Omeprazole

Description

The active ingredient in Omeprazole delayed-release capsules, USP, is a substituted benzimidazole, specifically 5-methoxy-2-[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl sulfinyl]-1H-benzimidazole. Its empirical formula is C17H19N3O3S, and it has a molecular weight of 345.42. Omeprazole appears as a white to off-white crystalline powder that melts with decomposition at approximately 155°C. It is classified as a weak base, being freely soluble in ethanol and methanol, slightly soluble in acetone and isopropanol, and very slightly soluble in water. The stability of omeprazole is pH-dependent; it is rapidly degraded in acidic media but maintains acceptable stability in alkaline conditions. Omeprazole is provided as delayed-release capsules for oral administration, with each capsule containing either 10 mg, 20 mg, or 40 mg of omeprazole in the form of enteric-coated granules. Inactive ingredients in the delayed-release capsules include ammonium hydroxide, colloidal anhydrous silica, dibutyl sebacate, ethylcellulose 20 cP, hypromellose, maize starch, methacrylic acid-ethyl acrylate copolymer, oleic acid, polysorbate 80, sodium lauryl sulfate, sucrose, talc, titanium dioxide, and triethyl citrate. The capsule shells contain inactive ingredients such as ammonium hydroxide, black iron oxide, ethyl alcohol, gelatin, isopropyl alcohol, n-butyl alcohol, potassium hydroxide, propylene glycol, shellac, and titanium dioxide.

Uses and Indications

This drug is indicated for the treatment of active duodenal ulcers in adults. It is also indicated for the eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults. Additionally, this drug is used for the treatment of active benign gastric ulcers in adults.

In pediatric patients aged 2 years and older, this drug is indicated for the treatment of symptomatic gastroesophageal reflux disease (GERD) and for the treatment of erosive esophagitis (EE) due to acid-mediated GERD. It is also indicated for the maintenance of healing of EE due to acid-mediated GERD in this age group.

Furthermore, this drug is indicated for the management of pathologic hypersecretory conditions in adults.

No teratogenic or nonteratogenic effects have been reported.

Dosage and Administration

For the treatment of active duodenal ulcers, the recommended dosage is 20 mg administered once daily for a duration of 4 weeks. In certain patients, an extension of an additional 4 weeks may be necessary based on clinical response.

For the eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence, two therapeutic regimens are available:

Triple Therapy consists of:

• Omeprazole delayed-release capsules: 20 mg taken twice daily for 10 days. If an ulcer is present, continue with Omeprazole delayed-release capsules at 20 mg once daily for an additional 18 days.

• Amoxicillin: 1000 mg.

• Clarithromycin: 500 mg.

Dual Therapy includes:

• Omeprazole delayed-release capsules: 40 mg once daily for 14 days. If an ulcer is present, continue with Omeprazole delayed-release capsules at 20 mg once daily for an additional 14 days.

• Clarithromycin: 500 mg taken three times daily for 14 days.

For the treatment of active benign gastric ulcers, the recommended dosage is 40 mg once daily for a period of 4 to 8 weeks.

In the management of symptomatic gastroesophageal reflux disease (GERD), the dosage is 20 mg once daily for up to 4 weeks. For pediatric patients aged 2 years and older, refer to the full prescribing information for weight-based dosing.

For erosive esophagitis (EE) due to acid-mediated GERD, the initial dosage is 20 mg once daily for 4 to 8 weeks. If there is no response, an additional 4 weeks of treatment may be warranted. In cases of recurrence, further courses of 4 to 8 weeks may be considered. Pediatric dosing for patients aged 2 years and older should be guided by the full prescribing information.

To maintain healing of EE due to acid-mediated GERD, a dosage of 20 mg once daily is recommended, with studies supporting this regimen for up to 12 months. For patients with hepatic impairment (Child-Pugh Class A, B, or C) and for Asian patients, the dosage should be reduced to 10 mg once daily. Pediatric dosing for patients aged 2 years and older should also refer to the full prescribing information.

In the case of pathological hypersecretory conditions, the starting dose is 60 mg once daily, with adjustments made based on individual patient needs as clinically indicated. For specific dosing recommendations, consult the full prescribing information.

