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TRI-JORDYNA is a brand name for Norgestimate, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 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.
Verbatim from this product's HC label. Tap a section to expand.
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.
, 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.
). • 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.
• 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
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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 […]
In general, solicited events are associated with […]
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. […]