Statements in which the resource exists as a subject.
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Ortho Tri-Cyclen (Kit)
dailymed-instance:dosage
Oral Contraception: To achieve maximum contraceptive effectiveness, ORTHO TRI-CYCLEN Tablets and ORTHO-CYCLEN Tablets must be taken exactly as directed and at intervals not exceeding 24 hours. ORTHO TRI-CYCLEN and ORTHO-CYCLEN are available in the DIALPAK Tablet Dispenser which is preset for a Sunday Start. Day 1 Start is also provided.<br/>28-Day Regimen (Sunday Start): When taking ORTHO TRI-CYCLEN 28 and ORTHO-CYCLEN 28 the first tablet should be taken on the first Sunday after menstruation begins. If period begins on Sunday, the first tablet should be taken that day. Take one active tablet daily for 21 days followed by one green tablet daily for 7 days. After 28 tablets have been taken, a new course is started the next day (Sunday). For the first cycle of a Sunday Start regimen, another method of contraception should be used until after the first 7 consecutive days of administration. If the patient misses one (1) active tablet in Weeks 1, 2, or 3, the tablet should be taken as soon as she remembers. If the patient misses two (2) active tablets in Week 1 or Week 2, the patient should take two (2) tablets the day she remembers and two (2) tablets the next day; and then continue taking one (1) tablet a day until she finishes the pack. 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. If the patient misses two (2) active tablets in the third week or misses three (3) ormore active tablets in a row, the patient should continue taking one tablet every day until Sunday. On Sunday 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. Complete instructions to facilitate patient counseling on proper pill usage may be found in the Detailed Patient Labeling ("How to Take the Pill" section).<br/>28-Day Regimen (Day 1 Start): The dosage of ORTHO TRI-CYCLEN 28 and ORTHO-CYCLEN 28, for the initial cycle of therapy is one 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" followed by one green tablet daily for 7 days. Tablets are taken without interruption for 28 days. After 28 tablets have been taken, a new course is started the next day. If the patient misses one (1) active tablet in Weeks 1, 2, or 3, the tablet should be taken as soon as she remembers. If the patient misses two (2) active tablets in Week 1 or Week 2, the patient should take two (2) tablets the day she remembers and two (2) tablets the next day; and then continue taking one (1) tablet a day until she finishes the pack. 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. If the patient misses two (2) active tablets in the third week or misses three (3) or more 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. Complete instructions to facilitate patient counseling on proper pill usage may be found in the Detailed Patient Labeling ("How to Take the Pill" section). The use of ORTHO TRI-CYCLEN and ORTHO-CYCLEN for contraception may be initiated 4 weeks postpartum in women who elect not to breast feed. When the tablets are administered during the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered. The possibility of ovulation and conception prior to initiation of medication should be considered. (See Discussion of Dose-Related Risk of Vascular Disease from Oral Contraceptives.)
dailymed-instance:clinicalP...
Oral Contraception: Combination oral contraceptives act by suppression of gonadotropins. Although the primary mechanism of this action is inhibition of ovulation, other alterations include changes in the cervical mucus (which increase the difficulty of sperm entry into the uterus) and the endometrium (which reduce the likelihood of implantation). Receptor binding studies, as well as studies in animals and humans, have shown that norgestimate and 17-deacetyl norgestimate, the major serum metabolite, combine high progestational activity with minimal intrinsic androgenicity (90���93). Norgestimate, in combination with ethinyl estradiol, does not counteract the estrogen-induced increases in sex hormone binding globulin (SHBG), resulting in lower serum testosterone (90,91,94).<br/>Acne: Acne is a skin condition with a multifactorial etiology. The combination of ethinyl estradiol and norgestimate may increase sex hormone binding globulin (SHBG) and decrease free testosterone resulting in a decrease in the severity of facial acne in otherwise healthy women with this skin condition. Norgestimate and ethinyl estradiol are well absorbed following oral administration of ORTHO-CYCLEN and ORTHO TRI-CYCLEN. On the average, peak serum concentrations of norgestimate and ethinyl estradiol are observed within two hours (0.5 2.0 hr for norgestimate and 0.75���3.0 hr for ethinyl estradiol) after administration followed by a rapid decline due to distribution and elimination. Although norgestimate serum concentrations following single or multiple dosing were generally below assay detection within 5 hours, a major norgestimate serum metabolite, 17-deacetyl norgestimate, (which exhibits a serum half-life ranging from 12 to 30 hours) appears rapidly in serum with concentrations greatly exceeding that of norgestimate. The 17 deacetylated metabolite is pharmacologically active and the pharmacologic profile is similar to that of norgestimate. The elimination half-life of ethinyl estradiol ranged from approximately 6 to 14 hours. Both norgestimate and ethinyl estradiol are extensively metabolized and eliminated by renal and fecal pathways. Following administration ofC-norgestimate, 47% (45���49%) and 37% (16���49%) of the administered radioactivity was eliminated in the urine and feces, respectively. Unchanged norgestimate was not detected in the urine. In addition to 17-deacetyl norgestimate, a number of metabolites of norgestimate have been identified in human urine following administration of radiolabeled norgestimate. These include 18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-hydroxy-13-ethyl,(17��)-(-);18,19-Dinor-5��-17-pregnan -20-yn,3��,17��-dihydroxy-13-ethyl,(17��), various hydroxylated metabolites and conjugates of these metabolites. Ethinyl estradiol is metabolized to various hydroxylated products and their glucuronide and sulfate conjugates.
