Dolpac 10

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

Pyrantel (Dolpac 10) is an antinematodal thiophene

Oral

Trichuris trichiura

Adult: 10-20 mg/kg as single dose; with pyrantel: 10-20 mg/kg as single dose

Child: 10-20 mg/kg as single dose; with pyrantel: 10-20 mg/kg as single dose

Oral

Enterobiasis; Hookworm infections; Trichostrongylus orientalis

Adult: With pyrantel: 10-20 mg/kg as single dose

Child: With pyrantel; 10-20 mg/kg as single dose

Praziquantel (Dolpac 10) (Praziquantel (Dolpac 10)) 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).

Oral

Single or mixed infections due to susceptible worms

Adult: 10 mg/kg as a single dose.

Child: 10 mg/kg as a single dose.

Oral

Ascariasis

Adult: 5 mg/kg as a single dose. Max: 1 g/dose. For mass treatment programmes: 2.5 mg/kg as a single dose given 3-4 times a yr.

Oral

Necatoriasis

Adult: 10 mg/kg daily for 3-4 days or 20 mg/kg daily for 2 days.

Oral

Enterobiasis

Adult: 10 mg/kg repeated once after 2-4 wk. Max dose: 1 g/dose.

Oral

Trichinosis

Adult: 10 mg/kg daily for 5 days.

Praziquantel (Dolpac 10) 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 (Dolpac 10) may also be used for other worm infections as determined by your doctor. However, it will not work for pinworms or other roundworms.

Praziquantel (Dolpac 10) belongs to the family of medicines called anthelmintics. Anthelmintics are used in the treatment of worm infections. Praziquantel (Dolpac 10) 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 (Dolpac 10) 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 (Dolpac 10) is used in certain patients with the following medical conditions:

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

Pyrantel (Dolpac 10) belongs to the family of medicines called anthelmintics. Anthelmintics are used in the treatment of worm infections.

Pyrantel (Dolpac 10) is used to treat pinworms (enterobiasis; oxyuriasis).

Pyrantel (Dolpac 10) may also be used for other worm infections as determined by your doctor.

Pyrantel (Dolpac 10) works by paralyzing the worms. They are then passed in the stool.

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 this use is not included in product labeling, Pyrantel (Dolpac 10) is used in certain patients with the following medical condition:

• Common roundworm infection
• Hookworm infection
• More than one worm infection at a time

For patients taking Pyrantel (Dolpac 10) for hookworm infection :

• Anemia (iron-poor blood) may occur in patients with hookworm infections. Therefore, your doctor may want you to take iron supplements to help clear up the anemia. If so, it is important to take iron every day while you are being treated for hookworms. Do not miss any doses. Your doctor may also want you to keep taking iron supplements for up to 6 months after you stop taking Pyrantel (Dolpac 10). If you have any questions about this, check with your doctor.

Oral

Trichuris trichiura

Adult: 10-20 mg/kg as single dose; with pyrantel: 10-20 mg/kg as single dose

Child: 10-20 mg/kg as single dose; with pyrantel: 10-20 mg/kg as single dose

Oral

Enterobiasis; Hookworm infections; Trichostrongylus orientalis

Adult: With pyrantel: 10-20 mg/kg as single dose

Child: With pyrantel; 10-20 mg/kg as single dose

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 (Dolpac 10) (Praziquantel (Dolpac 10)) 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 (Dolpac 10) (Praziquantel (Dolpac 10)) 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.

Usual Adult Dose for Enterobiasis

11 mg/kg base (maximum 1 g) orally once. Repeat dose in 2 weeks.

Usual Adult Dose for Pinworm Infection (Enterobius vermicularis)

11 mg/kg base (maximum 1 g) orally once. Repeat dose in 2 weeks.

Usual Adult Dose for Hookworm Infection (Necator or Ancylostoma)

11 mg/kg base (maximum 1 g) orally daily for 3 days.

Usual Adult Dose for Ascariasis

11 mg/kg base (maximum 1 g) orally once.

Usual Adult Dose for Trichostrongylosis

11 mg/kg base (maximum 1 g) orally once.

Usual Adult Dose for Moniliformis Infection

11 mg/kg base (maximum 1 g) orally once. Repeat dose twice at 2 weeks intervals.

Usual Pediatric Dose for Enterobiasis

>=2 years: 11 mg/kg base (maximum 1 g) once. Repeat dose in 2 weeks.

Usual Pediatric Dose for Pinworm Infection (Enterobius vermicularis)

>=2 years: 11 mg/kg base (maximum 1 g) once. Repeat dose in 2 weeks.

Usual Pediatric Dose for Hookworm Infection (Necator or Ancylostoma)

>=2 years: 11 mg/kg base (maximum 1 g) orally daily for 3 days.

Usual Pediatric Dose for Ascariasis

>=2 years: 11 mg/kg base (maximum 1 g) orally once.

Usual Pediatric Dose for Trichostrongylosis

>=2 years: 11 mg/kg base (maximum 1 g) orally once.

Usual Pediatric Dose for Moniliformis Infection

>=2 years: 11 mg/kg base (maximum 1 g) orally once. Repeat dose twice at 2 weeks intervals.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Pyrantel (Dolpac 10) is contraindicated in patients with hepatic disease.

Dose Adjustments

In the treatment of ascariasis, Pyrantel (Dolpac 10) may be used only if it has been determined that the worm load will not worsen obstruction.

Precautions

Pyrantel (Dolpac 10) is contraindicated in patients with hepatic disease.

When one individual in a household has pinworms, the entire household should be treated unless otherwise advised. Pinworm infections are easily transmitted to others in the same household.

