ℹ️ Compiled from public regulatory records · Last regulator revision: March 20, 2026🚩 Report this page
Norgestimate
Active ingredient
Sold asVyLibra · TRI-CIRA 21 · TRI-CIRA 28 · TRI-JORDYNA 28 · TRI-CIRA LO 21
CA Health CanadaUS FDAGB MHRA
Drug class
-
Availability
Prescription only
Routes
Oral
Markets covered
3
Products on record
9
FDA reports (12 mo)
147
Overview
Norgestimate is an active pharmaceutical ingredient. The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
CAOfficial regulatory label· revised September 17, 2025[1]
TRI-JORDYNA™ Tablets are indicated for: • Conception control. • The treatment of moderate acne vulgaris in females, ≥ 15 years of age, who have no known contraindications to oral contraceptive therapy, desire contraception, and have achieved menarche.
How to take
CA
USUnited States· FDA
3 products
Uses
USOfficial regulatory label· revised April 8, 2025[2]
1 INDICATIONS AND USAGE Sprintec ® is a combination of norgestimate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. 1 Oral Contraceptive Sprintec ® (norgestimate and ethinyl estradiol tablets) is indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies ( 14 )].
How to take
GBUnited Kingdom· MHRA
1 product
Uses
GBOfficial regulatory label· revised March 20, 2026[3]
Contraception and the recognised indications for such oestrogen/progestogen combinations. 4).
How to take
GB
Drug interactions
Known interactions involving Norgestimate. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
[1]Health Canada (DPD) · 02486318 · revised September 17, 2025
[2]FDA DailyMed · 00dd9b78-dd90-41… · revised April 8, 2025 [PDF]
[3]MHRA (UK) · PL201170220 · revised March 20, 2026
[4]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.
1 Dosing Considerations INFORMATION TO PATIENTS ON HOW TO TAKE THE BIRTH CONTROL PILL 1. READ THESE DIRECTIONS • before you start taking your pills, and • any time you are not sure what to do. 2. LOOK AT YOUR PILL PACK to see if it has 21 or 28 pills: • 21-Pill Pack: 21 active pills (with hormones) taken daily for three weeks, and then no pills taken for one week or • 28-Pill Pack: 21 active pills (with hormones) taken daily for three weeks, and then seven "reminder" pills (no hormones) taken daily for one week.
ALSO CHECK the pill pack for instructions on 1) where to start and 2) direction to take pills. 21-Day Package 28-Day Package 3. , latex or polyurethane condoms and spermicidal foam or gel) for the first seven days of the first cycle of pill use.
This will provide a back-up in case pills are forgotten while you are getting used to taking them. PrTRI-JORDYNA™ (Norgestimate and Ethinyl Estradiol Tablets USP) Page 6 of 60 4. When receiving any medical treatment, be sure to tell your doctor that you are using birth control pills.
5. MANY WOMEN HAVE SPOTTING OR LIGHT BLEEDING, OR MAY FEEL SICK TO THEIR STOMACH DURING THE FIRST THREE MONTHS ON THE PILL. If you do feel sick, do not stop taking the pill. The problem will usually go away. If it does not go away, check with your doctor or clinic.
6. MISSING PILLS ALSO CAN CAUSE SOME SPOTTING OR LIGHT BLEEDING, even if you make up the missed pills. You also could feel a little sick to your stomach on the days you take two pills to make up for missed pills. 7. IF YOU MISS PILLS AT ANY TIME, YOU COULD GET PREGNANT.
THE GREATEST RISKS FOR PREGNANCY ARE: • when you start a pack late, or • when you miss pills at the beginning or at the very end of the pack. 8. ALWAYS BE SURE YOU HAVE READY: • ANOTHER KIND OF BIRTH CONTROL (such as latex or polyurethane condoms and spermicidal foam or gel) to use as a back-up in case you miss pills, and • AN EXTRA, FULL PACK OF PILLS.
9. IF YOU EXPERIENCE VOMITING OR DIARRHEA, OR IF YOU TAKE CERTAIN MEDICINES, such as antibiotics, your pills may not work as well. Use a back-up method, such as latex or polyurethane condoms and spermicidal foam or gel, until you can check with your doctor or clinic.
10. IF YOU FORGET MORE THAN ONE PILL TWO MONTHS IN A ROW, talk to your doctor or clinic about how to make pill-taking easier or about using another method of birth control. 11. IF YOUR QUESTIONS ARE NOT ANSWERED HERE, CALL YOUR DOCTOR OR CLINIC.
