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|
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Confirms patient counseling | X | X |
Enters the 2 contraception forms | X | |
chosen by the patient | ||
Enters pregnancy test results | X | |
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Answers educational questions before | X | |
every prescription | ||
Enters 2 forms of contraception | X | |
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Contacts system to get an authorization | X | X |
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|
Fed* | 10,004 (22%) | 862 (22%) | 5.3 (77%) | 21 (39%) |
Fasted | 3,703 (46%) | 301 (63%) | 3.2 (56%) | 21 (30%) |
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|
|
Cmax (ng/mL) | 573.25 (278.79) | 731.98 (361.86) |
AUC(0-12) (ng⋅hr/mL) | 3033.37 (1394.17) | 5082 (2184.23) |
AUC(0-24) (ng⋅hr/mL) | 6003.81 (2885.67) | – |
Tmax (hr)† | 6 (1 to 24.6) | 4 (0 to12) |
Css min (ng/mL) | – | 352.32 (184.44) |
T1/2 (hr) | – | 15.69 (5.12) |
CL/F (L/hr) | – | 17.96 (6.27) |
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|
• tubal sterilization |
|
• male vasectomy | • male latex condom with or without spermicide |
• intrauterine device | • diaphragm with spermicide |
• hormonal (combination oral contraceptives,transdermal patch,injectables, implantables, or vaginal ring) | • cervical cap with spermicide |
Other: • vaginal sponge (contains spermicide) |
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|
40 | 88 | 20 | 40 | 80 |
50 | 110 | 25 | 50 | 100 |
60 | 132 | 30 | 60 | 120 |
70 | 154 | 35 | 70 | 140 |
80 | 176 | 40 | 80 | 160 |
90 | 198 | 45 | 90 | 180 |
100 | 220 | 50 | 100 | 200 |
Access the iPLEDGE REMS system via the internet (www.ipledgeprogram.com), or telephone (1-866495-0654) to obtain an authorization and the REFILLS REQUIRE A NEW PRESCRIPTION AND A NEW AUTHORIZATION FROM THE iPLEDGE SYSTEM. A Zenatane Medication Guide must be given to the patient each time Zenatane is dispensed, as required by law. This Zenatane Medication Guide is an important part of the risk management program for the patient. |
|
|
• tying my tubes (tubal sterilization) |
|
• male vasectomy | • male latex condom with or without spermicide |
• intrauterine device | • diaphragm with spermicide |
• hormonal (combination birth control pills, skin patches, shots, under- the-skin implants, or vaginal ring) | • cervical cap with spermicide |
|
|
• vaginal sponge (contains spermicide) |