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APRI is a brand name for Desogestrel, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: APRI® (desogestrel/ ethinyl estradiol tablets, USP) is indicated for: • Conception control 1.1 Pediatrics Pediatrics: The safety and efficacy of desogestrel and ethinyl estradiol tablets has not been established in women under the age of 18 years. Use of this product before menarche is not indicated. 1.2 Geriatrics…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Patients should be instructed to read the package insert prior to starting APRI® and any time they are unsure of administration. In the case of APRI®, patients should be instructed to read the package insert and the Day of the Week Label Strip.
If they have additional questions they should call their doctor or clinic. APRI 21 and APRI 28 (Desogestrel and Ethinyl estradiol Tablets) Page 6 of 70 Protected B / Protégé B APRI® tablets may be prescribed as a 21-day or a 28-day regimen.
APRI® tablets must be taken at approximately the same time every day until the pack is empty. , the first day of menstrual flow) or on the first Sunday after her period begins. If the patient’s period starts on Sunday, she should start that same day.
2 Recommended Dose and Dosage Adjustment APRI® 21 (21-Day Regimen): One rose tablet is to be taken for 21 consecutive days (three weeks). Tablets are then discontinued for one week. The patient must not be off the pill for more than seven consecutive days.
A new pack will be started on the eighth day. ) APRI® 28 (28-Day Regimen): One rose tablet is to be taken for 21 consecutive days (three weeks), followed by a white tablet for seven consecutive days (one week). A new pack (rose tablet) will be started on the eighth day, following the completion of the white tablets.
The patient will have a period while they are on the white tablet. On this regimen the patient must not go a day without taking a pill. 4 Administration It is recommended that APRI® be taken at the same time each day. The patient should be counselled to associate taking the pill with some regular activity like eating a meal or going to bed.
g. latex 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 they are getting used to taking them. If spotting, light bleeding, or feeling sick to their stomach occurs during the first three months the women should be counselled to not stop taking the pill.
The problem will usually go away. If it does not subside, the patient should consult her doctor or clinic. , the pill should not be stopped) even if the women does not have sex very often. When receiving any medical treatment, patients should tell their doctor that they are using birth control pills.
, retinal thrombosis) • pulmonary embolism • thrombophlebitis The following other adverse reactions also have been reported in patients receiving combination hormonal contraceptives: nausea and vomiting, usually the most common adverse reaction, occurs in approximately 10% or fewer of patients during the first cycle.
The following other reactions, as a general rule, are seen less frequently or only occasionally: • abdominal pain • amenorrhea during and after treatment • angioedema (exogenous estrogens may induce or exacerbate symptoms of hereditary and acquired angioedema)a • auditory disturbances • breakthrough bleeding • breast changes (tenderness, enlargement, and secretion) • cataracts • changes in appetite APRI 21 and APRI 28 (Desogestrel and Ethinyl estradiol Tablets) Page 20 of 70 Protected B / Protégé B • change in corneal curvature (steepening) • changes in glucose tolerance or effect on peripheral insulin resistance • changes in libido • change in menstrual flow • change in weight (increase or decrease) • chloasma or melasma which may persist • cholestatic jaundice • chorea • Crohn’s disease • cystitis-like syndrome • diarrhea • dizziness • dysmenorrhea • edema • endocervical hyperplasia • erythema multiforme • erythema nodosum • gallstone formationa • gastrointestinal symptoms (such as abdominal cramps and bloating) • headache • hemolytic uremic syndrome • hemorrhagic eruption • herpes gestationisa • hirsutism • hypersensitivity • hypertensiona • hypertriglyceridemia (increased risk of pancreatitis when using COCs) • impaired renal function • increase in size of uterine leiomyomata • intolerance to contact lenses • jaundice related to cholestasisa • liver function disturbances • loss of scalp hair • mental depression • migraine • nervousness • optic neuritis • otosclerosis-related hearing lossa • pancreatitis • porphyria • possible diminution in lactation when given immediately postpartum APRI 21 and APRI 28 (Desogestrel and Ethinyl estradiol Tablets) Page 21 of 70 Protected B / Protégé B • premenstrual-like syndrome • pruritus related to cholestasisa • rash (allergic) • Raynaud's phenomenon • reduced tolerance to carbohydrates • retinal thrombosis • rhinitis • spotting • Sydenham’s choreaa • Systemic lupus erythematosusa • temporary infertility after discontinuation of treatment • ulcerative colitis • urticaria • vaginal candidiasis • vaginal discharge • vaginitis a Occurrence or deterioration of conditions for which association with COC use is not conclusive.
