Drug Information: Dosage, effects, applications, and other details
Introducing Opill: The First Over-the-Counter Oral Birth Control Pill in the U.S.
In a significant leap forward for women's health, Opill, the first over-the-counter (OTC) oral birth control pill in the United States, was approved by the Food and Drug Administration (FDA) in July 2023. The drug is expected to be available for purchase in stores and online from April 2024[4].
Opill, a progestin-only pill, does not contain estrogen and is 91% effective at preventing pregnancy[1]. This means that women now have a new, convenient option for birth control without the need for a prescription.
How to Use Opill
Opill is taken once per day for pregnancy prevention, and for 48 hours after the first dose, a barrier method of birth control should be used during sexual activity[2]. It can be taken with or without food, and it's recommended to take it at the same time each day, within 3 hours of the same time[3].
If a dose is missed, take it as soon as remembered, but for 48 hours after a missed dose, a barrier method of birth control should be used during sexual activity[2].
Safety and Side Effects
Opill is considered safe to take while breastfeeding, but it's still important to consult a doctor[5]. However, like any medication, Opill may cause mild or serious side effects. Some common side effects include abdominal pain, bloating or cramps, dizziness, headache, increased appetite, nausea, bleeding, spotting, or changes in periods[6].
In rare cases, a more severe allergic reaction is possible, and if it occurs, call your doctor right away or call 911 if symptoms feel life-threatening[6]. Opill may also interact with certain seizure drugs, antibiotics, bosentan, efavirenz, ella (morning-after pill), St. John's wort, and other medications and supplements[7].
Opill is not safe to take during pregnancy as it increases the risk of an ectopic pregnancy[8]. If more than the recommended dose of Opill is taken, call the doctor or America's Poison Centers at 800-222-1222[9].
Availability and Cost
Opill is now widely accessible at pharmacies and online retailers across the U.S.[4]. The cost of Opill can vary depending on your insurance plan, location, and pharmacy[10]. For financial and insurance assistance with Opill, help is available[11].
Conclusion
The arrival of Opill marks a major milestone in women's health, offering improved access to birth control without the need for a prescription. As always, it's important to consult with a healthcare professional before starting any new medication, and to be aware of potential side effects and interactions.
For more information about the possible side effects of Opill, talk with your doctor or pharmacist, or view Opill's label information. If you would like to notify the FDA about a side effect you've had with Opill, you can do so through MedWatch[12].
[1] FDA News Release: FDA approves first over-the-counter oral contraceptive pill, Phexxi. (2023, July 7). Retrieved from https://www.fda.gov/news-events/press-announcements/fda-approves-first-over-the-counter-oral-contraceptive-pill-phexxi
[2] Opill (norgestrel tablets) US prescribing information. (2023, July). Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211372Orig1s000lbl.pdf
[3] Opill (norgestrel tablets) US patient medication guide. (2023, July). Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211372s000lbl.pdf
[4] Opill (norgestrel tablets) [prescribing information]. (2024, April). Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/211372s000lbl.pdf
[5] Opill (norgestrel tablets) US patient medication guide. (2023, July). Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211372s000lbl.pdf
[6] Opill (norgestrel tablets) US prescribing information. (2023, July). Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211372Orig1s000lbl.pdf
[7] Opill (norgestrel tablets) US prescribing information. (2023, July). Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211372Orig1s000lbl.pdf
[8] Opill (norgestrel tablets) US prescribing information. (2023, July). Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211372Orig1s000lbl.pdf
[9] Opill (norgestrel tablets) US patient medication guide. (2023, July). Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211372s000lbl.pdf
[10] Opill (norgestrel tablets) US patient medication guide. (2023, July). Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211372s000lbl.pdf
[11] Opill Financial and Insurance Assistance. (n.d.). Retrieved from https://www.opill.com/financial-and-insurance-assistance
[12] MedWatch: The FDA Safety Information and Adverse Event Reporting Program. (n.d.). Retrieved from https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program
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