without delay [50:<50 mcg of estrogen with 2 sequences of progestin doses ( biphasic ), those containing> <50 mcg of estrogen with 3 sequences of progestin doses ( triphasic ), and those containing 3 sequences of estrogen (e.g., 20, 30, 35 mcg) with a fixed dose of progestin ( estrophasic ). Oral contraceptives usually are described in terms of their estrogen content, although the progestin content of the formulations also varies. a The estrogenic and progestinic dominance of oral contraceptives depends mainly on the amount of estrogen and the amount and specific progestin contained in the formulation. a The estrogenic or progestinic dominance of an oral contraceptive may contribute to hormone-related adverse effects and may be useful in selecting an alternate formulation when unacceptable adverse effects occur with a given formulation. a Biphasic oral contraceptives contain 2 sequentially administered, fixed combinations of hormones per dosage cycle. a The first sequence consists of tablets containing a fixed combination of low-dose estrogen and low-dose progestin, and the second sequence consists of tablets containing a fixed combination of low-dose estrogen and higher-dose progestin. a Biphasic oral contraceptives are not the same as previously available sequential oral contraceptives, which consisted of an estrogen alone for the first sequence. a Triphasic oral contraceptives contain graduated sequences of progestin or estrogen per dosage cycle. 294 299 With most commercially available triphasic oral contraceptives, each dosage cycle consists of 3 sequentially administered fixed combinations of the hormones in which the ratio of progestin to estrogen progressively increases with each sequence. a The first sequence consists of tablets containing a fixed combination of low-dose estrogen and low-dose progestin, the second sequence consists of tablets containing a fixed combination of low-dose or low but slightly higher-dose estrogen and higher-dose progestin, and the third sequence consists of tablets containing low-dose estrogen and either an even higher-dose progestin or low-dose progestin. a Estrophasic oral contraceptives are triphasic preparations in which the estrogen component progressively increases with each sequence. 294 299 Fixed-combination, conventional-cycle oral contraceptives are available as 21- or 28-day dosage preparations. a Some 28-day preparations contain 21 hormonally active tablets and 7 inert or ferrous fumarate-containing tablets. a Other 28-day preparations contain 24 hormonally active tablets and 4 inert or ferrous fumarate-containing tablets. 332 366 One monophasic, fixed-combination, extended-cycle oral contraceptive (e.g., Seasonale ) is available as a 91-day dosage preparation containing 84 hormonally active tablets and 7 inert tablets. 322 Other extended-cycle oral contraceptive preparations (e.g., LoSeasonique , Seasonique ) are available as 91-day preparations with 84 hormonally active tablets containing estrogen/progestin and 7 tablets containing low-dose estrogen. 331 354 One fixed-combination, continuous-regimen (noncyclic) oral contraceptive (i.e., Lybrel ) is available as a 28-day dosage preparation containing 28 hormonally active tablets. 339 The transdermal system (Ortho Evra ) is applied topically in a cyclic regimen using a 28-day cycle. 308 The vaginal contraceptive ring (NuvaRing ) is intended to be used for 1 cycle, which consists of a 3-week period of continuous use of the ring followed by a 1-week ring-free period. 309 Adults Contraception Oral (21- or 28-day conventional-cycle preparations) Start on the first Sunday after or on which menstrual bleeding begins or on the first day of the menstrual cycle. a If the first dose is on the first Sunday on or after menstrual bleeding starts, use a back-up method of contraception (e.g., condoms, foam, sponge) for 7 days following initiation of oral contraceptive therapy. 236 298 295 296 298 299 301 332 337 366 If the first dose is on the first day of the menstrual cycle, a back-up method of contraception is not necessary. 236 298 295 296 298 299 301 With 21-day conventional-cycle preparations , take 1 estrogen/progestin tablet once daily for 21 consecutive days, followed by 7 days without tablets. a Begin repeat dosage cycles on the eighth day after the last hormonally active tablet (i.e., on the same day of the week as the initial cycle). a With 28-day conventional-cycle preparations containing 21 hormonally active tablets , take 1 estrogen/progestin tablet once daily for 21 consecutive days, followed by inert tablets or ferrous fumarate tablets for 7 days. a Begin repeat dosage cycles on the eighth day after the last hormonally active tablet (i.e., on the same day of the week as the initial cycle). a With 28-day conventional-cycle preparations containing 24 hormonally active tablets, take 1 estrogen/progestin tablet once daily for 24 consecutive days, followed by inert tablets or ferrous fumarate tablets for 4 days. 332 366 Begin repeat dosage cycles on the fifth day after the last hormonally active tablet (i.e., on the same day of the week as the initial cycle). 