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AUDRINA is a brand name for Levonorgestrel, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AUDRINA 21 and AUDRINA 28 (Levonorgestrel and Ethinyl Estradiol tablets) are indicated for: • Conception control. • Treatment of moderate acne vulgaris in women >14 years of age who, have no known contraindications to oral contraceptive therapy, desire contraception, and have achieved menarche. 1.1 Pediatrics…
Verbatim from this product's HC label. Tap a section to expand.
2 Recommended Dose and Dosage Adjustment • CONTRACEPTION: AUDRINA 21 TABLETS REGIMEN: Each cycle consists of 21 days on medication and a 7-day interval without medication (three weeks on, one week off). The dosage of AUDRINA tablets is one tablet daily for 21 consecutive days per menstrual cycle, according to prescribed schedule.
For the first cycle of medication, the patient is instructed to take one AUDRINA tablet daily for 21 consecutive days beginning on Day 1 of her menstrual cycle, on Day 5, or on the first Sunday after her period begins. (For the first cycle only, the first day of menstrual flow is considered Day 1).
The tablets are then discontinued for seven days (one week). Withdrawal bleeding should usually occur within three days following discontinuation of AUDRINA. The patient begins her next and all subsequent 21-day courses of AUDRINA tablets (following the same 21 days on, 7 days off) on the same day of the week that she began her first course.
She begins taking her tablets seven days after discontinuation, regardless of whether or not withdrawal bleeding is still in progress.
AUDRINA 28 TABLETS REGIMEN:
Each cycle consists of 21 days of white AUDRINA tablets (active tablets) followed by 7 days of orange inert tablets (three weeks on AUDRINA, one week on inert tablets). PrAUDRINA® 21 and PrAUDRINA® 28 (Levonorgestrel and Ethinyl Estradiol Tablets, USP) Page 6 of 55 The dosage of AUDRINA tablets is one tablet daily for 21 consecutive days per menstrual cycle, according to prescribed schedule, followed by one inert tablet daily for 7 consecutive days according to prescribed schedule.
For the first cycle of medication, the patient is instructed to take one white tablet daily for 21 consecutive days beginning on Day 1 of her menstrual cycle, on Day 5, or on the first Sunday after her period begins. (For the first cycle only, the first day of menstrual flow is considered Day 1).
One orange tablet is taken daily for the following seven consecutive days. , during the week the patient is taking the orange inert tablets. The patient begins her next and all subsequent 28-day courses of tablets on the same day of the week that she began her first course.
She continues her next course of 28 tablets immediately after the last course, regardless of whether or not a period of withdrawal bleeding is still in progress. There is no need for the patient to count days between cycles because there are no "off-tablet days".
g. g. retinal thrombosis) • Pulmonary embolism • Stroke • Transient ischemic attach • Thrombophlebitis • Venous thrombosis * COCs may worsen existing gallbladder disease and may accelerate the development of this disease in previously asymptomatic women.
The following adverse reactions also have been reported in patients receiving COCs: Nausea and vomiting, usually the most common adverse reaction, occurs in approximately 10 percent or fewer of patients during the first cycle. Other reactions, as a general rule, are seen less frequently or only occasionally.
, hepatitis, hepatic function abnormal) • Intolerance to contact lenses • Mood changes, including depression • Rash (allergic) • Reduced tolerance to carbohydrates • Retinal vascular thrombosis • Spotting • Temporary infertility after discontinuance of treatment • Vaginitis including candidiasis The following adverse reactions have been reported in users of COCs and the association has been neither confirmed nor refuted: • Acne • Aggravation of varicose veins • Anaphylactic (anaphylactoid reactions, including very rare cases of urticaria, angioedema, and severe reactions with respiratory and circulatory symptoms) • Budd-Chiari syndrome • Cataracts • Cerebrovascular disease with mitral valve prolapse • Changes in appetite (increase or decrease) • Changes in libido • Changes in Serum Lipid levels, including hypertriglyceridemia • Colitis • Congenital anomalies • Cystitis-like syndrome • Decrease in serum folate levels** • Dizziness • Erythema multiforme • Erythema nodosum • Exacerbation of chorea • Exacerbation of porphyria • Exacerbation of systemic lupus erythematosus • Hemolytic uremic syndrome • Hemorrhagic eruption • Hepatic adenomas • Hepatocellular Carcinomas • Hirsutism • Impaired renal function • Ischemic colitis PrAUDRINA® 21 and PrAUDRINA® 28 (Levonorgestrel and Ethinyl Estradiol Tablets, USP) Page 20 of 55 • Loss of scalp hair • Lupus-like syndrome • Nervousness • Optic neuritis*** • Pancreatitis • Premenstrual syndrome • Sickle-cell disease • Vaginitis **Serum folate levels may be depressed by COC therapy.
4 DRUG INTERACTIONS). 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions • Cigarette smoking increases the risk of serious adverse effects on the heart and blood vessels. This risk increases with age and becomes significant in hormonal contraceptive users older than 35 years of age who smoke.