WHEN TO START THE FIRST PACK OF PILLS BE SURE TO READ THESE INSTRUCTIONS: • before you start taking your pills, and • any time you are not sure what to do. Decide with your doctor or clinic what is the best day for you to start taking your first pack of pills.
Your pills may be either a 21-day or a 28-day type. DIRECTIONS FOR 21-DAY AND 28-DAY PILL PACKS 1. THE FIRST DAY OF YOUR MENSTRUAL PERIOD (BLEEDING) IS DAY 1 OF YOUR CYCLE. The pills may be started up to Day 6 of your cycle. Your starting day will be chosen in discussion with your doctor.
You will always begin taking your pill on this day of the week. Your doctor may advise you to start taking the pills on Day 1, on Day 5, or on the first Sunday after your period begins. If your period starts on Sunday, start that same day.
PrTRI-JORDYNA™ (Norgestimate and Ethinyl Estradiol Tablets USP) Page 7 of 60 2.
IF YOU ARE USING A: 21-DAY Pill Pack:
With this type of birth control pill, you are on pills for 21 days and off pills for seven days. You must not be off the pills for more than seven days in a row. Take one pill at approximately the same time every day for 21 days. THEN DO NOT TAKE A PILL FOR SEVEN DAYS.
Start a new pack on the eighth day. You will probably have a period during the seven days off the pill. ) 28-DAY Pill Pack: With this type of birth control pill, you take 21 pills that contain hormones and seven pills that contain no hormones.
Take one pill at approximately the same time every day for 28 days. Begin a new pack the next day, NOT MISSING ANY DAYS ON THE PILLS. Your period should occur during the last seven days of using that pill pack. PrTRI-JORDYNA™ (Norgestimate and Ethinyl Estradiol Tablets USP) Page 8 of 60 INSTRUCTIONS FOR USING YOUR PACKAGE FOR BOTH 21-DAY AND 28-DAY PACKS.
FOLLOW THESE INSTRUCTIONS CAREFULLY:
The pill package indicates Sunday as the day you start your pills. If you are starting the pills on any other day but Sunday, peel the appropriate day label from the enclosed stickers and place the label over the pre-printed days of the week.
1.
For Day 1 start:
Label the pill package by selecting the day label that starts with Day 1 of your menstrual period (the first day of menstruation is Day 1). For example, if your first day of menstruation is Tuesday, attach the day label that begins with TUE over the pre-printed days of the week.
OR For Day 5 start:
Label the pill package by selecting the day label that starts with the day that is 5 days after your period begins. ) For example, if your first day of menstruation is Saturday, place the day label that starts with WED over the pre-printed days of the week.
OR For Sunday start:
No day label is required. The package is printed for a Sunday start. ) 2. Ensure the day label lines up with the pills. Having the package labelled with the days of the week will help remind you to take your pill every day. 3. To begin taking your pills, start with the pill inside the circle (beside the word START).
This pill should correspond to the day of the week that you are taking your first pill. To remove the pill, push through the back of the package. 4. On the following day, take the next pill in the same row, always proceeding from left to right (→).
Each row will always begin on the […]
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
CAOfficial regulatory label· Adverse reactions· revised September 17, 2025[1]
, retinal thrombosis) • Myocardial infarction • Cerebral thrombosis • Cerebral hemorrhage • Hypertension • Benign hepatic tumours • Gallbladder disease The following adverse reactions also have been reported in patients receiving oral contraceptives.
Nausea and vomiting, usually the most common adverse reaction, occurs in approximately 10 per cent or less patients during the first cycle. 2 Clinical Trial Adverse Drug Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. The safety of 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 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.
The most frequent Adverse Drug Reactions (ADRs) reported in >5% of subjects were headache, breast pain and vaginal infection. ADRs reported by ≥1% of subjects treated with norgestimate and ethinyl estradiol tablets in these trials are shown in Table 2.
3 Additional ADRs reported by <1% of subjects (N=4,826) treated with norgestimate and ethinyl estradiol tablets in the above clinical dataset are shown in Table 3. , using menstrual calendars or diary cards. These ADRs are not included in Tables 2 and 3, as the incidence of each ADR was reported separately by treatment cycle only and no overall subject incidence for the whole trial was reported.
In general, solicited events are associated with […]
CAOfficial regulatory label· Warnings and precautions· revised September 17, 2025[1]
). • Known or suspected carcinoma of the breast. • Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia. • Undiagnosed abnormal vaginal bleeding. • Any ocular lesion arising from ophthalmic vascular disease, such as partial or complete loss of vision or defect in visual fields.
