Zifam Prazi-Q 600

 

Praziquantel Tablets USP 600mg

 

COMPOSITION:

Each Film-coated tablet contains:

Praziquantel USP …….600 mg

Excipients ….q.s.

Colour. Titanium Dioxide BP

 

PHARMACOLOGICALACTION:

Trematodicide

 

PHARMACODYNAMICS

In vitro studies on trematodes and cestodes (tapeworms) have shown that praziquantel induces a rapid contraction of schistosomes by a specific effect on the permeability of the cell membranes. The medicine further causes vacuolization and disintegration of the schistosome tegument. An increased Ca2+ influx may play an important role. Secondary effects are inhibition of glucose uptake, lowering of glycogen levels and stimulation of lactate release. The action of praziquantel is limited very specifically to trematodes and cestodes; nematodes (including filariae) are not affected.

 

PHARMACOKINETICS:

Absorption: After oral administration, praziquantel is rapidly absorbed. Maximal plasma concentrations are achieved within I -2 hours.

The medicine’s concentration is 0.05 to mg/L in peripheral after administration of 5 to 50 mg/kg: the concentration in the mesenteric vein is 3 to 4 times higher compared to peripheral blood. The half-life of unchanged praziquantel is 1-2,5 hours. The half-life of total radioactivity praziquantel plus metabolites) after administration of 14C-praziquantd is 4 hours. For attaining therapeutic effect plasma levels of µM/L (= 0.19 mg/L) have to be maintained for (up to I0) hours.

Distribution: Unchanged praziquantel passes the blood brain barrier; its concentration in cerebrospinal fluid is estimated to be 10% to 20% plasma concentration.

Metabolism: Praziquantel is rapidly and extensively metabolized by a first pass effect. Main metabolites are hydroxylated degradation products of Praziquantel

Excretion: Praziquantel is eliminated predominantly via the kidneys as metabolites. More than 80% of the dose administered is eliminated renally within 4 days, 90% of this amount within the first 24 hours.

 

INDICATIONS:

Infections due to organisms of the following species pathogenic to man:

Schistosoma haematobium; Schistosoma mansoni.

Liver fluke, Blood fluke

 

CONTRAINDICATIONS:

ZIFAM PRAZI-Q 600 should not be used in cases of known hypersensitivity to praziquantel or any of its excipients.

 

DOSAGE&ADMINISTRATION:

For the treatment of Schistosomiasis, caused by S. haematobium and S. mansoni, the intake of 40 mg/kg body mass or 20 mg/kg body mass twice, on a single day is recommended.

 

Administration:

The tablets should be swallowed whole with little liquid. With single daily doses it is recommended to take the tablets in the evening. If ingestion of tablets several times a day is prescribed, the interval between the administrations should not be less than 4 hours and not more than 6 hours.

Children: Safety in children under 4 years of age has not been established.