Tri-Nymyo
Norgestimate and Ethinyl Estradiol · Kit
Uses
Tri-Nymyo is an estrogen/progestin COC, indicated for use by women to prevent pregnancy. ( 1.1 ) Tri-Nymyo is also indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Tri-Nymyo should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control. ( 1.2 ) 1.1 Oral Contraceptive Tri-Nymyo Tablets are indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies ( 14 )] . 1.2 Acen Tri-Nymyo is indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Tri-Nymyo should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control [see Clinical Studies (14) ] .
Dosage and administration
Take one tablet daily by mouth at the same time every day. ( 2.2 ) Take tablets in the order directed on the blister pack. ( 2.2 ) Do not skip or delay tablet intake. ( 2.2 ) 2.1 How to Start Tri-Nymyo Tri-Nymyo is dispensed in 28-tablet blister [see How Supplied/Storage and Handling ( 16 )]. Tri-Nymyo may be started using either a Day 1 start or a Sunday start (see Table 1). The plastic compact is pre-set for a Sunday start. Day 1 Start day-label stickers are available. 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. 2.2 How to Take Tri-Nymyo Starting Tri-Nymyo after Abortion or Miscarriage First-trimester After a first-trimester abortion or miscarriage, Tri-Nymyo may be started immediately. An additional method of contraception is not needed if Tri-Nymyo is started immediately. If Tri-Nymyo is 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 Tri-Nymyo. Second-trimester Do not start until 4 weeks after a second-trimester abortion or miscarriage, due to the increased risk of thromboembolic disease. Start Tri-Nymyo, 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 Tri-Nymyo. [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 ), and FDA-Approved Patient Labeling .] Starting Tri-Nymyo after Childbirth Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease. Start contraceptive therapy with Tri-Nymyo following the instructions in Table 1 for women not currently using hormonal contraception. Tri-Nymyo is not recommended for use in lactating women [see Use in Specific Populations ( 8.3 ) ]. If the woman has not yet had a period postpartum, consider the possibility of ovulation and conception occurring prior to use of Tri-Nymyo. [See Contraindications ( 4 ) , Warnings and Precautions ( 5.1 ) , Use in Specific Populations ( 8.1 and 8.3 ), and FDA-Approved Patient Labeling ]. Compact Blister Dispenser If the patient starts pill-taking on Sunday,the first active pill should be taken on the first Sunday after the patient's menstrual period begins.Remove the first active pill at the top of the dispenser (Sunday) by pressing the pill through the blister foil. If the patient will start pill-taking on "Day 1," place a day-label sticker on the compact which starts with the day of the week the patient will take the first pill. Remove the first active pill at the top of the dispenser (Day 1) by pressing the pill through the blister foil. 2.3 Missed Tablets 2.4 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 ] . 2.5 Tri-Nymyo Use for Acne The timing of initiation of dosing with Tri-Nymyo for acne should follow the guidelines for use of Tri-Nymyo as an oral contraceptive. Consult the DOSAGE AND ADMINISTRATION section (2.1) for instructions. 1 2
Dosage forms and strengths
Tri-Nymyo consists of 28 round, biconvex, coated tablets in the following order ( 3 ): 7 green tablets each containing 0.180 mg norgestimate and 0.035 mg ethinyl estradiol 7 light blue tablets each containing 0.215 mg norgestimate and 0.035 mg ethinyl estradiol 7 blue tablets each containing 0.250 mg norgestimate and 0.035 mg ethinyl estradiol 7 white tablets (inert) Tri-Nymyo Tablets are available in blister cards. Each blister card contains 28 tablets in the following order: 7 green, round, biconvex, tablets imprinted "C1" on one side of the tablet and contains 0.180 mg norgestimate and 0.035 mg ethinyl estradiol 7 light blue, round, biconvex tablets imprinted "C2" on one side of the tablet and contains 0.215 mg norgestimate and 0.035 mg ethinyl estradiol 7 blue, round, biconvex tablets imprinted "C3" on one side of the tablet and contains 0.250 mg norgestimate and 0.035 mg ethinyl estradiol 7 white, round, biconvex tablets (non-hormonal placebo) imprinted "P" on one side and " N " on the other side contains inert ingredients
Contraindications
