RIVA-OMEPRAZOLE DR

1 Dosing Considerations • No dose adjustment is required in patients with renal insufficiency, hepatic insufficiency, or in elderly patients. 3 Pharmacokinetics). 4 Drug-Drug Interactions). • Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.

2 Recommended Dose and Dosage Adjustment Omeprazole magnesium 20 mg tablets and Omeprazole magnesium 20 mg capsules have an equivalent effect on 24-hour intragastric pH (proportion of time with intragastric pH ≥ 4). These data support the conclusion that omeprazole magnesium tablet and the omeprazole magnesium capsule can be used with equal efficacy in the treatment of conditions where a reduction of gastric acid secretion is required.

Duodenal Ulcer Acute Therapy:

The recommended adult oral dose is 20 mg given once daily. Healing usually occurs within 2 weeks. For patients not healed after this initial course of therapy, an additional 2 weeks of treatment is recommended.

Refractory Patients:

In patients with duodenal ulcer refractory to other treatment regimens, the recommended adult doses are 20 mg - 40 mg given once daily. Healing is usually achieved within 4 weeks in such patients.

Maintenance Therapy for Duodenal Ulcer:

Over 95% of duodenal ulcer patients are H. pylori-positive, and should be treated with eradication therapy, as described below. A small percentage of patients who are H. pylori-negative will experience a disease recurrence and will require maintenance treatment with an antisecretory agent.

The recommended omeprazole magnesium dose is 10 mg* once daily, increased to 20-40 mg once daily as necessary. *RIVA-OMEPRAZOLE DR is NOT available in 10 mg strength.

Gastric Ulcer Acute Therapy:

The recommended adult dose is 20 mg given once daily. Healing usually occurs within 4 weeks. For patients not healed after this initial course of therapy, an additional 4 weeks of treatment is recommended.

Refractory Patients:

In patients with benign gastric ulcer refractory to other treatment regimens, the recommended adult dose is 40 mg given once daily. Healing is usually achieved within 8 weeks. RIVA-OMEPRAZOLE DR (Omeprazole Magnesium Delayed Release Tablets) Page 6 of 42 Maintenance Therapy for Gastric Ulcer: About 80% of gastric ulcer patients are H.

1 Adverse Reaction Overview Omeprazole is well tolerated. Most adverse reactions have been mild and transient, and have shown no consistent relationship with treatment. Adverse events have been recorded during controlled clinical investigations in 2,764 patients exposed to omeprazole (data taken from controlled clinical studies with omeprazole capsules) or reported from routine use.

2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.

Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. In a controlled clinical trial comparing omeprazole to placebo, the prevalence of adverse events with omeprazole 40 mg once daily was similar to that with placebo.

In short-term comparative double-blind studies with histamine H2-receptor antagonists, there was no significant difference in the prevalence of adverse events between omeprazole capsules and the H2-receptor antagonists. An extensive evaluation of laboratory variables has not revealed any significant changes during omeprazole treatment which are considered to be clinically important.

In two short-term studies (20 mg tablet once daily for a maximum duration of 7 days) in a limited number of patients with symptomatic gastroesophageal reflux disease, the adverse event profile seen with the omeprazole magnesium 20 mg tablet is similar to that seen with the omeprazole magnesium 20 mg capsule.

1%). The following is a list of adverse events reported in clinical trials or reported from routine use. Events are categorized by system organ class proposed by MedDRA in alphabetical order. 01%), including isolated reports Table 2: Adverse drug reactions reported in clinical trials or reported from routine use presented by MedDRA System Organ Class and frequency System Organ Class Frequency Adverse Reaction(s) Blood and lymphatic system disorders Rare Leukopenia, thrombocytopenia, agranulocytosis and pancytopenia Ear and labyrinth disorders Uncommon Vertigo Eye disorders Rare Blurred vision Gastrointestinal disorders Common Diarrhoea, constipation, abdominal pain, nausea/vomiting and flatulence Rare Dry mouth, stomatitis, gastrointestinal candidiasis RIVA-OMEPRAZOLE DR (Omeprazole Magnesium Delayed Release Tablets) Page 13 of 42 System Organ Class Frequency Adverse Reaction(s) General disorders and administration site conditions Uncommon Malaise Rare Increased sweating, peripheral edema Hepatobiliary disorders: Uncommon Increased liver enzyme levels Rare Encephalopathy in patients with pre-existing severe liver disease; hepatitis with or without jaundice and hepatic failure Immune system disorders Rare Hypersensitive reactions including angioedema, fever and anaphylactic shock Metabolism and nutrition disorders Rare Hyponatremia Very rare Hypomagnesemia (severe hypomagnesemia may result in hypocalcemia, and hypomagnesemia may also result in hypokalemia) Musculoskeletal and connective tissue disorders Rare Arthralgia, muscular weakness and myalgia Nervous system disorders Common Headache Uncommon Dizziness, paresthesia, somnolence Rare Taste disturbances Psychiatric disorders Uncommon Insomnia Rare Reversible mental confusion, agitation, aggression, depression and hallucination occurring predominantly in severely ill patients Renal and urinary disorders Rare Interstitial nephritis Reproductive system and breast disorders Rare Gynecomastia Respiratory, thoracic and mediastinal disorders Rare Bronchospasm Skin and subcutaneous tissue disorders Uncommon Rash, dermatitis and/or pruritus, and urticaria Rare Photosensitivity, erythema multiforme, Stevens- Johnsons syndrome, toxic epidermal necrolysis (TEN), alopecia H.

07/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. 1 Pediatrics.............................................................................................................................

2 Geriatrics ............................................................................................................................. 1 Dosing Considerations ........................................................................................................

2 Recommended Dose and Dosage Adjustment ................................................................... 4 Administration ....................................................................................................................

5 Missed Dose ........................................................................................................................ 1 Special Populations ...........................................................................................................

1 Pregnant Women .............................................................................................................. 2 Breast-feeding...................................................................................................................

3 Pediatrics........................................................................................................................... 4 Geriatrics ...........................................................................................................................

11 8 ADVERSE REACTIONS ........................................................................................................... 1 Adverse Reaction Overview ..............................................................................................

2 Clinical Trial Adverse Reactions ........................................................................................ 5 Post-Market Adverse Reactions........................................................................................

• RIVA-OMEPRAZOLE DR is contraindicated in patients who are hypersensitive to omeprazole, substituted benzimidazoles or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .

• RIVA-OMEPRAZOLE DR is contraindicated with co-administration of rilpivirine due to significant decrease in rilpivirine exposure and loss of therapeutic effect.