Tretin-X

Name: Tretin-X

Tretin-X Precautions

Do not use Tretin-X if:

  • you are pregnant or plan to become pregnant
  • you are sunburned or your skin is irritated
  • you are highly sensitive to sunlight
  • have eczema or other skin conditions
  • you are allergic to any of the ingredients in Tretin-X

Exposure to sunlight (including sunlamps) should be avoided or minimized during use of tretinoin topical use because of heightened sunburn susceptibility.

Tretin-X has been reported to cause severe irritation to patients with eczema and should be used only with caution if you have this particular skin condition.

Avoid contact with the eyes, ears, nostrils, angles of the nose, and mouth. Tretin-X may cause severe redness, itching, burning, stinging, and peeling if used on these areas.

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

Tretin-X and Pregnancy

  • Tell your doctor if you are pregnant or plan to become pregnant.
  • The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.
  • This medication falls into category C. Do not use tretinoin if you are pregnant or attempting to become pregnant. If you become pregnant while using Tretin-X, please contact your doctor immediately.

TRETIN-X® tretinoin Gel, Cream For External Use Only. Not For Ophthalmic Use. Rx Only


PATIENT INSTRUCTIONS
Acne Treatment
IMPORTANT
Read Directions Carefully Before Using


Read Directions Carefully Before Using.

THIS LEAFLET TELLS YOU ABOUT TRETIN-X 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 LONG-TERM SAFETY AND EFFECTIVENESS OF THIS PRODUCT IN OTHER DISORDERS HAVE NOT BEEN EVALUATED. IF YOU HAVE ANY QUESTIONS, BE SURE TO ASK YOUR DOCTOR.


WARNINGS

TRETIN-X GELS ARE FLAMMABLE. AVOID FIRE, FLAME OR SMOKING DURING USE. Keep out of reach of children. Keep tube tightly closed. Do not expose to heat or store at temperatures above 120°F (49°C).


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 TRETIN-X 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 TRETIN-X, tretinoin. In some studies, under different conditions, however, when mice treated with TRETIN-X were exposed to artificial sunlight, the incidence and rate of development of skin tumors was reduced. There is no evidence to date that TRETIN-X 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 TRETIN-X 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 TRETIN-X. If you do become sunburned, stop your therapy with TRETIN-X 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 TRETIN-X 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 TRETIN-X and consult your physician.

There have been reports that, in some patients, areas treated with TRETIN-X developed a temporary increase or decrease in the amount of skin pigment (color) present. The pigment in these areas returned to normal either when the skin was allowed to adjust to TRETIN-X or therapy was discontinued.

Use other medication only on your doctor'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 TRETIN-X 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 TRETIN-X 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 TRETIN-X 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 20-30 minutes before applying TRETIN-X. 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 TRETIN-X

To get the best results with TRETIN-X 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 TRETIN-X 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.

  • Apply TRETIN-X once daily before bedtime, or as directed by your physician. Your physician may advise, especially if your skin is sensitive, that you start your therapy by applying TRETIN-X every other night. 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.
  • TRETIN-X 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 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 TRETIN-X 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.
  • TRETIN-X Gel: Squeeze about a half inch or less of medication onto the fingertip While that should be enough for your whole face, after you have 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, or if dry flaking occurs from the gel within a minute or so, you are using too much. Cover the affected area lightly with TRETIN-X gel by first dabbing it on your forehead, chin and both cheeks, then spreading it over the entire affected area. Smooth gently into the skin.
  • It is recommended that you apply a moisturizer or a moisturizer with sunscreen that will not aggravate your acne (noncomedogenic) every morning after you wash.


WHAT TO EXPECT WITH YOUR NEW TREATMENT

TRETIN-X works deep inside your skin and this takes time. You cannot make TRETIN-X work any faster by applying more than one dose each day, but an excess amount of TRETIN-X 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 TRETIN-X 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 TRETIN-X.

