DROSPIRENONE AND ETHINYL ESTRADIOL

DROSPIRENONE AND ETHINYL ESTRADIOL — drospirenone and ethinyl estradiol
LUPIN LIMITED

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)].

1 INDICATIONS AND USAGE

Drospirenone and ethinyl estradiol tablets USP are indicated for use by women to prevent pregnancy.

2 DOSAGE AND ADMINISTRATION

2.1 How to Take Drospirenone and Ethinyl Estradiol 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 effectiveness, drospirenone and ethinyl estradiol tablets 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 and Ethinyl Estradiol Tablets

Instruct the patient to begin taking drospirenone and ethinyl estradiol tablets 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 and ethinyl estradiol tablets use, instruct the patient to take one yellow drospirenone and ethinyl estradiol tablets daily, beginning on Day 1 of her menstrual cycle. (The first day of menstruation is Day 1.) She should take one yellow drospirenone and ethinyl estradiol tablet daily for 21 consecutive days, followed by one white to off-white tablet daily on Days 22 through 28. Drospirenone and ethinyl estradiol tablets 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. Drospirenone and ethinyl estradiol tablets can be taken without regard to meals. If Drospirenone and ethinyl estradiol tablets are first taken later than the first day of the menstrual cycle, drospirenone and ethinyl estradiol tablets 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 drospirenone and ethinyl estradiol tablets use, instruct the patient to take one yellow drospirenone and ethinyl estradiol tablet daily, beginning on the first Sunday after the onset of her menstrual period. She should take one yellow drospirenone and ethinyl estradiol tablet daily for 21 consecutive days, followed by one white to off-white tablet daily on Days 22 through 28. Drospirenone and ethinyl estradiol tablets 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. Drospirenone and ethinyl estradiol tablets can be taken without regard to meals. Drospirenone and ethinyl estradiol tablets 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 drospirenone and ethinyl estradiol tablets on the same day of the week that she began her first regimen, following the same schedule. She should begin taking her yellow tablets on the next day after ingestion of the last white to off-white tablet, regardless of whether or not a menstrual period has occurred or is still in progress. Anytime a subsequent cycle of drospirenone and ethinyl estradiol tablets is started later than the day following administration of the last white to off-white tablet, the patient should use another method of contraception until she has taken a yellow drospirenone and ethinyl estradiol tablets daily for seven consecutive days.

When Switching from a Different Birth Control Pill

When switching from another birth control pill, drospirenone and ethinyl estradiol tablets 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, drospirenone and ethinyl estradiol tablets should be started when the next application would have been due. When switching from an injection, drospirenone and ethinyl estradiol tablets should be started when the next dose would have been due. When switching from an intrauterine contraceptive or an implant, drospirenone and ethinyl estradiol tablets should be started on the day of removal.

Withdrawal bleeding usually occurs within 3 days following the last yellow tablet. If spotting or breakthrough bleeding occurs while taking drospirenone and ethinyl estradiol tablets, instruct the patient to continue taking drospirenone and ethinyl estradiol tablets by the regimen described above. Counsel her that this type of bleeding is usually transient and without significance; however, advise her that if the bleeding is persistent or prolonged, she should consult her healthcare provider.

Although the occurrence of pregnancy is low if drospirenone and ethinyl estradiol tablets are taken according to directions, if withdrawal bleeding does not occur, consider the possibility of pregnancy. If the patient has not adhered to the prescribed dosing schedule (missed one or more active tablets or started taking them on a day later than she should have), consider the possibility of pregnancy at the time of the first missed period and take appropriate diagnostic measures. If the patient has adhered to the prescribed regimen and misses two consecutive periods, rule out pregnancy. Discontinue drospirenone and ethinyl estradiol tablets if pregnancy is confirmed.

The risk of pregnancy increases with each active yellow tablet missed. For additional patient instructions regarding missed pills, see the What to Do if You Miss Pills ” section in the FDA Approved Patient Labeling. If breakthrough bleeding occurs following missed tablets, it will usually be transient and of no consequence. If the patient misses one or more white to off-white tablets, she should still be protected against pregnancy provided she begins taking a new cycle of yellow tablets on the proper day.

For postpartum women who do not breastfeed or after a second trimester abortion, start drospirenone and ethinyl estradiol tablets no earlier than 4 weeks postpartum due to the increased risk of thromboembolism. If the patient starts drospirenone and ethinyl estradiol tablets postpartum and has not yet had a period, evaluate for possible pregnancy, and instruct her to use an additional method of contraception until she has taken drospirenone and ethinyl estradiol tablets for 7 consecutive days.

2.3 Advice in Case of Gastrointestinal Disturbances

In case of severe vomiting or diarrhea, absorption may not be complete and additional contraceptive measures should be taken. If vomiting occurs within 3-4 hours after tablet-taking, this can be regarded as a missed tablet.

3 DOSAGE FORMS AND STRENGTHS

Drospirenone and ethinyl estradiol tablets, 3 mg/0.03 mg are available in a carton containing 3 wallets.

Each wallet contains 28 film-coated, round, bi-convex tablets in the following order:

  • 21 active yellow colored, round, biconvex, film-coated tablets, debossed with ‘LU’ on one side and ‘K32’ on the other side each containing 3 mg drospirenone and 0.03 mg ethinyl estradiol
  • 7 inert white to off-white round, biconvex film-coated tablets debossed with “K33” on one side and ‘LU’ on the other side

4 CONTRAINDICATIONS

Do not prescribe drospirenone and ethinyl estradiol tablets to women who are known to have the following:

• Renal impairment

• Adrenal insufficiency

• 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 (5.5)]

○ Have diabetes mellitus with vascular disease [see WARNINGS AND PRECAUTIONS (5.7)]

○ Have headaches with focal neurological symptoms or have migraine headaches with or without aura if over age 35 [see WARNINGS AND PRECAUTIONS (5.8)]

• Undiagnosed abnormal uterine bleeding [see WARNINGS AND PRECAUTIONS (5.9)]

• Breast cancer or other estrogen- or progestin-sensitive cancer, now or in the past [see WARNINGS AND PRECAUTIONS (5.3)]

• Liver tumor (benign or malignant) or liver disease [see WARNINGS AND PRECAUTIONS (5.4) and USE IN SPECIFIC POPULATIONS (8.7)]

• Pregnancy, because there is no reason to use COCs during pregnancy [see WARNINGS AND PRECAUTIONS (5.10) and USE IN SPECIFIC POPULATIONS (8.1)]

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