Drospirenone, Ethinyl Estradiol And Levomefolate Calcium And Levomefolate Calcium Prescribing Information
Drospirenone, ethinyl estradiol and levomefolate calcium tablet and levomefolate calcium tablet is contraindicated in females who are known to have or develop the following conditions:
- Renal impairment
- Adrenal insufficiency
- A high risk of arterial or venous thrombotic diseases. Examples include women who are known to:
- Smoke, if over age 35[see Boxed Warning and Warnings And Precautions ]
- Have deep vein thrombosis or pulmonary embolism, now or in the past[see Warnings And Precautions ]
- Have cerebrovascular disease[see Warnings And Precautions ]
- Have coronary artery disease[see Warnings And Precautions ]
- 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 ]
- Have inherited or acquired hypercoagulopathies[see Warnings And Precautions ]
- Have uncontrolled hypertension[see Warnings And Precautions ]
- Have diabetes mellitus with vascular disease[see Warnings And Precautions ]
- Have headaches with focal neurological symptoms or have migraine headaches with or without aura if over age 35[see Warnings And Precautions ]
- Smoke, if over age 35
- Undiagnosed abnormal uterine bleeding[see Warnings And Precautions ]
- Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive[see Warnings And Precautions ]
- Liver tumors, benign or malignant, or liver disease[see Warnings And Precautions and Use In Specific Populations ]
- 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 and Drug Interactions ].
- Renal impairment
- Adrenal insufficiency
- A high risk of arterial or venous thrombotic diseases
- Undiagnosed abnormal uterine bleeding
- Breast cancer
- Liver tumors or liver disease
- Co-administration with Hepatitis C drug combinations containing ombitasvir, paritaprevir/ritonavir, with or without dasabuvir
Dosage and Administration (
In case of severe vomiting or diarrhea, absorption may not be complete and additional contraceptive measures should be taken. If vomiting occurs within 3 to 4 hours after tablet-taking, this can be regarded as a missed tablet.
Contraindications, Pregnancy (
Drospirenone, ethinyl estradiol and levomefolate calcium tablet and levomefolate calcium tablet is contraindicated in females who are known to have or develop the following conditions:
- Renal impairment
- Adrenal insufficiency
- A high risk of arterial or venous thrombotic diseases. Examples include women who are known to:
- Smoke, if over age 35[see Boxed Warning and Warnings And Precautions ]
- Have deep vein thrombosis or pulmonary embolism, now or in the past[see Warnings And Precautions ]
- Have cerebrovascular disease[see Warnings And Precautions ]
- Have coronary artery disease[see Warnings And Precautions ]
- 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 ]
- Have inherited or acquired hypercoagulopathies[see Warnings And Precautions ]
- Have uncontrolled hypertension[see Warnings And Precautions ]
- Have diabetes mellitus with vascular disease[see Warnings And Precautions ]
- Have headaches with focal neurological symptoms or have migraine headaches with or without aura if over age 35[see Warnings And Precautions ]
- Smoke, if over age 35
- Undiagnosed abnormal uterine bleeding[see Warnings And Precautions ]
- Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive[see Warnings And Precautions ]
- Liver tumors, benign or malignant, or liver disease[see Warnings And Precautions and Use In Specific Populations ]
- 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 and Drug Interactions ].
- Renal impairment
- Adrenal insufficiency
- A high risk of arterial or venous thrombotic diseases
- Undiagnosed abnormal uterine bleeding
- Breast cancer
- Liver tumors or liver disease
- Co-administration with Hepatitis C drug combinations containing ombitasvir, paritaprevir/ritonavir, with or without dasabuvir
Warnings and Precautions (
Women with a history of depression should be carefully observed and drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets discontinued if depression recurs to a serious degree.
Drospirenone, ethinyl estradiol and levomefolate calcium tablet and levomefolate calcium tablet is 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 Oral Contraceptive
Drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets are indicated for use by females of reproductive potential to prevent pregnancy.
- Treat symptoms of premenstrual dysphoric disorder (PMDD) for females of reproductive potential who choose to use an oral contraceptive for contraception. ()1.2 Premenstrual Dysphoric Disorder (PMDD)
Drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets are 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 drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets 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.
Drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets has not been evaluated for the treatment of premenstrual syndrome (PMS).
- 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 Acne
Drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets are indicated for the treatment of moderate acne vulgaris in females of reproductive potential at least 14 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control.
- Raise folate levels in females of reproductive potential who choose to use an oral contraceptive for contraception. ()1.4 Folate Supplementation
Drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets are indicated in females of reproductive potential who choose to use an oral contraceptive as their method of contraception, to raise folate levels for the purpose of reducing the risk of a neural tube defect in a pregnancy conceived while taking the product or shortly after discontinuing the product.
- Take one tablet daily by mouth at the same time every day. ()2.1 How to Take Drospirenone, Ethinyl Estradiol and Levomefolate Calcium Tablets and Levomefolate Calcium Tablets
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 and levomefolate calcium tablets and levomefolate calcium tablets must be taken as directed, in the order directed on the blister. Single missed pills should be taken as soon as remembered.
- Tablets must be taken in the order directed on the blister. ()2.1 How to Take Drospirenone, Ethinyl Estradiol and Levomefolate Calcium Tablets and Levomefolate Calcium Tablets
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 and levomefolate calcium tablets and levomefolate calcium tablets must be taken as directed, in the order directed on the blister. Single missed pills should be taken as soon as remembered.
Drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets are available in blister containing 28 tablets packed in a pouch. Such three pouches are packaged in a carton.
Each blister contains 28 film-coated, round, biconvex tablets in the following order:
- 24 pink tablets each containing 3 mg drospirenone (DRSP), 0.02 mg ethinyl estradiol (EE) and 0.451 mg levomefolate calcium
- 4 light orange tablets each containing 0.451 mg levomefolate calcium
Lactation: Can reduce milk production in breast-feeding females. (
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 7.0 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 drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets 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)]. Increase in folate concentration in milk is not expected (see Data).
The developmental and health benefits of breast-feeding should be considered along with the mother's clinical need for drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets and any potential adverse effects on the breast-fed child from drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets or from the underlying maternal condition.
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 Cmax of 13.5 ng/mL, while the mean Cmax 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 7.0 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.
A study in approximately 60 lactating women demonstrated no significant differences in folate concentrations in milk between women who received 416mcg/day [6S]-5-methyltetrahydrofolate or 400 mcg/day folic acid and women who received placebo over a 16 week period. Studies to date indicate there is no adverse effect of folate on nursing infants.