floo-oh-SIN-oh-nide

Commonly used brand name(s):

In the U.S.

• Lidex
• Lidex-E
• Vanos

In Canada

• Lidemol
• Lidex Mild
• Lidex Regular
• Lyderm
• Tcis
• Tiamol
• Topsyn
• Trisyn

Available Dosage Forms:

• Ointment
• Emollient Cream
• Cream
• Solution
• Gel/Jelly

Therapeutic Class: Corticosteroid, Strong

Pharmacologic Class: Adrenal Glucocorticoid

Uses For fluocinonide

Fluocinonide topical is used to help relieve redness, itching, swelling, or other discomfort caused by skin conditions. fluocinonide is a corticosteroid (cortisone-like medicine or steroid).

fluocinonide is available only with your doctor’s prescription.

Before Using fluocinonide

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 fluocinonide, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to fluocinonide 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 fluocinonide topical in the pediatric population. However, because of fluocinonide’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 fluocinonide, follow your doctor’s instructions very carefully. For Vanos® cream, safety and efficacy have not been established in children younger than 12 years of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Vanos® cream in the elderly. However, elderly patients are more likely to have age-related medical problems, which may require caution in patients receiving Vanos® cream.

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

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.

Other Medical Problems

The presence of other medical problems may affect the use of fluocinonide. 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.

• Perioral dermatitis (skin problem) or
• Rosacea (skin problem)—Vanos® cream should not be used in patients with these conditions.

Proper Use of fluocinonide

It is very important that you use fluocinonide 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.

fluocinonide is for use on the skin only. Do not get it in your eyes, nose, mouth, or vagina. 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.

fluocinonide 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. fluocinonide should not be used to treat certain kinds of skin infections or conditions, such as severe burns.

If you are using the Vanos® cream:

• Do not use it on the face, groin, or underarms unless directed to do so by your doctor.
• Do not use it for more than 2 weeks unless your doctor tells you otherwise.

To use:

• Wash your hands with soap and water before and after using fluocinonide.
• Apply a thin layer of fluocinonide to the affected area of the skin. 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.

Dosing

The dose of fluocinonide 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 fluocinonide. 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 forms (cream, gel, ointment, or solution):
  • For redness, itching, and swelling of the skin:
    • Adults—Apply to the affected area of the skin two to four times per day.
    • Children—Apply to the affected area of the skin two to four times per day.
• For topical dosage form (cream):
  • For atopic dermatitis:
    • Adults and children 12 years of age and older—Apply to the affected area of the skin once a day.
    • Children younger than 12 years of age—Use is not recommended.
  • For psoriasis:
    • Adults and children 12 years of age and older—Apply to the affected area of the skin one to two times per day.
    • Children younger than 12 years of age—Use is not recommended.

Missed Dose

If you miss a dose of fluocinonide, 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.

Precautions While Using fluocinonide

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 fluocinonide.

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 fluocinonide 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 fluocinonide: blurred vision; dizziness or fainting; a fast, irregular, or pounding heartbeat; increased thirst or urination; irritability; or unusual tiredness or weakness.

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

Do not use cosmetics or other skin care products on the treated areas.

fluocinonide Side Effects

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:

Incidence not known

• Blistering, burning, crusting, dryness, or flaking of the skin
• irritation
• itching, scaling, severe redness, soreness, or swelling of the skin
• redness and scaling around the mouth
• thinning of the skin with easy bruising, especially when used on the face or where the skin folds together (e.g. between the fingers)
• 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:

Less common

• Fever
• headache
• muscle aches
• sore throat
• stuffy or runny nose
• unusual tiredness or weakness

Incidence not known

• Acne or pimples
• burning and itching of the skin with pinhead-sized red blisters
• burning, itching, and pain in hairy areas, or pus at the root of the hair
• increased hair growth on the forehead, back, arms, and legs
• lightening of normal skin color
• lightening of treated areas of dark skin
• 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.

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Generic Name: Fluocinonide (floo-oh-SIN-oh-nide)
Brand Name: Examples include Lidex and Lidex-E

Fluocinonide Cream is used for:

Treating inflammation and itching due to certain skin conditions. It may also be used for other conditions as determined by your doctor.

Fluocinonide Cream is a topical adrenocortical steroid. It works by reducing skin inflammation (redness, swelling, itching, and irritation) by a way that is not clearly understood.

Do NOT use Fluocinonide Cream if:

• you are allergic to any ingredient in Fluocinonide Cream

Contact your doctor or health care provider right away if any of these apply to you.

Before using Fluocinonide Cream:

Some medical conditions may interact with Fluocinonide Cream. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have any kind of skin infection, cuts, scrapes, or lessened blood flow to your skin
• if you have had a recent vaccination; have measles, tuberculosis, chickenpox, or shingles; or have had a positive tuberculosis test
• if you are taking prednisone or similar medicines

Some MEDICINES MAY INTERACT with Fluocinonide Cream. Because little, if any, of Fluocinonide Cream is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Fluocinonide Cream may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Fluocinonide Cream:

Use Fluocinonide Cream as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Apply a small amount of medicine to the affected area. Gently rub the medicine in until it is evenly distributed. Wash your hands after applying Fluocinonide Cream, unless your hands are part of the treated area.
• Do not bandage or cover the treated skin area unless directed by your doctor.
• If you miss a dose of Fluocinonide Cream, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Fluocinonide Cream.

