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Adult Dosing .
Dosage forms: IUD: 52 mg
Restricted Distribution in US
- [1-866-318-3531 or www.whcsupport.com for more info]
Special Note
- [strength clarification]
- Info: release rate of levonorgestrel declines from approximately 21 mcg per day after 24 days to 11 mcg per day after 5 years and 7 mcg per day after 8 years
contraception
- [1 IUD q8y]
- Start: w/in 7 days of menses onset, immed. after 1st trimester abortion or miscarriage, immed. postpartum or after 2nd trimester abortion or miscarriage after placenta removal, or >6wk postpartum or after 2nd trimester abortion or miscarriage after complete uterus involution; Info: refer to pkg insert if switching from another contraceptive
heavy menstrual bleeding
- [1 IUD q5y]
- Start: w/in 7 days of menses onset, immed. after 1st trimester abortion or miscarriage, immed. postpartum or after 2nd trimester abortion or miscarriage after placenta removal, or >6wk postpartum or after 2nd trimester abortion or miscarriage after complete uterus involution
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- active hepatic dz: contraindicated
Peds Dosing .
- Dosage forms: IUD: 52 mg
Restricted Distribution in US
- [1-866-318-3531 or www.whcsupport.com for more info]
Special Note
- [strength clarification]
- Info: release rate of levonorgestrel declines from approximately 21 mcg per day after 24 days to 11 mcg per day after 5 years and 7 mcg per day after 8 years
contraception
- [postmenarchal females]
- Dose: 1 IUD q8y; Start: w/in 7 days of menses onset, immed. after 1st trimester abortion or miscarriage, immed. postpartum or after 2nd trimester abortion or miscarriage after placenta removal, or >6wk postpartum or after 2nd trimester abortion or miscarriage after complete uterus involution; Info: refer to pkg insert if switching from another contraceptive
heavy menstrual bleeding
- [postmenarchal females]
- Dose: 1 IUD q5y; Start: w/in 7 days of menses onset, immed. after 1st trimester abortion or miscarriage, immed. postpartum or after 2nd trimester abortion or miscarriage after placenta removal, or >6wk postpartum or after 2nd trimester abortion or miscarriage after complete uterus involution
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- active hepatic dz: contraindicated
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- pregnancy
- emergency contraception use
- cancer, hormone-sensitive
- cancer hx, hormone-sensitive
- breast CA, known or suspected
- endometrial CA (tx initiation use)
- hepatic tumor, benign
- hepatic tumor, malignant
- hepatic dz, active
- uterine malignancy, known or suspected
- cervical malignancy, known or suspected
- vaginal bleeding, undiagnosed
- infected abortion w/in prior 3mo
- sepsis, postpartum
- postseptic abortion, immediate
- postpartum endometritis w/in prior 3mo
- cervicitis, acute untreated
- vaginitis, acute untreated
- PID, acute
- PID hx w/o subsequent intrauterine pregnancy
- pelvic infection risk incr.
- uterine anomaly, distorting
- caution: breastfeeding
- caution: <6wk postpartum
- caution: uterine involution, incomplete
- caution: uterus, fixed
- caution: uterus, retroverted
- caution: ectopic pregnancy hx
- caution: ectopic pregnancy risk
- caution: thromboembolism
- caution: thromboembolism risk
- caution: coagulation disorder
- caution: arterial dz, severe
- caution: ischemic heart dz
- caution: ischemic heart dz hx
- caution: peripartum cardiomyopathy
- caution: HTN
- caution: hyperlipidemia
- caution: diabetes mellitus
- caution: breast CA hx
- caution: migraine
- caution: headache, severe
- caution: headache, frequent
- caution: immunocompromised pts
- caution: SLE antibody, positive or unknown
Drug Interactions .
