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SANDOZ OMEPRAZOLE is a brand name for Omeprazole, supplied as a capsule (delayed release). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Sandoz Omeprazole (omeprazole) is indicated in the treatment of conditions where a reduction of gastric acid secretion is required, such as: • Duodenal ulcer; • Gastric ulcer; • NSAID-associated gastric and duodenal ulcers; • Reflux esophagitis; • Symptomatic gastroesophageal reflux disease (GERD) i.e. heartburn and…
Verbatim from this product's HC label. Tap a section to expand.
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 Duodenal Ulcer Acute Therapy: The recommended adult oral dose is 20 mg given once daily. Healing usually occurs within two weeks. For patients not healed after this initial course of therapy, an additional two weeks of treatment is recommended.
Refractory Patients:
In patients with duodenal ulcer refractory to other treatment regimens, the recommended adult doses are 20 mg or 40 mg given once daily. Healing is usually achieved within four 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 Sandoz Omeprazole (omeprazole) dose is 10 mg once daily, increased to 20-40 mg once daily, as necessary.
Gastric Ulcer Acute Therapy:
The recommended adult dose is 20 mg given once daily. Healing usually occurs within four weeks. For patients not healed after this initial course of therapy, an additional four weeks of treatment is recommended.
Refractory Patients:
In patients with gastric ulcer refractory to other treatment regimens, the recommended dose is 40 mg given once daily. Healing is usually achieved within eight weeks.
Maintenance Therapy for Gastric Ulcer:
About 80% of gastric 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 Product Monograph Page 6 of 48 Sandoz Omeprazole (Omeprazole delayed release capsules USP) require maintenance treatment with an antisecretory agent.
1 Adverse Reaction Overview Omeprazole is well tolerated. Most adverse reactions have been mild and transient and there has been no consistent relationship with the treatment. Adverse events have been recorded during controlled clinical investigations in 2764 patients exposed to omeprazole 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 the placebo group.
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 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.
1%). The following is a list of adverse events reported in clinical trials or reported from routine use. Events are categorized by system organ proposed by MedRA in alphabetical order. 01%), including isolated reports Product Monograph Page 14 of 48 Sandoz Omeprazole (Omeprazole delayed release capsules USP) 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 Diarrhea, constipation, abdominal pain, nausea/vomiting and flatulence Rare Dry mouth, stomatitis, gastrointestinal candidiasis 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 Uncommon Hypersensitive reactions including urticaria Rare Hypersensitive reactions including angioedema, fever and anaphylactic shock Metabolism and nutrition disorders Rare Hyponatremia Product Monograph Page 15 of 48 Sandoz Omeprazole (Omeprazole delayed release capsules USP) System Organ Class Frequency Adverse Reaction(s) 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, paraesthesia, somnolence Rare Taste disturbances Psychiatric disorders Uncommon Insomnia Rare Reversible mental confusion, agitation, aggression, depression and hallucinations, 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.
05/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES .............................................................................................
2 TABLE OF CONTENTS ............................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION .......................................................................
4 1 INDICATIONS ................................................................................................................ 1 Pediatrics ..........................................................................................................................................
2 Geriatrics .......................................................................................................................................... 4 2 CONTRAINDICATIONS ..................................................................................................
4 4 DOSAGE AND ADMINISTRATION .................................................................................. 1 Dosing Considerations ..................................................................................................................
2 Recommended Dose and Dosage Adjustment ..................................................................... 4 Administration ................................................................................................................................
5 Missed Dose ................................................................................................................................... 8 5 OVERDOSAGE...............................................................................................................
8 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .................................. 8 7 WARNINGS AND PRECAUTIONS ................................................................................... 1 Special Populations................................................................................................
• Sandoz Omeprazole 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.
• Sandoz Omeprazole is contraindicated with co-administration of rilpirivine due to significant decrease in rilpivirine exposure and loss of therapeutic effect. Product Monograph Page 5 of 48 Sandoz Omeprazole (Omeprazole delayed release capsules USP)
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The recommended Sandoz Omeprazole dose is 20 mg once daily, increased to 40 mg once daily, as necessary. NSAID-Associated Gastric or Duodenal Ulcers The issue of whether or not eradication of H. pylori in patients with NSAID-associated ulcers might have beneficial preventive effects has not yet been settled.
Acute Therapy:
In patients with NSAID-associated gastric or duodenal ulcers, the recommended adult dose is 20 mg given once daily. Symptom resolution is rapid and healing usually occurs within four weeks. For those patients not healed after this initial course of therapy, an additional four weeks of treatment is recommended.
Maintenance Therapy:
For the prevention of relapse in patients with NSAID-associated gastric or duodenal ulcers, the recommended adult dose is 20 mg given once daily, for up to six months. Helicobacter pylori Associated Peptic Ulcer Disease Omeprazole, Amoxicillin and Clarithromycin Triple Therapy: The recommended dose for eradication of H.
pylori is Sandoz Omeprazole 20 mg, amoxicillin 1000 mg and clarithromycin 500 mg, all twice daily for seven days.
Omeprazole, Metronidazole and Clarithromycin Triple Therapy:
The recommended dose for eradication of H. pylori is Sandoz Omeprazole 20 mg, metronidazole 500 mg and clarithromycin 250 mg, all twice daily for seven days. To ensure healing and/or symptom control, further treatment with 20 mg Sandoz Omeprazole once daily for up to three weeks is recommended for patients with active duodenal ulcer, and with 20-40 mg Sandoz Omeprazole once daily for up to 12 weeks for patients with active gastric ulcer.