Important safety information:

• Fluocinonide Cream is for external use only. Do not get Fluocinonide Cream in your eyes. If contact is made with the eyes, flush them immediately with tap water.
• If Fluocinonide Cream is applied to the diaper area, apply a very small amount and do not use tight-fitting diapers or plastic pants.
• Do NOT use more than the recommended dose or use for longer than prescribed without checking with your doctor.
• Talk with your doctor before you receive any vaccine while you are using Fluocinonide Cream.
• Do not use Fluocinonide Cream for other skin conditions at a later time.
• Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use Fluocinonide Cream.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Fluocinonide Cream while you are pregnant. It is not known if Fluocinonide Cream is found in breast milk. If you are or will be breast-feeding while you use Fluocinonide Cream, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Fluocinonide Cream:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dryness; itching.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); acne-like rash; burning, cracking, irritation, or peeling not present before you began using Fluocinonide Cream; excessive hair growth; inflamed hair follicles; inflammation around the mouth; muscle weakness; thinning, softening, or discoloration of the skin; unusual weight gain, especially in the face.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Fluocinonide Cream may be harmful if swallowed.

Proper storage of Fluocinonide Cream:

Store Fluocinonide Cream at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Fluocinonide Cream out of the reach of children and away from pets.

General information:

• If you have any questions about Fluocinonide Cream, please talk with your doctor, pharmacist, or other health care provider.
• Fluocinonide Cream is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Fluocinonide Cream. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Generic Name: Fluocinolone Acetonide (floo-oh-SIN-oh-lone)
Brand Name: Retisert

Fluocinolone Acetonide Implant is used for:

Treating a certain type of inflammation of the eye (chronic noninfectious uveitis).

Fluocinolone Acetonide Implant is a corticosteroid. Exactly how it works is unknown. It may decrease the production of certain substances that cause inflammation. Fluocinolone Acetonide Implant releases slowly over 30 months through a surgical implant in the eye.

Do NOT use Fluocinolone Acetonide Implant if:

• you are allergic to any ingredient in Fluocinolone Acetonide Implant or other corticosteroids (eg, prednisone)
• you have certain viral, bacterial, or fungal eye infections (eg, herpes simplex, mycobacterial infection)
• you have chickenpox or a certain infection due to smallpox vaccination (vaccinia)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Fluocinolone Acetonide Implant:

Some medical conditions may interact with Fluocinolone Acetonide Implant. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have other eye problems (eg, glaucoma, increased pressure in the eyes)

Some MEDICINES MAY INTERACT with Fluocinolone Acetonide Implant. Because little, if any, of Fluocinolone Acetonide Implant is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Fluocinolone Acetonide Implant may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Fluocinolone Acetonide Implant:

Use Fluocinolone Acetonide Implant as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Fluocinolone Acetonide Implant will be surgically implanted into the eye at your doctor’s office, hospital, or clinic.
• If you miss a dose of Fluocinolone Acetonide Implant, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Fluocinolone Acetonide Implant.

Important safety information:

• After implantation of Fluocinolone Acetonide Implant, follow-up eye exams will be required. Be sure to keep all doctor and lab appointments.
• Most patients experience an immediate and temporary decrease in vision in the implanted eye for about 1 to 4 weeks after surgery. Do not drive or perform other possibly unsafe tasks until you know how you react to Fluocinolone Acetonide Implant. Contact your doctor if your vision does not return to normal after 4 weeks.
• Fluocinolone Acetonide Implant treats inflammation in the eye, but it may not treat the disease that caused the inflammation. You may need to use other medicines along with this one. Carefully follow your doctor’s instructions for other eye medicines.
• Fluocinolone Acetonide Implant may increase pressure in your eyes. You may need to use medicines or have procedures to control the pressure in your eyes. Carefully follow your doctor’s instructions for other eye medicines.
• Fluocinolone Acetonide Implant may cause cataracts. It may also decrease the ability of your eyes to heal after cataract surgery. Discuss any concerns with your doctor.
• Fluocinolone Acetonide Implant may increase the severity of eye infections and mask symptoms of eye infections. Contact your doctor if you suspect you have an eye infection.
• Lab tests, including eye exams, may be performed while you use Fluocinolone Acetonide Implant. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Fluocinolone Acetonide Implant should not be used in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Fluocinolone Acetonide Implant while you are pregnant. It is not known if Fluocinolone Acetonide Implant is found in breast milk. If you are or will be breast-feeding while you use Fluocinolone Acetonide Implant, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Fluocinolone Acetonide Implant:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Abnormal sensation in the eye; back or limb pain; blurred vision; cough; dizziness; drooping eyelids; dry eye; eye irritation, itching, or redness; eye pain; fever; flu-like symptoms; headache; increased tearing; joint pain; nausea; nose and throat irritation; reduced vision; sinus inflammation; swelling of the eye or eyelid; upper respiratory tract infection; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bleeding of the eye; eye discharge; eye infection; eye pain; implant problems; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately.

Proper storage of Fluocinolone Acetonide Implant:

Fluocinolone Acetonide Implant is usually handled and stored by a health care provider. If you are using Fluocinolone Acetonide Implant at home, store Fluocinolone Acetonide Implant as directed by your pharmacist or health care provider. Keep Fluocinolone Acetonide Implant out of the reach of children and away from pets.

