Ortho-mcneil Janssen Pharmaceuticals, Inc.

Ortho-mcneil Janssen Pharmaceuticals, Inc. Drugs

• Retin-a
  

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  Retin-a

  

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  RETIN-A Gel, Cream or Liquid should be applied once a day, before retiring, to the skin where acne lesions appear, using enough to cover the entire affected area lightly. Liquid: The liquid may be applied using a fingertip, gauze pad, or cotton swab. If gauze or cotton is employed, care should be taken not to oversaturate it to the extent that the liquid would run into areas where treatment is not intended. Gel: Excessive application results in "pilling" of the gel, which minimizes the likelihood of over application by the patient.

  Application may cause a transitory feeling of warmth or slight stinging. In cases where it has been necessary to temporarily discontinue therapy or to 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 vehicle, drug concentration, or dose frequency should be closely monitored by careful observation of the clinical therapeutic response and skin tolerance.

  During the early weeks of therapy, an apparent exacerbation of inflammatory lesions may occur. This is due 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.

  Once the acne lesions have responded satisfactorily, it may be possible to maintain the improvement with less frequent applications, or other dosage forms.

  Patients treated with RETIN-A (tretinoin) acne treatment may use cosmetics, but the area to be treated should be cleansed thoroughly before the medication is applied. (See Precautions.)

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• Renova
  

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  Renova

  

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  Do NOT use RENOVA® (tretinoin cream) 0.02% if the patient is pregnant or is attempting to become pregnant or is at high risk of pregnancy, Do NOT use RENOVA® (tretinoin cream) 0.02% if the patient is sunburned or if the patient has eczema or other chronic skin conditions of the face, Do NOT use RENOVA® (tretinoin cream) 0.02% if the patient is inherently sensitive to sunlight, Do NOT use RENOVA® (tretinoin cream) 0.02% if the patient is also taking drug(s) known to be photosensitizers (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the possibility of augmented phototoxicity.

  Patients require detailed instruction to obtain maximal benefits and to understand all the precautions necessary to use this product with greatest safety. The physician should review the Patient Package Insert.

  RENOVA® (tretinoin cream) 0.02% should be applied to the face once a day in the evening, using only enough to cover the entire affected area lightly. Patients should gently wash their faces with a mild soap, pat the skin dry, and wait 20 to 30 minutes before applying RENOVA® (tretinoin cream) 0.02%. The patient should apply a small pearl-sized (about ¼ inch or 5 millimeter diameter) amount of cream to cover the entire affected area lightly. Caution should be taken when applying the cream to avoid the eyes, ears, nostrils, and mouth.

  Application of RENOVA® (tretinoin cream) 0.02% may cause a transitory feeling of warmth or slight stinging.

  Mitigation (palliation) of fine facial wrinkling may occur gradually over the course of therapy. Up to six months of therapy may be required before the effects are seen.

  With discontinuation of RENOVA® (tretinoin cream) 0.02% therapy, some patients may lose the mitigating effects of RENOVA® (tretinoin cream) 0.02% on fine facial wrinkles. The safety and effectiveness of using RENOVA® (tretinoin cream) 0.02% daily for greater than 52 weeks have not been established.

  Application of larger amounts of medication than recommended may not lead to more rapid or better results, and marked redness, peeling, or discomfort may occur.

  Patients treated with RENOVA® (tretinoin cream) 0.02% may use cosmetics but the areas to be treated should be cleansed before the medication is applied. (See PRECAUTIONS section.)

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