Biltricide

Name: Biltricide

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Brand names

  • Biltricide®

What Is Praziquantel?

Praziquantel is an anthelmintic (an-thel-MIN-tik) or anti-worm medication. It prevents newly hatched insect larvae (worms) from growing or multiplying in your body.

Praziquantel is used to treat infections caused by Schistosoma worms, which enter the body through skin that has come into contact with contaminated water. Schistosoma worms are found in Africa, South America, Middle Eastern countries, the Caribbean, and parts of Asia.

Praziquantel is also used to treat infection with liver flukes, caused by a type of worm found in East Asia. This worm enters the body while eating contaminated fish.

Praziquantel should not be used to treat parasitic infections in the eye.

Praziquantel may also be used for purposes not listed in this medication guide.

You should not take this medicine if you are allergic to praziquantel, or if you have take rifampin (Rifadin, Rifater, Rifamate) in the last 4 weeks.

Before taking praziquantel, tell your doctor if you have kidney disease, heart disease, liver disease, or a history of seizures or epilepsy.

Do not give this medication to a child younger than 4 years old.

Praziquantel may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Praziquantel should be taken with a meal.

Do not crush or chew the praziquantel tablet. Swallow the pill whole.

Take this medication with a full glass (8 ounces) of water.

You should not take this medicine if you are allergic to praziquantel, or if you have take rifampin (Rifadin, Rifater, Rifamate) in the last 4 weeks.

To make sure you can safely take praziquantel, tell your doctor if you have any of these other conditions:

  • headaches, confusion;
  • seizures (or a history of seizures or epilepsy);
  • lumps (nodules) under your skin;
  • kidney disease;
  • heart disease; or
  • liver disease.

FDA pregnancy category B. Praziquantel is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Praziquantel can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Do not give this medication to a child younger than 4 years old.

Praziquantel Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects may include:

  • tired feeling;
  • headache, dizziness;
  • nausea, upset stomach;
  • mild fever; or
  • mild skin rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Praziquantel Dosage

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Take this medication with a full glass (8 ounces) of water.

Praziquantel is usually taken 3 times in one day. Your doses should be taken 4 to 6 hours apart on that day.

Praziquantel should be taken with a meal.

You may need to break a praziquantel tablet in order to get the correct dose. Follow your doctor's instructions.

Do not crush or chew the praziquantel tablet or portion of a tablet. Swallow the pill whole.

Store at room temperature away from moisture and heat.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Side effects

Adverse Events

In general BILTRICIDE (praziquantel) is very well tolerated. Side effects are usually mild and transient and do not require treatment. The following side effects were observed generally in order of severity: malaise, headache, dizziness, abdominal discomfort with or without nausea, rise in temperature and, rarely, urticaria. Such symptoms can, however, also result from the infection itself. Such side effects may be more frequent and/or serious in patients with a heavy worm burden.

Post Marketing Adverse Event Reports

Additional adverse events reported from worldwide post marketing experience and from publications with praziquantel include: abdominal pain, allergic reaction (generalized hypersensitivity) including polyserositis, anorexia, arrhythmia (including bradycardia, ectopic rhythms, ventricular fibrillation, AV blocks), asthenia, bloody diarrhea, convulsion, eosinophilia, myalgia, pruritis, somnolence, vertigo and vomiting.

What should I discuss with my healthcare provider before taking Biltricide (praziquantel)?

You should not take this medicine if you are allergic to praziquantel, or if you have take rifampin (Rifadin, Rifater, Rifamate) in the last 4 weeks.

To make sure you can safely take praziquantel, tell your doctor if you have any of these other conditions:

  • headaches, confusion;

  • seizures (or a history of seizures or epilepsy);

  • lumps (nodules) under your skin;

  • kidney disease;

  • heart disease; or

  • liver disease.

FDA pregnancy category B. Praziquantel is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Praziquantel can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Do not give this medication to a child younger than 4 years old.

What should I avoid while taking Biltricide (praziquantel)?