• When pregnancy is suspected or diagnosed. • Valvular heart disease with complications. • Steroid-dependent jaundice, cholestatic jaundice or history of jaundice of pregnancy. • Current or history of migraine with focal aura. • History of or actual pancreatitis if associated with severe hypertriglyceridemia.
, due to MTHFR C677T, A1298 mutations), prothrombin mutation G20210A, and antiphospholipid-antibodies (anticardiolipin antibodies, lupus anticoagulant) o severe dyslipoproteinemia o over age 35 and smoke o diabetes mellitus with vascular involvement o major surgery associated with an increased risk of postoperative thromboembolism o prolonged immobilization • Hypersensitivity to this drug or to any ingredient in the formulation or component of the container.
For a complete listing, see 4 DOSAGE FORMS, COMPOSITION AND PACKAGING section of the product monograph. PrTRI-JORDYNA™ (Norgestimate and Ethinyl Estradiol Tablets USP) Page 5 of 60 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive use.
This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, combination oral contraceptives, including TRI-JORDYNA™, should not be used by women who are over 35 years of age and smoke (see Cardiovascular section below).
Oral contraceptives DO NOT PROTECT against sexually transmitted infections (STIs) including HIV/AIDS. For protection against STIs, it is advisable to use latex or polyurethane condoms IN COMBINATION WITH oral contraceptives. 1 Dosing Considerations INFORMATION TO PATIENTS ON HOW TO TAKE THE BIRTH CONTROL PILL 1.
READ THESE DIRECTIONS • before you start taking your pills, and • any time you are not sure what to do. 2. LOOK AT YOUR PILL PACK to see if it has 21 or 28 pills: • 21-Pill Pack: 21 active pills (with hormones) taken daily for three weeks, and then no pills taken for one week or • 28-Pill Pack: 21 active pills (with hormones) taken daily for three weeks, and then seven "reminder" pills (no hormones) taken daily for one week.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
CAOfficial regulatory label· Contraindications· revised September 17, 2025[1]
• History of or actual thrombophlebitis or thromboembolic disorders. • Known thrombophilic conditions. • History of or actual cerebrovascular disorders. • History of or actual myocardial infarction or coronary arterial disease. , transient ischemic attack, angina pectoris).
• Active liver disease or history of or actual benign or malignant liver tumours. • Use with the Hepatitis C virus (HCV) combination drug regimen ombitasvir, paritaprevir, ritonavir, with or without dasabuvir (see 7 WARNINGS AND PRECAUTIONS).
• Known or suspected carcinoma of the breast. • Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia. • Undiagnosed abnormal vaginal bleeding. • Any ocular lesion arising from ophthalmic vascular disease, such as partial or complete loss of vision or defect in visual fields.
• When pregnancy is suspected or diagnosed. • Valvular heart disease with complications. • Steroid-dependent jaundice, cholestatic jaundice or history of jaundice of pregnancy. • Current or history of migraine with focal aura. • History of or actual pancreatitis if associated with severe hypertriglyceridemia.
, due to MTHFR C677T, A1298 mutations), prothrombin mutation G20210A, and antiphospholipid-antibodies (anticardiolipin antibodies, lupus anticoagulant) o severe dyslipoproteinemia o over age 35 and smoke o diabetes mellitus with vascular involvement o major surgery associated with an increased risk of postoperative thromboembolism o prolonged immobilization • Hypersensitivity to this drug or to any ingredient in the formulation or component of the container.
For a complete listing, see 4 DOSAGE FORMS, COMPOSITION AND PACKAGING section of the product monograph. PrTRI-JORDYNA™ (Norgestimate and Ethinyl Estradiol Tablets USP) Page 5 of 60
This is not medical advice. Consult a qualified healthcare professional.
2 DOSAGE AND ADMINISTRATION Take one tablet daily by mouth at the same time every day. 1 ) Take tablets in the order directed on the blister pack. 1 ) Do not skip or delay tablet intake. 1 Recommended Dosage and Administration Take one tablet by mouth at the same time each day with or without food.
Table 1 provides the recommended dosage and administration instructions for Sprintec.
Table 1:
Instructions for Administration of Sprintec 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:
Sprintec active tablets are blue (Day 1 to Day 21). Sprintec has white inactive tablets (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 white inactive 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) 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 Sprintec.
Take subsequent active tablets once daily at the same time each day for a total of 21 days. Take one white inactive 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 Sprintec 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 Sprintec Start Sprintec:
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 Sprintec after Abortion or Miscarriage First-trimester After a first-trimester abortion or miscarriage, Sprintec may be started immediately.
