ZEOSA- norethindrone and ethinyl estradiol, and ferrous fumarate
Teva Pharmaceuticals USA Inc
DESCRIPTION
ZEOSA� norethindrone and ethinyl estradiol tablets USP (chewable) and ferrous fumarate tablets USP (chewable) provides a regimen for oral contraception derived from 21 light yellow tablets composed of norethindrone and ethinyl estradiol followed by 7 brown ferrous fumarate (placebo) tablets. The chemical name for norethindrone is 17-hydroxy-19-nor-17α-pregn-4-en-20-yn-3-one and for ethinyl estradiol the chemical name is 19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol
NORETHINDRONE ETHINYL ESTRADIOL
C20 H26 O2 C20 H24 O2 Molecular Weight: 298.42 Molecular Weight: 296.40
The active light yellow norethindrone and ethinyl estradiol tablets contain 0.4 mg norethindrone USP and 0.035 mg ethinyl estradiol USP and the following inactive ingredients: anhydrous lactose, ferric oxide, magnesium stearate, natural spearmint flavor (gum acacia and maltodextrin), pregelatinized starch and sucralose powder.
The inert brown ferrous fumarate tablets contain confectioner's sugar, ferrous fumarate USP, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, sucralose powder and povidone. The ferrous fumarate tablets do not serve any therapeutic purpose.
CLINICAL PHARMACOLOGY
Combination oral contraceptives act by suppression of gonadotropins. Although the primary mechanism of this action is inhibition of ovulation, other alterations include changes in the cervical mucus (which increase the difficulty of sperm entry into the uterus) and the endometrium (which reduce the likelihood of implantation).
INDICATIONS AND USAGE
ZEOSA� norethindrone and ethinyl estradiol tablets USP (chewable) and ferrous fumarate tablets USP (chewable) are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.
Oral contraceptives are highly effective. Table 2 lists the typical unintended pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and implants, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.
CONTRAINDICATIONS
Combination oral contraceptives should not be used in women who currently have the following conditions:
�
Thrombophlebitis or thromboembolic disorders
�
History of deep vein thrombophlebitis or thromboembolic disorders
�
Cerebrovascular or coronary artery disease (current or history)
�
Valvular heart disease with thrombogenic complications
�
Uncontrolled hypertension
�
Diabetes with vascular involvement
�
Headaches with focal neurological symptoms, such as aura
�
Major surgery with prolonged immobilization
�
Known or suspected carcinoma of the breast or personal history of breast cancer
�
Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia
�
Undiagnosed abnormal genital bleeding
�
Cholestatic jaundice of pregnancy or jaundice with prior pill use
�
Hepatic adenomas or carcinomas, or active liver disease
�
Known or suspected pregnancy
�
Hypersensitivity to any component of this product
DOSAGE AND ADMINISTRATION
To achieve maximum contraceptive effectiveness, ZEOSA tablets must be taken exactly as directed and at intervals not exceeding 24 hours. The dosage is one light yellow tablet daily for 21 consecutive days, followed by one brown tablet daily for 7 consecutive days. It is recommended that tablets be taken at the same time each day. The pill may be swallowed whole or chewed and swallowed. If the pill is chewed, the patient should drink a full glass (8 ounces) of liquid immediately after swallowing. During the first cycle of use, the patient is instructed to begin taking tablets on either Day 1 or the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, the first tablet (light yellow) is taken that day. One light yellow tablet should be taken daily for 21 consecutive days followed by one brown tablet daily for 7 consecutive days. Withdrawal bleeding should usually occur within three days following discontinuation of light yellow tablets and may not have finished before the next pack is started. During the first cycle with a Sunday start, contraceptive reliance should not be placed on norethindrone and ethinyl estradiol tablets, until a light yellow tablet has been taken daily for 7 consecutive days and a nonhormonal back-up method of birth control (such as condoms or spermicides) should be used during those 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered.
The patient begins her next and all subsequent 28-day courses of tablets on the same day of the week on which she began her first course, following the same schedule: 21 days on light yellow tablets-7 days on brown tablets. If in any cycle the patient starts tablets later than the proper day, she should protect herself against pregnancy by using a nonhormonal back-up method of birth control until she has taken a light yellow tablet daily for 7 consecutive days.
When the patient is switching from a 21-day regimen of tablets, she should wait 7 days after her last tablet before she starts norethindrone and ethinyl estradiol tablets (chewable) and ferrous fumarate tablets (chewable). She will probably experience withdrawal bleeding during that week. She should be sure that no more than 7 days pass after her previous 21-day regimen. When the patient is switching from a 28-day regimen of tablets, she should start her first pack of norethindrone and ethinyl estradiol tablets (chewable) and ferrous fumarate tablets (chewable) on the day after her last tablet. She should not wait any days between packs. The patient may switch any day from a progestin-only pill and should begin norethindrone and ethinyl estradiol tablets (chewable) and ferrous fumarate tablets (chewable) the next day. If switching from an implant or injection, the patient should start norethindrone and ethinyl estradiol tablets (chewable) and ferrous fumarate tablets (chewable) on the day of implant removal or, if using an injection, the day the next injection would be due.
If spotting or breakthrough bleeding occurs, the patient is instructed to continue on the same regimen. This type of bleeding is usually transient and without significance; however, if the bleeding is persistent or prolonged, the patient is advised to consult her healthcare provider. Although pregnancy is unlikely if norethindrone and ethinyl estradiol tablets (chewable) and ferrous fumarate tablets (chewable) are taken according to directions, if withdrawal bleeding does not occur, the possibility of pregnancy must be considered. If the patient has not adhered to the prescribed schedule (missed one or more tablets or started taking them on a day later than she should have), the probability of pregnancy should be considered at the time of the first missed period and appropriate diagnostic measures taken. If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out. Hormonal contraceptives should be discontinued if pregnancy is confirmed.
