Synalar Ointment

Name: Synalar Ointment

What is the most important information I should know about Synalar Ointment (fluocinolone topical)?

Do not use this medicine 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.

Children can absorb larger amounts of this medication through the skin and may be more likely to have side effects. If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers.

Call your doctor if your symptoms do not improve, if they get worse, or if you develop signs of a skin infection.

What happens if I overdose?

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.

What other drugs will affect Synalar Ointment (fluocinolone topical)?

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.

Synalar Ointment - Clinical Pharmacology

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.

Overdosage

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).

Synalar Ointment Dosage and Administration

SYNALAR® Ointment is generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition. In hairy sites, the hair should be parted to allow direct contact with the lesion.

Occlusive dressing may be used for the management of psoriasis or recalcitrant conditions. Some plastic films may be flammable and due care should be exercised in their use. Similarly, caution should be employed when such films are used on children or left in their proximity, to avoid the possibility of accidental suffocation.

If an infection develops, the use of the occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

How is Synalar Ointment Supplied

SYNALAR® (fluocinolone acetonide) Ointment 0.025% is supplied in

  60 g Tube – NDC 43538-910-60   120 g Tube – NDC 43538-910-12

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

IP029
Iss. 8/12

PRINCIPAL DISPLAY PANEL - 120 g Tube Carton

Rx Only

NDC 43538-910-12

SYNALAR®
(FLUOCINOLONE ACETONIDE)

OINTMENT 0.025%
120 g

FOR TOPICAL USE ONLY
NOT FOR OPHTHALMIC USE

MEDIMETRIKS
PHARMACEUTICALS, INC.

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