CSF Otic Powder

 

CSF and HC otic insufflation capsules 

Edge Pharma is proud to be producing CSF powder capsules for ENT practices. Ever since the passing of the Drug Quality & Security Act in 2013, it has become increasingly more difficult to find a suitable supplier of CSF powder capsules which are available for purchase in bulk.  Local and State-licensed compounding pharmacies are no longer able to dispense compounded medications without individual patient scripts for each order.  As an FDA-Registered 503B outsourcing facility, Edge Pharma is able to dispense these capsules in bulk and without patient names.  This means that you can keep CSF powder capsules in your office as an in-stock medication.  Simply prescribe and dispense to your patients on an as-needed basis. 

CSF powder capsules from Edge are available in #4 sized capsules which are compatible with the most commonly used Sheehy-House Insufflator.  Each capsule lasts for approximately 10-15 puffs.

 

 CSF Otic Insufflation Powder Capsules

For Otic use with insufflator (do not administer orally). For Hospital/ Office use only. Each capsule administers 10-15 puffs.

Storage: refrigerate and protect from light.

  • Amphotericin 5mg
  • Chloramphenicol 50mg
  • Sulfacetamide Sodium 50mg            

 

 CSF-HC Otic Insufflation Powder Capsules

For Otic use with insufflator (do not administer orally). For Hospital/ Office use only. Each capsule administers 10-15 puffs.

Storage: refrigerate and protect from light.

  • Amphotericin 5mg
  • Chloramphenicol 50mg
  • Sulfamethoxazole 50mg              
  • Hydrocortisone 25mg (optional)

 

CSF otic application set

 

Literature Review

 

Acute otitis externa (AOE), often referred to as swimmer’s ear, is an inflammation of the external auditory canal. It is characterized by pain, redness, and swelling of the external ear canal. It is estimated that AOE accounts for 2.4 million health-care visits in the U.S. each year, with diagnoses peaking June through August.(1)

 

In North America, 98 percent of AOE is bacterial. “The most common pathogens are pseudomonas aeruginosa (20-60 percent prevalence) and staphylococcus aureus (10-70 percent prevalence), often occurring as a polymicrobial infection.”(2) A guide published by the American Academy of Otolaryngology – Head and Neck Surgery, stresses the importance of the clinician distinguishing AOE from Acute Otitis Media (AOM), as AOM may require systemic antimicrobials for treatment.(2) The guide continues, “Clinicians should not prescribe systemic antimicrobials as initial therapy for diffuse, uncomplicated AOE unless there is extension outside the ear canal or the presence of specific host factors that would indicate a need for systemic therapy.”(2)

 

Topical therapy has several advantages over systemic therapy, including:

  • A vastly higher concentration of antibiotic can be delivered to the site of infection
  • Medications delivered topically have no systemic effects
  • Topical delivery allows alteration of the local microenvironment(3)

 

Ototopical medicine can be delivered by powder, creams, ointments, or drops. “Powders have the advantage of adhering to moist surfaces and have long dwelling times with the external auditory canal, middle ear, or mastoid cavities.”(3) Powders also adhere to granulation tissue, which is an important consideration when treating chronic suppurative otitis media.(3) “The powders are relatively easy to apply. A Sheehy-House powder insufflator is readily available and inexpensive.”(3) A number of components are used in powders. Most powders consist of a mixture of antibacterial antibiotics, antifungal agents, and steroids.(3)

 

Chloramphenicol, amphotericin, and sulfacetamide are among the agents commonly compounded to treat otitis externa.(4)

 

Powders are also often used to treat a draining mastoid cavity. They have the advantage of having a mechanical drying effect, and are a good vehicle to deliver antibiotics and other medicines, such as antifungals.(5) 


(1) Piercefield, E. MD et al, Centers for Disease Control, Estimated Burden of Acute Otitis Externa, https://pubmed.ncbi.nlm.nih.gov/

(2) Rosenfeld, R. MD et al, American Academy of Otolaryngology – Head and Neck Surgery, Clinical Practice Guideline: Acute Otitis Externa, https://journals.sagepub.com/

(3) Billings, K. MD, Medscape, Ototopical Antibiotics https://emedicine.medscape.com/

(4) Hutson, C., PharmD, Jones, J. RPh, American Pharmacist, Compounding for Otolaryngology, http://www.ncpa.co/

(5)Haynes, David S., Ear, Nose and Throat Journal, Perioperative Antibiotics in Chronic Suppurative Otitis Media,  https://www.thefreelibrary.com/

 

Register To Order Online 

We are currently licensed to sell to all US states except Alabama and Virginia. Please fill the Form below to create an account. Medical, DEA, or hospital pharmacy licenses will be required to order CSF powder online.

Create an account to order

Log-In if you have an account