Names and pronunciation
Xulane
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Drug reference
Xulane
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ACTION: Prevents ovulation by sup- pressing FSH and LH; monophasic: estrogen/progestin (fixed dose) used during a 21-day cycle; ovulation is inhib- ited by suppression of FSH and LH; thickness of cervical mucus and endome- trial lining prevents pregnancy; biphasic: ovulation is inhibited by suppression of FSH and LH; alteration of cervical mucus, endometrial lining prevents pregnancy; triphasic: ovulation is inhibited by sup- pression of FSH and LH; change of cervi- cal mucus, endometrial lining prevents pregnancy; variable doses of estrogen/ progestin combinations may be similar to natural hormonal fluctuations; extended cycle: estrogen/progestin continuous for 84 days, off for 7 days, results in 4 men- strual periods/yr; progressive estrogen: constant progestin with 3 progressive doses of estrogen; progestin-only pill, implant, intrauterine: change of cervi- cal mucus and endometrial lining pre- vents pregnancy; ovulation may be suppressed
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USES: To prevent pregnancy, regula- tion of menstrual cycle, treatment of acne in women >14 yr for whom other treat- ment has failed, emergency contracep- tion; injection: inhibits gonadotropin secretion, ovulation, follicular matura- tion; emergency: inhibits ovulation and fertilization, decreases transport of sperm and egg from fallopian tube to uterus; vaginal ring, transdermal: inhibits ovulation, prevents sperm entry into uterus; antiacne: may decrease sex hormone binding globulin, results in decreased testosterone
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CONTRAINDICATIONS: Preg- nancy, breastfeeding, women ≥40 yr, reproductive cancer, thrombophlebitis, MI, hepatic tumors, hepatic disease, CAD, CVA, breast cancer, jaundice, stroke, vaginal bleeding Precautions: Depression, hypertension, renal disease, seizure disorders, lupus ery- thematosus, rheumatic disease, migraine headache, amenorrhea, irregular menses, gallbladder disease, diabetes mellitus, heavy smoking, acute mononucleosis, sickle cell disease
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Black Box Warning: Tobacco smoking Black Box Warning: Do not smoke; in- creased risk of CV side effects
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SIDE EFFECTS CNS: Depression, fatigue, dizziness, ner- vousness, anxiety, headache CV: Increased B/P, cerebral hemorrhage, thrombosis, pulmonary embolism, fluid retention, edema, MI EENT: Optic neuritis, retinal thrombosis, cataracts ENDO: Decreased glucose tolerance, increased TBG, PBI, T4, T3, temporary infertility GI: Nausea, vomiting, cramps, diarrhea, bloating, constipation, change in appe- tite, cholestatic jaundice, weight change GU: Breakthrough bleeding, amenor- rhea, spotting, dysmenorrhea, galactor- rhea, endocervical hyperplasia, vaginitis, cystitis-like syndrome, breast changes HEMA: Increased fibrinogen, clotting factor INTEG: Chloasma, melasma, acne, rash, urticaria, erythema, pruritus, hirsutism, alopecia, photosensitivity
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INTERACTIONS Decrease: oral contraceptives’ effective- ness—anticonvulsants, rifAMPin, analgesics, antibiotics, antihistamines, griseofulvin Decrease: oral anticoagulants’ action Drug/Herb • Altered action: black cohosh Decrease: oral contraceptives’ effect— saw palmetto, St. John’s wort Drug/Food Increase: peak level—grapefruit juice Drug/Lab Test Increase: PT; clotting factors VII, VIII, IX, X; TBG, PBI, T4, platelet aggregabil- ity, BSP, triglycerides, bilirubin, AST, ALT Decrease: T3, antithrombin III, folate, metyrapone test, GTT, 17-OHCS
