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PIPERAZINE

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Classification   |    Detailed evidence-based information

Substances Included Synonyms

Therapeutic Toxic Class

    A) Piperazine is a heterocyclic secondary amine that is a strong organic base. It is used as an anthelmintic, as a corrosion inhibitor, insecticide, and accelerator for curing polychloroprene.

Specific Substances

    1) Anhydrous piperazine citrate
    2) Anhydrous piperazine phosphate
    3) Antiren
    4) 1,4-Diethylenediamine
    5) 1,4-Diazacyclohexane
    6) 1,4-piperazine
    7) Diethylenediamine
    8) Diethyleneimine
    9) Dispermine
    10) Eraverm
    11) Hexahydro-1,4-diazine
    12) Hexahydropyrazine
    13) Lumbrical
    14) N,N-diethylene diamine
    15) Piperazidine
    16) Piperazin (german)
    17) Piperazine adipate
    18) Piperazine, anhydrous
    19) Piperazine citrate hydrate
    20) Piperazine dihydrochloride
    21) Piperazine hydrate
    22) Piperazine phosphate monohydrate
    23) Pipersol
    24) Pyrazine, hexahydro-
    25) Pyrazine hexahydride
    26) Uvilon
    27) Vermex
    28) Worm-a-ton
    29) Worm-away
    30) Wurmirazin
    31) CAS 110-85-0
    32) CAS 142-88-1 (piperazine adipate)
    33) CAS 144-29-6 (anhydrous piperazine citrate)
    34) CAS 41372-10-5 (piperazine citrate hydrate)
    35) CAS 142-64-3 (piperazine dihydrochloride)
    36) CAS 142-63-2 (piperazine hydrate)
    37) CAS 14538-56-8 (anhydrous piperazine phosphate)
    38) CAS 18534-18-4 (piperazine phosphate monohydrate)
    1.2.1) MOLECULAR FORMULA
    1) C4-H10-N2

Available Forms Sources

    A) FORMS
    1) Piperazine citrate tablets (equivalent to 250 mg piperazine hexahydrate)
    2) Piperazine citrate syrup (equivalent to 500 mg piperazine hexahydrate per 5 mL)
    3) Also available as a powder, granules, liquid, and tablets for veterinary use (JEF Reynolds , 1989).
    4) The primary routes of exposure (other than medicinal) are skin or eye contact as well as inhalation of vapors (or dusts of salts). The salts are less hazardous than anhydrous or hexahydrate forms of piperazine (Clayton & Clayton, 1981)
    B) USES
    1) Piperazine is a heterocyclic secondary amine that is a strong organic base (Grant, 1986). It has been used as an anthelmintic, as a corrosion inhibitor, insecticide, and accelerator for curing polychloroprene (Budavari, 1989; Sax & Lewis, 1987).
    2) Piperazine is an anthelmintic agent effective in the treatment of various parasitic infections. It has been used to treat ascariasis caused by intestinal nematodes Ascaris lumbricoides (roundworm) and enterobiasis (oxyuriasis) caused by Enterobius vermicularis (pinworm). Piperazine was especially useful in the treatment of partial intestinal obstruction caused by Ascaris worms, which is a condition primarily seen in children (Gilman et al, 1990; Rakel, 1992; Blumenthal, 1988; Brown & Neva, 1983; Katz, 1986; Plorde & Ramsey, 1991; Markell et al, 1992; Warren & Mahmoud, 1977). Piperazine dihydrochloride is also available for veterinary use.
    3) For information on recreational drugs, n-benzylpiperazine (BZP) and trifluoromethylphenylpiperazine (TFMPP), refer to managements N-BENZYLPIPERAZINE and HALLUCINOGENIC AMPHETAMINES, respectively.

Overview

Life Support

    A) This overview assumes that basic life support measures have been instituted.