General information:

• If you have any questions about Fluocinolone Acetonide Implant, please talk with your doctor, pharmacist, or other health care provider.
• Fluocinolone Acetonide Implant is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Fluocinolone Acetonide Implant. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Pronunciation: (floo-oh-SIN-oh-lone ah-SEE-toe-nide)
Class: Corticosteroid

Trade Names:
Capex
- Shampoo 0.01%

Trade Names:
Derma-Smoothe/FS
- Oil 0.01%

Trade Names:
Retisert
- Implant 0.59 mg

Trade Names:
Synalar
- Solution 0.01%
- Cream 0.025%
- Ointment 0.025%

Fluoderm (Canada)

Pharmacology

Low- to medium-potency topical corticosteroid with anti-inflammatory, antipruritic, and vasoconstrictive properties. Thought to act by induction of phospholipase A2 inhibitory proteins (lipocortins). Lipocortins appear to control biosynthesis of potent mediators of inflammation (prostaglandins, leukotrienes) by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.

Indications and Usage

Capex

Treatment of seborrheic dermatitis of the scalp.

Derma-Smoothe/FS

Treatment of scalp psoriasis.

Retisert intravitreal implant

Treatment of chronic noninfectious uveitis affecting the posterior segment of the eye.

Synalar

Relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatosis.

Contraindications

Hypersensitivity to any component of the product. Retisert : Most viral diseases of cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also mycobacterial infections of the eye and fungal diseases of ocular structures.

Dosage and Administration

Adults and Children

Topical Apply sparingly to affected areas 2 to 4 times daily (once daily for medicated shampoo and topical oil).

Chronic Non-Infectious Uveitis ( Retisert only)
Adults

Intravitreal implant Surgically inserted into posterior segment of affected every 30 mo.

General Advice

• Topical
• For topical use only. Not for ophthalmic, oral, or intravaginal use.
• Do not apply to face, groin, or axillae unless directed by health care provider.
• Avoid contact with eyes. If medication does come into contact with eyes, wash them with large amounts of cool water. Notify health care provider if eye irritation occurs.
• Apply medication sparingly, but in sufficient quantity to cover affected area(s), and rub in gently.
• Do not cover with occlusive dressing unless ordered by health care provider.
• If using solution on scalp, part the hair, apply a small amount of the medicine on the affected area, rub it in gently, then protect the area from washing and rubbing until the solution dries. Advise patient that they may wash hair as usual but not right after applying the medicine.
• Shampoo: Shake well before using. Apply approximately 1 oz to scalp area, work into a lather. Allow lather to remain on the scalp for about 5 min, then rinse hair and scalp thoroughly with water.
• Topical oil: Thoroughly wet or dampen hair and scalp; apply thin film of oil on scalp, massage well and cover scalp with supplied shower cap. Leave on overnight or for minimum of 4 h before washing off. Wash hair with regular shampoo and rinse thoroughly.

• Implant
• The ocular implant contains 1 tablet of fluocinolone 0.59 mg, designed to release fluocinolone at a nominal initial rate of 0.6 mcg/day, decreasing over the first month to a steady state between 0.3 to 0.4 mcg/day over approximately 30 months.

Storage/Stability

Store solution, cream, ointment, shampoo, and oil below 86°F. Protect from freezing. Store intravitreal implants at controlled room temperature (59° to 77°F). Protect from freezing.

Drug Interactions

None well documented.

Laboratory Test Interactions

None well documented.

Adverse Reactions

CNS

Retisert

Headache (31%); dizziness (5% to 15%).

Dermatologic

Burning; itching; irritation; dryness; folliculitis; hypertrichosis; acneiform eruptions; hypopigmentation; perioral dermatitis; allergic contact dermatitis; maceration of the skin; secondary infection; skin atrophy; striae; miliaria.

Retisert

Rash (5% to 15%).

EENT

Cataracts; glaucoma.

Retisert

Elevated IOP with possible development of glaucoma, eye pain, procedural complications (including cataract fragments, implant expulsion, injury, mechanical complications of implant, migration of implant, post-op complications, post-op wound complication, wound dehiscence [50% to 90%]); within 2 yr post-implant, nearly all phakic eyes are expected to develop cataracts and require surgery; within 34 wk post-implantation, about 60% of patients will require IOP-lowering medication to control IOP; within an average post-implantation period of about 2 yr, approximately 32% of patients are expected to require filtering procedures to control IOP; reduced visual acuity, conjunctival hemorrhage, conjunctival hyperemia, glaucoma, blurred vision, abnormal sensation in the eye, eye irritation, hypotony, pruritus, vitreous floaters, maculopathy, vitreous hemorrhage, ptosis, eye inflammation, eyelid edema, increased tearing, dry eye (10% to 35%); macular edema, visual disturbances, eye discharge, conjunctival edema/chemosis, photophobia, blepharitis, corneal edema, photopsia, retinal hemorrhage, choroidal detachment, vitreous opacities, eye swelling (5% to 9%); nasopharyngitis (5% to 15%); optic nerve damage, visual acuity and field defects; posterior subcapsular cataract formation; delayed wound healing; perforation of the globe where there is thinning of the sclera; development of secondary ocular infections (including bacterial, fungal, and viral).

GI

Retisert

Nausea, vomiting (5% to 15%).

Musculoskeletal

Retisert

Arthralgia, back pain, limb pain (5% to 15%).

