Drospirenone and Ethinyl Estradiol Kit
🆔 Identity & classification
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
- It's primarily a birth control pill, but it can do more than that. Depending on which brand you have, it may also be approved to treat moderate acne or the emotional and physical s...
- What is this pill actually used for — is it just birth control?
- Take one tablet every day at the same time, following the order printed on your blister pack — the order really matters. If you miss a pill, take it as soon as you remember and kee...
- How do I take this pill and what happens if I miss one?
Patient education
Supplement & herbal interactions
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Where does this data come from?
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Drospirenone and Ethinyl Estradiolthis 61916-0090-30 | Pharmaceutics | 1 kit | — | AB | Discontinued | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 61916-0090-30 You're viewing this | 3 BLISTER PACK in 1 CARTON (61916-090-30) / 1 KIT in 1 BLISTER PACK | 2017-10-26 | Inactivated by FDA |
🧭 About this NDC listing & data coverage
Kit / multi-component package
This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
Why is there no price listed?
What does the discontinued status mean for this NDC?
Is the NDC printed on the package the same as the 11-digit billing NDC?
What do the three segments of this NDC mean?
Who lists this product with the FDA?
Do I need a prescription for this product?
Where does this data come from?
📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
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. [See Contraindications ( 4 )].
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, USP 3 mg/0.02 mg ( 4 ). Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use.
( 4 )
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Drospirenone and Ethinyl Estradiol Tablets, USP 3 mg/0.02 mg are an estrogen/progestin COC, indicated for use by women to: Prevent pregnancy. ( 1.1 ) Treat moderate acne for women at least 14 years old only if the patient desires an oral contraceptive for birth control. ( 1.3 )
1.1Oral Contraceptive Drospirenone and Ethinyl Estradiol Tablets, USP 3 mg/0.02 mg are indicated for use by women to prevent pregnancy.
1.3Acne Drospirenone and Ethinyl Estradiol Tablets, USP 3 mg/0.02 mg are indicated for the treatment of moderate acne vulgaris in women at least 14 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Drospirenone and Ethinyl Estradiol Tablets, USP 3 mg/0.02 mg should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Take one tablet daily by mouth at the same time every day. ( 2.1 ) Tablets must be taken in the order directed on the blister pack. ( 2.1 )
2.1How to Take Drospirenone and Ethinyl Estradiol Tablets, USP 3 mg/0.02 mg 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 and Ethinyl Estradiol Tablets, USP 3 mg/0.02 mg must be taken exactly as directed, in the order directed on the blister pack. Single missed pills should be taken as soon as remembered.
2.2How to Start Drospirenone and Ethinyl Estradiol Tablets, USP 3 mg/0.02 mg Instruct the patient to begin taking Drospirenone and Ethinyl Estradiol Tablets, USP 3 mg/0.02 mg either on the first day of her menstrual period (Day 1 Start) or on the first Sunday after the onset of her menstrual period (Sunday Start). Day 1 Start During the first cycle of Drospirenone and Ethinyl Estradiol Tablets, USP 3 mg/0.02 mg use, instruct the patient to take one pink Drospirenone and Ethinyl Estradiol Tablets, USP 3 mg/0.02 mg daily, beginning on Day 1 of her menstrual cycle.
(The first day of menstruation is Day 1.) She should take one pink Drospirenone and Ethinyl Estradiol Tablets, USP 3 mg/0.02 mg daily for 24 consecutive days, followed by one white inert tablet daily on Days 25 through 28. Drospirenone and Ethinyl Estradiol Tablets, USP 3 mg/0.02 mg should be taken in the order directed on the package at the same time each day, preferably after the evening meal or at bedtime with some liquid, as needed. Drospirenone and Ethinyl Estradiol Tablets, USP 3 mg/0.02 mg can be taken without regard to meals.
