What is Spinosad?

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• Overview
• Proper Use
• Dosing
• Use & Storage
• Before Using
• Allergies
• Pediatric
• Geriatric
• Pregnancy
• Breast Feeding
• Drug Interactions
• Other Interactions
• Precautions

OverviewTOP

Spinosad 0.9% topical suspension is used to treat head lice infestations.

This medicine is available only with your doctor's prescription.

Proper UseTOP

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. Do not swallow the medicine.

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

To use:

• 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. Do not wet your hair before applying the medicine. 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.

DosingTOP

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 and children 6 months of age and older—Apply directly to dry hair and scalp one time only. If you need a second treatment, it should be spaced 1 week apart.
    • Children younger than 6 months of age—Use is not recommended.

Use & StorageTOP

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.

Before UsingTOP

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:

AllergiesTOP

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.

PediatricTOP

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

GeriatricTOP

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

PregnancyTOP

Breast FeedingTOP

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.

Drug InteractionsTOP

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.

Other InteractionsTOP

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.

PrecautionsTOP

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 and dry them in a hot dryer.

Do not use this medicine for a hair or scalp problem that has not been checked by your doctor.