Alprazitel Tablet

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 tablets are 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 , …

• Schistosomiasis : 20 mg/kg body weight 3 times a day separated by 4 to 6 hours for 1 day only
• Clonorchiasis and Opisthorchiasis : 25 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
• Recommended Dosage Schistosomiasis The recommended dosage
• For the treatment of schistosomiasis is 20 mg/kg bodyweight administered orally three times a day separated by 4 to 6 hours, for 1 day only
• Clonorchiasis and Opisthorchiasis The recommended dosage
• For the treatment of clonorchiasis and opisthorchiasis is 25 mg/kg bodyweight administered orally three times a day separated by 4 to 6 hours for 1 day only
• Administration Take tablets with water during meals
• Do not chew or keep the tablets (or parts of tablets) in the mouth; the bitter taste may cause gagging or vomiting
• To prevent choking
• In pediatric patients under 6 years of age, the tablets may be crushed or disintegrated and mixed with semi-solid food or liquid

Praziquantel tablets, USP contain 600 mg of 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. Tablets: 600 mg (with three scores (notches) on the tablet) ( 3 )

• Safety and dosing recommendations of praziquantel
• In pediatric patients 1 to 17 years have been established
• Safety of praziquantel
• In pediatric patients younger than 1 year of age has not been established
• Post-marketing experience and published literature indicates that pediatric patients 1 to 17 years of age treated with praziquantel experience similar adverse reactions as
• Adults treated with praziquantel [see Adverse Reactions ]

Clinical studies of praziquantel did not include a sufficient number of subjects ages 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older patients cannot be ruled out. This drug is known to be substantially excreted by the kidney. …

• Advise patients to take praziquantel during meals as directed [see Dosage and Administration ]
• Advise patients not to chew tablets and to take them with water [see Dosage and Administration ] 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 [see Dosage and Administration ]
• Advise patients not to take praziquantel tablets if they are allergic to praziquantel or any of its components [see Contraindications ]. …

• 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. …

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 praziquantel with Strong and Moderate CYP 3A inducers decrease praziquantel AUC and C max [see Clinical Pharmacology (12.3) ] which may reduce the efficacy of praziquantel. Concomitant administration of a Strong CYP 3A inducer, such as rifampin, with praziquantel is contraindicated [see Contraindications (4) ]. …

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 involvement such as subcutaneous nodules suggestive of cysticercosis. ( 5.2 ) Potential Lack of Efficacy for Acute Schistosomiasis : This has been reported in observational studies ( 5.3 ). …

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 praziquantel were identified in cli …

8.1 Pregnancy Risk Summary Published studies have not identified an association with praziquantel use during pregnancy and major birth defects, miscarriage or adverse maternal or fetal outcomes (see Data) . In animal reproduction studies conducted in pregnant rats and rabbits no adverse developmental outcomes were observed with oral administration of praziquantel during organogenesis at approximately 0.65 times (rats) or 1.3 times (rabbits) the h …

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