If TRETIN-X is going to have a beneficial effect for you, you should notice a continued improvement in your appearance after 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 TRETIN-X until your physician instructs otherwise.


IF YOU HAVE QUESTIONS

All questions of a medical nature should be taken up with your doctor. For more information about TRETIN-X, call our toll-free number: 1-800-978-5060. Call between 9:00 a.m. and 5:00 p.m. Eastern Time, Monday through Friday.


Manufactured for Triax Pharmaceuticals, LLC,
Cranford, NJ 07016
by DPT Laboratories, San Antonio, TX 78215

535F402
Rev 04/06

In Summary

More frequent side effects include: exfoliation of skin, stinging of the skin, localized warm feeling, and mild erythema. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to tretinoin topical: topical cream, topical gel/jelly, topical liquid, topical solution

In some animal studies, tretinoin has been shown to cause skin tumors to develop faster when the treated area is exposed to ultraviolet light (sunlight or artificial sunlight from a sunlamp). Other studies have not shown the same result and more studies need to be done. It is not known if tretinoin causes skin tumors to develop faster in humans.

Along with its needed effects, tretinoin topical (the active ingredient contained in Tretin-X) 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 as soon as possible if any of the following side effects occur while taking tretinoin topical:

More common
  • Burning feeling or stinging skin (severe)
  • lightening of skin of treated area, unexpected
  • peeling of skin (severe)
  • redness of skin (severe)
  • unusual dryness of skin (severe)
Rare
  • Darkening of treated skin

Some side effects of tretinoin topical 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:

More common
  • Burning feeling, stinging, or tingling of skin (mild)lasting for a short time after first applying the medicine
  • chapping or slight peeling of skin (mild)
  • redness of skin (mild)
  • unusual dryness of skin (mild)
  • unusually warm skin (mild)

The side effects will go away after you stop using tretinoin. On the rare chance that your skin color changes, this effect may last for several months before your skin color returns to normal.

For Healthcare Professionals

Applies to tretinoin topical: topical cream, topical gel, topical kit, topical liquid

Dermatologic

Cream:
Very common (10% or more): Severe skin irritation (Up to 32%)
Frequency not reported: Mild irritation, peeling/skin exfoliation, erythema, pruritus, blistering, pain, crusting, tenderness, dry skin, burning/warmth/stinging, photosensitivity/increased sensitivity to light
Postmarketing reports: Temporary hyper/hypopigmentation, rash, skin atrophy

Gel:
Very common (10% or more): Dry skin (Up to 16%), peeling/scaling/flaking skin (Up to 12%)
Common (1% to 10%): Burning sensation, erythema, pruritus, skin pain, sunburn
Frequency not reported: Blistering/crusting skin
Postmarketing reports: Temporary hypo/hyperpigmentation, increased susceptibility to sunlight

Microsphere Gel:
Common (1% to 10%): Skin irritation, skin burning, erythema, dermatitis
Frequency not reported: Peeling, dryness, stinging, itching
Postmarketing reports: Temporary hypo/hyperpigmentation[Ref]

Erythema, peeling, dryness, burning/stinging, and/or itching occurred most frequently during the first 2 weeks of therapy.

Most of the dermatologic side effects were mild in severity (approximately 63%), and approximately 34% were of moderate severity.

Dry, peeling, scaling, and/or flaking skin occurred most often in the gel formulation.[Ref]

Hepatic

Cream:
Frequency not reported: Reversible liver function test changes (bilirubin, alkaline phosphatase, ALT, AST)[Ref]

Metabolic

Cream:
Frequency not reported: Thymol turbidity elevations, increased flocculation[Ref]

Cardiovascular

Cream:
Postmarketing reports: Edema/swelling of application site[Ref]

Hypersensitivity

Cream:
Frequency not reported: Allergic contact dermatitis
Postmarketing reports: Allergic reaction[Ref]

Some side effects of Tretin-X may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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