ZO COMPLEX A Tretinoin (Emollient)

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Overview

What is ZO COMPLEX A Tretinoin (Emollient)?

Complex A™ Tretinoin Cream, USP (Emollient) 0.05% contains the active ingredient tretinoin (a retinoid) in an emollient 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--retinoic acid and has a molecular weight of 300.44. The structural formula is represented below.

Tretinoin is available as Complex A™ Tretinoin Cream, USP (Emollient) at a concentration of 0.05% w/w in a water-in-oil emulsion formulation consisting of light mineral oil, sorbitol solution, hydroxyoctacosanyl hydroxystearate; methoxy PEG-22/dodecyl glycol copolymer, PEG-45/dodecyl glycol copolymer, stearoxytrimethylsilane and stearyl alcohol, dimethicone 50 cs, methylparaben, edetate disodium, propylparaben, butylated hydroxytoluene, citric acid monohydrate, and purified water.

What does ZO COMPLEX A Tretinoin (Emollient) look like?

What are the available doses of ZO COMPLEX A Tretinoin (Emollient)?

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What should I talk to my health care provider before I take ZO COMPLEX A Tretinoin (Emollient)?

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How should I use ZO COMPLEX A Tretinoin (Emollient)?

(To understand fully the indication for this product, please read the entire INDICATIONS AND USAGE section of the labeling.

Complex A™ Tretinoin Cream, USP (Emollient) 0.05% is indicated as an adjunctive agent (see below) for use in the mitigation (palliation) of wrinkles, mottled hyperpigmentation, and tactile roughness of facial skin in patients who do not achieve such palliation using comprehensive skin care and sun avoidance programs (see for populations in which effectiveness has not been established). Many patients achieve desired palliative effects on fine wrinkling, mottled hyperpigmentation, and tactile roughness of facial skin with the use of comprehensive skin care and sun avoidance programs including sunscreens, protective clothing, and emollient creams containing tretinoin.

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.

Complex A™ Tretinoin Cream, USP (Emollient) should be applied to the face once a day before retiring, 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 Complex A™ Tretinoin Cream, USP (Emollient). The patient should apply a pea-sized amount of cream to cover the entire face lightly. Special caution should be taken when applying the cream to avoid the eyes, ears, nostrils, and mouth.

Application of Complex A™ Tretinoin Cream, USP (Emollient) may cause a transitory feeling of warmth or slight stinging.

Mitigation (palliation) of facial fine wrinkling, mottled hyperpigmentation, and tactile roughness may occur gradually over the course of therapy. Up to six months of therapy may be required before the effects are seen. Most of the improvement noted with Complex A™ Tretinoin Cream, USP (Emollient) 0.05% is seen during the first 24 weeks of therapy. Thereafter, therapy primarily maintains the improvement realized during the first 24 weeks.

With discontinuation of Complex A™ Tretinoin Cream, USP (Emollient) 0.05% therapy, a majority of patients will lose most mitigating effects of Complex A™ Tretinoin Cream, USP (Emollient) 0.05% on fine wrinkles, mottled hyperpigmentation, and tactile roughness of facial skin;

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

Patients treated with Complex A™ Tretinoin Cream, USP (Emollient) 0.05% may use cosmetics, but the areas to be treated should be cleansed thoroughly before the medication is applied. (See section.)

What interacts with ZO COMPLEX A Tretinoin (Emollient)?

This drug is contraindicated in individuals with a history of sensitivity reactions to any of its components. It should be discontinued if hypersensitivity to any of its ingredients is noted.

What are the warnings of ZO COMPLEX A Tretinoin (Emollient)?

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Because of heightened burning susceptibility, exposure to sunlight (including sunlamps) should be avoided or minimized during use of Complex A™ Tretinoin Cream, USP (Emollient). Patients must be warned to use sunscreens (minimum SPF of 15) and protective clothing when using Complex A™ Tretinoin Cream, USP (Emollient). Patients with sunburn should be advised not to use Complex A™ Tretinoin Cream, USP (Emollient) 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 particular caution when using Complex A™ Tretinoin Cream, USP (Emollient) and assure that the precautions outlined in the Patient Package Insert are observed.

Complex A™ Tretinoin Cream, USP (Emollient) 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.

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 will not lead to more rapid or better results, and marked redness, peeling, or discomfort may occur.

Complex A™ Tretinoin Cream, USP (Emollient) is a dermal irritant, and the results of continued irritation of the skin for greater than 48 weeks in chronic long-term use are not known. There is evidence of atypical changes in melanocytes and keratinocytes, and of increased dermal elastosis in some patients treated with Complex A™ Tretinoin Cream, USP (Emollient) for longer than 48 weeks. The significance of these findings is unknown.
Safety and effectiveness of Complex A™ Tretinoin Cream, USP (Emollient) 0.05% in individuals with moderately or heavily pigmented skin have not been established.
Complex A™ Tretinoin Cream, USP (Emollient) should not be administered if the patient is also taking drugs known to be photosensitizers (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sul-fonamides) because of the possibility of augmented phototoxicity.

