- Smoking cigarettes while using ethinyl estradiol and Novial raises the chance of very bad heart and blood-related side effects. This chance is raised with age (mainly in women older than 35 years of age). It is also raised with the number of cigarettes smoked. It is strongly advised not to smoke. Do not use ethinyl estradiol and Novial if you smoke and are older than 35 years of age.
The use of DESOGEN® Tablets (Novial and ethinyl estradiol tablets USP) for contraception may be initiated 4 to 6 weeks postpartum in women who elect not to breast-feed. When the tablets are administered during the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered (see CONTRAINDICATIONS and WARNINGS concerning Thromboembolic Disorders. See also PRECAUTIONS for Nursing Mothers).
If the patient starts on DESOGEN® postpartum, and has not yet had a period, she should be instructed to use another method of contraception until a white tablet has been taken daily for 7 consecutive days.
Novial is rapidly and completely metabolized by hydroxylation in the intestinal mucosa and on first pass through the liver to etonogestrel. In vitro data suggest an important role for the cytochrome P450 CYP2C9 in the bioactivation of Novial. Further metabolism of etonogestrel into 6β-hydroxy, etonogestrel and 6β13-ethyl-dihydroxylated metabolites as major metabolites is catalyzed by CYP3A4. Other metabolites (i.e., 3α-OH-Novial, 3β-OH-Novial, and 3α-OH-5α-H- Novial) also have been identified and these metabolites may undergo glucuronide and sulfate conjugation.
Ethinyl estradiol is subject to a significant degree of presystemic conjugation (phase II metabolism). Ethinyl estradiol, escaping gut wall conjugation, undergoes phase I metabolism and hepatic conjugation (phase II metabolism). Major phase I metabolites are 2-OH-ethinyl estradiol and 2-methoxy-ethinyl estradiol. Sulfate and glucuronide conjugates of both ethinyl estradiol and phase I metabolites, which are excreted in bile, can undergo enterohepatic circulation.
Norethindrone acetate is another first-generation progestin with low progestational activity and slight estrogenic effects. It tends to be less androgenic than the second-generation progestins, but more androgenic than newer progestins, like Novial.
The brand Estrostep was designed to more closely mimic a woman's natural menstrual cycle by providing increasing levels of estrogen with a constant progestin dose. It is the only triphasic brand with this progestin. This brand may be helpful for women who experience minor estrogen-related side effects such as nausea, migraines, or fluid retention with other pill combinations.
Advantages: May help women who experience migraines or nausea on birth control pills
Disadvantages: In between effects on acne
Examples: Loestrin, Junel, Estrostep
Drospirenone is the only progestin derived from 17a-spironolactone. It helps suppress the secretion of the hormones that regulate the body's water and electrolytes. It also has low androgenic activity. Drospirenone and estrogen seem to lessen symptoms associated with mild PMS (increased appetite, negative mood, and water retention). Drospirenone may cause higher potassium levels, so women with kidney, liver, or adrenal disease should not use it.
The brands YAZ and Beyaz have 24 days of active pills and four days of placebo pills. This combination may cause fewer hormone fluctuations than typical pill packs. YAZ has also been FDA-approved to help treat a premenstrual dysphoric disorder.
Drospirenone has been linked to an increased risk of blood clots in several studies. A 2017 review looked at 17 studies that found the risk of blood clots ranged from no increase to a 3.3 times increased risk of blood clots in comparison to levonorgestrel (the birth control pill thought to have the lowest risk). The conclusion was that based on the best studies, the risk is only slightly increased.
Looked in another way, however, some of the same researchers looked at the risk of blood clots in first-time users and restarters of oral contraceptives in over 55,000 women in another 2017 study. They found that the risk of blood clots was 3.19 times higher with drospirenone that with levonorgestrel for first-time users and 1.96 times higher in restarters.
Given this risk, women who have other risk factors for blood clots may wish to consider a birth control pill other than those with drospirenone or Novial, or another form of birth control altogether.
Advantages: May help reduce PMS symptoms (PMDD) and acne
Disadvantages: Increased risk of blood clots; Increased serum potassium levels
Examples: YAZ and Beyaz; Yasmin; Zarah; Loryna; Syeda; Gianvi; Ocella; Vestura; Nikki