If Drospirenone and Ethinyl Estradiol Tablets, USP 3 mg/0.02 mg are first taken later than the first day of the menstrual cycle, Drospirenone and Ethinyl Estradiol Tablets, USP 3 mg/0.02 mg should not be considered effective as a contraceptive until after the first 7 consecutive days of product administration. Instruct the patient to use a non - hormonal contraceptive as back - up during the first 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered.
Sunday Start During the first cycle of Drospirenone and Ethinyl Estradiol Tablets, USP 3 mg/0.02 mg use, instruct the patient to take one pink Drospirenone and Ethinyl Estradiol Tablets, USP 3 mg/0.02 mg daily, beginning on the first Sunday after the onset of her menstrual period. She should take one pink Drospirenone and Ethinyl Estradiol Tablets, USP 3 mg/0.02 mg daily for 24 consecutive days, followed by one white inert tablet daily on Days 25 through 28. Drospirenone and Ethinyl Estradiol Tablets, USP 3 mg/0.02 mg should be taken in the order directed on the package at the same time each day, preferably after the evening meal or at bedtime with some liquid, as needed.
Drospirenone and Ethinyl Estradiol Tablets, USP 3 mg/0.02 mg can be taken without regard to meals. Drospirenone and Ethinyl Estradiol Tablets, USP 3 mg/0.02 mg should not be considered effective as a contraceptive until after the first 7 consecutive days of product administration. Instruct the patient to use a non - hormonal contraceptive as back - up during the first 7 days.
The possibility of ovulation and conception prior to initiation of medication should be considered. The patient should begin her next and all subsequent 28 - day regimens of Drospirenone and Ethinyl Estradiol Tablets, USP 3 mg/0.02 mg on the same day of the week that she began her first regimen, following the same schedule. She should begin taking her pink tablets on the next day after ingestion of the last white tablet, regardless of whether or not a menstrual period has occurred or is still in progress.
Anytime a subsequent cycle of Drospirenone and Ethinyl Estradiol Tablets, USP 3 mg/0.02 mg is started later than the day following administration of the last white tablet, the patient should u…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Drospirenone and Ethinyl Estradiol Tablets, USP 3 mg/0.02 mg are available in blister packs. Each blister pack (28 film - coated tablets) contains in the following order: 24 pink tablets each containing 3 mg drospirenone, USP (DRSP) (micronized) and 0.02 mg ethinyl estradiol, USP (EE) (micronized) 4 white inert tablets Drospirenone and Ethinyl Estradiol Tablets, USP 3 mg/0.02 mg consist of 28 film - coated, biconvex tablets in the following order ( 3 ): 24 pink tablets, each containing 3 mg drospirenone, USP (DRSP) (micronized) and 0.02 mg ethinyl estradiol, USP (EE) (micronized) 4 white inert tablets
⛔ Contraindications ▾
4 CONTRAINDICATIONS Do not prescribe Drospirenone and Ethinyl Estradiol Tablets, USP 3 mg/0.02 mg to women who are known to have the following: Renal impairment Adrenal insufficiency A high risk of arterial or venous thrombotic diseases. Examples include women who are known to: Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions ( 5.1 )] Have deep vein thrombosis or pulmonary embolism, now or in the past [see Warnings and Precautions ( 5.1 )] Have cerebrovascular disease [see Warnings and Precautions ( 5.1 )] Have coronary artery disease [see Warnings and Precautions ( 5.1 )] Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see Warnings and Precautions ( 5.1 )] Have inherited or acquired hypercoagulopathies [see Warnings and Precautions ( 5.1 )] Have uncontrolled hypertension [see Warnings and Precautions ( 5.5 )] Have diabetes mellitus with vascular disease [see Warnings and Precautions ( 5.7 )] Have headaches with focal neurological symptoms or have migraine headaches with or without aura if over age 35 [see Warnings and Precautions ( 5.8 )] Undiagnosed abnormal uterine bleeding [see Warnings and Precautions ( 5.9 )] Breast cancer or other estrogen - or progestin - sensitive cancer, now or in the past [see Warnings and Precautions ( 5.3 )] Liver tumors, benign or malignant, or liver disease [see Warnings and Precautions ( 5.4 ) and Use in Specific Populations ( 8.7 )] Pregnancy, because there is no reason to use COCs during pregnancy [see Warnings and Precautions ( 5.10 ) and Use in Specific Populations ( 8.1 )] Renal impairment ( 4 ) Adrenal insufficiency ( 4 ) A high risk of arterial or venous thrombotic diseases ( 4 ) Undiagnosed abnormal uterine bleeding ( 4 ) Breast cancer or other estrogen - or progestin - sensitive cancer ( 4 ) Liver tumors or liver disease ( 4 ) Pregnancy ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Vascular risks : Stop Drospirenone and Ethinyl Estradiol Tablets, USP 3 mg/0.02 mg 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, USP 3 mg/0.02 mg 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 antimineralocorticoid activity.