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DOSAGE AND ROUTES Monophasic • Adult: PO Take first tablet on Sunday after start of menses × 21 days; skip 7 days, then repeat cycle; may contain 7 placebo C tablets when 1 tablet is taken daily Biphasic • Adult: PO Take 10 days of small pro- gestin, then large progestin; estrogen is the same during cycle; skip 7 days, then repeat cycle; may contain 7 placebo tab- lets when 1 tablet is taken daily Triphasic • Adult: PO Estrogen dose remains con- stant; progestin changes throughout 21- day cycle; some products contain 28 tablets per month Extended cycle • Adult: PO Start taking on first day of menses; continue for 84 days of active tablets, then 7 days of placebo; repeat cycle Progestin • Adult: PO Start on first day of menses, then daily and continuously Progressive estrogen • Adult: PO Progestin dose remains constant; estrogen increases q7days throughout 21-day cycle; may include 7 placebo tablets for 28-day cycle Emergency • Adult/adolescent: PO Give within 72 hr of intercourse, repeat 12 hr later; Plan B 1 tablet, then 1 tablet 12 hr later; Preven 2 tablets, then 2 tablets 12 hr later; Ovral 2 white tablets; Lo/Ovral (unla- beled) 4 white tablets; Levlen, Nordette 4 orange tablets; Triphasil, Tri-Levlen 4 yellow tablets Injectable • Adult: IM (Depo-Provera) 150 mg within 5 days of start of menses or within 5 days postpartum (must not be breast- feeding); if breastfeeding, give 6 wk post- partum, repeat q3mo Intrauterine • Adult: INTRAUTERINE To be inserted using the levonorgestrel-releasing intra- uterine system (LRIS) by those trained in procedure; inserted into uterine cavity within 7 days of the onset of menstruation; use should not exceed 5 yr per implant Vaginal ring • Adult: VAG Insert 1 ring on or prior to day 5 of cycle; leave in place 3 wk; remove for 1 wk, then repeat Transdermal • Adult: TD Apply patch within 7 days of menses; change weekly × 3 wk; no patch wk 4; repeat cycle Implant • Adult: SUBDERMAL In inner side of upper arm on days 1-5 of menses, replace q3yr Acne • Adult: PO (Ortho Tri-Cyclen) Take daily × 21 days, off 7 days
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Administer: • PO with food for GI symptoms; give at same time each day • Subdermal implant of 6 capsules effec- tive for 5 yr, then should be removed • IM injection deep in large muscle mass after shaking suspension; ensure patient not pregnant if injections are 2 wk or more apart
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Assess: • Glucose, thyroid function, LFTs, B/P • Reproductive changes: changes in breasts, tumors; positive Pap smear; product should be discontinued
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Evaluate: • Therapeutic response: absence of preg- nancy, endometriosis, hypermenorrhea
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CLINICAL CONSIDERATIONS
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Patient and caregiver information: • To use sunscreen or avoid sunlight; photosensitivity can occur • To take at same time each day to en- sure equal product level • To report GI symptoms that occur af- ter 4 mo • Pregnancy/breastfeeding: to use another birth control method during first 3 wk of oral contraceptive use; to avoid use in breastfeeding; many antibiotics in- terfere with oral contraceptives • To take another tablet as soon as pos- sible if one is missed • That, after product is discontinued, preg- nancy may not occur for several months • To report abdominal pain, change in vision, shortness of breath, change in menstrual flow, spotting, breakthrough bleeding, breast lumps, swelling, headache, severe leg pain • That continuing medical care is needed: Pap smear and gynecologic ex- aminations q12mo • To notify health care providers and den- tists of oral contraceptive use; many antibi- otics interfere with oral contraceptive effect
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PHARMACOKINETICS Excreted in breast milk
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• Adult/adolescent: PO Give within 72 hr of intercourse, repeat 12 hr later; Plan B 1 tablet, then 1 tablet 12 hr later; Preven 2 tablets, then 2 tablets 12 hr later; Ovral 2 white tablets; Lo/Ovral (unla- beled) 4 white tablets; Levlen, Nordette 4 orange tablets; Triphasil, Tri-Levlen 4 yellow tablets Injectable
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