332 366 When 1 estrogen/progestin tablet of a conventional-cycle oral contraceptive is missed, take the missed tablet as soon as it is remembered, followed by resumption of the regular schedule. a Additional contraceptive methods are not necessary if only 1 tablet is missed. 295 296 298 299 301 321 332 337 366 When 2 estrogen/progestin tablets are missed during the first 1 or 2 weeks of the cycle, take the 2 missed tablets as soon as they are remembered, take 2 tablets the next day, then resume the regular schedule. 295 296 298 299 301 321 332 337 366 If 2 consecutive estrogen/progestin tablets are missed during the third or fourth week of a dosage cycle that was initiated on the first day of the menstrual cycle, discard the remainder of the tablets in the pack for that cycle and start a new dosage cycle the same day. 295 296 298 299 301 321 332 337 366 If 2 consecutive estrogen/progestin tablets are missed during the third or fourth week of a dosage cycle that was initiated on the first Sunday on or after menstruation started, continue to take 1 tablet daily until Sunday, then discard the remainder of the tablets for that cycle and start a new dosage cycle that same day. 295 296 298 299 301 321 332 337 366 When 2 or more estrogen/progestin tablets are missed on consecutive days, a back-up method of contraception should be used for each sexual encounter until a hormonally active tablet has been taken for 7 consecutive days. 321 332 337 366 If 3 or more consecutive estrogen/progestin tablets are missed during a dosage cycle that was initiated on the first day of the menstrual cycle, discard the remainder of the tablets in that cycle and start a new dosage cycle the same day. 295 296 298 299 301 321 332 337 366 If 3 or more consecutive estrogen/progestin tablets are missed during a dosage cycle that was initiated on the first Sunday on or after menstruation started, take 1 tablet daily until Sunday, then discard the remainder of the tablets for that cycle and start a new dosage cycle that same day. 295 296 298 299 301 321 332 337 366 A back-up method of contraception should be used for each sexual encounter until a hormonally active tablet has been taken for 7 consecutive days. 321 332 337 366 During week 4 of a 28-day dosage cycle, any inactive or ferrous fumarate tablets that are missed should be discarded; continue to take the remaining tablets until the cycle is finished. 295 296 298 299 301 332 337 366 A back-up contraceptive method is not required during the fourth week as a result of missed inactive or ferrous fumarate tablets. 295 296 298 299 301 332 337 366 With 28-day contraceptive cycles, a new cycle of tablets should be started the day after taking the last tablet of the previous 28-day dosage cycle (i.e., no days without tablets). 295 296 298 299 301 332 337 366 If unsure of what drug regimen to take as a result of missed tablets, use a back-up method of contraception for each sexual encounter and take 1 estrogen/progestin tablet daily until the next clinician contact. 295 296 298 299 301 321 332 337 366 Oral (91-day extended-cycle preparations) Start on the first Sunday after or on which bleeding begins. 322 331 354 Use a back-up method of contraception (e.g., condom, spermicide) for 7 days following initiation of therapy. 322 331 354 Take 1 estrogen/progestin tablet daily for 84 days, followed by inert tablets or tablets containing 10 mcg of estrogen for 7 days. 322 331 354 Repeat dosage cycles begin on the same day of the week (Sunday) as the initial cycle. 322 331 354 If a repeat cycle is started later than the scheduled day, use a back-up method of contraception until an estrogen/progestin tablet has been taken for 7 consecutive days. 322 331 354 When 1 estrogen/progestin tablet is missed, take the missed tablet as soon as it is remembered, followed by resumption of the regular schedule. 322 331 354 Additional contraceptive measures are not necessary if only one tablet is missed. 322 331 354 When 2 estrogen/progestin tablets are missed, take the 2 missed tablets as soon as they are remembered, 2 tablets the next day, then resume the regular cycle. 