Do not use in patients predisposed to hyperkalemia. Check serum potassium concentration during the first treatment cycle in women on long - term treatment with medications that may increase serum potassium concentration. ( 5.2 , 7.1 , 7.2 ) Liver disease : Discontinue Drospirenone and Ethinyl Estradiol Tablets, USP 3 mg/0.02 mg if jaundice occurs.
( 5.4 ) High blood pressure : Do not prescribe Drospirenone and Ethinyl Estradiol Tablets, USP 3 mg/0.02 mg for women with uncontrolled hypertension or hypertension with vascular disease. ( 5.5 ) Carbohydrate and lipid metabolic effects : Monitor prediabetic and diabetic women taking Drospirenone and Ethinyl Estradiol Tablets, USP 3 mg/0.02 mg. Consider an alternative contraceptive method for women with uncontrolled dyslipidemia.
( 5.7 ) Headache : Evaluate significant change in headaches and discontinue Drospirenone and Ethinyl Estradiol Tablets, USP 3 mg/0.02 mg if indicated. ( 5.8 ) Uterine bleeding : Evaluate irregular bleeding or amenorrhea. ( 5.9 )
5.1Thromboembolic Disorders and Other Vascular Problems Stop Drospirenone and Ethinyl Estradiol Tablets, USP 3 mg/0.02 mg if an arterial or venous thrombotic (VTE) event occurs. Based on presently available information on DRSP-containing COCs with 0.03 mg ethinyl estradiol (that is, Yasmin), DRSP-containing COCs may be associated with a higher risk of venous thromboembolism (VTE) than COCs containing the progestin levonorgestrel or some other progestins. Epidemiologic studies that compared the risk of VTE reported that the risk ranged from no increase to a three-fold increase.
Before initiating use of Drospirenone and Ethinyl Estradiol Tablets, USP 3 mg/0.02 mg 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. Known risk factors for VTE include smoking, obesity, and family history of VTE, in addition to other factors that contraindicate use of COCs [see Contraindications ( 4 )]. A number of studies have compared the risk of VTE for users of Yasmin (which contains 0.03 mg of EE and 3 mg of DRSP) to the risk for users of other COCs, including COCs containing levonorgestrel.
Those that were required or sponsored by regulatory agencies are summarized in Table 1 . Table 1: Estimates (Hazard Ratios) of Venous Thromboembolism Risk in Current Users of Yasmin Compared to Users of Oral Contraceptives that Contain Other Progestins Epidemiologic Study (Author, Year of Publication) Population Studied Comparator Product (all are low-dose COCs; with ≤ 0.04 mg of EE) Hazard Ratio (HR) (95% CI) * “New users” – no use of combination hormonal contraception for at least the prior 6 months † Includes low-dose COCs containing the following progestins: norgestimate, norethindrone, levonorgestrel, desogestrel, norgestrel, medroxyprogesterone, or ethynodiol diacetate ‡ Includes low-dose COCs containing the following progestins: levonorgestrel, desogestrel, dienogest, chlomadinone acetate, gestodene, cyproterone acetate, norgestimate, or norethidrone § Includes low-dose COCs containing the following progestins: norgestimate, norethindrone, or levonorgestrel i3 Inge…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS 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 )] Adverse reactions commonly reported by COC users are: Irregular uterine bleeding Nausea Breast tenderness Headache The most frequent adverse reactions (≥ 2%) in contraception and acne clinical trials were: headache/migraine (6.7%), menstrual irregularities (4.7%), nausea/vomiting (4.2%), breast pain/tenderness (4.0%) and mood changes (2.2%).