Respiratory

Retisert

Cough, sinusitis, upper respiratory tract infection (5% to 15%).

Miscellaneous

Systemic absorption may produce reversible hypothalamic pituitary adrenal (HPA) axis suppression, manifestations of Cushing syndrome, hyperglycemia, and glycosuria.

Retisert

Influenza, pain, pyrexia (5% to 15%).

Precautions

Monitor Assess and document skin condition before initial topical application and periodically throughout treatment. Inform health care provider if condition does not improve, worsens, or if application site reactions develop. Periodically evaluate patient applying medication to a large surface area, or to areas under occlusion, for evidence of HPA axis suppression (eg, ACTH stimulation, A.M. plasma cortisol, urinary free cortisol tests). If HPA axis suppression is noted, ensure that attempts are made to discontinue the drug, reduce frequency of application, or substitute a less potent corticosteroid. Be prepared to supplement with systemic corticosteroids if symptoms of glucocorticosteroid insufficiency occur. Monitor IOP following implantation of vitreal implant.

Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy not established. Children may be more susceptible to systemic toxicity from equivalent doses because of their larger skin surface to body mass ratios. Safety and efficacy of intravitreal implant has not been established in children younger than 12 years of age.

Topical Products

Concomitant skin infection

Ensure that appropriate antifungal or antibacterial therapy is used in a patient who has a concomitant skin infection.

Systemic effects

Systemic absorption may produce reversible HPA axis suppression, manifestations of Cushing syndrome, hyperglycemia, and glucosuria. Prolonged application or application to large surface areas or areas under occlusion increase risk of systemic effects.

Intravitreal Implant

Surgical risk

Potential complications accompanying intraocular surgery may include: cataract formation, choroidal detachment, temporary decreased visual acuity, endophthalmitis, hypotony, increased IOP, exacerbation of intraocular inflammation, retinal detachment, vitreous hemorrhage, vitreous loss, wound dehiscence.

Glaucoma

Use with caution in presence of glaucoma. Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation.

Decreased visual acuity

Following implantation nearly all patients will experience an immediate and temporary decrease in visual acuity in the implanted eye which lasts for approximately 1 to 4 wk.

Viral infection of the eye

Ocular steroids may prolong the course and may exacerbate severity of many viral infections of the eye. Use with great caution in patients with viral disease of the cornea and conjunctiva or in patients with history of herpes simplex infection.

Secondary ocular infections

Ocular corticosteroids may suppress host response and increase the hazard of secondary ocular infections.

Cataract surgery

Use of corticosteroids after cataract surgery may delay healing and increase incidence of bleb formation.

Overdosage

Symptoms

Absorption may be sufficient to produce systemic effects.

Patient Information

• Topical Products
• Advise patient to apply cream, ointment, or solution 2 to 4 times daily as directed by health care provider.
• Caution patient not to apply in greater quantity, or more frequently than prescribed by health care provider.
• Teach patient or caregiver proper technique for applying cream, ointment, or solution: wash or soak the affected area before applying medication, unless it irritates the affected area(s); wash hands; apply sufficient cream, ointment, or solution to cover affected area(s) sparingly then gently massage into skin; wash hands after applying fluocinonide.
• Advise patient using solution on scalp to part the hair, apply a small amount of the medicine on the affected area, rub it in gently, then protect the area from washing and rubbing until the solution dries. Advise patient that they may wash hair as usual but not right after applying the medicine.
• Advise patient using medicated shampoo to shake well before using, then apply approximately 1 oz to scalp area and work into a lather. Allow lather to remain on the scalp for about 5 min, then rinse hair and scalp thoroughly with water.
• Advise patient using topical oil to thoroughly wet or dampen hair and scalp then apply thin film of oil on scalp, massage well and cover scalp with supplied shower cap. Leave on overnight or for minimum of 4 h before washing off. Wash hair with regular shampoo and rinse thoroughly.
• Advise patient who has been instructed to use an occlusive dressing to do the following after applying medication to affected area(s): cover the area with plastic wrap. The plastic may be held in place with gauze or an elastic bandage or adhesive tape on the normal skin beside the treated area. Advise patient that instead of using plastic wrap, plastic gloves may be used for the hands, plastic bags for the feet, or a shower cap for the scalp; leave the plastic wrapping or covering in place as long as instructed by health care provider. Instruct patient to cleanse the skin and reapply the medication each time a new plastic wrapping is applied.
• Advise patient that if an application is missed, to apply it as soon as remembered and then continue on a regular schedule. If it is almost time for the next application, instruct patient to skip the application and continue on a regular schedule. Caution patient not to apply double doses.
• Caution patient not to apply to face, underarms, or groin area unless directed by health care provider.
• Caution caregiver of child not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area.
• Caution patient not to bandage, cover, or wrap treated skin areas or use cosmetics or other skin products over treated areas unless advised by health care provider.
• Caution patient to avoid contact with eyes. Advise patient that if medication does come into contact with eyes to wash them with large amounts of cool water and to contact their health care provider if eye irritation occurs.
• Advise patient that symptoms should begin to improve fairly soon after starting treatment and to notify health care provider if condition does not improve, worsens, or if application site reactions (eg, burning, stinging, redness, itching) develop.
• Advise patient that therapy is usually discontinued when control has been achieved.

