Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1709
| Subject | Predicate | Object | Context |
|---|---|---|---|
| dailymed-drugs:1709 | rdf:type | http://www4.wiwiss.fu-berli... | lld:dailymed |
| dailymed-drugs:1709 | rdf:type | dailymed-instance:drugs | lld:dailymed |
| dailymed-drugs:1709 | rdfs:label | Ortho Tri-Cyclen Lo (Kit) | lld:dailymed |
| dailymed-drugs:1709 | dailymed-instance:dosage | Oral Contraception: To achieve maximum contraceptive effectiveness, ORTHO TRI-CYCLEN Lo Tablets must be taken exactly as directed and at intervals not exceeding 24 hours. The possibility of ovulation and conception prior to initiation of medication should be considered. ORTHO TRI-CYCLEN Lo is available in the DIALPAK Tablet Dispenser which is preset for a Sunday Start. Day 1 Start is also provided.<br/>Sunday Start: When taking ORTHO TRI-CYCLEN Lo the first white "active" tablet should be taken on the first Sunday after menstruation begins. If the menstrual period begins on Sunday, the first white "active" tablet should be taken that day. Take one white, light blue or dark blue "active" tablet daily for 21 days followed by one dark green "reminder" 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) white, light blue, or dark blue "active" tablet in Weeks 1, 2, or 3, the tablet should be taken as soon as she remembers. If the patient misses two (2) white or light blue "active" tablets in Week 1 or Week 2, the patient should take two (2) "active" tablets the day she remembers and two (2) "active" 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) dark blue "active" tablets in the third week or misses three (3) or more "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/>Day 1 Start: The dosage of ORTHO TRI-CYCLEN Lo for the initial cycle of therapy is one white, light blue or dark blue "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 dark green "reminder" 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) white, light blue, or dark blue "active" tablet in Weeks 1, 2, or 3, the tablet should be taken as soon as she remembers. If the patient misses two (2) white or light blue "active" tablets in Week 1 or Week 2, the patient should take two (2) "active" tablets the day she remembers and two (2) "active" tablets the next day; and then continue taking one (1) tablet a day until she finishes the pack. The patient should be instructedto 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) dark blue "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). When switching from another oral contraceptive, ORTHO TRI-CYCLEN Lo should be started on the same day that a new pack of the previous oral contraceptive would have been started. The use of ORTHO TRI-CYCLEN Lo for contraception may be initiated 4 weeks postpartum in women who elect not to breastfeed. When the tablets are administered during the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered. (See CONTRAINDICATIONS and WARNINGS concerning thromboembolic disease. See also PRECAUTIONS for "Nursing Mothers.") 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.)<br/>ADDITIONAL INSTRUCTIONS FOR ALL DOSING REGIMENS: 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, nonfunctional 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 pathology has been excluded, time or a change to another formulation 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: | lld:dailymed |
| dailymed-drugs:1709 | dailymed-instance:descripti... | ORTHO TRI-CYCLEN Lo Tablets is a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol. ORTHO TRI-CYCLEN Lo Tablets Each white tablet contains 0.180 mg of the progestational compound, norgestimate (+)-3-Ethyl-17-hydroxy-18, 19-dinor-17��-pregn-4-en-20-yn-3-one oxime acetate (ester) and 0.025 mg of the estrogenic compound, ethinyl estradiol (19-nor-17��-pregna,1,3,5(10)-trien-20-yne-3,17-diol). Inactive ingredients include lactose, magnesium stearate, croscarmellose sodium, microcrystalline cellulose, carnauba wax, hypromellose, polyethylene glycol, titanium dioxide, and purified water. Each light blue tablet contains 0.215 mg of the progestational compound norgestimate (+)-13-Ethyl-17-hydroxy-18, 19-dinor-17��-pregn-4-en-20-yn-3-one oxime acetate (ester) and 0.025 mg of the estrogenic compound, ethinyl estradiol (19-nor-17��-pregna,1,3,5(10)-trien-20-yne-3,17-diol). Inactive ingredients include FD&C Blue No. 2 Aluminum Lake, lactose, magnesium stearate, croscarmellose sodium, microcrystalline cellulose, carnauba wax, hypromellose, polyethylene glycol, titanium dioxide, and purified water. Each dark blue tablet contains 0.250 mg of the progestational compound norgestimate (+)-13-Ethyl-17-hydroxy-18, 19-dinor-17��-pregn-4-en-20-yn-3-one oxime acetate (ester) and 0.025 mg of the estrogenic compound, ethinyl estradiol (19-nor-17��-pregna,1,3,5(10)-trien-20-yne-3,17-diol). Inactive ingredients include FD&C Blue No. 2 Aluminum Lake, lactose, magnesium stearate, croscarmellose sodium, microcrystalline cellulose, polysorbate 80, carnauba wax, hypromellose, polyethylene glycol, titanium dioxide, and purified water. Each dark green tablet contains only inert ingredients, as follows: FD&C Blue No. 2 Aluminum Lake, lactose, magnesium stearate, pregelatinized starch, ferric oxide, hypromellose, polyethylene glycol, titanium dioxide, talc and purified water. Norgestimate EthinylEstradiol | lld:dailymed |
