Drug Detail:Desogen (Ethinyl estradiol and desogestrel [ eh-thih-nill-ess-tra-dye-ole-and-des-oh-jess-trel ])
Generic Name: desogestrel 0.15mg, ethinyl estradiol 0.03mg;
Dosage Form: tablets
Drug Class: Contraceptives
To achieve maximum contraceptive effectiveness, DESOGEN® Tablets (desogestrel and ethinyl estradiol tablets USP) must be taken exactly as directed, at the same time every day, and at intervals not exceeding 24 hours. DESOGEN® may be initiated using either a Sunday start or a Day 1 start.
NOTE: Seven different "day label strips" are provided to accommodate the selected start regimen. The patient should place the self-adhesive "day label strip" that corresponds to her starting day on the blister card above the first row of tablets.
DURING THE FIRST CYCLE OF USE
IMPORTANT: The possibility of ovulation and conception prior to initiation of use of DESOGEN® Tablets (desogestrel and ethinyl estradiol tablets USP) should be considered. A woman can begin to take DESOGEN® either on the first Sunday after the onset of her menstrual period (Sunday Start) or on the first day of her menstrual period (Day 1 Start). When switching from another oral contraceptive, DESOGEN® should be started on the same day that a new pack of the previous oral contraceptive would have been started.
SUNDAY START
When initiating a Sunday start regimen, another method of contraception, such as condoms or spermicide, should be used for the first 7 consecutive days of taking DESOGEN® Tablets (desogestrel and ethinyl estradiol tablets USP).
Using a Sunday start, tablets are taken daily without interruption as follows: The first white tablet should be taken on the first Sunday after menstruation begins (if menstruation begins on Sunday, the first white tablet is taken on that day). Tablets are then taken sequentially following the arrows marked on the blister card. One white tablet is taken daily for 21 days, followed by 1 green (inactive) tablet daily for 7 days. For all subsequent cycles, the patient then begins a new 28-tablet regimen on the next day (Sunday) after taking the last green (inactive) tablet. [If switching from a different Sunday Start oral contraceptive, the first DESOGEN® tablet should be taken on the same day that a new pack of the previous oral contraceptive would have been started.]
If a patient misses 1 white (active) tablet in Weeks 1, 2, or 3, she should take the missed tablet as soon as she remembers. If the patient misses 2 consecutive white tablets in Week 1 or Week 2, the patient should take 2 tablets the day she remembers and 2 tablets the next day; thereafter, the patient should resume taking 1 tablet daily until she finishes the cycle pack. The patient should be instructed to use a back-up method of birth control (such as condoms or spermicide) if she has intercourse in the 7 days after she restarts her pills. If the patient misses 2 consecutive white tablets in the third week or misses 3 or more white tablets in a row at any time during the cycle, the patient should keep taking 1 white tablet daily until the next Sunday. On Sunday the patient should throw out the rest of that cycle pack and start a new cycle pack that same day. The patient should be instructed to use a back-up method of birth control if she has intercourse in the 7 days after restarting her pills.
Complete instructions to facilitate patient counseling on proper pill usage can be found in Detailed or Brief Patient Labeling ("How to Take the Pill" section).
DAY 1 START
Counting the first day of menstruation as "Day 1", the first white tablet should be taken on the first day of menstrual bleeding. Tablets are then taken sequentially without interruption as follows: One white tablet daily for 21 days, then one green (inactive) tablet daily for 7 days. For all subsequent cycles, the patient then begins a new 28-tablet regimen on the next day after taking the last green (inactive) tablet. [If switching directly from another oral contraceptive, the first white tablet should be taken on the same day that a new pack of the previous oral contraceptive would have been started.] If a patient misses 1 white tablet, she should take the missed tablet as soon as she remembers. If the patient misses 2 consecutive white tablets in Week 1 or Week 2, the patient should take 2 tablets the day she remembers and 2 tablets the next day; thereafter, the patient should resume taking 1 tablet daily until she finishes the cycle pack. The patient should be instructed to use a back-up method of birth control (such as condoms or spermicide) if she has intercourse in the 7 days after she restarts her pills. If the patient misses 2 consecutive white tablets in the third week or misses 3 or more white tablets in a row at any time during the cycle, the patient should throw out the rest of that cycle pack and start a new cycle pack that same day. The patient should be instructed to use a back-up method of birth control if she has intercourse in the 7 days after restarting her pills.
Complete instructions to facilitate patient counseling on proper pill usage can be found in Detailed or Brief Patient Labeling ("How to Take the Pill" section).
ADDITIONAL INSTRUCTIONS FOR BOTH SUNDAY AND DAY 1 STARTS
If Spotting or Breakthrough Bleeding Occurs
Breakthrough bleeding, spotting, and amenorrhea are frequent reasons for patients discontinuing oral contraceptives. In breakthrough bleeding, as in all cases of irregular bleeding from the vagina, non-functional causes should be considered. In undiagnosed persistent or recurrent abnormal bleeding from the vagina, adequate diagnostic measures are indicated to rule out pregnancy or malignancy. If both pregnancy and pathology have been excluded, time or a change to another preparation may solve the problem. Changing to an oral contraceptive with a higher estrogen content, while potentially useful in minimizing menstrual irregularity, should be done only if necessary since this may increase the risk of thromboembolic disease.
Use of DESOGEN® in the Event of a Missed Menstrual Period
- If the patient has not adhered to the prescribed schedule, the possibility of pregnancy should be considered at the time of the first missed period and DESOGEN® Tablets (desogestrel and ethinyl estradiol tablets USP) use should be discontinued if pregnancy is confirmed.
- If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out. DESOGEN® should be discontinued if pregnancy is confirmed.
Use of DESOGEN® Postpartum
The use of DESOGEN® Tablets (desogestrel and ethinyl estradiol tablets USP) for contraception may be initiated 4 to 6 weeks postpartum in women who elect not to breast-feed. When the tablets are administered during the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered (see CONTRAINDICATIONS and WARNINGS concerning Thromboembolic Disorders. See also PRECAUTIONS for Nursing Mothers).
If the patient starts on DESOGEN® postpartum, and has not yet had a period, she should be instructed to use another method of contraception until a white tablet has been taken daily for 7 consecutive days.
