Pronto Maximum Strength (Topical)

Medicine with pyrethrins is used to treat head, body, and pubic lice infections. This medicine is taken in by the lice and kills them by working on their nervous systems. It does not affect humans in this way. The piperonyl butoxide is added to enhance the effectiveness of the pyrethrins in killing the lice. This combination medicine is called a pediculicide.

This medicine is available without a prescription.

To prevent reinfection or spreading the infection to others, it is important to follow good health habits. These include:

• For head lice: Machine wash all clothing (including hats, scarves, and coats), bedding, towels, and washcloths in very hot water and dry them on the hot cycle of a dryer for at least 20 minutes. Clothing or bedding that cannot be washed should 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 others. 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 very hot water and dry them on the hot cycle of a dryer for at least 20 minutes. Clothing or bedding that cannot be washed should be dry-cleaned or sealed in 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 on the hot cycle of a dryer for at least 20 minutes. Clothing or bedding that cannot be washed should be dry-cleaned or sealed in a plastic bag for 2 weeks. Scrub toilet seats frequently.

In deciding to use a medicine, you need to think about the risks compared to the benefits. This is a decision you will make with your doctor. For this medicine, consider the following:

Allergies

Let your doctor know if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, inform your healthcare professional about any other allergies you have, such as to foods, dyes, preservatives, or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatric

There is no specific information comparing the use of pyrethrins and piperonyl butoxide combination in children to its use in other age groups. This medicine is not expected to cause different side effects or problems in children compared to adults.

Geriatric

Many medicines have not been specifically studied in older adults. Therefore, it may not be known if they work the same way they do in younger adults. There is no specific information comparing the use of pyrethrins and piperonyl butoxide combination medicine in older people to its use in other age groups. This medicine is not expected to cause different side effects or problems in older adults compared to younger adults.

Breast Feeding

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

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might occur. In these situations, your doctor may want to adjust the dose, or other precautions may be needed. Inform your healthcare professional if you are taking any other prescription or over-the-counter (OTC) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken at or around mealtime, or with certain types of food, because interactions may occur. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect the use of this medicine. Be sure to tell your doctor if you have any other medical problems, especially:

• Inflammation of the skin (severe)—Using the pyrethrins and piperonyl butoxide combination may worsen this condition.

Along with its benefits, this medicine can cause some unwanted effects. Not everyone will experience these side effects, but if they do happen, you may need to see a doctor.

Contact your doctor right away if you notice any of the following side effects:

Less common or rare

• Skin irritation that was not there before using this medicine
• Skin rash or infection
• Sudden sneezing attacks
• Stuffy or runny nose
• Wheezing or trouble breathing

Other side effects not mentioned may also happen in some patients. If you see any other effects, talk to your healthcare professional.

Call your doctor for advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

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:

• Foam
• Gel/Jelly
• Liquid
• Shampoo

Therapeutic Class: Pediculicide

Chemical Class: Pyrethrums

Pyrethrins and 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 more of it and do not use it more often than recommended on the label. To do so may increase the chance of absorption through the skin and the chance of side effects.

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

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

Keep this medicine away from the eyes and other mucous membranes, such as the inside of the nose, mouth, or vagina, because it may cause irritation. If you accidentally get some in your eyes, flush them 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 or skin. Allow the medicine to remain on the affected areas for exactly 10 minutes.
• Then, thoroughly wash the affected areas with warm water and soap or 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 or skin. 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 and scalp or skin until a lather forms. Rinse thoroughly and dry with a clean towel.

After rinsing and drying, use a nit removal comb (special fine-toothed comb, 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 medicine that may be on them.

This medicine should be used again in 7 to 10 days after the first treatment in 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 of infected persons. Therefore, all members of your household should be examined for lice and receive treatment if they are found to be infected.

To use this medicine for pubic (crab) lice:

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

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

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

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.