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 (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) 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 (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

Praziquantel is an anthelmintic drug.

• Schistosomiasis: 20 mg/kg bodyweight 3 times a day separated by 4 to 6 hours for 1 day only. • Clonorchiasis and Opisthorchiasis: 2 5 mg/kg 3 times a day separated by 4 to 6 hours for 1 day only. • Take with water during meals. Do not chew or keep segments in the mouth. • For pediatric patients under 6 years of age, the tablets may be crushed or disintegrated and mixed with semi-solid food or liquid. • For additional administration instructions see the full prescribing information.

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,. • Known hypersensitivity to Biltricide or any of its ingredients. • Concomitant administration with strong Cytochrome P450 3A enzyme (CYP 3A) inducers such as rifampin. ( 4, 5.6 7.1)

• Clinical Deterioration: Potentially life threatening clinical deterioration can occur in patients treated during the acute phase of schistosomiasis. • Central Nervous System (CNS) Effects: Biltricide 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 involvement such as subcutaneous nodules suggestive of cysticercosis. • Potential Lack of Efficacy for Acute Schistosomiasis: This has been reported in observational studies. • Cardiac Arrhythmias: Bradycardia, ectopic rhythms, ventricular fibrillation, and AV blocks has been observed with Biltricide administration. Monitor patients with cardiac arrhythmias during treatment.

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.

Moderate CYP 3A Inducers: Avoid concomitant administration of moderate CYP 3A inducers, for example, efavirenz CYP 3A Inducers Strong and Moderate CYP 3A Inducers Concomitant administration of Biltricide with Strong and Moderate CYP 3A inducers decrease praziquantel AUC and Cmax which may reduce the efficacy of Biltricide. Concomitant administration of a Strong CYP 3A inducer, such as rifampin, with Biltricide is contraindicated. Concomitant administration of a Moderate CYP 3A inducer, such as efavirenz, should be avoided unless the benefit outweighs the risks CYP450 inhibitors Concomitant administration of drugs that decrease the activity of drug metabolizing liver enzymes (CYP450 inhibitors), for example, cimetidine, ketoconazole, itraconazole, erythromycin, and ritonavir may increase plasma concentrations of praziquantel.

Store below 86°F (30°C).