Dosing & Uses
Dosage Forms & Strengths
intrauterine foam
- Syringe A: 5 mL of gel (polymer type A [hydroxyethyl cellulose], glycerin, purified water)
- Syringe B: 5 mL sterile purified water
- Combifix adaptor (coupling device)
Infertility Diagnostic
Ultrasound contrast agent indicated for sonohysterosalpingography to assess fallopian tube patency in women with known or suspected infertility
2-3 mL via intrauterine infusion; may repeat in 2- to 3-mL increments as needed to achieve fallopian tube visualization
Not to exceed total dose of 10 mL
Dosing Considerations
Ensure that patient is not pregnant before administration by confirming a negative pregnancy test within 24 hr beforehand
Confirm the patient is in preovulatory phase of her menstrual cycle (cycle days 6 through 11)
Safety and efficacy not established
Adverse Effects
Frequency Not Defined
Pelvic and abdominal pain
Vasovagal reactions and associated symptoms (eg, nausea, faintness)
Postprocedure spotting
Postmarketing Reports
Gynecologic infections: Pelvic inflammatory disease, salpingitis, and tubo-ovarian abscess
Warnings
Contraindications
Pregnancy
Known or suspected lower genital tract inflammation or infection
Gynecologic procedure within last 30 days
Known or suspected reproductive tract neoplasia, owing to the risk of peritoneal spread of neoplasm
Patients with vaginal bleeding
- Owing to risk of intravasation of foam as a result of exposure of the endometrial vessels during bleeding, and
- Owing to the potential risk of endometriosis as a result of seeding the peritoneum with endometrial tissue
Cautions
Risk of postprocedure gynecological infections
Pregnancy & Lactation
Pregnancy
Contraindicated for use in pregnancy owing to potential fetal risk from an intrauterine procedure
Confirm a negative pregnancy test within 24 hr before administration and patient is in the preovulatory phase of her menstrual cycle (days 6 through 11)
Lactation
Data are not available regarding presence in human milk
No adverse effects in breastfed infants are anticipated following maternal administration based on the wide safety margin for glycerol in infants and the expected negligible absorption of hydroxyethyl cellulose
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Air polymer type A intrauterine foam is formed by mixing the clear (polymer type A [hydroxyethyl cellulose], glycerin, purified water) with air and sterile purified water
When mixed, an echogenic contrast agent is created, which when visualized with ultrasound, the foam appears echogenic or bright within the fallopian tubes and peritoneal cavity
Absorption
No literature data are available regarding hydroxyethyl cellulose (HEC) absorption from the female reproductive tract and peritoneum
HEC is poorly permeable across GI epithelial mucosa; therefore, HEC is expected to exhibit very low permeability after administration and to produce negligible HEC systemic exposure
Metabolism
Unknown
Administration
Foam Preparation
Examine package and do not use if previously opened or damaged
Ensure all components are at room temperature
Handle products following aseptic practices (eg, sterile gloves)
Generate foam by mixing syringe A (gel) with syringe B (sterile purified water) included in the kit as precisely described in the prescribing information
Infuse foam within 5 minutes of reconstitution
Intrauterine Administration
Administer through a 5-Fr or larger catheter with Luer connection only; if there is resistance when infusing foam, use a larger catheter; do not infuse forcefully
Infuse 1 mL of foam to confirm proper placement of the catheter tip in the cervix and access to the uterine cavity
Slowly infuse 2-3 mL of the foam at a time to avoid patient discomfort; not to exceed total dose of 10 mL
Discard unused portion after use
Imaging guidance
- Conduct transvaginal ultrasound imaging in accordance with ultrasound manufacturer recommendations
- Foam in the fallopian tube appears as an echogenic line along the length of the tube on the image
- A fallopian tube is classified as patent if foam is observed to pass from the tube and spill into the peritoneal cavity; tube appears as a thin, bright line
- A fallopian tube is classified as occluded if foam is not observed to pass from the tube and spill into the peritoneal cavity; as secondary findings, (1) there may be no bright line due to no flow into the fallopian tube, or (2) the tubal lumen may appear distended and contrast flow might be observed only in the intramural or isthmic part of the tube
Storage
Store at controlled room temperature of 20-25ºC (68-77ºF); excursions permitted to 15-30ºC (59-86ºF)
Do not refrigerate or freeze
Images
Formulary
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