What are the precautions of ZO COMPLEX A Tretinoin (Emollient)?

General

Complex A™ Tretinoin Cream, USP (Emollient) should only be used as an adjunct to a comprehensive skin care and sun avoidance program. (See section.)

If a drug sensitivity, chemical irritation, or a systemic adverse reaction develops, use of Complex A™ Tretinoin Cream, USP (Emollient) should be discontinued.

Weather extremes, such as wind or cold, may be more irritating to patients using Complex A™ Tretinoin Cream, USP (Emollient).

Information for Patients

See .

Drug Interactions

Concomitant topical medications, medicated or abrasive soaps, shampoos, cleansers, cosmetics with a strong drying effect, products with high concentrations of alcohol, astringents, spices or lime, permanent wave solutions, electrolysis, hair depilatories or waxes, and products that may irritate the skin should be used with caution in patients being treated with Complex A™ Tretinoin Cream, USP (Emollient) because they may increase irritation with Complex A™ Tretinoin Cream, USP (Emollient).

Complex A™ Tretinoin Cream, USP (Emollient) 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.

Carcinogenesis, Mutagenesis, Impairment of Fertility

In a lifetime dermal study in CD-1 mice at 100 and 200 times the average recommended human topical clinical dose, a few skin tumors in the female mice and liver tumors in male mice were observed. The biological significance of these findings is not clear because they occurred at doses that exceeded the dermal maximally tolerated dose (MTD) of tretinoin and because they were within the background natural occurrence rate for these tumors in this strain of mice. There was no evidence of carcinogenic potential when tretinoin was administered topically at a dose 5 times the average recommended human topical clinical dose. For purposes of comparisons of the animal exposure to the human exposure, the "recommended human topical clinical dose" is defined as 500 mg of Complex A™ Tretinoin Cream, USP (Emollient) 0.05% applied daily to a 50 kg person.

In a chronic, two-year bioassay of Vitamin A acid in mice performed by Tsubura and Yamamoto, gen-eralized amyloid deposition was reported in all groups in the basal layer of the Vitamin A treated skin. In CD-1 mice, a similar study reported hyalinization of the treated skin sites and the incidence of this finding was 0/50, 3/50, and 2/50 in male mice and 1/50, 0/50, 4/50 and 2/50 in female mice from the vehicle control, 0.25 mg/kg, 0.5 mg/kg, and 1 mg/kg groups, respectively.

Studies in hairless albino mice suggest that tretinoin may enhance the tumorigenic potential of carcino-genic doses of UVB and UVA light from a solar simulator. In other studies, when lightly pigmented hairless mice treated with tretinoin were exposed to carcinogenic doses of UVB light, the incidence and rate of development of skin tumors were either reduced or no effect was seen. Due to significantly different experimental conditions, no strict comparison of these disparate data is possible at this time. Although the significance of these studies in humans is not clear, patients should minimize exposure to sun.

The mutagenic potential of tretinoin was evaluated in the Ames assay and in the mouse micro-nucleus assay, both of which were negative.

Dermal Segment l and III studies with Complex A™ Tretinoin Cream, USP (Emollient) have not been performed in any species. In oral Segment I and Segment III studies in rats with tretinoin, decreased survival of neonates and growth retardation were observed at doses in excess of 2 mg/kg/day (>400 times the average human topical clinical dose).

Pregnancy

Teratogenic effects

Non-teratogenic effects

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 Complex A™ Tretinoin Cream, USP (Emollient) is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in patients less than 18 years of age have not been established.

Geriatric Use

Safety and effectiveness in individuals older than 50 years of age have not been established.

What are the side effects of ZO COMPLEX A Tretinoin (Emollient)?

(See and sections.)

In double-blind, vehicle-controlled studies involving 179 patients who applied Complex A™ Tretinoin Cream, USP (Emollient) 0.05% to their faces, adverse reactions associated with the use of Complex A™ Tretinoin Cream, USP (Emollient) 0.05% were limited primarily to the skin. During these trials, 4% of patients had to discontinue use of Complex A™ Tretinoin Cream, USP (Emollient) 0.05% because of adverse reactions. These discontinuations were due to skin irritation or related cutaneous adverse reactions.

Local reactions such as peeling, dry skin, burning, stinging, erythema, and pruritus were reported by almost all subjects during therapy with Complex A™ Tretinoin Cream, USP (Emollient) 0.05%. These signs and symptoms were usually of mild to moderate severity and generally occurred early in therapy. In most patients the dryness, peeling, and redness recurred after an initial (24 week) decline.

What should I look out for while using ZO COMPLEX A Tretinoin (Emollient)?

