Low-Ogestrel
Norgestrel and Ethinyl Estradiol · KIT · Mayne Pharma Inc.
Low-Ogestrel is a kit containing norgestrel and ethinyl estradiol. Manufactured by Mayne Pharma Inc..
Key Facts
- Brand Name
- Low-Ogestrel
- Generic Name
- Norgestrel and Ethinyl Estradiol
- NDC Code (Product)
51862-564- Manufacturer
- Mayne Pharma Inc.
- Dosage Form
- KIT
- Marketing Status
- Application #
- ANDA075288
- Marketing Start
- 08/03/2016
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 Low-Ogestrel 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 15-40 years was approximately 1 pregnancy per 100 women-years of use.
Dosage & Administration
DOSAGE AND ADMINISTRATION To achieve maximum contraceptive effectiveness, Low-Ogestrel (norgestrel and ethinyl estradiol tablets) must be taken exactly as directed and at intervals not exceeding 24 hours. The dosage of Low-Ogestrel is one white tablet daily for 21 consecutive days, followed by one peach inert tablet daily for 7 consecutive days, according to prescribed schedule. It is recommended that Low-Ogestrel tablets be taken by mouth at the same time each day. How to Start Low-Ogestrel Consider the possibility of ovulation and conception prior to initiation of medication. Instruct the patient to begin taking Low-Ogestrel on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, the first tablet (white) is taken that day. The patient should take one white tablet daily for 21 consecutive days followed by one peach inert tablet daily for 7 consecutive days. Withdrawal bleeding will usually occur within 3 days following discontinuation of white tablets and may not have finished before the next pack is started. During the first cycle, the patient should not rely on Low-Ogestrel for contraception until a white tablet has been taken daily for 7 consecu…
Warnings
WARNINGS 1. Thromboembolic Disorders and Other Vascular Problems Stop Low-Ogestrel if an arterial thrombotic event or venous thromboembolic (VTE) event occurs. Stop Low-Ogestrel if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately. If feasible, stop Low-Ogestrel at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of VTE as well as during and following prolonged immobilization. Start Low-Ogestrel no earlier than 4 weeks after delivery, in women who are not breastfeeding. The risk of postpartum VTE decreases after the third postpartum week, whereas the risk of ovulation increases after the third postpartum week. The use of COCs increases the risk of VTE. However, pregnancy increases the risk of VTE as much or more than the use of COCs. The risk of VTE in women using COCs is 3 to 9 cases per 10,000 woman-years. The risk of VTE is highest during the first year of use of COCs and when restarting hormonal contraception after a break of 4 weeks or longer. The risk of thromboembolic disease due to COCs gradually disappears after us…
Contraindications
CONTRAINDICATIONS Low-Ogestrel 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 of, or history of, breast cancer, which may be hormone-sensitive Hypersensitivity to any of the components of Low-Ogestrel Women who are receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to t…
Drug Interactions
4. Drug Interactions Consult the labeling of all concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations . Concomitant Use with HCV Combination Therapy – Liver Enzyme Elevation Do not co-administer Low-Ogestrel with HCV drug combinations containing ombitasvir/ paritaprevir/ritonavir, with or without dasabuvir, due to potential for ALT elevations (see Warnings, Risk of liver enzyme elevations with concomitant hepatitis c treatment ). Effects of Other Drugs on Combined Oral Contraceptives Substances decreasing the plasma concentrations of COCs and potentially diminishing the efficacy of COCs Drugs or herbal products that induce certain enzymes, including cytochrome P450 3A4 (CYP3A4), may decrease the plasma concentrations of COCs and potentially diminish the effectiveness of COCs or increase breakthrough bleeding. Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate rifabutin, rufinamide, aprepitant, and products containing St. John's wort. …
Adverse Reactions
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 Low-Ogestrel was evaluated in 1,343 healthy women of child-bearing potential who participated in 9 clinical trials and received at least one dose of Low-Ogestrel 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 15-40 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 (…
Frequently Asked Questions
What is Low-Ogestrel used for?
Low-Ogestrel contains Norgestrel and Ethinyl Estradiol. It is a kit taken as directed. Consult your doctor for specific uses.
Is Low-Ogestrel a controlled substance?
Low-Ogestrel is not classified as a controlled substance by the DEA.
What is the generic name for Low-Ogestrel?
The generic name for Low-Ogestrel is Norgestrel and Ethinyl Estradiol. There are 8 other brand versions of Norgestrel and Ethinyl Estradiol.
What is the NDC code for Low-Ogestrel ?
The NDC (National Drug Code) for Low-Ogestrel is 51862-564, listed by Mayne Pharma Inc..