Application Information

This drug has been submitted to the FDA under the reference 016709/001.

Names and composition

"ORTHO-NOVUM 1/50 28" is the commercial name of a drug composed of MESTRANOL and NORETHINDRONE.

Forms

ApplId/ProductId Drug name Active ingredient Form Strenght
016709/001 ORTHO-NOVUM 1/50 28 MESTRANOL; NORETHINDRONE TABLET/ORAL-28 0.05MG and 1MG

Similar Active Ingredient

ApplId/ProductId Drug name Active ingredient Form Strenght
012728/001 ORTHO-NOVUM 10-21 MESTRANOL; NORETHINDRONE TABLET/ORAL-21 0.06MG and 10MG
012728/004 ORTHO-NOVUM 1/50 21 MESTRANOL; NORETHINDRONE TABLET/ORAL-21 0.05MG and 1MG
012728/005 ORTHO-NOVUM 2-21 MESTRANOL; NORETHINDRONE TABLET/ORAL-21 0.1MG and 2MG
013625/002 NORINYL 1+50 21-DAY MESTRANOL; NORETHINDRONE TABLET/ORAL-21 0.05MG and 1MG
013625/004 NORINYL MESTRANOL; NORETHINDRONE TABLET/ORAL-20 0.1MG and 2MG
016659/001 NORINYL 1+50 28-DAY MESTRANOL; NORETHINDRONE TABLET/ORAL-28 0.05MG and 1MG
016709/001 ORTHO-NOVUM 1/50 28 MESTRANOL; NORETHINDRONE TABLET/ORAL-28 0.05MG and 1MG
016715/001 ORTHO-NOVUM 1/80 21 MESTRANOL; NORETHINDRONE TABLET/ORAL-21 0.08MG and 1MG
016715/002 ORTHO-NOVUM 1/80 28 MESTRANOL; NORETHINDRONE TABLET/ORAL-28 0.08MG and 1MG
016724/001 NORINYL 1+80 21-DAY MESTRANOL; NORETHINDRONE TABLET/ORAL-21 0.08MG and 1MG
016725/001 NORINYL 1+80 28-DAY MESTRANOL; NORETHINDRONE TABLET/ORAL-28 0.08MG and 1MG
070758/001 NORETHINDRONE AND MESTRANOL MESTRANOL; NORETHINDRONE TABLET/ORAL-21 0.05MG and 1MG
070759/001 NORETHINDRONE AND MESTRANOL MESTRANOL; NORETHINDRONE TABLET/ORAL-28 0.05MG and 1MG
071539/001 NORETHIN 1/50M-21 MESTRANOL; NORETHINDRONE TABLET/ORAL-21 0.05MG and 1MG
071540/001 NORETHIN 1/50M-28 MESTRANOL; NORETHINDRONE TABLET/ORAL-28 0.05MG and 1MG

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Answered questions

Information about harmonal pills?
is it true that harmonal pills reduces the libido? (like overoll 21.) Asked by Eulah Dragna 1 year ago.