An additional method of contraception is not needed if Sprintec is started immediately. If Sprintec 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 Sprintec.
Second-trimester Do not start until 4 weeks after a second-trimester abortion or miscarriage, due to the increased risk of thromboembolic disease. Start Sprintec, following the instructions in Table 1 for Day 1 or Sunday start, as desired.
1 )]. Starting Sprintec after Childbirth Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease. Start contraceptive therapy with Sprintec following the instructions in Table 1 for women not currently using hormonal contraception.
2 )]. 2 )]. 2 Recommendations Regarding Missed Doses Contraceptive failure may occur when active tablets are missed. Table 2 describes instructions for Sprintec dosing and use of additional non-hormonal contraception (such as condoms) when active tablets are missed.
Table 2:
Instructions for Missed Sprintec 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.
3 Dosage Recommendations if Vomiting or Diarrhea Occurs 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.
This is not medical advice. Consult a qualified healthcare professional.
Most-reported reactions to the US regulator (12 mo to June 4, 2026): 147 reports total. [4]
Product Dose Omission Issue 15
Nausea 14
Vomiting 12
Injection Site Pain 11
Drug Ineffective 10
Fatigue 8
Headache 8
Pruritus 8
Diarrhoea 6
Inappropriate Schedule Of Product Administration 6
Off Label Use 6
Dermatitis Atopic 5
Side effects & warnings
USOfficial regulatory label· Adverse reactions· revised April 8, 2025[2]
2 )] The most common adverse reactions reported during clinical trials (≥2%) were: Sprintec: headache/migraine, abdominal/gastrointestinal pain, vaginal infection, genital discharge, breast issues (including breast pain, discharge, and enlargement), mood disorders (including depression and mood altered), flatulence, nervousness, rash.
gov/medwatch. 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 1,647 healthy women of child-bearing potential who participated in 3 clinical trials and received at least 1 dose of norgestimate and ethinyl estradiol for contraception.
Two trials were randomized active-controlled trials and 1 was an uncontrolled open-label trial. In all 3 trials, subjects were followed for up to 24 cycles. 6%).
Adverse Reactions Leading to Study Discontinuation :
Over the three trials, between 11 to 21% of subjects discontinued the trial due to an adverse reaction. 1%). Serious Adverse Reactions : breast cancer (1 subject), mood disorders including depression, irritability, and mood swings (1 subject), myocardial infarction (1 subject), and venous thromboembolic events including pulmonary embolism (1 subject) and deep vein thrombosis (DVT) (1 subject).
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:
Relevant Studies of 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 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 : Anaphylactic reaction, 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, venous thrombosis (including Budd Chiari Syndrome and hepatic vein thrombosis); 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.
1
USOfficial regulatory label· Warnings and precautions· revised April 8, 2025[2]
5 WARNINGS AND PRECAUTIONS Thromboembolic Disorders and Other Vascular Problems : Stop Sprintec 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.
1 ) Liver disease : Discontinue Sprintec if jaundice occurs. 2 ) High blood pressure : If used in women with well-controlled hypertension, monitor blood pressure and stop Sprintec if blood pressure rises significantly. 4 ) Carbohydrate and lipid metabolic effects : Monitor prediabetic and diabetic women taking Sprintec.
Consider an alternate contraceptive method for women with uncontrolled dyslipidemia. 6 ) Headache : Evaluate significant change in headaches and discontinue Sprintec if indicated. 7 ) Bleeding Irregularities and Amenorrhea : Evaluate irregular bleeding or amenorrhea.
1 Thromboembolic Disorders and Other Vascular Problems Stop Sprintec if an arterial thrombotic event or venous thromboembolic (VTE) event occurs. Stop Sprintec if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions.
2 )]. If feasible, stop Sprintec 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 Sprintec 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 is not medical advice. Consult a qualified healthcare professional.
Who should not take it
USOfficial regulatory label· Contraindications· revised April 8, 2025[2]
4 CONTRAINDICATIONS Sprintec is contraindicated in females who are known to have or develop the following conditions: A high risk of arterial or venous thrombotic diseases. 3 )] A high risk of arterial or venous thrombotic diseases ( 4 ) Liver tumors or liver disease ( 4 ) Undiagnosed abnormal uterine bleeding ( 4 ) Breast cancer ( 4 ) Coadministration with Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir ( 4 )
This is not medical advice. Consult a qualified healthcare professional.
For oral administration. Adults How to take Lizinna One tablet is taken daily at the same time (preferably in the evening) without interruption for 21 days, followed by a break of 7 tablet-free days. Each subsequent pack is started after the 7 tablet-free days have elapsed.