Overview
levonorgestrel intrauterine device (contraceptive)
progestin
- CYP3A4 substrate
- binds to encapsulating agent
- progesterone agonist
Contraindicated
- mifepristone
Avoid/Use Alternative
- deferasirox
- fosaprepitant
- ivosidenib
- modafinil
- pitolisant
- repotrectinib
- sugammadex
Monitor/Modify Tx
- ulipristal (post-coital contraceptive)
Caution Advised
- apalutamide
- aprepitant
- armodafinil
- artemether/lumefantrine
- belzutifan
- bexarotene
- bosentan
- brigatinib
- butalbital
- carbamazepine
- cenobamate
- clobazam
- dabrafenib
- danshen
- darolutamide
- dexamethasone
- dicloxacillin
- echinacea
- efavirenz
- elafibranor
- elagolix
- enasidenib
- encorafenib
- enzalutamide
- eslicarbazepine acetate
- etravirine
- felbamate
- fexinidazole
- fosamprenavir
- fosphenytoin
- garlic
- ginkgo
- ginseng, Asian
- glycerol phenylbutyrate
- griseofulvin
- lopinavir/ritonavir
- lorlatinib
- lumacaftor/ivacaftor
- mavacamten
- meropenem
- mitapivat
- mitotane
- mobocertinib
- nafcillin
- nelfinavir
- nevirapine
- olutasidenib
- omaveloxolone
- oxcarbazepine
- pacritinib
- pentobarbital
- perampanel
- pexidartinib
- phenobarbital
- phenytoin
- pioglitazone
- prednisone
- primidone
- rifabutin
- rifampin
- rifapentine
- ritonavir
- rufinamide
- sarilumab
- somatropin
- sotorasib
- St. John's wort
- stiripentol
- tazemetostat
- tecovirimat
- telotristat ethyl
- tesamorelin
- tocilizumab
- topiramate
- tovorafenib
- vaborbactam
- vamorolone
- vemurafenib
- vinblastine
- vorasidenib
- zanubrutinib
Adverse Reactions .
Serious Reactions
- ectopic pregnancy
- septic abortion
- sepsis
- PID
- ovarian cysts
- myometrial embedment
- uterine perforation
- cervical perforation
- hypersensitivity rxn
- thrombosis
- thromboembolism
Common Reactions
- infection, vulvovaginal mycotic
- menstrual irregularities
- amenorrhea
- vaginitis
- acne
- ovarian cysts
- anxiety
- abdominal pain
- pelvic pain
- headache
- migraine
- dysmenorrhea
- depression
- menorrhagia
- nausea
- vomiting
- dyspareunia
- breast pain
- breast tenderness
- expulsion
- leukorrhea
- nervousness
- back pain
- weight gain
- libido decr.
- cervicitis
- HTN
Safety/Monitoring .
Monitoring Parameters
pelvic exam 4-6wk after insertion, then annually or as clinically indicated; glucose if diabetes
Pregnancy/Lactation .
Pregnancy
Clinical Summary
contraindicated during pregnancy; no known risk of teratogenicity, though possible risk of ectopic pregnancy, miscarriage, virilization of female fetus genitalia, sepsis, premature labor, and premature delivery based on human data
Lactation
Clinical Summary
weigh risk/benefit while breastfeeding, esp. if <6wk postpartum or before complete uterus involution; no known risk of infant harm based on limited human data and drug properties; possible risk of maternal uterine perforation based on limited human data; possible decr. milk production, esp. during early postpartum, based on conflicting human data and drug's mechanism of action
Pharmacology .
Metabolism: liver; CYP450: 3A4 substrate
Excretion: urine 45%, feces 32%; Half-life: 13.9-17h (daily PO route); 20h (IV route)
Subclass: Contraceptives, Intrauterine/Vaginal ; Menorrhagia
Mechanism of Action
exact mechanism of action unknown; may thicken cervical mucus preventing sperm passing into the uterus; may inhibit sperm capacitation or survival; may alter the endometrium
Formulary .
No Formulary Selected
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