Very low-dose pills Alesse Loestrin 1/20 Lybrel Mircette YAZ Low-dose pills Lo/Ovral Seasonale Seasonique Yasmin Phasic pills Ortho-Novum 7/7/7 Ortho Tri-Cyclen Lo Triphasil High-dose pills Demulen 1/50 Ortho-Novum 1/50 Ovral. Skin patch 20 mcg estrogen, plus progestin Ortho Evra patch Vaginal ring 15 mcg estrogen, plus progestin NuvaRing Birth control pills Very low-dose pills have 20 mcg of estrogen plus progestin. Low-dose pills have 30–35 mcg estrogen plus progestin. Phasic pills have changing levels of estrogen and progestin. High-dose pills have about 50 mcg of estrogen plus progestin. Combination (estrogen and progestin) hormonal methods-pills, skin patch, or vaginal ring-help to prevent pregnancy by preventing eggs from being released from the ovaries (a process called ovulation). These methods also thicken cervical mucus to prevent sperm from entering the uterus. Birth control pills come in packs, each containing 3 weeks of hormone pills. The 28-day packs include a 4th week of no-hormone sugar pills. The 21-day packs do not-after finishing a pack, you take 7 days off, which is when you have your menstrual period. After the 7 days off, you start a new 3-week pack. Seasonique has 12 weeks (84 days) of estrogen/progestin pills followed by 7 days of low-estrogen pills. Seasonale has 12 weeks of estrogen/progestin pills followed by 7 days of no-hormone pills. You have your menstrual period during the 7 days, which is every 3 months. This dosing schedule changes your menstrual cycle to only 4 periods each year. Lybrel has 28 hormone pills. After finishing a pack, you start a new one the next day. Because you take a hormone pill every day of the month, you have no monthly periods. (But it is common to have unexpected spotting or bleeding, especially during the first year.) The YAZ and Yasmin birth control pills have a new progestin that reduces water retention (bloating) during the menstrual cycle. This type of pill may help reduce severe mood and physical symptoms that some women get before they start their monthly periods.1 These symptoms are called premenstrual dysphoric disorder (PMDD). In fact, YAZ has been approved by the U.S. Food and Drug Administration (FDA) for treating PMDD symptoms. (These two pills have the same amount of progestin, called drospirenone. YAZ is very low-estrogen, and Yasmin is low-estrogen.) Answered by Rhiannon Englehart 1 year ago.

the surgeon will ask approximately your scientific history, any surgical procedures, allergies, smoking history, what your sessions are like. you're able to be able to get a pelvic examination and pap smear and std verify. the tablet is an fantastic thank you to regulate and control your cycles. you probable dont % to cease them altogether because it is complicated to do, yet you are able to take the pills in the kind of way as to furnish you in elementary terms some sessions a 365 days. you're able to be able to desire to bleed finally or you're able to be able to desire to have problems with persevering with spottng. tell the surgeon you have an interest in a protracted cycle recurring beginning administration tablet. having fewer sessions will advance the contraceptive effectiveness of the tablet, decrease your pms issues and consequence in much less soreness and blood loss throughout the time of the bleeding circumstances Answered by Megan Viray 1 year ago.


What birth control pills have the most estrogen?
and are estrogen pills harmful and do they increase breast size Asked by Nu Baim 1 year ago.

