Acticin Topical

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

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of topical permethrin in children with use in other age groups.

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 or if they cause different side effects or problems in older people. There is no specific information comparing use of topical permethrin in the elderly with use in other age groups.

Pregnancy

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during 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:

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

• Severe inflammation of the scalp—Use of permethrin may make the condition worse

This section provides information on the proper use of a number of products that contain permethrin. It may not be specific to Acticin. Please read with care.

Keep this medicine away from the eyes. If you accidentally get some in your eyes, flush them thoroughly with water at once.

Permethrin lotion which is used to treat lice, comes in a container that holds only one treatment. Use as much of the medicine as you need and discard any remaining lotion properly.

For the treatment of head lice (1% lotion):

• Shampoo the hair and scalp using regular shampoo.
• Thoroughly rinse and towel dry the hair and scalp.
• Allow hair to air dry for a few minutes.
• Shake the permethrin lotion well before applying.
• Thoroughly wet the hair and scalp with the permethrin lotion. Be sure to cover the areas behind the ears and on the back of the neck also. Allow the lotion to remain in place for 10 minutes.
• Then, rinse the hair and scalp thoroughly and dry with a clean towel.
• When the hair is dry, you may want to comb the hair with a fine-toothed comb to remove any remaining nits (eggs) or nit shells.

Head lice can be easily transferred from one person to another by direct contact with clothing, hats, scarves, bedding, towels, washcloths, hairbrushes and combs, or hairs from infected persons. Therefore, all members of your household should be examined for head lice and should receive treatment if they are found to be infected. If you have any questions about this, check with your doctor.

For the treatment of scabies (5% cream):

• Read package directions carefully before using.
• Thoroughly wash and dry skin.
• Massage the cream into the skin from the head to the soles of the feet, paying special attention to creases in the skin, hands, feet, between fingers and toes, underarms, and groin.
• Scabies rarely infests the scalp of adults, although the hairline, neck, side of the head, and forehead may be infested in older people and in infants. Infants should be treated on the scalp, side of the head, and forehead.
• Leave the permethrin cream on the skin for 8 to 14 hours.
• Wash off by taking a shower or bath.
• Change into clean clothes.
• After treatment, itching may continue for up to 4 weeks.

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 (cream and lotion):
  • For head lice:
    • Adults and children 2 years of age and older—Apply to the hair and scalp one time.
    • Children up to 2 years of age—Use and dose must be determined by your doctor.
  • For scabies:
    • Adults and children 2 months of age and older—Apply to the skin one time.
    • Children up to 2 months of age—Use and dose must be determined by your doctor.

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.

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

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Burning, itching, numbness, rash, redness, stinging, swelling, or tingling of the scalp

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

This medication is used to treat scabies, a condition caused by tiny insects called mites that infest and irritate your skin. Permethrin belongs to a class of drugs known as pyrethrins. Permethrin works by paralyzing and killing the mites and their eggs.

How to use Acticin Cream

This medication is for use on the skin only. Apply this medication as soon as possible after it is prescribed. Apply the medicine from your head to the soles of your feet, including under your nails and in skin folds such as between the toes, as directed. Massage the cream into the skin. Do not use more medication than prescribed. Wash off the cream after 8-14 hours by showering or taking a bath.

Avoid getting the cream into your eyes, nose, mouth, or vagina. If the medication gets in your eyes, flush the eyes with plenty of water. Consult your doctor if irritation persists.

Symptoms of scabies include an intense itching that is usually worse at bedtime. You may also see small, fine, wavy lines on the skin with a tiny insect at the end (a burrow). Burrows are usually found on finger/toe webs, wrists, elbows, armpits, belt line, lower buttocks, female nipples, or male genitals. Even if permethrin kills all the scabies, the dead mites can still make you itch for up to 4 weeks after treatment. Ask your doctor about other medications that may be used to soothe the itching. Inform your doctor if your condition persists or worsens 2 weeks after treatment. Your doctor may need to look for living mites and recommend more treatment.

Skin irritation, including itching, swelling, and redness, may occur with scabies and temporarily worsen after treatment with permethrin. Mild burning or stinging may also occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.