Dermazone

Each gram of cream contains betamethasone dipropionate 0.64 mg equivalent to betamethasone 0.5 mg, clotrimazole 10 mg and gentamicin sulfate equivalent to gentamicin base 1 mg. It also contains the following inactive ingredients: Mineral oil, white petrolatum, cetostearyl alcohol, polyethylene glycol 1000 monocetyl ether, benzyl alcohol, monobasic sodium phosphate, phosphoric acid monohydrate, sodium hydroxide, propylene glycol and purified water.

Ophthalmic Diseases

Dermazone® (Dermazone injectable suspension) 40 mg/mL is indicated for:

• sympathetic ophthalmia,
• temporal arteritis,
• uveitis, and
• ocular inflammatory conditions unresponsive to topical corticosteroids.

Visualization during Vitrectomy

Dermazone® (Dermazone injectable suspension) suspension is indicated for visualization during vitrectomy.

Dermazone contains triamcinolone, a corticosteroid. It prevents the release of substances in the body that cause inflammation.

Dermazone is injected into the eye to treat inflammation caused by disease or injury. It is usually given after steroid eye drops have been used without successful treatment of symptoms.

Dermazone is also used during a certain type of eye surgery (vitrectomy).

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

Dosage for Treatment of Ophthalmic Diseases

The initial recommended dose of Dermazone® (Dermazone injectable suspension) suspension is 4 mg (100 microliters of 40 mg/mL suspension) with subsequent dosage as needed over the course of treatment.

Dosage for Visualization during Vitrectomy

The recommended dose of Dermazone® (Dermazone injectable suspension) suspension is 1 to 4 mg (25 to 100 microliters of 40 mg/mL suspension) administered intravitreally

Preparation for Administration

STRICT ASEPTIC TECHNIQUE IS MANDATORY. The vial should be vigorously shaken for 10 seconds before use to ensure a uniform suspension. Prior to withdrawal, the suspension should be inspected for clumping or granular appearance (agglomeration). An agglomerated product results from exposure to freezing temperatures and should not be used. After withdrawal, Dermazone® (Dermazone injectable suspension) suspension should be injected without delay to prevent settling in the syringe. Careful technique should be employed to avoid the possibility of entering a blood vessel or introducing organisms that can cause infection.

Administration

The injection procedure should be carried out under controlled aseptic conditions, which include the use of sterile gloves, a sterile drape, and a sterile eyelid speculum (or equivalent). Adequate anesthesia and a broad-spectrum microbicide should be given prior to the injection. Following the injection, patients should be monitored for elevation in intraocular pressure and for endophthalmitis. Monitoring may consist of a check for perfusion of the optic nerve head immediately after the injection, tonometry within 30 minutes following the injection, and biomicroscopy between two and seven days following the injection. Patients should be instructed to report any symptoms suggestive of endophthalmitis without delay.

Each vial should only be used for the treatment of a single eye. If the contralateral eye requires treatment, a new vial should be used and the sterile field, syringe, gloves, drapes, eyelid speculum, and injection needles should be changed before Dermazone® (Dermazone injectable suspension) suspension is administered to the other eye.

How supplied

Dosage Forms And Strengths

Single use 1 mL vial containing 40 mg/mL of sterile Dermazone suspension.

Dermazone® (Dermazone injectable suspension) 40 mg/mL is supplied as 1 mL of a 40 mg/mL sterile Dermazone suspension in a flint Type 1 single use glass vial with a gray rubber stopper and an open target aluminum seal. Each labeled vial is sealed in a polycarbonate blister with a backing material which provides tamper evidence and is stored in a carton.

• 1 mL single use vial (NDC 0065-0543-01)

Storage

Store at 4° - 25° C (39° - 77° F); Do Not Freeze. Protect from light by storing in carton.

ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USA. 9003982-0908.

See also:
What is the most important information I should know about Dermazone?

Dermazone® is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation; it is also contraindicated in the presence of fungal, viral, or bacterial infections of the mouth or throat.

