Brand Name
Biltricide
Generic Name
Praziquantel
View Brand Information FDA approval date: April 21, 2011
Classification: Anthelmintic
Form: Tablet
What is Biltricide (Praziquantel)?
Biltricide is indicated in patients aged 1 year and older for the treatment of the following infections: Schistosomiasis due to all species of schistosoma , and, Clonorchiasis and Opisthorchiasis due to the liver flukes, Clonorchis sinensis/Opisthorchis viverrini Biltricide is an anthelmintic indicated in patients aged one year and older for the treatment of the following infections:, Schistosomiasis due to all species of schistosoma , and, Clonorchiasis and Opisthorchiasis due to the liver flukes, Clonorchis sinensis and Opisthorchis viverrini.
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Brand Information
Biltricide (praziquantel)
1INDICATIONS AND USAGE
Biltricide is indicated in patients aged 1 year and older for the treatment of the following infections:
- Schistosomiasis due to all species of schistosoma (for example,
- Clonorchiasis and Opisthorchiasis due to the liver flukes,
2DOSAGE FORMS AND STRENGTHS
Biltricide tablets contain 600 mg of praziquantel. The tablets are white to orange tinged, film-coated, oblong with three scores (notches), imprinted with “BAYER” on one side and “LG” on the other side.
3CONTRAINDICATIONS
Biltricide is contraindicated in:
- Patients who previously have shown hypersensitivity to praziquantel or any of the excipients in Biltricide.
- 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 Biltricide.
- Patients taking strong Cytochrome P450 3A enzyme (CYP3A) inducers, such as rifampin,
4ADVERSE REACTIONS
The following serious or otherwise important adverse reactions are discussed elsewhere in the labeling:
- Clinical Deterioration
- Central Nervous System (CNS) Effects
- Potential Lack of Efficacy During the Acute Phase of Schistosomiasis
- Cardiac Arrhythmias
- Hepatic Impairment in Hepatosplenic Schistosomiasis Patients
- Concomitant Administration with Strong Cytochrome P450 Inducers
The following adverse reactions associated with the use of Biltricide were identified in clinical studies, published literature or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The following adverse reactions were observed in both adults and pediatric patients:
General disorders and administration site conditions: malaise, pyrexia
Nervous system disorders: headache, dizziness
Gastrointestinal disorders: abdominal discomfort, nausea
Skin and subcutaneous tissue disorders: urticaria
Such adverse reactions may be more frequent and/or serious in patients with a heavy worm burden.
Additional adverse reactions reported from worldwide post marketing experience and from publications with Biltricide and various formulations of praziquantel include:
Blood and lymphatic system disorders: eosinophilia
Cardiac disorders: arrhythmia (including bradycardia, ectopic rhythms, ventricular fibrillation, AV blocks)
Ear and labyrinth disorders: vertigo, tinnitus
Eye disorders: visual disturbance
Gastrointestinal disorders: abdominal pain, bloody diarrhea, vomiting
General disorders and administration site conditions: polyserositis, asthenia, fatigue, gait disturbance
Hepatobiliary disorders: hepatitis
Immune system disorders: allergic reaction, generalized hypersensitivity, anaphylactic reaction
Metabolism and nutrition disorders: anorexia
Musculoskeletal and connective tissue disorders: myalgia
Nervous system disorders: convulsion, somnolence, intention tremor
Respiratory, thoracic and mediastinal disorders: pneumonitis, dyspnea, wheezing
Skin and subcutaneous tissue disorders: pruritus, rash, Stevens-Johnson syndrome
Pediatric patients 1 to 17 years of age treated with Biltricide and various formulations of praziquantel experienced similar adverse reactions as those observed in adult patients.
5DESCRIPTION
Biltricide (praziquantel) is an anthelmintic, trematodicide provided in tablet form for oral administration.
Praziquantel is 2-(cyclohexylcarbonyl)-1,2,3,6,7, 11b-hexahydro-4H-pyrazino [2, 1-a] isoquinolin-4-one with the molecular formula; C
Praziquantel is a white to nearly white crystalline powder of bitter taste. The compound is stable under normal conditions and melts at 136 to 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, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium lauryl sulfate, and titanium dioxide .
6HOW SUPPLIED/STORAGE AND HANDLING
Biltricide is supplied as 600 mg tablets containing praziquantel. The tablets are white to orange tinged, film-coated, oblong tablets with three scores. The tablet is coded with “BAYER” on one side and “LG” on the reverse side.
Biltricide is available in bottles of six 600 mg tablets, NDC 50419-747-01.
Store below 86°F (30°C).
7PATIENT COUNSELING INFORMATION
- Advise patients to take Biltricide during meals as directed
- Advise patients not to chew tablets and to take them with water
- Advise patients that tablets may be crushed or disintegrated and mixed with semi-solid food or liquid or disintegrated to prevent choking in children under 6 years of age. Crushed or disintegrated tablets should be used within 1 hour of mixing
- Advise patients not to take Biltricide if they are allergic to Biltricide or any of its components
- Advise patients not to take Biltricide if they are taking rifampin
- Advise patients not to take Biltricide if they are taking efavirenz
- Advise patients that the use of praziquantel can be associated with clinical deterioration during the acute phase of schistosomiasis
- Advise patients that Biltricide should not be used if they have epilepsy of or other CNS effects
- Advise patients to report any cardiac irregularities to their healthcare provider
- Advise patients not to drive a car and not to operate machinery on the day of Biltricide treatment and the following day.
Manufactured for:
Bayer HealthCare Pharmaceuticals Inc.
Whippany, NJ 07981 USA
© 2018 Bayer HealthCare Pharmaceuticals Inc.
8PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
Biltricide 600 mg Tablets Bottle Label
8339661
Biltricide®
Tablets
(praziquantel)
600 mg
6 Tablets
Rx Only
