Supplier News Breaks Archives
CutisPharma launches vancomycin compounding kits
April 30th, 2014
WOBURN, Mass. – CutisPharma Inc. has introduced FIRST oral solution compounding kits for vancomycin, an antibiotic for the intestines.
The company said Wednesday that with FIRST Vancomycin, the oral solution is compounded within a minute by adding the premeasured white grape-flavored solution to the preweighed vancomycin hydrochloride powder bottle and shaking it. The white grape flavor helps mask the typical bitterness of vancomycin hydrochloride.
The kits come in two concentrations: 25 mg/mL, 5 oz. and 10 oz. sizes, and 50 mg/mL, 5 oz., 7 oz., and 10 oz. sizes for MultiFlex (multiple and flexible) dosing.
Vancomycin is used to treat an infection of the intestines caused by the bacteria Clostridium difficile (C. diff.), which can cause watery or bloody diarrhea. It is also used for staph infections that can cause inflammation of the colon and small intestines.
CutisPharma noted that for many years metronidazole and oral vancomycin have been used for the treatment of C. diff. First-line therapy, for mild to moderate cases, is restricted to metronidazole. Second-line therapy for severe infections and/or treatment failure is oral vancomycin. In 2011, Dificid (fidaxomicin) was introduced to the market for the treatment of C. diff.-associated diarrhea only in patients age 18 and older.
Given that there are only oral solid dosage forms commercially available for all three of these antibiotics, metronidazole and vancomycin are commonly prepared as oral suspensions/solutions to accommodate the pediatric and geriatric populations that typically encounter difficulty swallowing these solid oral dosage forms and/or patients requiring feeding tubes, according to CutisPharma. As a result, FIRST Vancomycin is now providing a grape-flavored, oral vancomycin solution for compounding in two concentrations and various package sizes.
In the United States, there are approximately 500,000 cases of C. diff. infections each year, and about 70% are treated in the hospital, CutisPharma reported. C. diff. continues to be on the rise, even in the pediatric population, according to recent studies.
Commonly, pharmacists will use lyophilized, sterile vancomycin hydrochloride powder for injection and sterile water for injection to compound an oral vancomycin solution, which tends to be unpalatable for patients, CutisPharma said. Also, the current method is cumbersome and time-consuming, taking the pharmacist an average of 20 minutes.
"Our company mission statement is to simplify the practice of traditional pharmacy compounding and to improve the customer's satisfaction for compounded drug products," stated Dr. Indu Muni, founder, chairman and chief executive officer of CutisPharma.
CutisPharma now has 24 prescription compounding kits on the market: five progesterone suppository compounding kits, two testosterone kits, one hydrocortisone kit, five Magic Mouthwash kits, three omeprazole suspension kits, three lansoprazole suspension kits, and five vancomycin solution kits. Several more compounding kits are in the planning stages, the company added.