Contraindications

Use of this product is contraindicated in patients with known hypersensitivity to substituted benzimidazoles or any component of the formulation. Additionally, it should not be administered to patients receiving rilpivirine-containing products due to potential drug interactions. When used in combination with clarithromycin and amoxicillin, refer to the contraindications section of their respective prescribing information for further guidance.

Warnings and Precautions

In adults, the symptomatic response to treatment does not exclude the possibility of gastric malignancy. Therefore, healthcare professionals should consider additional follow-up and diagnostic testing in patients presenting with symptoms.

Acute tubulointerstitial nephritis has been reported in patients receiving treatment. If this condition is suspected, it is imperative to discontinue the medication and evaluate the patient accordingly.

There is an association between proton pump inhibitor (PPI) therapy and an increased risk of Clostridium difficile-associated diarrhea. Clinicians should be vigilant for this potential complication, particularly in patients with risk factors.

Long-term use of PPIs, especially at multiple daily doses, may increase the risk of osteoporosis-related fractures of the hip, wrist, or spine. It is advisable to assess the need for continued therapy in patients at risk for bone fractures.

Severe cutaneous adverse reactions have been observed. Treatment should be discontinued at the first signs or symptoms of such reactions or any other signs of hypersensitivity, and further evaluation should be considered.

Patients may experience new onset or exacerbation of cutaneous and systemic lupus erythematosus. In such cases, it is recommended to discontinue Omeprazole delayed-release capsules and refer the patient to a specialist for further evaluation.

Concomitant use of Omeprazole delayed-release capsules with clopidogrel is contraindicated due to potential interactions. Healthcare providers should avoid this combination to prevent adverse effects.

Long-term daily use of Omeprazole (beyond three years) may lead to malabsorption or deficiency of cyanocobalamin (Vitamin B-12). Monitoring of vitamin B-12 levels may be warranted in patients on prolonged therapy.

Hypomagnesemia and disturbances in mineral metabolism have been reported rarely with prolonged PPI treatment. Clinicians should monitor magnesium levels in patients receiving long-term therapy.

The concomitant use of Omeprazole delayed-release capsules with St. John's Wort or rifampin should be avoided due to potential interactions that may affect drug efficacy.

Increased levels of Chromogranin A (CgA) may interfere with diagnostic investigations for neuroendocrine tumors. It is recommended to temporarily discontinue Omeprazole delayed-release capsules at least 14 days prior to assessing CgA levels to ensure accurate diagnostic results.

Concomitant use of PPIs with methotrexate may elevate and prolong serum concentrations of methotrexate and its metabolites, potentially leading to toxicity. In cases of high-dose methotrexate administration, a temporary withdrawal of Omeprazole delayed-release capsules should be considered.

The risk of fundic gland polyps increases with long-term use of Omeprazole, particularly beyond one year. It is advisable to use the shortest duration of therapy necessary to manage the patient's condition.

Side Effects

Most common adverse reactions reported in adults, with an incidence of 2% or greater, include headache (7%), abdominal pain (5%), nausea (4%), diarrhea (4%), vomiting (3%), and flatulence (3%). Additional adverse reactions occurring with an incidence of 1% or greater include acid regurgitation (2%), upper respiratory infection (2%), constipation (2%), dizziness (2%), and rash (2%). Other less common reactions include asthenia (1%), back pain (1%), and cough (1%).

In pediatric patients aged 1 to 16 years, the safety profile is similar to that observed in adults; however, respiratory system events and fever were the most frequently reported reactions in pediatric studies. Notably, adverse reactions related to the respiratory system were reported in 19% of subjects aged 2 to 16 years. Additionally, accidental injuries were reported in 4% of this age group.

Postmarketing experience has revealed a range of adverse reactions across various systems. Hypersensitivity reactions, including anaphylaxis, anaphylactic shock, angioedema, bronchospasm, and urticaria, have been reported. Other systemic reactions include fever, pain, fatigue, malaise, and systemic lupus erythematosus. Cardiovascular events such as chest pain, tachycardia, bradycardia, palpitations, elevated blood pressure, and peripheral edema have also been noted.

