Praziquantel

What is Praziquantel?

• Praziquantel (Biltricide) is an anthelmintic used to treat schistosomiasis, clonorchiasis, opisthorchiasis, tapeworm infections, cysticercosis, hydatid disease, and other fluke infections.
• It should not be used for worm infections of the eye.
• It is used to treat a number of types of parasitic worm infections in mammals, birds, amphibians, reptiles, and fish.

Praziquantel

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Praziquantel Enantiomers Structural Formulae

What are the uses of this medicine?

Praziquantel (Biltricide) is used in patients aged 1 year and older for the treatment of the following infections:

• Schistosomiasis due to all species of schistosoma (infection with a type of worm that lives in the bloodstream), and
• Clonorchiasis and Opisthorchiasis due to the liver flukes(infection with a type of worm that lives in or near the liver) , Clonorchis sinensis/Opisthorchis viverrini

How does this medicine work?

• Praziquantel is an anthelmintic drug.
• Praziquantel induces a rapid contraction of schistosomes by a specific effect on the permeability of the cell membrane.
• The drug further causes vacuolization and disintegration of the schistosome tegument.
• However, the mechanism of action is unknown.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• hypersensitivity to praziquantel or any of the excipients in praziquantel tablets
• ocular cysticercosis
• Patients taking strong Cytochrome P450 (CYP450) inducers, such as rifampin

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention any of the following:

• chloroquine (Aralen)
• cimetidine (Tagamet)
• dexamethasone (Decadron, Dexpak)
• erythromycin (E.E.S., E-Mycin, Erythrocin)
• itraconazole (Sporanox)
• ketoconazole (Nizoral)
• certain medications for seizures such as phenytoin (Dilantin), phenobarbital, and carbamazepine (Equetro, Tegretol).

Is this medicine FDA approved?

• Praziquantel was approved for medical use in the United States in 1982.

How should this medicine be used?

Recommended dosage: Schistosomiasis:

• The recommended dosage for the treatment of schistosomiasis is 20 mg/kg body weight 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 body weight administered orally three times a day separated by 4 to 6 hours for 1 day only.

Administration:

• Praziquantel comes as a tablet to take by mouth with water and a meal. It is usually taken for one day as three doses; each dose spaced 4 to 6 hours apart.
• 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.
• Praziquantel 600 mg tablets have three scores which can be split into four segments at the scores.
• When broken, each of the four segments contains 150 mg of praziquantel so that the dosage can be adjusted to the patient’s body weight.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 600 mg (with three scores (notches) on the tablet)

This medicine is available in fallowing brand namesː

• Biltricide

What side effects can this medication cause?

The most common side effects of this medicine include:

• malaise
• headache
• dizziness
• abdominal discomfort (with or without nausea)
• pyrexia
• urticaria

Serious side effects may include:

• 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

What special precautions should I follow?

• Potentially life threatening clinical deterioration can 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.
• 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.
• Treatment with praziquantel in the acute phase of infection may not prevent progression from asymptomatic infection to acute schistosomiasis.
• Advise patients not to drive a car and not to operate machinery on the day of praziquantel treatment and the following day.
• Advise patients to report any cardiac irregularities to their healthcare provider.
• praziquantel should not be used if they have epilepsy or other CNS effects.
• Patients not to take praziquantel if they are taking rifampin.
• Advise patients not to chew tablets and to take them with water.
• 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.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Published studies have not identified an association with praziquantel use during pregnancy and major birth defects, miscarriage or adverse maternal or fetal outcomes.

Can this medicine be used in children?

• 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.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• PRAZIQUANTEL

Inactive ingredients:

• STARCH, CORN
• CROSCARMELLOSE SODIUM
• MAGNESIUM STEARATE
• MICROCRYSTALLINE CELLULOSE
• POVIDONE
• SODIUM LAURYL SULFATE
• POLYETHYLENE GLYCOL 1000
• TITANIUM DIOXIDE
• HYPROMELLOSE

Who manufactures and distributes this medicine?

Dist. by:

• Par Pharmaceutical
• Chestnut Ridge, NY U.S.A.

Mfg. by:

• Par Formulations Private Limited,
• 9/215, Pudupakkam, Kelambakkam
• Made in India

What should I know about storage and disposal of this medication?

• Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F).

The following are antihelmintic agents 

• Albendazole
• Ivermectin
• Mebendazole
• Nitazoxanide
• Pentamidine
• Praziquantel
• Pyrantel
• Thiabendazole

• Dailymed label info on Praziquantel
• FDA Praziquantel