Isibloom (Page 4 of 7)
13. Pediatric Use
Safety and efficacy of desogestrel and ethinyl estradiol tablets have been established in women of reproductive age. Safety and efficacy are expected to be the same for postpubertal adolescents under the age of 16 and for users 16 years and older. Use of this product before menarche is not indicated.
14. Geriatric Use
This product has not been studied in women over 65 years of age and is not indicated in this population.
INFORMATION FOR THE PATIENT
See Patient Labeling printed below
ADVERSE REACTIONS
Post Marketing Experience
Five studies that compared breast cancer risk between ever-users (current or past use) of COCs and never-users of COCs reported no association between ever use of COCs and breast cancer risk, with effect estimates ranging from 0.90 — 1.12 (Figure 2).
Three studies compared breast cancer risk between current or recent COC users (<6 months since last use) and never users of COCs (Figure 2). One of these studies reported no association between breast cancer risk and COC use. The other two studies found an increased relative risk of 1.19 — 1.33 with current or recent use. Both of these studies found an increased risk of breast cancer with current use of longer duration, with relative risks ranging from 1.03 with less than one year of COC use to approximately 1.4 with more than 8-10 years of COC use.
Figure 2: Risk of Breast Cancer with Combined Oral Contraceptive Use
An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (see WARNINGS).
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- Thrombophlebitis and venous thrombosis with or without embolism
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- Arterial thromboembolism
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- Pulmonary embolism
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- Myocardial infarction
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- Cerebral hemorrhage
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- Cerebral thrombosis
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- Hypertension
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- Gallbladder disease
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- Hepatic adenomas or benign liver tumors
There is evidence of an association between the following conditions and the use of oral contraceptives:
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- Mesenteric thrombosis
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- Retinal thrombosis
The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug-related:
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- Nausea
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- Vomiting
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- Gastrointestinal symptoms (such as abdominal cramps and bloating)
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- Breakthrough bleeding
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- Spotting
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- Change in menstrual flow
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- Amenorrhea
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- Temporary infertility after discontinuation of treatment
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- Edema
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- Melasma which may persist
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- Breast changes: tenderness, enlargement, secretion
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- Change in weight (increase or decrease)
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- Change in cervical erosion and secretion
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- Diminution in lactation when given immediately postpartum
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- Cholestatic jaundice
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- Migraine
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- Allergic reaction, including rash, urticaria, and angioedema
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- Mental depression
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- Reduced tolerance to carbohydrates
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- Vaginal candidiasis
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- Change in corneal curvature (steepening)
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- Intolerance to contact lenses
The following adverse reactions have been reported in users of oral contraceptives and a causal association has been neither confirmed nor refuted:
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- Pre-menstrual syndrome
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- Cataracts
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- Changes in appetite
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- Cystitis-like syndrome
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- Headache
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- Nervousness
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- Dizziness
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- Hirsutism
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- Loss of scalp hair
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- Erythema multiforme
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- Erythema nodosum
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- Hemorrhagic eruption
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- Vaginitis
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- Porphyria
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- Impaired renal function
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- Hemolytic uremic syndrome
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- Acne
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- Changes in libido
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- Colitis
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- Budd-Chiari Syndrome
OVERDOSAGE
Serious ill effects have not been reported following acute ingestion of large doses of oral contraceptives by young children. Overdosage may cause nausea, and withdrawal bleeding may occur in females.
NON-CONTRACEPTIVE HEALTH BENEFITS
The following non-contraceptive health benefits related to the use of oral contraceptives are supported by epidemiological studies which largely utilized oral contraceptive formulations containing estrogen doses exceeding 0.035 mg of ethinyl estradiol or 0.05 mg of mestranol.73-78
Effects on menses:
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- increased menstrual cycle regularity
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- decreased blood loss and decreased incidence of iron deficiency anemia
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- decreased incidence of dysmenorrhea
Effects related to inhibition of ovulation:
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- decreased incidence of functional ovarian cysts
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- decreased incidence of ectopic pregnancies
Effects from long-term use:
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- decreased incidence of fibroadenomas and fibrocystic disease of the breast
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- decreased incidence of acute pelvic inflammatory disease
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- decreased incidence of endometrial cancer
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- decreased incidence of ovarian cancer
DOSAGE AND ADMINISTRATION
To achieve maximum contraceptive effectiveness, Isibloom (desogestrel and ethinyl estradiol tablets, USP) must be taken exactly as directed and at intervals not exceeding 24 hours. Isibloom (desogestrel and ethinyl estradiol tablets, USP) may be initiated using either a Sunday start or a Day 1 start.
Day 1 Start
The dosage of Isibloom (desogestrel and ethinyl estradiol tablets, USP) for the initial cycle of therapy is one orange “active” tablet administered daily from the 1st day through the 21st day of the menstrual cycle, counting the first day of menstrual flow as “Day 1”. Tablets are taken without interruption as follows: One orange “active” tablet daily for 21 days, then one green “reminder” tablet daily for 7 days. After 28 tablets have been taken, a new course is started and an orange “active” tablet is taken the next day.
The use of Isibloom (desogestrel and ethinyl estradiol tablets, USP) for contraception may be initiated 4 weeks postpartum in women who elect not to breastfeed. When the tablets are administered during the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered. (See CONTRAINDICATIONS and WARNINGS concerning thromboembolic disease. See also PRECAUTIONS: Nursing Mothers.) If the patient starts on Isibloom (desogestrel and ethinyl estradiol tablets, USP) postpartum, and has not yet had a period, she should be instructed to use another method of contraception until an orange “active” tablet has been taken daily for 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered. If the patient misses one (1) orange “active” tablet in Weeks 1, 2, or 3, the orange “active” tablet should be taken as soon as she remembers. If the patient misses two (2) orange “active” tablets in Week 1 or Week 2, the patient should take two (2) orange “active” tablets the day she remembers and two (2) orange “active” tablets the next day; and then continue taking one (1) orange “active” tablet a day until she finishes the pack. The patient should be instructed to use a back-up method of birth control such as a condom or spermicide if she has sex in the seven (7) days after missing pills. If the patient misses two (2) orange “active” tablets in the third week or misses three (3) or more orange “active” tablets in a row, the patient should throw out the rest of the pack and start a new pack that same day. The patient should be instructed to use a back-up method of birth control if she has sex in the seven (7) days after missing pills.
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