Microgestin 1/20 (Page 5 of 8)

DOSAGE AND ADMINISTRATION

The compact tablet dispenser has been designed to make oral contraceptive dosing as easy and as convenient as possible. The tablets are arranged in three rows of seven tablets each, with the days of the week appearing on the compact tablet dispenser above the first row of tablets.

Note: Each compact tablet dispenser has been preprinted with the days of the week, starting with Sunday, to facilitate a Sunday-Start regimen. Six different day label stickers have been provided with the Detailed Patient & Brief Summary Patient Package Insert in order to accommodate a Day-1 Start regimen. If the patient is using the Day-1 Start regimen, she should place the self-adhesive day label sticker that corresponds to her starting day over the preprinted days.

Important: The patient should be instructed to use an additional method of protection until after the first week of administration in the initial cycle when utilizing the Sunday-Start regimen.

The possibility of ovulation and conception prior to initiation of use should be considered.

Dosage and Administration for 21-Day Dosage Regimen

To achieve maximum contraceptive effectiveness, Microgestin 1/20 should be taken exactly as directed and at intervals not exceeding 24 hours. Microgestin 1/20 provides the patient with a convenient tablet schedule of “3 weeks on-1 week off”. Two dosage regimens are described, one of which may be more convenient or suitable than the other for an individual patient. For the initial cycle of therapy, the patient begins her tablets according to the Day 1 Start or Sunday-Start regimen. With either regimen, the patient takes one tablet daily for 21 consecutive days followed by one week of no tablets.

A. Sunday-Start Regimen: The patient begins taking tablets from the top row of the dispenser (labeled Sunday) on the first Sunday after menstrual flow begins. When the menstrual flow begins on Sunday, the first tablet is taken on the same day. The last tablet in the dispenser will be taken on a Saturday, followed by no tablets for a week (7 days). For all subsequent cycles, the patient then begins a new 21-tablet regimen on the eighth day, Sunday, after taking her last tablet. Following this regimen, of 21 days on-7 days off, the patient will start all subsequent cycles on a Sunday.

B. Day-1 Start Regimen: The first day of menstrual flow is Day 1. The patient places the self-adhesive day label sticker that corresponds to her starting day over the preprinted days on the tablet dispenser. She starts taking one tablet daily, beginning with the first tablet in the top row. The patient completes her 21-tablet regimen when she has taken the last tablet in the tablet dispenser. She will then take no tablets for a week (7 days). For all subsequent cycles, the patient begins a new 21-tablet regimen on the eighth day after taking her last tablet, again starting with the first tablet in the top row after placing the appropriate day label sticker over the preprinted days on the tablet dispenser. Following this regimen of 21 days on–7 days off, the patient will start all subsequent cycles on the same day of the week as the first course. Likewise, the interval of no tablets will always start on the same day of the week.

Tablets should be taken regularly with a meal or at bedtime. It should be stressed that efficacy of medication depends on strict adherence to the dosage schedule.

Special Notes on Administration

Menstruation usually begins two or three days, but may begin as late as the fourth or fifth day, after discontinuing medication. If spotting occurs while on the usual regimen of one tablet daily, the patient should continue medication without interruption.

If the patient forgets to take one or more tablets, the following is suggested:

One tablet is missed

● take tablet as soon as remembered

● take next tablet at the regular time

Two consecutive tablets are missed (week 1 or week 2)

● take two tablets as soon as remembered

● take two tablets the next day

● use another birth control method for seven days following the missed tablets

Two consecutive tablets are missed (week 3)

Sunday-Start Regimen:

● take one tablet daily until Sunday

● discard remaining tablets

● start new pack of tablets immediately (Sunday)

● use another birth control method for seven days following the missed tablets

Day-1 Start Regimen:

● discard remaining tablets

● start new pack of tablets that same day

● use another birth control method for seven days following the missed tablets

Three (or more) consecutive tablets are missed

Sunday-Start Regimen:

● take one tablet daily until Sunday

● discard remaining tablets

● start new pack of tablets immediately (Sunday)

● use another birth control method for seven days following the missed tablets

Day-1 Start Regimen:

● discard remaining tablets

● start new pack of tablets that same day

● use another birth control method for seven days following the missed tablets

The possibility of ovulation occurring increases with each successive day that scheduled pale yellow tablets are missed. While there is little likelihood of ovulation occurring if only one pale yellow tablet is missed, the possibility of spotting or bleeding is increased. This is particularly likely to occur if two or more consecutive pale yellow tablets are missed.

