Lo-Zumandimine Drospirenone and Ethinyl Estradiol Kit, 3 pouches — NDC 59651-029-88 (Billing 59651-0029-88)
This is a package of 3 pouches of Lo-Zumandimine Drospirenone and Ethinyl Estradiol Kit from Aurobindo Pharma Limited, marketed since Feb 2018 and currently FDA-listed; retail pharmacies pay about $0.1909 per pouche (NADAC). It is the main listing for this product, which comes in 2 package sizes.
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 060548
- GCN: 26737
- GPI-14 (Medi-Span): 25990002150316
- HICL (First Databank): 022026
- AHFS class code: 68:12.00.00
- RxCUI (RxNorm): 630734
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Progestin class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
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?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.191 | $0.57 / 3 kit |
| Medicaid paysCMS SDUD · 12 mo | $0.3595 | $1.08 / 3 kit |
| 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?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 59651-0029-87 59651-029-87 | 1 POUCH in 1 CARTON / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK | — | — | 2018-02-27 | — | Active |
| 59651-0029-88 You're viewing this Main listing | 3 POUCH in 1 CARTON / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK | $0.1909 / ea | $0.57 | 2018-02-27 | — | Active |
In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in this package?
How does this package differ from NDC 59651-0029-87?
What NDC number is used to bill for this package of Lo-Zumandimine Drospirenone and Ethinyl Estradiol Kit?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Drospirenone And Ethinyl Estradiol 00378-7300-53 | Mylan | 3 pouches | $0.149 | AB | Availability likely | save 22% |
| Drospirenone and Ethinyl Estradiol 31722-0945-31 | Camber | 1 kit | $0.151 | AB | Availability likely | save 21% |
| Zumandimine 59651-0030-28 | Aurobindo | 1 kit | $0.151 | AB | Availability likely | save 21% |
| Syeda 70700-0115-85 | Xiromed, | 1 kit | $0.151 | AB | Availability likely | save 21% |
| Drospirenone And Ethinyl Estradiol 60505-4897-08 | Apotex | 63 tablets | $0.151 | AB | Availability likely | save 21% |
| Drospirenone And Ethinyl Estradiol 68180-0868-73 | Lupin | 63 tablets | $0.151 | AB | Availability likely | save 21% |
| drospirenone and ethinyl estradiol 68462-0733-29 | Glenmark | 1 kit | $0.151 | AB | Availability likely | save 21% |
| Ocella 00555-9131-67 | TEVA | 1 kit | $0.154 | AB | Discontinued | save 19% |
| Drospirenone and ethinyl estradiol 31722-0934-31 | Camber | 1 kit | $0.191 | AB | Availability likely | — |
| Lo-Zumandiminethis 59651-0029-88 | Aurobindo | 3 pouches | $0.191 | AB | Availability likely | — |
| Nikki 68180-0886-73 | Lupin | 1 kit | $0.191 | AB | Availability likely | — |
| Vestura 00480-4000-62 | Teva | 72 tablets | $0.191 | AB | Availability likely | — |
| drospirenone and ethinyl estradiol 68462-0720-29 | Glenmark | 1 kit | $0.191 | AB | Availability likely | — |
| Jasmiel 50102-0240-23 | Afaxys | 3 pouches | $0.191 | AB | Availability likely | — |
| Drospirenone and Ethinyl Estradiol 72603-0875-03 | NorthStar | 3 pouches | $0.191 | AB | Availability likely | — |
| Yasmin 50419-0402-03 | Bayer | 1 kit | $4.397 | AB | Availability likely | +2203% |
| Yaz 50419-0405-03 | Bayer | 1 kit | $5.844 | AB | Availability likely | +2961% |
| drospirenone and ethinyl estradiol 71205-0144-28 | Proficient | 1 kit | — | AB | FDA listed | — |
| Syeda 63629-2335-01 | Bryant | 1 kit | — | AB | FDA listed | — |
| Drospirenone And Ethinyl Estradiol 79929-0019-07 | Naari | 21 tablets | — | AB | FDA listed | — |
| drospirenone and ethinyl estradiol 50090-2494-00 | A-S | 1 kit | — | AB | FDA listed | — |
| drospirenone and ethinyl estradiol 50090-2594-00 | A-S | 1 kit | — | AB | FDA listed | — |
| Drospirenone And Ethinyl Estradiol 67296-2286-03 | Redpharm | 63 tablets | — | AB | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
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?
- FDA Orange Book · refreshed Oct 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 1, 2026
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.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
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 Lo- Zumandimine ( 4 ). Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use.
( 4 )
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Lo-Zumandimine is a combination of drospirenone, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to: Prevent pregnancy. ( 1.1 ) Treat symptoms of premenstrual dysphoric disorder (PMDD) for females of reproductive potential who choose to use an oral contraceptive for contraception. ( 1.2 ) 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 Lo-Zumandimine TM is indicated for use by females of reproductive potential to prevent pregnancy.
