Renova
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Questions & Answers
Side Effects & Adverse Reactions
- RENOVA® (tretinoin cream) 0.02% is a dermal irritant, and the results of continued irritation of the skin for greater than 52 weeks in chronic use with RENOVA® (tretinoin cream) 0.02% are not known. There is evidence of atypical changes in melanocytes and keratinocytes and of increased dermal elastosis in some patients treated with RENOVA® (tretinoin cream) 0.05% for longer than 48 weeks. The significance of these findings and their relevance for RENOVA® (tretinoin cream) 0.02% are unknown.
- RENOVA® (tretinoin cream) 0.02% should not be administered if the patient is also taking drugs known to be photosensitizers (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the possibility of augmented phototoxicity.
Exposure to sunlight (including sunlamps) should be avoided or minimized during use of RENOVA® (tretinoin cream) 0.02% because of heightened sunburn susceptibility. Patients should be warned to use sunscreens (minimum SPF of 15) and protective clothing when using RENOVA® (tretinoin cream) 0.02%. Patients with sunburn should be advised not to use RENOVA® (tretinoin cream) 0.02% until fully recovered. Patients who may have considerable sun exposure, e.g., due to their occupation, and those patients with inherent sensitivity to sunlight should exercise caution when using RENOVA® (tretinoin cream) 0.02% and follow the precautions outlined in the Patient Package Insert.
RENOVA® (tretinoin cream) 0.02% should be kept out of the eyes, mouth, angles of the nose, and mucous membranes. Topical use may cause severe local erythema, pruritus, burning, stinging, and peeling at the site of application. If the degree of local irritation warrants, patients should be directed to use less medication, decrease the frequency of application, discontinue use temporarily, or discontinue use altogether and consider additional appropriate therapy.
Tretinoin has been reported to cause severe irritation on eczematous skin and should be used only with caution in patients with this condition.
Application of larger amounts of medication than recommended has not been shown to lead to more rapid or better results, and marked redness, peeling, or discomfort may occur.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
(To understand fully the indication for this product, please read the entire INDICATIONS AND USAGE section of the labeling.)
RENOVA® (tretinoin cream) 0.02% is indicated as an adjunctive agent (see second bullet point below) for use in the mitigation (palliation) of fine facial wrinkles in patients who use comprehensive skin care and sunlight avoidance programs. RENOVA® (tretinoin cream) 0.02% DOES NOT ELIMINATE WRINKLES, REPAIR SUN-DAMAGED SKIN, REVERSE PHOTOAGING, or RESTORE MORE YOUTHFUL or YOUNGER SKIN. In double-blinded, vehicle-controlled clinical studies, many patients in the vehicle group achieved desired palliative effects on fine wrinkling of facial skin with the use of comprehensive skin care and sunlight avoidance programs including sunscreens, protective clothing, and non-prescription emollient creams.
- RENOVA® (tretinoin cream) 0.02% has NOT DEMONSTRATED A MITIGATING EFFECT on significant signs of chronic sunlight exposure such as coarse or deep wrinkling, tactile roughness, mottled hyperpigmentation, lentigines, telangiectasia, skin laxity, keratinocytic atypia, melanocytic atypia, or dermal elastosis.
- RENOVA® (tretinoin cream) 0.02% should be used under medical supervision as an adjunct to a comprehensive skin care and sunlight avoidance program that includes the use of effective sunscreens (minimum SPF of 15) and protective clothing.
- Patients with visible actinic keratoses and patients with a history of skin cancer were excluded from clinical trials of RENOVA® (tretinoin cream) 0.02%. Thus the effectiveness and safety of RENOVA® (tretinoin cream) 0.02% in these populations are not known at this time.
- Neither the safety nor the effectiveness of RENOVA® (tretinoin cream) 0.02% for the prevention or treatment of actinic keratoses or skin neoplasms has been established.
- Neither the safety nor the efficacy of RENOVA® (tretinoin cream) 0.02% daily for greater than 52 weeks has been established, and daily use beyond 52 weeks has not been systematically and histologically investigated in adequate and well-controlled trials. (See WARNINGS section.)
Four adequate and well-controlled multi-center trials and one single-center randomized, controlled trial were conducted involving a total of 324 evaluable patients treated with RENOVA® (tretinoin cream) 0.02% and 332 evaluable patients treated with the vehicle cream on the face for 24 weeks with a comprehensive skin care and sun avoidance program, to assess the effects on fine and coarse wrinkling, mottled hyperpigmentation, tactile skin roughness, and laxity. Patients were evaluated at baseline on a 10 unit scale and changes from the baseline rating were categorized as follows:
| Worsening: | Increase of 1 unit or more. |
| No improvement: | No change. |
| Minimal improvement: | Reduction of 1 unit. |
| Mild improvement: | Reduction of 2 units. |
| Moderate improvement: | Reduction of 3 units or more. |
In these trials, the fine and coarse wrinkling, mottled hyperpigmentation, tactile roughness, and laxity of the facial skin were thought to be caused by multiple factors which included intrinsic aging or environmental factors, such as chronic sunlight exposure.