4 CONTRAINDICATIONS 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 ) Do not prescribe Tri-Nymyo to women who are known to have the following conditions: A high risk of arterial or venous thrombotic diseases. Examples include women who are known to: Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions ( 5.1 )]] Have deep vein thrombosis or pulmonary embolism, now or in the past [see Warnings and Precautions ( 5.1 )] Have inherited or acquired hypercoagulopathies [see Warnings and Precautions (5.1) ] Have cerebrovascular disease [see Warnings and Precautions (5.1) ] Have coronary artery disease [see Warnings and Precautions (5.1) ] Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see Warnings and Precautions (5.1) ] Have uncontrolled hypertension [see Warnings and Precautions (5.4) ] Have diabetes mellitus with vascular disease [see Warnings and Precautions (5.6) ] Have headaches with focal neurological symptoms or have migraine headaches with aura [see Warnings and Precautions (5.7) ] Women over age 35 with any migraine headaches [see Warnings and Precautions (5.7) ] Liver tumors, benign or malignant, or liver disease [see Warnings and Precautions (5.2) ] Undiagnosed abnormal uterine bleeding [see Warnings and Precautions (5.8) ] Pregnancy, because there is no reason to use COCs during pregnancy [ see Warnings and Precautions (5.9) and Use in Specific Populations (8.1) ] Breast cancer or other estrogen- or progestin-sensitive cancer, now or in the past [see Warnings and Precautions (5.11) ] Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations [see Warnings and Precautions (5.3) ]
Warnings and precautions
Thromboembolic Disorders and Other Vascular Problems: Stop Tri-Nymyo if a thrombotic event occurs. Stop at least 4 weeks before and through 2 weeks after major surgery. Start no earlier than 4 weeks after delivery, in women who are not breastfeeding. ( 5.1 ) Liver disease: Discontinue Tri-Nymyo if jaundice occurs. ( 5.2 ) High blood pressure: If used in women with well-controlled hypertension, monitor blood pressure and stop Tri-Nymyo if blood pressure rises significantly. ( 5.4 ) Carbohydrate and lipid metabolic effects: Monitor prediabetic and diabetic women taking Tri-Nymyo. Consider an alternate contraceptive method for women with uncontrolled dyslipidemia. ( 5.6 ) Headache: Evaluate significant change in headaches and discontinue Tri-Nymyo if indicated. ( 5.7 ) Bleeding Irregularities and Amenorrhea: Evaluate irregular bleeding or amenorrhea. ( 5.8 ) 5.1 Thrombotic Disorders and Other Vascular Problems Stop Tri-Nymyo if an arterial thrombotic event or venous thromboembolic (VTE) event occurs. Stop Tri-Nymyo if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately [see Adverse Reactions ( 6.2 )] . If feasible, stop Tri-Nymyo 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 Tri-Nymyo 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 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). This 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. 5.2 Liver Disease Impaired Liver Function Do not use Tri-Nymyo 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 Tri-Nymyo if jaundice develops. Liver Tumors Tri-Nymyo is contraindicated in women with benign and malignant liver tumors [see Contraindications ( 4 )] . Hepatic adenomas are associated with COC use. An estimate of the attributable risk is 3.3 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. 5.3 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 Tri-Nymyo prior to starting therapy with the combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir [see Contraindications ( 4 )] . Tri-Nymyo can be restarted approximately 2 weeks following completion of treatment with the Hepatitis C combination drug regimen. 5.4 High Blood Pressure Tri-Nymyo 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 Tri-Nymyo 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. 5.5 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. 5.6 Carbohydrate and Lipid Metabolic Effects Carefully monitor prediabetic and diabetic women who take Tri-Nymyo. 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. 5.7 Headache If a woman taking Tri-Nymyo develops new headaches that are recurrent, persistent, or severe, evaluate the cause and discontinue Tri-Nymyo if indicated. Consider discontinuation of Tri-Nymyo in the case of increased frequency or severity of migraine during COC use (which may be prodromal of a cerebrovascular event).
