Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium
Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium · KIT · Sandoz Inc
Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium is a kit containing drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium. Manufactured by Sandoz Inc.
Key Facts
- Brand Name
- Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium
- Generic Name
- Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium
- NDC Code (Product)
0781-4075- Manufacturer
- Sandoz Inc
- Dosage Form
- KIT
- Marketing Status
- Application #
- NDA022532
- Marketing Start
- 10/12/2016
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium a combination of drospirenone, a progestin and ethinyl estradiol, an estrogen containing a folate, indicated for use by females of reproductive potential to: • Prevent pregnancy. ( 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 females of reproductive potential at least 14 years old only if the patient desires an oral contraceptive for birth control. ( 1.3 ) • Raise folate levels in females of reproductive potential who choose to use an oral contraceptive for contraception. ( 1.4 ) 1.1 Oral Contraceptive Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium is indicated for use by females of reproductive potential to prevent pregnancy. 1.2 Premenstrual Dysphoric Disorder (PMDD) Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium is also indicated for the treatment of symptoms of premenstrual dysphoric disorder (PMDD) in females of reproductive potential who choose to use an oral contracept…
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 Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium Take one tablet by mouth at the same time every day. The failure rate may increase when pills are missed or taken incorrectly. To achieve maximum contraceptive and PMDD effectiveness, Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium must be taken as directed, in the order directed on the blister pack. Single missed pills should be taken as soon as remembered. 2.2 How to Start Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium Instruct the patient to begin taking Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium 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/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium use, instruct the patient to take one pink Drospirenone/Ethinyl Estradiol/Levomef…
Contraindications
4 CONTRAINDICATIONS Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium is contraindicated in females who are known to have or develop the following conditions: • Renal impairment • Adrenal insufficiency • A high risk of arterial or venous thrombotic diseases. 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 withou…
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%) in contraception, acne and folate clinical trials are headache/migraine (5.9%), menstrual irregularities (4.1%), nausea/vomiting (3.5%) and breast pain/tenderness (3.2%). ( 6.1 ) • The most frequent adverse reactions (≥ 2%) in PMDD clinical trials are 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 Sandoz Inc. at 1-800-525-8747 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 …
Frequently Asked Questions
What is Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium used for?
Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium contains Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium. It is a kit taken as directed. Consult your doctor for specific uses.
Is Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium a controlled substance?
Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium is not classified as a controlled substance by the DEA.
What is the generic name for Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium?
The generic name for Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium is Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium. There are 3 other brand versions of Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium.
What is the NDC code for Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium ?
The NDC (National Drug Code) for Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium is 0781-4075, listed by Sandoz Inc.