Synalar

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

An overdose of fluocinolone topical is not expected to produce life threatening symptoms. However, long term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

It is not likely that other drugs you take orally or inject will have an effect on topically applied fluocinolone. But many drugs can interact with each other. Tell each of your health care providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

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

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

Topical corticosteroids share anti-inflammatory, anti-pruritic and vasoconstrictive actions.

The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.

Pharmacokinetics

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.

Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses (see DOSAGE AND ADMINISTRATION).

Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

Synalar® (fluocinolone acetonide) Cream 0.025% is supplied in

STORAGE

Store at room temperature 15-25°C (59-77°F); avoid freezing and excessive heat above 40°C (104°F).

Manufactured for:

MEDIMETRIKS
PHARMACEUTICALS, INC.

363 Route 46 West, Fairfield, NJ 07004-2402 USA
www.medimetriks.com

Manufactured by: IGI Laboratories, Inc., Buena, NJ 08310

IP027
Iss. 8/12

NDC 43538-900-99

SAMPLE. NOT FOR SALE.
6 Tubes (Net wt. 3 g Each)

Rx Only

Synalar®
(FLUOCINOLONE ACETONIDE)
CREAM 0.025%

FORMULA: Fluocinolone acetonide 0.25 mg/g in a water-washable
aqueous base of butylated hydroxytoluene, cetyl alcohol, citric acid,
edetate disodium, methylparaben and propylparaben (preservatives),
mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, simethicone,
stearyl alcohol, water (purified) and white beeswax.

SEE PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION.

STORE AT ROOM TEMPERATURE 15-25°C (59-77°F);
AVOID FREEZING AND EXCESSIVE HEAT ABOVE 40°C (104°F).

You should not use Synalar if you are allergic to fluocinolone.

To make sure Synalar is safe for you, tell your doctor if you have any type of skin infection.

Also tell your doctor if you have diabetes. Topical steroid medicines absorbed through the skin may increase the glucose (sugar) levels in your blood or urine.

FDA pregnancy category C. It is not known whether Synalar will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether fluocinolone passes into breast milk or if it could harm a nursing baby. Do not apply Synalar to your chest area if you are breast-feeding a baby.

Children can absorb larger amounts of fluocinolone through the skin and may be more likely to have side effects, or a delay in growth with long-term use. Talk with your doctor if you think your child is not growing at a normal rate while using this medication over a long treatment period.

Get emergency medical help if you have any of these signs of an allergic reaction to Synalar: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have severe irritation of any treated skin, or if you show signs of absorbing Synalar through your skin, such as:

• blurred vision, headache;

• thinning skin, easy bruising;

• mood changes;

• weight gain, puffiness in your face; or

• muscle weakness, feeling tired.

Common Synalar side effects may include:

• mild skin itching, burning, peeling, or dryness;

• thinning or softening of your skin;

• swollen hair follicles;

• blisters, pimples, or crusting of treated skin;

• changes in color of treated skin;

• skin rash or irritation around your mouth; or

• stretch marks.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.