Gastrointestinal adverse reactions include pancreatitis (some fatal), anorexia, irritable colon, fecal discoloration, esophageal candidiasis, and mucosal atrophy of the tongue. Hepatic adverse reactions encompass liver disease, including hepatic failure (some fatal), liver necrosis (some fatal), and elevations in liver function tests. Infections such as Clostridium difficile-associated diarrhea have been reported.

Metabolic and nutritional disorders include hypoglycemia, hypomagnesemia, and weight gain. Musculoskeletal reactions consist of muscle weakness, myalgia, and joint pain. Neurological and psychiatric disturbances include depression, agitation, hallucinations, and insomnia. Respiratory reactions such as epistaxis and pharyngeal pain have also been observed.

Skin reactions can be severe, including toxic epidermal necrolysis (some fatal), Stevens-Johnson syndrome, and photosensitivity. Ocular adverse reactions include optic atrophy and dry eye syndrome. Urogenital reactions such as interstitial nephritis and urinary tract infections have been reported, along with hematologic reactions including agranulocytosis (some fatal) and thrombocytopenia.

Additionally, confusion, drowsiness, blurred vision, tachycardia, nausea, vomiting, diaphoresis, flushing, headache, and dry mouth have been reported in cases of overdosage, reflecting adverse reactions similar to those seen in normal clinical experience.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

The table below lists all NDC Code configurations of Omeprazole, the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

The safety and effectiveness of omeprazole delayed-release capsules have been established in pediatric patients aged 2 to 16 years for the treatment of symptomatic gastroesophageal reflux disease (GERD), the treatment of erosive esophagitis (EE) due to acid-mediated GERD, and the maintenance of healing of EE due to acid-mediated GERD. The use of omeprazole in this age group is supported by adequate and well-controlled studies in adults, as well as uncontrolled safety, efficacy, and pharmacokinetic studies conducted in pediatric and adolescent patients.

In the pediatric population, adverse reactions affecting the respiratory system were frequently reported among patients aged 2 to 16 years. Additionally, accidental injuries were commonly noted in this age group.

The safety and effectiveness of omeprazole delayed-release capsules have not been established in patients younger than 1 year of age for the treatment of symptomatic GERD or for the maintenance of healing of EE due to acid-mediated GERD. Furthermore, omeprazole is not indicated for pediatric patients for the treatment of active duodenal ulcers, H. pylori eradication to reduce the risk of duodenal ulcer recurrence, treatment of active benign gastric ulcers, or pathological hypersecretory conditions. The safety and effectiveness of omeprazole have not been established in patients less than 1 month of age for any indication.

Geriatric Use

Omeprazole has been administered to over 2000 elderly individuals (≥ 65 years of age) in clinical trials conducted in the U.S. and Europe, demonstrating no significant differences in safety and effectiveness when compared to younger subjects. While other clinical experiences have not identified notable differences in response between elderly and younger patients, it is important to acknowledge that some older individuals may exhibit greater sensitivity to the medication.

Pharmacokinetic studies indicate that the elimination rate of omeprazole is somewhat decreased in the elderly population, with an increased bioavailability observed. Specifically, the plasma clearance of omeprazole in elderly patients is approximately 250 mL/min, which is about half that of younger volunteers. Additionally, the plasma half-life of omeprazole in geriatric patients averages one hour, which is roughly twice that observed in young healthy volunteers.

Despite these pharmacokinetic variations, no dosage adjustment is necessary for elderly patients. Healthcare providers should remain vigilant in monitoring for any potential adverse effects, given the possibility of increased sensitivity in some older individuals.

Pregnancy

There are no adequate and well-controlled studies with omeprazole in pregnant patients. Available epidemiologic data do not demonstrate an increased risk of major congenital malformations or other adverse pregnancy outcomes with the use of omeprazole during the first trimester. However, reproduction studies in rats and rabbits have shown dose-dependent embryo-lethality at doses approximately 3.4 to 34 times the oral human dose of 40 mg, based on body surface area for a 60 kg person.

Teratogenicity was not observed in animal reproduction studies with esomeprazole magnesium, an enantiomer of omeprazole, when administered during organogenesis at doses about 68 times and 42 times the oral human dose of 40 mg for rats and rabbits, respectively. Changes in bone morphology were noted in offspring of rats dosed throughout most of pregnancy and lactation at doses equal to or greater than approximately 34 times the oral human dose of 40 mg. However, when maternal administration was limited to gestation only, no effects on bone physeal morphology in the offspring were observed at any age.