Additional contraceptive precautions are not then required. During the tablet-free period, bleeding can be expected, usually beginning 2 to 4 days after the last tablet. Starting treatment It is preferable that tablet intake from the first pack is started up to and including day 5 of menstruation in which case no extra contraceptive precautions are necessary.
Lizinna can be started at any other time, if pregnancy can reasonably be excluded. In this case additional contraceptive precautions must be taken for the first 7 days of tablet taking Switching from another contraceptive Hormonal methods: Lizinna can be started immediately if the patient has been using the current hormonal method consistently and correctly, or if pregnancy can reasonably be excluded.
There is no need to wait for the next menstruation. Additional contraceptive precautions are not required.
Non-hormonal methods:
If Lizinna is started after the first 5 days of menstruation, additional contraceptive precautions are required for the next 7 days. Post-partum administration Following a vaginal delivery, oral contraceptive administration to non-breast- feeding mothers can be started 21 days post-partum provided the patient is fully ambulant and there are no puerperal complications.
No additional contraceptive precautions are required. If post-partum administration begins more than 21 days after delivery, additional contraceptive precautions are required for the first 7 days of pill-taking. If intercourse has taken place post-partum, oral contraceptive use should be delayed until the first day of the first menstrual period.
6. Use after Abortion or Miscarriage After an abortion or miscarriage that occurs prior to 24 weeks gestation, oral contraceptives can be started immediately. An additional method of contraception is not needed. After an induced or spontaneous abortion that occurs at or after 24 weeks gestation, hormonal contraceptives may be started either on Day 21 post- abortion or on the first day of the first spontaneous menstruation, whichever comes first.
No additional contraceptive precautions are required. To skip a period To skip a period, a new pack of Lizinna should be started on the day after finishing the current pack (the patient skips the tablet-free days). Tablet-taking should be continued in the usual way.
During the use of the second pack she may experience slight spotting or break- through bleeding but contraceptive protection will not be diminished provided there are no tablet omissions. The next pack of Lizinna is started after the usual 7 tablet-free days, regardless of whether the period has completely finished or not.
Reduced reliability When Lizinna is taken according to the directions for use, the occurrence of pregnancy is highly unlikely. However, the reliability of oral contraceptives may be reduced under the following circumstances: (i) Missed tablets If the patient forgets to take one tablet or if a new strip is started one day late, she should take it as soon as she remembers and take the next one at the normal time.
This may mean that two tablets are taken in one day. No additional contraceptive precautions are required. If more than one tablet is missed or if a new strip is started more than one day late, she should take the last missed tablet as soon as she remembers but leave the other missed tablets in the strip.
g. condom, diaphragm, plus spermicide) for the next 7 days. If the tablets are missed: • In week 1 If unprotected sex has taken place, the use of emergency contraception should be considered. The usual 7-day break can be left before starting the next strip.
• In week 2 The usual 7-day break can be left before starting the next strip. • In week 3 When the strip is finished the next strip should be started the next day without a break. If withdrawal bleeding does not occur at the end of the second strip, a pregnancy test should be performed.
(ii) Vomiting or diarrhoea If a patient vomits within two hours of taking a tablet she should take another tablet from a spare strip. If severe vomiting or diarrhoea continues for more than one day, she should follow the procedure for missed tablets (and continue taking the tablets if she can).
Elderly:
Use of this product is not indicated in post-menopausal women.
Children:
Use of this product before menarche is not indicated.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
GBOfficial regulatory label· Adverse reactions· revised March 20, 2026[3]
Description of selected adverse reactions An increased risk of arterial and venous thrombotic and thromboembolic events, including myocardial infarction, stroke, transient ischemic attacks, venous thrombosis and pulmonary embolism has been observed in women using CHCs.
4. These adverse drug reactions (ADRs) require immediate medical attention and/or cessation of oral contraceptive use. The following ADRs may also require immediate medical attention and/or cessation of CHC use: retinal vein thrombosis, new onset of migraine -type headache, breast cancer, hepatic tumours, adenomas, high blood pressure, angioedema, urticaria and hypersensitivity.
Alternative non-hormonal methods of contraception should be used, while appropriate diagnostic and therapeutic measures are undertaken. 9%). 8%). 9%). The incidence of these ADRs was highest in cycle 1 and decreased over time with the exception dysmenorrhoea.
8%). The 5 clinical trials (2 randomised active-controlled trials and 3 uncontrolled open- label trials), which were used to evaluate the safety of , included 1,891 healthy women of child bearing potential. In 3 trials, subjects were followed for up to 24 cycles and in the other 2 trials for up to 12 cycles.
