Dronspot

Praziquantel (Dronspot) (Praziquantel (Dronspot)) is indicated for the treatment of infections due to: all species of schistosoma (for example, Schistosoma mekongi, Schistosoma japonicum, Schistosoma mansoni and Schistosoma hematobium), and infections 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 (Dronspot) is used to treat infections caused by parasites such as liver flukes (worms) or schistosoma (blood fluke). These infections are also known as snail fever, schistosomiasis, or bilharziasis. Praziquantel (Dronspot) may also be used for other worm infections as determined by your doctor. However, it will not work for pinworms or other roundworms.

Praziquantel (Dronspot) belongs to the family of medicines called anthelmintics. Anthelmintics are used in the treatment of worm infections. Praziquantel (Dronspot) 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 intestine.

Praziquantel (Dronspot) is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in the product labeling, Praziquantel (Dronspot) is used in certain patients with the following medical conditions:

• Some kinds of fluke infections.
• Some kinds of tapeworm infections.

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.

How supplied

Praziquantel (Dronspot) (Praziquantel (Dronspot)) is supplied as a 600 mg white to orange tinged, film-coated, oblong tablet with three scores. The tablet is coded with “BAYER” on one side and “LG” on the reverse side. When broken, each of the four segments contains 150 mg of active ingredient so that the dosage can be easily adjusted to the patient's bodyweight.

Segments are broken off by pressing the score (notch) with thumbnails. If ¼ of a tablet is required, this is best achieved by breaking the segment from the outer end.

Praziquantel (Dronspot) (Praziquantel (Dronspot)) is available in bottles of 6 tablets.

Store below 86°F (30°C).

Manufactured by: Bayer HealthCare Pharmaceuticals Inc. Wayne, NJ 07470. Made in Germany. Distributed and Marketed by: Schering Corporation, a subsidiary of Whitehouse Station, NJ 08889, USA. Revised: 08/10.

See also:
What is the most important information I should know about Praziquantel (Dronspot)?

Praziquantel (Dronspot) (Praziquantel (Dronspot)) 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 (Dronspot) may not be achieved. In patients receiving rifampin who need immediate treatment for schistosomiasis, alternative agents for schistosomiasis should be considered. However, if treatment with Praziquantel (Dronspot) is necessary, rifampin should be discontinued 4 weeks before administration of Praziquantel (Dronspot). Treatment with rifampin can then be restarted one day after completion of Praziquantel (Dronspot) treatment.

Use Praziquantel (Dronspot) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Praziquantel (Dronspot) with a full glass of water during meals.
• Do not crush or chew before swallowing.
• Take your doses at least 4 hours apart but not more than 6 hours apart unless directed otherwise by your doctor.
• If you miss a dose of Praziquantel (Dronspot), take it as soon as possible. If it less than 4 hours until your next dose, contact your doctor to see if you need to establish a new dosing schedule.

Ask your health care provider any questions you may have about how to use Praziquantel (Dronspot).

Use: Labeled Indications

Helminths: Treatment of infections in patients ≥1 year caused by the following: All species of Schistosoma (eg, Schistosoma mekongi, Schistosoma japonicum, Schistosoma mansoni, Schistosoma haematobium) and the liver flukes Clonorchis sinensis/Opisthorchis viverrini

Off Label Uses

Neurocysticercosis, parenchymal

Data from the phase II and phase III portions of a randomized, double blind, placebo-controlled study supports the use of Praziquantel (Dronspot) (in combination with albendazole) in the treatment of parenchymal neurocysticercosis.

See also:
What other drugs will affect Praziquantel (Dronspot)?

Concomitant administration of rifampin, a strong P450 inducer, with Praziquantel (Dronspot) is contraindicated and must be avoided. In a crossover study with a 2-week washout period, 10 healthy subjects ingested a single 40 mg/kg dose of Praziquantel (Dronspot) following pre-treatment with oral rifampin (600 mg daily for 5 days). Plasma Praziquantel (Dronspot) concentrations were undetectable in 7 out of 10 subjects. When a single 40 mg/kg dose of Praziquantel (Dronspot) was administered to these healthy subjects two weeks after discontinuation of rifampin, the mean Praziquantel (Dronspot) AUC and Cmax were 23% and 35% lower, respectively, than when Praziquantel (Dronspot) was given alone. In patients receiving rifampin, for example, as part of a combination regimen for the treatment of tuberculosis, alternative agents for schistosomiasis should be considered. However, if treatment with Praziquantel (Dronspot) is necessary, treatment with rifampin should be discontinued 4 weeks before administration of Praziquantel (Dronspot). Treatment with rifampin can then be restarted one day after completion of Praziquantel (Dronspot) treatment.

Concomitant administration of other drugs that increase the activity of drug metabolizing liver enzymes (P450 inducers), for example, antiepileptic drugs (phenytoin, phenobarbital and carbamazepine), and dexamethasone, may also reduce plasma levels of Praziquantel (Dronspot). Concomitant administration of drugs that decrease the activity of drug metabolizing liver enzymes (P 450 inhibitors), for example, cimetidine, ketoconazole, itraconazole, erythromycin may increase plasma levels of Praziquantel (Dronspot).

Chloroquine, when taken simultaneously, may lead to lower concentrations of Praziquantel (Dronspot) in blood. The mechanism of this drug-drug interaction is unclear.

Grapefruit juice was reported to produce a 1.6-fold increase in the Cmax and a 1.9-fold increase in the AUC of Praziquantel (Dronspot). However, the effect of this exposure increase on the therapeutic effect and safety of Praziquantel (Dronspot) has not been systematically evaluated.

See also:
What are the possible side effects of Praziquantel (Dronspot)?

Applies to Praziquantel (Dronspot): oral tablet

In addition to its needed effects, some unwanted effects may be caused by Praziquantel (Dronspot) (the active ingredient contained in Praziquantel (Dronspot)). In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking Praziquantel (Dronspot):

Incidence not known:

• Abdominal or stomach discomfort with or without nausea
• abdominal or stomach pain
• black, tarry stools
• bloody diarrhea
• chest pain or discomfort
• chills
• convulsions
• cough
• dizziness
• fainting
• fast, slow, or irregular heartbeat
• fever
• hives
• hoarseness
• irritation
• itching
• joint pain, stiffness, or swelling
• lightheadedness, dizziness, or fainting
• painful or difficult urination
• rash
• redness of the skin
• severe abdominal or stomach pain
• shortness of breath
• slow or irregular heartbeat
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• sweating
• swelling of the eyelids, face, lips, hands, or feet
• swollen glands
• tightness in the chest
• troubled breathing or swallowing
• unusual bleeding or bruising
• unusual tiredness or weakness
• wheezing

Minor Side Effects

Some of the side effects that can occur with Praziquantel (Dronspot) may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common:

• Drowsiness
• increased sweating
• general feeling of discomfort or illness
• nausea or vomiting

• Skin rash, hives, or itching

• Difficulty with moving
• dizziness or lightheadedness
• feeling of constant movement of self or surroundings
• headache
• hives or welts
• joint pain
• lack or loss of strength
• loss of appetite
• muscle aching or cramping
• muscle pains or stiffness
• redness of the skin
• sensation of spinning
• sleepiness or unusual drowsiness
• swollen joints
• weight loss

An anthelmintic used in most schistosome and many cestode infestations. [PubChem]