In the rare case of bleeding which resembles menstruation, the patient should be advised to discontinue medication and then begin taking tablets from a new compact tablet dispenser on the next Sunday or the first day (Day-1), depending on her regimen. Persistent bleeding which is not controlled by this method indicates the need for reexamination of the patient, at which time nonfunctional causes should be considered.

Use of Oral Contraceptives in the Event of a Missed Menstrual Period

1. If the patient has not adhered to the prescribed dosage regimen, the possibility of pregnancy should be considered after the first missed period and oral contraceptives should be withheld until pregnancy has been ruled out.

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

After several months on treatment, bleeding may be reduced to a point of virtual absence. This reduced flow may occur as a result of medication, in which event it is not indicative of pregnancy.

HOW SUPPLIED

Microgestin 1/20 is available in dispensers (NDC 51862-868-01) each containing 21 pale yellow tablets. Each pale yellow, biconvex, round tablet debossed with “L2″ on one side contains 1mg of norethindrone acetate and 20 mcg of ethinyl estradiol.

Microgestin 1/20 Tablets are available in the following configurations:

Carton of 1 NDC 51862-868-02

Carton of 3 NDC 51862-868-03

Carton of 6 NDC 51862-868-06

Store at 20 ˚C ~ 25 ˚C (68 ˚F~77 ˚F) [See USP Controlled Room Temperature].

REFERENCES

1. Back DJ, Breckenridge AM, Crawford FE, McIver M, Orme ML’E, Rowe PH and Smith E: Kinetics of norethindrone in women II. Single-dose kinetics. Clin Pharmacol Ther 1978; 24:448-453.

2. Humpel M, Nieuweboer B, Wendt H and Speck U: Investigations of pharmacokinetics of ethinyloestradiol to specific consideration of a possible first-pass effect in women. Contraception 1979; 19:421-432.

3. Back DJ, Breckenridge AM, Crawford FE, MacIver M, Orme ML’E, Rowe PH and Watts MJ. An investigation of the pharmacokinetics of ethynylestradiol in women using radioimmunoassay. Contraception 1979; 20:263-273.

4. Hammond GL, Lahteenmaki PLA, Lahteenmaki P and Luukkainen T. Distribution and percentages of non-protein bound contraceptive steroids in human serum. J Steriod Biochem 1982; 17:375-380.

5. Fotherby K. Pharmacokinetics and metabolism of progestins in humans, in Pharmacology of the contraceptive steroids, Goldzieher JW, Fotherby K (eds), Raven Press, Ltd., New York, 1994; 99-126.

6. Goldzieher JW. Pharmacokinetics and metabolism of ethynyl estrogens, in Pharmacology of the contraceptive steroids, Goldzieher JW, Fotherby K (eds), Raven Press Ltd., New York, 1994; 127-151.

7. Hatcher RA, et al. 1998. Contraceptive Technology, Seventeenth Edition. New York: Irvington Publishers.

8. Stadel, B.V.: Oral contraceptives and cardiovascular disease. (Pt. 1). New England Journal of Medicine, 305:612-618, 1981.

9. Stadel, B.V.: Oral contraceptives and cardiovascular disease. (Pt. 2). New England Journal of Medicine, 305:672-677, 1981.

10. Adam, S.A., and M. Thorogood: Oral contraception and myocardial infarction revisited: The effects of new preparations and prescribing patterns. Brit. J. Obstet. and Gynec., 88:838-845, 1981.

11. Mann, J.I., and W.H. Inman: Oral contraceptives and death from myocardial infarction. Brit. Med. J., 2(5965): 245-248, 1975.