1.2Premenstrual Dysphoric Disorder (PMDD) Lo-Zumandimine is also indicated for the treatment of symptoms of premenstrual dysphoric disorder (PMDD) in females of reproductive potential who choose to use an oral contraceptive as their method of contraception. The effectiveness of Lo-Zumandimine for PMDD when used for more than three menstrual cycles has not been evaluated. The essential features of PMDD according to the Diagnostic and Statistical Manual-4th edition (DSM-IV) include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability.
Other features include decreased interest in usual activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. Physical symptoms associated with PMDD include breast tenderness, headache, joint and muscle pain, bloating and weight gain. In this disorder, these symptoms occur regularly during the luteal phase and remit within a few days following onset of menses; the disturbance markedly interferes with work or school, or with usual social activities and relationships with others.
Diagnosis is made by healthcare providers according to DSM-IV criteria, with symptomatology assessed prospectively over at least two menstrual cycles. In making the diagnosis, care should be taken to rule out other cyclical mood disorders. Lo-Zumandimine has not been evaluated for the treatment of premenstrual syndrome (PMS).
1.3Acne Lo-Zumandimine is 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. Lo-Zumandimine 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 Lo-Zumandimine 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 and PMDD effectiveness, Lo-Zumandimine 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 Lo-Zumandimine Instruct the patient to begin taking Lo-Zumandimine 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 Lo-Zumandimine use, instruct the patient to take one light pink to pink Lo-Zumandimine daily, beginning on Day 1 of her menstrual cycle. (The first day of menstruation is Day 1.) She should take one light pink to pink Lo-Zumandimine daily for 24 consecutive days, followed by one green inert tablet daily on Days 25 through 28.
Lo-Zumandimine 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. Lo-Zumandimine can be taken without regard to meals. If Lo-Zumandimine is first taken later than the first day of the menstrual cycle, Lo-Zumandimine 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 Lo-Zumandimine use, instruct the patient to take one light pink to pink Lo-Zumandimine daily, beginning on the first Sunday after the onset of her menstrual period.
She should take one light pink to pink Lo-Zumandimine daily for 24 consecutive days, followed by one green inert tablet daily on Days 25 through 28. Lo-Zumandimine 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. Lo-Zumandimine can be taken without regard to meals.
Lo-Zumandimine 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 Lo-Zumandimine on the same day of the week that she began her first regimen, following the same schedule. She should begin taking her light pink to pink tablets on the next day after ingestion of the last green tablet, regardless of whether or not a menstrual period has occurred or is still in progress. Anytime a subsequent cycle of Lo-Zumandimine is started later than the day following administration of the last green tablet, the patient should use another method of contraception until she has taken a light pink to pink Lo-Zumandimine daily for seven consecutive days.
When switching from a different birth control pill When switching from another birth control pill, Lo-Zumandimine should be started on the same day that a new pack of the previous oral contraceptive would have been started. When switching from a method other than a birth control pill When switching from a transdermal patch or vaginal ring, Lo-Zumandimine should be started when the next application would have been due. When switching from an injection, Lo-Zumandimine should be started when the next dose would have been due.
When switching from an intrauterine contraceptive or an implant, Lo-Zumandimine should be started on the day of removal. Withdrawal bleeding usually occurs… [Excerpted — this section continues on DailyMed.]
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Lo-Zumandimine (drospirenone and ethinyl estradiol tablets, USP) are available in blister packs. Each blister pack (28 tablets) contains in the following order: 24 light pink to pink tablets each containing 3 mg drospirenone USP (DRSP) and 0.02 mg ethinyl estradiol USP (EE) 4 green inert tablets Lo-Zumandimine consists of 28 uncoated, flat faced, beveled-edge tablets in the following order (3) : 24 light pink to pink tablets, each containing 3 mg drospirenone USP (DRSP) and 0.02 mg ethinyl estradiol USP (EE) 4 green inert tablets
⛔ Contraindications ▾
4 CONTRAINDICATIONS Lo-Zumandimine 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. 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 (5.6) ] Have diabetes mellitus with vascular disease [see Warnings and Precautions (5.8) ] Have headaches with focal neurological symptoms or have migraine headaches with or without aura if over age 35 [see Warnings and Precautions (5.9) ] Undiagnosed abnormal uterine bleeding [see Warnings and Precautions (5.10) ] Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive [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) ] Use of Hepatitis C drug combinations containing ombitasvir, paritaprevir/ritonavir, with or without dasabuvir due to the potential for ALT elevations [see Warnings and Precautions (5.5) and Drug Interactions (7.3) ].