Side effects
The most common adverse reactions reported during clinical trials (≥2%) were: headache/migraine, breast issues (including breast pain, enlargement, and discharge), vaginal infection, abdominal/gastrointestinal pain, mood disorders (including mood alteration and depression), genital discharge, changes in weight (including weight increased or decreased). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Mayne Pharma Toll-Free at 1-844-825-8500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The following serious adverse reactions with the use of COCs are discussed elsewhere in labeling: Serious cardiovascular events and stroke [see Boxed Warning and Warnings and Precautions (5.1) ] Vascular events [see Warnings and Precautions ( 5.1 )] Liver disease [see Warnings and Precautions ( 5.2 )] Adverse reactions commonly reported by COC users are: Irregular uterine bleeding Nausea Breast tenderness Headache 6.1 Clinical Trial 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 tri-cycle norgestimate and ethinyl estradiol Tablets was evaluated in 4,826 healthy women of child-bearing potential who participated in 6 clinical trials and received at least 1 dose of tri-cycle norgestimate and ethinyl estradiol Tablets for contraception. Two trials were randomized active-controlled trials and 4 were uncontrolled open-label trials. In 3 trials, subjects were followed for up to 24 cycles; in 2 trials, subjects were followed for up to 12 cycles; and in 1 trial, subjects were followed for up to 6 cycles. Common Adverse Reactions (≥2% of subjects): The most common adverse reactions reported by at least 2% of the 4,826 women were the following in order of decreasing incidence: headache/migraine (33.6%), breast issues (including breast pain, enlargement, and discharge) (8.0%), vaginal infection (7.1%), abdominal/gastrointestinal pain (5.6%), mood disorders (including mood alteration and depression) (3.8%), genital discharge (3.2%), and changes in weight (including weight fluctuation, increased or decreased) (2.5%). Adverse Reactions Leading to Study Discontinuation : Over the trials, between 9 to 27% of subjects discontinued the trial due to an adverse reaction. The most common adverse reactions (≥1%) leading to discontinuation were: metrorrhagia (4.3%), nausea/vomiting (2.8%), headache/migraine (2.4%), mood disorders (including depression and mood altered) (1.1%), and weight increased (1.1%). Serious Adverse Reactions : breast cancer (1 subject), carcinoma of the cervix in situ (1 subject), hypertension (1 subject), and migraine (2 subjects). 6.2 Postmarketing Experience The following additional adverse drug reactions have been reported from worldwide postmarketing experience with norgestimate/ethinyl estradiol. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Infections and Infestations : Urinary tract infection; Neoplasms Benign, Malignant and Unspecified (Incl. Cysts and Polyps) : Breast cancer, benign breast neoplasm, hepatic adenoma, focal nodular hyperplasia, breast cyst; Immune System Disorders : Hypersensitivity; Metabolism and Nutrition Disorders : Dyslipidemia; Psychiatric Disorders : Anxiety, insomnia; Nervous System Disorders : Syncope, convulsion, paresthesia, dizziness; Eye Disorders : Visual impairment, dry eye, contact lens intolerance; Ear and Labyrinth Disorders : Vertigo; Cardiac Disorders : Tachycardia, palpitations; Vascular Events : Deep vein thrombosis, pulmonary embolism, retinal vascular thrombosis, hot flush; Arterial Events: Arterial thromboembolism, myocardial infarction, cerebrovascular accident; Respiratory, Thoracic and Mediastinal Disorders : Dyspnea; Gastrointestinal Disorders : Pancreatitis, abdominal distension, diarrhea, constipation; Hepatobiliary Disorders: Hepatitis; Skin and Subcutaneous Tissue Disorders : Angioedema, erythema nodosum, hirsutism, night sweats, hyperhidrosis, photosensitivity reaction, urticaria, pruritus, acne; Musculoskeletal, Connective Tissue, and Bone Disorders : Muscle spasms, pain in extremity, myalgia, back pain; Reproductive System and Breast Disorders : Ovarian cyst, suppressed lactation, vulvovaginal dryness; General Disorders and Administration Site Conditions : Chest pain, asthenic conditions.
