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Pyrethrins and Piperonyl Butoxide (Topical)


VA CLASSIFICATION
Primary: AP300{07}

Commonly used brand name(s): A-200 Gel Concentrate; A-200 Shampoo Concentrate; Barc; Blue; Licetrol; Pronto Lice Killing Shampoo Kit; Pyrinyl; R & C; Rid; Tisit; Tisit Blue; Tisit Shampoo; Triple X.

Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).



Category:


Pediculicide—

Indications

Accepted

Pediculosis corporis (treatment)
Pediculosis capitis (treatment) or
Pediculosis pubis (treatment)—Pyrethrins and piperonyl butoxide combination is indicated for the treatment of pediculosis (lice) infestations caused by Pediculus humanus var. corporis (body louse), P. humanus var. capitis (head louse), and Phthirus pubis (pubic or crab louse). {01} {02} {03} {21} {22}


Pharmacology/Pharmacokinetics

Physicochemical characteristics:
Source—
    Pyrethrins: Obtained from flowers of the pyrethrum plant, Chrysanthemum cincerariaefolium , which is related to the ragweed plant; esters formed by the combination of chrysanthenic and pyrethric acids and pyrethrolone, cinerolone, and jasmolone alcohols.
    Piperonyl butoxide: A synthetic piperic acid derivative.

Mechanism of action/Effect:

Pyrethrins—Are absorbed through the chitinous exoskeleton of arthropods and stimulate the nervous system, probably by competitively interfering with cationic conductances in the lipid layer of nerve cells, thereby blocking nerve impulse transmissions, which results in paralysis and death.

Piperonyl butoxide—Has little or no insecticidal activity but potentiates that of pyrethrins by inhibiting the hydrolytic enzymes responsible for metabolism of pyrethrins in arthropods, thereby increasing the insecticidal activity of pyrethrins by 2 to 12 times.

Absorption:

Pyrethrins and piperonyl butoxide are poorly absorbed through intact skin when applied topically; if pyrethrins are absorbed, they are rapidly metabolized in mammals.


Precautions to Consider

Cross-sensitivity and/or related problems

Patients allergic to the ragweed or chrysanthemum plant may be allergic to the pyrethrins in this medication also.

Patients sensitive to kerosene may also be sensitive to the pyrethrins and piperonyl butoxide combination preparations that contain kerosene.

Pregnancy/Reproduction

Pregnancy—
Problems in humans have not been documented; however, pyrethrins and piperonyl butoxide may be absorbed systemically in small amounts through intact skin.

Breast-feeding

Problems in humans have not been documented; however, pyrethrins and piperonyl butoxide may be absorbed systemically in small amounts through intact skin.

Pediatrics

Appropriate studies on the relationship of age to the effects of pyrethrins and piperonyl butoxide have not been performed in the pediatric population. However, no pediatrics-specific problems have been documented to date.


Geriatrics


Appropriate studies on the relationship of age to the effects of pyrethrins and piperonyl butoxide have not been performed in the geriatric population. However, no geriatrics-specific problems have been documented to date.

Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Risk-benefit should be considered when the following medical problems exist
Inflammation of skin, acute    (condition may be exacerbated)


Sensitivity to pyrethrins or piperonyl butoxide


Side/Adverse Effects

Note: Pyrethrins and piperonyl butoxide combination applied topically in recommended dosage appears to be relatively free of the risk of causing systemic toxicity.
When pyrethrins are injected or inhaled, they can cause nausea, vomiting, muscle paralysis, and even death; however, severe poisoning from pyrethrins is rare.
Piperonyl butoxide has been reported to cause nausea, vomiting, diarrhea, central nervous system (CNS) depression, and hemorrhagic enteritis when large amounts are ingested orally.

The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
Incidence less frequent or rare
    
Allergic reaction (skin rash; sudden attacks of sneezing; stuffy or runny nose; wheezing or difficulty in breathing)
    
skin infection
    
skin irritation not present before therapy





Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Pyrethrins and Piperonyl Butoxide (Topical).

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Before using this medication
»   Conditions affecting use, especially:
Allergy to ragweed or chrysanthemum plants or sensitivity to pyrethrins, piperonyl butoxide, or kerosene or other petroleum products

Proper use of this medication
» Importance of not using more medication than the amount recommended

» Importance of keeping away from mouth and not inhaling; harmful if swallowed or inhaled

» Applying in a well-ventilated room to minimize possibility of inhalation

» Avoiding contact with the eyes and mucous membranes, such as the inside of the nose, mouth, or vagina {05}; flushing eyes thoroughly with water if medication accidentally gets in eyes

» Not using on eyelashes or eyebrows; checking with physician if they become infested

Proper administration
Reading patient directions carefully before using

Applying sufficient amount to thoroughly wet the dry hair and scalp or skin of affected areas