• Intravitreal Implant
• Review action, potential surgical risks, and potential adverse reactions (eg, decreased visual acuity, elevation of IOP, cataract formation) of intravitreal implant.
• Advise patient that implant locally treats inflammation in the eye but does not treat the underlying disease and that additional medications may be prescribed to treat the underlying condition.
• Advise patient that regular ophthalmic follow-up examinations of both eyes will be required and to keep appointments.

Copyright © 2009 Wolters Kluwer Health.

Generic Name: fluocinolone ophthalmic implant (floo oh SIN oh lone off THAL mik IM plant)
Brand Names: Retisert

What is fluocinolone ophthalmic implant?

Fluocinolone is in a group of drugs called corticosteroids. It prevents the release of substances in the body that cause inflammation.

Fluocinolone ophthalmic (for the eye) implant is used to treat inflammation within the eye that may be caused by a variety of diseases or infections. The implant slowly releases fluocinolone into the eye over a period of approximately 30 months. Fluocinolone will not treat an eye infection.

Fluocinolone ophthalmic implant may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about fluocinolone ophthalmic implant?

The fluocinolone ophthalmic implant is surgically placed into the eye. If both eyes will be treated, the implants will most likely be placed at two separate times, to decrease your risk of infection in both eyes at the same time.

Before receiving the implant, tell your doctor if you are allergic to any drugs, or if you have glaucoma, herpes simplex or other eye infection, or if you have recently had cataract surgery.

Do not use any eye medications that your doctor has not prescribed. Fluocinolone ophthalmic implant can cause dizziness or blurred vision. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

For the first 1 to 4 weeks after receiving the implant, you may have a temporary decrease in vision. Call your doctor if your vision does not return to normal after 4 weeks. Fluocinolone ophthalmic implant will not correct vision problems (such as near-sightedness or far-sightedness) that you had before receiving the implant.

The placement of the fluocinolone ophthalmic implant may increase your risk of developing cataracts and eventually needing cataract surgery. Talk with your doctor if you have concerns about this risk.

What should I discuss with my healthcare provider before receiving a fluocinolone ophthalmic implant?

You should not receive this medication if you are allergic to fluocinolone, or if you have:

• a viral, bacterial, or fungal infection of your eye; or

• a history of allergy to a steroid medicine.

If you have certain conditions, you may need special tests or other medications after receiving a fluocinolone implant. Tell your doctor if you are allergic to any drugs, or if you have:

• glaucoma;

• herpes simplex or other eye infection; or

• if you have recently had cataract surgery.

The placement of the fluocinolone ophthalmic implant may increase your risk of developing cataracts and eventually needing cataract surgery. Talk with your doctor if you have concerns about this risk.

FDA pregnancy category C. It is not known whether the fluocinolone ophthalmic implant is harmful to an unborn baby if you receive the implant while you are pregnant. Tell your doctor if you are pregnant or plan to become pregnant during the 30 months after you receive the implant. It is not known whether fluocinolone from the ophthalmic implant passes into breast milk or if it could harm a nursing baby. Do not receive this implant without telling your doctor if you are breast-feeding a baby.

How is the fluocinolone ophthalmic implant put into place?

This implant is surgically placed into the eye. If both eyes will be treated, the implants will most likely be placed at two separate times, to decrease your risk of infection in both eyes at the same time.

Your doctor may prescribe other medications to help control the pressure inside your eyes. Increased pressure inside the eye (also called ocular hypertension) can damage the optic nerve and lead to permanent blindness.

You may need to use the medications to control pressure inside your eyes for several weeks after receiving the fluocinolone ophthalmic implant. Be sure to use this medication as directed by your doctor to avoid complications or needing further surgical procedures to control ocular hypertension.

To be sure the implant is helping your condition and is not causing harmful effects, your eyes will need to be checked on a regular basis. Do not miss any scheduled visits to your doctor.

What happens if I miss a dose?

Since the fluocinolone ophthalmic implant is surgically put into place, you will not be on a dosing schedule for this medication.

If you are taking medication to control pressure inside your eyes and you miss a dose, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

An overdose of fluocinolone is unlikely to occur with the ophthalmic implant.

What should I avoid after receiving a fluocinolone ophthalmic implant?

Do not use any eye medications that your doctor has not prescribed. Fluocinolone ophthalmic implant can cause dizziness or blurred vision. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Avoid wearing contact lenses after receiving the fluocinolone ophthalmic implant unless your doctor has told you to.

Fluocinolone ophthalmic implant side effects

For the first 1 to 4 weeks after receiving the implant, you may have a temporary decrease in vision. Call your doctor if your vision does not return to normal after 4 weeks. Fluocinolone ophthalmic implant will not correct vision problems (such as near-sightedness or far-sightedness) that you had before receiving the implant.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

• sudden vision loss, eye pain or redness;

• bleeding, oozing, or crusting of your eyes;

• cloudiness in the pupils or iris of your eyes;

• seeing flashes of light, halos around lights, or “floaters” in your vision; or

• tunnel vision, problems with peripheral (side) vision.

Less serious side effects may include:

• swelling of the eyelids;

• mild eye irritation;

• dry or watery eyes;

• itching, mild skin rash;

• the feeling that something is in your eye;

• headache, dizziness;

• runny or stuffy nose, sore throat, fever, cough;

• nausea, vomiting; or

• back pain, joint or muscle pain.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Fluocinolone ophthalmic implant Dosing Information

Usual Adult Dose for Uveitis:

Initial dose: 1 implant, containing one tablet of 0.59 mg of fluocinolone acetonide, to be surgically implanted into the posterior segment of the affected eye.

