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Leena (Norethindrone / Ethinyl Estradiol) - Drug Interactions, Contraindications, Overdosage, etc

 
 



DRUG INTERACTIONS

7. DRUG INTERACTIONS

Reduced efficacy and increased incidence of breakthrough bleeding and menstrual irregularities have been associated with concomitant use of rifampin. A similar association though less marked, has been suggested with barbiturates, phenylbutazone, phenytoin sodium, and possibly with griseofulvin, ampicillin and tetracyclines.76

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.6–11

Effects on menses:

  • Increased menstrual cycle regularity

  • Decreased blood loss and decreased incidence of iron deficiency anemia

  • Decreased incidence of dysmenorrhea

Effects related to inhibition of ovulation:

  • Decreased incidence of functional ovarian cysts

  • Decreased incidence of ectopic pregnancies

Effects from long-term use:

  • Decreased incidence of fibroadenomas and fibrocystic disease of the breast

  • Decreased incidence of acute pelvic inflammatory disease

  • Decreased incidence of endometrial cancer

  • Decreased incidence of ovarian cancer

Keep this and all medication out of the reach of children.

CONTRAINDICATIONS

Oral contraceptives should not be used in women who have the following conditions:

  • Thrombophlebitis or thromboembolic disorders

  • A past history of deep vein thrombophlebitis or thromboembolic disorders

  • Cerebral vascular or coronary artery disease

  • Known or suspected carcinoma of the breast

  • Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia

  • Undiagnosed abnormal genital bleeding

  • Cholestatic jaundice of pregnancy or jaundice with prior pill use

  • Hepatic adenomas, carcinomas or benign liver tumors

  • Known or suspected pregnancy

REFERENCES

1. Hatcher, R.A., Trussell, J. Stewart, F., et al.: Contraceptive Technology: Sixteenth Revised Edition, New York, NY, 1998. 2. Mann, J., et al.: Br Med J 2(5956): 241–245, 1975. 3. Knopp, R.H.: J Reprod Med 31(9): 913–921, 1986. 4. Mann, J.I., et al.: Br Med J 2: 445–447, 1976. 5. Ory, H.: JAMA 237: 2619–2622, 1977. 6. The Cancer and Steroid Hormone Study of the Centers for Disease Control: JAMA 249(2): 1596–1599, 1983. 7. The Cancer and Steroid Hormone Study of the Centers for Disease Control: JAMA 257(6): 796–800, 1987. 8. Ory, H.W.: JAMA 228(1): 68–69, 1974. 9. Ory, H.W., et al.: N Engl J Med 294: 419–422, 1976. 10. Ory, H.W.: Fam Plann Perspect 14: 182–184, 1982. 11. Ory, H.W., et al.: Making Choices, New York, The Alan Guttmacher Institute, 1983. 12. Stadel, B.: N Engl J Med 305(11): 612–618, 1981. 13. Stadel, B.: N Engl J Med 305(12): 672–677, 1981. 14. Adam, S., et al.: Br J Obstet Gynaecol 88: 838–845, 1981. 15. Mann, J., et al.: Br Med J 2(5965): 245–248, 1975. 16. Royal College of General Practitioners’ Oral Contraceptive Study: Lancet 1: 541–546, 1981. 17. Slone, D., et al.: N Engl J Med 305(8): 420–424, 1981. 18. Vessey, M.P.: Br J Fam Plann 6 (supplement): 1–12, 1980. 19. Russell-Briefel, R., et al.: Prev Med 15: 352–362, 1986. 20. Goldbaum, G., et al.: JAMA 258(10): 1339–1342, 1987. 21. LaRosa, J.C.: J Reprod Med 31 (9): 906–912, 1986. 22. Krauss, R.M., et al.: Am J Obstet Gynecol 145: 446–452, 1983. 23. Wahl, P., et al.: N Engl J Med 308(15): 862–867, 1983. 24. Wynn, V., et al.: Am J Obstet Gynecol 142(6): 766–771, 1982. 25. Wynn, V., et al.: J Reprod Med 31(9): 892–897, 1986. 26. Inman, W.H., et al.: Br Med J 2(5599): 193–199, 1968. 27. Maguire, M.G., et al.: Am J Epidemiol 110(2): 188–195, 1979. 28. Petitti, D., et al.: JAMA 242(11): 1150–1154, 1979. 29. Vessey, M.P., et al.: Br Med J 2(5599): 199–205, 1968. 30. Vessey, M.P., et al.: Br Med J 2(5658): 651–657, 1969. 31. Porter, J.B., et al.: Obstet Gynecol 59(3): 299–302, 1982. 32. Vessey, M.P., et al.: J Biosoc Sci 8: 373–427, 1976. 