Praziquantel may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Grapefruit and grapefruit juice may interact with praziquantel and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Cautions for Biltricide

Contraindications

  • Hypersensitivity to the drug.1

  • Intraocular cysticercosis.1 88

Warnings/Precautions

Warnings

Interactions

Therapeutically effective praziquantel concentrations may not be achieved in patients receiving concomitant therapy with drugs that are strong inducers of CYP450 (e.g., rifampin).1 (See Specific Drugs and Food under Interactions.)

Sensitivity Reactions

Urticaria,1 14 15 16 42 93 100 128 maculopapular rash,102 103 111 128 pruritus,14 15 16 42 93 102 and a generalized hypersensitivity reaction, including polyserositis, have been reported.1

Mild eosinophilia has occurred in patients with schistosomiasis treated with praziquantel.19 40 Consider that eosinophilia can be associated with schistosomiasis38 50 and may be a consequence of a host-mediated immunologic response to antigen release during drug-induced killing of the worms.65 77 78 Similarly, urticaria may result from an immunologic response to antigen release from the worms.100

General Precautions

Precautions Related to Treatment of Neurocysticercosis

CSF reaction syndrome (headache, exacerbation of neurologic signs and symptoms such as seizures, increased CSF protein concentrations and anticysticercal IgG levels, arachnoiditis, meningism, hyperthermia, and intracranial hypertension)52 53 72 73 74 76 114 115 116 121 123 137 occurs in almost all53 74 121 patients during treatment for neurocysticercosis and may rarely be life-threatening.73 114 115 116 Use appropriate corticosteroid therapy to reduce the frequency and severity of adverse nervous system effects.72 73 74 76 114 115 116 121 123

Manufacturer recommends that patients with schistosomiasis who have cerebral cysticercosis be hospitalized during treatment.1

GI Effects

Abdominal pain or discomfort (with or without nausea) occurs frequently.1 3 4 14 15 16 17 38 40 41 42 89 90 91 93 94 96 98 100 102 104 107 108 112 126 130 Vomiting,1 14 15 16 19 38 41 42 93 100 103 107 112 epigastric pain,90 91 93 94 107 126 anorexia,1 14 90 91 92 93 94 98 126 urge to defecate,89 and diarrhea14 16 41 91 93 94 104 107 112 126 130 have been reported.

GI reactions, principally colicky, crampy abdominal pain, occasionally may be severe and occur suddenly within 1 hour after administration of the drug; may be accompanied by fever, sweating, and bloody stools.89

Hepatic Effects

Mild to moderate, transient increases in serum AST and/or ALT concentrations1 occur in about 3–27% of patients;16 104 no evidence of serious adverse hepatic effects, even in patients with schistosomal infection associated with severe hepatosplenic involvement.1 16 81 112

Patients with Cardiac Irregularities

Monitor patients with cardiac irregularities during praziquantel treatment.1

Specific Populations

Pregnancy

Category B.1

Lactation

Distributed into milk; temporarily discontinue nursing on the day of therapy and for 72 hours after administration of the last dose.1

Pediatric Use

Safety in children <4 years of age not established.1

Geriatric Use

Insufficient experience in those ≥65 years of age to determine whether they respond differently than younger adults.1 No evidence of substantial differences in safety and efficacy relative to younger adults, but increased sensitivity cannot be ruled out.1

Substantially eliminated by kidneys; decreased renal function associated with advanced age may increase risk of toxicity.1

Hepatic Impairment

Use caution in hepatosplenic patients with schistosomiasis who have moderate to severe liver impairment (Child-Pugh class B and C);1 hepatic metabolism may be decreased, resulting in considerably higher and more prolonged plasma concentrations of unchanged drug.1

Common Adverse Effects

Dizziness,1 3 15 16 19 41 42 89 90 91 92 93 94 98 102 103 104 107 111 112 126 128 headache,1 4 14 16 19 41 42 89 90 91 92 93 94 96 98 100 102 103 104 107 111 112 121 126 128 130 malaise,1 4 104 121 126 abdominal discomfort (with or without nausea).1 3 4 14 15 16 17 38 40 41 42 89 90 91 93 94 96 98 100 102 104 107 108 112 126 130

