The first proton pump inhibitor to be made available over-the-counter, Prilosec OTC is the #1 Doctor Recommended OTC frequent heartburn medication.†
Prilosec OTC is a great option for your patients with frequent heartburn: Omeprazole delayed-release tablet 20 mg (equivalent to 20.6 mg omeprazole magnesium) is available over-the-counter for frequent heartburn.
Prilosec OTC Clear Labeling
The labeling for Prilosec OTC emphasizes safe and proper use, and studies have proven strong patient compliance and label comprehension.
One tablet per day taken in the morning before eating treats frequent heartburn for 24 hours as part of a 14-day course of treatment.
QD dosing offers convenience and encourages compliance.
Label directions indicate when consumers should see a healthcare professional.
Consumers are advised to take no more than one 14-day course of treatment every four months unless otherwise directed by a physician.
A History of Trust
Omeprazole has been proven safe and well-tolerated in more than 1,350 clinical trials, and the safety of omeprazole magnesium has been confirmed in more than 15 additional OTC clinical trials (n > 18,000).1
Side effects associated with Prilosec OTC are transient and comparable to placebo.1 The most common side effects include headache and diarrhea.
Clinical Study Results
In a head-to-head clinical study, Prilosec OTC® had superior 24-hour acid control vs. Prevacid® 15 mg (OTC)1††
††Relative acid control (mean time pH > 4) does not imply symptom relief. The correlation of pH data to clinical outcome has not been directly established. Measured on Day 5. Not for immediate relief.
More PPIs are becoming available over-the-counter (OTC), so it's important for healthcare professionals to have accurate information and know how OTC products compare to the original Rx PPI. For instance, the tested formulation in the study is lansoprazole 15 mg. It should be noted that lansoprazole 15 mg is the same formulation as Prevacid24HR2.
The study design for our clinical trials was randomized and double-blind.
The primary objective was to compare the 24-hour gastric acid control of omeprazole magnesium 20.6 mg vs. lansoprazole 15 mg at steady state (Day 5).
The primary end point was % of time pH > 4.0 on Day 5.
It should be noted that the tested formulation is lansoprazole 15 mg, which is the same formulation as Prevacid24HR.
Patients taking/who took Prilosec OTC experienced 24% longer acid control vs. Prevacid 15 mg (OTC)1 on average.††
72.5% of patients had greater acid control with Prilosec OTC.1††
Prilosec OTC provided some patients up to 2X longer acid control than Prevacid 15 mg (OTC).1††
1NDA; Data on file. The Procter & Gamble Company and AstraZeneca LP.
2PPIs are not interchangeable. Prescription PPIs and OTC PPIs may differ in dose, indication, duration, efficacy, and directions for use. Use Prilosec OTC as directed for 14 days to treat frequent heartburn. Do not take for more than 14 days or more often than every four months unless directed by a doctor. All patients should talk to their doctor before stopping or starting any medication therapy. Prilosec OTC contains omeprazole-Mg 20.6 mg, equivalent to omeprazole 20 mg, which is the leading dose strength for prescription omeprazole (Prilosec).
3Plavix is a registered trademark of Sanofi.
4Pletal is a registered trademark of Otsuka Pharmaceutical Co.