322 331 354 Use a back-up method of contraception until an estrogen/progestin tablet has been taken for 7 consecutive days. 322 331 354 When 3 or more consecutive estrogen/progestin tablets are missed, continue to take 1 tablet daily; the missed tablets should be discarded. 322 331 354 Use a back-up method of contraception until an estrogen/progestin tablet has been taken for 7 consecutive days. 322 331 354 If unsure of what drug regimen to take as a result of missed tablets, use a back-up method of contraception for each sexual encounter, and take 1 tablet daily until the next clinician contact. 322 331 354 Discard inert tablets or estrogen-containing tablets that are missed; continue to take the remaining tablets until the cycle is finished. 322 331 354 If inert tablets or estrogen-containing tablets are missed, a back-up contraceptive method is not required. 322 331 354 Oral (continuous-regimen [noncyclic] preparation) Women who did not use hormonal contraception in the preceding month: Start on the first day of the menstrual cycle. 339 If the first dose is on the first day of the menstrual cycle, a back-up method of contraception is not necessary. 339 Women switching from cyclic estrogen-progestin oral contraceptives: Start on the first day of withdrawal bleeding, within 7 days of the last hormonally active tablet. 339 A back-up method of contraception is not needed. 339 Women switching from progestin-only oral contraceptives: Start on the day after the last progestin tablet. 339 Use a back-up method of contraception (e.g., condom, spermicide) until an estrogen/progestin tablet has been taken for 7 consecutive days. 339 Women switching from a progestin-only implant: Start on the day that the implant is removed. 339 Use a back-up method of contraception until an estrogen/progestin tablet has been taken for 7 consecutive days. 339 Women switching from a progestin-only contraceptive injection: Start on the day that the next contraceptive injection would have been due. 339 Use a back-up method of contraception until an estrogen/progestin tablet has been taken for 7 consecutive days. 339 Take 1 estrogen/progestin tablet each day and continue daily without interruption. 339 When 1 tablet is missed, take the missed tablet as soon as it is remembered, then resume the regular schedule (2 tablets may be taken on the same day). 339 Use a back-up method of contraception until an estrogen/progestin tablet has been taken for 7 consecutive days. 339 When 2 tablets are missed and the missed doses are remembered on the day of the second missed dose, take the 2 missed tablets as soon as remembered, then resume the regular schedule. 339 When the 2 tablets are missed and the missed doses are remembered on the day after the second missed dose, take the 2 missed tablets as soon as remembered, take 2 tablets the next day, then resume the regular schedule. 339 Use a back-up method of contraception until an estrogen/progestin tablet has been taken for 7 consecutive days. 339 When 3 or more tablets are missed, contact clinician and continue to take 1 tablet daily until clinician contact. 339 Use a back-up method of contraception until an estrogen/progestin tablet has been taken for 7 consecutive days. 339 If unsure of what drug regimen to take as a result of missed tablets, use a back-up method of contraception for each sexual encounter. 339 Nonlactating postpartum women may start the fixed-combination, continuous-regimen oral contraceptive no earlier than 28 days after delivery; a back-up method of contraception is needed until an estrogen/progestin tablet has been taken for 7 consecutive days. 339 Women may start the continuous regimen immediately after a complete first-trimester abortion; a back-up method of contraception is not needed. 339 Women may start the continuous regimen no earlier than 28 days after a second-trimester abortion; a back-up method of contraception is needed until an estrogen/progestin tablet has been taken for 7 consecutive days. 339 Vaginal To initiate therapy in women who did not use hormonal contraception in the preceding month, insert the vaginal contraceptive ring (NuvaRing ) on or before day 5 of the cycle. 309 During the first cycle, use a back-up method of contraception (e.g., condom, spermicide) until the vaginal ring has been used continuously for 7 days. 309 After 3 weeks, remove the vaginal ring on the same day of the week as it was inserted and at about the same time of day. 309 For contraceptive effectiveness, insert a new vaginal ring 1 week after the previous vaginal ring is removed even if menstrual bleeding is not finished. 