JAMP ITRACONAZOLE ORAL SOLUTION 10MGML

Ülke: Singapur

Dil: İngilizce

Kaynak: HSA (Health Sciences Authority)

Aktif bileşen:

Itraconazole

Mevcut itibaren:

GOLDPLUS UNIVERSAL PTE LTD

ATC kodu:

J02AC02

Farmasötik formu:

SOLUTION

Kompozisyon:

Itraconazole 10 mg/mL

Uygulama yolu:

ORAL

Reçete türü:

Prescription Only

Tarafından üretildi:

Kleva Pharmaceuticals S.A.

Yetkilendirme durumu:

ACTIVE

Yetkilendirme tarihi:

2021-11-17

Ürün özellikleri

PRODUCT NAME
Pr
JAMP Itraconazole Oral Solution 10mg/mL
GENERIC
NAME/INTERNATIONAL
NON-PROPRIETARY
NAME
Itraconazole
DOSAGE FORMS AND STRENGTHS
JAMP Itraconazole Oral Solution is yellow and transparent solution.
1 mL JAMP Itraconazole Oral Solution contains 10 mg itraconazole.
For excipients, see
_List of Excipients. _
CLINICAL INFORMATION
INDICATIONS
JAMP Itraconazole Oral Solution is indicated:
•
For
the
treatment
of
oral
and/or
esophageal
candidosis
in
HIV-positive
or
other
immunocompromised patients.
As prophylaxis of deep fungal infections, in patients with
hematological malignancy or
undergoing bone marrow transplant, and who are expected to become
neutropenic (i.e. < 500
cells/mcL).
For empiric therapy of febrile neutropenic patients with suspected
systemic mycoses as follow-
up therapy to itraconazole IV.
•
•
DOSAGE AND ADMINISTRATION
For optimal absorption, JAMP Itraconazole Oral Solution should be
taken without food (patients
are
advised to refrain from eating for at least 1 hour after intake).
For the treatment of oral and/or esophageal candidosis, the oral
solution should be swished around
the oral cavity (approx. 20 seconds) and swallowed. There should be no
rinsing after swallowing.
TREATMENT OF ORAL CANDIDOSIS
200 mg (20 mL) per day in two intakes, or alternatively in one intake,
for 1 week. If there is no
response after 1 week, treatment should be continued for another week.
TREATMENT OF ESOPHAGEAL CANDIDOSIS
100 mg (10 mL) daily for a minimum treatment of three weeks. Treatment
should continue for
2 weeks following resolution of symptoms. Doses up to 200 mg (20 mL)
per day may be used
based on the clinical response of the patient.
TREATMENT OF FLUCONAZOLE RESISTANT ORAL AND/OR ESOPHAGEAL CANDIDOSIS
100 to 200 mg twice daily for 2 weeks. If there is no response after 2
weeks, treatment should be
continued for another 2 weeks. The 400 mg daily dose should not be
used for longer than 14 days
if there are no signs of improvement.
1
PROPHYLAXIS OF FUNGAL INFECTIONS
5 mg/kg per day administered i