1. What is FDA announcing today?
2. What is Prilosec OTC used to treat?
3. How does Prilosec OTC work?
4. Will Prilosec OTC work as well as the prescription strength Prilosec?
5. How is Prilosec OTC taken?
6. If Prilosec OTC takes a few days to take effect, can I take more each day to make it work faster?
7. Who should take prescription strength Prilosec rather than Prilosec OTC?
8. Who should NOT take Prilosec OTC?
9. Does Prilosec OTC interact with food or other drugs?
10. How is Prilosec OTC different from the other OTC treatments for heartburn?
11. What are some possible side effects of Prilosec OTC?
12. How can I report a side effect with Prilosec OTC to the FDA?
13. When will Prilosec OTC be available?
14. What if I have other questions about Prilosec OTC?
The FDA is announcing the approval of Prilosec OTC (omeprazole) as an over-the-counter (OTC) drug product. Until today, Prilosec was available only with a doctor’s prescription. FDA originally approved prescription Prilosec in 1989.
Prilosec OTC is used to treat frequent heartburn. Heartburn occurs when the stomach contents back up and out of the stomach into the esophagus (the tube that connects the throat to the stomach). Frequent heartburn is when you have heartburn 2 or more days a week.
Prilosec OTC is not the right medicine for you if you have occasional heartburn, one episode of heartburn a week or less, or if you want immediate relief of heartburn.
It is very important that you carefully read and understand the Prilosec OTC label directions, warnings, and side effects. Most importantly, the label will tell you when you should seek medical attention instead of taking Prilosec OTC.
Prilosec OTC stops the stomach from making acid. This causes less heartburn.
Both prescription Prilosec and Prilosec OTC contain the same active ingredient, omeprazole, which effectively stops acid production. Prescription Prilosec treats diseases that require diagnosis and supervision by a doctor. Prilosec OTC treats only symptoms of frequent heartburn. Used as directed, Prilosec OTC will not treat the conditions that prescription Prilosec treats.
Prilosec OTC is a delayed-release 20mg tablet, taken once a day (every 24 hours) for 14 days before eating. You should not take it for more than 14 days or repeat a 14-day course more often than every 4 months unless directed by a doctor.
Do not crush, break, or chew the tablet. This decreases how well Prilosec OTC works in the body.
No. Prilosec OTC is not intended for immediate relief of occasional heartburn. Prilosec OTC may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours.
Although the two products contain omeprazole, prescription Prilosec is for treating conditions such as inflammation of the esophagus (esophagitis), ulcers, and other medical conditions for which a doctor’s supervision is needed.
For this reason, stop taking Prilosec OTC and tell your doctor if you:
• are not feeling better and your heartburn continues to worsen
• need to take this product for more than 14 days
• need to take more than 1 course of treatment every 4 months
Prilosec OTC is not appropriate for adults who:
• have only occasional heartburn
• have one episode of heartburn a week or less
• want immediate relief of heartburn
Do not take Prilosec OTC if you have:
• had an allergic reaction to Prilosec in the past
• trouble or pain swallowing food
• vomiting with blood
• bloody or black stools
When you are taking Prilosec OTC, it is especially important that your health care provider know if you are taking any of the following:
• warfarin (blood-thinning medicine)
• prescription antifungal or anti-yeast medicines
• diazepam (anxiety medicine)
• digoxin (heart medicine)
There are other OTC drug products used to provide immediate relief for heartburn. These include antacids and acid reducer drug products such as Pepcid, Zantac, Tagamet, and Axid. Prilosec OTC should not be confused with these products because it works differently and is not intended for immediate relief.
Although side effects from Prilosec OTC are not common, they can occur. Tell your doctor if any of these symptoms are severe or do not go away:
• upset stomach
• stomach pain
• cold symptoms
You can report a side effect the following ways:
• Visit www.fda.gov/medwatch and click on "How to Report"
• Call 1 - 800-FDA-1088
• Fax 1 - 800-FDA-0178
The company marketing Prilosec OTC makes the decision on availability. For further information, please contact the manufacturer, Procter and Gamble, directly.
If you have further questions regarding Prilosec OTC or any medications, please contact the Center for Drug's Division of Drug Information at: 888-INFOFDA (888-463-6332), or email us at: firstname.lastname@example.org.