309 Women switching from estrogen-progestin oral contraceptives: Insert the vaginal ring within 7 days of the last hormonally active tablet and no later than the day that a new oral contraceptive cycle would have been started; a back-up method of contraception is not needed. 309 Women switching from progestin-only oral contraceptives: Insert the vaginal ring on any day of the month (without skipping any day between receiving the last progestin oral contraceptive and the initial administration of the vaginal ring). 309 Use a back-up method of contraception until the vaginal ring has been used continuously for 7 days. 309 Women switching from a progestin-only contraceptive injection: Insert the vaginal ring on the same day as the next contraceptive injection would have been due. 309 Use a back-up method of contraception until the vaginal ring has been used continuously for 7 days. 309 Women who are switching from a progestin-only implant or a progestin-containing intrauterine device: Insert the vaginal ring on the same day as the implant or intrauterine device is removed. 309 Use a back-up method of contraception until the vaginal ring has been used continuously for 7 days. 309 If a woman forgets to insert a new vaginal ring at the start of any cycle, insert the ring as soon as remembered; use a back-up method of contraception until the ring has been used continuously for 7 days. 309 If the vaginal ring is left in place for up to 1 extra week (up to 4 weeks total), remove the ring and insert a new ring after a 1-week drug-free interval. 309 If the ring is left in place for longer than 4 weeks, rule out pregnancy and use a back-up method of contraception until a new ring has been used continuously for 7 days. 309 Women may start using the vaginal contraceptive ring in the first 5 days following a complete first-trimester abortion; a back-up method of contraception is not needed in these women. 309 If the contraceptive ring is not used within the first 5 days, follow the general instructions for women who did not use hormonal contraception in the preceding month. 309 If a nonlactating woman chooses to initiate contraception postpartum with the contraceptive vaginal ring before menstruation has started, consider the possibility that ovulation and conception may have occurred prior to initiation of contraceptive therapy; use a back-up method of contraception for the first 7 days. 309 Topical To initiate therapy, start on the first day of the menstrual cycle or on the first Sunday after menstrual bleeding has started. 308 Use a back-up method of contraception (condom, spermicide, diaphragm) for the first 7 days if therapy is started after day 1 of the menstrual cycle. 308 A back-up method of contraception is not needed if the first system is applied on the first day of the menstrual cycle. 308 One transdermal system (containing ethinyl estradiol 0.75 mg and norelgestromin 6 mg) is applied once weekly (same day each week) for 3 weeks, followed by a 1-week drug-free interval (drug-free interval should not exceed 7 days); the regimen is then repeated. 309 Women switching from estrogen-progestin oral contraceptives: Apply the transdermal system on the first day of withdrawal bleeding. 308 If there is no withdrawal bleeding within 5 days of the last hormonally active tablet, rule out pregnancy. 309 If therapy with the transdermal system is initiated after the first day of bleeding, use a back-up method of contraception for 7 days. 308 If more than 7 days elapse after receiving the last hormonally active tablet, consider the possibility of ovulation and conception. 309 When a woman has not adhered to the prescribed transdermal contraceptive regimen by not applying the estrogen and progestin-containing system at the initiation of any cycle (i.e., day 1/first week), apply the system as soon as it is remembered and start a new dosage cycle the same day; use a back-up method of contraception for the first 7 days of the new cycle. 308 If, in the middle of the cycle (i.e., on day 8/week 2 or day 15/week 3), the transdermal system has not been changed for 1 2 days (> <48 hours), apply a new system as soon as it is remembered and continue the application schedule employed; back-up contraception is not needed. 308 If, in the middle of the cycle the transdermal system has not been changed for more than 2 days (≥48 hours), start a new dosage cycle; use a back-up method of contraception for the first 7 days of the new cycle. 308 When the transdermal system is not removed at the end of the application schedule (i.e., on day 22/week 4), remove the system as soon as it is remembered and continue the application schedule employed (i.e., apply system on day 28); back-up contraception is not needed. 