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Zenchent FE is a brand name for Norethindrone (also known as Norethisterone). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 1 INDICATIONS AND USAGE Zenchent Fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets are indicated for use by females of reproductive potential to prevent pregnancy. • Zenchent Fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets is a…
Verbatim from this product's FDA label. Tap a section to expand.
2 DOSAGE AND ADMINISTRATION Take one tablet by mouth at the same time every day. Tablets may be chewed or swallowed. 1 How to Start Zenchent Fe, Norethindrone and Ethinyl Estradiol Tablets, Chewable and Ferrous Fumarate Tablets Zenchent Fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets are dispensed in a blister card [see How Supplied/Storage and Handling (16) ] .
Zenchent Fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets may be started using either a Day 1 start or a Sunday start (see Table 1). For the first cycle of a Sunday Start regimen, an additional method of contraception should be used until after the first 7 consecutive days of administration.
2 How to Take Zenchent Fe, Norethindrone and Ethinyl Estradiol Tablets, Chewable and Ferrous Fumarate Tablets Zenchent Fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets (light yellow active tablets and brown placebo tablets) may be swallowed whole or chewed and swallowed.
If the tablet is chewed, the patient should drink a full glass (8 ounces) of liquid immediately after swallowing.
Table 1:
Instructions for Administration of Zenchent Fe, Norethindrone and Ethinyl Estradiol Tablets, Chewable and Ferrous Fumarate Tablets Starting CHCs in women not currently using hormonal contraception (Day 1 Start or Sunday Start) Important: Consider the possibility of ovulation and conception prior to initiation of this product.
Tablet Color:
Zenchent Fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets active tablets are light yellow (Day 1 to Day 21). Zenchent Fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets placebo tablets are brown (Day 22 to Day 28).
Day 1 Start:
Take first light yellow active tablet on the first day of menses. Take subsequent light yellow active tablets once daily at the same time each day for a total of 21 days. Take one brown placebo tablet daily for 7 days and at the same time of day that active tablets were taken.
, on the day after taking the last inactive tablet).
2) ] The following adverse reactions are commonly reported by COC users. Because these reactions are voluntarily reported by from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: Irregular uterine bleeding Nausea Breast tenderness Headache The most common adverse reactions were: irregular uterine bleeding, nausea, breast tenderness, and headache.
gov/medwatch. 12 (Figure 1). Three studies compared breast cancer risk between current or recent COC users (<6 months since last use) and never users of COCs (Figure 1). One of these studies reported no association between breast cancer risk and COC use.
33 with current or recent use. 4 with more than 8 to 10 years of COC use.
Figure 1:
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. 1
5 WARNINGS AND PRECAUTIONS Thrombotic Disorders and Other Vascular Problems: Stop Zenchent Fe if a thrombotic event occurs. Stop at least 4 weeks before through 2 weeks after major surgery. 2 ) High blood pressure : If used in women with well-controlled hypertension, monitor blood pressure and stop Zenchent Fe if blood pressure rises significantly.
4 ) Carbohydrate and lipid metabolic effects : Monitor prediabetic and diabetic women taking Zenchent Fe. 1 Thrombotic Disorders and Other Vascular Problems Stop Zenchent Fe if an arterial thrombotic event or venous thromboembolic (VTE) event occurs.
Stop Zenchent Fe if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately. If feasible, stop Zenchent Fe 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 the following prolonged immobilization.
Start Zenchent Fe 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 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 use is discontinued. Use of COCs also increases the risk of arterial thromboses such as strokes and myocardial infarctions, especially in women with other risk factors for these events.
COCs have been shown to increase both the relative and attributable risks of cerebrovascular events (thrombotic and hemorrhagic strokes). The risk increases with age, particularly in women over 35 years of age who smoke. Use COCs with caution in women with cardiovascular disease risk factors.
4 CONTRAINDICATIONS Zenchent Fe is contraindicated in females who are known to have or develop the following conditions: A high risk of arterial or venous thrombotic diseases. 1) ] . 11) ] Hypersensitivity to any of the components. 3) ] A high risk of arterial or venous thrombotic diseases ( 4 ) Liver tumors or liver disease ( 4 ) Undiagnosed abnormal uterine bleeding ( 4 ) Pregnancy ( 4 ) Breast cancer or other estrogen- or progestin-sensitive cancer ( 4 ) Co-administration with Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir ( 4 )
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Sunday Start:
Take first active tablet on the first Sunday after the onset of menses. Due to the potential risk of becoming pregnant, use additional non-hormonal contraception (such as condoms and spermicide) for the first seven days of the patient’s first cycle pack of Zenchent Fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets.
Take subsequent light yellow active tablets once daily at the same time each day for a total of 21 days. Take one brown placebo tablet daily for the following 7 days and at the same time of day that active tablets were taken. , on the Sunday after taking the last inactive tablet) and additional non-hormonal contraceptive is not needed.