33. Mishell, D.R., et al.: Reproductive Endocrinology, Philadelphia, F.A. Davis Co., 1979. 34. Petitti, D.B., et al.: Lancet 2: 234–236, 1978. 35. Collaborative Group for the Study of Stroke in Young Women: JAMA 231(7): 718–722, 1975. 36. Inman, W.H., et al.: Br Med J 2: 203–209, 1970. 37. Meade, T.W., et al.: Br Med J 280(6224): 1157–1161, 1980. 38. Kay, C.R.: m J Obstet Gynecol 142(6): 762–765, 1982. 39. Gordon, T., et al.: Am J Med 62: 707–714, 1977. 40. Royal College of General Practitioners’ Oral Contraception Study: J Coll Gen Pract 33: 75–82, 1983. 41. Ory, H.W.: Fam Plann Perspect 15(2): 57–63, 1983. 42. Paul, C., et al.: Br Med J 293: 723–725, 1986. 43. The Cancer and Steroid Hormone Study of the Centers for Disease Control: N Engl J Med 315(7): 405–411, 1986. 44. Pike, M.C., et al.: Lancet 2: 926–929, 1983. 45. Miller, D.R., et al.: Obstet Gynecol 68: 863–868, 1986. 46. Olsson, H., et al.: Lancet 2: 748–749, 1985. 47. McPherson, K., et al.: Br J Cancer 56: 653–660, 1987. 48. Huggins, G.R., et al.: Fertil Steril 47(5): 733–761, 1987. 49. McPherson, K., et al.: Br Med J 293: 709–710, 1986. 50. Ory, H., et al.: Am J Obstet Gynecol 124(6): 573–577, 1976. 51. Vessey, M.P., et al.: Lancet 2: 930, 1983. 52. Brinton, L.A., et al.: Int J Cancer 38: 339–344, 1986. 53. WHO Collaborative Study of Neoplasia and Steroid Contraceptives: Br Med J 290: 961–965, 1985. 54. Rooks, J.B., et al.: JAMA 242(7): 644–648, 1979. 55. Bein, N.N., et al.: Br J Surg 64: 433–435, 1977. 56. Klatskin, G.: Gastroenterology 73: 386–394, 1977. 57. Henderson, B.E., et al.: Br J Cancer 48: 437–440, 1983. 58. Neuberger, J., et al.: Br Med J 292: 1355–1357, 1986. 59. Forman, D., et al.: Br Med J 292: 1357–1361, 1986. 60. Harlap, S., et al.: Obstet Gynecol 55(4): 447–452, 1980. 61. Savolainen, E., et al.: Am J Obstet Gynecol 140(5): 521–524, 1981. 62. Janerich, D.T., et al.: Am J Epidemiol 112(1): 73–79, 1980. 63. Ferencz, C., et al.: Teratology 21: 225–239, 1980. 64. Rothman, K.J., et al.: Am J Epidemiol 109(4): 433–439, 1979. 65. Boston Collaborative Drug Surveillance Program: Lancet 1: 1399–1404, 1973. 66. Royal College of General Practitioners: Oral contraceptives and health. New York, Pittman, 1974. 67. Rome Group for the Epidemiology and Prevention of Cholelithiasis: Am J Epidemiol 119(5): 796–805, 1984. 68. Strom, B.L., et al.: Clin Pharmacol Ther 39(3): 335–341, 1986. 69. Perlman, J.A., et al.: J Chronic Dis 38(10): 857–864, 1985. 70. Wynn, V., et al.: Lancet 1: 1045–1049, 1979. 71. Wynn, V.: Progesterone and Progestin, New York, Raven Press, 1983. 72. Wynn, V., et al.: Lancet 2: 720–723, 1966. 73. Fisch, I.R., et al.: JAMA 237(23): 2499–2503, 1977. 74. Laragh, J.H.: Am J Obstet Gynecol 126(1): 141–147, 1976. 75. Ramcharan, S., et al.: Pharmacology of Steroid Contraceptive Drugs, New York, Raven Press, 1977. 76. Stockley, I.: Pharm J 216: 140–143, 1976. 77. Dickey, R.P.: Managing Contraceptive Pill Patients, Oklahoma, Creative Informatics Inc., 1984. 78. Porter J.B., Hunter J., Jick H., et al.: Obstet Gynecol 1985; 66: 1–4. 79. Porter J.B., Hershel J., Walker A.M.: Obstet Gynecol 1987; 70: 29–32. 80. Fertility and Maternal Health Drugs Advisory Committee, F.D.A., October, 1989. 81. Schlesselman J., Stadel B.V., Murray P., Lai S.: Breast cancer in relation to early use of oral contraceptives. JAMA 1988; 259: 1828–1833. 82. Hennekens C.H., Speizer F.E., Lipnick R.J., Rosner B., Bain C., Belanger C., Stampfer M.J., Willett W., Peto R.: A case-control study of oral contraceptive use and breast cancer. JNCI 1984; 72: 39–42. 83. Royal College of General Practitioners: Oral contraceptives, venous thrombosis, and varicose veins. J Coll Gen Pract 28: 393–399, 1978. 84. Royal College of General Practitioners’ Oral Contraception Study: Effect on Hypertension and benign breast disease of progestogen component in combined oral contraceptives. Lancet 1: 624, 1977.

