Generic Name
Ethynodiol
Brand Names
Valtya, Kelnor, Zovia
FDA approval date: June 20, 2005
Form: Kit
What is Valtya (Ethynodiol)?
Ethynodiol diacetate and ethinyl estradiol tablets USP, 1 mg/35 mcg are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. 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. Emergency Contraceptive Pills : Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%. The treatment schedule is one dose within 72 hours after unprotected intercourse and a second dose 12 hours after the first dose. The Food and Drug Administration has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral , Alesse , Nordette or Levlen , Lo/Ovral , Triphasil or Tri-Levlen . Lactational Amenorrhea Method : LAM is a highly effective, temporary method of contraception. However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches six months of age. Source: Trussell J, Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers, 1998, in press. 1 % of women experiencing an unintended pregnancy within the first year of use % of women continuing use at one year Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. Method Typical use Among typical couples who initiate use of a method , the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. Perfect use Among couples who initiate use of a method and who use it perfectly , the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. Chance The percents becoming pregnant in columns and are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. 85 85 Spermicides Foams, creams, gels, vaginal suppositories, and vaginal film. 26 6 40 Periodic abstinence 25 63 Calendar 9 Ovulation method 3 Sympto-thermal Cervical mucus method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. 2 Post-ovulation 1 Withdrawal 19 4 Cap With spermicidal cream or jelly. Parous women 40 26 42 Nulliparous women 20 9 56 Sponge Parous women 40 20 42 Nulliparous women 20 9 56 Diaphragm 20 6 56 Condom Without spermicides. Female 21 5 56 Male 14 3 61 Pill 5 71 Progestin only.
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Brand Information
VALTYA 1/50 (ethynodiol diacetate and ethinyl estradiol)
1DESCRIPTION
Valtya 1/50: Each orange tablet contains 1 mg of ethynodiol diacetate and 50 mcg of ethinyl estradiol, and the inactive ingredients include lactose monohydrate, povidone K-25, microcrystalline cellulose, polacrilin potassium, magnesium stearate. In addition, the coloring agent is FD&C Yellow No. 6 Aluminum Lake. Each green tablet in the Valtya 1/50 package is an inert tablet containing no active ingredients, and the inactive ingredients include lactose monohydrate, polacrilin potassium, magnesium stearate, yellow iron oxide and FD&C Blue No. 1 Aluminum Lake.
The chemical name for ethynodiol diacetate is 19-Nor-17α-pregn-4-en-20-yne-3β, 17-diol diacetate, and for ethinyl estradiol it is 19-Nor-17α-pregna-1,3,5(10)-trien-20-yne-3, 17-diol. The structural formulas are as follows:
Therapeutic class: Oral contraceptive.
2CLINICAL PHARMACOLOGY
Combination oral contraceptives act primarily by suppression of gonadotropins. Although the primary mechanism of this action is inhibition of ovulation, other alterations in the genital tract, including changes in the cervical mucus (which increase the difficulty of sperm entry into the uterus) and the endometrium (which may reduce the likelihood of implantation) may also contribute to contraceptive effectiveness.
3INDICATIONS 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.
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 RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F,
(A) Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.
(B) Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.
(C) Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year.
(D) The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether.
(E) Foams, creams, gels, vaginal suppositories, and vaginal film.
(F) Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases.
(G) With spermicidal cream or jelly.
(H) Without spermicides.
(I) The treatment schedule is one dose within 72 hours after unprotected intercourse and a second dose 12 hours after the first dose. The Food and Drug Administration has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral (1 dose is 2 white pills), Alesse (1 dose is 5 pink pills), Nordette or Levlen (1 dose is 2 light-orange pills), Lo/Ovral (1 dose is 4 white pills), Triphasil or Tri-Levlen (1 dose is 4 yellow pills).
(J) However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches six months of age.
4CONTRAINDICATIONS
Valtya 1/50 is contraindicated in females who are known to have or develop the following conditions:
Thrombophlebitis or thromboembolic disorders A past history of deep vein thrombophlebitis or thromboembolic disorders Cerebral vascular disease, myocardial infarction, or coronary artery disease, or a past history of these conditions Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive Known or suspected carcinoma of the female reproductive organs or suspected estrogen-dependent neoplasia, or a history of these conditions Undiagnosed abnormal genital bleeding History of cholestatic jaundice of pregnancy or jaundice with prior oral contraceptive use Past or present, benign or malignant liver tumors Known or suspected pregnancy Are receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations (see
5PRECAUTIONS
1. Physical examination and follow-up
It is good medical practice for all women to have annual history and physical examinations, including women using oral contraceptives. The physical examination, however, may be deferred until after initiation of oral contraceptives if requested by the woman and judged appropriate by the clinician. The physical examination should include special reference to blood pressure, breasts, abdomen, and pelvic organs, including cervical cytology, and relevant laboratory tests. In case of undiagnosed, persistent, or recurrent abnormal vaginal bleeding, appropriate measures should be conducted to rule out malignancy. Women with a strong family history of breast cancer or who have breast nodules should be monitored with particular care.