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)
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Vascular risks : Stop Lo-Zumandimine 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 Lo-Zumandimine 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. 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 Lo-Zumandimine if jaundice occurs.
(5.4) High blood pressure : Do not prescribe Lo-Zumandimine for women with uncontrolled hypertension or hypertension with vascular disease. ( 5.6 ) Carbohydrate and lipid metabolic effects : Monitor prediabetic and diabetic women taking Lo-Zumandimine. Consider an alternate contraceptive method for women with uncontrolled dyslipidemia.
( 5.8 ) Headache : Evaluate significant change in headaches and discontinue Lo-Zumandimine if indicated. ( 5.9 ) Uterine bleeding : Evaluate irregular bleeding or amenorrhea. ( 5.10 )
5.1Thromboembolic Disorders and Other Vascular Problems Stop Lo-Zumandimine 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 Lo-Zumandimine 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 2. Table 2: Estimates (Hazard Ratios) of Venous Thromboembolism Risk in Current Users of Yasmin Compared to Users of Oral Contraceptives that Contain Other Progestins a) “New users” - no use of combination hormonal contraception for at least the prior 6 months b) Includes low-dose COCs containing the following progestins: norgestimate, norethindrone, levonorgestrel, desogestrel, norgestrel, medroxyprogesterone, or ethynodiol diacetate c) Includes low-dose COCs containing the following progestins: levonorgestrel, desogestrel, dienogest, chlormadinone acetate, gestodene, cyproterone acetate, norgestimate, or norethindrone d) Includes low-dose COCs containing the following progestins: norgestimate, norethindrone, or levonorgestrel 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) i3 Ingenix (Seeger 2007) Initiators, including new users a All COCs available in the US during the conduct of the study b HR: 0.9 (0.5 to 1.6) EURAS (Dinger 2007) Initiators, including new users a All COCs available in Europe during the conduct of the study c Levonorgestrel/EE HR: 0.9 (0.6 to 1.4) HR: 1.0 (0.6 to 1.8) “FDA-funded study” (2011) New users a All users (i.e., initi… [Excerpted — this section continues on DailyMed.]
🤒 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) ] 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) The most frequent adverse reactions (≥ 2%) in PMDD clinical trials were: menstrual irregularities (24.9%), nausea (15.8%), headache (13.0%), breast tenderness (10.5%), fatigue (4.2%), irritability (2.8%), decreased libido (2.8%), increased weight (2.5%), and affect lability (2.1%). (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 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 Lo-Zumandimine 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 to 36 who took at least one dose of Lo-Zumandimine.
A second Phase 3 study was a single center, open-label, active-controlled study to evaluate the effect of 7 28-day cycles of Lo-Zumandimine on carbohydrate metabolism, lipids and hemostasis in 29 women aged 18 to 35. For acne, two multicenter, double-blind, randomized, placebo-controlled studies, in 536 women aged 14 to 45 with moderate acne vulgaris who took at least one dose of Lo-Zumandimine, 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%). PMDD Clinical Trials Safety data from trials for the indication of PMDD are reported separately due to differences in study design and setting in the Contraception and Acne studies as compared to the PMDD clinical program.
Two (one parallel and one crossover designed) multicenter, double-blind, randomized, placebo-controlled trials for the secondary indication of treating the symptoms of PMDD evaluated safety and efficacy of Lo-Zumandimine during up to 3 cycles among 285 women aged 18 to 42, diagnosed with PMDD and who took at least one dose of Lo-Zumandimine. Common adverse reactions (≥ 2% of users) were: menstrual irregularities (including vaginal hemorrhage [primarily spotting] and metrorrhagia) (24.9%), nausea (15.8%), headache (13.0%), breast tenderness (10.5%), fatigue (4.2%), irritability (2.8%), decreased libido (2.8%), increased weight (2.5%), and affect lability (2.1%).
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 irre… [Excerpted — this section continues on DailyMed.]
🔄 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, 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. 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. 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 have a weak or moderate increase.
Clinical studies did not indicate an inhibitory potential of DRSP towards human… [Excerpted — this section continues on DailyMed.]
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Lactation: Can reduce milk production in breast-feeding females. ( 8.2 )
8.1Pregnancy Risk Summary There is no use for contraception in pregnancy; therefore, Lo-Zumandimine should be discontinued during 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 CHCs before conception or during early pregnancy. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4 percent and 15 to 20 percent, respectively.
Data Human Data A retrospective database study of women in Norway, that included 44,734 pregnancies of which 368 were women who inadvertently took DRSP/EE during the first trimester of a pregnancy, found there were no adverse effects on pre-term birth, small for gestational age, or birth weight Z-scores. Post-marketing adverse event data on the use of Lo-Zumandimine in pregnant women suggest that frequencies of miscarriage and congenital anomalies were not higher than the estimated background risk in the general population.