12. Mann, J.I., M.P. Vessey, M. Thorogood, and R. Doll: Myocardial infarction in young women with special reference to oral contraceptive practice. Brit. Med. J., 2(5956):241-245, 1975.

13. Royal College of General Practitioners’ Oral Contraception Study: Further analyses of mortality in oral contraceptive users. Lancet, 1:541-546, 1981.

14. Slone, D., S. Shapiro, D.W. Kaufman, L. Rosenberg, O.S. Miettinen, and P.D. Stolley: Risk of myocardial infarction in relation to current and discontinued use of oral contraceptives. N.E.J.M., 305:420-424, 1981.

15. Vessey, M.P.: Female hormones and vascular disease: An epidemiological overview. Brit. J. Fam. Plann., 6:1-12, 1980.

16. Russell-Briefel, R.G., T.M. Ezzati, R. Fulwood, J.A. Perlman, and R.S. Murphy: Cardiovascular risk status and oral contraceptive use, United States, 1976-80. Preventive Medicine, 15:352-362, 1986.

17. Goldbaum, G.M., J.S. Kendrick, G.C. Hogelin, and E.M. Gentry: The relative impact of smoking and oral contraceptive use on women in the United States. J.A.M.A., 258:1339-1342, 1987.

18. Layde, P.M., and V. Beral: Further analyses of mortality in oral contraceptive users: Royal College General Practitioners’ Oral Contraception Study. (Table 5) Lancet, 1:541-546, 1981.

19. Knopp, R.H.: Arteriosclerosis risk: The roles of oral contraceptives and postmenopausal estrogens. J. of Reprod. Med., 31(9) (Supplement): 913-921, 1986.

20. Krauss, R.M., S. Roy, D.R. Mishell, J. Casagrande, and M.C. Pike: Effects of two low-dose oral contraceptives on serum lipids and lipoproteins: Differential changes in high-density lipoproteins subclasses. Am. J. Obstet. Gyn., 145:446-452, 1983.

21. Wahl, P., C. Walden, R. Knopp, J. Hoover, R. Wallace, G. Heiss, and B. Rifkind: Effect of estrogen/progestin potency on lipid/lipoprotein cholesterol. N.E.J.M., 308:862-867, 1983.

22. Wynn, V., and R. Niththyananthan: The effect of progestin in combined oral contraceptives on serum lipids with special reference to high-density lipoproteins. Am. J. Obstet. and Gyn., 142:766-771, 1982.

23. Wynn, V., and I. Godsland: Effects of oral contraceptives on carbohydrate metabolism. J. Reprod. Medicine, 31 (9) (Supplement): 892-897, 1986.

24. LaRosa, J.C.: Atherosclerotic risk factors in cardiovascular disease. J. Reprod. Med., 31(9) (Supplement): 906-912, 1986.

25. Inman, W.H., and M.P. Vessey: Investigations of death from pulmonary, coronary, and cerebral thrombosis and embolism in women of child-bearing age. Brit. Med. J., 2(5599): 193-199, 1968.

26. Maguire, M.G., J. Tonascia, P.E. Sartwell, P.D. Stolley, and M.S. Tockman: Increased risk of thrombosis due to oral contraceptives: A further report. Am. J. Epidemiology, 110(2): 188-195, 1979.

27. Pettiti, D.B., J. Wingerd, F. Pellegrin, and S. Ramacharan: Risk of vascular disease in women: Smoking, oral contraceptives, noncontraceptive estrogens, and other factors. J.A.M.A., 242:1150-1154, 1979.

28. Vessey, M.P., and R. Doll: Investigation of relation between use of oral contraceptives and thromboembolic disease. Brit. Med. J., 2(5599): 199-205, 1968.

29. Vessey, M.P., and R. Doll: Investigation of relation between use of oral contraceptives and thromboembolic disease: A further report. Brit. Med. J., 2(5658): 651-657, 1969.

30. Porter, J.B., J.R. Hunter, D.A. Danielson, H. Jick, and A. Stergachis: Oral contraceptives and non-fatal vascular disease: Recent experience. Obstet. and Gyn., 59(3):299-302, 1982.

