Ethynodiol

INDICATIONS AND USAGE Valtya 1/50 is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptive products such as Valtya 1/50, which contain 50 mcg of estrogen, should not be used unless medically indicated. Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization and progestogen implants and injections, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. Table 1. Percentage of women experiencing an unintended pregnancy during the first year of typical use and the first year of perfect use of contraception and the percentage continuing use at the end of the first year. United States. % of women experiencing an unintended pregnancy within the first year of use % of women continuing use at one year (C) Method (1) Typical use (A) (2) Perfect use (B) (3) (4) Chance (D) 85 85 Spermicides (E) 26 6 40 Periodic abstinence 25 63 Calendar 9 Ovulation method 3 Sympto-thermal (F) 2 Post-ovulation 1 Withdrawal 19 4 Cap (G) Parous women 40 26 42 Nulliparous women 20 9 56 Sponge Parous women 40 20 42 Nulliparous women 20 9 56 Diaphragm (G) 20 6 56 Condom (H) Female (Reality ) 21 5 56 Male 14 3 61 Pill 5 71 Progestin only 0.5 Combined 0.1 IUD Progesterone T 2 1.5 81 Copper T 380A 0.8 0.6 78 LNg 20 0.1 0.1 81 Injection (Depo-Provera) 0.3 0.3 70 Implant (Norplant and Norplant-2) 0.05 0.05 88 Female sterilization 0.5 0.5 100 Male sterilization 0.15 0.1 100 Emergency Contraceptive Pills : Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%. (I) Lactational Amenorrhea Method : LAM is a highly effective, temporary method of contraception. (J) Source: Trussell J, Contraceptive efficacy. In Hatcher

DOSAGE AND ADMINISTRATION To achieve maximum contraceptive effectiveness, oral contraceptives must be taken exactly as directed and at intervals of 24 hours. IMPORTANT: If the Sunday start schedule is selected, the patient should be instructed to use an additional method of protection until after the first week of administration in the initial cycle. The possibility of ovulation and conception prior to initiation of use should be considered. Dosage Schedules Each Valtya 1/50 tablet dispenser contains 21 orange colored active tablets arranged in three numbered rows of 7 tablets each, followed by a fourth row of 7 green inert tablets. Days of the week are printed above the tablets, starting with Sunday on the left. 28-Day Schedule: For a DAY 1 START, count the first day of menstrual flow as Day 1 and the first tablet (orange) is then taken on Day 1. For a SUNDAY START when menstrual flow begins on or before Sunday, the first tablet (orange) is taken on that day. With either a DAY 1 START or SUNDAY START, 1 tablet (orange) is taken each day at the same time for 21 days. Then the green tablets are taken for 7 days, whether bleeding has stopped or not. After all 28 tablets have been taken, whether bleeding has stopped or not, the same dosage schedule is repeated beginning on the following day. Special notes Spotting, breakthrough bleeding, or nausea. If spotting (bleeding insufficient to require a pad), breakthrough bleeding (heavier bleeding similar to a menstrual flow), or nausea occurs the patient should continue taking her tablets as directed. The incidence of spotting, breakthrough bleeding or nausea is minimal, most frequently occurring in the first cycle. Ordinarily spotting or breakthrough bleeding will stop within a week. Usually the patient will begin to cycle regularly within two or three courses of tablet-taking. In the event of spotting or breakthrough bleeding organic causes should be borne in mind. (See WARNING No. 11. ) Missed menstrual periods. Withdrawal flow will normally occur 2 or 3 days after the last active tablet is taken. Failure of withdrawal bleeding ordinarily does not mean that the patient is pregnant, providing the dosage schedule has been correctly followed. (See WARNING No. 6. ) If the patient has not adhered to the prescribed dosage regimen, the possibility of pregnancy should be considered after the first missed period, and oral contraceptives should be withheld until pregnancy has been ruled out. If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out before continuing the contraceptive regimen. The first intermenstrual interval after discontinuing the tablets is usually prolonged; consequently, a patient for whom a 28-day cycle is usual might not begin to menstruate for 35 days or longer. Ovulation in such prolonged cycles will occur correspondingly later in the cycle. Post-treatment cycles after the first one, however, are usually typical for the individual woman prior to taking tablets. (See WARNING No. 11. ) Missed tablets. If a woman misses taking one active tablet, the missed tablet should be taken as soon as it is remembered. In addition, the next tablet should be taken at the usual time. If two consecutive active tablets are missed in week 1 or week 2 of the dispenser, the dosage should be doubled for the next 2 days. The regular schedule should then be resumed, but an additional method of protection must be used as backup for the next 7 days if she has sex during that time or she may become pregnant. If two consecutive active tablets are missed in week 3 of the dispenser or three consecutive active tablets are missed during any of the first 3 weeks of the dispenser, direct the patient to do one of the following: Day 1 Starters should discard the rest of the dispenser and begin a new dispenser that same day; Sunday Starters should continue to take 1 tablet daily until Sunday, discard the rest of the dispenser and begin a new dispenser that same day. The patient may not have a period this month; however, if she has missed two consecutive periods, pregnancy should be ruled out. An additional method of protection must be used as a backup for the next 7 days after the tablets are missed if she has sex during that time or she may become pregnant. While there is little likelihood of ovulation if only one active tablet is missed, the possibility of spotting or breakthrough bleeding is increased and should be expected if two or more successive active tablets are missed. However, the possibility of ovulation increases with each successive day that scheduled active tablets are missed. If one or more inert tablets are missed, the schedule should be resumed on the eighth day after the last orange colored tablet was taken. Omission of inert tablets in the 28-tablet courses does not increase the possibility of conception provided that this schedule is followed.