Usual Pediatric Dose for Uveitis:

12 years to 18 years:
Initial dose: 1 implant, containing one tablet of 0.59 mg of fluocinolone acetonide, to be surgically implanted into the posterior segment of the affected eye.

What other drugs will affect fluocinolone ophthalmic implant?

Before using this medication, tell your doctor if you are using any other steroid medications, including:

• nasal or inhaled steroids such as budesonide (Pulmicort, Rhinocort, Symbicort), flunisolide (AeroBid, Nasarel), fluticasone (Advair, Flonase, Flovent), mometasone (Asmanex, Nasonex), or triamcinolone (Azmacort); or

• steroid medication taken by mouth such as betamethasone (Celestone), budesonide (Entocort), dexamethasone (Decadron, Hexadrol), fludrocortisone (Florinef), hydrocortisone (Cortef, Hydrocortone), prednisone (Deltasone, Meticorten, Orasone, others), methylprednisolone (Medrol), triamcinolone (Aristocort).

There may be other drugs that can affect fluocinolone ophthalmic implant. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

• Your doctor can provide more information about fluocinolone ophthalmic implant written for health professionals that you may read.

• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 3.02. Revision Date: 4/12/2009 4:45:48 PM.

Generic Name: fluocinolone topical (floo oh SIN oh lone TOP i kal)
Brand Names: Capex, Flurosyn, Synalar

What is fluocinolone topical?

Fluocinolone is a topical (for the skin) steroid. It reduces the actions of chemicals in the body that cause inflammation, redness, and swelling.

Fluocinolone topical is used to treat the inflammation and itching caused by a number of skin conditions such as allergic reactions, eczema, seborrhea, and psoriasis.

Fluocinolone topical may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about fluocinolone topical?

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts or for longer than recommended. Topical steroid medicine can be absorbed through the skin, which may cause steroid side effects throughout the body.

Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. Plastic film covering (such as plastic wrap) is sometimes used when treating psoriasis. Follow your doctor’s instructions.

If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with fluocinolone topical can increase the amount of medicine your skin absorbs, which may lead to unwanted side effects.

Do not use this medication on a child without a doctor’s advice. Children are more likely to absorb large amounts of a topical steroid through the skin. Steroid absorption in children may cause unwanted 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. Contact your doctor if your condition does not improve, or if you develop signs of a skin infection.

What should I discuss with my healthcare provider before using fluocinolone topical?

Do not use this medication if you are allergic to fluocinolone.

Before using fluocinolone topical, tell your doctor if you are allergic to any drugs, or 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. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether fluocinolone topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not use this medication on a child without a doctor’s advice. Children are more likely to absorb large amounts of a topical steroid through the skin. Steroid absorption in children may cause unwanted 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.

How should I use fluocinolone topical?

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts or for longer than recommended. Topical steroid medicine can be absorbed through the skin, which may cause steroid side effects throughout the body.

Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers.

Covering the skin that is treated with fluocinolone topical can increase the amount of medicine your skin absorbs, which may lead to unwanted side effects. However, plastic film covering (such as plastic wrap or a shower cap) is sometimes used when treating psoriasis. Follow your doctor’s instructions.

Wash your hands before and after using fluocinolone topical, unless you are using the medication to treat the skin on your hands.

Apply a small amount of the medicine to the affected area and rub it gently into the skin. Do not use this medication over a large area of skin.

If you are using the shampoo form of this medication, apply a small amount (1 ounce or less) to wet hair and work into a lather. Leave the shampoo on the scalp for 5 minutes and then rinse thoroughly.

Contact your doctor if your skin condition does not improve, if it gets worse, or if you develop signs of a skin infection.

To be sure this medication is not causing harmful effects with long-term use, you may need blood tests. Do not miss any scheduled appointments.

Store fluocinolone topical at room temperature away from moisture and heat.

What happens if I miss a dose?

Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and use the medicine at the next regularly scheduled time. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

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.

What should I avoid while using fluocinolone topical?

Fluocinolone topical should not be used to treat any skin condition your doctor has not prescribed it for.

Avoid getting this medication in your eyes. If contact does occur, rinse with water. Do not use fluocinolone topical on broken or infected skin. Also avoid using this medication in open wounds.

Fluocinolone topical side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty 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 fluocinolone topical through your skin, such as:

• blurred vision, or seeing halos around lights;

• mood changes;

• sleep problems (insomnia);

• weight gain, puffiness in your face; or

• muscle weakness, feeling tired.

Less serious side effects may include:

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

• thinning or softening of your skin;

• skin rash or irritation around your mouth;

• swollen hair follicles;

• changes in color of treated skin;

• blisters, pimples, or crusting of treated skin; or

• stretch marks.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Fluocinolone topical Dosing Information

Usual Adult Dose for Dermatitis:

Apply a thin layer to affected area 2-4 times a day.

Fluocinolone 0.01% topical oil: Apply a thin layer to moistened skin of affected area three times a day for not more than 4 weeks.

Usual Pediatric Dose for Dermatitis:

>= 1 year:

Apply a thin layer to affected area 2 to 4 times a day.

fluocinolone 0.01% topical oil:

>=2 years:

Apply a thin layer to moistened skin of affected area twice daily for not more than 4 weeks.