31. Vessey, M., R. Doll, R. Peto, B. Johnson, and P. Wiggins: A long-term follow-up study of women using different methods of contraception: An interim report. J. Biosocial. Sci., 8:375-427, 1976.

32. Royal College of General Practitioners: Oral contraceptives, venous thrombosis, and varicose veins. J. of Royal College of General Practitioners, 28:393-399, 1978.

33. Collaborative Group for the study of stroke in young women: Oral contraception and increased risk of cerebral ischemia or thrombosis. N.E.J.M., 288:871-878, 1973.

34. Petitti, D.B., and J. Wingerd: Use of oral contraceptives, cigarette smoking, and risk of subarachnoid hemorrhage. Lancet, 2:234-236, 1978.

35. Inman, W.H.: Oral contraceptives and fatal subarachnoid hemorrhage. Brit. Med. J., 2(6203): 1468-70, 1979.

36. Collaborative Group for the study of stroke in young women: Oral contraceptives and stroke in young women: Associated risk factors. J.A.M.A., 231:718-722, 1975.

37. Inman, W.H., M.P. Vessey, B. Westerholm, and A. Engelund: Thromboembolic disease and the steroidal content of oral contraceptives. A report to the Committee on Safety of Drugs. Brit. Med. J., 2:203¬ 209, 1970.

38. Meade, T.W., G. Greenberg, and S.G. Thompson: Progestogens and cardiovascular reactions associated with oral contraceptives and a comparison of the safety of 50-and 35-mcg oestrogen preparations. Brit. Med. J., 280(6224): 1157-1161, 1980.

39. Kay, C.R.: Progestogens and arterial disease: Evidence from the Royal College of General Practitioners’ study. Amer. J. Obstet. Gyn., 142:762-765, 1982.

40. Royal College of General Practitioners: Incidence of arterial disease among oral contraceptive users. J. Coll. Gen. Pract., 33:75-82, 1983.

41. Ory, H.W: Mortality associated with fertility and fertility control: 1983. Family Planning Perspectives, 15:50-56, 1983.

42. The Cancer and Steroid Hormone Study of the Centers for Disease Control and the National Institute of Child Health and Human Development: Oral-contraceptive use and the risk of breast cancer. N.E.J.M., 315: 405-411, 1986.

43. Pike, M.C., B.E. Henderson, M.D. Krailo, A. Duke, and S. Roy: Breast cancer in young women and use of oral contraceptives: Possible modifying effect of formulation and age at use. Lancet, 2:926-929, 1983.

44. Paul, C., D.G. Skegg, G.F.S. Spears, and J.M. Kaldor: Oral contraceptives and breast cancer: A national study. Brit. Med. J., 293:723-725, 1986.

45. Miller, D.R., L. Rosenberg, D.W. Kaufman, D. Schottenfeld, P.D. Stolley, and S. Shapiro: Breast cancer risk in relation to early oral contraceptive use. Obstet. Gynec., 68:863-868, 1986.

46. Olson, H., K.L. Olson, T.R. Moller, J. Ranstam, P. Holm: Oral contraceptive use and breast cancer in young women in Sweden (letter). Lancet, 2:748-749, 1985.

47. McPherson, K., M. Vessey, A. Neil, R. Doll, L. Jones, and M. Roberts: Early contraceptive use and breast cancer: Results of another case-control study. Brit. J. Cancer, 56: 653-660, 1987.

48. Huggins, G.R., and P.F. Zucker: Oral contraceptives and neoplasia: 1987 update. Fertil. Steril., 47:733-761, 1987.

49. McPherson, K., and J.O. Drife: The pill and breast cancer: Why the uncertainty? Brit. Med. J., 293:709-710, 1986.

50. Shapiro, S.: Oral contraceptives: Time to take stock. N.E.J.M., 315:450-451, 1987.

51. Ory, H., Z. Naib, S.B. Conger, R.A. Hatcher, and C.W. Tyler: Contraceptive choice and prevalence of cervical dysplasia and carcinoma in situ. Am. J. Obstet. Gynec., 124:573-577, 1976.