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Pharmaceutics International, Inc. (Pii) at 1-410-584-0001 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Contraception and Acne Clinical Trials The data provided reflect the experience with the use of Drospirenone and Ethinyl Estradiol Tablets, USP 3 mg/0.02 mg in the adequate and well - controlled studies for contraception (N=1,056) and for moderate acne vulgaris (N=536).
For contraception, a Phase 3, multicenter, multinational, open - label study was conducted to evaluate safety and efficacy up to one year in 1,027 women aged 17 - 36 who took at least one dose of Drospirenone and Ethinyl Estradiol Tablets, USP 3 mg/0.02 mg. A second Phase 3 study was a single center, open - label, active - controlled study to evaluate the effect of 7 28 - day cycles of Drospirenone and Ethinyl Estradiol Tablets, USP 3 mg/0.02 mg on carbohydrate metabolism, lipids and hemostasis in 29 women aged 18 - 35.
For acne, two multicenter, double-blind, randomized, placebo - controlled studies, in 536 women aged 14 - 45 with moderate acne vulgaris who took at least one dose of Drospirenone and Ethinyl Estradiol Tablets, USP 3 mg/0.02 mg, evaluated the safety and efficacy during up to 6 cycles. The adverse reactions seen across the 2 indications overlapped, and are reported using the frequencies from the pooled dataset. The most common adverse reactions (≥ 2% of users) were: headache/migraine (6.7%), menstrual irregularities (including vaginal hemorrhage [primarily spotting] and metrorrhagia (4.7%), nausea/vomiting (4.2%), breast pain/tenderness (4%) and mood changes (mood swings, depression, depressed mood and affect lability) (2.2%).
Adverse Reactions (≥1%) Leading to Study Discontinuation: Contraception Clinical Trials Of 1,056 women, 6.6% discontinued from the clinical trials due to an adverse reaction; the most frequent adverse reactions leading to discontinuation were headache/migraine (1.6%) and nausea/vomiting (1.0%). Acne Clinical Trials Of 536 women, 5.4% discontinued from the clinical trials due to an adverse reaction; the most frequent adverse reaction leading to discontinuation was menstrual irregularities (including menometrorrhagia, menorrhagia, metrorrhagia and vaginal hemorrhage) (2.2%).
Serious Adverse Reactions Contraception Clinical Trials: migraine and cervical dysplasia Acne Clinical Trials : none reported in the clinical trials
6.2Postmarketing Experience The following adverse reactions have been identified during post approval use of Drospirenone and Ethinyl Estradiol Tablets, USP 3 mg/0.02 mg. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Adverse reactions are grouped into System Organ Classes, and ordered by frequency.
Vascular disorders: Venous and arterial thromboembolic events (including pulmonary emboli, deep vein thrombosis, cerebral thrombosis, retinal thrombosi…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS 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.
( 7.1 )
7.1Effects 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, rifampicin, topiramate and products containing St. John's wort.
Interactions between oral contraceptives and other drugs may lead to breakthrough bleeding and/or contraceptive failure. Counsel women to use an alternative method of contraception or a back-up method when enzyme inducers are used with COCs, and to continue back-up contraception for 28 days after discontinuing the enzyme inducer to ensure contraceptive reliability. Substances increasing the plasma concentrations of COCs: Co-administration of atorvastatin and certain COCs containing EE increase AUC values for EE by approximately 20%.