Clinical Effects

    0.2.1) SUMMARY OF EXPOSURE
    A) USES: Piperazine is a heterocyclic secondary amine that is a strong organic base. It has been used as an anthelmintic agent to treat ascariasis caused by intestinal nematodes Ascaris lumbricoides (roundworm) and enterobiasis (oxyuriasis) caused by Enterobius vermicularis (pinworm). Piperazine dihydrochloride is available for veterinary use. It has also been used as a corrosion inhibitor, insecticide, and accelerator for curing polychloroprene. Piperazine is no longer manufactured in the United States. For information on recreational drugs containing, n-benzylpiperazine (BZP) and trifluoromethylphenylpiperazine (TFMPP), refer to managements N-BENZYLPIPERAZINE and HALLUCINOGENIC AMPHETAMINES, respectively.
    B) PHARMACOLOGY: Piperazine salts have shown activity against the human pinworm (Enterobius vermicularis) and against the roundworm (Ascaris lumbricoides). Piperazine blocks the response of ascaris smooth muscle to acetylcholine. This produces paralysis of the muscle and expulsion via peristalsis.
    C) TOXICOLOGY: In mice, piperazine produces sedation in low doses, muscular paralysis in high doses and increases hexobarbital sleep time. Urinary excretion is the main route of elimination and thus increased toxicity is seen in patients with decreased renal function.
    D) EPIDEMIOLOGY: Overdose is rare.
    E) WITH THERAPEUTIC USE
    1) Nausea, vomiting, abdominal pain, diarrhea, urticaria, confusion, euphoria, headache, muscular weakness, ataxia, lethargy, nystagmus, visual disturbances, vertigo, paresthesias, myoclonic contractions, tremor, choreiform movements, contact dermatitis, acute allergic reactions, seizures, and coma have been reported with therapeutic use. A confusional state, characterized by a sense of detachment, euphoria, hallucinations, and an inability to think clearly, has also been reported.
    F) WITH POISONING/EXPOSURE
    1) Piperazine is moderately toxic by ingestion, skin contact, intravenous and subcutaneous routes; it is mildly toxic by inhalation. Overdose effects are anticipated to be an extension of adverse effects following therapeutic doses. A child developed transient neurologic dysfunction (drowsiness, refusal to eat, unsteadiness, and frequent falling episodes) after ingesting 300 mg/kg/day (usual recommended dose: 65 mg/kg/day) of piperazine hydrochloride over 2 days for the treatment of anal pruritus. Piperazine has been associated with the occurrence of asthma in workers handling piperazine. In studies, exposed workers had a higher incidence of airway symptoms (dyspnea, wheezing, severe hacking cough) than the unexposed group.
    0.2.20) REPRODUCTIVE
    A) Piperazine has been associated with negative reports in human studies although a causal relationship was not established.

Laboratory Monitoring

    A) Plasma concentrations are not readily available or clinically useful in the management of overdose.
    B) Monitor vital signs and mental status.
    C) Monitor serum electrolytes in patients with significant vomiting and/or diarrhea.

Treatment Overview

    0.4.2) ORAL/PARENTERAL EXPOSURE
    A) MANAGEMENT OF MILD TO MODERATE TOXICITY
    1) Treatment is symptomatic and supportive.
    B) MANAGEMENT OF SEVERE TOXICITY
    1) Treatment is symptomatic and supportive. Correct any significant fluid and/or electrolyte abnormalities in patients with severe diarrhea and/or vomiting. Treat seizures with IV benzodiazepines; barbiturates or propofol may be needed if seizures persist or recur. In patients with acute allergic reaction, oxygen therapy, bronchodilators, diphenhydramine, corticosteroids, vasopressors and epinephrine may be required.
    C) DECONTAMINATION
    1) PREHOSPITAL: Prehospital gastrointestinal decontamination is generally not recommended because of the potential for CNS depression or persistent seizures and subsequent aspiration.
    2) HOSPITAL: Consider activated charcoal if the overdose is recent, the patient is not vomiting, and is able to maintain airway.
    D) AIRWAY MANAGEMENT
    1) Ensure adequate ventilation and perform endotracheal intubation early in patients with severe allergic reactions or persistent seizures.
    E) ANTIDOTE
    1) None.
    F) ENHANCED ELIMINATION
    1) It is unknown if hemodialysis would be effective in overdose.
    G) PATIENT DISPOSITION
    1) HOME CRITERIA: A patient with an inadvertent exposure, that remains asymptomatic can be managed at home.
    2) OBSERVATION CRITERIA: Patients with a deliberate overdose, and those who are symptomatic, need to be monitored until they are clearly improving and clinically stable.
    3) ADMISSION CRITERIA: Patients with severe symptoms despite treatment should be admitted.
    4) CONSULT CRITERIA: Consult a regional poison center or medical toxicologist for assistance in managing patients with severe toxicity or in whom the diagnosis is not clear.
    H) PITFALLS
    1) When managing a suspected overdose, the possibility of multidrug involvement should be considered. Symptoms of overdose are similar to reported side effects of the medication.
    I) PHARMACOKINETICS
    1) Readily absorbed from the gastrointestinal tract. Bioavailability: 20% to 40% of an administered dose. Excretion: Urinary excretion, partly as metabolites, is the main route of elimination. Approximately 60% to 90% of a piperazine oral dose is eliminated by the kidney, with unchanged drug approximating 1% to 2% of the total excretory products. Elimination half-life: 2 to 6 hours.
    J) DIFFERENTIAL DIAGNOSIS
    1) Includes other agents that may cause CNS toxicity, including seizures.

Range Of Toxicity

    A) TOXICITY: Toxicity has been noted at therapeutic or near therapeutic doses. Doses as low as 30 mg/kg/day in patients with renal failure and 50 to 75 mg/kg/day in patients with normal renal function have resulted in toxicity. Transient neurologic dysfunction was observed in a 2-year-old girl receiving an estimated dose of piperazine 300 mg/kg/day for 2 days. Neurologic dysfunction resolved within 72 hours of admission. Recovery has been reported following ingestion of 11.6 g. THERAPEUTIC DOSE: ADULT: Varies by indication; up to 3.5 g/day for 2 days. CHILD: 75 mg/kg/day for 2 days; up to 3.5 g/day.

