TRI-LO-ESTARYLLA 0.18MG/0.25MG 3X28 TAB
Generic: norgestimate and ethinyl estradiol
TRI-LO-ESTARYLLA 0.18MG/0.25MG 3X28 TAB
Sign up to see pricing
Licensed pharmacies, clinics, doctor's offices, and veterinary practices get instant account approval
Sign Up — Instant ApprovalDrug Information
Identification
norgestimate and ethinyl estradiol
Tri-Lo- Estarylla
Xiromed, LLC.
HUMAN PRESCRIPTION DRUG
Administration
KIT
ANDA091232
Data sourced from openFDA / DailyMed. For full prescribing information, consult the drug label.
Wholesale compliance resources
Clinical Drug Information
Indications & Usage
1 INDICATIONS AND USAGE Tri-Lo-Estarylla (norgestimate and ethinyl estradiol tablets) is an estrogen/progestin COC, indicated for use by women to prevent pregnancy. ( 1.1 ) 1.1 Oral Contraception Tri-Lo-Estarylla (norgestimate and ethinyl estradiol tablets) are indicated for use by females of reproductive potential to prevent pregnancy [see CLINICAL STUDIES (14) ].
Dosage & Administration
2 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-Lo-Estarylla Tri-Lo-Estarylla is dispensed in a blister pack [see HOW SUPPLIED/STORAGE AND HANDLING (16) ]. Tri-Lo-Estarylla 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. 2.2 How to Take Tri-Lo-Estarylla Table 1: Instructions for Administration of Tri-Lo-Estarylla Starting COCs 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: • Tri-Lo-Estarylla active tablets are white (Day 1 to Day 7), light blue (Day 8 to Day 14) and blue (Day 15 to Day 21). • Tri-Lo-Estarylla inactive tablets are green (Day 22 to Day 28). Day 1 Start: • Take first active tablet without regard to meals on the first day of menses. • Take subsequent active tablets once daily at the same time each day for a total of 21 days. • Take one green inactive tablet daily for 7 days and at the same time of day that active tablets were taken. • Begin each subsequent pack on the same day of the week as the first cycle pack (i.e., on the day after taking the last inactive tablet) Sunday Start: • Take first active tablet without regard to meals 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 Tri-Lo-Estarylla . • Take subsequent active tablets once daily at the same time each day for a total of 21 days. • Take one green inactive tablet daily for the following 7 days and at the same time of day that active tablets were taken. • Begin each subsequent pack on the same day of the week as the first cycle pack (i.e., on the Sunday after taking the last inactive tablet) and additional non-hormonal contraceptive is not needed. Switching to Tri-Lo-Estarylla from another oral contraceptive Start on the same day that a new pack of the previous oral contraceptive would have started. Switching from another contraceptive method to Tri-Lo-Estarylla Start Tri-Lo-Estarylla: • 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 Tri-Lo-Estarylla after Abortion or Miscarriage Starting Tri-Lo-Estarylla after Abortion or Miscarriage First Trimester First-trimester • After a first-trimester abortion or miscarriage, Tri-Lo-Estarylla may be started immediately. An additional method of contraception is not needed if Tri-Lo-Estarylla is started immediately. • If Tri-Lo-Estarylla 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-Lo-Estarylla. Second Trimester 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-Lo-Estarylla, 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-Lo-Estarylla. [See CONTRAINDICATIONS (4) , WARNINGS AND PRECAUTIONS (5.1) , and FDA-APPROVED PATIENT LABELING .] Starting Tri-Lo-Estarylla after childbirth Starting Tri-Lo-Estarylla after Childbirth • Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease. Start contraceptive therapy with Tri-Lo-Estarylla following the instructions in Table 1 for women not currently using hormonal contraception. • Tri-Lo-Estarylla 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-Lo-Estarylla. [See CONTRAINDICATIONS (4) , WARNINGS AND PRECAUTIONS (5.1) , USE IN SPECIFIC POPULATIONS (8.1 and 8.3) , and FDA-Approved Patient Labeling ]. BEFORE YOU START TAKING YOUR PILLS 1. DECIDE WHAT TIME OF DAY YOU WANT TO TAKE YOUR PILL. It is important to take it at about the same time every day. 2. The 28-pill pack has 21 white, light blue, and blue "active" pills (with hormones) to take for 3 weeks. This is followed by 1 week of green "reminder" pills (without hormones). 