Pyrantel (Dolpac 10) should be used with caution in patients with severe malnutrition or anemia. Supportive therapy is recommended for anemic, dehydrated, or malnourished patients prior to administration of the drug.

Other medications are known to antagonize the anthelmintic effect of Pyrantel (Dolpac 10). Patients should be advised to consult with their physician before initiating any drug therapy while receiving Pyrantel (Dolpac 10).

Dialysis

Data not available

Other Comments

The dose should be taken as a single oral dose. It may be taken alone or with milk or fruit juice.

Pyrantel (Dolpac 10) pamoate 2.9 g is approximately equivalent to 1 g of Pyrantel (Dolpac 10) (base).

See also:
What is the most important information I should know about Praziquantel (Dolpac 10)?

Praziquantel (Dolpac 10) (Praziquantel (Dolpac 10)) 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 (Dolpac 10) 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 (Dolpac 10) is necessary, rifampin should be discontinued 4 weeks before administration of Praziquantel (Dolpac 10). Treatment with rifampin can then be restarted one day after completion of Praziquantel (Dolpac 10) treatment.

See also:
What is the most important information I should know about Pyrantel (Dolpac 10)?

This medicine is contraindicated in patients with known hypersensitivity to the benzimidazole class of compounds or any components of this medicine.

Use Praziquantel (Dolpac 10) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Praziquantel (Dolpac 10) 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 (Dolpac 10), 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 (Dolpac 10).

Use Pyrantel (Dolpac 10) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Pyrantel (Dolpac 10) may be taken on an empty stomach or with food, milk, or juice.
• Shake well before using a dose of Pyrantel (Dolpac 10).
• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
• Wear tight underwear both day and night while taking Pyrantel (Dolpac 10).
• Pyrantel (Dolpac 10) is usually prescribed as a single dose.
• Only one dose of Pyrantel (Dolpac 10) is required. If you forget to take Pyrantel (Dolpac 10), take it as soon as you remember.

Ask your health care provider any questions you may have about how to use Pyrantel (Dolpac 10).

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 (Dolpac 10) (in combination with albendazole) in the treatment of parenchymal neurocysticercosis.

See also:
What other drugs will affect Praziquantel (Dolpac 10)?

Concomitant administration of rifampin, a strong P450 inducer, with Praziquantel (Dolpac 10) 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 (Dolpac 10) following pre-treatment with oral rifampin (600 mg daily for 5 days). Plasma Praziquantel (Dolpac 10) concentrations were undetectable in 7 out of 10 subjects. When a single 40 mg/kg dose of Praziquantel (Dolpac 10) was administered to these healthy subjects two weeks after discontinuation of rifampin, the mean Praziquantel (Dolpac 10) AUC and Cmax were 23% and 35% lower, respectively, than when Praziquantel (Dolpac 10) 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 (Dolpac 10) is necessary, treatment with rifampin should be discontinued 4 weeks before administration of Praziquantel (Dolpac 10). Treatment with rifampin can then be restarted one day after completion of Praziquantel (Dolpac 10) 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 (Dolpac 10). 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 (Dolpac 10).

Chloroquine, when taken simultaneously, may lead to lower concentrations of Praziquantel (Dolpac 10) 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 (Dolpac 10). However, the effect of this exposure increase on the therapeutic effect and safety of Praziquantel (Dolpac 10) has not been systematically evaluated.

See also:
What other drugs will affect Pyrantel (Dolpac 10)?

• Dexamethasone

Steady-state trough concentrations of albendazole sulfoxide were about 56% higher when 8 mg dexamethasone was coadministered with each dose of albendazole (15 mg/kg/day) in 8 neurocysticercosis patients.

• Pyrantel (Dolpac 10)

• Cimetidine

Albendazole sulfoxide concentrations in bile and cystic fluid were increased (about 2-fold) in hydatid cyst patients treated with cimetidine (10 mg/kg/day) (n = 7) compared with albendazole (20 mg/kg/day) alone (n = 12). Albendazole sulfoxide plasma concentrations were unchanged 4 hours after dosing.

• Theophylline

The pharmacokinetics of theophylline (aminophylline 5.8 mg/kg infused over 20 minutes) were unchanged following a single oral dose of albendazole (400 mg) in 6 healthy subjects.

Headache, abdominal pain, diarrhoea

See also:
What are the possible side effects of Praziquantel (Dolpac 10)?

Applies to Praziquantel (Dolpac 10): oral tablet

In addition to its needed effects, some unwanted effects may be caused by Praziquantel (Dolpac 10) (the active ingredient contained in Praziquantel (Dolpac 10)). 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 (Dolpac 10):

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 (Dolpac 10) 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

See also:
What are the possible side effects of Pyrantel (Dolpac 10)?

Applies to Pyrantel (Dolpac 10): oral suspension, oral tablet, oral tablet chewable

In addition to its needed effects, some unwanted effects may be caused by Pyrantel (Dolpac 10) (the active ingredient contained in Pyrantel (Dolpac 10)). In the event that any of these side effects do occur, they may require medical attention.

Severity: Moderate

If any of the following side effects occur while taking Pyrantel (Dolpac 10), check with your doctor or nurse as soon as possible:

Rare

• Skin rash

Minor Side Effects

Some of the side effects that can occur with Pyrantel (Dolpac 10) 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:

Less common:

• Abdominal or stomach cramps or pain
• diarrhea
• dizziness
• drowsiness
• headache
• irritability
• loss of appetite
• nausea or vomiting
• trouble in sleeping