Clinical Effects

Summary Of Exposure

    A) USES: Piperazine is a heterocyclic secondary amine that is a strong organic base. It has been used as an anthelmintic agent to treat ascariasis caused by intestinal nematodes Ascaris lumbricoides (roundworm) and enterobiasis (oxyuriasis) caused by Enterobius vermicularis (pinworm). Piperazine dihydrochloride is available for veterinary use. It has also been used as a corrosion inhibitor, insecticide, and accelerator for curing polychloroprene. Piperazine is no longer manufactured in the United States. For information on recreational drugs containing, n-benzylpiperazine (BZP) and trifluoromethylphenylpiperazine (TFMPP), refer to managements N-BENZYLPIPERAZINE and HALLUCINOGENIC AMPHETAMINES, respectively.
    B) PHARMACOLOGY: Piperazine salts have shown activity against the human pinworm (Enterobius vermicularis) and against the roundworm (Ascaris lumbricoides). Piperazine blocks the response of ascaris smooth muscle to acetylcholine. This produces paralysis of the muscle and expulsion via peristalsis.
    C) TOXICOLOGY: In mice, piperazine produces sedation in low doses, muscular paralysis in high doses and increases hexobarbital sleep time. Urinary excretion is the main route of elimination and thus increased toxicity is seen in patients with decreased renal function.
    D) EPIDEMIOLOGY: Overdose is rare.
    E) WITH THERAPEUTIC USE
    1) Nausea, vomiting, abdominal pain, diarrhea, urticaria, confusion, euphoria, headache, muscular weakness, ataxia, lethargy, nystagmus, visual disturbances, vertigo, paresthesias, myoclonic contractions, tremor, choreiform movements, contact dermatitis, acute allergic reactions, seizures, and coma have been reported with therapeutic use. A confusional state, characterized by a sense of detachment, euphoria, hallucinations, and an inability to think clearly, has also been reported.
    F) WITH POISONING/EXPOSURE
    1) Piperazine is moderately toxic by ingestion, skin contact, intravenous and subcutaneous routes; it is mildly toxic by inhalation. Overdose effects are anticipated to be an extension of adverse effects following therapeutic doses. A child developed transient neurologic dysfunction (drowsiness, refusal to eat, unsteadiness, and frequent falling episodes) after ingesting 300 mg/kg/day (usual recommended dose: 65 mg/kg/day) of piperazine hydrochloride over 2 days for the treatment of anal pruritus. Piperazine has been associated with the occurrence of asthma in workers handling piperazine. In studies, exposed workers had a higher incidence of airway symptoms (dyspnea, wheezing, severe hacking cough) than the unexposed group.

Heent

    3.4.3) EYES
    A) WITH THERAPEUTIC USE
    1) NYSTAGMUS
    a) VISUAL DISTURBANCES: Blurred vision and transient visual disturbances may occur (Miller & Carpenter, 1967).
    b) NYSTAGMUS: Nystagmus has been reported (JEF Reynolds , 1989).
    B) WITH POISONING/EXPOSURE
    1) IRRITATION: Piperazine is a severe eye irritant (Sax & Lewis, 1989)
    C) ANIMAL STUDIES
    1) EYE INJURY: One drop of full strength piperazine instilled in rabbit eyes produced severe injury after 24 hours (Carpenter & Smith, 1946).

Respiratory

    3.6.2) CLINICAL EFFECTS
    A) BRONCHOSPASM
    1) WITH POISONING/EXPOSURE
    a) OCCUPATIONAL ASTHMA: Piperazine has been associated with the occurrence of asthma in workers handling piperazine (Pepys et al, 1972).
    b) Hagmar et al (1982) estimated an 8% cumulative incidence of piperazine-associated asthma in a cross-sectional study of workers in a chemical industry (Hagmar et al, 1982).
    c) In a cohort study of 602 workers, the most exposed group had a higher incidence of airway symptoms (dyspnea, wheezing, severe hacking cough) than the unexposed group (Hagmar et al, 1984).

