Package Insert for Praziquantel Tablets

Package Insert for Praziquantel Tablets

[Veterinary Drug Name]

Generic name: 吡喹酮片

Trade name: Baochongjing

English name: Praziquantel Tablets

Chinese phonetic: Bikuitong Pian

[Main Composition] Praziquantel

[Description] This drug is a white tablet.

[Pharmacological Actions] Pharmacodynamics: Praziquantel has broad-spectrum anti-schistosome and anti-cestode effects. It has remarkable activity against adult cestodes and good activity against larvae; it also has a good expelling-killing effect on schistosomes.

Praziquantel has an yet-determined exact mechanism of action on cestodes, while it is hypothesized to involve interactions with phospholipids in the parasite tegument, resulting in the efflux of sodium, potassium, and calcium ions. Low concentrations of praziquantel in vitro may damage the sucker function of cestodes and stimulate their peristalsis, while higher concentrations of the drug may enhance the contraction of cestode strobila (proglottids) (irreversible contraction at extremely high concentrations). In addition, praziquantel induces focal vacuolation in specific regions of the cestode tegument, leading to worm disintegration. In schistosomes and other trematodes, praziquantel is thought to directly kill the parasites by increasing the influx of calcium ion into the parasite, leading to focal vacuolation and subsequent phagocytosis.

Pharmacokinetics: This drug is rapidly and almost completely absorbed after oral administration, but exhibits a significant first-pass effect. After administration, peak plasma concentrations are reached within 0.5~2 h in dogs and 2 h in sheep. Intramuscular and subcutaneous injections maintain longer plasma concentration compared to oral administration. Praziquantel distributes in various tissues throughout the body, with the highest levels in the liver and kidneys, and may cross the blood-brain barrier to enter the central nervous system. This extensive tissue distribution facilitates the elimination of larvae from various host organs, including muscle, brain, viscera, and the peritoneal cavity. After absorption, praziquantel is rapidly metabolized by the liver into inactive monohydroxylated and polyhydroxylated metabolites, which are primarily excreted in the urine. The elimination half-life following oral administration is: 7.7 h for yellow cattle, 1.1~2.5 h for sheep/goats and pigs, and 3~3.5 h for dogs. Only a negligible amount of the parent drug (0.1% in sheep) is excreted via urine or feces.

[Drug Interactions] When used concomitantly with albendazole or dexamethasone, the plasma concentration of praziquantel may be reduced.

[Indications] This drug is an anthelmintic agent, primarily used for the treatment of schistosomiasis in animals, and also indicated for cestodiasis and cysticercosis.

[Dosage and Administration] Oral administration (single dose per 10 kg body weight): 0.5~1.75 tablets for cattle, sheep/goats, and pigs; 0.125~0.25 tablets for dogs and cats; 0.5~1 tablet for poultry.

[Adverse Reactions] (1) At high doses, cattle may occasionally experience mild elevation of serum alanine aminotransferase, and some cattle may experience elevated body temperature, muscle tremors, and bloat, etc.

(2) Oral administration in dogs may cause anorexia, vomiting, or diarrhea, with an incidence of less than 5%, and adverse reactions in cats are rare.

[Precautions] Use with caution in puppies under 4 weeks old and kittens under 6 weeks old.

[Withdrawal Period] 28 d for cattle and poultry, 4 d for sheep/goats, and 5 d for pigs; 7 d of milk discard period.

[Shelf Life] 2 years

[Specification] 0.2 g

[Packaging] 50 tablets × 80 bottles/carton

[Storage] Store in a tightly sealed manner in a dark place.