308 Women may start using the transdermal contraceptive system immediately after a first-trimester abortion; a back-up method of contraception is not needed. 308 If the contraceptive preparation is not used within 5 days of a first-trimester abortion, follow instructions as if initiating transdermal contraception for the first time. 308 Postcoital Contraception Oral Yuzpe regimen † : Take 100 mcg of ethinyl estradiol and 1 mg of norgestrel within 72 hours after unprotected intercourse, repeating the dose 12 hours later. 254 255 257 258 259 261 262 264 265 275 282 284 345 Other regimens † : Take 100 120 mcg of ethinyl estradiol and 1.2 mg of norgestrel or 0.5 0.6 mg of levonorgestrel within 72 hours after intercourse, repeating the dose 12 hours later. 264 265 275 282 284 345 If necessary, the first dose can be administered up to 120 hours after unprotected intercourse, but efficacy decreases the longer initiation of contraception is delayed. 345 346 347 Repeated postcoital (emergency) contraception use indicates need for counseling about other contraceptive options. 345 350 Safety of recurrent use not established but risk appears low, even within same menstrual cycle. 345 350 Consider possibility that risk of adverse effects may be increased with frequently repeated postcoital contraception. 350 * Dose is administered initially and then repeated 12 hours later Dosage of Estrogen-progestin Combinations for Postcoital Contraception Estrogen-progestin Combination Formulation [Brand Name] Number and Color of Tablets per Dose* Ethinyl estradiol (50 mcg) with norgestrel (0.5 mg) [Ovral ] 2 white tablets (any of 21 tablets) Ethinyl estradiol (50 mcg) with norgestrel (0.5 mg) [Ovral -28] 2 white tablets (any of first 21 tablets) Ethinyl estradiol (30 mcg) with norgestrel (0.3 mg) [Lo-Ovral ] 4 white tablets (any of 21 tablets) Ethinyl estradiol (30 mcg) with norgestrel (0.3 mg) [Lo-Ovral -28] 4 white tablets (any of first 21 tablets) Ethinyl estradiol (30 mcg) with levonorgestrel (0.15 mg) [Nordette ] 4 light-orange tablets (any of 21 tablets) Ethinyl estradiol (30 mcg) with levonorgestrel (0.15 mg) [Nordette -28] 4 light-orange tablets (any of first 21 tablets) Ethinyl estradiol (30 mcg) with levonorgestrel (0.15 mg) [Levlen 21] 4 light-orange tablets (any of 21 tablets) Ethinyl estradiol (30 mcg) with levonorgestrel (0.15 mg) [Levlen 28] 4 light-orange tablets (any of first 21 tablets) Ethinyl estradiol (30 mcg) with levonorgestrel (0.125 mg) [Tri-Levlen 21] 4 yellow tablets (any of last 10 tablets) Ethinyl estradiol (30 mcg) with levonorgestrel (0.125 mg) [Tri-Levlen 28] 4 yellow tablets (any of tablets 12 21) Ethinyl estradiol (30 mcg) with levonorgestrel (0.125 mg) [Tri-Phasil 21] 4 yellow tablets (any of last 10 tablets) Ethinyl estradiol (30 mcg) with levonorgestrel (0.125 mg) [Tri-Levlen 28] 4 yellow tablets (any of tablets 12 21) Ethinyl estradiol (20 mcg) with levonorgestrel (0.1 mg) [Lessina 28] 5 pink tablets (any of first 21 tablets) Contraception and Folate Supplementation Oral Beyaz or Safyral is used in the same dosage and administration (i.e., timing of initiation of therapy) as used in contraception. 367 368 Acne Vulgaris Oral Ortho Tri-Cyclen , Estrostep , Yaz , or Beyaz is used in the same dosage and administration (i.e., timing of initiation of therapy) as used in contraception. a Premenstrual Dysphoric Disorder Oral Yaz or Beyaz is used in the same dosage and administration (i.e., timing of initiation of therapy) as used in contraception. 366 367 (See Oral [21- or 28-day conventional-cycle preparations] under Dosage and Administration.) Cautions for Estrogen-Progestin Combinations Contraindications Hypersensitivity to the drug or any ingredient in the formulation. a Known or suspected pregnancy. a Undiagnosed abnormal genital bleeding. a Diplopia or any ocular lesion arising from ophthalmic vascular disease. a Classical migraine. a Active liver disease or history of cholestatic jaundice with pregnancy or with prior use of oral contraceptives. a Breast-feeding. a Thrombophlebitis or thromboembolic disorders. a Cerebrovascular disease or CAD (including MI). a Severe hypertension. a Diabetes with vascular involvement. a Known or suspected carcinoma of the breast. a Known or suspected estrogen-dependent neoplasia (e.g., carcinoma of the endometrium). a Benign or malignant liver tumor that developed during oral contraceptive or other estrogen use. a Oral contraceptives containing drospirenone: Contraindicated in women with renal impairment, hepatic tumors (benign or malignant) or hepatic disease, adrenal insufficiency, high risk of arterial or venous thrombotic diseases, undiagnosed abnormal uterine bleeding, history of breast cancer or other estrogen- or progestin-sensitive cancer, and in pregnancy. 