Two of the five trials provided adequate demonstration of efficacy for mitigation of fine facial wrinkling. No two of the five trials adequately demonstrated efficacy for mitigation of coarse wrinkling, mottled hyperpigmentation, tactile skin roughness, and laxity. Data for fine wrinkling (the indication for which RENOVA® (tretinoin cream) 0.02% demonstrated efficacy) from all five trials (four studies in lightly pigmented subjects with Fitzpatrick Skin Types I-III and one study in darkly pigmented subjects with Fitzpatrick Skin Types IV-VI) is provided below:
| Subjects using RENOVA® (tretinoin cream) 0.02% + CSP* (N=279) | Vehicle + CSP* (N=280) | |
| A single-center study (N=107) in darkly pigmented, mostly African-American, subjects with Fitzpatrick Skin Types IV-VI demonstrated minimal or mild improvement in fine facial wrinkling in 43% of patients using Vehicle + CSP* compared to 29% of subjects using RENOVA® (tretinoin cream) 0.02% + CSP*. Although fewer darkly pigmented subjects improved with RENOVA® (tretinoin cream) 0.02% than with vehicle, these findings may reflect the small size of this study. | ||
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| Worsened | 1% | 3% |
| No Change | 40% | 58% |
| Minimal Improvement | 35% | 27% |
| Mild Improvement | 15% | 9% |
| Moderate Improvement | 10% | 3% |
Self-assessment of fine wrinkles after 24 weeks of treatment with either RENOVA® (tretinoin cream) 0.02% or Vehicle from the four studies in lightly pigmented patients showed the following:
No studies have been conducted comparing the facial irritation or efficacy of RENOVA® (tretinoin cream) 0.02% to RENOVA® (tretinoin cream) 0.05% (older marketed formulation).
Patients may lose some of the mitigating effects of RENOVA® (tretinoin cream) 0.02% after 12 weeks of discontinuation of RENOVA® (tretinoin cream) 0.02% from their comprehensive skin care and sunlight avoidance program.
History
There is currently no drug history available for this drug.
Other Information
RENOVA® (tretinoin cream) 0.02% contains the active ingredient tretinoin in a cream base. Tretinoin is a yellow- to light-orange crystalline powder having a characteristic floral odor. Tretinoin is soluble in dimethylsulfoxide, slightly soluble in polyethylene glycol 400, octanol, and 100% ethanol. It is practically insoluble in water and mineral oil, and it is insoluble in glycerin. The chemical name for tretinoin is (all-E)-3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclonexen-1-yl)-2,4,6,8-nonatetraenoic acid. Tretinoin is also referred to as all-trans-retinoic acid and has a molecular weight of 300.44. The structural formula is represented below.
TRETINOIN
Tretinoin is available as RENOVA® at a concentration of 0.02% w/w in an oil-in-water emulsion formulation consisting of benzyl alcohol, butylated hydroxytoluene, capriylic/capric triglyceride, cetyl alcohol, edetate disodium, fragrance, methylparaben, propylparaben, purified water, stearic acid, stearyl alcohol, steareth 2, steareth 20, and xanthan gum.
Sources
Renova Manufacturers
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Rebel Distributors Corp
![Renova (Tretinoin) Cream [Rebel Distributors Corp]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Renova | Rebel Distributors Corp
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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Ortho-mcneil Janssen Pharmaceuticals, Inc.
Renova | Ortho-mcneil Janssen Pharmaceuticals, Inc.
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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Valeant Pharmaceuticals North America Llc
Renova | Zydus Pharmaceuticals (usa) Inc.
Carvedilol should be taken with food to slow the rate of absorption and reduce the incidence of orthostatic effects.
2.2 Left Ventricular Dysfunction Following Myocardial InfarctionDOSAGE MUST BE INDIVIDUALIZED AND MONITORED DURING UP-TITRATION. Treatment with carvedilol tablets may be started as an inpatient or outpatient and should be started after the patient is hemodynamically stable and fluid retention has been minimized. It is recommended that carvedilol tablets be started at 6.25 mg twice daily and increased after 3 to 10 days, based on tolerability, to 12.5 mg twice daily, then again to the target dose of 25 mg twice daily. A lower starting dose may be used (3.125 mg twice daily) and/or the rate of up-titration may be slowed if clinically indicated (e.g., due to low blood pressure or heart rate, or fluid retention). Patients should be maintained on lower doses if higher doses are not tolerated. The recommended dosing regimen need not be altered in patients who received treatment with an IV or oral β-blocker during the acute phase of the myocardial infarction.
2.3 HypertensionDOSAGE MUST BE INDIVIDUALIZED. The recommended starting dose of carvedilol tablets is 6.25 mg twice daily. If this dose is tolerated, using standing systolic pressure measured about 1 hour after dosing as a guide, the dose should be maintained for 7 to 14 days, and then increased to 12.5 mg twice daily if needed, based on trough blood pressure, again using standing systolic pressure 1 hour after dosing as a guide for tolerance. This dose should also be maintained for 7 to 14 days and can then be adjusted upward to 25 mg twice daily if tolerated and needed. The full antihypertensive effect of carvedilol tablet is seen within 7 to 14 days. Total daily dose should not exceed 50 mg.
Concomitant administration with a diuretic can be expected to produce additive effects and exaggerate the orthostatic component of carvedilol action.
2.4 Hepatic ImpairmentCarvedilol tablets should not be given to patients with severe hepatic impairment [see Contraindications (4)].
![Renova (Tretinoin) Cream [Ortho-mcneil Janssen Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=e334034e-36d5-4e2d-b2ec-d1410b3374c3&name=renova-cream-03.jpg)
![Renova (Tretinoin) Cream [Valeant Pharmaceuticals North America Llc]](https://www.recallguide.org/wp-content/themes/bootstrap/assets/img/drug-image-placeholder.jpg)
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