An additional uncontrolled study (n=8,331) reported ADRs by treatment cycle for up to 24 cycles. As the frequency of ADRs vary according to the cycle of treatment, the highest cycle incidence has been used to assign the ADR to a frequency category.
The table below displays all ADRs that have been reported with the use of Norgestimate / Ethinylestradiol in clinical trials or from post marketing experiences with norgestimate and ethinyl estradiol tablets.
The displayed frequency categories use the following convention:
Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); and not known (cannot be estimated from the available data). Infections and infestations Common Urinary tract infection, vaginal infection Neoplasms benign, malignant and unspecified (including cysts and polyps) Uncommon Cervical dysplasia Rare Breast cyst Frequency not known Hepatic adenomas , breast cancer, benign breast neoplasm, focal nodular hyperplasia, fibroadenoma of breast Immune system disorders Common Hypersensitivity Metabolism and nutrition disorders Common Fluid retention Uncommon Increase and decrease in appetite, weight fluctuation Rare Appetite disorder Frequency not known Dyslipidaemia Psychiatric disorders Common Mood altered, depression, nervousness, insomnia Uncommon Anxiety, libido disorder Nervous system disorders Very common Headache Common Migraine, dizziness Uncommon Syncope, paraesthesia Frequency not known Cerebrovascular accident, convulsion Eye disorders Uncommon Visual impairment, dry eye Frequency not known Intolerance to contact lenses, retinal vascular thrombosis* Ear and labyrinth disorders Rare Vertigo Cardiac disorders Uncommon Palpitations Rare Tachycardia Frequency not known Myocardial infarction Vascular disorders Uncommon Thrombosis, hypertension, hot flush Rare Venous thromboembolism, Arterial thromboembolism Frequency not known Deep venous thrombosis* Respiratory, thoracic and mediastinal disorders Uncommon Dyspnoea Frequency not known Pulmonary embolism* Gastrointestinal disorders Very common Gastrointestinal disorder, vomiting, diarrhoea, nausea Common Gastrointestinal pain, abdominal pain, abdominal distension, constipation, flatulence Rare Pancreatitis Hepato-biliary disorders Rare Hepatitis Frequency not known Transaminase increased Skin and subcutaneous tissue disorders Common Acne, rash Uncommon Alopecia, hirsutism, urticaria, pruritus, erythema, skin discolouration Rare Hyperhidrosis, photosensitivity reaction Frequency not known Angioedema, erythema nodosum, night sweats Musculoskeletal and connective tissue disorders Common Muscle spasms, pain in extremity, back pain Uncommon Myalgia Reproductive system and breast disorders Very common Dysmenorrhoea, metrorrhagia, abnormal withdrawal bleeding Common Amenorrhoea, genital discharge, breast pain Uncommon Breast discharge, breast enlargement, ovarian cyst, vulvovaginal dryness Rare Vaginal discharge Frequency not known Suppressed lactation General disorders and administration site conditions Common Chest pain, oedema, asthenic conditions Investigations Common Weight increased Uncommon Weight decreased * Not seen in clinical trials therefore frequency cannot be estimated.
4 for frequency based on standard reporting rates for similar combined hormonal contraceptives. Exogenous estrogens may induce or exacerbate symptoms of hereditary and acquired angioedema. (Frequency ‘unknown’)
GBOfficial regulatory label· Warnings and precautions· revised March 20, 2026[3]
Warnings If any of the conditions/risk factors mentioned below is present, the suitability of Lizinna should be discussed with the woman. In the event of aggravation, or first appearance of any of these conditions or risk factors, the woman should be advised to contact her doctor to determine whether the use of Lizinna should be discontinued.
Exclude likelihood of pregnancy before starting treatment. Undiagnosed vaginal bleeding should be investigated further. Serum folate levels may be depressed by oral contraceptive therapy. This may be of clinical significance if a woman becomes pregnant shortly after discontinuing oral contraceptives.
8). Depression can be serious and is a well-known risk factor for suicidal behaviour and suicide. Women should be advised to contact their physician in case of mood changes and depressive symptoms, including shortly after initiating the treatment.
Medical examination/consultation Prior to the initiation or reinstitution of Lizinna a complete medical history (including family history) should be taken and pregnancy must be ruled out. 4). It is important to draw a woman’s attention to the information on venous and arterial thrombosis, including the risk of Lizinna compared with other CHCs, the symptoms of VTE and ATE, the known risk factors and what to do in the event of a suspected thrombosis.