Low-dose pills (Alesse, Aviane, Levlite, Loestrin 1/20, Mircette) Regular-dose pills (Brevicon, Demulen, Desogen, Levlen, Lo/Ovral, Modicon, Nordette, Levora, Loestrin, Low-Ogestrel, Necon 1/35, Norethin, Norinyl 1+35, Ortho-Cept, Ortho-Cyclen, Ortho-Novum 1/35, Ortho Tri-Cyclen Lo, Ovcon 35, Seasonale, Yasmin, Zovia) Phasic pills (Ortho-Tri-Cyclen Lo, Cyclessa, Trivora, Triphasil, Tri-Levlen, Ortho-Novum 10/11, Jenest, Tri-Norinyl, Ortho-Novum 7/7/7, Ortho-Tri-Cyclen, Estrostep Fe) High-dose pills (Ortho-Novum 1/50, Ovral, Ogestrel, Demulen 1/50, Ovcon 50) Note: This is not a complete list of all brand-name birth control pills available. Skin patch 20 mcg estrogen, plus progestin (Ortho Evra patch) Vaginal ring 15 mcg estrogen, plus progestin (NuvaRing) Birth control pills Low-dose pills have 20 mcg of estrogen plus progestin. Regular-dose pills have 30–35 mcg estrogen plus progestin. Phasic pills have changing levels of estrogen and progestin. High-dose pills have about 50 mcg of estrogen plus progestin. How It Works Combination (estrogen and progestin) hormonal methods—pills, skin patch, or vaginal ring—help to prevent pregnancy by preventing eggs from being released from the ovaries (a process called ovulation). These methods also thicken cervical mucus to prevent sperm from entering the uterus. Birth control pills Birth control pills come in packs, each containing 3 weeks of hormone pills. The 28-day packs include a 4th week of no-hormone sugar pills. The 21-day packs do not—after finishing a pack, you take 7 days off, which is when you have your menstrual period. After the 7 days off, you start a new 3-week pack. Seasonale contains 12 weeks (84 days) of hormone pills followed by 7 days of no-hormone pills. You have your menstrual period while taking the no-hormone pills, which is every 3 months. This dosing schedule changes your menstrual cycle to only 4 periods per year. The Yasmin birth control pill contains a new progestin that reduces water retention (bloating) during the menstrual cycle. For this reason, Yasmin cannot be used by women who have kidney, liver, or adrenal gland disease. Contraceptive skin patch The transdermal patch is an adhesive patch [about 1.75 in.(4.4 cm)] that is prescribed by your health professional. You can wear it on your lower abdomen, buttocks, or upper arm. Each patch releases estrogen and progestin through your skin for 7 days. Over a 4-week period, you use 1 patch per week for 3 weeks, then no patch for 1 week. During this week, you have your menstrual period. For more information, see how to use the patch. Patch warnings. The patch delivers more estrogen than low-dose birth control pills do. In general, more estrogen raises the chance of blood clots in the legs and lungs, heart attack, and stroke. It is not yet known whether women who use the patch are more likely to have these serious problems. Direct sunlight or high heat can increase, then lower, the amount of hormone released from a patch. This can give you a big dose at the time and leave less hormone for the patch to release later in the week. This increases your risk of pregnancy. Avoid direct sunlight on the hormone patch. Also avoid using a tanning bed, heating pad, electric blanket, hot tub, or sauna while you are using a hormone patch. Contraceptive vaginal ring (CVR) The vaginal ring is small [about 2 in.(5.1 cm) in diameter], flexible, and colorless. It releases a continuous low dose of hormones into the vagina to prevent pregnancy for that month. You insert the vaginal ring at home and leave it in place for 3 weeks. This gives you continuous birth control for the month. On the first day of the fourth week, you remove the ring and you have a menstrual period. The exact position of the ring in the vagina is not critical for it to work because the ring is not a barrier contraceptive and therefore cannot be incorrectly inserted. For more information, see how to use a vaginal ring. Why It Is Used Combination hormonal pills, skin patch, or vaginal ring are good choices for women who: Need short- or long-term birth control that can be stopped at any time. Prefer a form of birth control that does not interfere with sexual spontaneity. Have heavy, painful, or irregular menstrual periods. Have endometriosis. Have ovarian cysts. Have a family history of ovarian cancer. Combination pills reduce the risk of ovarian cancer after 1 year of use. This benefit seems to last for years after stopping the pill.1 How Well It Works Combination hormonal pills, skin patches, or vaginal rings are effective methods of birth control when they are used exactly as directed. Each method will not usually be used perfectly all the time, so typically the method will fail to prevent a pregnancy in a certain number of women. This has been shown by studies of actual users. Among pill users, 3 women in 100 become pregnant per year.2 The method usually fails when women forget to take a pill every day. Of women who take their pills every day, only 3 in 1,000 become pregnant per year.3 Among skin patch and contraceptive vaginal ring users, 1 woman in 100 is expected to become pregnant per year.2 Small, recent studies have shown that when patches and rings are used carefully, only about 7 in 1,000 users become pregnant per year.4 Low-dose pills are as highly