Switching to Zenchent Fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets from another hormonal contraceptive Start on the same day that a new pack of the previous hormonal contraceptive would have started.
Switching from another contraceptive method to Zenchent Fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets Start Zenchent Fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets: Transdermal patch On the day when next application would have been scheduled Vaginal ring On the day when next insertion would have been scheduled Injection On the day when next injection would have been scheduled Intrauterine contraceptive On the day of removal If the IUD is not removed on first day of the patient’s menstrual cycle, additional non-hormonal contraceptive (such as condoms and spermicide) is needed for the first seven days of the first cycle pack.
Implant On the day of removal Complete instructions to facilitate patient counseling on proper tablet usage are located in the FDA-Approved Patient Labeling. Starting Zenchent Fe, Zenchent Fe, norethindrone and Ethinyl Estradiol Tablets, Chewable and Ferrous Fumarate Tablets after Abortion or Miscarriage First-trimester After a first-trimester abortion or miscarriage, Zenchent Fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets may be started immediately.
An additional method of contraception is not needed if Zenchent Fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets are started within 5 days after termination of the pregnancy. If Zenchent Fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets are not started within 5 days after termination of the pregnancy, the patient should use additional non-hormonal contraception (such as condoms and spermicide) for the first seven days of her first cycle pack of Zenchent Fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets.
Second-trimester Do not start until 4 weeks after a second-trimester abortion or miscarriage, due to the increased risk of thromboembolic disease. Start Zenchent Fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets, following the instructions in Table 1 for Day 1 or Sunday start, as desired.
If using Sunday start, use additional non-hormonal contraception (such as condoms and spermicide) for the first seven days of the patient’s first cycle pack of Zenchent Fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets.
] Starting Zenchent Fe, Norethindrone and Ethinyl Estradiol Tablets, Chewable and Ferrous Fumarate Tablets after Childbirth Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease. Start contraceptive therapy with Zenchent Fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets following the instructions in Table 1 for women not currently using hormonal contraception.
If the woman has not yet had a period postpartum, consider the possibility of ovulation and conception occurring prior to use of Zenchent Fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets. 3 ), and FDA-Approved Patient Labeling].
3 Missed Tablets Table 2: Instructions for Missed Zenchent Fe, Norethindrone and Ethinyl Estradiol Tablets, Chewable and Ferrous Fumarate Tablets If one light yellow active tablet is missed in Weeks 1, 2, or 3 Take the tablet as soon as possible.
Continue taking one tablet a day until the pack is finished. If two light yellow active tablets are missed in Week 1 or Week 2 Take the two missed tablets as soon as possible and the next two active tablets the next day. Continue taking one tablet a day until the pack is finished.
Additional non-hormonal contraception (such as condoms and spermicide) should be used as back-up if the patient has sex within 7 days after missing tablets. If two light yellow active tablets are missed in Week 3 or three or more light yellow active tablets are missed in a row in Weeks 1, 2, or 3 Day 1 start : Throw out the rest of the pack and start a new pack that same day.
Sunday start :
Continue taking one tablet a day until Sunday, then throw out the rest of the pack and start a new pack that same day. Additional non-hormonal contraception (such as condoms and spermicide) should be used as back-up if the patient has sex within 7 days after missing tablets.
4 Advice in Case of Gastrointestinal Disturbances In case of severe vomiting or diarrhea, absorption may not be complete and additional contraceptive measures should be taken. If vomiting or diarrhea occurs within 3 to 4 hours after taking an active tablet, handle this as a missed tablet [see FDA-Approved Patient Labeling] .
2 Liver Disease Impaired Liver Function Do not use Zenchent Fe in women with liver disease, such as acute viral hepatitis or severe (decompensated) cirrhosis of liver [see Contraindications (4) ] . Acute or chronic disturbances of liver function may necessitate the discontinuation of COC use until markers of liver function return to normal and COC causation has been excluded.
Discontinue Zenchent Fe if jaundice develops. Liver Tumors Zenchent Fe is contraindicated in women with benign and malignant liver tumors [see Contraindications (4) ] . Hepatic adenomas are associated with COC use. 3 cases/100,000 COC users.
Rupture of hepatic adenomas may cause death through intra-abdominal hemorrhage. Studies have shown an increased risk of developing hepatocellular carcinoma in long-term (>8 years) COC users. However, the risk of liver cancers in COC users is less than one case per million users.
3 Risk of Liver Enzyme Elevations with Concomitant Hepatitis C Treatment During clinical trials with the Hepatitis C combination drug regimen that contains ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, ALT elevations greater than 5 times the upper limit of normal (ULN),including some cases greater than 20 times the ULN, were significantly more frequent in women using ethinyl estradiol-containing medications, such as COCs.