Allowing to remain on affected areas for exactly 10 minutes {18} {19}

Then



• For gel and solution dosage forms: Thoroughly washing affected areas with warm water and soap or regular shampoo


• For shampoo dosage form: Using small amount of water and working shampoo into the hair and scalp or skin until a lather forms


Rinsing thoroughly; drying with clean towel
Using nit removal comb to remove dead lice and eggs from hair

Washing hands immediately after using medication

Repeating treatment once in 7 to 10 days to kill any newly hatched lice {18} {19}

» Importance of all members of household being examined for infestation, and treated if infested

Importance of concurrent treatment of sexual partner in pediculosis pubis

» Proper dosing

» Proper storage

Precautions while using this medication

Using hygienic measures to control reinfestation or spread of infestation

For head lice
Machine washing all clothing (including hats, scarves, and coats), bedding, towels, and washcloths in very hot water and drying them by using hot cycle of dryer for at least 20 minutes; for clothing or bedding not washable, dry-cleaning or sealing in a plastic bag for 2 weeks

Shampooing all wigs and hairpieces

Washing hairbrushes and combs in very hot soapy water (at least 130 °F) for 5 to 10 minutes; not sharing them with other people

Cleaning house or room by thoroughly vacuuming upholstered furniture, rugs, and floors

For body lice
Machine washing all clothing, bedding, towels, and washcloths in very hot water and drying them by using hot cycle of dryer for at least 20 minutes; for clothing or bedding not washable, dry-cleaning or sealing in a plastic bag for 2 weeks

Cleaning house or room by thoroughly vacuuming upholstered furniture, rugs, and floors

For pubic lice
Machine washing all clothing (especially underwear), bedding, towels, and washcloths in very hot water and drying them by using hot cycle of dryer for at least 20 minutes; for clothing or bedding not washable, dry-cleaning or sealing in a plastic bag for 2 weeks

Scrubbing toilet seats frequently


Side/adverse effects
Signs of potential side effects, especially allergic reaction, skin infection, or skin irritation not present before therapy


General Dosing Information
Following the initial treatment, a second treatment should be made in 7 to 10 days to kill any newly hatched lice. {18} {19}

When used in the treatment of pediculosis pubis (pubic or crab lice), the sexual partner should receive concurrent therapy, since the infestation may spread to persons in close contact.

For treatment of systemic toxicity
   • For accidental ingestion—Primarily supportive treatment; induction of vomiting if patient is conscious; gastric lavage if patient is unconscious. Saline cathartics may be administered to minimize absorption of pyrethrins and piperonyl butoxide.
   • For accidental inhalation—Artificial respiration, if necessary.


Topical Dosage Forms

PYRETHRINS AND PIPERONYL BUTOXIDE GEL

Usual adult and adolescent dose
Pediculicide
Topical, to the hair and scalp or skin, for one application, repeated once in seven to ten days. {19}


Usual adult prescribing limits
No more than two applications within twenty-four hours. {19}

Usual pediatric dose
See Usual adult and adolescent dose .

Strength(s) usually available
U.S.—


0.18% pyrethrins, 2.2% piperonyl butoxide technical (equivalent to 1.76% [butylcarbityl] [6-propylpiperonyl] ether and 0.44% related compounds), and 4.80% petroleum distillate (OTC) [Barc{14}{15}]


0.3% pyrethrins, 3% piperonyl butoxide technical (equivalent to 2.4% [butylcarbityl] [6-propylpiperonyl] ether and 0.6% related compounds), and 1.2% petroleum distillate (OTC) [Blue{11}] [Tisit Blue{01}{11}]


0.33% pyrethrins, 4% piperonyl butoxide technical (equivalent to 3.2% [butylcarbityl] [6-propylpiperonyl] ether and 0.8% related compounds) (OTC) [A-200 Gel Concentrate{08}{19} (benzyl alcohol)]{04}

Canada—
Not commercially available.

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a well-closed container, unless otherwise specified by manufacturer. Protect from freezing.

Auxiliary labeling:
   • For external use only.
   • Harmful if swallowed or inhaled.

Note: When dispensing, include patient instructions.



PYRETHRINS AND PIPERONYL BUTOXIDE SOLUTION SHAMPOO

Usual adult and adolescent dose
See Pyrethrins and Piperonyl Butoxide Gel. {18} {21}

Usual adult prescribing limits
See Pyrethrins and Piperonyl Butoxide Gel. {18}

Usual pediatric dose
See Usual adult and adolescent dose .