The estimated background risks of major birth defects and miscarriage for the general population are unknown, but all pregnancies carry a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Several epidemiological studies have compared the frequency of congenital abnormalities among infants born to women who used omeprazole during pregnancy with those of women exposed to H2-receptor antagonists or other controls. A population-based retrospective cohort study from the Swedish Medical Birth Registry reported on 955 infants whose mothers used omeprazole during pregnancy, revealing similar rates of malformations, low birth weight, low Apgar scores, or hospitalization compared to the general population. Another study from Denmark reported an overall rate of birth defects in infants born to mothers with first trimester exposure to omeprazole of 2.9%, comparable to 2.6% in infants born to mothers not exposed to any proton pump inhibitor during the first trimester.

A retrospective cohort study indicated an overall malformation rate of 3.6% in offspring born to mothers with first trimester exposure to omeprazole, compared to 5.5% for H2-blockers and 4.1% for unexposed mothers. A small prospective observational cohort study involving 113 women exposed to omeprazole during pregnancy reported a rate of major congenital malformations of 4% in the omeprazole group, compared to 2% in controls exposed to non-teratogens.

Additionally, several studies have indicated no apparent adverse short-term effects on the infant when single doses of oral or intravenous omeprazole were administered to over 200 pregnant women as premedication for cesarean section under general anesthesia. Reproductive studies conducted with omeprazole in rats did not reveal any evidence of teratogenic potential, although in rabbits, omeprazole was associated with dose-related increases in embryo-lethality, fetal resorptions, and pregnancy disruptions.

In summary, while the available data suggest that omeprazole does not significantly increase the risk of major congenital malformations, caution is advised when prescribing to pregnant patients, particularly during the first trimester.

Lactation

Limited data suggest that omeprazole may be present in human milk. However, there are no clinical data available regarding the effects of omeprazole on breastfed infants or on milk production.

Healthcare professionals should consider the developmental and health benefits of breastfeeding alongside the mother's clinical need for omeprazole delayed-release capsules. Additionally, potential adverse effects on the breastfed infant from omeprazole or from the underlying maternal condition should be taken into account.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the text. Therefore, healthcare professionals should exercise caution and consider individual patient factors when prescribing to this population. Regular assessment of renal function may be warranted to ensure safe and effective use of the medication in patients with reduced kidney function.

Hepatic Impairment

In patients with hepatic impairment (Child-Pugh Class A, B, or C), exposure to omeprazole is substantially increased compared to healthy subjects. Therefore, a dosage reduction of omeprazole delayed-release capsules to 10 mg once daily is recommended for these patients to maintain the healing of erosive esophagitis (EE).

It is important for healthcare providers to monitor liver function in patients with hepatic impairment who are prescribed omeprazole, as adjustments in therapy may be necessary based on individual patient response and tolerance.

Overdosage

Reports of overdosage with omeprazole in humans have documented instances involving doses as high as 2400 mg, which is approximately 120 times the usual recommended clinical dose. The manifestations associated with omeprazole overdosage can include a range of symptoms such as confusion, drowsiness, blurred vision, tachycardia, nausea, vomiting, diaphoresis, flushing, headache, and dry mouth.

It is important to note that the symptoms of omeprazole overdosage are typically transient, and no serious clinical outcomes have been reported when omeprazole is taken in isolation. In cases of suspected overdosage, there is no specific antidote available; therefore, management should focus on symptomatic and supportive care.

Given that omeprazole is extensively protein-bound, it is not readily dialyzable, which limits the effectiveness of dialysis in cases of overdosage. Healthcare professionals are advised to contact the Poison Control Center at 1-800-222-1222 for the most current information regarding the management of poisoning or overdosage situations involving omeprazole.