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dailymed-instance:supply
ORTHO TRI-CYCLEN 28 Tablets are available in a DIALPAK Tablet Dispenser (NDC 0062-1903-15) containing 28 tablets. Each white tablet contains 0.180 mg of the progestational compound, norgestimate, together with 0.035 mg of the estrogenic compound, ethinyl estradiol. Each light blue tablet contains 0.215 mg of the progestational compound, norgestimate, together with 0.035 mg of the estrogenic compound, ethinyl estradiol. Each blue tablet contains 0.250 mg of the progestational compound, norgestimate, together with 0.035 mg of the estrogenic compound,ethinyl estradiol. Each green tablet contains inert ingredients. The white tablets are unscored, with "Ortho" and "180" debossed on each side; the light blue tablets are unscored with "Ortho" and "215" debossed on each side; the blue tablets are unscored with "Ortho" and "250" debossed on each side. ORTHO TRI-CYCLEN 28 Tablets are also available as Refills (NDC 0062-1903-23) ORTHO TRI-CYCLEN 28 Tablets are available for clinic usage in a VERIDATE Tablet Dispenser (unfilled) and VERIDATE Refills (NDC 0062-1903-20). ORTHO-CYCLEN 28 Tablets are available in a DIALPAK Tablet Dispenser (NDC 0062-1901-15) containing 28 tablets as follows: 21 blue tablets , and 7 green tablets. Each blue tablet contains 0.250 mg of the progestational compound, norgestimate, together with 0.035 mg of the estrogenic compound, ethinyl estradiol which are unscored with "Ortho" and "250" debossed on each side. Each green tablet contains inert ingredients. ORTHO-CYCLEN 28 Tablets are also available as Refills (NDC 0062-1901-23) ORTHO-CYCLEN 28 Tablets are available for clinic usage in a VERIDATE Tablet Dispenser (unfilled) and VERIDATE Refills (NDC 0062-1901-20).
dailymed-instance:boxedWarn...
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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dailymed-instance:precautio...
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 such drugs, the medication should be discontinued. Steroid hormones may be poorly metabolized in patients with impaired liver function.<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 which might be aggravated by fluid retention.<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 with barbiturates, phenylbutazone, phenytoin sodium, carbamazepine, griseofulvin, topiramate, and possibly with ampicillin and tetracyclines (72). A possible interaction has been suggested with hormonal contraceptives and the herbal supplement St. John's Wort based on some reports of oral contraceptive users experiencing breakthrough bleeding shortly after starting St.John's Wort. Pregnancies have been reported by users of combined hormonal contraceptives who also used some form of St. John's Wort. Healthcare prescribers are advised to consult the package inserts of medication administered concomitantly with oral contraceptives.<br/>8. Interactions with Laboratory Tests: Certain endocrine and liver function tests and blood components may be affected by oral contraceptives:<br/>9. Carcinogenesis: See WARNINGS Section.<br/>10. Pregnancy:<br/>Pregnancy Category X: See CONTRAINDICATIONS and WARNINGS Sections.<br/>11. Nursing Mothers: Small amounts of oral contraceptive steroids have been identified in the milk of nursing mothers and a few adverse effects on the child have been reported, including jaundice and breast enlargement. In addition, combination 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 combination oral contraceptives but to use other forms of contraception until she has completely weaned her child.<br/>12. Pediatric Use: Safety and efficacy of ORTHO TRI-CYCLEN Tablets and ORTHO-CYCLEN 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.<br/>13. Sexually Transmitted Diseases: Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
dailymed-instance:overdosag...
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.
dailymed-instance:genericMe...
norgestimate and ethinyl estradiol
dailymed-instance:fullName
Ortho Tri-Cyclen (Kit)
dailymed-instance:adverseRe...
An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives . The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug-related: The following adverse reactions have been reported in users of oral contraceptives and the association has been neither confirmed nor refuted:
dailymed-instance:indicatio...
ORTHO-CYCLEN and ORTHO TRI-CYCLEN Tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. ORTHO TRI-CYCLEN is indicated for the treatment of moderate acne vulgaris in females,���15 years of age, who have no known contraindications to oral contraceptive therapy, desire contraception, have achieved menarche and are unresponsive to topical anti-acne medications. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. In clinical trials with ORTHO-CYCLEN, 1,651 subjects completed 24,272 cycles and a total of 18 pregnancies were reported. This represents an overall use-efficacy (typical user efficacy) pregnancy rate of 0.96 per 100 women-years. This rate includes patients who did not take the drug correctly. In four clinical trials with ORTHO TRI-CYCLEN, the use-efficacy pregnancy rate ranged from 0.68 to 1.47 per 100 women-years. In total, 4,756 subjects completed 45,244 cycles and a total of 42 pregnancies were reported. This represents an overall use-efficacy rate of 1.21 per 100 women-years. One of these 4 studies was a randomized comparative clinical trial in which 4,633 subjects completed 22,312 cycles. Of the 2,312 patients on ORTHO TRI-CYCLEN, 8 pregnancies were reported. This represents an overall use-efficacy pregnancy rate of 0.94 per 100 women-years. In two double-blind, placebo-controlled, six month, multicenter clinical trials, ORTHO TRI-CYCLEN showed a statistically significant decrease in inflammatory lesion count and total lesion count (Table II). The adverse reaction profile of ORTHO TRI-CYCLEN from these two controlled clinical trials is consistent with what has been noted from previous studies involving ORTHO TRI-CYCLEN and are the known risks associated with oral contraceptives.
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dailymed-instance:name
Ortho Tri-Cyclen