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HEARTBURN CONTROL 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: HEARTBURN CONTROL (Omeprazole delayed-release capsules) capsules are indicated for: • the treatment of frequent heartburn. Frequent heartburn is heartburn that occurs 2 or more days a week. HEARTBURN CONTROL capsules are not indicated for infrequent heartburn (i.e. one episode of heartburn a week or less) or immediate…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • Patients should use the lowest dose and shortest duration of Proton Pump Inhibitor (PPI) therapy appropriate to the condition being treated. • Concomitant use of omeprazole and clopidogrel should be avoided.
4 Drug-Drug Interactions, Clopidogrel. , for heartburn that occurs more than 2 days a week). The maximum dose is 1 capsule in a 24-hour period. Symptom relief should be rapid. If symptom control is HEARTBURN CONTROL (Omeprazole Delayed Release Capsules) Page 5 of 45 not achieved after 2 weeks, further investigation is recommended.
• A 14-day course of therapy may be repeated every 4 months. • Patients with Renal Impairment: No dose adjustment is required. See 7 WARNINGS AND PRECAUTIONS, Renal. • Patients with Hepatic Impairment: No dose adjustment is required. The maximum daily dose (20 mg) should not be exceeded.
See 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic. • Geriatrics (>65 years of age): No dose adjustment is required. The maximum daily dose (20 mg) should not be exceeded. 4 Geriatrics. 4 Administration The capsules should be swallowed whole with sufficient water.
The capsules must not be chewed or crushed. 5 Missed Dose If you miss a dose of HEARTBURN CONTROL and remember within 12 hours, take it as soon as possible. Then go back to your regular schedule. However, if more than 12 hours have passed when you remember, do not take the missed capsule.
Do not double the dose. Just take your next dose on time.
Renal Acute tubulointerstitial nephritis (TIN) has been observed in patients taking omeprazole and may occur at any point during omeprazole therapy. Acute tubulointerstitial nephritis can HEARTBURN CONTROL (Omeprazole Delayed Release Capsules) Page 9 of 45 progress to renal failure.
Omeprazole should be discontinued in case of suspected TIN, and appropriate treatment should be promptly initiated. 5 Post-Market Adverse Reactions.
Renal Impairment:
Information on the bioavailability of omeprazole 20 mg capsules in patients with renal insufficiency is not currently available. v. administration of omeprazole and oral administration of omeprazole capsules, the disposition of intact omeprazole is unchanged in patients with impaired renal function, and no dose adjustment is needed in these patients.
2 Recommended Dose and Dosage Adjustment.
Reproductive Health:
Female and Male Potential • Fertility In animal studies, fertility and reproductive performance were not affected. See 16 NON- CLINICAL TOXICOLOGY, Reproductive and Developmental Toxicity. • Teratogenic Risk There was no evidence of teratogenicity following administration of omeprazole to pregnant rats and rabbits during the period of organogenesis.
See 16 NON-CLINICAL TOXICOLOGY, Reproductive and Developmental Toxicity. 1 Pregnant Women The safety of omeprazole in pregnancy has not been established. HEARTBURN CONTROL capsules should not be administered to pregnant women unless the expected benefits outweigh the potential risks.
2 Breast-feeding Omeprazole is secreted in human milk. HEARTBURN CONTROL capsules should not be given to breastfeeding mothers unless its use is considered essential. 3 Pediatrics Pediatrics (<18 years of age): The safety and effectiveness of omeprazole delayed-release capsules in children have not yet been established.
4 Geriatrics 04/2024 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 ....................................................................................................................... 9 8 ADVERSE REACTIONS .......................................................................................................
1 Adverse Reaction Overview ........................................................................................ 2 Clinical Trial Adverse Reactions ...................................................................................
Omeprazole delayed-release capsules are contraindicated in: • Patients who have hypersensitivity to this drug, 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. • Co-administration with rilpivirine due to significant decrease in rilpivirine exposure and loss of therapeutic effect. 4 Drug-Drug Interactions, Rilpivirine.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Omeprazole in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Omeprazole capsules should not be used in children under 18 years of age. 0 hour). The dose in elderly patients should not exceed the maximum daily dose (20 mg). 2 Recommended Dose and Dosage Adjustment. HEARTBURN CONTROL (Omeprazole Delayed Release Capsules) Page 10 of 45 Geriatrics (>71 years of age): Benefits of use of PPIs should be weighed against the increased risk of fractures as patients in this category may already be at high risk for osteoporosis-related fractures.
If the use of PPIs is required, they should be managed carefully according to established treatment guidelines. 5 Post-Market Adverse Reactions. 1 Adverse Reaction Overview Omeprazole is well tolerated. Most adverse reactions have been mild and transient, and have shown no consistent relationship with treatment.
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. Adverse events have been recorded during 6 placebo-controlled clinical investigations of OTC omeprazole involving 6,286 subjects who took omeprazole (3,146 on omeprazole 20 mg and 3,139 on omeprazole 10 mg) and 3,120 subjects who took placebo.
The most commonly reported adverse events in the omeprazole 20 mg group were headache (3%), diarrhea (2%) and infection (2%). These incidences were not significantly greater than those observed in subjects treated with placebo. 6%), and were primarily due to nausea, headache, vomiting, diarrhea and/or abdominal pain.
1% for placebo subjects. No SAE reported by subjects receiving omeprazole 20 mg was considered to be possibly or probably related to study medication. The following is a list of adverse events reported in clinical trials or reported from routine post-marketing surveillance of short term and chronic use of omeprazole.
Events are classified within body system categories. The following definitions of frequencies are used: common: ≥1/100; uncommon: ≥1/1,000 and <1/100, rare: ≥1/10,000 and <1/1,000 and very rare: <1/10,000. Blood and lymphatic system disorders Rare: leukopenia, thrombocytopenia, agranulocytosis and pancytopenia.
Very rare: aplastic anemia and bone marrow suppression. Cardiac disorders Very rare: serious arrhythmia (increased QT interval, torsade de pointes, ventricular fibrillation, ventricular tachycardia). Ear and labyrinth disorders Very rare: tinnitus, vertigo, hearing loss and ear pain.
Eye disorders Rare: blurred vision Very rare: eye pain, papilledema, optic atrophy. […]
5 Post-Market Adverse Reactions .................................................................................. 13 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 .............................................................................. 20 10 CLINICAL PHARMACOLOGY ..............................................................................................
1 Mechanism of Action .................................................................................................. 2 Pharmacodynamics .....................................................................................................
3 Pharmacokinetics ........................................................................................................ 22 11 STORAGE, STABILITY AND DISPOSAL ................................................................................
25 12 SPECIAL HANDLING INSTRUCTIONS.................................................................................. 25 PART II: SCIENTIFIC INFORMATION .........................................................................................
26 13 PHARMACEUTICAL INFORMATION................................................................................... 26 14 CLINICAL TRIALS ...............................................................................................................
1 Clinical Trials by Indication .......................................................................................... 2 Comparative Bioavailability Studies ............................................................................
27 15 MICROBIOLOGY ............................................................................................................... 30 16 NON-CLINICAL TOXICOLOGY […]