Nonclinical Toxicology

In two 24-month carcinogenicity studies conducted in rats, omeprazole was administered at daily doses of 1.7, 3.4, 13.8, 44.0, and 140.8 mg/kg/day, corresponding to approximately 0.4 to 34 times the human dose of 40 mg/day based on body surface area. The studies revealed a dose-related increase in the incidence of gastric ECL cell carcinoids in both male and female rats, with a notably higher incidence observed in female rats, which exhibited elevated blood levels of omeprazole. Gastric carcinoids are infrequently observed in untreated rats. Additionally, ECL cell hyperplasia was noted across all treated groups of both sexes. In one study, female rats treated with 13.8 mg/kg/day for one year and subsequently observed for an additional year without treatment did not develop carcinoids. However, a significant increase in treatment-related ECL cell hyperplasia was recorded at the end of the first year (94% in treated rats versus 10% in controls). By the second year, the difference diminished (46% in treated versus 26% in controls), yet hyperplasia remained more prevalent in the treated group. Gastric adenocarcinoma was identified in one rat (2%), but no similar tumors were observed in male or female rats over the two-year period. Historically, this strain of rat has not shown similar tumors, making the interpretation of a single tumor finding challenging.

In a 52-week toxicity study involving Sprague-Dawley rats, brain astrocytomas were detected in a small number of male rats receiving omeprazole at doses of 0.4, 2, and 16 mg/kg/day (approximately 0.1 to 3.9 times the human dose of 40 mg/day based on body surface area). No astrocytomas were reported in female rats during this study. Conversely, a 2-year carcinogenicity study in Sprague-Dawley rats did not reveal any astrocytomas in either sex at the high dose of 140.8 mg/kg/day (about 34 times the human dose of 40 mg/day based on body surface area). A 78-week carcinogenicity study in mice did not demonstrate an increased occurrence of tumors, although the results were inconclusive. Additionally, a 26-week p53 (+/-) transgenic mouse carcinogenicity study yielded negative results.

Omeprazole exhibited clastogenic effects in an in vitro human lymphocyte chromosomal aberration assay, as well as in one of two in vivo mouse micronucleus tests and an in vivo bone marrow cell chromosomal aberration assay. However, omeprazole was negative in the in vitro Ames test, an in vitro mouse lymphoma cell forward mutation assay, and an in vivo rat liver DNA damage assay.

In terms of reproductive toxicity, omeprazole administered at oral doses up to 138 mg/kg/day in rats (approximately 34 times the oral human dose of 40 mg based on body surface area) did not adversely affect fertility or reproductive performance. The observed dose-related significant increase in gastric carcinoid tumors and ECL cell hyperplasia in both male and female rats aligns with findings from other studies involving long-term treatment with proton pump inhibitors or high doses of H2-receptor antagonists.

Postmarketing Experience

During post-approval use of Omeprazole delayed-release capsules, various adverse reactions have been reported voluntarily or through surveillance programs. Due to the nature of these reports, which originate from a population of uncertain size, it is not always feasible to reliably estimate their actual frequency or establish a causal relationship to drug exposure.

Body As a Whole: Hypersensitivity reactions have been noted, including anaphylaxis, anaphylactic shock, angioedema, bronchospasm, interstitial nephritis, and urticaria. Other reported reactions include fever, pain, fatigue, malaise, and systemic lupus erythematosus.

Cardiovascular: Adverse events such as chest pain or angina, tachycardia, bradycardia, palpitations, elevated blood pressure, and peripheral edema have been documented.

Endocrine: Cases of gynecomastia have been reported.

Gastrointestinal: Serious gastrointestinal events, including pancreatitis (some fatal), anorexia, irritable colon, fecal discoloration, esophageal candidiasis, mucosal atrophy of the tongue, stomatitis, abdominal swelling, dry mouth, microscopic colitis, and fundic gland polyps, have been observed. Additionally, gastroduodenal carcinoids have been reported in patients with Zollinger-Ellison syndrome on long-term treatment, believed to be related to the underlying condition.

Hepatic: Reports of liver disease, including hepatic failure (some fatal), liver necrosis (some fatal), hepatic encephalopathy, hepatocellular disease, cholestatic disease, mixed hepatitis, jaundice, and elevations in liver function tests (ALT, AST, GGT, alkaline phosphatase, and bilirubin) have been noted.

Infections and Infestations: Clostridium difficile-associated diarrhea has been reported.

Metabolism and Nutritional Disorders: Instances of hypoglycemia, hypomagnesemia (with or without hypocalcemia and/or hypokalemia), hyponatremia, and weight gain have been documented.

