Synalar Regular

In the U.S.

• Capex
• Derma-Smoothe/FS
• Synalar

In Canada

• Fluoderm Mild Cream
• Fluoderm Mild Ointment
• Fluoderm Regular Cream
• Fluoderm Regular Ointment
• Fluolar Mild
• Fluolar Regular
• Fluonide Mild-Cream
• Synalar Mild
• Synalar Regular
• Synamol

Available Dosage Forms:

• Cream
• Solution
• Shampoo
• Oil
• Ointment
• Lotion
• Gel/Jelly
• Kit

Therapeutic Class: Corticosteroid, Intermediate

Pharmacologic Class: Fluocinolone

Fluocinolone topical is used to relieve redness, itching, swelling, or other discomfort caused by skin conditions. Fluocinolone scalp oil is used to treat psoriasis of the scalp, and fluocinolone shampoo for seborrheic dermatitis of the scalp. This medicine is a corticosteroid (cortisone-like medicine or steroid).

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

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 fluocinolone topical in the pediatric population. However, because of this medicine's toxicity, it should be used with caution. Children may absorb large amounts through the skin, which can cause serious side effects. If your child is using this medicine, follow your doctor's instructions very carefully. For the body oil form, safety and efficacy in children 3 months of age and younger have not been established.

Geriatric

No information is available on the relationship of age to the effects of fluocinolone topical in geriatric patients.

Pregnancy

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.

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:

• Cushing's syndrome (adrenal gland disorder) or
• Diabetes or
• Hyperglycemia (high blood sugar) or
• Intracranial hypertension (increased pressure in the head)—Use with caution. May make these conditions worse.

• Infection of the skin at or near the place of application or
• Large sores, broken skin, or severe skin injury at the place of application—The chance of side effects may be increased.

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

It is very important that you use this medicine only 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 ordered. To do so may cause unwanted side effects or skin irritation.

This medicine is for use on the skin only. Do not get it in your eyes. Do not use it on skin areas that have cuts, scrapes, or burns. If it does get on these areas, rinse it off right away with water.

This medicine should only be used for skin conditions that your doctor is treating. Check with your doctor before using it for other conditions, especially if you think that a skin infection may be present. This medicine should not be used to treat certain kinds of skin infections or conditions, such as severe burns.

To use cream, ointment, solution, and body oil:

• Wash your hands with soap and water before and after using this medicine.
• Apply a thin layer of this medicine to the affected area of the skin or scalp. Rub it in gently.
• Do not bandage or otherwise wrap the skin being treated unless directed to do so by your doctor.
• If the medicine is applied to the diaper area of an infant, do not use tight-fitting diapers or plastic pants unless directed to do so by your doctor.
• If your doctor ordered an occlusive dressing or airtight covering to be applied over the medicine, make sure you know how to apply it. Occlusive dressings increase the amount of medicine absorbed through your skin, so use them only as directed. If you have any questions about this, check with your doctor.

To use shampoo:

• Wash your hands with soap and water before and after using this medicine.
• Wet hair and scalp thoroughly.
• Shake the container well, and apply about an ounce of the shampoo to the scalp area.
• Work the shampoo into a lather, and leave on the scalp for 5 minutes.
• Wash hair and scalp thoroughly with water.

To use scalp oil:

• Wash your hands with soap and water before and after using this medicine.
• Wet hair and scalp thoroughly.
• Apply a thin layer of this medicine to the affected area of the scalp. Rub it in gently.
• Cover the scalp with the supplied shower cap overnight for at least 4 hours.
• Wash hair with regular shampoo and clean well.

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 redness, itching, and swelling of the skin:
  • For topical dosage form (cream, ointment, and solution):
    • Adults—Apply to the affected areas of the skin three to four times a day.
    • Children—Use and dose must be determined by your doctor.
  • For topical dosage form (body oil):
    • Adults—Apply to the affected areas of the skin three times a day for up to 2 weeks.
    • Children 3 months of age and older—Apply to the affected areas two times a day for up to 4 weeks.

• For seborrheic dermatitis:
  • For topical dosage form (shampoo):
    • Adults—Use on the scalp area once a day.
    • Children—Use and dose must be determined by your doctor.

• For scalp psoriasis:
  • For topical dosage form (scalp oil):
    • Adults—Apply to the affected areas of the scalp and leave overnight.
    • Children 2 years of age and older—Apply to the affected areas 2 times a day for up to 4 weeks.

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

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.

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

It is very important that your doctor check the progress of you or your child at regular visits for any unwanted effects that may be caused by this medicine.

If your or your child's symptoms do not improve within a few days, or if they become worse, check with your doctor.

Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. The risk is greater for children and patients who use large amounts for a long time. Talk to your doctor right away if you or your child have more than one of these symptoms while you are using this medicine: blurred vision; dizziness or fainting; a fast, irregular, or pounding heartbeat; increased thirst or urination; irritability; or unusual tiredness or weakness.

Stop using this medicine and check with your doctor right away if you or your child have a skin rash, burning, stinging, swelling, or irritation on the skin.

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.

Check with your doctor immediately if any of the following side effects occur:

• Body aches or pain
• congestion
• cough
• dryness or soreness of the throat
• fever
• headache
• hoarseness
• lightening of normal skin color
• lightening of treated areas of dark skin
• sore throat
• stuffy or runny nose
• tender, swollen glands in the neck
• trouble swallowing
• unusual tiredness or weakness
• voice changes

• Acne or pimples
• accumulation of pus
• blistering, crusting, irritation, itching, or reddening of the skin
• burning, itching, and pain in hairy areas, or pus at the root of the hair
• burning and itching of the skin with pinhead-sized red blisters
• change in hearing
• cracked, dry, scaly skin
• diarrhea
• dry skin
• earache or pain in the ear
• ear drainage
• flushing or redness of the skin
• darkening of the skin
• itching, scaling, severe redness, soreness, or swelling of the skin
• itchy, raised, round, smooth, skin-colored bumps found on just one area of the body
• ooze thick white fluid
• raised, dark red, wart-like spots on skin, especially when used on the face
• redness or swelling in the ear
• skin irritation
• skin rash, encrusted, scaly and oozing
• spots on your skin resembling a blister or pimple
• swelling
• swollen, red, tender area of infection
• thickened patches of the skin
• vomiting

• Redness and scaling around the mouth
• thinning, weakness, or wasting away of the skin

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:

• Changes in skin color
• shiny skin

• increased hair growth on the forehead, back, arms, and legs
• reddish purple lines on the arms, face, legs, trunk, or groin
• softening of the skin

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.