365 366 367 368 Most experts state that there currently is no real contraindication to postcoital (emergency) contraception with the recommended regimens and that the benefits generally outweigh any theoretical or proven risk. 345 346 350 Warnings/Precautions Warnings Increased risk of several serious conditions, including thromboembolism, stroke, MI, liver tumor, gallbladder disease, visual disturbances, fetal abnormalities, and hypertension. a However, risk of serious morbidity or mortality is very small in healthy women without underlying risk factors. a Ethinyl Estradiol/Norelgestromin Transdermal System Overall exposure to ethinyl estradiol and norelgestromin is higher in women receiving Ortho Evra than in women receiving an oral contraceptive preparation containing ethinyl estradiol 35 mcg and norgestimate 0.25 mg. 308 (See Absorption under Pharmacokinetics.) Increased exposure to estrogen may increase the risk of certain adverse effects (e.g., venous thromboembolism). 308 Case controlled, epidemiologic studies evaluating the risk of venous thromboembolism with Ortho Evra relative to use of oral contraceptives containing norgestimate or levonorgestrel and ethinyl estradiol 30 35 mcg reported odds ratios from 0.9 (indicating no increased risk) to 2.4 (indicating increased risk). 308 334 351 352 353 Continuous Regimen of Ethinyl Estradiol/Levonorgestrel Exposure to ethinyl estradiol and levonorgestrel is higher in women receiving Lybrel than in women receiving a conventional-cycle oral contraceptive containing the same ethinyl estradiol dose and a similar dose of the progestin component; use of Lybrel results in 13 additional weeks of hormone intake per year. 339 Cardiovascular and Cerebrovascular Disorders Positive association observed between the amount of estrogen and progestin in oral contraceptives and the risk of vascular disease. a Use smallest dosage of estrogen and progestin compatible with a low failure rate and the individual needs of the woman. a Use with caution in women with cardiovascular disease risk factors. 299 301 365 366 367 368 Increased risk of MI, mainly in women who smoke or who have risk factors for CAD (hypertension, hypercholesterolemia, obesity, diabetes, preeclamptic toxemia). a Women who smoke cigarettes during oral contraceptive use have an increased risk of serious adverse cardiovascular effects; risk increases with age and heavy smoking (≥15 cigarettes daily). a (See Boxed Warning.) Women who use oral contraceptives should be strongly advised not to smoke. a Increases in BP may occur. a Perform regular BP measurements prior to and during therapy. a Fluid retention may occur. a Exercise caution and carefully monitor patients with conditions that might be aggravated by fluid retention. a Increased risk of thromboembolic and thrombotic disorders, including arterial thrombosis (e.g., stroke, MI). a 365 366 367 368 Risk of thrombotic events is even higher in women with other risk factors for such events. 365 366 367 368 Known risk factors for venous thromboembolism (VTE) include smoking, obesity, family history, and other factors (see Contraindications under Cautions). 356 365 366 367 368 Increased risk of cerebrovascular disorders, including thrombotic and hemorrhagic stroke; risk generally is greatest in older (>35 years of age) hypertensive women who smoke. a 365 366 367 368 Risk of stroke also increased in women with other underlying risk factors. 365 366 367 368 Risk of VTE is highest during first year of oral contraceptive therapy. 365 366 367 368 373 Some data suggest risk is highest during first 6 months of use. 365 366 367 368 Highest VTE risk reported after initiation or resumption of therapy (after ≥4-week drug-free interval) with the same or a different oral contraceptive combination. 365 366 367 368 Risk of thromboembolic disease gradually disappears after oral contraceptive therapy discontinued. 365 366 367 368 Clinicians and women should be alert to earliest possible manifestations of thromboembolic and thrombotic disorders (e.g., thrombophlebitis, pulmonary embolism, cerebrovascular insufficiency, coronary occlusion, retinal thrombosis, mesenteric thrombosis); discontinue contraceptive immediately when any of these disorders occurs or is suspected. a FDA safety review indicates that oral contraceptives containing drospirenone may be associated with increased risk of VTE compared with oral contraceptives containing levonorgestrel or other progestins; 364 365 366 367 368 373 in epidemiologic studies, increase in risk with drospirenone-containing combinations ranged from no increase to threefold increase. 