Musculoskeletal: Reports of muscle weakness, myalgia, muscle cramps, joint pain, leg pain, and bone fractures have been received.

Nervous System/Psychiatric: Various psychiatric and sleep disturbances, including depression, agitation, aggression, hallucinations, confusion, insomnia, nervousness, apathy, somnolence, anxiety, and dream abnormalities, have been reported. Other neurological events include tremors and paresthesia, as well as vertigo.

Respiratory: Adverse reactions such as epistaxis and pharyngeal pain have been noted.

Skin: Severe generalized skin reactions, including toxic epidermal necrolysis (some fatal), Stevens-Johnson syndrome, cutaneous lupus erythematosus, and erythema multiforme, have been reported. Other skin-related events include photosensitivity, urticaria, rash, skin inflammation, pruritus, petechiae, purpura, alopecia, dry skin, and hyperhidrosis.

Special Senses: Reports of tinnitus and taste perversion have been documented.

Ocular: Adverse ocular events, including optic atrophy, anterior ischemic optic neuropathy, optic neuritis, dry eye syndrome, ocular irritation, blurred vision, and double vision, have been noted.

Urogenital: Instances of interstitial nephritis, hematuria, proteinuria, elevated serum creatinine, microscopic pyuria, urinary tract infections, glycosuria, urinary frequency, and testicular pain have been reported.

Hematologic: Serious hematologic events, including agranulocytosis (some fatal), hemolytic anemia, pancytopenia, neutropenia, anemia, thrombocytopenia, leukopenia, and leukocytosis, have been documented.

Patient Counseling

Patients should be advised to take Omeprazole delayed-release capsules before meals to ensure optimal effectiveness. It is important to inform patients that antacids may be used concurrently with Omeprazole, providing flexibility in their treatment regimen.

In the event that a patient misses a dose, they should be instructed to take it as soon as possible. However, if the time for the next scheduled dose is approaching, they should skip the missed dose and resume their regular dosing schedule. Patients must be cautioned against taking two doses at once to compensate for a missed dose.

Patients should be reminded to swallow the Omeprazole delayed-release capsules whole and not to chew them. For those who have difficulty swallowing intact capsules, it is permissible to open the capsules and mix the contents with applesauce. The following steps should be communicated clearly:

1. Place one tablespoon of applesauce into a clean container, ensuring that the applesauce is not hot and is soft enough to swallow without chewing.

2. Open the capsule carefully.

3. Empty all the pellets from the capsule onto the applesauce.

4. Mix the pellets thoroughly with the applesauce.

5. Instruct patients to swallow the mixture immediately with a glass of cool water to ensure complete ingestion of the pellets. They should be advised not to chew or crush the pellets and not to save any mixture for future use.

These instructions are essential for ensuring the safe and effective use of Omeprazole delayed-release capsules.

Storage and Handling

Omeprazole delayed-release capsules are supplied in a tight container to ensure protection from light and moisture. It is essential to store the capsules at a temperature range of 15°C to 30°C (59°F to 86°F) to maintain their efficacy and stability. Proper storage conditions are crucial for preserving the integrity of the product.

Additional Clinical Information

Standardized susceptibility test procedures necessitate the use of laboratory control microorganisms to ensure the technical accuracy of laboratory procedures.

During postmarketing surveillance of Omeprazole delayed-release capsules, various adverse reactions have been reported. These include hypersensitivity reactions such as anaphylaxis and angioedema, cardiovascular issues like chest pain and tachycardia, and gastrointestinal disorders including pancreatitis and Clostridium difficile-associated diarrhea. Other reported effects span multiple systems, including endocrine disorders like gynecomastia, hepatic complications such as liver failure, metabolic disturbances including hypoglycemia and hypomagnesemia, and musculoskeletal symptoms like muscle weakness and joint pain. Neurological and psychiatric effects have also been noted, including depression and sleep disturbances. Additionally, skin reactions can be severe, with reports of toxic epidermal necrolysis and Stevens-Johnson syndrome. Ocular issues, urogenital complications, and hematologic conditions such as agranulocytosis have also been documented. Due to the voluntary nature of these reports, estimating the actual frequency or establishing a causal relationship to drug exposure remains challenging.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Omeprazole as submitted by Golden State Medical Supply, Inc.. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)