effective as higher-dose pills when they are taken as directed. However, your risk of pregnancy is higher after missing low-dose pills than after missing higher-dose pills.1 Side Effects Combination hormonal pills, skin patches, and vaginal rings have similar possible side effects because they all contain a combination of estrogen and progestin. The pill causes hormone levels to peak and drop each day. Each weekly patch takes 3 days after application to reach a steady hormone level. The ring releases a steady dose every day throughout the day. This may explain why the ring is less likely to cause headaches and nausea than the pill and patch. Common side effects of combination hormonal methods The most common side effects are changes in menstrual periods, including: Very light or skipped periods. Bleeding between periods (spotting), which usually decreases after using a hormonal method for 3 to 4 months. The contraceptive skin patch may cause skin irritation at the site. The contraceptive vaginal ring may cause: Vaginal discharge. Irritation and inflammation of the vagina (vaginitis). Less common side effects of combination hormonal methods Less common side effects include: Nausea and vomiting, especially during the first month of use. This side effect usually goes away after the first few months of use. Frequent or more severe headaches. Migraine headaches may get worse. Weight gain. Breast tenderness for the first few months. Depression or mood changes. Darkening of the skin on the upper lip, under the eyes, or on the forehead (chloasma). This may slowly fade after you stop using hormonal methods, but in some cases, it is permanent. Decreased interest in sex. Rare but serious side effects of combination hormonal methods The following symptoms, called ACHES, are rare but serious and should be reported to your health professional immediately. Abdominal pain that is severe or persists may be a sign of blood clots (thrombophlebitis) in the pelvis, liver blood clots or tumors, or gallbladder disease. Chest pain may be a sign of blood clots in the lungs (pulmonary embolism), heart attack, or heart disease. Smoking increases this risk. Headaches that are severe may be a sign of stroke, migraine, or hypertension. Smoking increases this risk. Eye problems, such as blurred vision or loss of vision, may be a sign of migraine, blood clots in the eye, or a change in the shape of the cornea. Severe leg pain or sudden swelling of one leg may be a sign of leg blood clots (thrombophlebitis) or deep vein thrombosis (DVT). See Drug Reference for a full list of side effects. (Drug Reference is not available in all systems.) What To Think About Cancer protection, cancer risk? Recent studies have shown that using the Pill (with estrogen and progestin) for a year or more helps protect against uterine cancer. Long-term Pill use protects against ovarian cancer. However, the research is mixed about breast cancer.5, 6 Breast cancer risk may be slightly increased by the Pill for women with a family history of breast cancer.7 Women who have a personal history of breast cancer should not take the Pill. If you're considering hormonal birth control, let your health professional know if you have any family history of breast cancer. Combined hormonal contraceptive methods are usually not prescribed for women who: Smoke and are older than 35. Have diabetes and are older than 35 or have diabetes with complications. Have migraines. Have a risk for blood clots, including a family history of clots or a past clot in the lung (pulmonary embolism) or leg (thrombophlebitis). Have coronary artery disease, uncontrolled high blood pressure, or high triglyceride levels. Other factors to consider include the following: Birth control pills may not be as effective when combined with other medications. Be sure to tell your health professional or pharmacist that you are taking birth control pills whenever you get a new prescription. The herbal medication St. John's wort also makes birth control pills less effective. Be sure to tell your health professional about all medications and supplements that you're taking when starting hormonal birth control.8 After stopping high-dose birth control pill use in order to start a planned pregnancy, it may take longer to become pregnant than after stopping use of a low-dose pill, diaphragm, or intrauterine device (IUD).9 If you are taking birth control pills, take special precautions for backup birth control if you miss or skip pills. Birth control pills may not be as effective if you are vomiting or have diarrhea. Use another method of birth control for 7 days after vomiting or diarrhea, even if you have not missed any pills. Be sure to use a backup birth control method during the first 7 days of starting hormonal contraception. Emergency contraception is available if any birth control method fails and you are concerned about unprotected sex. Answered by Ivey Volbert 1 year ago.

High Estrogen Birth Control Answered by Zoe Sarks 1 year ago.

This Site Might Help You. RE: what birth control pills have the most estrogen? and are estrogen pills harmful and do they increase breast size Answered by Petronila Parekh 1 year ago.

Rch Asthma Action Plan Answered by Aletha Dixie 1 year ago.


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