Indication:
Symptomatic relef and parasitic cure for chronic crytosporidiosis in immunodeficiency.
FIXED DOSE COMBINATIONS APPROVED BY DCG(I)
FROM JANUARY 1961 TILL NOVEMBER 2014
Name of Drug Indication Date of Approval
Spiramycin 0.75MIU /1.50 MIU + 15-03-1994
Metronidazole 1.25mg/250mg
Film coated tablets
NM
Patient Information:
AVOID CONCURRENT USE WITH ERYTHROMYCIN
Ref - USP PDI Vol II 17th Edition (1997)
SPIRAMYCIN- SYSTEMIC
1.Allergies-
Tell your doctor if you have ever had any unusual or allergic reaction to
Spiramycin or any related medicines, such as erythromycin, azithromycin,
clarithromycin,treleandomycin, dirithromycin or josamycin. Also tell your
healthcare care professional if you are allergic to any other substances
such as foods. preservatives or dyes.
2.Pregnancy-
Spiromycin is used to treat toxoplasmosis in pregnant women since this
medicine decreases the chance that the unborn baby will get the infection,
if the unborn baby is already infected with toxoplasmosis, spiramycin does
not treat the infection. This medicine has not been found to cause birth defects
or other problems in humans
3. Breast-feeding-
Spiramycin passes into breast milk. However, spiramycin has not shown to
cause problems in nursing babies to date.
4.Children-
This medicine has been tested in a limited number of children, and in effective
doses,has not been shown to cause different side effects or problems than
it does in adults.
5.Older adults-
There is no specific information comparing use of spiramycin in the elderly
with use in other age groups.
6. Other medicines-
Tell your doctor if you are using any other prescription or non-prescription
(Over-the counter) OTC medicine.
7. Other medical problems-
Make sure you tell your doctor if you have any other medical problems
especially-
Liver disease or
Obstruction of the bile ducts- liver disease or obstructions in the bile duct
may increase the chance of side effects