Neurologic

    3.7.2) CLINICAL EFFECTS
    A) CLOUDED CONSCIOUSNESS
    1) WITH THERAPEUTIC USE
    a) A confused state characterized by inability to think clearly, sense of detachment, staring blankly, euphoria, and hallucinations may occur (Combes et al, 1956; Schuch et al, 1966).
    B) COMA
    1) WITH THERAPEUTIC USE
    a) Lethargy is common and coma may occur occasionally (Miller & Carpenter, 1967).
    C) COORDINATION PROBLEM
    1) WITH THERAPEUTIC USE
    a) Muscular weakness, ataxia and incoordination (dropping objects), vertigo, and paresthesias may also be present (Combes et al, 1956; Miller & Carpenter, 1967; Parsons, 1971).
    D) SEIZURE
    1) WITH THERAPEUTIC USE
    a) Tonic-clonic seizures, petit mal seizures have also been reported (Nickey, 1966), and status epilepticus (Schuch et al, 1966).
    b) CASE REPORT: An 11-year-old who died following status epilepticus of 6 day duration after being given therapeutic doses of piperazine (Schuch et al, 1966).
    E) CHOREOATHETOSIS
    1) WITH THERAPEUTIC USE
    a) Myoclonic contractions, tremor, and choreiform movements may occur (Combes et al, 1956; Miller & Carpenter, 1967).
    b) CASE REPORT: An 8-year-old uremic patient, who was given 86.7 mg/kg/day of piperazine for 3 days, died after his mental status had improved and myoclonic jerks had subsided, all other cases recovered completely within a few days after the drug was discontinued with symptomatic and supportive care (Miller & Carpenter, 1967).
    F) HEADACHE
    1) WITH THERAPEUTIC USE
    a) Headache may occur (Miller & Carpenter, 1967).
    G) TOXIC ENCEPHALOPATHY
    1) WITH POISONING/EXPOSURE
    a) CASE REPORT: A 2-year-old girl presented with transient neurologic dysfunction (drowsiness, refusal to eat, unsteadiness, and frequent falling episodes). This was associated with an estimated ingestion of 300 mg/kg/day (usual recommended dose: 65 mg/kg/day) of piperazine hydrochloride over 2 days for treatment of anal pruritus. The EEG normalized and clinical findings resolved by 72 hours after admission (Yohai & Barnett, 1989).

Gastrointestinal

    3.8.2) CLINICAL EFFECTS
    A) VOMITING
    1) WITH THERAPEUTIC USE
    a) In some patients toxic symptoms may be noted at therapeutic or near therapeutic doses. Nausea and vomiting are common (JEF Reynolds , 1989).
    B) DIARRHEA
    1) WITH THERAPEUTIC USE
    a) Abdominal pain and diarrhea may occur (Titterton, 1956; JEF Reynolds , 1989; Kaleysa & Kurup, 1968).

Hematologic

    3.13.2) CLINICAL EFFECTS
    A) HEMOLYTIC ANEMIA
    1) WITH THERAPEUTIC USE
    a) CASE REPORT: A 4-year-old boy developed hemolytic anemia 2 days after taking Pripsen (piperazine and senna). He was found to have a deficiency of glucose-6-phosphate dehydrogenase (Buchanan et al, 1971).

Dermatologic

    3.14.2) CLINICAL EFFECTS
    A) URTICARIA
    1) WITH THERAPEUTIC USE
    a) Urticaria has been reported following therapeutic doses of piperazine (JEF Reynolds , 1989).
    B) CONTACT DERMATITIS
    1) WITH POISONING/EXPOSURE
    a) There is a potential for cross-reaction with zinc pyrithione, piperazine hydrochloride, and ethylenediamine (Calnan, 1975).
    b) Contact dermatitis is rare, but has been reported. One case involved a 13-year-old sensitive to a plastic watch strap where piperazine was used as a stabilizer (Savini et al, 1990).

Immunologic

    3.19.2) CLINICAL EFFECTS
    A) ACUTE ALLERGIC REACTION
    1) WITH THERAPEUTIC USE
    a) Individuals sensitized during occupational exposure to piperazine may develop hypersensitivity reactions.
    b) CASE REPORT: A 55-year-old man with occupation exposure to piperazine developed pruritus and respiratory symptoms on patch testing with piperazine (Fregert, 1976).
    c) CASE REPORT: A 25-year-old woman developed a reaction to piperazine on 2 occasions that resembled viral hepatitis (Hamlyn et al, 1976).

Reproductive

    3.20.1) SUMMARY
    A) Piperazine has been associated with negative reports in human studies although a causal relationship was not established.
    3.20.3) EFFECTS IN PREGNANCY
    A) PREGNANCY DISORDER
    1) Piperazine has been associated with negative reports in human studies although a causal relationship was not established (Heinonen et al, 1977).
    B) PREGNANCY CATEGORY
    PIPERAZINEB
    Reference: Briggs et al, 1998

Carcinogenicity

    3.21.1) IARC CATEGORY
    A) IARC Carcinogenicity Ratings for CAS110-85-0 (International Agency for Research on Cancer (IARC), 2016; International Agency for Research on Cancer, 2015; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2010; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2010a; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2008; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2007; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2006; IARC, 2004):
    1) Not Listed
    3.21.3) HUMAN STUDIES
    A) CARCINOMA
    1) Piperazine can undergo mononitrosation in the stomach to produce N-mononitrosopiperazine, a potential carcinogen (Bellander et al, 1981). There is no direct proof of a causal role in the etiology of specific human disease (Tannenbaum, 1983).

Laboratory Monitoring

Monitoring Parameters Levels

    4.1.1) SUMMARY
    A) Plasma concentrations are not readily available or clinically useful in the management of overdose.
    B) Monitor vital signs and mental status.
    C) Monitor serum electrolytes in patients with significant vomiting and/or diarrhea.

