25
Not currently covered by the CDC-
sponsored IND protocol
• Use undiluted drug.
• Consider premedication (eg, with
EMLA: lidocaine/prilocaine).
• In children, sedation/anesthesia may be
required.
• Avoid body sites as per heat therapy
(see Recs. below).
No. In US, would require investigator-
sponsored IND protocol.
• The capsule formulation of
paromomycin is FDA approved for
other indications.
• Use of the capsules to compound
antileishmanial ointment constitutes
off- label use.
• Local irritation (from MBCL) may lead
some patients to discontinue therapy.
• Higher response rates noted for
infection caused by L. major than
L. tropica
• See above about paromomycin capsules.
• Treatment under expanded-access IND
protocol currently is limited to US
military health care beneficiaries.
Local erythema and/or mild pain are
commonly noted. See Recs. 38–39
for some similar drug compounding
instructions and the US military point of
contact.
Yes, cleared for CL indication • Avoid applying over eyelids, tip of nose,
lips, mucus membranes, cartilaginous
structures, or superficial nerves.
• Use topical antibiotics for several days
after the heat treatment.
• Keloids may be less common than with
cryotherapy.
Yes. "Grandfathered in" Increased efficacy has been noted if used in
combination with IL Sb
V
.
• Avoid applying over eyelids, tip of nose,
lips, mucus membranes, cartilaginous
structures, or superficial nerves.
FDA Approval Comments
