PRAZIQUANTEL tablet, film coated

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Par Pharmaceutical, Inc.

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Praziquantel tablets are indicated in patients aged 1 year and older for the treatment of the following infections: - Schistosomiasis due to all species of schistosoma (for example, Schistosoma mekongi, Schistosoma japonicum, Schistosoma mansoni and Schistosoma hematobium ), and - Clonorchiasis and Opisthorchiasis 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) Praziquantel is contraindicated in: - Patients who previously have shown hypersensitivity to praziquantel or any of the excipients in praziquantel tablets. - Patients with ocular cysticercosis; since parasite destruction within the eye that occurs because of hypersensitivity reaction to the dead parasite after treatment may cause irreversible lesions, ocular cysticercosis must not be treated with praziquantel. - Patients taking strong Cytochrome P450 (CYP450) inducers, such as rifampin, [see Warnings and  Precautions (5.6)  and D

Ringkasan produk:

Praziquantel tablets, USP are supplied as 600 mg tablets containing praziquantel, USP. The tablets are white to off white, film-coated, oblong tablet with three scores coded with “PAR” on one side “231” on the reverse side. Praziquantel tablets, USP 600 mg are available in bottles of 6 tablets (NDC 49884-231-83). Store at 20° to 25° C (68° to 77° F); excursions permitted between 15° and 30° C (59° and 86° F) [see USP Controlled Room Temperature].

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

PRAZIQUANTEL- PRAZIQUANTEL TABLET, FILM COATED
PAR PHARMACEUTICAL, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PRAZIQUANTEL TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PRAZIQUANTEL
TABLETS.
PRAZIQUANTEL TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1982
INDICATIONS AND USAGE
Praziquantel tablets are an anthelmintic indicated in patients aged
one year and older for the treatment of the following
infections: (1)
Schistosomiasis due to all species of schistosoma (for example_,
Schistosoma mekongi_, _Schistosoma japonicum_,
_Schistosoma mansoni _and _Schistosoma hematobium_), and,
Clonorchiasis and Opisthorchiasis due to the liver flukes, _Clonorchis
sinensis _and _Opisthorchis viverrini_
DOSAGE AND ADMINISTRATION
Schistosomiasis: 20 mg/kg body weight 3 times a day separated by 4 to
6 hours for 1 day only. (2.1)
Clonorchiasis and Opisthorchiasis: 25 mg/kg 3 times a day separated by
4 to 6 hours for 1 day only. (2.1)
Take with water during meals. Do not chew or keep segments in the
mouth. (2.2)
For pediatric patients under 6 years of age, the tablets may be
crushed or disintegrated and mixed with semi-solid food
or liquid. (2.2)
For additional administration instructions see the full prescribing
information.
DOSAGE FORMS AND STRENGTHS
Tablets: 600 mg (with three scores (notches) on the tablet) (3)
CONTRAINDICATIONS
Known hypersensitivity to praziquantel or any of its ingredients.
(4.1)
Concomitant administration with strong Cytochrome P450 (CYP450)
inducers such as rifampin. (4., 5.4, 7.1)
WARNINGS AND PRECAUTIONS
Clinical Deterioration: Potentially life threatening clinical
deterioration can occur in patients treated during the acute
phase of schistosomiasis. (5.1)
Central Nervous System (CNS) Effects: Praziquantel can exacerbate
central nervous system pathology due to
schistosomiasis. Consider whether to administer to individuals
reporting a history of epilepsy and/or other signs of
potential central nervous systems i