2. Lipid disorders
Women who are being treated for hyperlipidemias should be followed closely if they elect to use oral contraceptives. Some progestogens may elevate LDL levels and may render the control of hyperlipidemias more difficult.
3. Liver function
If jaundice develops in any woman receiving oral contraceptives, they should be discontinued. Steroids may be poorly metabolized in patients with impaired liver function and should be administered with caution in such patients. Cholestatic jaundice has been reported after combined treatment with oral contraceptives and troleandomycin. Hepatotoxicity following a combination of oral contraceptives and cyclosporine has also been reported.
4. Fluid retention
Oral contraceptives may cause some degree of fluid retention. They should be prescribed with caution, and only with careful monitoring, in patients with conditions that might be aggravated by fluid retention, such as convulsive disorders, migraine syndrome, asthma, or cardiac, hepatic, or renal dysfunction.
5. Emotional disorders
Women with a history of depression should be carefully observed and the drug discontinued if depression recurs to a serious degree.
6. Contact lenses
Contact lens wearers who develop visual changes or changes in lens tolerance should be assessed by an ophthalmologist.
7. Drug interactions
Reduced efficacy and increased incidence of breakthrough bleeding and menstrual irregularities have been associated with concomitant use of rifampin. A similar association, though less marked, has been suggested for barbiturates, phenylbutazone, phenytoin sodium, and possibly with griseofulvin, ampicillin, and tetracyclines. Administration of troglitazone concomitantly with a combination oral contraceptive (estrogen and progestin) reduced the plasma concentrations of both hormones by approximately 30%. This could result in loss of contraceptive efficacy.
Concomitant Use with HCV Combination Therapy – Liver Enzyme Elevation
Do not co-administer ethynodiol diacetate and ethinyl estradiol with HCV drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to potential for ALT elevations (see
8. Laboratory test interactions
Certain endocrine and liver function tests and blood components may be affected by oral contraceptives:
- Increased prothrombin and factors VII, VIII, IX and X; decreased antithrombin III; increased platelet aggregability.
- Increased thyroid binding globulin (TBG), leading to increased circulating total thyroid hormone as measured by proteinbound iodine (PBI), T
- Other binding proteins may be elevated in the serum.
- Sex-steroid binding globulins are increased and result in elevated levels of total circulating sex steroids and corticoids; however, free or biologically active levels remain unchanged.
- Triglycerides and phospholipids may be increased.
- Glucose tolerance may be decreased.
- Serum folate levels may be depressed. This may be of clinical significance if a woman becomes pregnant shortly after discontinuing oral contraceptives.
- Increased sulfobromophthalein and other abnormalities in liver function tests may occur.
- Plasma levels of trace minerals may be altered.
- Response to the metyrapone test may be reduced.
9. Carcinogenesis
(See
10. Pregnancy
11. Nursing mothers
Small amounts of oral contraceptive steroids have been identified in the milk of nursing mothers
12. Pediatric use
Safety and efficacy of Ethynodiol Diacetate and Ethinyl Estradiol Tablets have been established in women of reproductive age. Safety and efficacy are expected to be the same for postpubertal adolescents under the age of 16 and for users 16 years and older. Use of this product before menarche is not indicated.
13. Venereal diseases
Oral contraceptives are of no value in the prevention or treatment of venereal disease. The prevalence of cervical
14. General
- The pathologist should be advised of oral contraceptive therapy when relevant specimens are submitted.
- Treatment with oral contraceptives may mask the onset of the climacteric. (See
6INFORMATION FOR THE PATIENT
See
7ADVERSE REACTIONS
An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (see
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
7.1Post 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.
8OVERDOSAGE
Serious ill effects have not been reported following acute ingestion of large doses of oral contraceptives by young children.
NON-CONTRACEPTIVE HEALTH BENEFITS
The following non-contraceptive health benefits related to the use of oral contraceptives are supported by epidemiological studies that largely utilized oral contraceptive formulations containing estrogen doses exceeding 35 mcg of ethinyl estradiol or 50 mcg of mestranol.
Effects on menses:
Increased menstrual cycle regularity Decreased blood loss and decreased risk of iron-deficiency anemia Decreased frequency of dysmenorrhea
Effects related to inhibition of ovulation:
Decreased risk of functional ovarian cysts Decreased risk of ectopic pregnancies
Effects from long-term use:
Decreased risk of fibroadenomas and fibrocystic disease of the breast Decreased risk of acute pelvic inflammatory disease Decreased risk of endometrial cancer Decreased risk of ovarian cancer Decreased risk of uterine fibroids
9DOSAGE 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
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
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
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.
10HOW SUPPLIED
Each orange Valtya 1/50 tablet is round in shape, unscored and debossed with
Valtya 1/50 is packaged in cartons of three (NDC 70700-305-85) tablet dispensers. Each dispenser (NDC 70700-305-84) contains 21 orange tablets and 7 green inert tablets. (Inert tablets are debossed with
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
11REFERENCES
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12PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 70700-305-85
Rx only
Valtya™ 1/50 (Ethynodiol Diacetate and Ethinyl Estradiol Tablets USP, 1 mg/50 mcg)
3 pouches, each contains one blister pack of 28 tablets
