biltricide
Biltricide (Praziquantel) is an anthelmintic used to treat Clonorchiasis, Cysticercosis, Parasitic Intestinal Diseases, Opisthorchiasis.
Praziquantel · by Bayer Hlthcare
Key facts
- Active ingredient
- Praziquantel
- Drug class
- Anthelmintic
- Form
- Tablet
- Strength
- Praziquantel 600MG **Federal Register Determination That Product was not Discontinued or Withdrawn for Safety or Effectiveness reasons**
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- clonorchiasis, cysticercosis, parasitic intestinal diseases
- Manufacturer
- Bayer Hlthcare
- What the pharmacy pays
- ~$1634.11 for 30 — not your price
- FDA application
- NDA018714
- Availability
- Discontinued (per FDA)
What is Biltricide?
From the FDA label: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 19 H 24 N 2 O 2 . The structural formula is as follows: 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 . Chemical Structure
How to use
Schistosomiasis : 20 mg/kg bodyweight 3 times a day separated by 4 to 6 hours for 1 day only. ( 2.1 ) • Clonorchiasis and Opisthorchiasis : 2 5 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. 2.1 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. 2.2 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. Use crushed or disintegrated tablets within 1 hour of mixing. Biltricide 600 mg tablets have three scores which can be split into four…
Side effects
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.…
Warnings
Important safety information
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 : 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. ( 5.2) • Potential Lack of Efficacy for Acute Schistosomiasis : This has been reported in observational studies ( 5.3 ). • Cardiac Arrhythmias: Bradycardia, ectopic rhythms, ventricular fibrillation, and AV blocks has been observed with Biltricide administration. Monitor patients with cardiac arrhythmias during treatment ( 5.4). 5.1 Clinical Deterioration The use of Biltricide in patients with schistosomiasis may be associated with clinical deterioration (for example, paradoxical reactions, serum sickness Jarisch-Herxheimer like reactions: sudden inflammatory immune response suspected to be caused by the release of schistosomal antigens). These reactions predominantly occur in patients treated during the acute phase of schistosomiasis. They may lead to potentially life-threatening events, for example, respiratory failure, encephalopathy, papilledema, and/or cerebral vasculitis. 5.2 Central Nervous System (CNS) Effects Biltricide can exacerbate central nervous system pathology due to schistosomiasis, paragonimiasis, or Taenia solium cysticercosis. As a general rule, consider whether to administer Biltricide to individuals reporting a history of epilepsy and/or other signs of potential central nervous systems involvement such as subcutaneous nodules suggestive of cysticercosis unless the potential benefit justifies the potential risk. Hospitalize the patient for duration of treatment when schistosomiasis or fluke infection is found to be associated with cerebral cysticercosis. 5.3 Potential Lack of Efficacy During the Acute Phase of Schistosomiasis Data from two observational cohort studies in patients indicate that treatment with Biltricide in the acute phase of infection may not prevent progression from asymptomatic infection to acute schistosomiasis, or from asymptomatic infection/acute schistosomiasis into chronic phase. 5.4 Cardiac Arrhythmias Bradycardia, ectopic rhythms, ventricular fibrillation, and AV blocks has been observed with Biltricide administration. Monitor patients with cardiac arrhythmias during treatment. 5.5 Hepatic Impairment in Hepatosplenic Schistosomiasis Patients Reduced hepatic metabolism of praziquantel results in higher and sustained plasma concentrations of unmetabolized praziquantel in patients with liver impairment [see Clinical Pharmacology ( 12.3 )]. Monitor patients for adverse reactions when administering the recommended dose of Biltricide to hepatosplenic schistosomiasis patients with moderate or severe liver impairment (Child-Pugh Class B or C). 5.6 Concomitant Administration with Cytochrome P450 Enzyme Inducers Strong Cytochrome P450 3A Enzyme (CYP 3A) Inducers Concomitant administration of strong CYP 3A inducers, such as rifampin, with Biltricide is contraindicated since therapeutically effective levels of praziquantel are unlikely to be achieved. [see Contraindications ( 4 ), Drug Interactions ( 7.1 ), and Clinical Pharmacology ( 12.3 )]. Moderate CYP 3A Inducers Avoid concomitant administration of Biltricide with moderate CYP 3A inducers, such as efavirenz, due to risk of a clinically significant decrease in praziquantel plasma concentrations which may lead to reduced therapeutic effect of Biltricide [see Drug Interactions ( 7.1 )] . In patients receiving a clinically significant CYP 3A inducer drug who need immediate treatment for schistosomiasis, alternative agents for schistosomiasis should be considered, where possible. If Biltricide is necessary immediately, increase monitoring for reduced anthelmintic efficacy associated with Biltricide [see Drug Interactions ( 7.1 )]. In patients receiving a clinically significant CYP 3A inducer drug whose treatment could be delayed, discontinue the CYP 3A inducer drug at least 2 weeks to 4 weeks before administration of Biltricide and, where possible, consider starting alternative medications that are not CYP 3A inducers. The CYP 3A inducer drug can be restarted one day after completion of Biltricide treatment, if needed [see Drug Interactions ( 7.1 )].
Who should not take Biltricide
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)
Interactions
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 )].
Storing Biltricide, and how long it keeps
Quoted from this product’s own FDA label. Storage belongs to the product and its device, not to the drug in general — a pen and a tablet of the same medicine are kept completely differently.
- “Crushed or disintegrated tablets should be used within 1 hour of mixing [see Dosage and Administration ( 2.”
Drug class
May treat (source: NIH RxClass)
- clonorchiasis
- cysticercosis
- parasitic intestinal diseases
- opisthorchiasis
- schistosomiasis
Dosage forms
Tablet
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
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Frequently asked questions
- What does Biltricide treat?
- Biltricide (Praziquantel) may be used to treat clonorchiasis, cysticercosis, parasitic intestinal diseases, opisthorchiasis, schistosomiasis, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How much does Biltricide cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $1634.11 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins. Pharmacies pay less for a same-class option, Albendazole — about $131.25 on the same basis.
- Is there a coupon or discount for Biltricide?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Biltricide. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Biltricide?
- Biltricide is marketed by Bayer Hlthcare. You can see Bayer Hlthcare's full profile, rating, and other products on pharmaranks.
- Is Biltricide a brand-name or generic drug?
- Biltricide is a brand-name product with the active ingredient Praziquantel.
- Is Biltricide available over the counter?
- No. Biltricide is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Biltricide come in?
- Biltricide is currently marketed as tablet, per the FDA's National Drug Code Directory.
- What class of drug is Biltricide?
- Biltricide is classified as anthelmintic, per the FDA's Established Pharmacologic Class.
- Is Biltricide FDA-registered?
- Biltricide is on record with the U.S. FDA under application number NDA018714. You can verify this on its official FDA label.
- Is Biltricide safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Biltricide. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Biltricide?
- Biltricide's side effects are taken directly from its FDA label. From the label: 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… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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