8.2Lactation Risk Summary DRSP is present in human milk. After a single oral administration of 3 mg DRSP/0.03 mg EE tablets, DRSP concentration in breast milk over the 24-h period ranged from 1.4 to 7 ng/mL, with a mean ± standard deviation value of 3.7 ± 1.9 ng/mL. The estimated mean infant dose was 0.003 mg/day, which is about 0.1% of maternal dose (see Data) .
There is limited information on the effects of Lo-Zumandimine on the breast-fed infant. CHCs can reduce milk production in breast-feeding females. This reduction can occur at any time but is less likely to occur once breast-feeding is well-established.
When possible, advise the nursing female to use other methods of contraception until she discontinues breast-feeding [See also Dosage and Administration (2.2) ]. The developmental and health benefits of breast-feeding should be considered along with the mother’s clinical need for Lo-Zumandimine and any potential adverse effects on the breast-fed child from Lo-Zumandimine or from the underlying maternal condition. Data Human Data An open-label study evaluated the degree of DRSP transfer into milk within 72 hours following a single oral administration of 3 mg DRSP/0.03 mg EE tablets to 6 healthy lactating women who were 1 week to 3 months post-partum.
DRSP was present in breast milk with a mean C max of 13.5 ng/mL, while the mean C max in serum of lactating women was 30.8 ng/mL. The DRSP concentration in breast milk over the 24-hour period following dosing ranged from 1.4 to 7 ng/mL, with a mean ± standard deviation value of 3.7 ± 1.9 ng/mL. Based on single dose data, the maximal daily infant dose of DRSP was calculated to be 0.003 mg/day, which represented a mean of 0.1% of the maternal dose.
8.4Pediatric Use Safety and efficacy of Lo-Zumandimine 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 Lo-Zumandimine has not been studied in postmenopausal women and is not indicated in this population.
8.6Patients with Renal Impairment Lo-Zumandimine is contraindicated in patients with renal impairment [see Contraindications (4) and Warnings and Precautions (5.2) ] . In subjects with creatinine clearance (CLcr) of 50 to 79 mL/min, serum DRSP levels were comparable to those in a control group with CLcr ≥ 80 mL/min. In subjects with CLcr of 30 to 49 mL/min, 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 Clinic… [Excerpted — this section continues on DailyMed.]
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary There is no use for contraception in pregnancy; therefore, Lo-Zumandimine should be discontinued during 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 CHCs before conception or during early pregnancy. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4 percent and 15 to 20 percent, respectively.
Data Human Data A retrospective database study of women in Norway, that included 44,734 pregnancies of which 368 were women who inadvertently took DRSP/EE during the first trimester of a pregnancy, found there were no adverse effects on pre-term birth, small for gestational age, or birth weight Z-scores. Post-marketing adverse event data on the use of Lo-Zumandimine in pregnant women suggest that frequencies of miscarriage and congenital anomalies were not higher than the estimated background risk in the general population.
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and efficacy of Lo-Zumandimine 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 Lo-Zumandimine has 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.
12.2Pharmacodynamics Drospirenone is a spironolactone analogue with anti-mineralocorticoid and antiandrogenic activity. The estrogen in Lo-Zumandimine 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 Lo-Zumandimine, which is a combination tablet of DRSP and EE, has not been evaluated.
Serum concentrations of DRSP and EE reached peak levels within 1 to 2 hours after administration of Lo-Zumandimine. The pharmacokinetics of DRSP are dose proportional following single doses ranging from 1 to 10 mg. Following daily dosing of Lo-Zumandimine, steady state DRSP concentrations were observed after 8 days.
There was about 2 to 3 fold accumulation in serum C max and AUC (0 to 24h) values of DRSP following multiple dose administration of Lo-Zumandimine (see Table 3). For EE, steady-state conditions are reported during the second half of a treatment cycle. Following daily administration of Lo-Zumandimine, serum C max and AUC (0 to 24h) values of EE accumulate by a factor of about 1.5 to 2 (see Table 3).
Table 3: Pharmacokinetic Parameters Of Lo-Zumandimine (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 to 24h) a (ng•h/mL) t 1/2 a (h) 1/1 23 38.4 (25) 1.5 (1 to 2) 268 (19) NAc 1/21 23 70.3 (15) 1.5 (1 to 2) 763 (17) 30.8 (22) EE Cycle / Day No. of Subjects C max a (pg/mL) T max b (h) AUC (0 to 24h) a (pg•h/mL) t 1/2 a (h) 1/1 23 32.8 (45) 1.5 (1 to 2) 108 (52) NA c 1/21 23 45.1 (35) 1.5 (1 to 2) 220 (57) NA c Food Effect The rate of absorption of DRSP and EE following single administration of a formulation similar to Lo-Zumandimine was slower under fed (high fat meal) conditions with the serum C max being reduced about 40% for both components.