Advice to Patients

  • Importance of immediately swallowing tablets, halves, and/or quarters with a sufficient amount of water during meals.1 Retention of tablets or tablet segments in the mouth may cause gagging or vomiting as a result of the drug’s bitter taste.1

  • Importance of notifying clinician of persistent or worsening symptoms of infection.1

  • Importance of completing full course of therapy, even if feeling better after a few days.1

  • Importance of not performing activities requiring mental alertness or physical coordination (e.g., operating machinery, driving a motor vehicle) on the day of, and the day following, praziquantel therapy.1

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.1

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1

  • Importance of informing patients of other important precautionary information.1 (See Cautions.)

How is this medicine (Biltricide) best taken?

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • To gain the most benefit, do not miss doses.
  • Keep taking Biltricide as you have been told by your doctor or other health care provider, even if you feel well.
  • Take your doses at least 4 hours apart but not more than 6 hours apart, unless told to do so by your doctor.
  • Take with a full glass of water.
  • Take with meals.
  • Do not chew or crush.

What do I do if I miss a dose?

  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.

Contraindications

Biltricide is contraindicated in patients who previously have shown hypersensitivity to the drug or any of the excipients. Since parasite destruction within the eye may cause irreversible lesions, ocular cysticercosis must not be treated with this compound.

Concomitant administration with strong Cytochrome P450 (P450) inducers, such as rifampin, is contraindicated since therapeutically effective blood levels of praziquantel may not be achieved (see PRECAUTIONS/Drug Interactions). In patients receiving rifampin who need immediate treatment for schistosomiasis, alternative agents for schistosomiasis should be considered. However, if treatment with praziquantel is necessary, rifampin should be discontinued 4 weeks before administration of praziquantel. Treatment with rifampin can then be restarted one day after completion of praziquantel treatment (see PRECAUTIONS/ Drug Interactions).

Adverse events

The following side effects were observed generally in order of severity: malaise, headache, dizziness, abdominal discomfort with or without nausea, rise in temperature and urticaria. Such side effects may be more frequent and/or serious in patients with a heavy worm burden.

Post Marketing Adverse Event Reports

Additional adverse events reported from worldwide post marketing experience and from publications with praziquantel include: abdominal pain, allergic reaction (generalized hypersensitivity, including polyserositis), anorexia, arrhythmia (including bradycardia, ectopic rhythms, ventricular fibrillation, AV blocks), asthenia, bloody diarrhea, convulsion, eosinophilia, fatigue, myalgia, pruritus, rash, somnolence, vertigo and vomiting.

Biltricide Dosage and Administration

The dosage recommended for the treatment of schistosomiasis is: 20 mg/kg bodyweight three times a day as a one day treatment, at intervals of not less than 4 hours and not more than 6 hours. The recommended dose for clonorchiasis and opisthorchiasis is: 25 mg/kg bodyweight three times a day as a one day treatment, at intervals of not less than 4 hours and not more than 6 hours. The tablets should be washed down unchewed with water during meals. Keeping the tablets or segments thereof in the mouth can reveal a bitter taste which can promote gagging or vomiting.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For the treatment of schistosomiasis:
      • Adults, teenagers, and children 4 years of age and older—Dose is based on body weight and must be determined by your doctor. The dose is 20 milligrams (mg) per kilogram (kg) of body weight taken three times a day for 1 day. Each dose should be at least 4 hours apart and not more than 6 hours apart.
      • Children younger than 4 years of age—Use and dose must be determined by the doctor.
    • For the treatment of clonorchiasis (Chinese or Oriental liver fluke) and opisthorchiasis (liver flukes):
      • Adults, teenagers, and children 4 years of age and older—Dose is based on body weight and must be determined by your doctor. The dose is 25 milligrams (mg) per kilogram (kg) of body weight taken three times a day for 1 day. Each dose should be at least 4 hours apart and not more than 6 hours apart.
      • Children younger than 4 years of age—Dose must be determined by the doctor.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

For Healthcare Professionals

Applies to praziquantel: compounding powder, oral tablet

General

Side effects varied according to dose and duration of praziquantel (the active ingredient contained in Biltricide) therapy. Side effects depended on parasite species, extent of infestation, infection duration, and parasite location in the body. Side effects occurred earlier and were more frequent and/or serious in patients with severe infestation.