This drug is contraindicated in individuals with a history of sensitivity reactions to any of its components. It should be discontinued if hypersensitivity to any of its ingredients is noted.

Because of heightened burning susceptibility, exposure to sunlight (including sunlamps) should be avoided or minimized during use of Complex A™ Tretinoin Cream, USP (Emollient). Patients must be warned to use sunscreens (minimum SPF of 15) and protective clothing when using Complex A™ Tretinoin Cream, USP (Emollient). Patients with sunburn should be advised not to use Complex A™ Tretinoin Cream, USP (Emollient) 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 particular caution when using Complex A™ Tretinoin Cream, USP (Emollient) and assure that the precautions outlined in the Patient Package Insert are observed.

Complex A™ Tretinoin Cream, USP (Emollient) 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.

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 will not lead to more rapid or better results, and marked redness, peeling, or discomfort may occur.

What might happen if I take too much ZO COMPLEX A Tretinoin (Emollient)?

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. Oral ingestion of the drug may lead to the same side effects as those associated with excessive oral intake of Vitamin A.

How should I store and handle ZO COMPLEX A Tretinoin (Emollient)?

Store at 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Store at 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Complex A™ Tretinoin Cream, USP (Emollient) 0.05% is available in these sizes:

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Clinical Information

Chemical Structure

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Clinical Pharmacology

The exact mechanism of action of tretinoin is unknown although retinoids are believed to exert an effect on the growth and differentiation of various epithelial cells. When applied topically, however, there was no noted increase in desmosine, hydroxyproline, or elastin mRNA in human skin. In addition, the role of the irritative nature of this product in effecting the positive effects attributed to this product for its indication has not yet been fully determined.

The transdermal absorption of tretinoin from various topical formulations ranged from 1% to 31% of applied dose, depending on whether it was applied to healthy skin or dermatitic skin. When percutaneous absorption of Complex A™ Tretinoin Cream, USP (Emollient) 0.05% was assessed in healthy male subjects (n=14) after a single application, as well as after repeated daily applications for 28 days, the absorption of tretinoin was less than 2% and endogenous concentrations of tretinoin and its major metabolites were unaltered.

Non-Clinical Toxicology

This drug is contraindicated in individuals with a history of sensitivity reactions to any of its components. It should be discontinued if hypersensitivity to any of its ingredients is noted.

Because of heightened burning susceptibility, exposure to sunlight (including sunlamps) should be avoided or minimized during use of Complex A™ Tretinoin Cream, USP (Emollient). Patients must be warned to use sunscreens (minimum SPF of 15) and protective clothing when using Complex A™ Tretinoin Cream, USP (Emollient). Patients with sunburn should be advised not to use Complex A™ Tretinoin Cream, USP (Emollient) 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 particular caution when using Complex A™ Tretinoin Cream, USP (Emollient) and assure that the precautions outlined in the Patient Package Insert are observed.

Complex A™ Tretinoin Cream, USP (Emollient) 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.

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 will not lead to more rapid or better results, and marked redness, peeling, or discomfort may occur.

Concomitant topical medications, medicated or abrasive soaps, shampoos, cleansers, cosmetics with a strong drying effect, products with high concentrations of alcohol, astringents, spices or lime, permanent wave solutions, electrolysis, hair depilatories or waxes, and products that may irritate the skin should be used with caution in patients being treated with Complex A™ Tretinoin Cream, USP (Emollient) because they may increase irritation with Complex A™ Tretinoin Cream, USP (Emollient).

Complex A™ Tretinoin Cream, USP (Emollient) 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.

Complex A™ Tretinoin Cream, USP (Emollient) should only be used as an adjunct to a comprehensive skin care and sun avoidance program. (See section.)

If a drug sensitivity, chemical irritation, or a systemic adverse reaction develops, use of Complex A™ Tretinoin Cream, USP (Emollient) should be discontinued.

Weather extremes, such as wind or cold, may be more irritating to patients using Complex A™ Tretinoin Cream, USP (Emollient).

(See and sections.)

In double-blind, vehicle-controlled studies involving 179 patients who applied Complex A™ Tretinoin Cream, USP (Emollient) 0.05% to their faces, adverse reactions associated with the use of Complex A™ Tretinoin Cream, USP (Emollient) 0.05% were limited primarily to the skin. During these trials, 4% of patients had to discontinue use of Complex A™ Tretinoin Cream, USP (Emollient) 0.05% because of adverse reactions. These discontinuations were due to skin irritation or related cutaneous adverse reactions.

Local reactions such as peeling, dry skin, burning, stinging, erythema, and pruritus were reported by almost all subjects during therapy with Complex A™ Tretinoin Cream, USP (Emollient) 0.05%. These signs and symptoms were usually of mild to moderate severity and generally occurred early in therapy. In most patients the dryness, peeling, and redness recurred after an initial (24 week) decline.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Review

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

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