The extent of absorption of DRSP, however, remained unchanged. In contrast, the extent of absorption of EE was reduced by about 20% under fed conditions. Distribution DRSP and EE serum concentrations decline in two phases.
The apparent volume of… [Excerpted — this section continues on DailyMed.]
🧬 Mechanism of Action ▾
12.1Mechanism of Action COCs lower the risk of becoming pregnant primarily by suppressing ovulation.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1How Supplied Lo-Zumandimine (drospirenone and ethinyl estradiol tablets, USP) are available in Blister Pack Containing 28 tablets in the following order. Each blister pack (28 tablets) contains in the following order: 24 active light pink to pink, round, flat faced, beveled-edge tablets, debossed with “S” on one side and “77” on other side 4 inert green, round, mottled, flat faced beveled-edge, uncoated tablets, debossed with “S” on one side and “37” on other side. The blister packs are available in the following packages: The Blister Packs are packed in Pouches and the pouches are packaged in cartons Carton of 1 Pouch NDC 59651-029-87 Carton of 3 Pouches NDC 59651-029-88
16.2Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
📋 Description ▾
11 DESCRIPTION Lo-Zumandimine (drospirenone and ethinyl estradiol tablets, USP) provides an oral contraceptive regimen consisting of 24 light pink to pink active uncoated tablets each containing 3 mg of drospirenone USP and 0.02 mg of ethinyl estradiol USP and 4 green inert uncoated tablets. The inactive ingredients in the light pink to pink tablets are corn starch, FD&C Red No. 40, lactose monohydrate, magnesium stearate, povidone, talc and vitamin-E.
The green inert uncoated tablets contain anhydrous lactose, croscarmellose sodium, FD &C Blue No. 2 aluminum lake, ferric oxide yellow, magnesium stearate, microcrystalline cellulose and povidone. 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: FDA approved dissolution test specifications differ from USP. Chemical Structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the 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 Lo-Zumandimine does not protect against HIV-infection (AIDS) and other sexually transmitted diseases. Counsel patients on Warnings and Precautions associated with COCs.
Counsel patients that Lo-Zumandimine contains 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 Lo-Zumandimine 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 or taking strong CYP3A4 inhibitors. Inform patients that Lo-Zumandimine is not indicated during pregnancy. If pregnancy occurs during treatment with Lo-Zumandimine, 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. 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 light pink to 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. Distributed by: Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Revised: 10/2023
🧬 Pharmacokinetics ▾
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 Lo-Zumandimine, which is a combination tablet of DRSP and EE, has not been evaluated.
Serum concentrations of DRSP and EE reached peak levels within 1 to 2 hours after administration of Lo-Zumandimine. The pharmacokinetics of DRSP are dose proportional following single doses ranging from 1 to 10 mg. Following daily dosing of Lo-Zumandimine, steady state DRSP concentrations were observed after 8 days.
There was about 2 to 3 fold accumulation in serum C max and AUC (0 to 24h) values of DRSP following multiple dose administration of Lo-Zumandimine (see Table 3). For EE, steady-state conditions are reported during the second half of a treatment cycle. Following daily administration of Lo-Zumandimine, serum C max and AUC (0 to 24h) values of EE accumulate by a factor of about 1.5 to 2 (see Table 3).
Table 3: Pharmacokinetic Parameters Of Lo-Zumandimine (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 to 24h) a (ng•h/mL) t 1/2 a (h) 1/1 23 38.4 (25) 1.5 (1 to 2) 268 (19) NAc 1/21 23 70.3 (15) 1.5 (1 to 2) 763 (17) 30.8 (22) EE Cycle / Day No. of Subjects C max a (pg/mL) T max b (h) AUC (0 to 24h) a (pg•h/mL) t 1/2 a (h) 1/1 23 32.8 (45) 1.5 (1 to 2) 108 (52) NA c 1/21 23 45.1 (35) 1.5 (1 to 2) 220 (57) NA c Food Effect The rate of absorption of DRSP and EE following single administration of a formulation similar to Lo-Zumandimine was slower under fed (high fat meal) conditions with the serum C max being reduced about 40% for both components.
The extent of absorption of DRSP, however, remained unchanged. In contrast, the extent of absorption of EE was reduced by about 20% under fed conditions. Distribution DRSP and EE serum concentrations decline in two phases.
The apparent volume of distribution of DRSP is approximately 4 L/kg and that of EE is reported to be approximately 4 to 5 L/kg. DRSP does not bind to SHBG or corticosteroid binding globulin (CBG) but binds about 97% to other serum proteins. Multiple dosing over 3 cycles resulted in no change in the free fraction (as measured at trough concentrations).
