Mircette

[desogestrel/ ethinyl estradiol and ethinyl estradiol]

ALL ORAL CONTRACEPTIVES

Breakthrough bleeding, spotting, and amenorrhea are frequent reasons for patients discontinuing oral contraceptives. In breakthrough bleeding, as in all cases of irregular bleeding from the vagina, non-functional causes should be borne in mind. In undiagnosed persistent or recurrent abnormal bleeding from the vagina, adequate diagnostic measures are indicated to rule out pregnancy or malignancy. If both pregnancy and pathology have been excluded, time or a change to another preparation may solve the problem. Changing to an oral contraceptive with a higher estrogen content, while potentially useful in minimizing menstrual irregularity, should be done only if necessary since this may increase the risk of thromboembolic disease.

Use of oral contraceptives in the event of a missed menstrual period:

Text Continues Below

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1. If the patient has not adhered to the prescribed schedule, the possibility of pregnancy should be considered at the time of the first missed period and oral contraceptive use should be discontinued until pregnancy is ruled out.

2. If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out before continuing oral contraceptive use.

HOW SUPPLIED

Mircette ® (desogestrel/ ethinyl estradiol and ethinyl estradiol) Tablets contain 21 round white tablets, 2 round green tablets and 5 round yellow tablets in a blister card within a recyclable plastic dispenser. Each white tablet (debossed with " T 4 R " on one side and "Organon" on the other side) contains 0.15 mg desogestrel and 0.02 mg ethinyl estradiol. Each green tablet (debossed with " K 2 H " on one side and "Organon" on the other side) contains inert ingredi-ents. Each yellow tablet (debossed with " K 2 S " on one side and "Organon" on the other side)
contains 0.01 mg ethinyl estradiol.
Boxes of 6 NDC 0052-0281-06
Storage
Store at controlled room temperature 20Ð 25° C (68Ð 77° F).
only

REFERENCES

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93. Data on file, Organon Inc.

94. Fotherby, K. Oral contraceptives, lipids and cardiovascu-lar diseases. Contraception, 1985; Vol. 31; 4: 367Ð 94.

95. Lawrence, DM et al. Reduced sex hormone binding globulin and derived free testosterone levels in women with severe acne.
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96. Cullberg, G et al. Effects of a low-dose deso-gestrel-ethinyl estradiol combination on hirsutism, androgens and sex hormone binding
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97. Jung-Hoffmann, C and Kuhl, H. Divergent effects of two low-dose oral con-traceptives on sex hormone-binding globulin and free testosterone. AJOG, 1987; 156: 199Ð 203.

98. Hammond, G et al. Serum steroid binding protein concentrations, distri-bution of progestogens, and bioavailability of testosterone
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99. Palatsi, R et al. Serum total and unbound testosterone and sex hor-mone binding globulin (SHBG) in female acne patients treat-ed
with two different oral contraceptives. Acta Derm Venereol, 1984; 64: 517Ð 23.

100. Porter JB, Hunter J, Jick
H et al. Oral contraceptives and nonfatal vascular disease. Obstet Gynecol 1985; 66: 1Ð 4.

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102. Jick H, Jick SS, Gurewich V, Myers MW, Vasilakis C. Risk of idiopathic cardiovascular death and non-fatal venous thromboembolism in women
using oral contraceptives with differing progestagen com-ponents. Lancet, 1995; 346: 1589Ð 93.

103. World Health Organization Collaborative Study of Cardiovascular Disease and Steroid Hormone Contraception. Effect of different pro-gestagens in low oestrogen oral contraceptives on venous thromboembolic disease. Lancet, 1995; 346: 1582Ð 88.

104. Spitzer WO, Lewis MA, Heinemann LAJ, Thorogood M, MacRae KD on behalf of Transnational Research Group on Oral Contraceptives and Health of Young Women. Third generation oral contraceptives and risk of venous throm-boembolic disorders: An international case-control study. Br Med J, 1996; 312: 83Ð 88. Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

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