Spinosad (Topical application route)
Uses of This Medicine:
Spinosad 0.9% topical suspension is used to treat head lice infestations.
This medicine is available only with your doctor's prescription.
Before Using This Medicine:
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:
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.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of spinosad topical in children 4 years of age and older. However, safety and efficacy have not been established in children younger than 4 years of age, and is not recommended in infants younger than 6 months of age.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of spinosad topical in the elderly.
|All Trimesters||B||Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.|
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.
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.
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 This Medicine:
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 with your doctor first.
Use this medicine 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.
This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.
- Shake the bottle well before using.
- Wash your hands before and after using this medicine.
- Apply the medicine directly to dry hair (up to 120 mL for long hair) and scalp. 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, you will need to use this medicine again.
- Children will need an adult to apply the medicine for them.
Do not use cosmetics and other hair products on the treated hair and scalp areas.
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 (suspension):
- For head lice:
- Adults, teenagers, and children 4 years of age and older—Apply directly to dry hair and scalp one time only. If you need a second treatment, it should be spaced one week apart.
- Children and infants 6 months to 4 years of age—Use and dose must be determined by your doctor.
- Infants younger than 6 months of age—Use is not recommended.
- For head lice:
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.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions While Using This Medicine:
This medicine contains benzyl alcohol which may cause serious reactions to newborn, premature, or low-birthweight infants. Check with your doctor if you are concerned.
Head lice can be easily spread from one person to another by direct contact with clothing, hats, scarves, bedding, towels, washcloths, hairbrushes and combs, or hairs from infected persons. All members of your household should be checked 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.
To prevent spread of lice: Dry-clean or wash your clothes, bedding, and personal items (including washcloths, towels, hats, scarves, combs, brushes, hairpieces, and wigs) in hot, soapy water.
Do not use this medicine for a hair or scalp problem that has not been checked by your doctor.
Side Effects of This Medicine:
- Less common
- Dry skin
- hair loss
- itching, burning, flaking, dryness, or redness of the scalp
- redness of the eye or skin
- thinning of the hair
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:
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.
Last Updated: 11/4/2014