Notice to Readers U.S.-Manufactured Pentamidine
Isethionate Cleared for Investigational Use
A U.S.-manufactured preparation of pentamidine isethionate has
undergone satisfactory completion of chemical and biologic tests,
and
CDC is now able to include this preparation in its claimed
investigational exemption for a new drug for treatment of
Pneumocystis
carinii pneumonia. The Investigational New Drug status for the
U.S.-manufactured preparation makes it unnecessary for CDC to
distribute the foreign-produced product (pentamidine
methanesulfonate)
described in the May 4, 1984, issue of the MMWR (33:225-6). The
U.S.
preparation is being synthesized by Aldrich Chemical Company,
Milwaukee, Wisconsin, and packaged for pharmaceutical use by
LyphoMed,
Inc., Melrose Park, Illinois.
There are two minor differences between the
LyphoMed-manufactured
product and the previously used May & Baker preparation of
pentamidine
isethionate. First, the LyphoMed product contains more pentamidine
per vial than the May & Baker product (300 mg, compared with 200
mg).
Second, the two preparations differ in their physical appearance.
May
& Baker uses a "dry fill" manufacturing process that leaves a
fluffy
white powder in the vial, whereas LyphoMed uses a "wet fill"
process,
followed by lyophilization, leaving a dry "plug" of white powder at
the bottom of the vial.
The dosage of the LyphoMed product is the same as for the May &
Baker product (4 mg (salt)/kg body weight).
Reported by Div of Parasitic Diseases, Div of Host Factors, Center
for
Infectious Diseases, CDC.
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