What other drugs will affect fluocinolone topical?

It is not likely that other drugs you take orally or inject will have an effect on topically applied fluocinolone topical. But many drugs can interact with each other. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about fluocinolone topical.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 6.03. Revision Date: 4/12/2009 4:39:36 PM.

Generic Name: Fluocinolone (floo-oh-SIN-oh-lone)
Brand Name: Synalar

Fluocinolone Cream is used for:

Relieving itching and inflammation of the skin. It may also be used for other conditions as determined by your doctor.

Fluocinolone Cream is a topical corticosteroid. Exactly how it works is unknown.

Do NOT use Fluocinolone Cream if:

• you are allergic to any ingredient in Fluocinolone Cream

Contact your doctor or health care provider right away if any of these apply to you.

Before using Fluocinolone Cream:

Some medical conditions may interact with Fluocinolone Cream. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have measles, chickenpox, or tuberculosis
• if you have hardening or thinning of the skin or a skin infection
• if you have recently been vaccinated or you have had a positive tuberculin skin test

Some MEDICINES MAY INTERACT with Fluocinolone Cream. Because little, if any, of Fluocinolone Cream is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Fluocinolone Cream may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Fluocinolone Cream:

Use Fluocinolone Cream as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Fluocinolone Cream is for external use only.
• Apply a small amount of medicine to the affected area. Gently rub the medicine in until it is evenly distributed. Wash your hands after applying Fluocinolone Cream, unless your hands are part of treated area.
• If Fluocinolone Cream is applied to a hairy site, the hair should be parted to allow the medicine direct contact with the skin.
• Do not bandage or wrap the affected area unless directed otherwise by your doctor.
• If you miss a dose of Fluocinolone Cream, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Fluocinolone Cream.

Important safety information:

• Avoid contact with eyes. In case of contact, wash eyes immediately with water.
• If Fluocinolone Cream was prescribed to treat the diaper area of a child, avoid using tight-fitting diapers or plastic pants.
• Fluocinolone Cream has a corticosteroid in it. Before you start any new medicine, check the label to see if it has a corticosteroid in it too. If it does or if you are not sure, check with your doctor or pharmacist.
• Do NOT use more than the recommended dose or use for longer than prescribed without checking with your doctor.
• Do not use Fluocinolone Cream for any conditions other than the one for which it was prescribed.
• Talk with your doctor before you receive any vaccine while you are using Fluocinolone Cream.
• Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use Fluocinolone Cream.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Fluocinolone Cream while you are pregnant. It is not known if Fluocinolone Cream is found in breast milk. If you are or will be breast-feeding while you use Fluocinolone Cream, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Fluocinolone Cream:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dryness; itching.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); acne-like rash; excessive hair growth; inflamed hair follicles; inflammation around the mouth; irritation, burning, redness, or swelling not present before using Fluocinolone Cream; thinning, softening, or discoloration of the skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include increased thirst or urination; muscle weakness; unusual weight gain, especially in the face.

Proper storage of Fluocinolone Cream:

Store Fluocinolone Cream at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Avoid temperatures above 104 degrees F (40 degrees C). Do not freeze. Do not store in the bathroom. Keep Fluocinolone Cream out of the reach of children and away from pets.

General information:

• If you have any questions about Fluocinolone Cream, please talk with your doctor, pharmacist, or other health care provider.
• Fluocinolone Cream is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Fluocinolone Cream. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Generic Name: Fluocinolone (floo-oh-SIN-oh-lone)
Brand Name: Synalar

Fluocinolone Solution is used for:

Relieving itching and inflammation of the skin. It may also be used for other conditions as determined by your doctor.

Fluocinolone Solution is a topical corticosteroid. Exactly how it works is unknown.

Do NOT use Fluocinolone Solution if:

• you are allergic to any ingredient in Fluocinolone Solution

Contact your doctor or health care provider right away if any of these apply to you.

Before using Fluocinolone Solution:

Some medical conditions may interact with Fluocinolone Solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have measles, chickenpox, or tuberculosis
• if you have hardening or thinning of the skin or a skin infection
• if you have recently been vaccinated or you have had a positive tuberculin skin test

Some MEDICINES MAY INTERACT with Fluocinolone Solution. Because little, if any, of Fluocinolone Solution is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Fluocinolone Solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Fluocinolone Solution:

Use Fluocinolone Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Fluocinolone Solution is for external use only.
• Apply a thin film of medicine to the affected area. Wash your hands after applying Fluocinolone Solution, unless your hands are part of the treated area.
• Do not bandage or wrap the affected area unless directed otherwise by your doctor.
• If Fluocinolone Solution is applied to a hairy site, the hair should be parted to allow the medicine direct contact with the skin.
• If you miss a dose of Fluocinolone Solution, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Fluocinolone Solution.