Methods

    A) MULTIPLE ANALYTICAL METHODS
    1) Piperazine in urine may be estimated colorimetrically with 1,2-naphtoquinone-4-sulphonic acid (Rogers, 1958).
    2) Skarping et al (1986) described a gas chromatographic method for determining piperazine in working atmosphere and in human urine (Skarping et al, 1986).

Treatment

Life Support

    A) Support respiratory and cardiovascular function.

Patient Disposition

    6.3.1) DISPOSITION/ORAL EXPOSURE
    6.3.1.1) ADMISSION CRITERIA/ORAL
    A) Patients with severe symptoms despite treatment should be admitted.
    6.3.1.2) HOME CRITERIA/ORAL
    A) A patient with an inadvertent exposure, that remains asymptomatic can be managed at home.
    6.3.1.3) CONSULT CRITERIA/ORAL
    A) Consult a regional poison center or medical toxicologist for assistance in managing patients with severe toxicity or in whom the diagnosis is not clear.
    6.3.1.5) OBSERVATION CRITERIA/ORAL
    A) Patients with a deliberate overdose, and those who are symptomatic, need to be monitored until they are clearly improving and clinically stable.

Monitoring

    A) Plasma concentrations are not readily available or clinically useful in the management of overdose.
    B) Monitor vital signs and mental status.
    C) Monitor serum electrolytes in patients with significant vomiting and/or diarrhea.