Ascorbic acid and acetaminophen may increase plasma EE concentrations, possibly by inhibition of conjugation. CYP3A4 inhibitors such as itraconazole or ketoconazole may increase plasma hormone concentrations. Concomitant administration of moderate or strong CYP3A4 inhibitors such as azole antifungals (e.g., ketoconazole, itraconazole, voriconazole, fluconazole), verapamil, macrolides (e.g., clarithromycin, erythromycin), diltiazem, and grapefruit juice can increase the plasma concentrations of the estrogen or the progestin or both.
In a clinical drug-drug interaction study conducted in premenopausal women, once daily co-administration of DRSP 3 mg/EE 0.02 mg containing tablets with strong CYP3A4 inhibitor, ketoconazole 200 mg twice daily for 10 days resulted in a moderate increase of DRSP systemic exposure. The exposure of EE was increased mildly [see Warnings and Precautions ( 5.2 ) and Clinical Pharmacology ( 12.3 )]. Human immunodeficiency virus (HIV)/ Hepatitis C virus (HCV) protease inhibitors and non-nucleoside reverse transcriptase inhibitors: Significant changes (increase or decrease) in the plasma concentrations of estrogen and progestin have been noted in some cases of co-administration with HIV/HCV protease inhibitors or with non-nucleoside reverse transcriptase inhibitors.
Antibiotics : There have been reports of pregnancy while taking hormonal contraceptives and antibiotics, but clinical pharmacokinetic studies have not shown consistent effects of antibiotics on plasma concentrations of synthetic steroids.
7.2Effects of Combined Oral Contraceptives on Other Drugs COCs containing EE may inhibit the metabolism of other compounds. COCs have been shown to significantly decrease plasma concentrations of lamotrigine, likely due to induction of lamotrigine glucuronidation. This may reduce seizure control; therefore, dosage adjustments of lamotrigine may be necessary.
Consult the labeling of the concurrently-used drug to obtain further information about interactions with COCs or the potential for enzyme alterations. COCs Increasing the Plasma Concentrations of CYP450 Enzymes: In clinical studies, administration of a hormonal contraceptive containing EE did not lead to any increase or only to a weak increase in plasma concentrations of CYP3A4 substrates (e.g., midazolam) while plasma concentrations of CYP2C19 substrates (e.g., omeprazole and voriconazole) and CYP1A2 substrates (e.g., theophylline and tizanidine) can hav…
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Nursing Mothers: Not recommended; can decrease milk production. ( 8.3 )
8.1Pregnancy There is little or no increased risk of birth defects in women who inadvertently use COCs during early pregnancy. Epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to low dose COCs prior to conception or during early pregnancy. The administration of COCs to induce withdrawal bleeding should not be used as a test for pregnancy.
COCs should not be used during pregnancy to treat threatened or habitual abortion. Women who do not breastfeed may start COCs no earlier than four weeks postpartum.
8.3Nursing Mothers When possible, advise the nursing mother to use other forms of contraception until she has weaned her child. Estrogen-containing COCs can reduce milk production in breastfeeding mothers. This is less likely to occur once breastfeeding is well-established; however, it can occur at any time in some women.
Small amounts of oral contraceptive steroids and/or metabolites are present in breast milk. After oral administration of 3 mg DRSP/0.03 mg EE (Yasmin) tablets, about 0.02% of the DRSP dose was excreted into the breast milk of postpartum women within 24 hours. This results in a maximal daily dose of about 0.003 mg DRSP in an infant.
8.4Pediatric Use Safety and efficacy of Drospirenone and Ethinyl Estradiol Tablets, USP 3 mg/0.02 mg has been established in women of reproductive age. Efficacy is expected to be the same for postpubertal adolescents under the age of 18 and for users 18 years and older. Use of this product before menarche is not indicated.
8.5Geriatric Use Drospirenone and Ethinyl Estradiol Tablets, USP 3 mg/0.02 mg have not been studied in postmenopausal women and is not indicated in this population.