52. Vessey, M.P., M. Lawless, K. McPherson, D. Yeates: Neoplasia of the cervix uteri and contraception: A possible adverse effect of the pill. Lancet, 2:930, 1983.

53. Brinton, L.A., G.R. Huggins, H.F. Lehman, K. Malli, D.A. Savitz, E. Trapido, J. Rosenthal, and R. Hoover: Long-term use of oral contraceptives and risk of invasive cervical cancer. Int. J. Cancer, 38:339-344, 1986.

54. WHO Collaborative Study of Neoplasia and Steroid Contraceptives: Invasive cervical cancer and combined oral contraceptives. Brit. Med. J., 290:961-965, 1985.

55. Rooks, J.B., H.W. Ory, K.G. Ishak, L.T. Strauss, J.R. Greenspan, A.P. Hill, and C.W. Tyler: Epidemiology of hepatocellular adenoma: The role of oral contraceptive use. J.A.M.A., 242:644-648, 1979.

56. Bein, N.N., and H.S. Goldsmith: Recurrent massive hemorrhage from benign hepatic tumors secondary to oral contraceptives. Brit. J. Surg., 64:433-435, 1977.

57. Klatskin, G.: Hepatic tumors: Possible relationship to use of oral contraceptives. Gastroenterology, 73:386-394, 1977.

58. Henderson, B.E., S. Preston-Martin, H.A. Edmondson, R.L. Peters, and M.C. Pike: Hepatocellular carcinoma and oral contraceptives. Brit. J. Cancer, 48:437-440, 1983.

59. Neuberger, J., D. Forman, R. Doll, and R. Williams: Oral contraceptives and hepatocellular carcinoma. Brit. Med. J., 292:1355-1357, 1986.

60. Forman, D., T.J. Vincent, and R. Doll: Cancer of the liver and oral contraceptives. Brit. Med. J., 292: 1357-1361, 1986.

61. Harlap, S., and J. Eldor: Births following oral contraceptive failures. Obstet. Gynec., 55:447-452, 1980.

62. Savolainen, E., E. Saksela, and L. Saxen: Teratogenic hazards of oral contraceptives analyzed in a national malformation register. Amer. J. Obstet. Gynec., 140:521-524, 1981.

63. Janerich, D.T., J.M. Piper, and D.M. Glebatis: Oral contraceptives and birth defects. Am. J. Epidemiology, 112:73-79, 1980.

64. Ferencz, C., G.M. Matanoski, P.D. Wilson, J.D. Rubin, C.A. Neill, and R. Gutberlet: Maternal hormone therapy and congenital heart disease. Teratology, 21:225-239, 1980.

65. Rothman, K.J., D.C. Fyler, A. Goldbatt, and M.B. Kreidberg: Exogenous hormones and other drug exposures of children with congenital heart disease. Am. J. Epidemiology, 109:433-439, 1979.

66. Boston Collaborative Drug Surveillance Program: Oral contraceptives and venous thromboembolic disease, surgically confirmed gallbladder disease, and breast tumors. Lancet, 1:1399-1404, 1973.

67. Royal College of General Practitioners: Oral Contraceptives and Health. New York, Pittman, 1974, 100p.

68. Layde, P.M., M.P. Vessey, and D. Yeates: Risk of gallbladder disease: A cohort study of young women attending family planning clinics. J. of Epidemiol. and Comm. Health, 36: 274-278, 1982.

69. Rome Group for the Epidemiology and Prevention of Cholelithiasis (GREPCO): Prevalence of gallstone disease in an Italian adult female population. Am. J. Epidemiol., 119:796-805, 1984.

70. Strom, B.L., R.T. Tamragouri, M.L. Morse, E.L. Lazar, S.L. West, P. D. Stolley, and J.K. Jones: Oral contraceptives and other risk factors for gallbladder disease. Clin. Pharmacol. Ther., 39:335-341, 1986.