Discontinue Zenchent Fe prior to starting therapy with the combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir [see Contraindications (4) ] . Zenchent Fe can be restarted approximately 2 weeks following completion of treatment with the Hepatitis C combination drug regimen.
4 High Blood Pressure Zenchent Fe is contraindicated in women with uncontrolled hypertension or hypertension with vascular disease [see Contraindications (4) ] . For women with well-controlled hypertension, monitor blood pressure and stop Zenchent Fe if blood pressure rises significantly.
An increase in blood pressure has been reported in women taking COCs, and this increase is more likely in older women with extended duration of use. The incidence of hypertension increases with increasing concentrations of progestin.
5 Gallbladder Disease Studies suggest a small increased relative risk of developing gallbladder disease among COC users. Use of COCs may worsen existing gallbladder disease. A past history of COC-related cholestasis predicts an increased risk with subsequent COC use.
Women with a history of pregnancy-related cholestasis may be at an increased risk for COC related cholestasis. 6 Carbohydrate and Lipid Metabolic Effects Carefully monitor prediabetic and diabetic women who take Zenchent Fe. COCs may decrease glucose tolerance.
Consider alternative contraception for women with uncontrolled dyslipidemia. A small proportion of women will have adverse lipid changes while on COCs. Women with hypertriglyceridemia, or a family history thereof, may be at an increased risk of pancreatitis when using COCs.
7 Headache If a woman taking Zenchent Fe develops new headaches that are recurrent, persistent, or severe, evaluate the cause and discontinue Zenchent Fe if indicated. Consider discontinuation of Zenchent Fe in the case of increased frequency or severity of migraine during COC use (which may be prodromal of a cerebrovascular event).
8 Bleeding Irregularities and Amenorrhea Unscheduled Bleeding and Spotting Unscheduled (breakthrough or intracyclic) bleeding and spotting sometimes occur in patients on COCs, especially during the first three months of use. If bleeding persists or occurs after previously regular cycles, check for causes such as pregnancy or malignancy.
If pathology and pregnancy are excluded, bleeding irregularities may resolve over time or with a change to a different contraceptive product. Amenorrhea and Oligomenorrhea Women who use Zenchent Fe may experience amenorrhea. Some women may experience amenorrhea or oligomenorrhea after discontinuation of COCs, especially when such a condition was preexistent.
If scheduled (withdrawal) bleeding does not occur, consider the possibility of pregnancy. If the patient has not adhered to the prescribed dosing schedule (missed one or more active tablets or started taking them on a day later than she should have), consider the possibility of pregnancy at the time of the first missed period and take appropriate diagnostic measures.
If the patient has adhered to the prescribed regimen and misses two consecutive periods, rule out pregnancy. 9 COC Use Before or During Early Pregnancy Extensive epidemiologic studies have revealed no increased risk of birth defects in women who have used oral contraceptives prior to pregnancy.
Studies also do not suggest a teratogenic effect, particularly in so far as cardiac anomalies and limb reduction defects are concerned, when oral contraceptives are taken inadvertently during early pregnancy. Discontinue Zenchent Fe use if pregnancy is confirmed.
1) ] . 10 Depression Carefully observe women with a history of depression and discontinue Zenchent Fe if depression recurs to a serious degree. 11 Malignant Neoplasms Breast Cancer Zenchent Fe is contraindicated in females who currently have or have had breast cancer because breast cancer may be hormonally sensitive [see Contraindications (4) ] .
Epidemiology studies have not found a consistent association between use of combined oral contraceptives (COCs) and breast cancer risk. Studies do not show an association between ever (current or past) use of COCs and risk of breast cancer.
2) ] . Cervical Cancer Some studies suggest that COC use has been associated with an increase in the risk of cervical cancer or intraepithelial neoplasia. However, there continues to be controversy about the extent to which such findings may be due to differences in sexual behavior and other factors.
Women who use birth control pills may have a slightly higher chance of getting cervical cancer. However, this may be due to other reasons such as having more sexual partners. 12 Effect on Binding Globulins The estrogen component of COCs may raise the serum concentrations of thyroxine-binding globulin, sec hormone-binding globulin, and cortisol-binding globulin.
The dose of replacement thyroid hormone or cortisol therapy may need to be increased. 13 Monitoring A woman who is taking COCs should have a yearly visit with her healthcare provider for a blood pressure check and for other indicated healthcare.
14 Hereditary Angioedema In women with hereditary angioedema, exogenous estrogens may induce or exacerbate symptoms of angioedema. 15 Chloasma Chloasma may occasionally occur, especially in women with a history of chloasma gravidarum.
Women with a tendency to chloasma should avoid exposure to the sun or ultraviolet radiation while taking Zenchent Fe.