8.6Patients with Renal Impairment Drospirenone and Ethinyl Estradiol Tablets, USP 3 mg/0.02 mg are contraindicated in patients with renal impairment [ see Contraindications ( 4 ) and Warnings and Precautions ( 5.2 ) ]. In subjects with creatinine clearance (CLcr) of 50–79 mL/min, serum DRSP levels were comparable to those in a control group with CLcr ≥ 80 mL/min. In subjects with serum DRSP concentrations were on average 37% higher than those in the control group.
In addition, there is a potential to develop hyperkalemia in subjects with renal impairment whose serum potassium is in the upper reference range, and who are concomitantly using potassium sparing drugs [see Clinical Pharmacology ( 12.3 )] .
8.7Patients with Hepatic Impairment Drospirenone and Ethinyl Estradiol Tablets, USP 3 mg/0.02 mg is contraindicated in patients with hepatic disease [ see Contraindications ( 4 ) and Warnings and Precautions ( 5.4 )] . The mean exposure to DRSP in women with moderate liver impairment is approximately three times higher than the exposure in women with normal liver function. Drospirenone and Ethinyl Estradiol Tablets, USP 3 mg/0.02 mg has not been studied in women with severe hepatic impairment.
8.8Race No clinically significant difference was observed between the pharmacokinetics of DRSP or EE in Japanese versus Caucasian women [see Clinical Pharmacology ( 12.3 )] .
🤰 Pregnancy ▾
8.1Pregnancy There is little or no increased risk of birth defects in women who inadvertently use COCs during early pregnancy. Epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to low dose COCs prior to conception or during early pregnancy. The administration of COCs to induce withdrawal bleeding should not be used as a test for pregnancy.
COCs should not be used during pregnancy to treat threatened or habitual abortion. Women who do not breastfeed may start COCs no earlier than four weeks postpartum.
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and efficacy of Drospirenone and Ethinyl Estradiol Tablets, USP 3 mg/0.02 mg has been established in women of reproductive age. Efficacy is expected to be the same for postpubertal adolescents under the age of 18 and for users 18 years and older. Use of this product before menarche is not indicated.
🧓 Geriatric Use ▾
8.5Geriatric Use Drospirenone and Ethinyl Estradiol Tablets, USP 3 mg/0.02 mg have not been studied in postmenopausal women and is not indicated in this population.
🆘 Overdosage ▾
10 OVERDOSAGE There have been no reports of serious ill effects from overdose, including ingestion by children. Overdosage may cause withdrawal bleeding in females and nausea. DRSP is a spironolactone analogue which has anti-mineralocorticoid properties. Serum concentration of potassium and sodium, and evidence of metabolic acidosis, should be monitored in cases of overdose.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action COCs lower the risk of becoming pregnant primarily by suppressing ovulation. Other possible mechanisms may include cervical mucus changes that inhibit sperm penetration and the endometrial changes that reduce the likelihood of implantation.
12.2Pharmacodynamics Drospirenone is a spironolactone analogue with anti-mineralocorticoid and antiandrogenic activity. The estrogen in Drospirenone and Ethinyl Estradiol Tablets, USP 3 mg/0.02 mg is ethinyl estradiol. Contraception Two studies evaluated the effect of 3 mg DRSP / 0.02 mg EE combinations on the suppression of ovarian activity as assessed by measurement of follicle size via transvaginal ultrasound and serum hormone (progesterone and estradiol) analyses during two treatment cycles (21-day active tablet period plus 7-day pill-free period).
More than 90% of subjects in these studies demonstrated ovulation inhibition. One study compared the effect of 3 mg DRSP/0.02 mg EE combinations with two different regimens (24-day active tablet period plus 4-day pill-free period vs. 21-day active tablet period plus 7-day pill-free period) on the suppression of ovarian activity during two treatment cycles.
During the first treatment cycle, there were no subjects (0/49, 0%) taking the 24-day regimen who ovulated compared to 1 subject (1/50, 2%) using the 21-day regimen. After intentionally introduced dosing errors (3 missed active tablets on Days 1 to 3) during the second treatment cycle, there was 1 subject (1/49, 2%) taking the 24-day regimen who ovulated compared to 4 subjects (4/50, 8%) using the 21-day regimen. Acne Acne vulgaris is a skin condition with a multifactorial etiology including androgen stimulation of sebum production.
