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Miudella
copper intrauterine device
Black Box Warnings .
Appropriate Use
avail. only through restricted program (Miudella REMS) to ensure proper training of prescribers prior to first use; prescribers, healthcare settings, pharmacies must enroll at 1-855-337-0772 or miudellarems.com
Improper Insertion Risks
improper insertion incr. risk of complications such as pregnancy loss if pregnancy occurs w/ device in place, perforation, infection, undiagnosed abnormal bleeding, expulsion; proper training prior to use can minimize risk of improper insertion
Adult Dosing .
Dosage forms: IUD: 175 mm^2
Restricted Distribution in US
- [1-855-337-0772 or miudellarems.com for more info]
contraception
- [1 IUD q3y]
- Start: any time during menstrual cycle; Info: see pkg insert for insertion instructions
Peds Dosing .
- Dosage forms: IUD: 175 mm^2
Restricted Distribution in US
- [1-855-337-0772 or miudellarems.com for more info]
contraception
- [postmenarchal females]
- Dose: 1 IUD q3y; Start: any time during menstrual cycle; Info: see pkg insert for insertion instructions
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- pregnancy
- emergency contraception use
- IUD use, concurrent
- uterine neoplasia, known or suspected
- cervical neoplasia, known or suspected
- uterine bleeding, undiagnosed
- 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
- lower genital tract infection, untreated
- PID, acute
- pelvic infection risk incr.
- uterine anomaly, distorting
- Wilson dz
- caution: immunocompromised pts
Drug Interactions .
Overview
copper intrauterine device
contraceptive
-
None
No significant interactions known or found for this drug. Caution always advised with multiple medications.
Adverse Reactions .
Serious Reactions
- ectopic pregnancy
- sepsis
- PID
- myometrial embedment
- uterine perforation
- cervical perforation
Common Reactions
- vaginal bleeding
- vaginal spotting
- abdominal pain
- pelvic discomfort
- pelvic pain
- pain w/ insertion
- dysmenorrhea
- dyspareunia
- expulsion
- vasovagal reaction w/ insertion
- anemia
Safety/Monitoring .
Monitoring Parameters
pregnancy test at baseline
Pregnancy/Lactation .
Pregnancy
Clinical Summary
contraindicated during pregnancy as indication is contraception; possible risk of teratogenicity, incl. anencephaly, spontaneous abortion, and preterm labor based on limited human data
Lactation
Clinical Summary
weigh risk/benefit while breastfeeding, consider starting tx >4wk postpartum; no known risk of infant harm based on human data; possible risk of maternal uterine perforation and IUD expulsion based on conflicting human data; no known adverse effects on milk production based on human data
Pharmacology .
Metabolism: none; CYP450: none; Info: minimal to no systemic absorption
Excretion: feces, bile; Half-life: unknown
Subclass: Contraceptives, Intrauterine/Vaginal
Mechanism of Action
continuously releases copper into uterine cavity, immobilizing and inhibiting sperm penetration into cervical mucus; possibly interferes w/ egg fertilization and implantation
Formulary .
No Formulary Selected
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