3. ALSO FIND: 1) where on the pack to start taking pills, 2) in what order to take the pills (follow the arrows), 3) The week numbers as shown in the diagram below. 4. BE SURE YOU HAVE READY AT ALL TIMES: ANOTHER KIND OF BIRTH CONTROL (such as condoms or spermicide) to use as a back-up method in case you miss pills. AN EXTRA, FULL PILL PACK. After childbirth 2.3 Missed Tablets Table 2: Instructions for Missed Tri-Lo-Estarylla Tablets • If one 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 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 active tablets are missed in the third week or three or more 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. 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 ]. After childbirth
Adverse Reactions
6 ADVERSE REACTIONS 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 The most common adverse reactions reported during clinical trials (≥2%) were: headache/migraine, nausea/vomiting, breast issues, abdominal pain, menstrual disorders, mood disorders, acne, vulvovaginal infection, abdominal distension, weight increased, fatigue. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Xiromed, LLC. at 1-844-XIROMED (844-947-6633) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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 norgestimate and ethinyl estradiol was evaluated in 1,723 subjects who participated in a randomized, partially blinded, multicenter, active-controlled clinical trial of norgestimate and ethinyl estradiol for contraception. This trial examined healthy, nonpregnant, volunteers aged 18 to 45 (nonsmoker if 35 to 45 years of age), who were sexually active with regular coitus. Subjects were followed for up to 13 28-day cycles. Common Adverse Reactions Common Adverse Reactions (≥ 2% of subjects) The most common adverse reactions reported by at least 2% of the 1,723 women using the 28-day regimen were the following in order of decreasing incidence: headache/migraine (30.5%), nausea/vomiting (16.3%); breast issues (including tenderness, pain, enlargement, swelling, discharge, discomfort, cyst, and nipple pain) (10.3%), abdominal pain (9.2%), menstrual disorders (including dysmenorrhea, menstrual discomfort, menstrual disorder) (9.2%), mood disorders (including depression, mood altered, mood swings and depressed mood) (7.6%); acne (5.1%), vulvovaginal infection (3.5%), abdominal distension (2.8%), weight increased (2.4%) , fatigue (2.1%). Adverse Reactions Leading to Study Discontinuation Adverse Reactions Leading to Study Discontinuation In the clinical trial of norgestimate and ethinyl estradiol 4% of subjects discontinued the trial due to an adverse reaction. The most common adverse reactions leading to discontinuation were headache/migraine (1.2%), nausea/vomiting (0.7%), cervical dysplasia (0.7%), abdominal pain (0.4%), ovarian cyst (0.3%), acne (0.2%), flatulence (0.2%) and depression (0.2%). Serious Adverse Reactions Serious Adverse Reactions Carcinoma of the cervix in situ (1 subject) and cervical dysplasia (1 subject). 6.2 Postmarketing Experience 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 - 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 - 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 8-10 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. 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 (Including 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.
Information for Patients
17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Patient Information and Instruction 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-Lo-Estarylla does not protect against HIV infection (AIDS) and other sexually transmitted infections. • Tri-Lo-Estarylla is not to be used during pregnancy; if pregnancy occurs during use of Tri-Lo-Estarylla 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-Lo-Estarylla [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 a white 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) ]. Tri-Estarylla is a registered trademark of Xiromed Pharma España, S.L. Manufactured by Laboratorios Leon Farma S.A., Spain for Xiromed LLC. Florham Park, NJ 07932 Product of Spain PI-121-03 Rev. 02/2023
Clinical data sourced from openFDA drug labeling. For complete prescribing information, consult the full drug label.