Medical Editor: John P. Cunha, DO, FACOEP
What Is Cyonanz?
Cyonanz (norethindrone and ethinyl estradiol kit) is a combined oral contraceptive (COC) indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.
What Are Side Effects of Cyonanz?
Side effects of Cyonanz include:
- gastrointestinal symptoms (such as abdominal cramps and bloating),
- breakthrough bleeding,
- change in menstrual flow,
- missed menstrual periods,
- temporary infertility after discontinuation of treatment,
- fluid retention (edema)
- skin discoloration (melasma) which may persist,
- breast changes: tenderness, enlargement, secretion,
- change in weight,
- change in cervical erosion and secretion,
- reduced lactation when given immediately postpartum,
- cholestatic jaundice,
- allergic reaction, including rash, hives, skin swelling,
- reduced tolerance to carbohydrates,
- vaginal yest infection,
- change in corneal curvature (steepening), and
- intolerance to contact lenses.
Dosage for Cyonanz
The dosage of Cyonanz, 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 green “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.
Cyonanz In Children
The safety and efficacy of Cyonanz Tablets has been established in women of reproductive age. Safety and efficacy are expected to be the same for postpubertal adolescents under the age of 16 and for users 16 years and older. Use of this product before menarche is not indicated.What Drugs, Substances, or Supplements Interact with Cyonanz?
Cyonanz may interact with other medicines such as:
- drugs or herbal products that induce certain enzymes, including cytochrome P450 3A4 (CYP3A4) such as phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, rifabutin, rufinamide, aprepitant, and products containing St. John’s wort,
- atorvastatin or rosuvastatin,
- CYP3A4 inhibitors such as itraconazole, voriconazole, fluconazole, grapefruit juice, or ketoconazole,
- HIV protease inhibitors (nelfinavir, ritonavir, darunavir/ritonavir, (fos)amprenavir/ritonavir, lopinavir/ritonavir, and tipranavir/ritonavir] or increase [e.g., indinavir and atazanavir/ritonavir)/hepatitis C (HCV) protease inhibitors (boceprevir and telaprevir) or with non-nucleoside reverse transcriptase inhibitors (nevirapine or etravirine),
- HCV drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir,
- clofibric acid,
- salicylic acid,
- lamotrigine, and
- thyroid hormone replacement therapy.
Tell your doctor all medications and supplements you use.
Cyonanz During Pregnancy and Breastfeeding
Cyonanz is not intended for use during pregnancy. Small amounts of oral contraceptive steroids pass into breast milk and a few adverse effects on the child have been reported, including jaundice and breast enlargement. Combined oral contraceptives may interfere with lactation by decreasing the quantity and quality of breast milk. Combined oral contraceptive use is not recommended while breastfeeding and nursing mothers are advised to use other forms of contraception until the child is completely weaned. Consult your doctor before breastfeeding.
Our Cyonanz (norethindrone and ethinyl estradiol kit) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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
- 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:
- Gastrointestinal symptoms (such as abdominal cramps and bloating)
- Breakthrough bleeding
- Change in menstrual flow
- Temporary infertility after discontinuation of treatment
- 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
- 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
- Changes in appetite
- Cystitis-like syndrome
- Loss of scalp hair
- Erythema multiforme
- Erythema nodosum
- Hemorrhagic eruption
- Impaired renal function
- Hemolytic uremic syndrome
- Changes in libido
- 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.
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 to 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 to 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 to 10 years of COC use.
Figure 2: Risk of Breast Cancer with Combined Oral Contraceptive 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.|
Consult the labeling of concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations.
Effects of Other Drugs on Combined Hormonal 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 CHCs 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. Interactions between hormonal contraceptives and other drugs may lead to breakthrough bleeding and/or contraceptive failure. Counsel women to use an alternative method of contraception or a back-up method when enzyme inducers are used with CHCs, and to continue back-up contraception for 28 days after discontinuing the enzyme inducer to ensure contraceptive reliability.
Substances Increasing The Plasma Concentrations Of Cocs
Co-administration of atorvastatin or rosuvastatin and certain COCs containing EE increase AUC values for EE by approximately 20 to 25%. Ascorbic acid and acetaminophen may increase plasma EE concentrations, possibly by inhibition of conjugation. CYP3A4 inhibitors such as itraconazole, voriconazole, fluconazole, grapefruit juice, or ketoconazole may increase plasma hormone concentrations.
Human Immunodeficiency Virus (HIV)/Hepatitis C Virus (HCV) Protease Inhibitors And Non-Nucleoside Reverse Transcriptase Inhibitors
Significant changes (increase or decrease) in the plasma concentrations of estrogen and/or progestin have been noted in some cases of co-administration with HIV protease inhibitors (decrease [e.g., nelfinavir, ritonavir, darunavir/ritonavir, (fos)amprenavir/ritonavir, lopinavir/ritonavir, and tipranavir/ritonavir] or increase [e.g., indinavir and atazanavir/ritonavir]) /HCV protease inhibitors (decrease [e.g., boceprevir and telaprevir]) or with non-nucleoside reverse transcriptase inhibitors (decrease [e.g., nevirapine] or increase [e.g., etravirine]).
Concomitant Use With Hcv Combination Therapy - Liver Enzyme Elevation
Do not co-administer Cyonanz™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).
Colesevelam, a bile acid sequestrant, given together with a combination oral hormonal contraceptive, has been shown to significantly decrease the AUC of EE. A drug interaction between the contraceptive and colesevelam was decreased when the two drug products were given 4 hours apart.
Effects Of Combined Hormonal Contraceptives On Other Drugs
COCs containing EE may inhibit the metabolism of other compounds (e.g., cyclosporine, prednisolone, theophylline, tizanidine, and voriconazole) and increase their plasma concentrations. COCs have been shown to decrease plasma concentrations of acetaminophen, clofibric acid, morphine, salicylic acid, temazepam and lamotrigine. Significant decrease in plasma concentration of lamotrigine has been shown, likely due to induction of lamotrigine glucuronidation. This may reduce seizure control; therefore, dosage adjustments of lamotrigine may be necessary.
Women on thyroid hormone replacement therapy may need increased doses of thyroid hormone because serum concentrations of thyroid-binding globulin increases with use of COCs.
Read the entire FDA prescribing information for Cyonanz (Norethindrone and Ethinyl Estradiol Tablets)
© Cyonanz Patient Information is supplied by Cerner Multum, Inc. and Cyonanz Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
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