357 358 359 360 361 362 365 366 367 368 369 371 372 373 Because of data limitations, causality is unclear. 373 FDA will provide updates when available. 373 Before initiating use of drospirenone-containing oral contraceptives in new users or in women switching from other oral contraceptives, consider risks and benefits of drospirenone-containing combinations, including VTE risk, specific to that woman. 356 364 365 366 367 368 373 Discontinue use if arterial or venous thrombotic event occurs. 365 366 367 368 (See Advice to Patients.) Discontinue estrogen-progestin contraceptive therapy, when feasible, at least 4 weeks before surgery associated with an increased risk of thromboembolism or prolonged immobilization. a 365 366 367 368 Wait 2 weeks after elective surgery associated with an increased risk of thromboembolism or after immobilization before resuming use. a 365 366 367 368 Do not start estrogen-progestin contraceptive therapy earlier than 4 weeks after delivery in women who elect not to breast-feed or in women who have had a midtrimester pregnancy termination. a 365 366 367 368 Risk of thromboembolism decreases while risk of ovulation increases after first 3 weeks postpartum. 365 366 367 368 Carcinoma of Breast and Reproductive Organs Many studies have shown no increased risk of breast cancer in women receiving oral contraceptives or estrogens. 318 Some studies, however, have suggested an overall increased risk of breast cancer in women receiving oral contraceptives; certain subgroups of women may be at increased risk (e.g., women> <45 years of age, use early in childbearing years, use for extended periods of time, use before a first full-term pregnancy). 223 224 225 228 229 230 These findings have occurred in only some studies and other large studies have shown no such possible associations. 318 319 230 Some evidence suggests that use of oral contraceptives may be associated with an increased risk of cervical carcinoma. a All users of estrogen-progestin contraceptives should be monitored carefully with physical examinations and Papanicolaou tests, at least annually. a Hepatic Effects Benign hepatic adenomas associated with oral contraceptive use; risk appears to increase after ≥4 years of use. a Rupture of benign hepatic adenomas may cause death through intraabdominal hemorrhage. a Increased risk of hepatocellular carcinoma in women using oral contraceptives for >8 years; these cancers are rare. a May alter liver function test results. a If such test results are abnormal, repeat 2 months after contraceptive has been discontinued. a Discontinue if jaundice occurs. a Ocular Effects Retinal thrombosis reported. a Discontinue contraceptive and initiate evaluation for retinal vein thrombosis immediately along with other appropriate diagnostic and therapeutic measures upon occurrence of unexplained, sudden or gradual, partial or complete loss of vision; proptosis or diplopia; papilledema; or retinal vascular lesions. a 365 366 367 368 Obtain ophthalmologist assessment for contact lens wearers who develop visual disturbances or changes in lens tolerance and consider temporary or permanent cessation of contact lens wear. a Gallbladder Disease Oral contraceptive use and estrogens associated with an increased lifetime relative risk of gallbladder disease/surgery, especially in young women. a 321 Recent studies indicate that risk may be minimal in patients using low-dose formulations. a Endocrine and Metabolic Effects Decreased glucose tolerance reported. a Monitor prediabetic and diabetic patients. a Increased concentrations of plasma triglyceride, low-density lipoproteins, and total phospholipids may occur. a Closely monitor women with hyperlipidemia receiving estrogen-progestin oral contraceptives. a Potential exists for hyperkalemia to occur in high-risk patients (e.g., those with renal or hepatic impairment, adrenal insufficiency) receiving oral contraceptives containing drospirenone because of its antimineralocorticoid activity. 365 366 367 368 Headache Discontinue contraceptive and evaluate cause if migraine occurs or is exacerbated, or when a new headache pattern develops that is recurrent, persistent, or severe. a Bleeding Irregularities Breakthrough bleeding and/or spotting (especially within the first 3 months of use), changes in menstrual flow, missed menses (during use), or amenorrhea (after use) may occur. a Evaluate for non-hormonal causes, malignancy, or pregnancy; if pathology is excluded, change to another formulation may solve the problem, or it may resolve with time. a Rule out pregnancy in patients with am agency
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