DETAILED PATIENT LABELING

This product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

INTRODUCTION

Any woman who considers using oral contraceptives (“birth control pills” or “the pill”) should understand the benefits and risks of using this form of birth control. This leaflet will give you much of the information you will need to make this decision and also will help you determine if you are at risk of developing any of the serious side effects of the pill. It will tell you how to use the pill properly so that it will be as effective as possible. However, this leaflet is not a replacement for a careful discussion between you and your health care provider. You should discuss the information provided in this leaflet with him or her, both when you first start taking the pill and during your regular visits. You also should follow the advice of your health care provider with regard to regular checkups while you are on the pill.

EFFECTIVENESS OF ORAL CONTRACEPTIVES

Oral contraceptives are used to prevent pregnancy and are more effective than other non-surgical methods of birth control. When they are taken correctly, without missing any pills, the chance of becoming pregnant is less than 1% (1 pregnancy per 100 women per year of use). Typical failure rates are actually 3% per year. The chance of becoming pregnant increases with each missed pill during a menstrual cycle.

In comparison, typical failure rates for other nonsurgical methods of birth control during the first year are as follows:

Table l: Percentage of women experiencing an unintended pregnancy during the first year of typical use and the first year of perfect use of contraception and the percentage continuing use at the end of the first year. United States.
% of Women Experiencing an Unintended% of Women
Pregnancy within the First Year of UseContinuing Use
at One Year3
MethodTypical use1Perfect use2
(1)(2)(3)(4)
Source: Trussell J. Contraceptive Efficacy Table from Hatcher R.A., Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, in Contraceptive Technology: Seventeenth Revised Edition. New York, NY: Irvington Publishers, 1998.
1 Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.
2 Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.
3 Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year.
4 The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether.
5 Foams, creams, gels, vaginal suppositories, and vaginal film.
6 Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases.
7 With spermicidal cream or jelly.
8 Without spermicides.
9 The treatment schedule is one dose within 72 hours after unprotected intercourse and a second dose 12 hours after the first dose. The Food and Drug Administration has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral (1 dose is 2 white pills), Aleese (1 dose is 5 pink pills), Nordette or Levlen (1 dose is 2 light-orange pills), Lo/Ovral (1 dose is 4 white pills), Triphasil or Tri-Levlen (1 dose is 4 yellow pills).
10 However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches six months of age.
Chance48585
Spermicides526640
Periodic abstinence2563
Calendar9
Ovulation method3
Sympto-thermal62
Post-ovulation1
Withdrawal194
Cap7
Parous women402642
Nulliparous women20956
Sponge
Parous women402042
Nulliparous women20956
Diaphragm720656
Condom8
Female (Reality)21556
Male14361
Pill571
Progestin only0.5
Combined0.1
IUD
Progesterone T2.01.581
Copper T 380A0.80.678
LNg 200.10.181
Depo-Provera0.30.370
Norplant and Norplant-20.050.0588
Female sterilization0.50.5100
Male sterilization0.150.10100
Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9
Lactational Amenorrhea Method: LAM is a highly effective, temporary method of contraception.10

WHO SHOULD NOT TAKE ORAL CONTRACEPTIVES

Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives are strongly advised not to smoke.