, due to MTHFR C677T, A1298 mutations), prothrombin mutation G20210A, and antiphospholipid- antibodies (anticardiolipin antibodies, lupus anticoagulant) o severe dyslipoproteinemia o smoking and over age 35 o diabetes mellitus with vascular involvement o major surgery associated with an increased risk of postoperative thromboembolism (see 7 WARNINGS AND PRECAUTIONS) o prolonged immobilization (see 7 WARNINGS AND PRECAUTIONS) 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 oral contraceptive users older than 35 years of age, and with the number of cigarettes smoked. For this reason, combination oral contraceptives, including APRI®, should not be used by women who are over 35 years of age and smoke (see 7 WARNINGS AND PRECAUTIONS).
Patients should be counseled that birth control pills DO NOT PROTECT against sexually transmitted diseases (STDs) including HIV/AIDS. For protection against STDs, patients should be counseled to use latex condoms IN COMBINATION WITH birth control pills.
1 Dosing Considerations Patients should be instructed to read the package insert prior to starting APRI® and any time they are unsure of administration. In the case of APRI®, patients should be instructed to read the package insert and the Day of the Week Label Strip.
If they have additional questions they should call their doctor or clinic. APRI 21 and APRI 28 (Desogestrel and Ethinyl estradiol Tablets) Page 6 of 70 Protected B / Protégé B APRI® tablets may be prescribed as a 21-day or a 28-day regimen.
APRI® tablets must be taken at approximately the same time every day until the pack is empty. , the first day of menstrual flow) or on the first Sunday after her period begins. If the patient’s period starts on Sunday, she should start that same day.
Combined hormonal contraceptives (CHCs) should not be used in the presence of any of the conditions listed below. Should any of the conditions appear for the first time during CHC use, the product should be stopped immediately. • APRI® is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient or component of the container.
For a complete listing, see Dosage Forms, Strengths, Composition and Packaging. , due to MTHFR C677T, A1298 mutations), prothrombin mutation G20210A, and antiphospholipid- antibodies (anticardiolipin antibodies, lupus anticoagulant) o severe dyslipoproteinemia o smoking and over age 35 o diabetes mellitus with vascular involvement o major surgery associated with an increased risk of postoperative thromboembolism (see 7 WARNINGS AND PRECAUTIONS) o prolonged immobilization (see 7 WARNINGS AND PRECAUTIONS)
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Desogestrel in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Advice in case of vomiting In case of severe gastro-intestinal disturbance, absorption may not be complete and additional APRI 21 and APRI 28 (Desogestrel and Ethinyl estradiol Tablets) Page 7 of 70 Protected B / Protégé B contraceptive measures should be taken.
If vomiting occurs within 3-4 hours after tablet-taking, the advice concerning the management of missed tablets is outlined below. If the woman does not want to change her normal tablet-taking schedule, she has to take the extra tablet(s) needed from another pack.
When to start APRI® No hormonal contraceptive use in the preceding cycle:
Tablet taking should start on Day 1 of the woman’s menstrual cycle or on the first Sunday after her period begins. Switching from another combination hormonal contraceptive (combined oral contraceptive (COC), vaginal ring, or transdermal patch): The woman should start APRI® 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 of her previous COC.
In case a vaginal ring or transdermal patch has been used, the woman should start using APRI® preferably on the day of removal, but at the latest when the next application would have been due. Switching from a progestogen-only-method (mini-pill, injection, implant) or from a progestogen-releasing intrauterine system (IUS): The woman may switch from the mini-pill to APRI® on any day of her cycle.
Patients using a progestogen injection should start APRI® on the day the next injection is due. Patients using an implant or an IUS should start APRI® on the day it is removed. In all cases, the woman should be advised to use an additional barrier method for the first 7 days of APRI® use.
Following complete first-trimester abortion:
The woman may start using APRI® immediately. When doing so, she need not take additional contraceptive measures.
Following delivery or second-trimester abortion:
Women should be advised to start APRI® on Day 21 to 28 after delivery or second trimester abortion, after consulting with their physician. When starting later, the woman should be advised to use an additional barrier method for the first seven days of tablet-taking.
