Drospirenone-Ethinyl Estradiol — Discount Pricing

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What Drospirenone-Ethinyl Estradiol is approved for (FDA label)

Drospirenone and ethinyl estradiol tablet USP is a combination of drospirenone, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. ( 1 ) Drospirenone and ethinyl estradiol tablet USP is indicated for use by females of reproductive potential to prevent pregnancy.

Source: Read the full FDA label on DailyMed. Label effective date: July 30, 2026.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Boxed warning for Drospirenone-Ethinyl Estradiol (FDA label)

WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS See full prescribing information for complete boxed warning. Women over 35 years old who smoke should not use drospirenone and ethinyl estradiol tablets. ( 4 ) Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. ( 4 ) 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 [see CONTRAINDICATIONS ( 4 )]. WARNING TO WOMEN WHO SMOKE Do not use drospirenone and ethinyl estradiol tablets if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects (heart and blood vessel problems) from birth control pills, including death from heart attack, blood clots or stroke. This risk increases with age and the number of cigarettes you smoke.

Source: FDA prescribing information (DailyMed). Set ID: 57d1d945-9fc9-4e79-e063-6294a90a738a. SPL document ID: 57d1d72f-b7f6-49ca-e063-6294a90a5d7e. Label effective date: July 30, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Dosage forms and strengths for Drospirenone-Ethinyl Estradiol (FDA label)

Drospirenone and ethinyl estradiol tablets consists of 28, biconvex tablets in the following order (3): 21 yellow film-coated tablets, each containing 3 mg drospirenone (DRSP) and 0.03 mg ethinyl estradiol (EE), 7 inert white to off-white tablets Drospirenone and ethinyl estradiol tablets, 3 mg and 0.03 mg are available in blister packs. Each blister pack contains 28, round, bi-convex tablets in the following order: 21 yellow colored, round, biconvex, film-coated tablets, debossed with 'LU' on one side and 'K32' on the other side each containing 3 mg drospirenone and 0.03 mg ethinyl estradiol 7 inert white to off-white round, biconvex tablets, debossed with "K33" on one side and 'LU' on the other side

Source: FDA prescribing information (DailyMed). Set ID: 57d1d945-9fc9-4e79-e063-6294a90a738a. SPL document ID: 57d1d72f-b7f6-49ca-e063-6294a90a5d7e. Label effective date: July 30, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Adverse reactions for Drospirenone-Ethinyl Estradiol (FDA label)

The most frequent adverse reactions (≥ 2%) are premenstrual syndrome (13.2%), headache /migraine (10.7%), breast pain/tenderness/discomfort (8.3%), nausea/vomiting (4.5%), abdominal pain/tenderness/discomfort (2.3%), mood changes (2.3%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals Inc. at 1-800-399-2561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling: Serious cardiovascular events and stroke [see BOXED WARNING and WARNINGS AND PRECAUTIONS ( 5.1 ) ] Vascular events [see WARNINGS AND PRECAUTIONS ( 5.1 ) ] Liver disease [see WARNINGS AND PRECAUTIONS ( 5.4 ) ] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in practice. The data provided reflect the experience with the use of drospirenone and ethinyl estradiol tablets (3 mg DRSP/0.03 mg EE) in the adequate and well-controlled studies for contraception (N=2,837). The US pivotal clinical study (N=326) was a multicenter, open-label trial in healthy women aged 18 to 35 who were treated for up to 13 cycles. The second pivotal study (N=442)was a multicenter, randomized, open-label comparative European study of drospirenone and ethinyl estradiol tablets vs. 0.150 mg desogestrel/0.03 mg EE conducted in healthy women aged 17 to 40 who were treated for up to 26 cycles. The most common adverse reactions (≥ 2% of users) were: premenstrual syndrome (13.2%), headache/migraine (10.7%), breast pain/tenderness/discomfort (8.3%), nausea/vomiting (4.5%) abdominal pain/discomfort/tenderness (2.3%) and mood changes (depression, depressed mood, irritability, mood swings, mood altered and affect lability (2.3%).

Source: FDA prescribing information (DailyMed). Set ID: 57d1d945-9fc9-4e79-e063-6294a90a738a. SPL document ID: 57d1d72f-b7f6-49ca-e063-6294a90a5d7e. Label effective date: July 30, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Contraindications for Drospirenone-Ethinyl Estradiol (FDA label)

Renal impairment ( 4 ) Adrenal insufficiency ( 4 ) A high risk of arterial or venous thrombotic diseases ( 4 ) Undiagnosed abnormal uterine bleeding ( 4 ) Breast cancer ( 4 ) Liver tumors or liver disease ( 4 ) Co-administration with Hepatitis C drug combinations containing ombitasvir, paritaprevir/ritonavir, with or without dasabuvir ( 4 ) Drospirenone and ethinyl estradiol tablet 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: FDA prescribing information (DailyMed). Set ID: 57d1d945-9fc9-4e79-e063-6294a90a738a. SPL document ID: 57d1d72f-b7f6-49ca-e063-6294a90a5d7e. Label effective date: July 30, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Warnings and precautions for Drospirenone-Ethinyl Estradiol (FDA label)

Vascular risks : Stop drospirenone and ethinyl estradiol tablets 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. ( 5.1 ) COCs containing DRSP may be associated with a higher risk of venous thromboembolism (VTE) than COCs containing levonorgestrel or some other progestins. Before initiating drospirenone and ethinyl estradiol tablets in a new COC user or a woman who is switching from a contraceptive that does not contain DRSP, consider the risks and benefits of a DRSP-containing COC in light of her risk of a VTE. ( 5.1 ) Hyperkalemia : DRSP has anti-mineralocorticoid activity. Do not use in patients predisposed to hyperkalemia.

Source: FDA prescribing information (DailyMed). Set ID: 57d1d945-9fc9-4e79-e063-6294a90a738a. SPL document ID: 57d1d72f-b7f6-49ca-e063-6294a90a5d7e. Label effective date: July 30, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Drug interactions for Drospirenone-Ethinyl Estradiol (FDA label)

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. ( 7.1 ) Consult the labeling of all concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations. 7.1 Effects of Other Drugs on Combined Oral Contraceptives Substances Diminishing the Efficacy of COCs Drugs or herbal products that induce certain enzymes, including cytochrome P450 3A4 (CYP3A4), may decrease the effectiveness of COCs or increase breakthrough bleeding. Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampin, topiramate and products containing St. John's wort. Interactions between oral contraceptives and other drugs may lead to breakthrough bleeding and/or contraceptive failure.

Source: FDA prescribing information (DailyMed). Set ID: 57d1d945-9fc9-4e79-e063-6294a90a738a. SPL document ID: 57d1d72f-b7f6-49ca-e063-6294a90a5d7e. Label effective date: July 30, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.