Praziquantel: uses, dosing, side effects & brands

The following serious or otherwise important adverse reactions are discussed elsewhere in the labeling: • Clinical Deterioration [see Warnings and Precautions ( 5.1 )] • Central Nervous System (CNS) Effects [see Warnings and Precautions ( 5.2 )] • Potential Lack of Efficacy During the Acute Phase of Schistosomiasis [see Warnings and Precautions ( 5.3 )] • Cardiac Arrhythmias [see Warnings and Precautions ( 5.4 )] • Hepatic Impairment in Hepatosplenic Schistosomiasis Patients [see Warnings and Precautions ( 5.5 )] • Concomitant Administration with Strong Cytochrome P450 Inducers [see Warnings and Precautions ( 5.6 )] 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.…

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, [see Warnings and Precautions ( 5.6 ) and Drug Interactions ( 7.1 , 7.2 )] . • Known hypersensitivity to Biltricide or any of its ingredients. ( 4.1 ) • Concomitant administration with strong Cytochrome P450 3A enzyme (CYP 3A) inducers such as rifampin. ( 4 , 5.6 7.1)

Moderate CYP 3A Inducers : Avoid concomitant administration of moderate CYP 3A inducers, for example, efavirenz ( 5.6 , 7.1 ) 7.1 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 [see Clinical Pharmacology ( 12.3 )] which may reduce the efficacy of Biltricide. Concomitant administration of a Strong CYP 3A inducer, such as rifampin, with Biltricide is contraindicated [see Contraindications ( 4)] . Concomitant administration of a Moderate CYP 3A inducer, such as efavirenz, should be avoided unless the benefit outweighs the risks [see Warnings and Precautions ( 5.6 ) and Clinical Pharmacology ( 12.3 ).] 7.2 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. In addition, grapefruit juice was also reported to produce a 1.6-fold increase in the C max and a 1.9-fold increase in the AUC of praziquantel. The effect of this exposure increase on the safety of Biltricide has not been systematically evaluated [see Dosage and Administration ( 2.2 )].