EE is reported to be highly but non-specifically bound to serum albumin (approximately 98.5 %) and induces an increase in the serum concentrations of both SHBG and CBG. EE induced effects on SHBG and CBG were not affected by variation of the DRSP dosage in the range of 2 to 3 mg. Metabolism The two main metabolites of DRSP found in human plasma were identified to be the acid form of DRSP generated by opening of the lactone ring and the 4,5-dihydrodrospirenone-3-sulfate, formed by reduction and subsequent sulfation.
These metabolites were shown not to be pharmacologically active. Drospirenone is also subject to oxidative metabolism catalyzed by CYP3A4. EE has been reported to be subject to significant gut and hepatic first-pass metabolism.
Metabolism of EE and its oxidative metabolites occur primarily by conjugation with glucuronide or sulfate. CYP3A4 in the liver is responsible for the 2-hydroxylation which is the major oxidative reaction. The 2-hydroxy metabolite is further transformed by methylation and glucuronidation prior to urinary and fecal excretion.
Excretion DRSP serum concentrations are characterized by a terminal disposition phase half-life of approximately 30 hours after both single and multiple dose regimens. Excretion of DRSP was nearly complete after ten days and amounts excreted were slightly higher in feces compared to urine. DRSP was extensively metabolized and only trace amounts of unchanged DRSP were excreted in urine and feces.
At least 20 different metabolites were observed in urine and feces. About 38 to 47… [Excerpted — this section continues on DailyMed.]
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics Drospirenone is a spironolactone analogue with anti-mineralocorticoid and antiandrogenic activity. The estrogen in Lo-Zumandimine 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.
🔬 Clinical Studies ▾
14 CLINICAL STUDIES
14.1Oral Contraceptive Clinical Trial In the primary contraceptive efficacy study of Lo-Zumandimine (3 mg DRSP/0.02 mg EE) of up to 1 year duration, 1,027 subjects were enrolled and completed 11,480 28-day cycles of use. The age range was 17 to 36 years. The racial demographic was: 87.8% Caucasian, 4.6% Hispanic, 4.3% Black, 1.2% Asian, and 2.1% other.
Women with a BMI greater than 35 were excluded from the trial. The pregnancy rate (Pearl Index) was 1.41 (95% CI [0.73, 2.47]) per 100 woman-years of use based on 12 pregnancies that occurred after the onset of treatment and within 14 days after the last dose of Lo-Zumandimine in women 35 years of age or younger during cycles in which no other form of contraception was used.
14.2Premenstrual Dysphoric Disorder Clinical Trials Two multicenter, double-blind, randomized, placebo-controlled studies were conducted to evaluate the effectiveness of Lo-Zumandimine in treating the symptoms of PMDD. Women aged 18 to 42 who met DSM-IV criteria for PMDD, confirmed by prospective daily ratings of their symptoms, were enrolled. Both studies measured the treatment effect of Lo-Zumandimine using the Daily Record of Severity of Problems scale, a patient-rated instrument that assesses the symptoms that constitute the DSM-IV diagnostic criteria.
The primary study was a parallel group design that included 384 evaluable reproductive-aged women with PMDD who were randomly assigned to receive Lo-Zumandimine or placebo treatment for 3 menstrual cycles. The supportive study, a crossover design, was terminated prematurely prior to achieving recruitment goals due to enrollment difficulties. A total of 64 women of reproductive age with PMDD were treated initially with Lo-Zumandimine or placebo for up to 3 cycles followed by a washout cycle and then crossed over to the alternate medication for 3 cycles.
Efficacy was assessed in both studies by the change from baseline during treatment using a scoring system based on the first 21 items of the Daily Record of Severity of Problems. Each of the 21 items was rated on a scale from 1 (not at all) to 6 (extreme); thus a maximum score of 126 was possible. In both trials, women who received Lo-Zumandimine had statistically significantly greater improvement in their Daily Record of Severity of Problems scores.
In the primary study, the average decrease (improvement) from baseline was 37.5 points in women taking Lo-Zumandimine, compared to 30.0 points in women taking placebo.