Patient compliance with treatment regimens for the eradication of H. pylori has been demonstrated to have a positive effect on eradication outcome. In clinical trials, patients treated with triple-therapy regimens have shown high compliance rates.
Susceptibility testing (MIC values derived from the Agar dilution method) of H. pylori to metronidazole and clarithromycin is available for 486 primary isolates from patients with a history of duodenal ulcer in one European study. Resistance to metronidazole (MIC >8 mg/L) was detected in 131 strains (27%), while nine strains (2%) were resistant to clarithromycin (MIC >1 mg/L).
Secondary resistance to metronidazole developed in strains from four patients treated with omeprazole/metronidazole/clarithromycin. Similarly, in those patients treated with Product Monograph Page 7 of 48 Sandoz Omeprazole (Omeprazole delayed release capsules USP) omeprazole/metronidazole/clarithromycin or omeprazole/amoxicillin/clarithromycin combinations, secondary resistance to clarithromycin developed in strains from four patients.
For amoxicillin, the MIC values at pre- or post-therapy did not indicate any primary, or the development of secondary, resistance of H. pylori.
Reflux Esophagitis Acute Therapy:
The recommended adult dose is 20 mg given once daily. In most patients, healing occurs within four weeks. For patients not healed after this initial course of therapy, an additional four weeks of treatment is recommended.
Refractory Patients:
For patients with reflux esophagitis refractory to other treatment regimens, the recommended dose is 40 mg given once daily. Healing is usually achieved within eight weeks.
Maintenance Therapy for Reflux Esophagitis:
For the long-term management of patients with healed reflux esophagitis, 10 mg omeprazole once daily has been found to be effective in controlled clinical trials of 12 months’ duration, and in continuous maintenance treatment in a limited number of patients for a period of up to six years.
In the case of recurrence, the dose can be increased to 20-40 mg omeprazole. , Heartburn and Regurgitation) The […]
pylori Eradication Combination Therapy: The following adverse events (at a rate of more than 1%) were recorded during controlled clinical trials in 493 patients receiving omeprazole, Product Monograph Page 16 of 48 Sandoz Omeprazole (Omeprazole delayed release capsules USP) amoxicillin and clarithromycin: diarrhea (28%), taste disturbances (15%), headache (5%), flatulence (4%), nausea (3%), abdominal pain (2%), ALT increased (1%), epigastric pain (1%), pharyngitis (1%) and glossitis (1%).
The following adverse events (at a rate of more than 1%) were recorded during controlled clinical trials in 494 patients receiving omeprazole, metronidazole and clarithromycin: taste disturbances (14%), diarrhea (13%), headache (6%), ALT increased (6%), flatulence (5%), nausea (5%), AST increased (5%), dyspepsia (3%), dry mouth (2%), dizziness/vertigo (2%), epigastric pain (1%), pharyngitis (1%), eructation (1%) and fatigue (1%).
5 Post-Market Adverse Reactions Gastrointestinal Disorders Withdrawal of long-term PPI therapy can lead to aggravation of acid related symptoms and may result in rebound acid hypersecretion. There have been post-marketing reports of microscopic colitis fundic gland polyps (PGPs) (7 WARNINGS AND PRECAUTIONS).
Musculoskeletal and Connective Tissue Disorders Osteoporosis and osteoporosis-related fractures have been reported with multiple daily doses and long-term PPI therapy (See 7 WARNINGS AND PRECAUTIONS). Renal and urinary disorders There have been post-marketing reports of tubulointerstitial nephritis (with possible progression to renal failure).
Skin and Subcutaneous Disorders There have been post-marketing reports of acute generalized exanthematous pustulosis (AGEP), drug rash with eosinophilia and systematic […]
1 Pregnant Women .............................................................................................. 2 Breast-feeding ................................................................................................... 3 Pediatrics ..........................................................................................................
4 Geriatrics .......................................................................................................... 12 8 ADVERSE REACTIONS .................................................................................................
1 Adverse Reaction Overview ................................................................................... 2 Clinical Trial Adverse Reactions.............................................................................. 5 Post-Market Adverse Reactions ............................................................................
16 9 DRUG INTERACTIONS ................................................................................................. 1 Serious Drug Interactions ......................................................................................
2 Drug Interactions Overview ................................................................................... 3 Drug-Behavioural Interactions............................................................................... 4 Drug-Drug Interactions ..........................................................................................
5 Drug-Food Interactions.......................................................................................... 6 Drug-Herb Interactions .......................................................................................... 7 Drug-Laboratory Test Interactions.........................................................................
23 10 CLINICAL PHARMACOLOGY ........................................................................................ 1 Mechanism of Action............................................................................................. 2 Pharmacodynamics ...............................................................................................
3 Pharmacokinetics .................................................................................................. 25 11 STORAGE, STABILITY AND DISPOSAL .......................................................................... 28 12 SPECIAL HANDLING INSTRUCTIONS ............................................................................
28 PART II: SCIENTIFIC INFORMATION ........................................................................................ 29 13 PHARMACEUTICAL INFORMATION .............................................................................
29 14 CLINICAL TRIALS ......................................................................................................... 1 Clinical Trials by Indication ....................................................................................
3 Comparative Bioavailability Studies ...................................................................... 33 15 MICROBIOLOGY .........................................................................................................
35 16 NON-CLINICAL TOXICOLOGY ...................................................................................... 36 17 SUPPORTING PRODUCT MONOGRAPHS ..................................................................... 40 PATIENT MEDICATION INFORMATION ...................................................................................
41 Product Monograph Page 4 of 48 Sandoz […]