71. Wynn, V., P.W. Adams, I.F. Godsland, J. Melrose, R. Niththyananthan, N.W. Oakley, and A. Seedj: Comparison of effects of different combined oral-contraceptive formulations on carbohydrate and lipid metabolism. Lancet, 1:1045-1049, 1979.

72. Wynn, V.: Effect of progesterone and progestins on carbohydrate metabolism. In Progesterone and Progestin. Edited by C.W. Bardin, E. Milgrom, P. Mauvis-Jarvis. New York, Raven Press, pp. 395-410, 1983.

73. Perlman, J.A., R. G. Roussell-Briefel, T.M. Ezzati, and G. Lieberknecht: Oral glucose tolerance and the potency of oral contraceptive progestogens. J. Chronic Dis., 38:857-864, 1985.

74. 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.

75. Fisch, I.R., and J. Frank: Oral contraceptives and blood pressure. J.A.M.A., 237:2499-2503, 1977.

76. Laragh, A.J.: Oral contraceptive induced hypertension: Nine years later. Amer. J. Obstet. Gynecol., 126:141-147, 1976.

77. Ramcharan, S., E. Peritz, F.A. Pellegrin, and W.T. Williams: Incidence of hypertension in the Walnut Creek Contraceptive Drug Study cohort. In Pharmacology of Steroid Contraceptive Drugs. Edited by S. Garattini and H.W. Berendes. New York, Raven Press, pp. 277-288, 1977. (Monographs of the Mario Negri Institute for Pharmacological Research, Milan.)

78. Back DJ, Orme ML’E. Drug interactions, in Pharmacology of the contracepive steroids. Goldzieher JW, Fotherby K (eds), Raven Press, Ltd., New York, 1994, 407-425.

79. The Cancer and Steroid Hormone Study of the Centers for Disease Control and the National Institute of Child Health and Human Development: Oral contraceptive use and the risk of ovarian cancer. J.A.M.A., 249:1596-1599, 1983.

80. The Cancer and Steroid Hormone Study of the Centers for Disease Control and the National Institute of Child Health and Human Development: Combination oral contraceptive use and the risk of endometrial cancer. J.A.M.A., 257:796-800, 1987.

81. Ory, H.W.: Functional ovarian cysts and oral contraceptives: Negative association confirmed surgically. J.A.M.A., 228:68-69, 1974.

82. Ory, H.W., P. Cole, B. Macmahon, and R. Hoover: Oral contraceptives and reduced risk of benign breast disease. N.E.J.M., 294:41-422, 1976.

83. Ory, H.W.: The noncontraceptive health benefits from oral contraceptive use. Fam. Plann. Perspectives, 14:182-184, 1982.

84. Ory, H.W., J.D. Forrest, and R. Lincoln: Making Choices: Evaluating the health risks and benefits of birth control methods. New York, The Alan Guttmacher Institute, p.1, 1983.

85. Miller, D.R., L. Rosenberg, D.W. Kaufman, P. Stolley, M.E. Warshauer, and S. Shapiro: Breast cancer before age 45 and oral contraceptive use: new findings. Am. J. Epidemiol., 129:269-280, 1989.

86. Kay, C.R., and P.C. Hannaford: Breast cancer and the pill: a further report from the Royal College of General Practitioners Oral Contraception Study. Br. J. Cancer, 58:675-680, 1988.

87. Stadel, B.V., S. Lai, J.J. Schlesselman, and P. Murray: Oral contraceptives and premenopausal breast cancer in nulliparous women. Contraception, 38:287-299, 1988.

88. UK National Case—Control Study Group: Oral contraceptive use and breast cancer risk in young women. Lancet, 973-982, 1989.

89. Romieu, I., W.C. Willett, G.A. Colditz, M.J. Stampfer, B. Rosner, C.H. Hennekens, and F.E. Speizer: Prospective study of oral contraceptive use and risk of breast cancer in women. J. Natl. Cancer Inst., 81:1313-1321, 1989.

The patient labeling for oral contraceptive drug products is set forth below.

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

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2020. All Rights Reserved.