Women should be counselled not to smoke. (See 7 WARNINGS AND PRECAUTIONS: Cardiovascular). • Patients should be counselled that birth control pills 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 birth control pills.
2 Recommended Dose and Dosage Adjustment • CONTRACEPTION: AUDRINA 21 TABLETS REGIMEN: Each cycle consists of 21 days on medication and a 7-day interval without medication (three weeks on, one week off). The dosage of AUDRINA tablets is one tablet daily for 21 consecutive days per menstrual cycle, according to prescribed schedule.
For the first cycle of medication, the patient is instructed to take one AUDRINA tablet daily for 21 consecutive days beginning on Day 1 of her menstrual cycle, on Day 5, or on the first Sunday after her period begins. (For the first cycle only, the first day of menstrual flow is considered Day 1).
The tablets are then discontinued for seven days (one week). Withdrawal bleeding should usually occur within three days following discontinuation of AUDRINA. The patient begins her next and all subsequent 21-day courses of AUDRINA tablets (following the same 21 days on, 7 days off) on the same day of the week that she began her first course.
She begins taking her tablets seven days after discontinuation, regardless of whether or not withdrawal bleeding is still in progress.
AUDRINA 28 TABLETS REGIMEN:
08/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. 1 Pediatrics ...............................................................................................................
2 Geriatrics ............................................................................................................... 4
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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2 DOSAGE AND ADMINISTRATION: Recommended Dose and Dosage Adjustment, CONTRACEPTION). 4 Administration Tablets for oral use. SPECIAL NOTES ON ADMINISTRATION It is recommended that AUDRINA 21 and AUDRINA 28 tablets be taken at the same time each day, preferably after the evening meal or at bedtime.
AUDRINA 21 and AUDRINA 28 are effective from the first day of therapy if the tablets are begun on the first day of the menstrual cycle. If AUDRINA 21 and AUDRINA 28 tablets administration is initiated postpartum (no earlier than day 28 after delivery in the nonlactating mother) or after Day 1 of the first menstrual cycle, contraceptive reliance should not be placed on AUDRINA 21 and AUDRINA 28 until after the first seven consecutive days of administration.
The possibility of ovulation and conception prior to initiation of medication should be considered. Therefore, nonhormonal methods of contraception (such as condoms and spermicide) should be used for the first 7 days of tablet taking.
If spotting or breakthrough bleeding occurs, the patient is instructed to continue on the same regimen. This type of bleeding usually is transient and without significance; however, if the bleeding is persistent or prolonged, the patient is advised to consult her physician.
Advice in case of vomiting and/or diarrhea If vomiting and/or diarrhea occurs within 4 hours after tablet-taking, tablet absorption may be incomplete. In such event, advice concerning the Management of Missed Tablet is outlined in PrAUDRINA® 21 and PrAUDRINA® 28 (Levonorgestrel and Ethinyl Estradiol Tablets, USP) Page 7 of 55 the above chart.
The woman must take the extra active tablet(s) needed from a backup pack. No hormonal contraceptive use in the past month Tablet-taking should start on day 1 of the woman’s natural cycle (ie, the first day of her menstrual bleeding).
Starting on days 2-7 is allowed, but for the first 7 days of tablet-taking during the first cycle, a nonhormonal back-up method of birth control (such as condoms and spermicide) is recommended. Changing from another COC pill The woman should start AUDRINA 21 and AUDRINA 28 preferably on the day after the last active tablet of her previous COC, but at the latest, on the day following the usual tablet-free or inactive tablet interval of her previous COC.
Changing from a progestin only method (progestin-only pill, implant, intrauterine device [IUD], injection) The woman may switch any day from the progestin-only pill and should begin AUDRINA 21 and AUDRINA 28 the next day. She should start AUDRINA 21 and AUDRINA 28 on the day that a progestin-only implant or a progestin-only IUD is removed.
AUDRINA 21 and AUDRINA 28use should begin on the day that the next progestin-only injection is scheduled. In all of these situations, the woman should be advised to use a nonhormonal back-up method for the first 7 days of tablet-taking.
Following first-trimester abortion The woman may start AUDRINA 21 and AUDRINA 28 immediately. Additional contraceptive measures are not needed. Following delivery or second-trimester abortion Since the immediate post-partum period is associated with an increased risk of thromboembolism, oral contraceptives should be started no earlier than day 28 after […]
***Optic neuritis may lead to partial or complete loss of vision. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. Oral Contraception Treatment-emergent adverse events were analyzed for 1,477 subjects exposed to the study drug for 7,870 cycles.
One or more treatment emergent adverse events were reported for 1,106 (75%) subjects. Table-1 lists the frequency of treatment emergent adverse events that were reported by > 2% of subjects.
