Avita (Page 2 of 3)

Nonteratogenic Effects

Dermal tretinoin has been shown to be fetotoxic in rabbits when administered in doses 100 times the recommended topical human clinical dose. Oral tretinoin has been shown to be fetotoxic in rats when administered in doses 500 times the recommended topical human clinical dose. There are, however, no adequate and well-controlled studies in pregnant women. AVITA® Cream should not be used during pregnancy.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when AVITA® Cream is administered to a nursing woman.

ADVERSE REACTIONS

The skin of certain sensitive individuals may become excessively red, edematous, blistered, or crusted. If these effects occur, the medication should either be discontinued until the integrity of the skin is restored, or the medication dosing frequency should be adjusted temporarily to a level the patient can tolerate. However, efficacy has not been established for lower dosing frequencies. True contact allergy to topical tretinoin is rarely encountered. Temporary hyper- or hypopigmentation has been reported with repeated application of AVITA® Cream. Some individuals have been reported to have heightened susceptibility to sunlight while under treatment with AVITA® Cream. Adverse effects of AVITA® Cream have been reversible upon discontinuation of therapy (see Dosage and Administration Section).

OVERDOSAGE

If medication is applied excessively, no more rapid or better results will be obtained and marked redness, peeling, or discomfort may occur. Oral ingestion of the drug may lead to the same side effects as those associated with excessive oral intake of vitamin A.

DOSAGE AND ADMINISTRATION

AVITA® Cream should be applied once a day, in the evening, to the skin where acne lesions appear, using enough to cover the entire affected area lightly. Application may cause a transient feeling of warmth or slight stinging. In cases where it has been necessary to temporarily discontinue therapy or reduce the frequency of application, therapy may be resumed or frequency of application increased when the patients become able to tolerate the treatment. Alterations of dose frequency should be closely monitored by careful observation of the clinical therapeutic response and skin tolerance. Efficacy has not been established for less than once-daily dosing frequencies.

During the early weeks of therapy, an apparent increase in number and exacerbation of inflammatory acne lesions may occur. This is due, in part, to the action of the medication on deep, previously unseen lesions and should not be considered a reason to discontinue therapy. Therapeutic results should be noticed after two to three weeks but more than six weeks of therapy may be required before definite beneficial effects are seen. Patients treated with AVITA® Cream may use cosmetics, but the areas to be treated should be cleansed thoroughly before the medication is applied (see Precautions Section).

HOW SUPPLIED

AVITA® (tretinoin cream) Cream, 0.025% is supplied as:

NDC Code Strength Quantity
62794-141-02 0.025% 20 g
62794-141-03 0.025% 45 g

Storage Conditions

Store below 30°C (86°F); avoid freezing.

Rx Only

MYLAN BERTEK PHARMACEUTICALS INC.
Research Triangle Park, NC 27709-4149

Revised April 2005

023.2

AVITA® (tretinoin cream) CREAM, 0.025%

PATIENT INSTRUCTIONS
Acne Treatment

IMPORTANT

Read Directions Carefully Before Using

THIS LEAFLET TELLS YOU ABOUT AVITA® (TRETINOIN) CREAM ACNE TREATMENT AS PRESCRIBED BY YOUR PHYSICIAN. THIS PRODUCT IS TO BE USED ONLY ACCORDING TO YOUR DOCTOR’S INSTRUCTIONS, AND IT SHOULD NOT BE APPLIED TO OTHER AREAS OF THE BODY OR TO OTHER GROWTHS OR LESIONS. THE SAFETY AND EFFECTIVENESS OF THIS PRODUCT IN OTHER DISORDERS HAVE NOT BEEN EVALUATED. IF YOU HAVE ANY QUESTIONS, BE SURE TO ASK YOUR DOCTOR.

PRECAUTIONS

The effects of the sun on your skin. As you know, overexposure to natural sunlight or the artificial sunlight of a sunlamp can cause sunburn. Overexposure to the sun over many years may cause premature aging of the skin and even skin cancer. The chances of these effects occurring will vary depending on skin type, the climate and the care taken to avoid overexposure to the sun. Therapy with AVITA® Cream may make your skin more susceptible to sunburn and other adverse effects of the sun, so unprotected exposure to natural or artificial sunlight should be minimized.

Laboratory findings. When laboratory mice are exposed to artificial sunlight, they often develop skin tumors. These sunlight-induced tumors may appear more quickly and in greater number if the mouse is also topically treated with the active ingredient in AVITA® Cream, tretinoin. In some studies, under different conditions, however, when mice treated with tretinoin were exposed to artificial sunlight, the incidence and rate of development of skin tumors was reduced. There is no evidence to date that tretinoin alone will cause the development of skin tumors in either laboratory animals or humans. However, investigations in this area are continuing.

Use caution in the sun. When outside, even on hazy days, areas treated with AVITA® Cream should be protected. An effective sunscreen should be used any time you are outside (consult your physician for a recommendation of an SPF level which will provide you with the necessary high level of protection). For extended sun exposure, protective clothing, like a hat, should be worn. Do not use artificial sunlamps while you are using AVITA® Cream. If you do become sunburned, stop your therapy with AVITA® Cream until your skin has recovered.

