Dolishale 20 ug/1
Levonorgestrel and Ethinyl Estradiol · TABLET · Ingenus Pharmaceuticals, LLC
Dolishale is an oral birth control pill containing levonorgestrel and ethinyl estradiol that is used to prevent pregnancy. It combines two hormones—a progestin and an estrogen—to work as a contraceptive medication.
Key Facts
- Brand Name
- Dolishale
- Generic Name
- Levonorgestrel and Ethinyl Estradiol
- NDC Code (Product)
50742-659- Manufacturer
- Ingenus Pharmaceuticals, LLC
- Strength
- 20 ug/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA091692
- Drug Class
- Estrogen [EPC]; Progestin [EPC]
- Marketing Start
- 01/03/2021
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE DOLISHALE is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective for pregnancy prevention. Table 2 lists the typical unintended pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and implants, depend upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. Table 2: 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 3 Method (1) Typical Use 1 (2) Perfect Use 2 (3) (4) Chance 4 85 85 Spermicides 5 26 6 40 Periodic abstinence 25 63 Calendar 9 Ovulation Method 3 Sympto-Thermal 6 2 Post-Ovulation 1 Cap 7 Parous Women 40 26 42 Nulliparous Women 20 9 56 Sponge Parous Women 40 20 42 Nulliparous Wome…
Dosage & Administration
DOSAGE AND ADMINISTRATION To achieve maximum contraceptive effectiveness, DOLISHALE (levonorgestrel and ethinyl estradiol tablets) must be taken exactly as directed and at intervals not exceeding 24 hours. The possibility of ovulation and conception prior to initiation of medication should be considered. Women who do not wish to become pregnant after discontinuation should be advised to immediately use another method of birth control. The dosage of DOLISHALE is one green tablet daily without any tablet-free interval. It is recommended that DOLISHALE tablets be taken at the same time each day. Initiation of Therapy Instructions for beginning DOLISHALE are provided in Table 4 below. Table 4 Current contraceptive therapy DOLISHALE start day Nonhormonal back-up method of birth control needed when correctly starting DOLISHALE? None Day 1 of patient's menstrual cycle (during the first 24 hours of her period) No 21-day COC regimen OR 28-day COC regimen Day 1 of patient's withdrawal bleed, at the latest 7 days after her last active tablet. No Progestin-only pill Day after taking a progestin-only pill Yes, for the first 7 days of DOLISHALE tablet taking Implant Day of implant removal Yes, f…
Warnings
WARNINGS Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with the extent of smoking (in epidemiologic studies, 15 or more cigarettes per day was associated with a significantly increased risk) 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 risks of several serious conditions including venous and arterial thrombotic and thromboembolic events (such as myocardial infarction, thromboembolism, stroke, and transient ischemic attack), hepatic neoplasia, gallbladder disease, and hypertension, although the risk of serious morbidity or mortality is very small in healthy women without underlying risk factors. The risk of morbidity and mortality increases significantly in the presence of other underlying risk factors such as certain inherited or acquired thrombophilias, hypertension, hyperlipidemias, obesity, diabetes, and surgery or trauma with increased risk of thrombosis (see CONTRAINDICATIONS ). Practitioners prescribing oral contraceptives should be familiar with …
Contraindications
CONTRAINDICATIONS Combination oral contraceptives should not be used in women with any of the following conditions: • Thrombophlebitis or thromboembolic disorders • History of deep-vein thrombophlebitis or thromboembolic disorders • Cerebrovascular or coronary artery disease (current or past history) • Valvular heart disease with thrombogenic complications • Thrombogenic rhythm disorders • Hereditary or acquired thrombophilias • Major surgery with prolonged immobilization • Diabetes with vascular involvement • Headaches with focal neurological symptoms such as aura • Uncontrolled hypertension • Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive • Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia Undiagnosed abnormal genital bleeding • Cholestatic jaundice of pregnancy or jaundice with prior pill use • Hepatic adenomas or carcinomas, or active liver disease • Known or suspected pregnancy • Hypersensitivity to any of the components of DOLISHALE • Are receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations (see Warnings, R…
Adverse Reactions
ADVERSE REACTIONS 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 6). Three studies compared breast cancer risk between current or recent COC users (<6 months since last use) and never users of COCs (Figure 6). 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 6. 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. An increased risk of the following serious adverse reactions (see WARNINGS section for additional information) has been a…
Frequently Asked Questions
What is Dolishale used for?
Dolishale is an oral birth control pill containing levonorgestrel and ethinyl estradiol that is used to prevent pregnancy. It combines two hormones—a progestin and an estrogen—to work as a contraceptive medication.
Is Dolishale a controlled substance?
Dolishale is not classified as a controlled substance by the DEA.
What is the generic name for Dolishale?
The generic name for Dolishale is Levonorgestrel and Ethinyl Estradiol. There are 12 other brand versions of Levonorgestrel and Ethinyl Estradiol.
What is the NDC code for Dolishale 20 ug/1?
The NDC (National Drug Code) for Dolishale 20 ug/1 is 50742-659, listed by Ingenus Pharmaceuticals, LLC.