Drug interactions
Drugs or herbal products that induce certain enzymes including CYP3A4, may decrease the effectiveness of COCs or increase breakthrough bleeding. Counsel patients to use a back-up or alternative method of contraception when enzyme inducers are used with COCs. ( 7.1 ) Consult the labeling of concurrently used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations. No drug-drug interaction studies were conducted with Tri-Nymyo. 7.1 Effects of Other Drugs on Combined Oral Contraceptives Substances decreasing the plasma concentrations 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. 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 COCs, and to continue back-up contraception for 28 days after discontinuing the enzyme inducer to ensure contraceptive reliability. Colesevelam: Colesevelam, a bile acid sequestrant, given together with a COC, has been shown to significantly decrease the AUC of EE. The drug interaction between the contraceptive and colesevelam was decreased when the two drug products were given 4 hours apart. Substances increasing the plasma concentrations of COCs : Co-administration of atorvastatin or rosuvastatin and certain COCs containing ethinyl estradiol (EE) increase AUC values for EE by approximately 20-25%. 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]). 7.2 Effects of Combined Oral Contraceptives on Other Drugs 7.2.1 COCs containing EE may inhibit the metabolism of other compounds (e.g., cyclosporine, prednisolone, theophylline, tizanidine, and voriconazole) and increase their plasma concentrations. 7.2.2 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 the serum concentration of thyroid-binding globulin increases with use of COCs. 7.3 Interference with Laboratory Tests The use of contraceptive steroids may influence the results of certain laboratory tests, such as coagulation factors, lipids, glucose tolerance, and binding proteins. 7.4 Concomitant Use with HCV Combination Therapy – Liver Enzyme Elevation Do not co-administer Tri-Nymyo with HCV drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to potential for ALT elevations [see Warnings and Precautions ( 5.3 )].
Use in specific populations
Nursing mothers: Not recommended; can decrease milk production. ( 8.3 ) 8.1 Pregnancy There is little or no increased risk of birth defects in women who inadvertently use COCs during early pregnancy. Epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb reduction defects) following exposure to low dose COCs prior to conception or during early pregnancy. Do not administer COCs to induce withdrawal bleeding as a test for pregnancy. Do not use COCs during pregnancy to treat threatened or habitual abortion. 8.3 Nursing Mothers Advise the nursing mother to use other forms of contraception, when possible, until she has weaned her child. COCs can reduce milk production in breastfeeding mothers. This is less likely to occur once breastfeeding is well-established; however, it can occur at any time in some women. Small amounts of oral contraceptive steroids and/or metabolites are present in breast milk. 8.4 Pediatric Use Safety and efficacy of norgestimate and ethinyl estradiol tablets have been established in women of reproductive age. Efficacy is expected to be the same for post- pubertal adolescents under the age of 18 and for users 18 years and older. Use of this product before menarche is not indicated. There was no significant difference between tri-cycle norgestimate and ethinyl estradiol tablets and placebo in mean change in total lumbar spine (L1-L4) and total hip bone mineral density between baseline and Cycle 13 in 123 adolescent females with anorexia nervosa in a double-blind, placebo-controlled, multicenter, one-year treatment duration clinical trial for the Intent To Treat (ITT) population. 8.5 Geriatric Use Tri-Nymyo has not been studied in postmenopausal women and are not indicated in this population. 8.6 Hepatic Impairment The pharmacokinetics of Tri-Nymyo has not been studied in subjects with hepatic impairment. However, steroid hormones may be poorly metabolized in patients with hepatic impairment. 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. [See Contraindications ( 4 ) and Warnings and Precautions ( 5.2 ) . ] 8.7 Renal Impairment The pharmacokinetics of Tri-Nymyo has not been studied in women with renal impairment.
Pregnancy
8.1 Pregnancy There is little or no increased risk of birth defects in women who inadvertently use COCs during early pregnancy. Epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb reduction defects) following exposure to low dose COCs prior to conception or during early pregnancy. Do not administer COCs to induce withdrawal bleeding as a test for pregnancy. Do not use COCs during pregnancy to treat threatened or habitual abortion.
