Norgestrel (13 brand names, 1 dosage form, 3 routes)
Available dosage forms: TABLET.
Routes of administration: ORAL-28, ORAL-21, ORAL.
Brand Names
- CRYSELLE
- ELINEST
- LO/OVRAL
- LO/OVRAL-28
- LOW-OGESTREL-21
- LOW-OGESTREL-28
- NORGESTREL AND ETHINYL ESTRADIOL
- OGESTREL 0.5/50-21
- OGESTREL 0.5/50-28
- OPILL
- OVRAL
- OVRAL-28
- TURQOZ
Boxed Warning
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs are contraindicated in women who are over 35 years of age and smoke [see Contraindications].
Indications and Usage
Turqoz is indicated for use by females of reproductive potential to prevent pregnancy. In a study of 1,287 women with a total of 11,085 cycles or 852.7 women-years of usage, the pregnancy rate in women age 15 to 40 years was approximately 1 pregnancy per 100 women-years of use.
Dosage and Administration
To achieve maximum contraceptive effectiveness, Turqoz (norgestrel and ethinyl estradiol tablets) must be taken exactly as directed and at intervals not exceeding 24 hours. The dosage of Turqoz is one white to off-white tablet daily for 21 consecutive days, followed by one orange inert tablet daily for 7 consecutive days, according to prescribed schedule. It is recommended that Turqoz tablets be taken by mouth at the same time each day. How to Start Turqoz Consider the possibility of ovulation and conception prior to initiation of medication. Instruct the patient to begin taking Turqoz on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, the first tablet (white to off-white) is taken that day. The patient should take one white to off-white tablet daily for 21 consecutive days followed by one orange inert tablet daily for 7 consecutive days. Withdrawal bleeding will usually occur within 3 days following discontinuation of white to off-white tablets and may not have finished before the next pack is started. During the first cycle, the patient should not rely on Turqoz for contraception until a white to off-white tablet has been taken daily for 7 consecutive days and she should use a non-hormonal back-up method of birth control during those 7 days. After the first cycle of use The patient is to begin her next and all subsequent 28-day courses of tablets on the same day of the week (Sunday) on which she began her first course, following the same schedule: 21 days of white to off-white tablets, followed by 7 days of orange inert tablets. If in any cycle the patient starts tablets later than the proper day, instruct her to protect herself against pregnancy by using a non-hormonal back-up method of birth control until she has taken a white to off-white tablet daily for 7 consecutive days. Switching from another hormonal method of contraception When the patient is switching from a 21-day regimen of tablets, instruct her to wait 7 days aft
Contraindications
Turqoz is contraindicated in females who are known to have or develop the following conditions: A high risk of arterial or venous thrombotic diseases. Examples include women who are known to: Smoke, if over age 35 Have deep-vein thrombosis or pulmonary embolism, now or in the past Have inherited or acquired coagulopathies Have cerebrovascular disease Have coronary artery disease Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease or atrial fibrillation) Have uncontrolled hypertension Have diabetes mellitus with vascular disease Headaches with focal neurological symptoms or migraine headaches with aura Women over age 35 with any migraine headaches Liver tumors, benign or malignant, or liver disease Undiagnosed abnormal uterine bleeding Pregnancy, because there is no reason to use COCs during pregnancy Current diagnosis or history of breast cancer, which may be hormone sensitive Hypersensitivity to any of the components of Turqoz Women who 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).
Adverse Reactions
An increased risk of the following serious adverse reactions (see Warnings section for additional information) has been associated with the use of oral contraceptives: Serious cardiovascular events and stroke [see Boxed Warning] Vascular events Liver disease Adverse reactions commonly reported by COC users are: Irregular uterine bleeding Nausea Breast tenderness Headache Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety of Turqoz was evaluated in 1,343 healthy women of child-bearing potential who participated in 9 clinical trials and received at least one dose of Turqoz for contraception. Subjects were exposed for a total of 11,085 cycles, with 429 women completing one year of exposure. Subjects ranged in age from 15 to 40 years. Demographics were 69 % Caucasian, 28 % Black, and 3 % other. Common Adverse Reactions (≥ 2 % of women) Weight increase (11 %) Cervical erosion (9 %) Weight decrease (6 %) Acne (4 %) Dysmenorrhea (4 %) Vaginal discharge (4 %) Abdominal pain, cramps, and bloating (3 %) Appetite increase (3 %) Depression (3 %) Nervousness (3 %) Chloasma/melasma (2 %) Fatigue (2 %) Varicose veins, aggravation of (2 %) A total of 8% of subjects discontinued the trials prematurely due to an adverse reaction, most commonly due to unscheduled bleeding, spotting, headache (including migraine), nausea, acne, changes in menstrual flow, weight increase, nervousness, high blood pressure, and depression. Postmarketing 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 to 1.12 (Figure 1). Three studies compared breast cancer ri
Overdosage
There have been no reports of serious ill effects from overdosage of oral contraceptives, including ingestion by children. Overdosage may cause withdrawal bleeding in females and nausea.