constipation (2%), dizziness (2%), rash (2%), asthenia (1%), back pain (1%), and cough (1%).
The clinical trial safety profile in patients greater than 65 years of age was similar to that in patients 65 years of age or less.
The clinical trial safety profile in pediatric patients who received omeprazole delayed-release capsules was similar to that in adult patients.
Unique to the pediatric population, however, adverse reactions of the respiratory system were frequently reported in the 2 to 16 years age group, and accidental injuries were frequently reported in the 2 to 16 years age group (4%) [see Use in Specific Populations( 8.4 )].
6.2 Clinical Trials Experience with Omeprazole in Combination Therapy for H.
pylori Eradication In clinical trials using either dual therapy with omeprazole and clarithromycin, or triple therapy with omeprazole, clarithromycin, and amoxicillin, no adverse reactions unique to these drug combinations were observed.
Adverse reactions observed were limited to those previously reported with omeprazole, clarithromycin, or amoxicillin alone.
Dual Therapy (omeprazole/clarithromycin) Adverse reactions observed in controlled clinical trials using combination therapy with omeprazole and clarithromycin (n=346) that differed from those previously described for omeprazole alone were taste perversion (15%), tongue discoloration (2%), rhinitis (2%), pharyngitis (1%) and flu-syndrome (1%).
(For more information on clarithromycin, refer to the clarithromycin prescribing information, Adverse Reactions section).
Triple Therapy (omeprazole/clarithromycin/amoxicillin) The most frequent adverse reactions observed in clinical trials using combination therapy with omeprazole, clarithromycin, and amoxicillin (n=274) were diarrhea (14%), taste perversion (10%), and headache (7%).
None of these occurred at a higher frequency than that reported by patients taking antimicrobial agents alone.
(For more information on clarithromycin or amoxicillin, refer to the respective prescribing information, Adverse Reactions sections).
6.3 Postmarketing Experience The following adverse reactions have been identified during post-approval use of omeprazole delayed-release capsules.
Because these reactions are voluntarily reported from a population of uncertain size, it is not always possible to reliably estimate their actual frequency or establish a causal relationship to drug exposure.
Body as a Whole Hypersensitivity reactions including anaphylaxis, anaphylactic shock, angioedema, bronchospasm, interstitial nephritis, urticaria, (see also Skin below); fever; pain; fatigue; malaise; systemic lupus erythematosus Cardiovascular Chest pain or angina, tachycardia, bradycardia, palpitations, elevated blood pressure, peripheral edema Endocrine Gynecomastia Gastrointestinal Pancreatitis (some fatal), anorexia, irritable colon, fecal discoloration, esophageal candidiasis, mucosal atrophy of the tongue, stomatitis, abdominal swelling, dry mouth, microscopic colitis.
Gastroduodenal carcinoids have been reported in patients with ZE syndrome on long-term treatment with omeprazole.
This finding is believed to be a manifestation of the underlying condition, which is known to be associated with such tumors.
Hepatic Liver disease including hepatic failure (some fatal), liver necrosis (some fatal), hepatic encephalopathy hepatocellular disease, cholestatic disease, mixed hepatitis, jaundice, and elevations of liver function tests [ALT, AST, GGT, alkaline phosphatase, and bilirubin] Infections and Infestations Clostridium difficile- associated diarrhea Metabolism and Nutritional Disorders Hypoglycemia, hypomagnesemia, with or without hypocalcemia and/or hypokalemia, hyponatremia, weight gain Musculoskeletal Muscle weakness, myalgia, muscle cramps, joint pain, leg pain, bone fracture Nervous System/Psychiatric Psychiatric and sleep disturbances including depression, agitation, aggression, hallucinations, confusion, insomnia, nervousness, apathy, somnolence, anxiety, and dream abnormalities; tremors, paresthesia; vertigo Respiratory Epistaxis, pharyngeal pain Skin Severe generalized skin reactions including toxic epidermal necrolysis (some fatal), Stevens-Johnson syndrome, cutaneous lupus erythematosus and erythema multiforme; photosensitivity; urticaria; rash; skin inflammation; pruritus; petechiae; purpura; alopecia; dry skin; hyperhidrosis Special Senses Tinnitus, taste perversion Ocular Optic atrophy, anterior ischemic optic neuropathy, optic neuritis, dry eye syndrome, ocular irritation, blurred vision, double vision Urogenital Interstitial nephritis, hematuria, proteinuria, elevated serum creatinine, microscopic pyuria, urinary tract infection, glycosuria, urinary frequency, testicular pain, erectile dysfunction Hematologic Agranulocytosis (some fatal), hemolytic anemia, pancytopenia, neutropenia, anemia, thrombocytopenia, leukopenia, leukocytosis Gastrointestinal Fundic gland polyps.
( 6 ) Pediatric patients (2 to 16 years of age): • Safety profile similar to that in adults, except that respiratory system events and fever were the most frequently reported reactions in pediatric studies.
( 8.4 ) To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc.
at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience with Omeprazole Monotherapy 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 practice.
The safety data described below reflects exposure to omeprazole delayed-release capsules in 3,096 patients from worldwide clinical trials (465 patients from US studies and 2,631 patients from international studies).
