BILTRICIDE- praziquantel tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PRAZIQUANTEL (UNII: 6490C9U457) (PRAZIQUANTEL - UNII:6490C9U457)

Available from:

Central Texas Community Health Centers

INN (International Name):

PRAZIQUANTEL

Composition:

PRAZIQUANTEL 600 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

BILTRICIDE is indicated for the treatment of infections due to: all species of schistosoma (for example, Schistosoma mekongi, Schistosoma japonicum, Schistosoma mansoni and Schistosoma hematobium ), and infections due to the liver flukes, Clonorchis sinensis/Opisthorchis viverrini (approval of this indication was based on studies in which the two species were not differentiated). BILTRICIDE is contraindicated in patients who previously have shown hypersensitivity to the drug or any of the excipients. Since parasite destruction within the eye may cause irreversible lesions, ocular cysticercosis must not be treated with this compound. Concomitant administration with strong Cytochrome P450 (P450) inducers, such as rifampin, is contraindicated since therapeutically effective blood levels of praziquantel may not be achieved (see PRECAUTIONS/Drug Interactions). In patients receiving rifampin who need immediate treatment for schistosomiasis, alternative agents for schistosomiasis should be considered. However, if

Product summary:

BILTRICIDE  is supplied as a 600 mg white to orange tinged, film-coated, oblong tablet with three scores. The tablet is coded with "BAYER" on one side and "LG" on the reverse side. When broken, each of the four segments contains 150 mg of active ingredient so that the dosage can be easily adjusted to the patient's bodyweight. Segments are broken off by pressing the score (notch) with thumbnails. If 1/4 of a tablet is required, this is best achieved by breaking the segment from the outer end. BILTRICIDE is available in bottles of 6 tablets. Bottles of 6 Strength 600 mg NDC 50419-747-01 Store below 86°F (30°C). Manufactured for: Bayer HealthCare Pharmaceuticals Inc. Whippany, NJ 07981 Manufactured in Germany BILTRICIDE is a registered trademark of Bayer Aktiengesellschaft. Rx Only 2/14    ©2014 Bayer HealthCare Pharmaceuticals Inc.      Printed in USA

Authorization status:

New Drug Application

Summary of Product characteristics

BILTRICIDE- PRAZIQUANTEL TABLET, FILM COATED
CENTRAL TEXAS COMMUNITY HEALTH CENTERS
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BILTRICIDE
TABLETS
(PRAZIQUANTEL)
DESCRIPTION
BILTRICIDE (praziquantel) is a trematodicide provided in tablet form
for the oral treatment of
schistosome infections and infections due to liver fluke.
BILTRICIDE (praziquantel) is 2-(cyclohexylcarbonyl)-1,2,3,6,7,
11b-hexahydro-4H-pyrazino [2, 1-a]
isoquinolin-4-one with the molecular formula; C
H N O . The structural formula is as follows:
Praziquantel is a white to nearly white crystalline powder of bitter
taste. The compound is stable under
normal conditions and melts at 136-140°C with decomposition. The
active substance is hygroscopic.
Praziquantel is easily soluble in chloroform and dimethylsulfoxide,
soluble in ethanol and very slightly
soluble in water.
BILTRICIDE tablets contain 600 mg of praziquantel. Inactive
ingredients: corn starch, magnesium
stearate, microcrystalline cellulose, povidone, sodium lauryl sulfate,
polyethylene glycol, titanium
dioxide and hypromellose.
CLINICAL PHARMACOLOGY
Praziquantel induces a rapid contraction of schistosomes by a specific
effect on the permeability of the
cell membrane. The drug further causes vacuolization and
disintegration of the schistosome tegument.
After oral administration BILTRICIDE is rapidly absorbed (80%),
subjected to a first pass effect,
metabolized and eliminated by the kidneys. Maximal serum concentration
is achieved 1-3 hours after
dosing. The half-life of praziquantel in serum is 0.8-1.5 hours.
SPECIAL POPULATIONS
The pharmacokinetics of praziquantel were studied in 40 patients with
_Schistosoma mansoni_ infections
with varying degrees of hepatic dysfunction (See table1). In patients
with schistosomiasis, the
pharmacokinetic parameters did not differ significantly between those
with normal hepatic function
(Group 1) and those with mild (Child-Pugh class A) hepatic impairment.
However, in patients with
moderate-to-severe hepatic dysfunction (Child-Pugh class B and C),
praziquantel half-life, C
, and
AUC incr