Some women should not use the pill. For example, you should not take the pill if you are pregnant or think you may be pregnant. You also should not use the pill if you have any of the following conditions:

  • A history of heart attack or stroke

  • Blood clots in the legs (thrombophlebitis), brain (stroke), lungs (pulmonary embolism) or eyes

  • A history of blood clots in the deep veins of your legs

  • Chest pain (angina pectoris)

  • Known or suspected breast cancer or cancer of the lining of the uterus, cervix or vagina

  • Unexplained vaginal bleeding (until a diagnosis is reached by your doctor)

  • Yellowing of the whites of the eyes or of the skin (jaundice) during pregnancy or during previous use of the pill

  • Liver tumor (benign or cancerous)

  • Known or suspected pregnancy

Tell your health care provider if you have ever had any of these conditions. Your health care provider can recommend a safer method of birth control.

OTHER CONSIDERATIONS BEFORE TAKING ORAL CONTRACEPTIVES

Tell your health care provider if you have or have had:

  • Breast nodules, fibrocystic disease of the breast, an abnormal breast x-ray or mammogram

  • Diabetes

  • Elevated cholesterol or triglycerides

  • High blood pressure

  • Migraine or other headaches or epilepsy

  • Mental depression

  • Gallbladder, heart or kidney disease

  • History of scanty or irregular menstrual periods

Women with any of these conditions should be checked often by their health care provider if they choose to use oral contraceptives.

Also, be sure to inform your doctor or health care provider if you smoke or are on any medications.

RISKS OF TAKING ORAL CONTRACEPTIVES

1. Risk of developing blood clots

Blood clots and blockage of blood vessels are the most serious side effects of taking oral contraceptives. In particular, a clot in the legs can cause thrombophlebitis and a clot that travels to the lungs can cause a sudden blocking of the vessel carrying blood to the lungs. Rarely, clots occur in the blood vessels of the eye and may cause blindness, double vision, or impaired vision.

If you take oral contraceptives and need elective surgery, need to stay in bed for a prolonged illness or have recently delivered a baby, you may be at risk of developing blood clots. You should consult your doctor about stopping oral contraceptives three to four weeks before surgery and not taking oral contraceptives for two weeks after surgery or during bed rest. You should also not take oral contraceptives soon after delivery of a baby. It is advisable to wait for at least four weeks after delivery if you are not breast feeding. If you are breast feeding, you should wait until you have weaned your child before using the pill (see GENERAL PRECAUTIONS—While breast feeding).

2. Heart attacks and strokes

Oral contraceptives may increase the tendency to develop strokes (stoppage or rupture of blood vessels in the brain) and angina pectoris and heart attacks (blockage of blood vessels in the heart). Any of these conditions can cause death or temporary or permanent disability.

Smoking greatly increases the possibility of suffering heart attacks and strokes. Furthermore, smoking and the use of oral contraceptives greatly increase the chances of developing and dying of heart disease.

3. Gallbladder disease

Oral contraceptive users may have a greater risk than non-users of having gallbladder disease, although this risk may be related to pills containing high doses of estrogen.

4. Liver tumors

In rare cases, oral contraceptives can cause benign but dangerous liver tumors. These benign liver tumors can rupture and cause fatal internal bleeding. In addition, a possible but not definite association has been found with the pill and liver cancers in 2 studies in which a few women who developed these very rare cancers were found to have used oral contraceptives for long periods. However, liver cancers are extremely rare. The chance of developing liver cancer from using the pill is thus even rarer.

5. Cancer of the breast and reproductive organs

There is, at present, no confirmed evidence that oral contraceptives increase the risk of cancer of the reproductive organs in human studies. Several studies have found no overall increase in the risk of developing breast cancer. However, women who use oral contraceptives and have a strong family history of breast cancer or who have breast nodules or abnormal mammograms should be followed closely by their doctors. Some studies have reported an increase in the risk of developing breast cancer, particularly at a younger age. This increased risk appears to be related to duration of use.

Some studies have found an increase in the incidence of cancer of the cervix in women who use oral contraceptives. However, this finding may be related to factors other than the use of oral contraceptives.