Indications clinically studied in US trials included duodenal ulcer, resistant ulcer, and Zollinger-Ellison syndrome.
The international clinical trials were double blind and open-label in design.
The most common adverse reactions reported (i.e., with an incidence rate ≥2%) from omeprazole-treated patients enrolled in these studies included headache (7%), abdominal pain (5%), nausea (4%), diarrhea (4%), vomiting (3%), and flatulence (3%).
Additional adverse reactions that were reported with an incidence ≥1% included acid regurgitation (2%), upper respiratory infection (2%), constipation (2%), dizziness (2%), rash (2%), asthenia (1%), back pain (1%), and cough (1%).
The clinical trial safety profile in patients greater than 65 years of age was similar to that in patients 65 years of age or less.
The clinical trial safety profile in pediatric patients who received omeprazole delayed-release capsules was similar to that in adult patients.
Unique to the pediatric population, however, adverse reactions of the respiratory system were frequently reported in the 2 to 16 years age group, and accidental injuries were frequently reported in the 2 to 16 years age group (4%) [see Use in Specific Populations( 8.4 )].
6.2 Clinical Trials Experience with Omeprazole in Combination Therapy for H.
pylori Eradication In clinical trials using either dual therapy with omeprazole and clarithromycin, or triple therapy with omeprazole, clarithromycin, and amoxicillin, no adverse reactions unique to these drug combinations were observed.
Adverse reactions observed were limited to those previously reported with omeprazole, clarithromycin, or amoxicillin alone.
Dual Therapy (omeprazole/clarithromycin) Adverse reactions observed in controlled clinical trials using combination therapy with omeprazole and clarithromycin (n=346) that differed from those previously described for omeprazole alone were taste perversion (15%), tongue discoloration (2%), rhinitis (2%), pharyngitis (1%) and flu-syndrome (1%).
(For more information on clarithromycin, refer to the clarithromycin prescribing information, Adverse Reactions section).
Triple Therapy (omeprazole/clarithromycin/amoxicillin) The most frequent adverse reactions observed in clinical trials using combination therapy with omeprazole, clarithromycin, and amoxicillin (n=274) were diarrhea (14%), taste perversion (10%), and headache (7%).
None of these occurred at a higher frequency than that reported by patients taking antimicrobial agents alone.
(For more information on clarithromycin or amoxicillin, refer to the respective prescribing information, Adverse Reactions sections).
6.3 Postmarketing Experience The following adverse reactions have been identified during post-approval use of omeprazole delayed-release capsules.
Because these reactions are voluntarily reported from a population of uncertain size, it is not always possible to reliably estimate their actual frequency or establish a causal relationship to drug exposure.
Body as a Whole Hypersensitivity reactions including anaphylaxis, anaphylactic shock, angioedema, bronchospasm, interstitial nephritis, urticaria, (see also Skin below); fever; pain; fatigue; malaise; systemic lupus erythematosus Cardiovascular Chest pain or angina, tachycardia, bradycardia, palpitations, elevated blood pressure, peripheral edema Endocrine Gynecomastia Gastrointestinal Pancreatitis (some fatal), anorexia, irritable colon, fecal discoloration, esophageal candidiasis, mucosal atrophy of the tongue, stomatitis, abdominal swelling, dry mouth, microscopic colitis.
Gastroduodenal carcinoids have been reported in patients with ZE syndrome on long-term treatment with omeprazole.
This finding is believed to be a manifestation of the underlying condition, which is known to be associated with such tumors.
Hepatic Liver disease including hepatic failure (some fatal), liver necrosis (some fatal), hepatic encephalopathy hepatocellular disease, cholestatic disease, mixed hepatitis, jaundice, and elevations of liver function tests [ALT, AST, GGT, alkaline phosphatase, and bilirubin] Infections and Infestations Clostridium difficile- associated diarrhea Metabolism and Nutritional Disorders Hypoglycemia, hypomagnesemia, with or without hypocalcemia and/or hypokalemia, hyponatremia, weight gain Musculoskeletal Muscle weakness, myalgia, muscle cramps, joint pain, leg pain, bone fracture Nervous System/Psychiatric Psychiatric and sleep disturbances including depression, agitation, aggression, hallucinations, confusion, insomnia, nervousness, apathy, somnolence, anxiety, and dream abnormalities; tremors, paresthesia; vertigo Respiratory Epistaxis, pharyngeal pain Skin Severe generalized skin reactions including toxic epidermal necrolysis (some fatal), Stevens-Johnson syndrome, cutaneous lupus erythematosus and erythema multiforme; photosensitivity; urticaria; rash; skin inflammation; pruritus; petechiae; purpura; alopecia; dry skin; hyperhidrosis Special Senses Tinnitus, taste perversion Ocular Optic atrophy, anterior ischemic optic neuropathy, optic neuritis, dry eye syndrome, ocular irritation, blurred vision, double vision Urogenital Interstitial nephritis, hematuria, proteinuria, elevated serum creatinine, microscopic pyuria, urinary tract infection, glycosuria, urinary frequency, testicular pain, erectile dysfunction Hematologic Agranulocytosis (some fatal), hemolytic anemia, pancytopenia, neutropenia, anemia, thrombocytopenia, leukopenia, leukocytosis Gastrointestinal Fundic gland polyps.