Strength(s) usually available
U.S.—


0.3% pyrethrins, 3% piperonyl butoxide technical (equivalent to 2.4% [butylcarbityl] [6-propylpiperonyl] ether and 0.6% related compounds), and 1.2% petroleum distillate (OTC) [R & C{12}]


0.3% pyrethrins, 3% piperonyl butoxide technical (equivalent to 2.4% [butylcarbityl] [6-propylpiperonyl] ether and 0.6% related compounds), 1.2% petroleum distillate, and 2.4% benzyl alcohol (OTC) [Triple X]


0.33% pyrethrins, 4% piperonyl butoxide technical (equivalent to 3.2% [butylcarbityl] [6-propylpiperonyl] ether and 0.8% related compounds) (OTC) [A-200 Shampoo Concentrate{04}{08}{18} (benzyl alcohol)] [Pronto Lice Killing Shampoo Kit{18}{20}{21}]

Canada—


0.3% pyrethrins, 3% piperonyl butoxide technical (equivalent to 2.4% [butylcarbityl] [6-propylpiperonyl] ether and 0.6% related compounds), and 1.2% petroleum distillate (OTC) [R & C{12}]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a well-closed container, unless otherwise specified by manufacturer. Protect from freezing.

Auxiliary labeling:
   • For external use only.
   • Harmful if swallowed or inhaled.

Note: When dispensing, include patient instructions.



PYRETHRINS AND PIPERONYL BUTOXIDE TOPICAL SOLUTION

Usual adult and adolescent dose
See Pyrethrins and Piperonyl Butoxide Gel. {22}

Usual adult prescribing limits
See Pyrethrins and Piperonyl Butoxide Gel.

Usual pediatric dose
See Usual adult and adolescent dose .

Strength(s) usually available
U.S.—


0.18% pyrethrins, 2.2% piperonyl butoxide (equivalent to 1.76% [butylcarbityl] [6-propylpiperonyl] ether and 0.44% related compounds), and 5.52% petroleum distillate (OTC) [Barc{14}{15}]


0.2% pyrethrins, 2% piperonyl butoxide technical (equivalent to 1.6% [butylcarbityl] [6-propylpiperonyl] ether and 0.4% related compounds), and 0.8% deodorized kerosene or petroleum distillate (OTC) [Licetrol{13}] [Pyrinyl{10}{13}]


0.3% pyrethrins and 2% piperonyl butoxide technical (equivalent to 1.6% [butylcarbityl] [6-propylpiperonyl] ether and 0.4% related compounds) (OTC) [Tisit{02}{03}]


0.3% pyrethrins, 3% piperonyl butoxide technical (equivalent to 2.4% [butylcarbityl] [6-propylpiperonyl] ether and 0.6% related compounds), 1.2% petroleum distillate, and 2.4% benzyl alcohol (OTC) [Rid] [Tisit Shampoo{02}{03}{09}{22}]

Canada—
Not commercially available.

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a well-closed container, unless otherwise specified by manufacturer. Protect from freezing.

Auxiliary labeling:
   • For external use only.
   • Harmful if swallowed or inhaled.

Note: When dispensing, include patient instructions.




Revised: 02/18/1994



References
  1. Tisit Blue Gel package insert (Pfeiffer—US), Rec 3/86.
  1. Tisit Topical Solution package insert (Pfeiffer—US), Rec 4/87.
  1. Tisit Solution Shampoo package insert (Pfeiffer—US), Rec 4/87.
  1. A-200 Solution Shampoo package insert (Norcliff Thayer—US), Rec 4/86.
  1. Pediculicide drug products for over-the-counter human use: final rule. Food and Drug Administration Federal Register 1993 Dec; 58(238): 65453.
  1. Hold.
  1. Hold.
  1. A-200 Gel Shampoo package insert (Norcliff Thayer—US), Rec 4/86.
  1. Rid package insert (Pfipharmics—US), Rec 5/87.
  1. Pyrinyl Liquid package insert (Barre—US), Rec 6/87.
  1. Blue Gel package insert (Ambix—US), Rec 5/88.
  1. R & C Solution Shampoo package insert (Reed & Carnrick—US), Rec 6/88.
  1. Licetrol 400 Topical Solution package insert (Republic—US), Rec 4/87.
  1. Barc Gel package insert (Commerce—US), Rec 4/86.
  1. Barc Liquid package insert (Commerce—US), Rec 4/86.
  1. Hold.
  1. Hold.
  1. A-200 Pediculicide Shampoo Concentrate package insert (SmithKline Beecham—US), PDR for nonprescription drugs 1990: 695.
  1. A-200 Pediculicide Gel Concentrate package insert (SmithKline Beecham—US), PDR for nonprescription drugs 1990: 695.
  1. Pronto Lice Killing Shampoo Kit package insert (Commerce—US), PDR for nonprescription drugs 1990: 552.
  1. A-200 Shampoo Concentrate package insert (SmithKline Beecham—US), PDR for nonprescription drugs 1993: 712.
  1. Rid package insert (Pfizer—US), PDR for nonprescription drugs 1993: 639.
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