Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/2285
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Kelnor 1/35 (Kit)
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To achieve maximum contraceptive effectiveness, oral contraceptives must be taken exactly as directed and at intervals of 24 hours. IMPORTANT: If the Sunday start schedule is selected, the patient should be instructed to use an additional method of protection until after the first week of administration in the initial cycle. The possibility of ovulation and conception prior to initiation of use should be considered. Kelnor���1/35 (28 Day Regimen) (ethynodiol diacetate and ethinyl estradiol tablets, USP)<br/>Dosage Schedule:: The Kelnor���1/35 (28 Day Regimen) tablet dispenser contains 21 light yellow active tablets arranged in three numbered rows of 7 tablets each, followed by a fourth row of 7 white placebo tablets. Days of the week are printed above the tablets, starting with Sunday on the left.<br/>28-Day Schedule:: For a DAY 1 START, count the first day of menstrual flow as Day 1 and the first tablet (light yellow) is then taken on Day 1. For a SUNDAY START when menstrual flow begins on or before Sunday, the first tablet (light yellow) is taken on that day. With either a DAY 1 START or SUNDAY START, 1 tablet (light yellow) is taken each day at the same time for 21 days. Then the white tablets are takenfor 7 days, whether bleeding has stopped or not. After all 28 tablets have been taken, whether bleeding has stopped or not, the same dosage schedule is repeated beginning on the following day.<br/>Special Notes::<br/>Spotting, Breakthrough Bleeding, or Nausea:: If spotting (bleeding insufficient to require a pad), breakthrough bleeding (heavier bleeding similar to a menstrual flow), or nausea occurs the patient should continue taking her tablets as directed. The incidence of spotting, breakthrough bleeding or nausea is minimal, most frequently occurring in the first cycle. Ordinarily spotting or breakthrough bleeding will stop within a week. Usually the patient will begin to cycle regularly within two to three courses of tablet-taking. In the event of spotting or breakthrough bleeding organic causes shouldbe borne in mind. (See WARNINGS, No. 11.)<br/>Missed Menstrual Periods:: Withdrawal flow will normally occur 2 or 3 days after the last active tablet is taken. Failure of withdrawal bleeding ordinarily does not mean that the patient is pregnant, providing the dosage schedule has been correctly followed. (See WARNINGS, No. 6.) 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. If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out before continuing the contraceptive regimen. The first intermenstrual interval after discontinuing the tablets is usually prolonged; consequently, a patient for whom a 28-day cycle is usual might not begin to menstruate for 35 days or longer. Ovulation in such prolonged cycles will occur correspondingly later in the cycle. Posttreatment cycles after the first one, however, are usually typical for the individual woman prior to taking tablets. (See WARNINGS, No. 11.)<br/>Missed Tablets:: If a woman misses taking one active tablet, the missed tablet should be taken as soon as it is remembered. In addition, the next tablet should be taken at the usual time. If two consecutive active tablets are missed in week 1 or week 2 of the dispenser, the dosage should be doubled for the next 2 days. The regular schedule should then be resumed, but an additional method of protection must be used as backup for the next 7 days if she has sex during that time or she may become pregnant. If two consecutive active tablets are missed in week 3 of the dispenser or three consecutive active tablets are missed during any of the first 3 weeks of the dispenser, direct the patient to do one of the following: Day 1 Starters should discard the rest of the dispenser and begin a new dispenser that same day; Sunday Starters should continue to take 1 tablet daily until Sunday, discard the rest of the dispenser and begin a new dispenser that same day. The patient may not have a period this month; however, if she has missed two consecutive periods, pregnancy should be ruled out. An additional method of protection must be used as a backup for the next 7 days after the tablets are missed if she has sex during that time or she may become pregnant. While there is little likelihood of ovulation if only one active tablet is missed, the possibility of spotting or breakthrough bleeding is increased and should be expected if two or more successive active tablets are missed. However, the possibility of ovulation increases with each successive day that scheduled active tablets are missed. If one or more placebo tablets of Kelnor���are missed, the Kelnor���schedule should be resumed on the eighth day after the last light yellow tablet was taken. Omission of placebo tablets in the 28-tablet courses does not increase the possibility of conception provided that this schedule is followed.