ADVERSE REACTIONS An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (see WARNINGS ): Thrombophlebitis and thrombosis Arterial thromboembolism Pulmonary embolism Myocardial infarction and coronary thrombosis Cerebral hemorrhage Cerebral thrombosis Hypertension Gallbladder disease Benign and malignant liver tumors, and other hepatic lesions There is evidence of an association between the following conditions and the use of oral contraceptives, although additional confirmatory studies are needed: Mesenteric thrombosis Neuro-ocular lesions (e.g., retinal thrombosis and optic neuritis) The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug-related: Nausea Vomiting Gastrointestinal symptoms (such as abdominal cramps and bloating) Breakthrough bleeding Spotting Change in menstrual flow Amenorrhea during or after use Temporary infertility after discontinuation of use Edema Chloasma or melasma, which may persist Breast changes: tenderness, enlargement, secretion Change in weight (increase or decrease) Change in cervical erosion or secretion Diminution in lactation when given immediately postpartum Cholestatic jaundice Migraine Rash (allergic) Mental depression Reduced tolerance to carbohydrates Vaginal candidiasis Change in corneal curvature (steepening) Intolerance to contact lenses The following adverse reactions or conditions have been reported in users of oral contraceptives and the association has been neither confirmed nor refuted: Premenstrual syndrome Cataracts Changes in appetite Cystitis-like syndrome Headache Nervousness Dizziness Hirsutism Loss of scalp hair Erythema multiforme Erythema nodosum Hemorrhagic eruption Vaginitis Porphyria Impaired renal function Hemolytic uremic syndrome Acne Changes in libido Colitis Budd-Chiari syndrome Endocervical hyperplasia or ectropion Post Marketing Experience Five studies that compared breast cancer risk between ever-users (current or past use) of COCs and never-users of COCs reported no association between ever use of COCs and breast cancer risk, with effect estimates ranging from 0.90 - 1.12 (Figure 2). Three studies compared breast cancer risk between current or recent COC users (<6 months since last use) and never users of COCs (Figure 2). One of these studies reported no association between breast cancer risk and COC use. The other two studies found an increased relative risk of 1.19 - 1.33 with current or recent use. Both of these studies found an increased risk of breast cancer with current use of longer duration, with relative risks ranging from 1.03 with less than one year of COC use to approximately 1.4 with more than 8-10 years of COC use. Figure 2. Risk of Breast Cancer with Combined Oral Contraceptive Use RR = relative risk; OR = odds ratio; HR = hazard ratio. “ever COC” are females with current or past COC use; “never COC use” are females that never used COCs. Figure 2. Risk of Breast Cancer with Combined Oral Contraceptive Use