Drugplain

Zumandimine

Drospirenone and Ethinyl Estradiol · KIT · Aurobindo Pharma Limited

No Recall HistoryCurrently in Shortage
Plain English

Zumandimine is a birth control medication that combines two hormones, drospirenone and ethinyl estradiol, to prevent pregnancy. It comes as a kit that you take by mouth according to your doctor's directions.

Key Facts

Brand Name
Zumandimine
Generic Name
Drospirenone and Ethinyl Estradiol
NDC Code (Product)
59651-030
Manufacturer
Aurobindo Pharma Limited
Dosage Form
KIT
Marketing Status
Application #
ANDA209407
Marketing Start
03/26/2018

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

pain1,718 reports
injury1,299 reports
cholecystitis chronic1,024 reports
anxiety784 reports
gallbladder disorder777 reports
pulmonary embolism761 reports
deep vein thrombosis715 reports
emotional distress688 reports
cholelithiasis672 reports
abdominal pain354 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Zumandimine ® (drospirenone and ethinyl estradiol tablets) are indicated for use by females of reproductive potential to prevent pregnancy. Zumandimine (drospirenone and ethinyl estradiol tablets) is a combination of drospirenone, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. ( 1 )

Dosage & 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 ) 2.1 How to Take 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 effectiveness, Zumandimine must be taken as directed, in the order directed on the blister pack. Single missed pills should be taken as soon as remembered. 2.2 How to Start Zumandimine Instruct the patient to begin taking 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 Zumandimine use, instruct the patient to take one light pink to pink 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 Zumandimine daily for 21 consecutive days, followed by one green tablet daily on Days 22 through 28. Zumandimine should be taken in the order directed on the package at the same time each day, preferably after the eveni…

Contraindications

4 CONTRAINDICATIONS 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…

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 ) 7.1 Effects of Other Drugs on Combined Oral Contraceptives Substances diminishing the efficacy of COCs: Drugs or herbal products that induce certain enzymes, including cytochrome P450 3A4 (CYP3A4), may decrease the effectiveness of COCs or increase breakthrough bleeding. Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampin, topiramate and products containing St. John’s wort. Interactions between oral contraceptives and other drugs may lead to breakthrough bleeding and/or contraceptive failure. Counsel women to use an alternative method of contraception or a back-up method when enzyme…

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%) are premenstrual syndrome (13.2%), headache /migraine (10.7%), breast pain/tenderness/discomfort (8.3%), nausea/vomiting (4.5%), abdominal pain/tenderness/discomfort (2.3%), mood changes (2.3%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in practice. The data provided reflect the experience with the use of Zumandimine (3 mg DRSP/0.03 mg EE) in the adequate and well-controlled studies for contraception (N=2,837). The US pivotal clinical study (N=326) was a multicenter, open-label tri…

Frequently Asked Questions

What is Zumandimine used for?

Zumandimine is a birth control medication that combines two hormones, drospirenone and ethinyl estradiol, to prevent pregnancy. It comes as a kit that you take by mouth according to your doctor's directions.

Is Zumandimine a controlled substance?

Zumandimine is not classified as a controlled substance by the DEA.

What is the generic name for Zumandimine?

The generic name for Zumandimine is Drospirenone and Ethinyl Estradiol. There are 11 other brand versions of Drospirenone and Ethinyl Estradiol.

What is the NDC code for Zumandimine ?

The NDC (National Drug Code) for Zumandimine is 59651-030, listed by Aurobindo Pharma Limited.

Product NDC

59651-030

Package NDC

59651-030-28

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)