Table-1:
Frequency of treatment emergent adverse events that occurred in > 2% of subjects Event Number (%) of Subjects (n=1,477) Headache Dysmenorrhea Infection Pharyngitis Abdominal pain Nausea Metrorrhagia Sinusitis Flu syndrome Vaginal moniliasis Pain Back pain Breast pain Accidental injury Acne 400 (27%) 210 (14%) 200 (14%) 146 (10%) 134 (9%) 134 (9%) 123 (8%) 90 (6%) 84 (6%) 71 (5%) 71 (5%) 66 (4%) 65 (4%) 64 (4%) 62 (4%) PrAUDRINA® 21 and PrAUDRINA® 28 (Levonorgestrel and Ethinyl Estradiol Tablets, USP) Page 21 of 55 Rhinitis Emotional lability Vaginitis Urinary tract infection Dizziness Diarrhea Bronchitis Depression Asthenia Vomiting Allergic reaction other than to study drug Amenorrhea 54 (4%) 50 (3%) 48 (3%) 41 (3%) 40 (3%) 40 (3%) 37 (3%) 36 (2%) 35 (2%) 34 (2%) 33 (2%) 30 (2%) A total of 133 (9%) subjects stopped taking the study medication because of adverse events.
Some of the study events that led to subject discontinuation were considered by the medical monitor to be potentially serious: headache (21), hypertension (7), migraine (3), phlebitis (1), palpitations (1), varicose veins (1), vascular disorder (1), hypercholesterolemia/hyperlipidemia (6), depression/emotional lability (16), hypesthesia (1), abnormal vision (2), visual field defect (1), amenorrhea (8), dysmenorrhea (4), menorrhagia (6), irregular bleeding (1), menstrual bloating (1), metrorrhagia (1), fibroid growth (1).
No deaths occurred during the multicentre study. Acne In the two acne studies (see 14 CLINICAL TRIALS), the safety profile of levonorgestrel and ethinyl estradiol tablets was compared with that of placebo. Treatment-emergent adverse events that were […]
Each cycle consists of 21 days of white AUDRINA tablets (active tablets) followed by 7 days of orange inert tablets (three weeks on AUDRINA, one week on inert tablets). PrAUDRINA® 21 and PrAUDRINA® 28 (Levonorgestrel and Ethinyl Estradiol Tablets, USP) Page 6 of 55 The dosage of AUDRINA tablets is one tablet daily for 21 consecutive days per menstrual cycle, according to prescribed schedule, followed by one inert tablet daily for 7 consecutive days according to prescribed schedule.
For the first cycle of medication, the patient is instructed to take one white tablet daily for 21 consecutive days beginning on Day 1 of her menstrual cycle, on Day 5, or on the first Sunday after her period begins. (For the first cycle only, the first day of menstrual flow is considered Day 1).
One orange tablet is taken daily for the following seven consecutive days. , during the week the patient is taking the orange inert tablets. The patient begins her next and all subsequent 28-day courses of tablets on the same day of the week that she began her first course.
She continues her next course of 28 tablets immediately after the last course, regardless of whether or not a period of withdrawal bleeding is still in progress. There is no need for the patient to count days between cycles because there are no "off-tablet days".
2 DOSAGE AND ADMINISTRATION: Recommended Dose and Dosage Adjustment, CONTRACEPTION). 4 Administration Tablets for oral use. SPECIAL NOTES ON ADMINISTRATION It is recommended that AUDRINA 21 and AUDRINA 28 tablets be taken at the same time each day, preferably after the evening meal or at bedtime.
AUDRINA 21 and AUDRINA 28 are effective from the first day of therapy if the tablets are begun on the first day of the menstrual cycle. If AUDRINA 21 and AUDRINA 28 tablets administration is initiated postpartum (no earlier than day 28 after delivery in the nonlactating mother) or after Day 1 of the first menstrual cycle, contraceptive reliance should not be placed on AUDRINA 21 and AUDRINA 28 until after the first seven consecutive days of administration.
The possibility of ovulation and conception prior to initiation of medication should be considered. Therefore, nonhormonal methods of contraception (such as condoms and spermicide) should be used for the first 7 days of tablet taking.
If spotting or breakthrough bleeding occurs, the patient is instructed to continue on the same regimen. This type of bleeding usually is transient and without significance; however, if the bleeding is persistent or prolonged, the patient is advised to consult her physician.
Advice in case of vomiting and/or diarrhea If vomiting and/or diarrhea occurs within 4 hours after tablet-taking, tablet absorption may be incomplete. In such event, advice concerning the Management of Missed Tablet is outlined in PrAUDRINA® 21 and PrAUDRINA® 28 (Levonorgestrel and Ethinyl Estradiol Tablets, USP) Page 7 of 55 the above chart.
The woman must take the extra active tablet(s) needed from a backup pack. No hormonal contraceptive use in the past month Tablet-taking should start on day 1 of the woman’s natural cycle (ie, the first day of her menstrual bleeding).
Starting on days 2-7 is allowed, but for the first 7 days of tablet-taking during the first cycle, a nonhormonal back-up method of birth control (such as condoms and spermicide) is recommended. Changing from another COC pill The woman should start AUDRINA 21 and AUDRINA 28 preferably on the day after the last active tablet of her previous COC, but at the latest, on the day following the usual tablet-free or inactive tablet interval of her previous COC.
Changing from a progestin only method (progestin-only pill, implant, intrauterine device [IUD], injection) The woman may switch any day from the progestin-only pill and should begin AUDRINA 21 and AUDRINA 28 […]