Necon
norethindrone and ethinyl estradiol · KIT · Mayne Pharma Inc.
Necon is a kit containing norethindrone and ethinyl estradiol, taken oral. Manufactured by Mayne Pharma Inc..
Key Facts
- Brand Name
- Necon
- Generic Name
- norethindrone and ethinyl estradiol
- NDC Code (Product)
51862-892- Manufacturer
- Mayne Pharma Inc.
- Dosage Form
- KIT
- Route
- ORAL
- Marketing Status
- Application #
- ANDA091204
- Marketing Start
- 10/12/2020
Recall History
Watson Laboratories Inc
Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, because certain lots could potentially be contaminated with trace amounts of Hydrochlorothiazide (HCTZ).
Watson Laboratories Inc
Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, because certain lots could potentially be contaminated with trace amounts of Hydrochlorothiazide (HCTZ).
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Necon Tablets are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the NORPLANT ® System 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. Adapted from Hatcher et al, 1998, Ref. #1. Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%. 9 Lactational Amenorrhea Method: LAM is a highly effective, temporary method of contraception. 1 0 Source: Trussell J, Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contrac…
Dosage & Administration
DOSAGE AND ADMINISTRATION To achieve maximum contraceptive effectiveness, Necon Tablets must be taken exactly as directed and at intervals not exceeding 24 hours. Necon Tablets are available in a compact blister card which is preset for a Sunday Start. Day 1 Start stickers are also provided. Sunday Start When taking Necon, the first "active" tablet should be taken on the first Sunday after menstruation begins. If the period begins on Sunday, the first "active" tablet should be taken that day. Take one active tablet daily for 21 days followed by one white "reminder" tablet daily for 7 days. After 28 tablets have been taken, a new course is started the next day (Sunday). For the first cycle of a Sunday Start regimen, another method of contraception, such as a condom or spermicide, should be used until after the first 7 consecutive days of administration. If the patient misses one (1) "active" tablet in Weeks 1, 2, or 3, the tablet should be taken as soon as she remembers. If the patient misses two (2) "active" tablets in Week 1 or Week 2, the patient should take two (2) tablets the day she remembers and two (2) tablets the next day; and then continue taking one (1) tablet a day until…
Warnings
WARNINGS Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, combination oral contraceptives, including Necon, should not be used by women who are over 35 years of age and smoke. The use of oral contraceptives is associated with increased risks of several serious conditions including myocardial infarction, thromboembolism, stroke, hepatic neoplasia, and gallbladder disease, 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 hypertension, hyperlipidemias, obesity and diabetes. Practitioners prescribing oral contraceptives should be familiar with the following information relating to these risks. The information contained in this package insert is principally based on studies carried out in patients who used oral contraceptives with higher formulations of estrogens and progestogens than those in common use today. The…
Contraindications
CONTRAINDICATIONS Oral contraceptives should not be used in women who currently have the following conditions: ● Thrombophlebitis or thromboembolic disorders ● A past history of deep vein thrombophlebitis or thromboembolic disorders ● Known thrombophilic conditions ● Cerebral vascular or coronary artery disease (current or history) ● Valvular heart disease with complications ● Persistent blood pressure values of ≥160 mm Hg systolic or ≥100 mg Hg diastolic 96 ● Diabetes with vascular involvement ● Headaches with focal neurological symptoms ● Major surgery with prolonged immobilization ●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 ● Acute or chronic hepatocellular disease with abnormal liver function ● Hepatic adenomas or carcinomas ● Known or suspected pregnancy ● Hypersensitivity to any component of this product ● Are receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential fo…
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 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. 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 has been associated with the use of oral contraceptives (See WARNINGS ). ● Thrombophlebitis and venous thrombosis with or withou…
Frequently Asked Questions
What is Necon used for?
Necon contains norethindrone and ethinyl estradiol. It is a kit taken oral. Consult your doctor for specific uses.
Is Necon a controlled substance?
Necon is not classified as a controlled substance by the DEA.
What is the generic name for Necon?
The generic name for Necon is norethindrone and ethinyl estradiol. There are 12 other brand versions of norethindrone and ethinyl estradiol.
What is the NDC code for Necon ?
The NDC (National Drug Code) for Necon is 51862-892, listed by Mayne Pharma Inc..