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

• Wash your hands immediately after using Dermazone, unless your hands are part of the treated area.
• Shake well before each use. Hold the container 3 to 6 inches (8 to 15 cm) from the infected area and spray lightly.
• Do not apply Dermazone on the underarms or groin areas unless directed to do so by your doctor.
• Do not wrap or otherwise cover the treated area with bandages or wear tight-fitting clothing unless specifically directed by your doctor. Do not use tight-fitting diapers or plastic pants on children using Dermazone in the diaper area.
• If you miss a dose of Dermazone, 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.

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

Dermazone is used in combination with other medications to treat inflammation and skin allergies like eczema, atopic dermatitis (patches of itchy, rough and inflamed skin with blisters), neurodermatitis (thick and leathery skin due to excessive itching and scratching), seborrhoeic dermatitis (scaly patches, red skin causing dandruff), contact dermatitis (red, itchy, inflamed skin caused due to contact with allergens), varicose eczema (skin condition caused by increased pressure in the veins of the legs), vesiculo-pustular dermatitis (blisters or small raised bubbles filled with a clear or pus-like liquid) and for the treatment of insect bites and allergic rhinitis. It is also used to treat otitis externa (inflammation of the external ear) and seasonal and allergic rhinitis.

See also:
What other drugs will affect Dermazone?

• Amphotericin B: There have been cases reported in which concomitant use of Amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure. See Potassium depleting agents.
• Anticholinesterase agents: Concomitant use of anticholinesterase agents and corticosteroids may produce severe weakness in patients with myasthenia gravis. If possible, anticholinesterase agents should be withdrawn at least 24 hours before initiating corticosteroid therapy.
• Anticoagulant agents: Co-administration of corticosteroids and warfarin usually results in inhibition of response to warfarin, although there have been some conflicting reports. Therefore, coagulation indices should be monitored frequently to maintain the desired anticoagulant effect.
• Antidiabetic agents: Because corticosteroids may increase blood glucose concentrations, dosage adjustments of antidiabetic agents may be required.
• Antitubercular drugs: Serum concentrations of isoniazid may be decreased.
• CYP 3A4 inducers (e.g., barbiturates, phenytoin, carbamazepine, and rifampin): Drugs such as barbiturates, phenytoin, ephedrine, and rifampin, which induce hepatic microsomal drug metabolizing enzyme activity may enhance metabolism of corticosteroid and require that the dosage of corticosteroid be increased.
• CYP 3A4 inhibitors (e.g., ketoconazole, macrolide antibiotics): Ketoconazole has been reported to decrease the metabolism of certain corticosteroids by up to 60% leading to an increased risk of corticosteroid side effects.
• Cholestyramine: Cholestyramine may increase the clearance of corticosteroids.
• Cyclosporine: Increased activity of both cyclosporine and corticosteroids may occur when the two are used concurrently Convulsions have been reported with concurrent use.
• Digitalis: Patients on digitalis glycosides may be at increased risk of arrhythmias due to hypokalemia.
• Estrogens, including oral contraceptives: Estrogens may decrease the hepatic metabolism of certain corticosteroids thereby increasing their effect.
• NSAIDS including aspirin and salicylates: Concomitant use of aspirin or other non-steroidal antiinflammatory agents and corticosteroids increases the risk of gastrointestinal side effects. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. The clearance of salicylates may be increased with concurrent use of corticosteroids.
• Potassium depleting agents (e.g., diuretics, Amphotericin B): When corticosteroids are administered concomitantly with potassium-depleting agents, patients should be observed closely for development of hypokalemia.
• Skin tests: Corticosteroids may suppress reactions to skin tests.
• Toxoids and live or inactivated vaccines: Due to inhibition of antibody response, patients on prolonged corticosteroid therapy may exhibit a diminished response to toxoids and live or inactivated vaccines. Corticosteroids may also potentiate the replication of some organisms contained in live attenuated vaccines.

See also:
What are the possible side effects of Dermazone?

Applies to Dermazone: topical application cream, topical application lotion, topical application ointment, topical application spray

In addition to its needed effects, some unwanted effects may be caused by Dermazone (the active ingredient contained in Dermazone). In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking Dermazone:

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)

Minor Side Effects

Some of the side effects that can occur with Dermazone may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

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