ESTIMATED RISK OF DEATH FROM A BIRTH CONTROL METHOD OR PREGNANCY

All methods of birth control and pregnancy are associated with a risk of developing certain diseases which may lead to disability or death. An estimate of the number of deaths associated with different methods of birth control and pregnancy has been calculated and is shown in the following table:

ESTIMATED ANNUAL NUMBER OF BIRTH-RELATED OR METHOD-RELATED DEATHS ASSOCIATED WITH CONTROL OF FERTILITY PER 100,000 NON-STERILE WOMEN, BY FERTILITY CONTROL METHOD ACCORDING TO AGE
Method of control and outcome15-1920-2425-2930-3435-3940-44
Estimates adapted from H.W. Ory 41.
No fertility7.07.49.114.825.728.2
control methods*
Oral contraceptives0.30.50.91.913.831.6
non-smoker* *
Oral contraceptives2.23.46.613.551.1117.2
smoker* *
IUD* *0.80.81.01.01.41.4
Condom*1.11.60.70.20.30.4
Diaphragm/Spermicide*1.91.21.21.32.22.8
Periodic abstinence*2.51.61.61.72.93.6
* Deaths are birth-related
* * Deaths are method-related

In the above table, the risk of death from any birth control method is less than the risk of childbirth except for oral contraceptive users over the age of 35 who smoke and pill users over the age of 40 even if they do not smoke. It can be seen from the table that for women aged 15 to 39 the risk of death is highest with pregnancy (7–26 deaths per 100,000 women, depending on age). Among pill users who do not smoke the risk of death is always lower than that associated with pregnancy for any age group, although over the age of 40 the risk increases to 32 deaths per 100,000 women compared to 28 associated with pregnancy at that age. However, for pill users who smoke and are over the age of 35 the estimated number of deaths exceeds those for other methods of birth control. If a woman is over the age of 40 and smokes, her estimated risk of death is 4 times higher (117/100,000 women) than the estimated risk associated with pregnancy (28/100,000 women) in that age group.

The suggestion that women over 40 who don’t smoke should not take oral contraceptives is based on information from older high-dose pills and on less selective use of pills than is practiced today. An Advisory Committee of the FDA discussed this issue in 1989 and recommended that the benefits of oral contraceptive use by healthy, non-smoking women over 40 years of age may outweigh the possible risks. However, all women, especially older women, are cautioned to use the lowest dose pill that is effective.

WARNING SIGNALS

If any of these adverse effects occur while you are taking oral contraceptives, call your doctor immediately:

  • Sharp chest pain, coughing of blood or sudden shortness of breath (indicating a possible clot in the lung)

  • Pain in the calf (indicating a possible clot in the leg)

  • Crushing chest pain or heaviness in the chest (indicating a possible heart attack)

  • Sudden severe headache or vomiting, dizziness or fainting, disturbances of vision or speech, weakness or numbness in an arm or leg (indicating a possible stroke)

  • Sudden partial or complete loss of vision (indicating a possible clot in the eye)

  • Breast lumps (indicating possible breast cancer or fibrocystic disease of the breast: ask your doctor or health care provider to show you how to examine your breasts)

  • Severe pain or tenderness in the stomach area (indicating a possible ruptured liver tumor)

  • Difficulty in sleeping, weakness, lack of energy, fatigue or change in mood (possibly indicating severe depression)

  • Jaundice or a yellowing of the skin or eyeballs, accompanied frequently by fever, fatigue, loss of appetite, dark colored urine or light colored bowel movements (indicating possible liver problems)

SIDE EFFECTS OF ORAL CONTRACEPTIVES

1. Vaginal bleeding

Irregular vaginal bleeding or spotting may occur while you are taking the pill. Irregular bleeding may vary from slight staining between menstrual periods to breakthrough bleeding which is a flow much like a regular period. Irregular bleeding occurs most often during the first few months of oral contraceptive use but may also occur after you have been taking the pill for some time. Such bleeding may be temporary and usually does not indicate any serious problem. It is important to continue taking your pills on schedule. If the bleeding occurs in more than 1 cycle or lasts for more than a few days, talk to your doctor or health care provider.

2. Contact lenses

If you wear contact lenses and notice a change in vision or an inability to wear your lenses, contact your doctor or health care provider.

3. Fluid retention

Oral contraceptives may cause edema (fluid retention) with swelling of the fingers or ankles and may raise your blood pressure. If you experience fluid retention, contact your doctor or health care provider.

4. Melasma (Mask of Pregnancy)

A spotty darkening of the skin is possible, particularly of the face.

5. Other side effects

Other side effects may include change in appetite, headache, nervousness, depression, dizziness, loss of scalp hair, rash and vaginal infections.

If any of these side effects occurs, contact your doctor or health care provider.

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