Important safety information:

• Avoid contact with eyes. In case of contact, wash eyes immediately with water.
• If Fluocinolone Solution was prescribed to treat the diaper area of a child, avoid using tight-fitting diapers or plastic pants.
• Fluocinolone Solution has a corticosteroid in it. Before you start any new medicine, check the label to see if it has a corticosteroid in it too. If it does or if you are not sure, check with your doctor or pharmacist.
• Do NOT use more than the recommended dose or use for longer than prescribed without checking with your doctor.
• Do not use Fluocinolone Solution for any conditions other than the one for which it was prescribed.
• Talk with your doctor before you receive any vaccine while you are using Fluocinolone Solution.
• Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use Fluocinolone Solution.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Fluocinolone Solution while you are pregnant. It is not known if Fluocinolone Solution is found in breast milk. If you are or will be breast-feeding while you use Fluocinolone Solution, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Fluocinolone Solution:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dryness; itching.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); acne-like rash; excessive hair growth; inflamed hair follicles; inflammation around the mouth; irritation, burning, redness, or swelling not present before using Fluocinolone Solution; thinning, softening, or discoloration of the skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include increased thirst or urination; muscle weakness; unusual weight gain, especially in the face.

Proper storage of Fluocinolone Solution:

Store Fluocinolone Solution at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not freeze. Do not store in the bathroom. Keep Fluocinolone Solution out of the reach of children and away from pets.

General information:

• If you have any questions about Fluocinolone Solution, please talk with your doctor, pharmacist, or other health care provider.
• Fluocinolone Solution is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Fluocinolone Solution. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Generic Name: Fluocinolone (FLOO-oh-SIN-oh-lone)
Brand Name: Derma-Smoothe/FS Body Oil and Derma-Smoothe/FS Scalp Oil

Fluocinolone Oil is used for:

Treating certain inflammatory conditions of the skin. The body oil is used to treat inflammation of the skin. The scalp oil is used to treat psoriasis of the scalp. Fluocinolone Oil may also be used for other conditions as determined by your doctor.

Fluocinolone Oil is a topical corticosteroid. Exactly how it works is unknown.

Do NOT use Fluocinolone Oil if:

• you are allergic to any ingredient in Fluocinolone Oil

Contact your doctor or health care provider right away if any of these apply to you.

Before using Fluocinolone Oil:

Some medical conditions may interact with Fluocinolone Oil. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you are allergic to peanuts
• if you have measles, chickenpox, or tuberculosis
• if you have hardening or thinning of the skin, or a skin infection
• if you have recently been vaccinated or you have had a positive tuberculin skin test

Some MEDICINES MAY INTERACT with Fluocinolone Oil. Because little, if any, of Fluocinolone Oil is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Fluocinolone Oil may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Fluocinolone Oil:

Use Fluocinolone Oil as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• To use the body oil in adults: Apply a thin layer of Fluocinolone Oil to the affected area 3 times a day or as directed by your doctor.
• To use the body oil in children: Moisten the affected area, and then apply a thin layer of Fluocinolone Oil twice a day for up to 4 weeks or as directed by your doctor.
• To use the scalp oil: Wet or dampen hair and scalp thoroughly, and then apply a thin layer of Fluocinolone Oil to the scalp. Massage the scalp well, and then cover the scalp with 1 of the shower caps provided. Leave the medicine on overnight or for a minimum of 4 hours before you wash it off of the scalp. Wash your hair with regular shampoo and rinse it thoroughly.
• Wash your hands after applying Fluocinolone Oil, unless your hands are part of treated area.
• If you miss a dose of Fluocinolone Oil, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Fluocinolone Oil.

Important safety information:

• Fluocinolone Oil is for external use only. Do not get it in your eyes. If you get Fluocinolone Oil in your eyes, wash them right away with water.
• Fluocinolone Oil contains refined peanut oil. However, Fluocinolone Oil has not been known to cause an allergic reaction in patients who have a peanut allergy. If you are allergic to peanuts and have questions about using Fluocinolone Oil, check with your doctor.
• If your condition does not improve within 2 weeks or if it gets worse, contact your doctor.
• Do not use Fluocinolone Oil on the face, under the arms, or on the groin unless directed otherwise by your doctor.
• Fluocinolone Oil has a corticosteroid in it. Before you start any new medicine, check the label to see if it has a corticosteroid in it too. If it does or if you are not sure, check with your doctor or pharmacist.
• Do NOT use more than the recommended dose or use for longer than prescribed without checking with your doctor.
• Do not use Fluocinolone Oil for any conditions other than the one for which it was prescribed.
• Check with your doctor before having vaccinations while using Fluocinolone Oil.
• Fluocinolone Oil is not approved to treat diaper rash. Do not apply Fluocinolone Oil to the diaper area of a child.
• Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use Fluocinolone Oil.
• The body oil should not be used in children younger than 3 months old. The scalp oil should not be used in CHILDREN younger than 2 years old. Safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Fluocinolone Oil while you are pregnant. It is not known if Fluocinolone Oil is found in breast milk after topical use. If you are or will be breast-feeding while you use Fluocinolone Oil, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Fluocinolone Oil:

All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with the scalp oil after topical use. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Cough; lightening of the skin; mild fever; nose or throat inflammation; runny nose.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); acne-like rash; excessive hair growth; inflamed hair follicles; inflammation around the mouth; irritation, burning, redness, or swelling not present before using Fluocinolone Oil; thinning, softening, or discoloration of the skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include increased thirst or urination; muscle weakness; unusual weight gain, especially in the face.

Proper storage of Fluocinolone Oil:

Store Fluocinolone Oil at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Fluocinolone Oil out of the reach of children and away from pets.

General information:

• If you have any questions about Fluocinolone Oil, please talk with your doctor, pharmacist, or other health care provider.
• Fluocinolone Oil is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Fluocinolone Oil. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.