Ethynodiol

• 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.ICD-10: Z30.9

• 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 Warnings , RISK OF LIVER ENZYME ELEVATIONS WITH CONCOMITANT HEPATITIS C TREATMENT).contraindicated

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.

Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke. The use of oral contraceptives is associated with increased risk of several serious conditions including venous and arterial thromboembolism, thrombotic and hemorrhagic stroke, myocardial infarction, liver tumors or other liver lesions, and gallbladder disease. The risk of morbidity and mortality increases significantly in the presence of other risk factors such as hypertension, hyperlipidemia, obesity, and diabetes mellitus. Practitioners prescribing oral contraceptives should be familiar with the following information relating to these and other risks. The information contained herein is principally based on studies carried out in patients who used oral contraceptives with formulations containing higher amounts of estrogens and progestogens than those in common use today. The effect of long-term use of the oral contraceptives with lesser amounts of both estrogens and progestogens remains to be determined. Throughout this labeling, epidemiological studies reported are of two types: retrospective case-control studies and prospective cohort studies. Case-control studies provide an estimate of the relative risk of a disease, which is defined as the ratio of the incidence of a disease among oral contraceptive users to that among nonusers.

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 …

Serious ill effects have not been reported following acute ingestion of large doses of oral contraceptives by young children. 180, 181 Overdosage may cause nausea, and withdrawal bleeding may occur in females. 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. 148, 149 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

• May 23, 2005ANDAANDA076785Barr
• Feb 9, 2016ANDAANDA204704Xiromed
• Jul 28, 2016ANDAANDA204703Xiromed
• Feb 11, 2019ANDAANDA209548Novast Labs

1. 1Headache127.6%
2. 2Nausea117.0%
3. 3Anxiety95.7%
4. 4Dizziness85.1%
5. 5Fatigue74.4%
6. 6Vomiting74.4%
7. 7Condition Aggravated63.8%
8. 8Diarrhoea63.8%
9. 9Muscle Spasms63.8%
10. 10Product Dose Omission Issue63.8%
11. 11Product Substitution Issue63.8%
12. 12Product Use In Unapproved Indication63.8%
13. 13Rash63.8%
14. 14Visual Impairment63.8%
15. 15Depression53.2%

The 1 most recently updated of 1 ClinicalTrials.gov registrations naming Ethynodiol as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Study To Determine Bioequivalence Between The Commercial Femulen Tablets And A Reformulation Of Femulen Tablets In Healthy Female Subjects
  Completed · Phase 1 · Interventional · 20 enrolled · Pfizer
  NCT01359163updated 2012-04-04

Frequently asked questions

What is Ethynodiol used for?

According to FDA labeling, Ethynodiol carries indications including: 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Ethynodiol?

Ethynodiol is classified as Estren derivatives, Progestin, Decreased Placental Human Chorionic Gonadotropin Secretion.

What are the contraindications for Ethynodiol?

Ethynodiol labeling lists contraindications including: 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 Warnings , RISK OF LIVER ENZYME ELEVATIONS WITH CONCOMITANT HEPATITIS C TREATMENT).. Always consult the full prescribing information and a clinician.