Indication:
New Drugs Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
Praziquintel 175mg 30-03-2010
+ Pyrantel 504mg
+Febental 535mg tablets
For the treatment of Mixed Infections with Roundworms and Tapeworms
in dogs
FIXED DOSE COMBINATIONS APPROVED BY DCG(I)
FROM JANUARY 1961 TILL NOVEMBER 2014
Name of Drug Indication Date of Approval
1.Praziquantal 20mg+ 25-11-2013
Pyrantel embonate 230mg tablet
Veterinary product
For the treatment of mixed infectations with roundworms
and tapeworms with dogs
2.Praziquantel 175mg + 30-03-2010
Pyrantel 504mg +
Febental 525mg tablets
For the treatment of mixed infections with roundworms
and tapeworms in dogs
Schistosomiasis
Patient Information:
1. Take with liquids during meals. Do not chew tablets
2. May cause dizziness or drowsiness, observe caution while driving or performing
other tasks requiring alertness
Ref - USP PDI Vol II 17th Edition (1997)
PRAZIQUANTEL- Systemic
1.Allergies-
Tell your doctor if you have ever had any unusual or allergic reaction to
praziquantel. Also tell your healthcare care professional if you are allergic to any
other substances such as foods. preservatives or dyes.
2.Pregnancy-
Studies have not been done in humans. However, studies in rats and rabbits
given up to 40 times the normal human dose have not shown to cause
birth defects. However, praziquantel has shown to cause a greater chance
of miscarriage in rats given 3 times the human dose.
3. Breast-feeding-
Praziquantel passes into breast milk. You should stop breast feeding on the day
you begin praziquantel. Do not restart breast-feeding until 72 hours after treatment
is completed. During this period the breast milk should be squeezed out or
sucked out with a breast pump and thrown away.
4.Children-
This medicine has been tested in a limited number of children 4 years age
or older and in effective dises , has not been reported to cause different
side effects or proplems in children over 4 years of age than it does in adults.
5.Older adults-
There is no specific information comparing use of praziquantel in the elderly
with use in other age groups
6. Other medicines-
Tell your doctor if you are using any of the 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- patients with moderate to severe liver disease may have
an increased chance of side effects
Worm cysts in the eye- the death of worm cysts in the eyes caused
by praziquinrel may cause damage to the eyes.
Manufacturer Details