A200 Maximum Strength Topical

Name: A200 Maximum Strength Topical

Commonly used brand name(s)

In the U.S.

  • A200 Maximum Strength
  • A200 Time-Tested Formula
  • Lice-X
  • Licide
  • Medi-Lice Maximum Strength
  • Pronto Maximum Strength
  • Pyrinex
  • Pyrinyl
  • Rid
  • Tisit

Available Dosage Forms:

  • Gel/Jelly
  • Liquid
  • Shampoo
  • Kit
  • Foam

Therapeutic Class: Pediculicide

Chemical Class: Pyrethrums

Before Using A200 Maximum Strength

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Although there is no specific information comparing use of pyrethrins and piperonyl butoxide combination in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of pyrethrins and piperonyl butoxide combination medicine in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Inflammation of the skin (severe)—Use of pyrethrins and piperonyl butoxide combination may make the condition worse

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Very bad irritation where this medicine is used.
  • Eye irritation.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take pyrethrins and piperonyl butoxide gel and liquid or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to pyrethrins and piperonyl butoxide gel and liquid. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Pyrethrins with Piperonyl Butoxide Dosage and Administration

General

Measures to Avoid Reinfestation and Transmission

  • To avoid reinfestation or transmission of pediculosis or scabies, most experts recommend that clothing and bed linen that may have been contaminated by the infested individual during the 2 days prior to treatment should be decontaminated (machine-washed in hot water and dried in a hot dryer, dry-cleaned, or treated with an appropriate pesticide) or removed from body contact for ≥72 hours.103 104 106 113

  • Although it may not be necessary, items that cannot be laundered or dry-cleaned should be removed from contact and sealed in a plastic bag for 10–14 days.103 106 116

  • Combs and brushes used by the infected patient may be disinfected by soaking in hot water (temperature >54°C) for 5–10 minutes;103 106 alternatively, they can be soaked in alcohol or a pediculicide for 1 hour.106 112

  • Furniture and floors of rooms inhabited by patients infested with lice should be thoroughly vacuumed.103 106 116 Fumigation of living areas is not necessary and is not recommended.103 106 114 116

  • In the treatment of pediculosis capitis (head lice infestation), a fine-toothed comb often is recommended to remove any remaining nits (eggs) or nit shells.103 106 112 113 116 117 118 Some experts do not consider nit removal necessary since only live lice can be transmitted, but recommend it for aesthetic reasons and to decrease diagnostic confusion and unnecessary retreatment.103 116 117 118 Others strongly recommend removal of nits (especially those within 1 cm of the scalp) since no pediculicide is 100% ovicidal and potentially viable nits may remain on the hair after pediculicide treatment.103 116 117 118 Although many schools will not allow children with nits to attend, AAP and other experts consider these no-nit policies excessive.103 114 116

Administration

Topical Administration

Apply topically, usually as a shampoo containing 0.33% pyrethrins and 4% piperonyl butoxide.120 121 122 123

For external use only.120 121 122 123 Do not administer orally and do not apply to mucous membranes (e.g., inside the nose, mouth, or vagina).120 121 122 123

Do not apply to eyebrows or eyelashes and avoid contact with eyes.120 121 122 123 Eyes should be closed tightly and covered with a soft towel or washcloth while the shampoo is applied to scalp hair or washed off.120 121 122 123

Shake containers of pyrethrins with piperonyl butoxide before using.120 123

Dosage

Pediatric Patients

Pediculosis Pediculosis Capitis (Head Lice Infestation) or Pediculosis Corporis (Body Lice Infestation) Topical

Apply to dry scalp hair or other affected areas in an amount sufficient to thoroughly wet the area.120 121 122 123 If treating head lice, first apply behind ears and to back of neck.120 121 After 10 minutes, add warm water to form a good lather, wash, and thoroughly rinse with water until all lather is gone.120 121 122 123 Dry the hair with a clean towel and comb with a fine tooth comb to remove any remaining nits.120 121 122 123

One treatment may be successful, but treatment should be repeated after 7–10 days to kill any newly hatched lice.103 107 113 116 117 121 122 123 Do no use more than twice in 24 hours.123

Adults

Pediculosis Pediculosis Capitis (Head Lice Infestation) or Pediculosis Corporis (Body Lice Infestation) Topical

Apply to dry scalp hair or other affected areas in an amount sufficient to thoroughly wet the area.120 121 122 123 If treating head lice, first apply behind ears and to back of neck.120 121 After 10 minutes, add warm water to form a good lather, wash, and thoroughly rinse with water until all lather is gone.120 121 122 123 Dry the hair with a clean towel and comb with a fine tooth comb to remove any remaining nits.120 121 122 123

