Fixed-dose combination
Drospirenone/ethinyl estradiol/levomefolate and Levomefolate is a fixed-dose combination medicine indicated by females of reproductive potential to prevent pregnancy, among other approved uses. It is available as kits. MedsAcross supplies Drospirenone/ethinyl estradiol/levomefolate and Levomefolate for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium is a combination of drospirenone, a progestin and ethinyl estradiol, an estrogen containing a folate, indicated for use by females of reproductive potential to: • Prevent pregnancy. • Raise folate levels in females of reproductive potential who choose to use an oral contraceptive for contraception.
Source: US FDA prescribing information
COCs lower the risk of becoming pregnant primarily by suppressing ovulation.
Source: US FDA prescribing information
• Take one tablet daily by mouth at the same time every day. • Tablets must be taken in the order directed on the blister pack. How to Take Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium Take one tablet by mouth at the same time every day. The failure rate may increase when pills are missed or taken incorrectly. To achieve maximum contraceptive effectiveness, Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium must be taken as directed, in the order directed on the blister pack. Single missed pills should be taken as soon as remembered.
Source: US FDA prescribing information
Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium is contraindicated in females who are known to have or develop the following conditions: • Renal impairment • Adrenal insufficiency • A high risk of arterial or venous thrombotic diseases.
Source: US FDA prescribing information
Boxed warning (cigarette smoking and serious cardiovascular events): Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs should not be used by women who are over 35 years of age and smoke. • Vascular risks: Stop Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium if a thrombotic event occurs. Stop at least 4 weeks before and through 2 weeks after major surgery. Start no earlier than 4 weeks after delivery, in women who are not breastfeeding. COCs containing DRSP may be associated with a higher risk of venous thromboembolism (VTE) than COCs containing levonorgestrel or some other progestins.
Source: US FDA prescribing information
The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling: • Serious cardiovascular events and stroke • Vascular events • Liver disease The most frequent adverse reactions (≥ 2%) in contraception and folate clinical trials are premenstrual syndrome (12.4%), headache/migraine (10.3%), breast pain/tenderness/discomfort (8.1%), nausea/vomiting (4.4%), mood changes (2.3%) and abdominal pain/tenderness/discomfort (2.2%).
Source: US FDA prescribing information
Consult the labeling of all concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations. Drugs or herbal products that induce certain enzymes (for example, CYP3A4) may decrease the effectiveness of COCs or increase breakthrough bleeding. Counsel patients to use a back-up or alternative method of contraception when enzyme inducers are used with COCs.
Source: US FDA prescribing information
Storage Store at 25°C (77°F), excursions permitted to 15-30°C (59-86°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
3 presentations of Drospirenone/ethinyl estradiol/levomefolate and Levomefolate, sorted by availability.
| Medicine | Active ingredient | Manufacturer | Register | Availability |
|---|---|---|---|---|
| Beyaz kit | Drospirenone/ethinyl estradiol/levomefolate and Levomefolate | Bayer HealthCare Pharmaceuticals | US FDA | Available on request |
| Safyral kit | Drospirenone/ethinyl estradiol/levomefolate and Levomefolate | Bayer HealthCare Pharmaceuticals | US FDA | Available on request |
| Drospirenone/ethinyl estradiol/levomefolate and Levomefolate kitGeneric name | Drospirenone/ethinyl estradiol/levomefolate and Levomefolate | — | US FDA | Available on request |
2 brand names across 1 markets.
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | Not recorded | — |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Yes, on request. MedsAcross lists 3 presentations of Drospirenone/ethinyl estradiol/levomefolate and Levomefolate and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 2 brand names for Drospirenone/ethinyl estradiol/levomefolate and Levomefolate, including Beyaz, Safyral.
No listed presentation of Drospirenone/ethinyl estradiol/levomefolate and Levomefolate is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.