Pediatric use
8.4 Pediatric Use Safety and efficacy of norgestimate and ethinyl estradiol tablets have been established in women of reproductive age. Efficacy is expected to be the same for post- pubertal adolescents under the age of 18 and for users 18 years and older. Use of this product before menarche is not indicated. There was no significant difference between tri-cycle norgestimate and ethinyl estradiol tablets and placebo in mean change in total lumbar spine (L1-L4) and total hip bone mineral density between baseline and Cycle 13 in 123 adolescent females with anorexia nervosa in a double-blind, placebo-controlled, multicenter, one-year treatment duration clinical trial for the Intent To Treat (ITT) population.
Geriatric use
8.5 Geriatric Use Tri-Nymyo has not been studied in postmenopausal women and are not indicated in this population.
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.
Description
Tri-Nymyo is a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol. Norgestimate is designated as (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime,(17 )-(+)-) and ethinyl estradiol is designated as (19-nor-17 -pregna,1,3,5(10)-trien-20-yne-3,17-diol). Each active green tablet contains 0.18 mg of norgestimate and 0.035 mg of ethinyl estradiol. Inactive ingredients include: FD&C Blue No.2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, D&C Yellow No. 10 Aluminum Lake, titanium dioxide, iron oxide black,iron oxide yellow, macrogol/ polyethylene glycol 3350 NF, lecithin, talc, polyvinyl alcohol,lactose monohydrate, magnesium stearate and pregelatinized corn starch. Each active light blue tablet contains 0.215 mg of norgestimate and 0.035 mg of ethinyl estradiol. Inactive ingredients include: FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, titanium dioxide, iron oxide black, polyvinyl alcohol, talc, macrogol/polyethylene glycol 3350 NF, lecithin, lactose monohydrate, magnesium stearate and pregelatinized corn starch. Each active blue tablet contains 0.25 mg of norgestimate and 0.035 mg of ethinyl estradiol. Inactive ingredients include: FD&C Blue No. 2 Aluminium Lake, FD&C Blue No. 1 Aluminum lake, FD&C Red No. 40 Aluminum Lake, D&C Yellow No. 10 Aluminum Lake,titanium dioxide, polyvinyl alcohol, talc, macrogol/PEG 3350 NF, lecithin, lactose monohydrate, magnesium stearate and pregelatinized corn starch. Each white placebo tablet containing only inert ingredients, as follows: titanium dioxide, polydextrose, hypromellose, triacetin, macrogol/polyethylene glycol, lactose monohydrate, magnesium stearate and pregelatinized corn starch. 3
Mechanism of action
12.1 Mechanism of Action Oral Contraception COCs lower the risk of becoming pregnant primarily by suppressing ovulation. Other possible mechanisms may include cervical mucus changes that inhibit sperm penetration and endometrial changes that reduce the likelihood of implantation. Acne Acne is a skin condition with a multifactorial etiology, including androgen stimulation of sebum production. While the combination of ethinyl estradiol and norgestimate increases sex hormone-binding globulin (SHBG) and decreases free testosterone, the relationship between these changes and a decrease in the severity of facial acne in otherwise healthy women with this skin condition has not been established.