Oral Exposure

    6.5.1) PREVENTION OF ABSORPTION/PREHOSPITAL
    A) Prehospital gastrointestinal decontamination is generally not recommended because of the potential for CNS depression or persistent seizures and subsequent aspiration.
    6.5.2) PREVENTION OF ABSORPTION
    A) ACTIVATED CHARCOAL
    1) CHARCOAL ADMINISTRATION
    a) Consider administration of activated charcoal after a potentially toxic ingestion (Chyka et al, 2005). Administer charcoal as an aqueous slurry; most effective when administered within one hour of ingestion.
    2) CHARCOAL DOSE
    a) Use a minimum of 240 milliliters of water per 30 grams charcoal (FDA, 1985). Optimum dose not established; usual dose is 25 to 100 grams in adults and adolescents; 25 to 50 grams in children aged 1 to 12 years (or 0.5 to 1 gram/kilogram body weight) ; and 0.5 to 1 gram/kilogram in infants up to 1 year old (Chyka et al, 2005).
    1) Routine use of a cathartic with activated charcoal is NOT recommended as there is no evidence that cathartics reduce drug absorption and cathartics are known to cause adverse effects such as nausea, vomiting, abdominal cramps, electrolyte imbalances and occasionally hypotension (None Listed, 2004).
    b) ADVERSE EFFECTS/CONTRAINDICATIONS
    1) Complications: emesis, aspiration (Chyka et al, 2005). Aspiration may be complicated by acute respiratory failure, ARDS, bronchiolitis obliterans or chronic lung disease (Golej et al, 2001; Graff et al, 2002; Pollack et al, 1981; Harris & Filandrinos, 1993; Elliot et al, 1989; Rau et al, 1988; Golej et al, 2001; Graff et al, 2002). Refer to the ACTIVATED CHARCOAL/TREATMENT management for further information.
    2) Contraindications: unprotected airway (increases risk/severity of aspiration) , nonfunctioning gastrointestinal tract, uncontrolled vomiting, and ingestion of most hydrocarbons (Chyka et al, 2005).
    6.5.3) TREATMENT
    A) SUPPORT
    1) MANAGEMENT OF MILD TO MODERATE TOXICITY
    a) Treatment is symptomatic and supportive.
    2) MANAGEMENT OF SEVERE TOXICITY
    a) Treatment is symptomatic and supportive. Correct any significant fluid and/or electrolyte abnormalities in patients with severe diarrhea and/or vomiting. Treat seizures with IV benzodiazepines; barbiturates or propofol may be needed if seizures persist or recur. In patients with acute allergic reaction, oxygen therapy, bronchodilators, diphenhydramine, corticosteroids, vasopressors and epinephrine may be required.
    B) MONITORING OF PATIENT
    1) Plasma concentrations are not readily available or clinically useful in the management of overdose.
    2) Monitor vital signs and mental status.
    3) Monitor serum electrolytes in patients with significant vomiting and/or diarrhea.
    C) SEIZURE
    1) SUMMARY
    a) Attempt initial control with a benzodiazepine (eg, diazepam, lorazepam). If seizures persist or recur, administer phenobarbital or propofol.
    b) Monitor for respiratory depression, hypotension, and dysrhythmias. Endotracheal intubation should be performed in patients with persistent seizures.
    c) Evaluate for hypoxia, electrolyte disturbances, and hypoglycemia (or, if immediate bedside glucose testing is not available, treat with intravenous dextrose).
    2) DIAZEPAM
    a) ADULT DOSE: Initially 5 to 10 mg IV, OR 0.15 mg/kg IV up to 10 mg per dose up to a rate of 5 mg/minute; may be repeated every 5 to 20 minutes as needed (Brophy et al, 2012; Prod Info diazepam IM, IV injection, 2008; Manno, 2003).
    b) PEDIATRIC DOSE: 0.1 to 0.5 mg/kg IV over 2 to 5 minutes; up to a maximum of 10 mg/dose. May repeat dose every 5 to 10 minutes as needed (Loddenkemper & Goodkin, 2011; Hegenbarth & American Academy of Pediatrics Committee on Drugs, 2008).
    c) Monitor for hypotension, respiratory depression, and the need for endotracheal intubation. Consider a second agent if seizures persist or recur after repeated doses of diazepam .
    3) NO INTRAVENOUS ACCESS
    a) DIAZEPAM may be given rectally or intramuscularly (Manno, 2003). RECTAL DOSE: CHILD: Greater than 12 years: 0.2 mg/kg; 6 to 11 years: 0.3 mg/kg; 2 to 5 years: 0.5 mg/kg (Brophy et al, 2012).
    b) MIDAZOLAM has been used intramuscularly and intranasally, particularly in children when intravenous access has not been established. ADULT DOSE: 0.2 mg/kg IM, up to a maximum dose of 10 mg (Brophy et al, 2012). PEDIATRIC DOSE: INTRAMUSCULAR: 0.2 mg/kg IM, up to a maximum dose of 7 mg (Chamberlain et al, 1997) OR 10 mg IM (weight greater than 40 kg); 5 mg IM (weight 13 to 40 kg); INTRANASAL: 0.2 to 0.5 mg/kg up to a maximum of 10 mg/dose (Loddenkemper & Goodkin, 2011; Brophy et al, 2012). BUCCAL midazolam, 10 mg, has been used in adolescents and older children (5-years-old or more) to control seizures when intravenous access was not established (Scott et al, 1999).
    4) LORAZEPAM
    a) MAXIMUM RATE: The rate of intravenous administration of lorazepam should not exceed 2 mg/min (Brophy et al, 2012; Prod Info lorazepam IM, IV injection, 2008).
    b) ADULT DOSE: 2 to 4 mg IV initially; repeat every 5 to 10 minutes as needed, if seizures persist (Manno, 2003; Brophy et al, 2012).
    c) PEDIATRIC DOSE: 0.05 to 0.1 mg/kg IV over 2 to 5 minutes, up to a maximum of 4 mg/dose; may repeat in 5 to 15 minutes as needed, if seizures continue (Brophy et al, 2012; Loddenkemper & Goodkin, 2011; Hegenbarth & American Academy of Pediatrics Committee on Drugs, 2008; Sreenath et al, 2009; Chin et al, 2008).
    5) PHENOBARBITAL
    a) ADULT LOADING DOSE: 20 mg/kg IV at an infusion rate of 50 to 100 mg/minute IV. An additional 5 to 10 mg/kg dose may be given 10 minutes after loading infusion if seizures persist or recur (Brophy et al, 2012).
    b) Patients receiving high doses will require endotracheal intubation and may require vasopressor support (Brophy et al, 2012).
    c) PEDIATRIC LOADING DOSE: 20 mg/kg may be given as single or divided application (2 mg/kg/minute in children weighing less than 40 kg up to 100 mg/min in children weighing greater than 40 kg). A plasma concentration of about 20 mg/L will be achieved by this dose (Loddenkemper & Goodkin, 2011).
    d) REPEAT PEDIATRIC DOSE: Repeat doses of 5 to 20 mg/kg may be given every 15 to 20 minutes if seizures persist, with cardiorespiratory monitoring (Loddenkemper & Goodkin, 2011).
    e) MONITOR: For hypotension, respiratory depression, and the need for endotracheal intubation (Loddenkemper & Goodkin, 2011; Manno, 2003).
    f) SERUM CONCENTRATION MONITORING: Monitor serum concentrations over the next 12 to 24 hours. Therapeutic serum concentrations of phenobarbital range from 10 to 40 mcg/mL, although the optimal plasma concentration for some individuals may vary outside this range (Hvidberg & Dam, 1976; Choonara & Rane, 1990; AMA Department of Drugs, 1992).
    6) OTHER AGENTS
    a) If seizures persist after phenobarbital, propofol or pentobarbital infusion, or neuromuscular paralysis with general anesthesia (isoflurane) and continuous EEG monitoring should be considered (Manno, 2003). Other anticonvulsants can be considered (eg, valproate sodium, levetiracetam, lacosamide, topiramate) if seizures persist or recur; however, there is very little data regarding their use in toxin induced seizures, controlled trials are not available to define the optimal dosage ranges for these agents in status epilepticus (Brophy et al, 2012):
    1) VALPROATE SODIUM: ADULT DOSE: An initial dose of 20 to 40 mg/kg IV, at a rate of 3 to 6 mg/kg/minute; may give an additional dose of 20 mg/kg 10 minutes after loading infusion. PEDIATRIC DOSE: 1.5 to 3 mg/kg/minute (Brophy et al, 2012).
    2) LEVETIRACETAM: ADULT DOSE: 1000 to 3000 mg IV, at a rate of 2 to 5 mg/kg/min IV. PEDIATRIC DOSE: 20 to 60 mg/kg IV (Brophy et al, 2012; Loddenkemper & Goodkin, 2011).
    3) LACOSAMIDE: ADULT DOSE: 200 to 400 mg IV; 200 mg IV over 15 minutes (Brophy et al, 2012). PEDIATRIC DOSE: In one study, median starting doses of 1.3 mg/kg/day and maintenance doses of 4.7 mg/kg/day were used in children 8 years and older (Loddenkemper & Goodkin, 2011).
    4) TOPIRAMATE: ADULT DOSE: 200 to 400 mg nasogastric/orally OR 300 to 1600 mg/day orally divided in 2 to 4 times daily (Brophy et al, 2012).