The woman should also be instructed to carefully read the user leaflet and to adhere to the advice given. The frequency and nature of examinations should be based upon established practice guidelines and should be adapted to the individual woman.
Women should be advised that oral contraceptives DO NOT protect against HIV infections (AIDS) or any other sexually transmitted disease. Conditions requiring supervision − The theoretical or proven risks usually outweigh the advantages of using Combined Oral Contraceptives (COCs) in the conditions listed below.
Consequently the decision to prescribe the COC must be made with specialist clinical judgement. 3 and “Circulatory disorders” below) − Adequately controlled hypertension (persistently elevated baseline systolic values 140-159 mmHg or diastolic values 90-94 mmHg) − Obesity (BMI ≥ 35kg/m2) − History of cholestasis (related to COCs), current or medically treated gall bladder disease, porphyria − History of breast cancer, 5 years disease-free.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
GBOfficial regulatory label· Contraindications· revised March 20, 2026[3]
g. g. g. g. 4) or to the presence of one serious risk factor such as: − diabetes mellitus with vascular symptoms − severe hypertension − severe dyslipoproteinaemia • Acute or chronic liver disease, including hepatitis (viral or non-viral) or severe cirrhosis, or a history of these conditions until at least 3 months after abnormal liver function tests have returned to normal; hepatic adenomas or carcinomas.
• Known or suspected carcinoma of the breast. 1. Should any of these conditions occur for the first time during use of Lizinna, the tablets should be discontinued immediately. 5).
This is not medical advice. Consult a qualified healthcare professional.
ALSO CHECK the pill pack for instructions on 1) where to start and 2) direction to take pills. 21-Day Package 28-Day Package 3. , latex or polyurethane condoms and spermicidal foam or gel) for the first seven days of the first cycle of pill use.
This will provide a back-up in case pills are forgotten while you are getting used to taking them. PrTRI-JORDYNA™ (Norgestimate and Ethinyl Estradiol Tablets USP) Page 6 of 60 4. When receiving any medical treatment, be sure to tell your doctor that you are using birth control pills.
5. MANY WOMEN HAVE SPOTTING OR LIGHT BLEEDING, OR MAY FEEL SICK TO THEIR STOMACH DURING THE FIRST THREE MONTHS ON THE PILL. If you do feel sick, do not stop taking the pill. The problem will usually go away. If it does not go away, check with your doctor or clinic.
6. MISSING PILLS ALSO CAN CAUSE SOME SPOTTING OR LIGHT BLEEDING, even if you make up the missed pills. You also could feel a little sick to your stomach on the days you take two pills to make up for missed pills. 7. IF YOU MISS PILLS AT ANY TIME, YOU COULD GET PREGNANT.
THE GREATEST RISKS FOR PREGNANCY ARE: • when you start a pack late, or • when you miss pills at the beginning or at the very end of the pack. 8. ALWAYS BE SURE YOU HAVE READY: • ANOTHER KIND OF BIRTH CONTROL (such as latex or polyurethane condoms and spermicidal foam or gel) to use as a back-up in case you miss pills, and • AN EXTRA, FULL PACK OF PILLS.
9. IF YOU EXPERIENCE VOMITING OR DIARRHEA, OR IF YOU TAKE CERTAIN MEDICINES, such as antibiotics, your pills may not work as well. Use a back-up method, such as latex or polyurethane condoms and spermicidal foam or gel, until you can check with your doctor or clinic.
10. IF YOU FORGET MORE THAN ONE PILL TWO MONTHS IN A ROW, talk to your doctor or clinic about how to make pill-taking easier or about using another method of birth control. 11. IF YOUR QUESTIONS ARE NOT ANSWERED HERE, CALL YOUR DOCTOR OR CLINIC.
WHEN TO START THE FIRST PACK OF PILLS BE SURE TO READ THESE INSTRUCTIONS: • before you start taking your pills, and • any time you are not sure what to do. Decide with your doctor or clinic what is the best day for you to start taking your first pack of pills.
Your pills may be either a 21-day or a 28-day type. DIRECTIONS FOR 21-DAY AND 28-DAY PILL PACKS 1. THE FIRST DAY OF YOUR MENSTRUAL PERIOD (BLEEDING) IS DAY 1 OF YOUR CYCLE. The pills may be started up to Day 6 of your cycle. Your starting day will be chosen in discussion with your doctor.
You will always begin taking your pill on this day of the week. Your doctor may advise you to start taking the pills on Day 1, on Day 5, or on the first Sunday after your period begins. If your period starts on Sunday, start that same day.
PrTRI-JORDYNA™ (Norgestimate and Ethinyl Estradiol Tablets USP) Page 7 of 60 2.
