Necon Drug Information

Combined 0.1

IUD Progesterone T 2.0 1.5 81 Copper T380A 0.8 0.6 78 LNg 20 0.1 0.1 81 Depo-Provera ® 0.3 0.3 70 Norplant ® and Norplant-2 ® 0.05 0.05 88 Female Sterilization 0.5 0.5 100 Male Sterilization 0.15 0.10 100 Necon has not been studied for and is not indicated for use in emergency contraception.

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 "active" tablet in Weeks 1, 2, or 3, the tablet should be taken as soon as she remembers. If the patient misses two "active" tablets in Week 1 or Week 2, the patient should take two tablets the day she remembers and two tablets the next day; and then continue taking one tablet a day until she finishes the pack.

The patient should be instructed to use a back-up method of birth control, such as a condom or spermicide, if she has sex in the seven days after missing pills. If the patient misses two "active" tablets in the third week or misses three or more "active" tablets in a row, the patient should continue taking one tablet every day until Sunday. On Sunday the patient should throw out the rest of the pack and start a new pack that same day.

The patient should be instructed to use a back-up method of birth control if she has sex in the seven days after missing pills. Complete instructions to facilitate patient counseling on proper pill usage may be found in the Detailed Patient Labeling (" How to Take the Pill " section). Day 1 Start The dosage of Necon, for the initial cycle of therapy, is one "active" tablet administered daily from the 1st through the 21st day of the menstrual cycle, counting the first day of menstrual flow as "Day 1" followed by one white "reminder" tablet daily for 7 days. Tablets are taken without interruption for 28 days.

After 28 tablets have been taken, a new course is started the next day. If the patient misses one "active" tablet in Weeks 1, 2, or 3, the tablet should be taken as soon as she remembers. If the patient misses two "active" tablets in Week 1 or Week 2, the patient should take two tablets the day she remembers and two tablets the next day; and then continue taking one tablet a day until she finishes the pack.

The patient should be instructed to use a back-up method of birth control, such as a condom or spermicide, if she has sex in the seven days after missing pills. If the patient misses two "active" tablets in the third week or misses three or more "active" tablets in a row, the patient should throw out the rest of the pack and start a new pack that same day. The patient should be instructed to use a back-up method of birth control if she has sex in the seven days after missing pills.

Complete instructions to facilitate patient counseling on proper pill usage may be found in the Detailed Patient Labeling (" How to Take the Pill " section). The use of Necon for contraception may be initiated 4 weeks postpartum in women who elect not to breastfeed. 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 disease. See also PRECAUTIONS : Nursing Mothers.) The possibility of ovulation and conception prior to initiation of medication should be considered. (See Discussion of Dose-Related Risk of Vascular Disease from Oral Contraceptives.) ADDITIONAL INSTRUCTIONS Breakthrough bleeding, spotting, and amenorrhea are frequent reasons for patients discontinuing oral contraceptives.

In breakthrough bleeding, as in all cases of irregular bleeding from the vagina, nonfunctional causes should be borne in mind. In undiagnosed persistent or recurrent abnormal bleeding from the vagina, adequate diagnostic measures are indicated to rule out pregnancy or malignancy. If pathology has been excluded, time or a change to another formulation may solve the problem.

Changing to an oral contraceptive with a higher estrogen content, while potentially useful in minimizing menstrual irregularity, should be done only if necessary since this may increase the risk of thromboembolic disease. Use of oral contraceptives in the event of a missed menstrual period: 1. If the patient has not adhered to the prescribed schedule, the possibility of pregnancy should be considered at the time of the first missed period and oral contraceptive use should be discontinued if pregnancy is confirmed. 2. If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out.

• 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 without embolism ● Arterial thromboembolism ● Pulmonary embolism ● Myocardial infarction ● Cerebral hemorrhage ● Cerebral thrombosis ● Hypertension ● Gallbladder disease ● Hepatic adenomas or benign liver tumors There is evidence of an association between the following conditions and the use of oral contraceptives: ● Mesenteric thrombosis ● Retinal thrombosis 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 ● Temporary infertility after discontinuation of treatment ● Edema ● Melasma which may persist ● Breast changes: tenderness, enlargement, secretion ● Change in weight (increase or decrease) ● Change in cervical erosion and secretion ● Diminution in lactation when given immediately postpartum ● Cholestatic jaundice ● Migraine ● Allergic reaction, including rash, urticaria, angioedema ● Mental depression ● Reduced tolerance to carbohydrates ● Vaginal candidiasis ● Change in corneal curvature (steepening) ● Intolerance to contact lenses The following adverse reactions have been reported in users of oral contraceptives and a causal association has been neither confirmed nor refuted: ● Pre-menstrual syndrome ● Cataracts ● Changes in appetite ● Cystitis-like syndrome ● Headache ● Nervousness ● Dizziness ● Hirsutism ● Loss of scalp hair ● Erythema multiforme ● Erythema nodosum ● Hemorrhagic eruption ● Vaginitis ● Porphyria ● Impaired renal function ● Hemolytic uremic syndrome ● Acne ● Changes in libido ● Colitis ● Budd-Chiari Syndrome The following adverse reactions were also reported in clinical trials or during post-marketing experience: Gastrointestinal Disorders: diarrhea, pancreatitis; Musculoskeletal and Connective Tissue Disorders: muscle spasms, back pain; Reproductive System and Breast Disorders: vulvovaginal pruritus, pelvic pain, dysmenorrhea, vulvovaginal dryness; Psychiatric Disorders: anxiety, mood swings, mood altered; Skin and Subcutaneous Tissue Disorders: pruritus, photosensitivity reaction; General Disorders and Administration Site Conditions: edema peripheral, fatigue, irritability, asthenia, malaise; Neoplasms Benign, Malignant, and Unspecified (Including Cysts and Polyps): breast cancer, breast mass, breast neoplasm, cervix carcinoma; Immune System Disorders: anaphylactic/anaphylactoid reaction; Hepatobiliary Disorders: hepatitis, cholelithiasis. image description

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 for ALT elevations (see WARNINGS, Risk of Liver Enzyme Elevations with Concomitant Hepatitis C Treatment ).

Serious ill effects have not been reported following acute ingestion of large doses of oral contraceptives by young children. 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 combined oral contraceptives are supported by epidemiological studies which largely utilized oral contraceptive formulations containing estrogen doses exceeding 0.035 mg of ethinyl estradiol or 0.05 mg mestranol. 73–78 Effects on menses: ● increased menstrual cycle regularity ● decreased blood loss and decreased incidence of iron deficiency anemia ● decreased incidence of dysmenorrhea Effects related to inhibition of ovulation: ● decreased incidence of functional ovarian cysts ● decreased incidence of ectopic pregnancies Other effects: ● decreased incidence of fibroadenomas and fibrocystic disease of the breast ● decreased incidence of acute pelvic inflammatory disease ● decreased incidence of endometrial cancer ● decreased incidence of ovarian cancer