While the combination of EE and DRSP increases sex hormone binding globulin (SHBG) and decreases free testosterone, the relationship between these changes and a decrease in the severity of facial acne in otherwise healthy women with this skin condition has not been established. The impact of the antiandrogenic activity of DRSP on acne is not known.
12.3Pharmacokinetics Absorption The absolute bioavailability of DRSP from a single entity tablet is about 76%. The absolute bioavailability of EE is approximately 40% as a result of presystemic conjugation and first-pass metabolism. The absolute bioavailability of Drospirenone and Ethinyl Estradiol Tablets, USP 3mg/0.02 mg , which are a combination tablet of DRSP and EE stabilized by betadex as a clathrate (molecular inclusion complex), has not been evaluated.
The bioavailability of EE is similar when dosed via a betadex clathrate formulation compared to when it is dosed as a free steroid. Serum concentrations of DRSP and EE reached peak levels within 1 to 2 hours after administration of Drospirenone and Ethinyl Estradiol Tablets, USP 3mg/0.02 mg. The pharmacokinetics of DRSP are dose proportional following single doses ranging from 1 to 10 mg.
Following daily dosing of Drospirenone and Ethinyl Estradiol Tablets, USP 3mg/0.02 mg, steady state DRSP concentrations were observed after 8 days. There was about 2 to 3 fold accumulation in serum C max and AUC (0–24h) values of DRSP following multiple dose administration of Drospirenone and Ethinyl Estradiol Tablets, USP 3 mg/0.02 mg (see Table 2 ). For EE, steady-state conditions are reported during the second half of a treatment cycle.
Following daily administration of Drospirenone and Ethinyl Estradiol Tablets, USP 3mg/0.02 mg, serum C max and AUC (0–24h) values of EE accumulate by a factor of about 1.5 to 2 (see Table 2 ). Table 2: Table of Pharmacokinetic Parameters of Drospirenone and Ethinyl Estradiol Tablets, USP 3mg/0.02 mg (DRSP 3 mg and EE 0.02 mg) a) geometric mean (geometric coefficient of variation) b) median (range) c) NA = Not available DRSP Cycle / Day No. of Subjects C max a (ng/mL) T max b (h) AUC (0-24h) a (ng•h/mL) t 1/2 a (h) 1/1 23 38.4 (25) 1.5 (1 - 2) 268 (19) NA c 1/21 23 70.3 (15) 1.5 (1 - 2) 763 (…
🧬 Mechanism of Action ▾
12.1Mechanism of Action COCs lower the risk of becoming pregnant primarily by suppressing ovulation. Other possible mechanisms may include cervical mucus changes that inhibit sperm penetration and the endometrial changes that reduce the likelihood of implantation.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1How Supplied Drospirenone and Ethinyl Estradiol Tablets, USP 3 mg/0.02 mg are available in packages of three blister packs (NDC 61916 - 090 - 30). The film - coated tablets are rounded with “P” debossed on one side. Each blister pack (28 film - coated tablets) contains in the following order: 24 active pink round, unscored, film - coated tablets debossed with a "P" on one side, each containing 3 mg drospirenone, USP (micronized) and 0.02 mg ethinyl estradiol, USP (micronized) 4 inert white round, unscored, film - coated tablets.
16.2Storage Store at 25°C (77°F); excursions permitted to 15-30°C (59 - 86°F) [see USP Controlled Room Temperature].
📦 Storage and Handling ▾
16.2Storage Store at 25°C (77°F); excursions permitted to 15-30°C (59 - 86°F) [see USP Controlled Room Temperature].
