Air polymer-type A
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Omid Afkhami-Ardakani
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Overview
Air polymer-type A is an Ultrasound Contrast Agent that is FDA approved for the {{{indicationType}}} of sonohysterosalpingography to assess fallopian tube patency in women with known or suspected infertility.. Common adverse reactions include Pelvic and abdominal pain, Nausea and faintness, Post-procedure spotting.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Recommended Dosage: The recommended initial dose of ExEm Foam is 2 mL to 3 mL by intrauterine infusion using a 5-Fr or larger catheter with a luer connection.
Administration: The dose may be repeated in increments of 2 mL to 3 mL, as needed, to achieve visualization of the fallopian tubes. The maximum total dose should not exceed 10 mL.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Air polymer-type A in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Air polymer-type A in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Air polymer-type A FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Air polymer-type A in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Air polymer-type A in pediatric patients.
Contraindications
ExEm Foam is contraindicated in pregnant women. Confirm that the patient has a negative pregnancy test within the 24 hours before administration and is in the pre-ovulatory phase of her menstrual cycle (cycle days 6 through 11).
Hypersensitivity: ExEm Foam is contraindicated in patients with known hypersensitivity to any of its components.
Warnings
Pelvic Infections: Use of ExEm Foam may increase the risk of pelvic infections. Ensure aseptic technique during administration.
Vasovagal Reactions: Vasovagal reactions, including faintness, have been reported. Monitor patients during and after the procedure.
Adverse Reactions
Clinical Trials Experience
Pelvic and abdominal pain, Nausea and faintness, Post-procedure spotting
Postmarketing Experience
There is limited information regarding Air polymer-type A Postmarketing Experience in the drug label.
Drug Interactions
There are no known significant drug interactions with ExEm Foam.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
ExEm Foam is contraindicated in pregnant women. Confirm that the patient has a negative pregnancy test within the 24 hours before administration and is in the pre-ovulatory phase of her menstrual cycle (cycle days 6 through 11).
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Air polymer-type A in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Air polymer-type A during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Air polymer-type A in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Air polymer-type A in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Air polymer-type A in geriatric settings.
Gender
There is no FDA guidance on the use of Air polymer-type A with respect to specific gender populations.
Race
There is no FDA guidance on the use of Air polymer-type A with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Air polymer-type A in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Air polymer-type A in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Air polymer-type A in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Air polymer-type A in patients who are immunocompromised.
Administration and Monitoring
Administration
Preparation: ExEm Foam is provided as a single-dose kit containing:
5 mL sterile clear Gel [polymer-type A (80.97 mg hydroxyethyl cellulose), 434.80 mg glycerin 85%, and purified water]; with a pH of 6 to 7.5. 5 mL Sterile Purified Water; with a pH of 6 to 7.5. Combifix Adapter (coupling device) Procedure: After preparation, ExEm Foam is a milky-white, water-soluble intrauterine foam with an osmolality of approximately 462 mOsm and will contain between 10,000 to 127,000 bubbles per mL with a median size of 45.6 to 60.6 micrometers (for bubbles between 20 to 200 micrometers).
Monitoring
Post-Procedure Observation: Monitor patients for any adverse reactions, such as pelvic pain, nausea, or vasovagal responses, following the procedure.
IV Compatibility
There is limited information regarding the compatibility of Air polymer-type A and IV administrations.
Overdosage
There is limited information regarding Air polymer-type A overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Air polymer-type A Pharmacology in the drug label.
Mechanism of Action
ExEm Foam is formed by mixing a clear gel containing hydroxyethyl cellulose and glycerin with sterile purified water and air, creating an echogenic contrast agent. When visualized with ultrasound, the foam appears bright within the fallopian tubes and peritoneal cavity, allowing assessment of tubal patency.
Structure
There is limited information regarding Air polymer-type A Structure in the drug label.
Pharmacodynamics
ExEm Foam has no known pharmacological activity beyond its use as a contrast agent for imaging purposes.
Pharmacokinetics
Absorption: Assuming a full 10 mL dose is used and all glycerol is absorbed, normal fasting endogenous glycerol plasma levels would not be affected. Hydroxyethyl cellulose (HEC) is expected to exhibit very low permeability after administration, leading to negligible systemic exposure.
Nonclinical Toxicology
There is limited information regarding Air polymer-type A Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Air polymer-type A Clinical Studies in the drug label.
How Supplied
ExEm Foam is supplied as a single-dose kit containing:
Syringe A: 5 mL clear gel [polymer-type A (hydroxyethyl cellulose), glycerin, and purified water].
Syringe B: 5 mL sterile purified water.
Combifix Adapter: Coupling device for mixing.
When prepared as directed, ExEm Foam will contain between 10,000 to 127,000 bubbles per mL.
Storage
Store ExEm Foam at room temperature, between 20°C to 25°C (68°F to 77°F). Ensure the kit is at room temperature before use.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
Risk for Post-Procedure Gynecologic Infections:
Inform patients about the risk of post-procedure gynecologic infections. Advise them to report any continued pelvic or abdominal pain, significant vaginal discharge, and/or fever following the procedure.
Risk for Fetal Harm:
Counsel patients on the importance of confirming a negative pregnancy test within 24 hours before the procedure and ensuring the procedure is performed during the pre-ovulatory phase (cycle days 6 through 11) to minimize the risk of fetal harm.
Precautions with Alcohol
Alcohol-Air polymer-type A interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
The product is marketed under the brand name ExEm Foam.
Look-Alike Drug Names
There is limited information regarding Air polymer-type A Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.