Description
Praziquantel is used to treat schistosomiasis, also known as snail fever or bilharzia, an infection of the urinary tract or bowels, caused by schistosoma (blood fluke), a flatworm parasite. It is also used to treat clonorchiasis infection caused by the Chinese or Oriental liver fluke (Clonorchis sinensis) or opisthorchiasis infection caused by the Southeast Asian liver fluke (Opisthorchis viverrini).
Blood flukes live in freshwater snails and are spread into the surrounding waters (eg, pond). You may get infected when you swim or get in these waters. They enter the body through the skin and travel until they reach your bowels where they grow and lay eggs. Sometimes, the eggs get in the liver, which causes chronic inflammation. Infections with a liver fluke usually occur after eating contaminated raw or undercooked freshwater fish, crabs, or crayfish. They travel from your bowels to the bile ducts in the liver where they live and grow. Most patients infected with liver flukes do not show any symptoms, which may cause the infection to last a long time.
Praziquantel belongs to the family of medicines called anthelmintics. Anthelmintics are used in the treatment of worm infections. Praziquantel works by causing severe spasms and paralysis of the worms' muscles. Some kinds of worms are then passed in the stool. However, you may not notice them since they are sometimes completely destroyed in the bowels.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of praziquantel in children 1 year of age and older. However, safety and efficacy have not been established in children younger than 1 year of age.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of praziquantel in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution for patients receiving praziquantel.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Apalutamide
- Carbamazepine
- Dexamethasone
- Enzalutamide
- Fosphenytoin
- Ivosidenib
- Lumacaftor
- Mitotane
- Phenytoin
- Rifampin
- Rifapentine
- St John's Wort
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Avacopan
- Bosentan
- Cenobamate
- Clarithromycin
- Dabrafenib
- Dipyrone
- Efavirenz
- Elagolix
- Etravirine
- Itraconazole
- Lorlatinib
- Mavacamten
- Modafinil
- Nafcillin
- Phenobarbital
- Primidone
- Rifabutin
- Tazemetostat
- Telotristat Ethyl
- Thioridazine
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Chloroquine
- Ketoconazole
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Grapefruit Juice
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Epilepsy or seizures, history of or
- Heart rhythm problems—Use with caution. May make these conditions worse.
- Kidney disease or
- Liver disease, moderate to severe—Use with caution. The effects may be increased by slower removal of the medicine from the body.
- Ocular cysticercosis (tapeworm cysts in the eye)—Should not be used in patients with this condition.
- Worm cysts in the brain—Your doctor may want you to be in the hospital to treat this infection.
Proper Use
Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.
Praziquantel has a bitter taste that may cause gagging or vomiting. The bitter taste may be more noticeable if the tablets are held in the mouth or chewed. Therefore, do not chew praziquantel tablets. Swallow the tablets whole with water during meals.
If your child cannot swallow the tablet, you may crush or dissolve and mix it with semi-solid food or liquid. Take the mixture within 1 hour of mixing.
Do not break the tablet unless your doctor tells you to. If you have been told to break your tablet, you can break off a part by pressing the notch with your thumbnails. If one-fourth of a tablet is required, break the tablet from the outer end.
Keep using this medicine for the full treatment time, even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon.
Do not eat grapefruit or drink grapefruit juice while you are using this medicine.
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 clonorchiasis (Chinese or Oriental liver fluke) and opisthorchiasis (liver flukes):
- Adults and children 1 year 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 3 times a day for 1 day only. Each dose should be at least 4 hours apart and not more than 6 hours apart.
- Children younger than 1 year of age—Use and dose must be determined by the doctor.
- For schistosomiasis:
- Adults and children 1 year 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 3 times a day for 1 day only. Each dose should be at least 4 hours apart and not more than 6 hours apart.
- Children younger than 1 year of age—Use and dose must be determined by the doctor.
- For clonorchiasis (Chinese or Oriental liver fluke) and opisthorchiasis (liver flukes):
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
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.
Precautions
It is important that your doctor check your or your child's progress after treatment. This is to make sure that the infection is cleared up completely and to check for unwanted effects.
If your or your child's symptoms do not improve, or if they become worse, check with your doctor.
Do not use this medicine together with rifampin (Rifadin®, Rimactane®).
This medicine kills the worms and could cause unwanted effects (eg, serum sickness, paradoxical reaction) as your body heals, especially during the early stages of schistosomiasis. Talk to your doctor if you have concerns.
This medicine may cause heart rhythm problems. Tell your doctor right away if you or your child gets dizzy or lightheaded, have a fast or irregular heart beat, or feel like fainting.
This medicine may cause some people to become dizzy, drowsy, or less alert than they are normally.Do not drive or do anything else that could be dangerous during treatment with this medicine and for 24 hours after your last dose.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Incidence not known
- Black, tarry stools
- blistering, peeling, or loosening of the skin
- bloody diarrhea
- blurred or loss of vision
- chest pain, discomfort, or tightness
- chills
- cough
- dark urine
- diarrhea
- difficulty swallowing
- difficulty with moving
- disturbed color perception
- dizziness
- double vision
- fainting
- fast, slow, or irregular heartbeat
- fever
- general feeling of discomfort or illness
- general tiredness and weakness
- halos around lights
- hives, itching, skin rash
- joint pain, stiffness, or swelling
- light-colored stools
- lightheadedness, dizziness, or fainting
- muscle pains, cramps, or stiffness
- nausea
- night blindness
- overbright appearance of lights
- painful or difficult urination
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- red skin lesions, often with a purple center
- red, irritated eyes
- redness of the skin
- severe abdominal or stomach pain
- seizures
- sleepiness or unusual drowsiness
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- stomach discomfort with or without nausea
- stomach pain
- sweating
- swelling of the eyelids, face, lips, hands, or feet
- swollen glands
- thickening of bronchial secretions
- tremor
- troubled breathing
- tunnel vision
- unusual bleeding or bruising
- unusual tiredness or weakness
- upper right abdominal or stomach pain
- vomiting
- yellow eyes and skin
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Incidence not known
- Change in walking and balance
- clumsiness or unsteadiness
- continuing ringing or buzzing or other unexplained noise in the ears
- dizziness or lightheadedness
- feeling of constant movement of self or surroundings
- headache
- hearing loss
- lack or loss of strength
- loss of appetite
- sensation of spinning
- weight loss
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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