| dailymed-drugs:1709 | dailymed-instance:activeIng... | dailymed-ingredient:norgest... | lld:dailymed |
| dailymed-drugs:1709 | dailymed-instance:supply | ORTHO TRI-CYCLEN Lo Tablets are available in a DIALPAK Tablet Dispenser (NDC 0062-1251-15) containing 28 tablets. Each of the 7 white, round, convex, coated tablets imprinted "O-M" on one side and "180" on the other side contains 0.180 mg of the progestational compound, norgestimate, together with 0.025 mg of the estrogenic compound, ethinyl estradiol. Each of the 7 light blue, round, convex, coated tablets imprinted "O-M" on one side and "215" on the other side contains 0.215 mg of the progestational compound, norgestimate, together with 0.025 mg of the estrogenic compound, ethinyl estradiol. Each of the 7 dark blue, round, convex, coated tablets imprinted "O-M" on oneside and "250" on the other side contains 0.250 mg of the progestational compound, norgestimate, together with 0.025 mg of the estrogenic compound, ethinyl estradiol. Each of the 7 dark green, round, convex, coated tablets imprinted "O-M" on one side and "P" on the other side contains inert ingredients. ORTHO TRI-CYCLEN Lo Tablets are available for clinic usage in a VERIDATE Tablet Dispenser (unfilled) and VERIDATE Refills (NDC 0062-1251-20). Store at 25��C (77��F); excursions permitted to 15�����30��C (59�����86��F). Protect from light. Rx only | lld:dailymed |
| dailymed-drugs:1709 | dailymed-instance:boxedWarn... | Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases. | lld:dailymed |
| dailymed-drugs:1709 | dailymed-instance:activeMoi... | dailymed-ingredient:norgest... | lld:dailymed |
| dailymed-drugs:1709 | dailymed-instance:inactiveI... | dailymed-ingredient:water | lld:dailymed |
| dailymed-drugs:1709 | dailymed-instance:inactiveI... | dailymed-ingredient:lactose | lld:dailymed |
| dailymed-drugs:1709 | dailymed-instance:inactiveI... | dailymed-ingredient:magnesi... | lld:dailymed |
| dailymed-drugs:1709 | dailymed-instance:inactiveI... | dailymed-ingredient:microcr... | lld:dailymed |
| dailymed-drugs:1709 | dailymed-instance:inactiveI... | dailymed-ingredient:hyprome... | lld:dailymed |
| dailymed-drugs:1709 | dailymed-instance:inactiveI... | dailymed-ingredient:titaniu... | lld:dailymed |
| dailymed-drugs:1709 | dailymed-instance:inactiveI... | dailymed-ingredient:polyeth... | lld:dailymed |
| dailymed-drugs:1709 | dailymed-instance:inactiveI... | dailymed-ingredient:croscar... | lld:dailymed |
| dailymed-drugs:1709 | dailymed-instance:inactiveI... | dailymed-ingredient:carnaub... | lld:dailymed |
| dailymed-drugs:1709 | 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. | lld:dailymed |
| dailymed-drugs:1709 | dailymed-instance:genericMe... | norgestimate and ethinyl estradiol | lld:dailymed |
| dailymed-drugs:1709 | dailymed-instance:fullName | Ortho Tri-Cyclen Lo (Kit) | lld:dailymed |
| dailymed-drugs:1709 | dailymed-instance:adverseRe... | An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives . There is evidence of an association between the following conditions and 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: | lld:dailymed |
| dailymed-drugs:1709 | dailymed-instance:indicatio... | ORTHO TRI-CYCLEN Lo Tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. In an active controlled clinical trial 1,673 subjects completed 11,003 cycles of ORTHO TRI-CYCLEN Lo use and a total of 20 pregnancies were reported in ORTHO TRI-CYCLEN Lo users.This represents an overall use-efficacy (typical user efficacy) pregnancy rate of 2.36 per 100 women-years of use. Oral contraceptives are highly effective for pregnancy prevention. Table 2 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, the IUD, and the Norplant' system, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. ORTHO TRI-CYCLEN Lo has not been studied for and is not indicated for use in emergency contraception. | lld:dailymed |
| dailymed-drugs:1709 | dailymed-instance:represent... | http://www4.wiwiss.fu-berli... | lld:dailymed |
| dailymed-drugs:1709 | dailymed-instance:routeOfAd... | http://www4.wiwiss.fu-berli... | lld:dailymed |
| dailymed-drugs:1709 | dailymed-instance:name | Ortho Tri-Cyclen Lo | lld:dailymed |
| http://www4.wiwiss.fu-berli... | dailymed-instance:producesD... | dailymed-drugs:1709 | lld:dailymed |