Avoid excessive exposure to wind or cold. Extremes of climate tend to dry or burn normal skin. Skin treated with AVITA® Cream may be more vulnerable to these extremes. Your physician can recommend ways to manage your acne treatment under such conditions.

Possible problems. The skin of certain sensitive individuals may become excessively red, swollen, blistered, or crusted. If you are experiencing severe or persistent irritation, discontinue the use of AVITA® Cream and consult your physician.

There have been reports that, in some patients, areas treated with AVITA® Cream developed a temporary increase or decrease in the amount of skin pigment (color) present.

Use other medication only on your physician’s advice. Only your physician knows which other medications may be helpful during treatment and will recommend them to you if necessary. Follow the physician’s instructions carefully. In addition, you should avoid preparations that may dry or irritate your skin. These preparations may include certain astringents, toiletries containing alcohol, spices or lime, or certain medicated soaps, shampoos, and hair permanent solutions. Do not allow anyone else to use this medication.

Do not use other medications with AVITA® Cream which are not recommended by your doctor. The medications you have used in the past might cause unnecessary redness or peeling.

If you are pregnant, think you are pregnant, or are nursing an infant: No studies have been conducted in humans to establish the safety of AVITA® Cream in pregnant women. If you are pregnant, think you are pregnant, or are nursing a baby, consult your physician before using this medication.

AND WHILE YOU’RE ON AVITA® THERAPY

Use a mild non-medicated soap. Avoid frequent washings and harsh scrubbing. Acne isn’t caused by dirt, so no matter how hard you scrub, you can’t wash it away. Washing too frequently or scrubbing too roughly may at times actually make your acne worse. Wash your skin gently with a mild, bland soap. Two or three times a day should be sufficient. Pat skin dry with a towel. Let the face dry 20 to 30 minutes before applying AVITA® Cream. Remember, excessive irritation such as rubbing, too much washing, use of other medications not suggested by your physician, etc., may worsen your acne.

HOW TO USE AVITA® (TRETINOIN) CREAM

To get the best results with AVITA® Cream therapy, it is necessary to use it properly. Forget about the instructions given for other products and the advice of friends. Just stick to the special plan your doctor has laid out for you and be patient. Remember, when AVITA® Cream is used properly, many users see improvement by 12 weeks. AGAIN, FOLLOW INSTRUCTIONS — BE PATIENT — DON’T START AND STOP THERAPY ON YOUR OWN — IF YOU HAVE QUESTIONS, ASK YOUR DOCTOR.

To help you use the medication correctly, keep these simple instructions in mind.

  • AVITA® Cream should be applied once a day, in the evening, or as directed by your physician, to the skin where acne lesions appear, using enough to cover the entire affected area lightly. First, wash with a mild soap and dry your skin gently. WAIT 20 to 30 MINUTES BEFORE APPLYING MEDICATION; it is important for skin to be completely dry in order to minimize possible irritation.
  • It is better not to use more than the amount suggested by your physician or to apply more frequently than instructed. Too much may irritate the skin, waste medication, and won’t give faster or better results.
  • Keep the medication away from the corners of the nose, mouth, eyes, and open wounds. Spread away from these areas when applying.
  • Cream: Squeeze about a half inch or less of medication onto the fingertip. While that should be enough for your whole face, after you have had some experience with the medication you may find you need slightly more or less to do the job. The medication should become invisible almost immediately. If it is still visible, you are using too much. Cover the affected area lightly with AVITA® Cream by first dabbing it on your forehead, chin, and both cheeks, then spreading it over the entire affected area. Smooth gently into the skin.
  • If needed, you may apply a moisturizer or a moisturizer with sunscreen that will not aggravate your acne (noncomedogenic) in the morning after you wash.

WHAT TO EXPECT WITH YOUR NEW TREATMENT

AVITA® Cream works deep inside your skin and this takes time. You cannot make AVITA® Cream work any faster by applying more than one dose each day, but an excess amount of AVITA® Cream may irritate your skin. Be patient.

There may be some discomfort or peeling during the early days of treatment. Some patients also notice that their skin begins to take on a blush.

These reactions do not happen to everyone. If they do, it is just your skin adjusting to AVITA® Cream and this usually subsides within two to four weeks. These reactions can usually be minimized by following instructions carefully. Should the effects become excessively troublesome, consult your doctor.

BY THREE TO SIX WEEKS, some patients notice an appearance of new blemishes (papules and pustules). At this stage it is important to continue using AVITA® Cream.

If AVITA® Cream is going to have a beneficial effect for you, you should notice an improvement in your appearance by 6 to 12 weeks of therapy. Don’t be discouraged if you see no immediate improvement. Don’t stop treatment at the first signs of improvement.

Once your acne is under control you should continue regular application of AVITA® Cream until your physician instructs otherwise.

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