Enhanced Elimination

    A) HEMODIALYSIS
    1) It is unknown if hemodialysis would be effective in overdose.

Range Of Toxicity

Summary

    A) TOXICITY: Toxicity has been noted at therapeutic or near therapeutic doses. Doses as low as 30 mg/kg/day in patients with renal failure and 50 to 75 mg/kg/day in patients with normal renal function have resulted in toxicity. Transient neurologic dysfunction was observed in a 2-year-old girl receiving an estimated dose of piperazine 300 mg/kg/day for 2 days. Neurologic dysfunction resolved within 72 hours of admission. Recovery has been reported following ingestion of 11.6 g. THERAPEUTIC DOSE: ADULT: Varies by indication; up to 3.5 g/day for 2 days. CHILD: 75 mg/kg/day for 2 days; up to 3.5 g/day.

Therapeutic Dose

    7.2.1) ADULT
    A) DISEASE STATE
    1) ASCARIASIS - 3.5 grams per 24 hours for 2 days (USPDI, 1995)
    2) ENTEROBIASIS - 65 milligrams/kilogram as a single dose, not to exceed 2.5 grams, orally daily for 7 consecutive days (USPDI, 1995).
    3) Piperazine is contraindicated in patients with epilepsy, liver disease, or renal failure (JEF Reynolds , 1989).
    7.2.2) PEDIATRIC
    A) DISEASE STATE
    1) ROUNDWORMS (Ascaris lumbricoides) -
    a) ORAL - 75 milligrams/kilogram/day given once daily for 2 days (very heavy infection or with biliary or intestinal obstruction) (USPDI, 1995).
    b) Maximum - Up to 3.5 grams/day (USPDI, 1995).
    2) ENTEROBIASIS - 65 milligrams/kilogram as a single dose, not to exceed 2.5 grams, orally daily for 7 consecutive days (USPDI, 1995).

Minimum Lethal Exposure

    A) CASE REPORTS
    1) PEDIATRIC
    a) An 11-year-old died after experiencing status epilepticus for 6 days following therapeutic doses of piperazine (Schuch et al, 1966).
    b) An 8-year-old uremic patient, who was given 86.7 mg/kg/day of piperazine for 3 days, died after his mental status had improved and myoclonic jerks had subsided, all other cases recovered completely within a few days after the drug was discontinued with symptomatic and supportive care (Miller & Carpenter, 1967).

Maximum Tolerated Exposure

    A) CASE REPORTS
    1) Toxic effects have been noted at doses as low as 30 mg/kg/day in a patient with renal failure (Combes et al, 1956) and 50 to 75 mg/kg/day in patients with normal renal function.
    2) Recovery has been reported following an ingestion of 11.6 g (Slaughter, 1896).
    3) Transient neurologic dysfunction was noted in a 2-year-old female receiving an estimated dose of 300 mg/kg/day for 2 days. Neurologic dysfunction resolved within 72 hours of admission (Yohai & Barnett, 1989).

Workplace Standards

    A) ACGIH TLV Values for CAS110-85-0 (American Conference of Governmental Industrial Hygienists, 2010):
    1) Editor's Note: The listed values are recommendations or guidelines developed by ACGIH(R) to assist in the control of health hazards. They should only be used, interpreted and applied by individuals trained in industrial hygiene. Before applying these values, it is imperative to read the introduction to each section in the current TLVs(R) and BEI(R) Book and become familiar with the constraints and limitations to their use. Always consult the Documentation of the TLVs(R) and BEIs(R) before applying these recommendations and guidelines.
    a) Notice of Intended Changes
    1) Piperazine
    a) TLV:
    1) TLV-TWA: 0.1 mg/m(3)
    2) TLV-STEL:
    3) TLV-Ceiling:
    b) Notations and Endnotes:
    1) Carcinogenicity Category: A4
    2) Codes: IFV, SEN
    3) Definitions:
    a) A4: Not Classifiable as a Human Carcinogen: Agents which cause concern that they could be carcinogenic for humans but which cannot be assessed conclusively because of a lack of data. In vitro or animal studies do not provide indications of carcinogenicity which are sufficient to classify the agent into one of the other categories.
    b) IFV: Inhalable fraction and vapor.
    c) SEN: The designation SEN refers to the potential for an agent to produce sensitization, as confirmed by human or animal data. The notation does not imply that this is the critical effect or that this is the sole basis for the TLV. Although, for those TLVs that are based on sensitization, the TLV is meant to protect workers from induction of this effect, but cannot protect workers who have already become sensitized. The notation should be used to assist in identifying sensitization hazards and reducing respiratory, dermal, and conjunctival exposures to sensitizing agents in the workplace. Please see "Definitions and Notations" (in TLV booklet) for full definition.
    c) TLV Basis - Critical Effect(s): Resp sens; asthma; liver and kidney dam
    d) Molecular Weight: 86.14
    1) For gases and vapors, to convert the TLV from ppm to mg/m(3):
    a) [(TLV in ppm)(gram molecular weight of substance)]/24.45
    2) For gases and vapors, to convert the TLV from mg/m(3) to ppm:
    a) [(TLV in mg/m(3))(24.45)]/gram molecular weight of substance
    e) Additional information:

    B) NIOSH REL and IDLH Values for CAS110-85-0 (National Institute for Occupational Safety and Health, 2007):
    1) Not Listed

    C) Carcinogenicity Ratings for CAS110-85-0 :
    1) ACGIH (American Conference of Governmental Industrial Hygienists, 2010): A4 ; Listed as: Piperazine
    a) A4 :Not Classifiable as a Human Carcinogen: Agents which cause concern that they could be carcinogenic for humans but which cannot be assessed conclusively because of a lack of data. In vitro or animal studies do not provide indications of carcinogenicity which are sufficient to classify the agent into one of the other categories.
    2) EPA (U.S. Environmental Protection Agency, 2011): Not Listed
    3) IARC (International Agency for Research on Cancer (IARC), 2016; International Agency for Research on Cancer, 2015; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2010; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2010a; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2008; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2007; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2006; IARC, 2004): Not Listed
    4) NIOSH (National Institute for Occupational Safety and Health, 2007): Not Listed
    5) MAK (DFG, 2002): Not Listed
    6) NTP (U.S. Department of Health and Human Services, Public Health Service, National Toxicology Project ): Not Listed

    D) OSHA PEL Values for CAS110-85-0 (U.S. Occupational Safety, and Health Administration (OSHA), 2010):
    1) Not Listed

Toxicity Information

    7.7.1) TOXICITY VALUES
    A) LD50- (INTRAPERITONEAL)MOUSE:
    1) 1900 mg/kg (RTECS , 1992a; Sax & Lewis, 1989a)
    B) LD50- (ORAL)MOUSE:
    1) 600 mg/kg (RTECS , 1992a; Sax & Lewis, 1989a)
    C) LD50- (SUBCUTANEOUS)MOUSE:
    1) 1100 mg/kg (RTECS , 1992a; Sax & Lewis, 1989a)
    D) LD50- (ORAL)RAT:
    1) 1900 mg/kg (RTECS , 1992a; Sax & Lewis, 1989a)
    E) LD50- (SUBCUTANEOUS)RAT:
    1) 3700 mg/kg (RTECS , 1992a; Sax & Lewis, 1989a)

Pharmacology Toxicology

Pharmacologic Mechanism

    A) Piperazine salts have shown activity against the human pinworm (Enterobius vermicularis) and against the roundworm (Ascaris lumbricoides) (Nickey, 1966). Piperazine blocks the response of ascaris smooth muscle to acetylcholine.
    1) This produces paralysis of the muscle and expulsion via peristalsis (Gilman et al, 1980).

Toxicologic Mechanism

    A) In mice, piperazine produces sedation in low doses, muscular paralysis in high doses and increases hexobarbital sleep time. Urinary excretion is the main route of elimination and thus increased toxicity is seen in patients with decreased renal function.

Physicochemical

Physical Characteristics

    A) PURE
    1) Piperazine has been described as leaflets from alcohol; colorless, deliquescent, transparent, needle-like or rhombic crystals with an ammoniacal or mild fish odor, which absorb carbon dioxide from the air (Budavari, 1989; Sax & Lewis, 1989; CHRIS , 1992) HSDB, 1992).
    2) It has been described as having a salty taste (Budavari, 1989) Windholz, 1983).
    B) HEXAHYDRATE: has been described as crystals from water (containing 44.34% anhydrous piperazine); the piperazine of commerce is usually this hydrate (Budavari, 1989)
    C) PHOSPHATE: has been described as minute crystals (Budavari, 1989)

Ph

    A) PURE
    1) strong base (Budavari, 1989)
    2) 10.8-11.8 (10% aqueous solution)(Budavari, 1989)
    B) HEXAHYDRATE: 10.8-11.8 (10% aqueous solution) (Budavari, 1989)
    C) PHOSPHATE: 6.5 (saturated aqueous solutuion) (Budavari, 1989)

Molecular Weight

    A) 86.14 (Budavari, 1989)

Other

    A) ODOR THRESHOLD
    1) Currently not available (CHRIS , 2002)

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