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  • CLASSES

    Antinematodal Agents

    DEA CLASS

    OTC

    DESCRIPTION

    Oral, anthelmintic agent
    Used for roundworm, hookworm, pinworm
    Available OTC

    COMMON BRAND NAMES

    Pin-X, Pronto Plus Pinworm

    HOW SUPPLIED

    Pin-X Oral Susp: 1mL, 144mg

    DOSAGE & INDICATIONS

    For the treatment of enterobiasis (pinworm infection).
    Oral dosage
    Adults

    11 mg/kg base (Max: 1 g) PO as a single dose. Retreatment may be necessary after 14 to 21 days. Treatment of the entire household is recommended.

    Children 2 years and older weighing 11 kg or more and Adolescents

    11 mg/kg base (Max: 1 g) PO as a single dose. Retreatment may be necessary after 14 to 21 days. Treatment of the entire household is recommended.

    Children 2 years and older weighing less than 11 kg†

    11 mg/kg base PO as a single dose. Retreatment may be necessary after 14 to 21 days. Treatment of the entire household is recommended. Consult physician and do not self-treat.

    Infants† and Children 1 year†

    11 mg/kg base PO as a single dose. Retreatment may be necessary after 14 to 21 days. Treatment of the entire household is recommended. Consult physician and do not self-treat.

    For the treatment of ascariasis†.
    Oral dosage
    Adults

    11 mg/kg base (Max: 1 g) PO once daily for 3 days as an alternative to albendazole or mebendazole.

    Infants, Children, and Adolescents

    11 mg/kg base (Max: 1 g) PO once daily for 3 days as an alternative to albendazole or mebendazole.

    For the treatment of uncinariasis† (hookworm infection).
    Oral dosage
    Adults

    11 mg/kg base (Max: 1 g) PO once daily for 3 days.

    Infants, Children, and Adolescents

    11 mg/kg base (Max: 1 g) PO once daily for 3 days.

    For the treatment of trichostrongyliasis†.
    Oral dosage
    Adults

    11 mg/kg base (Max: 1 g) PO as a single dose.

    Infants, Children, and Adolescents

    11 mg/kg base (Max: 1 g) PO as a single dose.

    †Indicates off-label use

    MAXIMUM DOSAGE

    Adults

    11 mg/kg/dose PO, not to exceed 1 g/dose PO.

    Geriatric

    11 mg/kg/dose PO, not to exceed 1 g/dose PO.

    Adolescents

    11 mg/kg/dose PO, not to exceed 1 g/dose PO.

    Children

    2 years and older: 11 mg/kg/dose PO, not to exceed 1 g/dose PO.
    1 year: 11 mg/kg/dose PO has been used off-label.

    Infants

    11 mg/kg/dose PO has been used off-label.

    Neonates

    Safety and efficacy have not been established.

    DOSING CONSIDERATIONS

    Hepatic Impairment

    Self-treatment is not recommended.

    Renal Impairment

    Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

    ADMINISTRATION

    Oral Administration

    Pyrantel is administered orally.
    May administer with food, milk or fruit juice, at any time of day.
    Fasting, purgation, or special diets are not necessary for effective treatment.

    Oral Liquid Formulations

    Shake well before use.
    Liquid products can be mixed with milk or fruit juice. Measure liquid products with a calibrated oral dosing device to administer an accurate dosage.

    STORAGE

    Pin-X:
    - Store at room temperature (between 59 to 86 degrees F)
    Pronto Plus Pinworm:
    - Store at room temperature (between 59 to 86 degrees F)

    CONTRAINDICATIONS / PRECAUTIONS

    Hepatic disease

    Pyrantel should be used with caution in patients with hepatic disease.

    Phenylketonuria

    Pyrantel chewable tablets contain phenylalanine; use with caution in patients with phenylketonuria.

    Pregnancy

    Pyrantel is poorly absorbed from the GI tract. There are no well controlled studies of pyrantel use in pregnant women. Use pyrantel with caution during pregnancy. Some experts suggest that single-dose pyrantel therapy may be given to pregnant women. Pregnant women should not take pyrantel unless directed by a doctor.

    Breast-feeding

    There are no data regarding the presence of pyrantel in breast milk. Pyrantel is poorly absorbed from the GI tract; therefore, excretion into breast milk may be minimal. Some experts suggest single-dose pyrantel therapy may be given to breast-feeding women. Breast-feeding infant exposure may be minimized if the drug is taken just before the longest sleep interval for the infant.

    ADVERSE REACTIONS

    Mild

    vomiting / Early / Incidence not known
    abdominal pain / Early / Incidence not known
    nausea / Early / Incidence not known
    diarrhea / Early / Incidence not known
    dizziness / Early / Incidence not known
    headache / Early / Incidence not known

    DRUG INTERACTIONS

    There are no drug interactions associated with Pyrantel products.

    PREGNANCY AND LACTATION

    Pregnancy

    Pyrantel is poorly absorbed from the GI tract. There are no well controlled studies of pyrantel use in pregnant women. Use pyrantel with caution during pregnancy. Some experts suggest that single-dose pyrantel therapy may be given to pregnant women. Pregnant women should not take pyrantel unless directed by a doctor.

    There are no data regarding the presence of pyrantel in breast milk. Pyrantel is poorly absorbed from the GI tract; therefore, excretion into breast milk may be minimal. Some experts suggest single-dose pyrantel therapy may be given to breast-feeding women. Breast-feeding infant exposure may be minimized if the drug is taken just before the longest sleep interval for the infant.

    MECHANISM OF ACTION

    By stimulating the release of acetylcholine, inhibiting cholinesterase, and stimulating ganglionic neurons, pyrantel acts as a depolarizing neuromuscular blocking agent in helminths. These actions cause extensive depolarization of the helminth muscle membrane, producing tension of the helminth's muscles, which causes paralysis and release of their hold to the intestinal wall. This action is unlike piperazine, which is a hyperpolarizing neuromuscular blocking agent that relaxes helminth muscles, causing a subsequent detachment from the intestinal wall. Expulsion of the parasites from the GI tract occurs by normal peristalsis.

    PHARMACOKINETICS

    Pyrantel is administered orally. The absorbed drug is partially metabolized in the liver, with approximately 7% or less of the dose being excreted in urine as unaltered drug and metabolites and more than 50% of each dose being excreted unchanged in the feces.
     
    Affected cytochrome P450 isoenzymes and drug transporters: none

    Oral Route

    Pyrantel has poor and incomplete absorption from the GI tract. Peak plasma concentrations (0.05 to 0.13 mcg/mL) occur within 1 to 3 hours.