📋 Description ▾
11 DESCRIPTION Drospirenone and Ethinyl Estradiol Tablets, USP 3 mg/0.02 mg provide an oral contraceptive regimen consisting of 24 pink active film - coated tablets each containing 3 mg of drospirenone, USP (micronized) and 0.02 mg of ethinyl estradiol, USP (micronized) and 4 white inert film coated tablets. The inactive ingredients in the pink tablets are lactose monohydrate NF, corn starch NF, magnesium stearate NF, povidone USP, Hypromellose, USP, Titanium Dioxide, USP, polyethylene glycol 400 and Ferric oxide red.
The white inert film-coated tablets contain lactose monohydrate NF, corn starch NF, povidone USP, magnesium stearate NF, polyvinyl alcohol, titanium dioxide, USP, talc, USP, and polyethylene glycol 4000 . Drospirenone (6R,7R,8R,9S,10R,13S,14S,15S,16S,17S) - 1,3',4',6,6a,7,8,9,10,11, 12,13,14,15,15a,16 - hexadecahydro - 10,13 - dimethylspiro - [17H-dicyclopropa - [6,7:15,16] cyclopenta [a]phenanthrene - 17,2'(5H)-furan] - 3,5'(2H) - dione) is a synthetic progestational compound and has a molecular weight of 366.5 and a molecular formula of C 24 H 30 O 3 .
Ethinyl estradiol (19 - nor - 17α-pregna 1, 3, 5(10) - triene - 20 - yne - 3, 17-diol) is a synthetic estrogenic compound and has a molecular weight of 296.4 and a molecular formula of C 20 H 24 O 2 . The structural formulas are as follows: "USP Dissolution Test Pending" Figure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION See “FDA-approved patient labeling ( Patient Information ).” Counsel patients that cigarette smoking increases the risk of serious cardiovascular events from COC use, and that women who are over 35 years old and smoke should not use COCs. Counsel patients that the increased risk of VTE compared to non-users of COCs is greatest after initially starting a COC or restarting (following a 4-week or greater pill-free interval) the same or a different COC. Counsel patients about the information regarding the risk of VTE with DRSP-containing COCs compared to COCs that contain levonorgestrel or some other progestins.
Counsel patients that Drospirenone and Ethinyl Estradiol Tablets, USP 3 mg/0.02 mg do not protect against HIV-infection (AIDS) and other sexually transmitted diseases. Counsel patients on Warnings and Precautions associated with COCs. Counsel patients that Drospirenone and Ethinyl Estradiol Tablets, USP 3 mg/0.02 mg contain DRSP.
Drospirenone may increase potassium. Patients should be advised to inform their healthcare provider if they have kidney, liver or adrenal disease because the use of Drospirenone and Ethinyl Estradiol Tablets, USP 3 mg/0.02 mg in the presence of these conditions could cause serious heart and health problems. They should also inform their healthcare provider if they are currently on daily, long-term treatment (NSAIDs, potassium-sparing diuretics, potassium supplementation, ACE inhibitors, angiotensin-II receptor antagonists, heparin or aldosterone antagonists) for a chronic condition.
Inform patients that Drospirenone and Ethinyl Estradiol Tablets, USP 3 mg/0.02 mg are not indicated during pregnancy. If pregnancy occurs during treatment with Drospirenone and Ethinyl Estradiol Tablets, USP 3 mg/0.02 mg, instruct the patient to stop further intake. Counsel patients to take one tablet daily by mouth at the same time every day.
Instruct patients what to do in the event pills are missed. See “ What to Do if You Miss Pills ” section in FDA-Approved Patient Labeling . Counsel patients to use a back-up or alternative method of contraception when enzyme inducers are used with COCs.
Counsel patients who are breastfeeding or who desire to breastfeed that COCs may reduce breast milk production. This is less likely to occur if breastfeeding is well established. Counsel any patient who starts COCs postpartum, and who has not yet had a period, to use an additional method of contraception until she has taken a pink tablet for 7 consecutive days.
Counsel patients that amenorrhea may occur. Rule out pregnancy in the event of amenorrhea in two or more consecutive cycles. Manufactured by: Pharmaceutics International, Inc.
(Pii) Hunt Valley, MD 21031 USA Pii Logo