Exem Foam Generic Name & Formulations
Legal Class
Rx
General Description
Air polymer-type A (80.97mg hydroxyethyl cellulose), 434.80mg glycerin 85%, purified water; intrauterine foam; for infusion after reconstitution.
Pharmacological Class
Contrast media.
How Supplied
Kit—1 (one syringe of clear gel + one syringe of sterile purified water + one Combifix adaptor)
Manufacturer
Generic Availability
NO
Exem Foam Indications
Indications
For sonohysterosalpingography to assess fallopian tube patency in women with known or suspected infertility.
Exem Foam Dosage and Administration
Adult
See full labeling. Give by slow intrauterine infusion using a 5-Fr or larger catheter with luer connection. Initially 2–3mL, may be repeated in increments of 2–3mL as needed to achieve visualization. Max total dose: 10mL.
Children
Not established.
Exem Foam Contraindications
Contraindications
Pregnancy. Known or suspected lower genital tract inflammation or infections (eg, pelvic inflammatory disease, suspected sexually transmitted disease). Gynecologic procedure within the last 30 days (eg, curettage, conization). Vaginal bleeding: due to the risk of intravasation of ExEm Foam as a result of exposure of the endometrial vessels during bleeding; and due to the potential risk of endometriosis as a result of seeding the peritoneum with endometrial tissue. Known or suspected reproductive tract neoplasia due to the risk of peritoneal spread of neoplasm.
Exem Foam Boxed Warnings
Not Applicable
Exem Foam Warnings/Precautions
Warnings/Precautions
Risk for fetal harm. Exclude pregnancy status within 24 hours prior to administration. Confirm patient is in the pre-ovulatory phase of menstrual cycle (cycle days 6–11). Risk for post-procedure gynecological infections. Nursing mothers.
Exem Foam Pharmacokinetics
See Literature
Exem Foam Interactions
Not Applicable
Exem Foam Adverse Reactions
Adverse Reactions
Pelvic/abdominal pain, vasovagal reactions (nausea, faintness), post-procedure spotting; gynecologic infections.
Exem Foam Clinical Trials
See Literature
Exem Foam Note
Not Applicable
Exem Foam Patient Counseling
See Literature
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