IF YOU ARE USING A: 21-DAY Pill Pack:
With this type of birth control pill, you are on pills for 21 days and off pills for seven days. You must not be off the pills for more than seven days in a row. […]
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. 2 Liver Disease Impaired Liver Function Sprintec is contraindicated 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 Sprintec if jaundice develops. Liver Tumors Sprintec 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 Sprintec prior to starting therapy with the combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir [see Contraindications ( 4 )] . Sprintec can be restarted approximately 2 weeks following completion of treatment with the Hepatitis C combination drug regimen.
4 High Blood Pressure Sprintec 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 Sprintec 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 Sprintec. 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 Sprintec develops new headaches that are recurrent, persistent, or severe, evaluate the cause and discontinue Sprintec if indicated. Consider discontinuation of Sprintec 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. In clinical trials of norgestimate and ethinyl estradiol, the frequency and duration of breakthrough bleeding and/or spotting was assessed in 1,647 patients (21,275 evaluable cycles) and 4,826 patients (35,546 evaluable cycles), respectively.
5%) women discontinued norgestimate and ethinyl estradiol, at least in part, due to bleeding or spotting. Based on data from the clinical trials, 14 to 34% of women using norgestimate and ethinyl estradiol experienced unscheduled bleeding per cycle in the first year.
The percent of women who experienced breakthrough/unscheduled bleeding tended to decrease over time. Amenorrhea and Oligomenorrhea Women who use Sprintec may experience amenorrhea. Some women may experience amenorrhea or oligomenorrhea after discontinuation of COCs, especially when such a condition was pre-existent.
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 Depression Carefully observe women with a history of depression and discontinue Sprintec if depression recurs to a serious degree.
10 Malignant Neoplasms Breast Cancer Sprintec 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. 11 Effect on Binding Globulins The estrogen component of COCs may raise the serum concentrations of thyroxine-binding globulin, sex hormone-binding globulin, and cortisol-binding globulin.
The dose of replacement thyroid hormone or cortisol therapy may need to be increased. 12 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.
13 Hereditary Angioedema In women with hereditary angioedema, exogenous estrogens may induce or exacerbate symptoms of angioedema. 14 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 Sprintec.
Circulatory disorders Risk of Venous Thromboembolism (VTE) The use of any CHCs increases the risk of venous thromboembolism (VTE) compared with no use. Products that contain levonorgestrel, norgestimate (including Lizinna) or norethisterone are associated with the lowest risk of VTE.
The decision to use Lizinna should be taken after a discussion with the woman to ensure she understands the risk of VTE with Lizinna, how her current risk factors influence this risk, and that her VTE risk is highest in the first ever year of use.
There is also some evidence that the risk is increased when a CHC is re- started after a break in use of 4 weeks or more. In women who do not use a CHC and are not pregnant, about 2 out of 10,000 will develop a VTE over the period of one year.
However, in any individual woman the risk may be far higher, depending on her underlying risk factors (see below). It is estimated that out of 10,000 women who use a CHC that contains levonorgestrel, about 6 will develop a VTE in a year.
Current evidence suggests that the risk of VTE with use of norgestimate-containing CHCs is similar to the risk with levonorgestrel-containing CHCs. This number of VTEs per year is fewer than the number expected in women during pregnancy or in the postpartum period.
VTE may be fatal in 1-2% of cases. g. hepatic, mesenteric, renal or retinal veins and arteries. Risk factors for VTE The risk for venous thromboembolic complications in CHC users may increase substantially in a woman with additional risk factors, particularly if there are multiple risk factors (see table).
3). If a woman has more than one risk factor, it is possible that the increase in risk is greater than the sum of the individual factors – in this case her total risk of VTE should be considered. 3).
Table:
Risk factors for VTE Risk factor Comment Obesity (body mass index over 30kg/m²) Risk increases substantially as BMI rises. Particularly important to consider if other risk factors also present. Prolonged immobilisation, major surgery, any surgery to the legs or pelvis, neurosurgery, or major trauma Note: temporary immobilisation including air travel >4 hours can also be a risk factor for VTE, particularly in women with other risk factors In these situations it is advisable to discontinue use of the Pill (in the case of elective surgery at least four weeks in advance) and not resume until two weeks after complete remobilisation.
Another method of contraception should be used to avoid unintentional pregnancy. Antithrombotic treatment should be considered if Lizinna has not been discontinued in advance. g. before 50) If a hereditary predisposition is suspected, the woman should be referred to a specialist for advice before deciding about any CHC use.