Lo-Zumandimine Prescribing Information
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[seeBoxed WarningandWarnings and Precautions (5.1)]
- Have deep vein thrombosis or pulmonary embolism, now or in the past[seeWarnings and Precautions (5.1)]
- Have cerebrovascular disease[seeWarnings and Precautions (5.1)]
- Have coronary artery disease[seeWarnings 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)[seeWarnings and Precautions (5.1)]
- Have inherited or acquired hypercoagulopathies[seeWarnings and Precautions (5.1)]
- Have uncontrolled hypertension[seeWarnings and Precautions (5.6)]
- Have diabetes mellitus with vascular disease[seeWarnings and Precautions (5.8)]
- Have headaches with focal neurological symptoms or have migraine headaches with or without aura if over age 35[seeWarnings and Precautions (5.9)]
- Smoke, if over age 35
- Undiagnosed abnormal uterine bleeding[seeWarnings and Precautions (5.10)]
- Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive[seeWarnings and Precautions (5.3)]
- Liver tumors, benign or malignant, or liver disease[seeWarnings and Precautions (5.4)andUse 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[seeWarnings and Precautions (5.5)andDrug Interactions (7.3)].
- Renal impairment (4)
- Adrenal insufficiency (4)
- A high risk of arterial or venous thrombotic diseases (4)
- Undiagnosed abnormal uterine bleeding
- 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)
Dosage and Administration (
| If one light pink to pink active tablet is missed | Take the missed active tablet as soon as possible. Take the next tablet at the regular time. This means two tablets may be taken in one day. A back-up birth control method is not required if the patient has sex. |
| If two light pink to pink active tablets in a row are missed in Week 1 or Week 2 | Take two active tablets as soon as possible and two tablets the next day. Then take one tablet a day until the pack is finished. Additional nonhormonal contraception (such as condoms and spermicide) should be used as back-up if the patient has sex within 7 days after missing tablets. |
| If two light pink to pink active tablets in a row are missed in Week 3 or Week 4 | Day 1 Start : Throw out the rest of the tablet pack and start a new pack that same day.Sunday Start : Keep taking one tablet every day until Sunday. On Sunday, throw out the rest of the pack and start a new pack of tablets that same day.Additional nonhormonal contraception (such as condoms and spermicide) should be used as back-up if the patient has sex within 7 days after missing tablets. The patient may not have their period this month but this is expected. However, if they miss their period two months in a row, they should call their healthcare provider because they might be pregnant. |
| If three or more light pink to pink active tablets in a row are missed during any week | Day 1 Start : Throw out the rest of the tablet pack and start a new pack that same day.Sunday Start : Keep taking one tablet every day until Sunday. On Sunday, throw out the rest of the pack and start a new pack of tablets that same day. The patient could become pregnant if they have sex in the 7 days after they restart their tablets. They must use another birth control method (such as condoms and spermicides) as a back-up for those 7 days. They should call their healthcare provider if they miss their period, because they might be pregnant. |
| If any of the four green inactive tablets are missed in Week 4 | Throw away the tablets that were missed. Keep taking one tablet each day until the pack is empty. They do not need a back-up method. |
| Finally, if they are still not sure what to do about the tablets they have missed: | Use nonhormonal contraception (such as condoms and spermicides) anytime they have sex. Contact their healthcare provider and continue taking one active light pink to pink tablet each day until otherwise directed. |
Contraindications, Pregnancy (
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[seeBoxed WarningandWarnings and Precautions (5.1)]
- Have deep vein thrombosis or pulmonary embolism, now or in the past[seeWarnings and Precautions (5.1)]
- Have cerebrovascular disease[seeWarnings and Precautions (5.1)]
- Have coronary artery disease[seeWarnings 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)[seeWarnings and Precautions (5.1)]
- Have inherited or acquired hypercoagulopathies[seeWarnings and Precautions (5.1)]
- Have uncontrolled hypertension[seeWarnings and Precautions (5.6)]
- Have diabetes mellitus with vascular disease[seeWarnings and Precautions (5.8)]
- Have headaches with focal neurological symptoms or have migraine headaches with or without aura if over age 35[seeWarnings and Precautions (5.9)]
- Smoke, if over age 35
- Undiagnosed abnormal uterine bleeding[seeWarnings and Precautions (5.10)]
- Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive[seeWarnings and Precautions (5.3)]
- Liver tumors, benign or malignant, or liver disease[seeWarnings and Precautions (5.4)andUse 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[seeWarnings and Precautions (5.5)andDrug Interactions (7.3)].
- Renal impairment (4)
- Adrenal insufficiency (4)
- A high risk of arterial or venous thrombotic diseases (4)
- Undiagnosed abnormal uterine bleeding
- 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 Precautions (
Women with a history of depression should be carefully observed and Lo-Zumandimine discontinued if depression recurs to a serious degree.
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 Oral ContraceptiveLo-ZumandimineTMis 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)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).
- Treat moderate acne for women at least 14 years old only if the patient desires an oral contraceptive for birth control. ()
1.3 AcneLo-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.
- Take one tablet daily by mouth at the same time every day.
2.1 How to Take Lo-ZumandimineTake 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. - Tablets must be taken in the order directed on the blister pack.
2.1 How to Take Lo-ZumandimineTake 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.
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
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 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)
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.
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 Cmaxof 13.5 ng/mL, while the mean Cmaxin 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.