INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo BILTRICIDE®

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

BILTRICIDE®
Tablets

COMPOSITON:
Each lacquered tablet contains 600 mg
praziquantel.

PHARMACOLOGICAL CLASSIFICATION:
A 12. Anthelmintics, Bilharzia medicines, Filaricides, etc.

PHARMACOLOGICAL ACTION:
Trematodicide

INDICATIONS:
Infections due to organisms of the following species pathogenic to man:
Schistosoma haematobium; Schistosoma mansoni.

CONTRA-INDICATIONS:
Known hypersensitivity to praziquantel. BILTRICIDE should not be taken during the first trimester of pregnancy.

WARNINGS:
Special care should be taken in patients with ocular cysticercosis.

DOSAGE AND DIRECTIONS FOR USE:
For the treatment of Schistosomiasis, caused by S. haematobium and S. mansoni, the intake of 40 mg/kg body mass once or 20 mg/kg body mass twice, on a single day is recommended.
Administration:
The tablets should be swallowed whole with a little liquid preferably after the evening meal. The tablets should not be chewed. In case of repeated intake on the same day, the interval between the individual doses should not be less than 4 and not more than 6 hours. One oblong tablet has 4 segments. Each segment contains 150 mg praziquantel so that dosage can be exactly adjusted to the patient’s body mass. If a quarter of a tablet is required this is best achieved by breaking the segment from the outer end. Segments are broken off by pressing notch with thumb nails.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Side effects are usually mild and temporary and include abdominal pain, nausea, vomiting, headache, fever, pruritis, drowsiness. Side effects may be more severe in heavy infestations.
Special precautions:
The patient’s ability to drive or to operate machinery may be temporarily impaired. Caution should be exercised where there is a possibility of a simultaneous occurrence of both Schistosomiasis and CNS-cysticercosis infection, as cerebral cysticercosis requires hospital-based treatment by a specialist.
The safety in pregnancy has not yet been established. A breastfeeding mother can undergo treatment provided her baby is fed otherwise on the day of treatment and during the subsequent 48 hours.
Interactions:
No interaction with other drugs has been observed to date.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Pronounced dizziness, “hang-over”feelings. There is no specific antidote and symptomatic measures should be applied.

IDENTIFICATION:
A white to orange-tinged oblong tablet with 4 equal segments, marked with LG on the one side and BAYER on the other.

PRESENTATION:
Packs of 10 and tins of 1000 lacquered tablets of 600 mg each.

STORAGE INSTRUCTIONS:
Store below 25°C. Keep out of reach of children.

REGISTRATION NUMBER:
P/12/23

ZIMBABWE : PID
        82/7.8/1576

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
BAYER (PTY) LTD
Wrench Road        Isando        1600

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
March 1988

® Registered trademark of Bayer AG, Germany.

PRAZIQUANTEL IS A JOINT DEVELOPMENT OF BAYER AG, LEVERKUSEN AND E MERCK, DARMSTADT, GERMANY

Updated on this site: February 2003
Source:Pharmaceutical Industry

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