However, if intercourse has already occurred, pregnancy should be excluded before the actual start of use or the woman should be advised to wait for her first menstrual period prior to starting APRI®. The increased risk of venous thromboembolism (VTE) during the postpartum period should be considered when restarting APRI® (see 7 WARNINGS AND PRECAUTIONS).
For breastfeeding women, see 7 WARNINGS AND PRECAUTIONS - Breastfeeding. 5 Missed Dose The patient should be instructed to use the following chart if she misses one or more of her birth control pills. She should be told to match the number of pills missed with the appropriate starting time for her dosing regimen.
Sunday Start Day One Start Miss One Pill Miss One Pill Take it as soon as you remember, and take the next pill at the usual time. This means that you might take 2 pills in one day. Take it as soon as you remember, and take the next pill at the usual time.
This means that you might take 2 pills in one day. Miss Two Pills in a Row Miss Two […]
2 Clinical Trial Adverse 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 reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. Eighty-six per cent of the 1,195 subjects reported 1 or more adverse experiences. The majority of these (64%) were considered (by the investigators) to be unrelated to desogestrel and ethinyl estradiol tablets usage.
Of the total population, approximately 12% of the subjects discontinued due to an adverse experience. 2) aPercentages are of total patients entered. bStarter/Switcher status could not be determined in one subject. cA total of 145 patients actually had a clinical AE as the primary reason for discontinuation.
With the exception of menses-related adverse experiences, no significant changes in the incidence of adverse experiences over time were seen. No drug-related adverse effects were observed during general physical or pelvic examination.
The breast examination showed a reduction in nodularity. No changes in body mass index or blood pressure were observed. Baseline distribution of abnormalities in cervical cytology was comparable to those at last visit. No patient developed a clinically significant abnormal value for routine laboratory analytes that led to either early discontinuation or hospitalization.
Detailed ophthalmologic examinations, including slit-lamp, were performed in a subset of 28 healthy women at baseline and after 12 cycles. No patients were found to have a decrease in visual acuity. Complete ophthalmological examination failed to identify possible desogestrel and ethinyl estradiol tablets-related changes.
3) APRI 21 and APRI 28 (Desogestrel and Ethinyl estradiol Tablets) Page 23 of 70 Protected B / Protégé B Malaise […]
2 Recommended Dose and Dosage Adjustment APRI® 21 (21-Day Regimen): One rose tablet is to be taken for 21 consecutive days (three weeks). Tablets are then discontinued for one week. The patient must not be off the pill for more than seven consecutive days.
A new pack will be started on the eighth day. ) APRI® 28 (28-Day Regimen): One rose tablet is to be taken for 21 consecutive days (three weeks), followed by a white tablet for seven consecutive days (one week). A new pack (rose tablet) will be started on the eighth day, following the completion of the white tablets.
The patient will have a period while they are on the white tablet. On this regimen the patient must not go a day without taking a pill. 4 Administration It is recommended that APRI® be taken at the same time each day. The patient should be counselled to associate taking the pill with some regular activity like eating a meal or going to bed.
g. latex 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 they are getting used to taking them. If spotting, light bleeding, or feeling sick to their stomach occurs during the first three months the women should be counselled to not stop taking the pill.
The problem will usually go away. If it does not subside, the patient should consult her doctor or clinic. , the pill should not be stopped) even if the women does not have sex very often. When receiving any medical treatment, patients should tell their doctor that they are using birth control pills.
Advice in case of vomiting In case of severe gastro-intestinal disturbance, absorption may not be complete and additional APRI 21 and APRI 28 (Desogestrel and Ethinyl estradiol Tablets) Page 7 of 70 Protected B / Protégé B contraceptive measures should be taken.
If vomiting occurs within 3-4 hours after tablet-taking, the advice concerning the management of missed tablets is outlined below. If the woman does not want to change her normal tablet-taking schedule, she has to take the extra tablet(s) needed from another pack.
When to start APRI® No hormonal contraceptive use in the preceding cycle:
Tablet taking should start on Day 1 of the woman’s menstrual cycle or on the first Sunday after her period begins. Switching from another combination hormonal contraceptive (combined oral contraceptive (COC), vaginal ring, or transdermal patch): The woman should start APRI® 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 […]