Sklice

Name: Sklice

Sklice Drug Class

Sklice is part of the drug class:

  • Avermectines

Sklice Usage

Oral:

  • Ivermectin comes as a tablet to take by mouth. It is usually taken as a single dose on an empty stomach with water. If you are taking ivermectin to treat onchocerciasis, additional doses 3, 6, or 12 months later may be necessary to control your infection. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take ivermectin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
  • If you are taking ivermectin to treat strongyloidiasis, you will need to have a stool exam at least three times during the first 3 months after your treatment to see if your infection has cleared. If your infection has not cleared, your doctor will probably prescribe additional doses of ivermectin.
  • Ivermectin tablets are usually taken as a single dose. Tell your doctor if you do not take your medication.

Topical:

  • Use ivermection lotion exactly as prescribed. Your healthcare provider will prescribe the treatment that is right for you. Do not change your treatment unless you talk to your healthcare provider.
  • Use ivermection lotion when your hair is dry.
  • It is important to use enough ivermection lotion to completely coat all of your hair and scalp. Leave lotion on your hair and scalp for a full 10 minutes.
  • You need to completely cover all the scalp and hair with lotion.
  • Children will need an adult to apply ivermection lotion for them.
  • Do not swallow ivermection lotion. If swallowed, call your healthcare provider or go to the nearest emergency room right away.
  • Do not get ivermection lotion into your eyes. If ivermection lotion gets in your eye, gently flush with water.
  • Wash your hands after applying ivermection lotion.

When you complete your dose of ivermection lotion, do not use ivermection lotion again without talking to your healthcare provider first.

Before you use ivermection lotion, ask your healthcare provider or pharmacist if you have questions about the right way to use ivermection lotion.

  • Your hair and scalp must be dry before applying ivermection lotion.
  • Use the top of cap to break the tamper seal on the tube.
  • Apply ivermection lotion directly to dry hair and scalp.
  • Completely cover your scalp and hair closest to the scalp first, and then apply outwards towards the ends of your hair.
  • Rub ivermection lotion throughout hair.
  • It is important to completely cover your entire head so that all lice and eggs are exposed to the lotion. Be sure that each hair is coated from the scalp to the tip.
  • Use up to 1 entire tube (4 oz) to completely cover hair and scalp.
  • Allow ivermection lotion to stay on your hair and scalp for 10 minutes after it has been applied. Use a timer or clock. Start timing after you have completely covered your hair and scalp with ivermection lotion.
  • After 10 minutes, completely rinse ivermection lotion from your hair and scalp using only water.
  • You or anyone who helps you apply ivermection lotion should wash their hands after application.
  • Do not use ivermection lotion again without talking to your healthcare provider first.

To help prevent the spread of lice from one person to another, here are some steps you can take:

  • Avoid direct head-to-head contact with anyone known to have live, crawling lice.
  • Do not share combs, brushes, hats, scarves, bandannas, ribbons, barrettes, hair bands, towels, helmets, or other hair-related personal items with anyone else, whether they have lice or not.
  • Avoid sleepovers and slumber parties during lice outbreaks. Lice can live in bedding, pillows, and carpets that have recently been used by someone with lice.
  • After finishing treatment with lice medicine, check everyone in your family for lice after one week. Be sure to talk to your healthcare provider about treatments for those who have lice.
  • Machine wash any bedding and clothing used by anyone having lice. Machine wash at high temperatures (150°F) and tumble in a hot dryer for 20 minutes.

Before Using Sklice

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

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of ivermectin topical lotion in children 6 months of age and older. However, use is not recommended in infants younger than 6 months of age.

Appropriate studies have not been performed on the relationship of age to the effects of ivermectin topical cream in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ivermectin topical lotion or cream in the elderly.

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.

Proper Use of ivermectin

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

Use this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor tells you. Do not change your treatment without checking first with your doctor.

This medicine comes with a patient information leaflet and patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

To use Sklice® topical lotion:

  • Use Sklice® on the hair and scalp only. Keep the medicine out of your eyes, nose, mouth, and vagina. If the medicine gets in your eyes, rinse them well with water.
  • Wash your hands before and after using this medicine.
  • Apply the medicine directly to the scalp and dry hair closest to the scalp and then apply outwards to the ends of your hair.
  • Completely cover your scalp and hair (up to 1 tube). Leave the medicine on the hair and scalp for 10 minutes.
  • After 10 minutes, rinse your hair with warm water and dry with a clean towel. Comb hair with a fine-toothed comb to remove any nits (eggs) or nit shells. They look like small white dots.
  • If live lice are seen 7 days after using this medicine, tell your doctor right away.
  • Do not use this medicine again without talking first with your doctor.
  • Children will need an adult to apply the medicine for them.
  • Throw away any unused medicine left in the tube after each use.
  • It is best to wait for 24 hours before applying shampoo on the treated hair and scalp areas. Do not use cosmetics and other hair products on these areas as well.

To use Soolantra® topical cream:

  • This medicine is for use on the skin only. Do not get it in your eyes, mouth, or vagina. Do not use it on skin areas that have cuts or scrapes. If it does get on these areas, rinse it off right away.
  • Wash your hands before and after using this medicine.
  • Use a pea-sized amount for each affected area of the face (forehead, chin, nose, cheeks).
  • Spread a thin layer and avoid the eyes and lips.

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 form (cream):
    • For rosacea:
      • Adults—Apply to the affected area(s) of the face once a day.
      • Children—Use and dose must be determined by your doctor.
  • For topical dosage form (lotion):
    • For head lice:
      • Adults and children 6 months of age and older—Apply directly to dry hair and scalp one time only.
      • Children younger than 6 months of age—Use is not recommended.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

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

Do not freeze Sklice® topical lotion.

Sklice Dosage and Administration

For topical use only. Sklice Lotion is not for oral, ophthalmic, or intravaginal use.

Apply Sklice Lotion to dry hair in an amount sufficient (up to 1 tube) to thoroughly coat the hair and scalp. Leave Sklice Lotion on the hair and scalp for 10 minutes, and then rinse off with water.

It is recommended to wait 24 hours before applying shampoo to hair and scalp.

The tube is intended for single use; discard any unused portion.

Avoid contact with eyes.

Warnings and Precautions

Ingestion in Pediatric Patients

In order to prevent ingestion, Sklice Lotion should only be administered to pediatric patients under the direct supervision of an adult.

How Supplied/Storage and Handling

Sklice Lotion, 0.5% is supplied in a 4 oz (117g) laminate tube (NDC 24338-183-04).

Store at room temperature 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30° C (59° to 86° F) [see USP controlled room temperature]. Do not freeze.

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