How supplied
16.1 How Supplied Tri-Nymyo Tablets are available in a compact blister card (NDC 51862-646-01). Each blister card (28 tablets) contains in the following order:
• 7 green, round, biconvex, tablets imprinted "C1" on one side of the tablet and contains 0.180 mg norgestimate and 0.035 mg ethinyl estradiol
• 7 light blue, round, biconvex tablets imprinted "C2" on one side of the tablet and contains 0.215 mg norgestimate and 0.035 mg ethinyl estradiol
• 7 blue, round, biconvex tablets imprinted "C3" on one side of the tablet and contains 0.250 mg norgestimate and 0.035 mg ethinyl estradiol
• 7 white, round, biconvex tablets (non-hormonal placebo) imprinted "P" on one side and " N " on the other side contains inert ingredients Tri-Nymyo is available in the following packaging configurations: Carton of 1 blister card NDC 51862-646-02 Carton of 3 blister cards NDC 51862-646-03 Carton of 6 blister cards NDC 51862-646-06 16.2 Storage Conditions Store at 20° to 25°C (68° to 77°F), [see USP Controlled Room Temperature]. Protect from light. Keep out of the reach of children. 16.1 How Supplied Tri-Nymyo Tablets are available in a compact blister card (NDC 51862-646-01). Each blister card (28 tablets) contains in the following order:
• 7 green, round, biconvex, tablets imprinted "C1" on one side of the tablet and contains 0.180 mg norgestimate and 0.035 mg ethinyl estradiol
• 7 light blue, round, biconvex tablets imprinted "C2" on one side of the tablet and contains 0.215 mg norgestimate and 0.035 mg ethinyl estradiol
• 7 blue, round, biconvex tablets imprinted "C3" on one side of the tablet and contains 0.250 mg norgestimate and 0.035 mg ethinyl estradiol
• 7 white, round, biconvex tablets (non-hormonal placebo) imprinted "P" on one side and " N " on the other side contains inert ingredients Tri-Nymyo is available in the following packaging configurations: Carton of 1 blister card NDC 51862-646-02 Carton of 3 blister cards NDC 51862-646-03 Carton of 6 blister cards NDC 51862-646-06
Patient information
See FDA-approved patient labeling (Patient Information and Instructions for Use). Counsel patients about the following information: Cigarette smoking increases the risk of serious cardiovascular events from COC use, and that women who are over 35 years old and smoke should not use COCs [see Boxed Warning ]. Increased risk of VTE compared to non-users of COCs is greatest after initially starting a COC or restarting (following a 4-week or greater pill-free interval) the same or a different COC [see Warnings and Precautions (5.1) ]. Tri-Nymyo does not protect against HIV infection (AIDS) and other sexually transmitted infections. Tri-Nymyo is not to be used during pregnancy; if pregnancy occurs during use of Tri-Nymyo instruct the patient to stop further use [see Warnings and Precautions ( 5.9 )] . Take one tablet daily by mouth at the same time every day. Instruct patients what to do in the event tablets are missed [see Dosage and Administration ( 2.2 )] . Use a back-up or alternative method of contraception when enzyme inducers are used with Tri-Nymyo [see Drug Interactions ( 7.1 )] . COCs may reduce breast milk production; this is less likely to occur if breastfeeding is well established [see Use in Specific Populations ( 8.3 )] . Women who start COCs postpartum, and who have not yet had a period, should use an additional method of contraception until they have taken an active tablet for 7 consecutive days [see Dosage and Administration ( 2.2 )] . Amenorrhea may occur. Consider pregnancy in the event of amenorrhea at the time of the first missed period. Rule out pregnancy in the event of amenorrhea in two or more consecutive cycles [see Warnings and Precautions ( 5.8 )] . Distributed by: Mayne Pharma Greenville, NC 27834 6
Label text from the FDA structured product label by Mayne Pharma Inc. (revised Dec 8, 2022). Long sections are shortened; the complete label is on DailyMed.
Tri-Nymyo NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 51862-646 | Kit | Mayne Pharma Inc. | ANDA |
Frequently asked questions
What is Tri-Nymyo used for?
Tri-Nymyo is an estrogen/progestin COC, indicated for use by women to prevent pregnancy. ( 1.1 ) Tri-Nymyo is also indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Tri-Nymyo should be used for the treatment of acne only if the patient desires an oral…
What are the side effects of Tri-Nymyo?
The most common adverse reactions reported during clinical trials (≥2%) were: headache/migraine, breast issues (including breast pain, enlargement, and discharge), vaginal infection, abdominal/gastrointestinal pain, mood disorders (including mood alteration and depression), genital discharge, changes in weight (including weight increased or decreased). ( 6.1 ) To report SUSPECTED ADVERSE… See the full label for the complete list.
Who makes Tri-Nymyo?
Tri-Nymyo is listed by 1 labeler in the FDA NDC directory, including Mayne Pharma Inc..