PYRETHRINSAND PIPERONYL BUTOXIDE (Topical)

Some commonly used brand names are:

In the U.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

In Canada?

• R & C

Category

• Pediculicide

Description

Medicine containing pyrethrins (pye-REE-thrins) is used to treat head,body, and pubic lice infections. This medicine is absorbed by the lice anddestroys them by acting on their nervous systems. It does not affect humansin this way. The piperonyl butoxide (pye-PEER-i-nil byoo-TOX-ide) is included to make the pyrethrinsmore effective in killing the lice. This combination medicine is known asa pediculicide (pe-DIK-yoo-li-side).

This medicine is available without a prescription; however, your doctormay have special instructions on the proper use of this medicine for yourmedical condition.

Pyrethrins and piperonyl butoxide combination medicine is available inthe following dosage forms:

Topical
• Gel (U.S.)
• Solution shampoo (U.S. and Canada)
• Topical solution (U.S.)

Before Using This Medicine

If you are using this medicinewithout a prescription, carefully read and follow any precautions on the label.For pyrethrins and piperonyl butoxide combination, the following should beconsidered:

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to pyrethrins, piperonyl butoxide, ragweed, chrysanthemumplants, or kerosene or other petroleum products. Also tell your health careprofessional if you are allergic to any other substances, such as preservativesor dyes.

Pregnancy?Pyrethrins and piperonyl butoxide may be absorbedthrough the skin. However, this medicine has not been shown to cause birthdefects or other problems in humans when used on the skin.

Breast-feeding?Pyrethrins and piperonyl butoxide combination maybe absorbed through the mother's skin. It is not known whether pyrethrinsand piperonyl butoxide combination passes into the breast milk. Although mostmedicines pass into breast milk in small amounts, many of them may be usedsafely while breast-feeding. Mothers who are using this medicine and who wishto breast-feed should discuss this with their doctor.

Children?Although there is no specific information comparinguse of pyrethrins and piperonyl butoxide combination in children with usein other age groups, this medicine is not expected to cause different sideeffects or problems in children than it does in adults.

Older adults?Many medicines have not been studied specificallyin older people. Therefore, it may not be known whether they work exactlythe same way they do in younger adults. Although there is no specific informationcomparing use of pyrethrins and piperonyl butoxide combination medicine inthe elderly with use in other age groups, this medicine is not expected tocause different side effects or problems in older people than it does in youngeradults.

Other medical problems?The presence of other medical problems may affectthe use of pyrethrins and piperonyl butoxide combination. Make sure you tellyour doctor if you have any other medical problems, especially:

• Inflammation of the skin (severe)?Use of pyrethrins and piperonylbutoxide combination may make the condition worse

Proper Use of This Medicine

Pyrethrinsand piperonyl butoxide combination medicine usually comes with patient directions.Read them carefully before using this medicine.

Use this medicine only as directed. Do not use moreof it and do not use it more often than recommended on the label. Todo so may increase the chance of absorption through the skin and the chanceof side effects.

Keep pyrethrins and piperonyl butoxide combinationmedicine away from the mouth and do not inhale it. This medicine is harmfulif swallowed or inhaled.

To lessen the chance of inhaling this medicine, applyit in a well-ventilated room (for example, one with free flowing airor with a fan turned on).

Keep this medicine away from the eyes and other mucousmembranes, such as the inside of the nose, mouth, or vagina, because it maycause irritation. If you accidentally get some in your eyes, flushthem thoroughly with water at once.

Do not apply this medicine to the eyelashes or eyebrows. If they become infected with lice, check with your doctor.

To use the gel or solution form of this medicine:

• Apply enough medicine to thoroughly wet the dry hair and scalp orskin. Allow the medicine to remain on the affected areas for exactly 10 minutes.
• Then, thoroughly wash the affected areas with warm water and soapor regular shampoo. Rinse thoroughly and dry with a clean towel.

To use the shampoo form of this medicine:

• Apply enough medicine to thoroughly wet the dry hair and scalp orskin. Allow the medicine to remain on the affected areas for exactly 10 minutes.
• Then use a small amount of water and work shampoo into the hair andscalp or skin until a lather forms. Rinse thoroughly and dry with a cleantowel.

After rinsing and drying, use a nit removal comb (special fine-toothedcomb, usually included with this medicine) to remove the dead lice and eggs(nits) from hair.

Immediately after using this medicine, wash your hands to remove any medicinethat may be on them.

This medicine should be used again in 7 to 10 days after the first treatmentin order to kill any newly hatched lice.

Lice can easily move from one person to another by close body contact.This can happen also by direct contact with such things as clothing, hats,scarves, bedding, towels, washcloths, hairbrushes and combs, or the hair ofinfected persons. Therefore, all members of your householdshould be examined for lice and receive treatment if they are found to beinfected.

To use this medicine for pubic (crab) lice:

• Your sexual partner may also need to be treated, since the infectionmay spread to persons in close contact. If your partner is not being treatedor if you have any questions about this, check with your doctor.

Dosing?The dose of pyrethrins and piperonyl butoxidecombination will be different for different patients. Follow your doctor's orders or the directions on the label. The followinginformation includes only the average doses of pyrethrins and piperonyl butoxidecombination. If your dose is different, do not changeit unless your doctor tells you to do so.

• For topical dosage forms (gel, solutionshampoo, and topical solution):
  • For head, body, or pubic lice:
    • Adults and children?Use one time, then repeat one time in sevento ten days.

Storage?To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Keep the medicine from freezing.
• Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

To preventreinfection or spreading of the infection to other people, good health habitsare also required. These include the following:

• For head lice
  • Machine wash all clothing (including hats, scarves, and coats), bedding,towels, and washcloths in very hot water and dry them by using the hot cycleof a dryer for at least 20 minutes. Clothing or bedding that cannot be washedshould be dry-cleaned or sealed in a plastic bag for 2 weeks.
  • Shampoo all wigs and hairpieces.
  • Wash all hairbrushes and combs in very hot soapy water (above 130?F) for 5 to 10 minutes and do not share them with other people.
  • Clean the house or room by thoroughly vacuuming upholstered furniture,rugs, and floors.
• For body lice
  • Machine wash all clothing, bedding, towels, and washcloths in veryhot water and dry them by using the hot cycle of a dryer for at least 20 minutes.Clothing or bedding that cannot be washed should be dry-cleaned or sealedin a plastic bag for 2 weeks.
  • Clean the house or room by thoroughly vacuuming upholstered furniture,rugs, and floors.
• For pubic lice
  • Machine wash all clothing (especially underwear), bedding, towels,and washcloths in very hot water and dry them by using the hot cycle of adryer for at least 20 minutes. Clothing or bedding that cannot be washed shouldbe dry-cleaned or sealed in a plastic bag for 2 weeks.
  • Scrub toilet seats frequently.

Side Effects of This Medicine

Along with its needed effects,a medicine may cause some unwanted effects. Although not all of these sideeffects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following sideeffects occur:

Less common or rare

Otherside effects not listed above may also occur in some patients. If you noticeany other effects, check with your health care professional.