14.3Acne Clinical Trials In two multicenter, double-blind, randomized, placebo-controlled studies, 889 subjects, ages 14 to 45 years, with moderate acne received Lo-Zumandimine or placebo for six 28-day cycles. The primary efficacy endpoints were the percent change in inflammatory lesions, non-inflammatory lesions, total lesions, and the percentage of subjects with a “clear” or “almost clear” rating on the Investigator's Static Global Assessment (ISGA) scale on day 15 of cycle 6, as presented in Table 4: Table 4: Efficacy Results for Acne Trials* * Evaluated at day 15 of cycle 6, last observation carried forward for the Intent to treat population Study 1 Study 2 Lo-Zumandimine N=228 Placebo N=230 Lo-Zumandimine N=218 Placebo N=213 ISGA Success Rate 35 (15%) 10 (4%) 46 (21%) 19 (9%) Inflammatory Lesions Mean Baseline Count Mean Absolute (%) Reduction 33 15 (48%) 33 11 (32%) 32 16 (51%) 32 11 (34%) Non-inflammatory Lesions Mean Baseline Count Mean Absolute (%) Reduction 47 18 (39%) 47 10 (18%) 44 17 (42%) 44 11 (26%) Total Lesions Mean Baseline Count Mean Absolute (%) Reduction 80 33 (42%) 80 21 (25%) 76 33 (46%) 76 22 (31%)
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility In a 24 month oral carcinogenicity study in mice dosed with 10 mg/kg/day DRSP alone or 1 + 0.01, 3 + 0.03 and 10 + 0.1 mg/kg/day of DRSP and EE, 0.1 to 2 times the exposure (AUC of DRSP) of women taking a contraceptive dose, there was an increase in carcinomas of the harderian gland in the group that received the high dose of DRSP alone. In a similar study in rats given 10 mg/kg/day DRSP alone or 0.3 + 0.003, 3 + 0.03 and 10 + 0.1 mg/kg/day DRSP and EE, 0.8 to 10 times the exposure of women taking a contraceptive dose, there was an increased incidence of benign and total (benign and malignant) adrenal gland pheochromocytomas in the group receiving the high dose of DRSP.
Mutagenesis studies for DRSP were conducted in vivo and in vitro and no evidence of mutagenic activity was observed [See Warnings and Precautions (5.3 , 5.4) ].
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility In a 24 month oral carcinogenicity study in mice dosed with 10 mg/kg/day DRSP alone or 1 + 0.01, 3 + 0.03 and 10 + 0.1 mg/kg/day of DRSP and EE, 0.1 to 2 times the exposure (AUC of DRSP) of women taking a contraceptive dose, there was an increase in carcinomas of the harderian gland in the group that received the high dose of DRSP alone. In a similar study in rats given 10 mg/kg/day DRSP alone or 0.3 + 0.003, 3 + 0.03 and 10 + 0.1 mg/kg/day DRSP and EE, 0.8 to 10 times the exposure of women taking a contraceptive dose, there was an increased incidence of benign and total (benign and malignant) adrenal gland pheochromocytomas in the group receiving the high dose of DRSP.
Mutagenesis studies for DRSP were conducted in vivo and in vitro and no evidence of mutagenic activity was observed [See Warnings and Precautions (5.3 , 5.4) ].
📚 References ▾
15 REFERENCES Seeger, J.D., Loughlin, J., Eng, P.M., Clifford, C.R., Cutone, J., and Walker, A.M. (2007). Risk of thromboembolism in women taking ethinylestradiol/drospirenone and other oral contraceptives.
Obstet Gynecol 110 , 587-593. Dinger, J.C., Heinemann, L.A., and Kuhl-Habich, D. (2007).
The safety of a drospirenone-containing oral contraceptive: final results from the European Active Surveillance Study on oral contraceptives based on 142,475 women-years of observation. Contraception 75 , 344-354. Combined hormonal contraceptives (CHCs) and the risk of cardiovascular endpoints.
Sidney, S. (primary author), http://www.fda.gov/downloads/Drugs/DrugSafety/UCM277384.pdf, accessed Oct 27, 2011. Lidegaard, O., Lokkegaard, E., Svendsen, A.L., and Agger, C.
(2009). Hormonal contraception and risk of venous thromboembolism: national follow-up study. BMJ 339 , b2890.
Lidegaard, O., Nielsen, L.H., Skovlund, C.W., Skjeldestad, F.E., and Lokkegaard, E. (2011). Risk of venous thromboembolism from use of oral contraceptives containing different progestogens and oestrogen doses: Danish cohort study, 2001-9.
BMJ 343 , d6423. van Hylckama Vlieg, A., Helmerhorst, F.M., Vandenbroucke, J.P., Doggen, C.J., and Rosendaal, F.R. (2009). The venous thrombotic risk of oral contraceptives, effects of oestrogen dose and progestogen type: results of the MEGA case-control study.
BMJ 339 , b2921. Dinger, J., Assmann, A., Mohner, S., and Minh, T.D. (2010).
Risk of venous thromboembolism and the use of dienogest- and drospirenone-containing oral contraceptives: results from a German case-control study. J Fam Plann Reprod Health Care 36 , 123-129. Jick, S.S., and Hernandez, R.K.
(2011). Risk of non-fatal venous thromboembolism in women using oral contraceptives containing drospirenone compared with women using oral contraceptives containing levonorgestrel: case-control study using United States claims data. BMJ 342 , d2151.