Often, it was unclear if praziquantel, an endogenous reaction to parasites dying from the drug, or symptoms of the infestation caused the reported side effects.

Side effects included malaise, headache, dizziness, abdominal discomfort (with or without nausea), rise in temperature, and urticaria; generally in order of severity. Such side effects were more frequent and/or serious in patients with heavy worm burden.

Nervous system

The inflammatory reaction produced by antigenic substances released from dying cysts frequently involved increased intracranial pressure, seizures, severe headaches, nausea, and vomiting. In areas where Taenia solium was endemic, these reactions may occur as the result of undiagnosed cysticercosis in patients being treated for other parasitic infections. The duration of the reaction differs among patients. Delayed reactions have been reported.[Ref]

Very common (10% or more): Headache, dizziness
Common (1% to 10%): Vertigo, somnolence (including drowsiness)
Very rare (less than 0.01%): Seizures
Frequency not reported: Cerebral inflammatory reaction
Postmarketing reports: Convulsion, somnolence, vertigo[Ref]

Gastrointestinal

Very common (10% or more): Gastrointestinal and abdominal pains, nausea, vomiting
Common (1% to 10%): Diarrhea
Frequency not reported: Abdominal discomfort (with or without nausea), gagging
Postmarketing reports: Abdominal pain, bloody diarrhea, vomiting[Ref]

A syndrome of severe abdominal pain and bloody diarrhea was reported less often during schistosomiasis therapy.

Gagging and vomiting have been reported due to the bitter taste of the tablets.[Ref]

Other

Very common (10% or more): Fatigue
Common (1% to 10%): Feeling unwell (asthenia, malaise), fever
Frequency not reported: Rise in temperature, transient edema
Very rare (less than 0.01%): Polyserositis
Postmarketing reports: Asthenia, fatigue[Ref]

Dermatologic

A 13-year-old male developed Mazzotti reaction after treatment with ivermectin, praziquantel (the active ingredient contained in Biltricide) and albendazole for presumptive schistosomiasis and strongyloidiasis. Six days after receiving standard empiric therapy, he developed epigastric pain, vomiting, and urticaria. This progressed in 4 hours and included fever, general myalgia, and edema of the face, lower extremities, and penis accompanied by urticaria of the arms, legs, and trunk. He was diagnosed with a Mazzotti reaction and treated with methylprednisolone; symptoms subsided within 12 hours.[Ref]

Very common (10% or more): Urticaria
Common (1% to 10%): Rash
Very rare (less than 0.01%): Pruritus
Frequency not reported: Mazzotti-like reaction
Postmarketing reports: Pruritus, rash[Ref]

Metabolic

Common (1% to 10%)/Postmarketing reports: Anorexia

Musculoskeletal

Common (1% to 10%)/Postmarketing reports: Myalgia
Frequency not reported: Musculoskeletal aches and fatigue[Ref]

Hepatic

Frequency not reported: Mild increases in liver enzymes

Cardiovascular

Very rare (less than 0.01%): Unspecified arrhythmias
Postmarketing reports: Arrhythmia (including bradycardia, ectopic rhythms, ventricular fibrillation, atrioventricular blocks)

Hypersensitivity

Postmarketing reports: Allergic reaction (generalized hypersensitivity, including polyserositis)

Hematologic

Postmarketing reports: Eosinophilia

Some side effects of Biltricide may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Praziquantel Identification

Substance Name

Praziquantel

CAS Registry Number

55268-74-1

Drug Class

Antiinfective Agents

Anthelmintics

Antiparasitic Agents

Administrative Information

LactMed Record Number

506

Last Revision Date

20170411

Disclaimer

Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.

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