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Kelnor���1/35 (28 Day Regimen) (ethynodiol diacetate and ethinyl estradiol tablets, USP) are packaged in cartons of three blister card dispensers. Each blister card dispenser contains 21 light yellow, round, flat-faced, beveled-edge, unscored tablets, debossed with stylized b on one side and 14 on the other side and 7 white, round, flat-faced, beveled-edge, unscored placebo tablets, debossed with stylized b on one side and 143 on the other side. Each light yellow tablet contains 1 mg of ethynodiol diacetate and 0.035 mg of ethinyl estradiol. Each white tablet contains inert ingredients. Store at 20��to 25��C (68��to 77��F) [See USP Controlled Room Temperature]. Keep this and all medications out of the reach of children.
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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 should be strongly advised not to smoke.
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1. Physical Examination and Follow-Up:: It is good medical practice for all women to have annual history and physical examinations, including women using oral contraceptives. The physical examination, however, may be deferred until after initiation of oral contraceptives if requested by the woman and judged appropriate by the clinician. The physical examination should include special reference to blood pressure, breasts, abdomen, and pelvic organs, including cervical cytology, and relevant laboratory tests. In case of undiagnosed, persistent, or recurrent abnormal vaginal bleeding, appropriate measures should be conducted to rule out malignancy. Women with a strong family history of breast cancer or who have breast nodules should be monitored with particular care.<br/>2. Lipid Disorders:: Women who are being treated for hyperlipidemias should be followed closely if they elect to use oral contraceptives. Some progestogens may elevate LDL levels and may render the control of hyperlipidemias more difficult.<br/>3. Liver Function:: If jaundice develops in any woman receiving oral contraceptives, they should be discontinued. Steroids may be poorly metabolized in patients with impaired liver function and should be administered with caution in such patients. Cholestatic jaundice has been reported after combined treatment with oral contraceptives and troleandomycin. Hepatotoxicity following a combination of oral contraceptives and cyclosporine has also been reported.<br/>4. Fluid Retention:: Oral contraceptives may cause some degree of fluid retention. They should be prescribed with caution, and only with careful monitoring, in patients with conditions that might be aggravated by fluid retention, such as convulsive disorders, migraine syndrome, asthma, or cardiac, hepatic, or renal dysfunction.<br/>5. Emotional Disorders:: Women with a history of depression should be carefully observed and the drug discontinued if depression recurs to a serious degree.<br/>6. Contact Lenses:: Contact lens wearers who develop visual changes or changes in lens tolerance should be assessed by an ophthalmologist.<br/>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 for barbiturates, phenylbutazone, phenytoin sodium, and possibly with griseofulvin, ampicillin, and tetracyclines. Administration of troglitazone concomitantly with a combination oral contraceptive (estrogen and progestin) reduced the plasma concentrations of both hormones by approximately 30%. This could result in loss of contraceptive efficacy.<br/>8. Laboratory Test Interactions:: Certain endocrine and liver function tests and blood components may be affected by oral contraceptives:<br/>9. Carcinogenesis:: See WARNINGS.<br/>10. Pregnancy:<br/>Pregnancy Category X.: (See CONTRAINDICATIONS and WARNINGS.)<br/>11. Nursing Mothers:: Small amounts of oral contraceptive steroids have been identified in the milk of nursing mothersand a few adverse effects on the child have been reported, including jaundice and breast enlargement. In addition, oral contraceptives given in the postpartum period may interfere with lactation by decreasing the quantity and quality of breast milk. If possible, the nursing mother should be advised not to use oral contraceptives, but to use other forms of contraception until she has completely weaned her child.<br/>12. Pediatric Use:: Safety and efficacy of Kelnor���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.<br/>13. Venereal Diseases:: Oral contraceptives are of no value in the prevention or treatment of venereal disease. The prevalence of cervical Chlamydia trachomatis and Neisseria gonorrhoeae in oral contraceptive users is increased several-fold.It should not be assumed that oral contraceptives afford protection against pelvic inflammatory disease from chlamydia.Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.<br/>14. General:: a. The pathologist should be advised of oral contraceptive therapy when relevant specimens are submitted. b. Treatment with oral contraceptives may mask the onset of the climacteric. (See WARNINGS regarding risks in this age group.)
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ethynodiol diacetate and ethinyl estradiol
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Kelnor 1/35 (Kit)
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An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (see WARNINGS): There is evidence of an association between the following conditions and the use of oral contraceptives, although additional confirmatory studies are needed: The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug-related: The following adverse reactions or conditions have been reported in users of oral contraceptives and the association has been neither confirmed nor refuted:
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Kelnor 1/35
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