Parkin, L., Sharples, K., Hernandez, R.K., and Jick, S.S. (2011). Risk of venous thromboembolism in users of oral contraceptives containing drospirenone or levonorgestrel: nested case-control study based on UK General Practice Research Database.
BMJ 342 , d2139.
📄 Patient Package Insert ▾
FDA Approved Patient Labeling Guide for Using Lo-Zumandimine WARNING TO WOMEN WHO SMOKE Do not use Lo-Zumandimine 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.
Birth control pills help to lower the chances of becoming pregnant when taken as directed. They do not protect against HIV infection (AIDS) and other sexually transmitted diseases. What is Lo-Zumandimine?
Lo-Zumandimine is a birth control pill. It contains two female hormones, a synthetic estrogen called ethinyl estradiol and a progestin called drospirenone. The progestin drospirenone may increase potassium.
Therefore, you should not take Lo-Zumandimine if you have kidney, liver or adrenal disease because this could cause serious heart and health problems. Other drugs may also increase potassium. If you are currently on daily, long-term treatment for a chronic condition with any of the medications below, you should consult your healthcare provider about whether Lo-Zumandimine is right for you, and during the first month that you take Lo-Zumandimine, you should have a blood test to check your potassium level.
NSAIDs (ibuprofen [Motrin, Advil], naproxen [Aleve and others] when taken long-term and daily for treatment of arthritis or other problems) Potassium-sparing diuretics (spironolactone and others) Potassium supplementation ACE inhibitors (Capoten, Vasotec, Zestril and others) Angiotensin-II receptor antagonists (Cozaar, Diovan, Avapro and others) Heparin Aldosterone antagonists Lo-Zumandimine may also be taken to treat premenstrual dysphoric disorder (PMDD) if you choose to use the Pill for birth control. Unless you have already decided to use the Pill for birth control, you should not start Lo-Zumandimine to treat your PMDD because there are other medical therapies for PMDD that do not have the same risks as the Pill.
PMDD is a mood disorder related to the menstrual cycle. PMDD significantly interferes with work or school, or with usual social activities and relationships with others. Symptoms include markedly depressed mood, anxiety or tension, mood swings, and persistent anger or irritability.
Other features include decreased interest in usual activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. Physical symptoms associated with PMDD may include breast tenderness, headache, joint and muscle pain, bloating and weight gain. These symptoms occur regularly before menstruation starts and go away within a few days following the start of the period.
Diagnosis of PMDD should be made by healthcare providers. You should only use Lo-Zumandimine for treatment of PMDD if you: Have already decided to use oral contraceptives for birth control, and Have been diagnosed with PMDD by your healthcare provider. Lo-Zumandimine has not been shown to be effective for the treatment of premenstrual syndrome (PMS), a less serious set of symptoms occurring before menstruation.
If you or your healthcare provider believe you have PMS, you should take Lo-Zumandimine only if you want to prevent pregnancy; and not for the treatment of PMS. Lo-Zumandimine may also be taken to treat moderate acne if all of the following are true: Your healthcare provider says it is safe for you to use Lo-Zumandimine. You are at least 14 years old.
You have started having menstrual periods. You want to use a birth control pill to prevent pregnancy. How Well Does Lo-Zumandimine Work?
Your chance of getting pregnant depends on how well you follow the directions for taking your birth control pills. The better you follow the directions, the less chance you have of getting pregnant. Based on the results of one clinical study, 1 to 2 women out of 100 women, may get pregnant during the first year they use Lo-Zum… [Excerpted — this section continues on DailyMed.]
📄 Recent Major Changes ▾
Dosage and Administration ( 2.3 ) 5/2023 Contraindications, Pregnancy ( 4 ) Removed 5/2023 Warnings and Precautions ( 5.11 ) Removed 5/2023
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 3 mg/0.02 mg Pouch Label NDC 59651-029-28 Lo-Zumandimine TM Drospirenone and Ethinyl Estradiol Tablets USP, 3 mg/0.02 mg This product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases. Rx only This pouch contains one blister pack of 28 tablets AUROBINDO PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 3 mg/0.02 mg Pouch Label
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 3 mg/0.02 mg Pouch Carton NDC 59651-029-88 Lo-Zumandimine TM Drospirenone and Ethinyl Estradiol Tablets USP, 3 mg/0.02 mg This product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases. Rx only This carton contains 3 pouches.
Each pouch contains 1 blister pack of 28 tablets. AUROBINDO PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 3 mg/0.02 mg Pouch Carton
Medicaid utilization & spend
Medicaid utilization by pack size
Medicare Part D spend CMS · PART D · 2026 (Q1)
Reported adverse events (FAERS)
Top reported reactions
Reporter sex
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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.
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| 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) | ✓ Available |
| 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) | ✓ Available |