Ethynodiol and ethinyl estradiol

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 Zovia 1/35 with HCV drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to potential for ALT elevations (see Warnings , RISK OF LIVER ENZYME ELEVATIONS WITH CONCOMITANT HEPATITIS C TREATMENT ). 8. Laboratory test interactions. Certain endocrine and liver function tests and blood components may be affected by oral contraceptives: a. Increased prothrombin and factors VII, VIII, IX and X; decreased antithrombin III; increased platelet aggregability. b.

Increased thyroid binding globulin (TBG), leading to increased circulating total thyroid hormone as measured by protein-bound iodine (PBI), T4 by column or by radioimmunoassay. Free T3 resin uptake is decreased, reflecting the elevated TBG; free T4 concentration is unaltered. c. Other binding proteins may be elevated in the serum. d. 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. e. Triglycerides and phospholipids may be increased. f. Glucose tolerance may be decreased. g. Serum folate levels may be depressed.

This may be of clinical significance if a woman becomes pregnant shortly after discontinuing oral contraceptives. h. Increased sulfobromophthalein and other abnormalities in liver function tests may occur. i. Plasma levels of trace minerals may be altered. j. Response to the metyrapone test may be reduced. 9.

Pregnancy. Pregnancy Category X. (See CONTRAINDICATIONS and WARNINGS .) 11. Nursing mothers. Small amounts of oral contraceptive steroids have been identified in the milk of nursing mothers 141-143 and a few adverse effects on the child have been reported, including jaundice and breast enlargement. In addition, oral contraceptives given in the postpartum period may interfere with lactation by decreasing the quantity and quality of breast milk. If possible, the nursing mother should be advised not to use oral contraceptives, but to use other forms of contraception until she has completely weaned her child. 12. Pediatric use.

Safety and efficacy of Zovia 1/35 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 Chlamydia trachomatis and Neisseria gonorrhoeae in oral contraceptive users is increased several-fold.

144, 145 It should not be assumed that oral contraceptives afford protection against pelvic inflammatory disease from chlamydia.144 Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases. 14. General. a. The pathologist should be advised of oral contraceptive therapy when relevant specimens are submitted. b. Treatment with oral contraceptives may mask the onset of the climacteric. (See WARNINGS regarding risks in this age group.) GENERAL PRECAUTIONS 1. Missed periods and use of oral contraceptives before or during early pregnancy. Occasionally women who are taking the pill miss periods.

It has been reported to occur as frequently as several times each year in some women, depending on various factors such as age and prior history (your doctor is the best source of information about this). The pill should not be used when you are pregnant or suspect you may be pregnant. Very rarely, women who are using the pill as directed become pregnant. The likelihood of becoming pregnant is higher if you occasionally miss one or two pills. Therefore, if you miss a period you should consult your physician before continuing to take the pill.

If you miss a period, especially if you have not taken the pill regularly, you should use an alternative method of contraception until pregnancy has been ruled out; if you have missed more than one pill at any time, you should…

Nursing mothers. Small amounts of oral contraceptive steroids have been identified in the milk of nursing mothers 141-143 and a few adverse effects on the child have been reported, including jaundice and breast enlargement. In addition, oral contraceptives given in the postpartum period may interfere with lactation by decreasing the quantity and quality of breast milk. If possible, the nursing mother should be advised not to use oral contraceptives, but to use other forms of contraception until she has completely weaned her child. 12. Pediatric use. Safety and efficacy of Zovia 1/35 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 Chlamydia trachomatis and Neisseria gonorrhoeae in oral contraceptive users is increased several-fold. 144, 145 It should not be assumed that oral contraceptives afford protection against pelvic inflammatory disease from chlamydia.144 Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases. 14.

General. a. The pathologist should be advised of oral contraceptive therapy when relevant specimens are submitted. b. Treatment with oral contraceptives may mask the onset of the climacteric. (See WARNINGS regarding risks in this age group.) GENERAL PRECAUTIONS 1. Missed periods and use of oral contraceptives before or during early pregnancy. Occasionally women who are taking the pill miss periods. It has been reported to occur as frequently as several times each year in some women, depending on various factors such as age and prior history (your doctor is the best source of information about this). The pill should not be used when you are pregnant or suspect you may be pregnant.

Very rarely, women who are using the pill as directed become pregnant. The likelihood of becoming pregnant is higher if you occasionally miss one or two pills. Therefore,…