One treatment may be successful, but treatment should be repeated after 7–10 days to kill any newly hatched lice.103 107 113 116 117 121 122 123 Do not use more than twice in 24 hours.123

Pediculosis Pubis (Pubic Lice Infestation) Topical

Apply to the pubic area.104 After 10 minutes, rinse off with water.104

CDC recommends reevaluating the patient 1 week after treatment if symptoms persist;104 retreatment may be necessary if lice or eggs are found.104 Some clinicians recommend routine retreatment 7–10 days after initial treatment.103 If retreatment is necessary, CDC recommends use of an alternative regimen.104

Cautions for Pyrethrins with Piperonyl Butoxide

Contraindications

  • Known hypersensitivity or intolerance to any ingredient in the formulation.

Warnings/Precautions

Sensitivity Reactions

Asthmatic Episodes

May cause breathing difficulty or an asthmatic episode in susceptible individuals.120 121 122

Use with caution in individuals allergic to ragweed.120 121 122 123

Discontinue use and contact a clinician if breathing difficulties occur.120 121

Contact Dermatitis

Pyrethrins may be contact allergens; sensitization characterized by dermatitis may be due to impurities from the pyrethrum flowers.a

Commercially available preparations of pyrethrins are refined, and only mild skin sensitization has been reported.a

General Precautions

Administration Precautions

Avoid contact with the eyes since ocular irritation may occur.120 121 122 123 Do not use for treatment of pediculosis of the eyebrows or eyelashes.120 121 122 123

If accidental contact with the eyes occurs, the affected eye(s) should be flushed thoroughly with water.120 121 122 123 If eye irritation occurs, discontinue use and contact a clinician.120 121 122

Avoid contact with mucous membranes (e.g., inside the nose, mouth, or vagina) since irritation may occur.120 121 122 123

Dermatologic Reactions

Local irritation or erythema may occur.120 121 a

If skin irritation or infection occurs, discontinue use and contact a clinician.120 121 122 123

Do not use on acutely inflamed skin or raw, weeping surfaces.a

Specific Populations

Pregnancy

CDC considers pyrethrins with piperonyl butoxide a pediculicide of choice when treatment is considered necessary in a pregnant woman.104

Pregnant women should consult a clinician before self-medicating with pyrethrins with piperonyl butoxide 120 121 122

Lactation

Not known whether distributed into milk. CDC considers pyrethrins with piperonyl butoxide a pediculicide of choice when treatment is considered necessary in a lactating woman.104

Lactating women should consult a clinician before self-medicating with pyrethrins with piperonyl butoxide.120 121 122

Pediatric Use

Should not be used in children <2 years of age unless directed by a clinician.120 121

Keep out of reach of children.120 121 122

Common Adverse Effects

Local irritation (erythema, pruritus, urticaria, edema, eczema).120 121 a 123

Pyrethrins with Piperonyl Butoxide Pharmacokinetics

Absorption

Bioavailability

Pyrethrins is absorbed through intact skin when applied topically.a Piperonyl butoxide is poorly absorbed through intact skin when applied topically.a

Distribution

Extent

Information regarding systemic distribution of pyrethrins and piperonyl butoxide following topical application not available.a

Elimination

Elimination Route

Information regarding elimination of pyrethrins and piperonyl butoxide following topical application not available.a

Advice to Patients

  • Importance of using only as directed.120 121 122 123

  • Advise patients regarding personal protective measures to avoid reinfestation or transmission of lice.103 104 106 113

  • Importance of not using on eyebrows or eyelashes and avoiding contact with the eyes since ocular irritation may occur.120 121 122 123 If accidental contact with the eyes occurs, the affected eye(s) should be flushed thoroughly with water.120 121 122 123

  • Importance of avoiding contact with mucous membranes (e.g., inside the nose, mouth, vagina).120 121 122 123

  • Advise patients to discontinue treatment and consult their clinician if skin or scalp irritation or infection is present or develops, if eyebrows or eyelashes are infested with lice, or if eye irritation occurs.120 121 122 123

  • Advise patients using pyrethrins with piperonyl butoxide that breathing problems or asthmatic episodes may occur in susceptible individuals.120 121 If breathing difficulties occur, discontinue treatment and consult a clinician.120 121

  • Importance of immediately consulting clinician and/or poison control center if pyrethrins with piperonyl butoxide is accidentally ingested.120 121

  • Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs.120 121 122

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.120 121 122

  • Importance of informing patients of other important precautionary information.120 121 122 (See Cautions.)

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