Adapalene Topical Solution

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Overview

What is Adapalene Topical Solution?

Adapalene Topical Solution 0.1%, containing adapalene is used for the topical treatment of acne vulgaris. Each mL of Adapalene Topical Solution, 0.1%, contains adapalene 0.1% (1 mg) in a vehicle consisting of polyethylene glycol 400 and alcohol, denatured, 30% (w/v).

The chemical name of adapalene is 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid. Adapalene is a white to off-white powder which is soluble in tetrahydrofuran, sparingly soluble in ethanol, and practically insoluble in water. The molecular formula is C H O and molecular weight is 412.52. Adapalene is represented by the following structural formula:

What does Adapalene Topical Solution look like?

What are the available doses of Adapalene Topical Solution?

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What should I talk to my health care provider before I take Adapalene Topical Solution?

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How should I use Adapalene Topical Solution?

Adapalene Topical Solution 0.1% is indicated for the topical treatment of acne vulgaris.

1. Adapalene Topical Solution 0.1% should be applied once a day to affected areas. 2. Before retiring in the evening, wash and dry areas to be treated. 3. Apply a thin film of medication to the affected areas. Avoid the eyes lips, and mucous membranes. 4. Replace cap after each use.

During the early weeks of therapy, an apparent exacerbation of acne may occur. This is due to the action of the medication on previously unseen lesions and should not be considered a reason to discontinue therapy. Therapeutic results should be noticed after eight to twelve weeks of treatment.

What interacts with Adapalene Topical Solution?

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What are the warnings of Adapalene Topical Solution?

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What are the precautions of Adapalene Topical Solution?

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What are the side effects of Adapalene Topical Solution?

Some adverse effects such as erythema, scaling, dryness, pruritus, and burning will occur in 30-60% of patients. Pruritus or burning immediately after application also occurs in approximately 30% of patients. The following additional adverse experiences were reported in approximately 1% or less of patients: skin irritation, burning/stinging, erythema, sunburn, and acne flares. These are most commonly seen during the first month of therapy and decrease in frequency and severity thereafter. All adverse effects with the use of similar products during clinical trials were reversible upon discontinuation of therapy.

To report , contact Rochester Pharmaceuticals at 1-866-458-1772 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

What should I look out for while using Adapalene Topical Solution?

Adapalene Topical Solution 0.1% should not be administered to individuals who are hypersensitive to adapalene or any of the components in the vehicle solution.

Use of Adapalene Topical Solution 0.1% should be discontinued if hypersensitivity to any of the ingredients is noted. Patients with sunburn should be advised not to use the product until fully recovered.

What might happen if I take too much Adapalene Topical Solution?

Adapalene Topical Solution 0.1% is intended for cutaneous use only. If the medication is applied excessively, no more rapid or better results will be obtained and marked redness, peeling, or discomfort may occur. The acute oral toxicity of Adapalene Topical Solution 0.1% in mice and rats is greater than 10 mL/kg. Chronic 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 Adapalene Topical Solution?

Store atAdapalene Topical Solution 0.1% is supplied in the following size:60 mL glass bottle – NDC 49908-117-60Storage:Adapalene Topical Solution 0.1% is supplied in the following size:60 mL glass bottle – NDC 49908-117-60Storage:Adapalene Topical Solution 0.1% is supplied in the following size:60 mL glass bottle – NDC 49908-117-60Storage:

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Adapalene is a chemically stable, retinoid-like compound. Biochemical and pharmacological profile studies have demonstrated that adapalene is a modulator of cellular differentiation, keratinization, and inflammatory processes all of which represent important features in the pathology of acne vulgaris. Mechanistically, adapalene binds to specific retinoic acid nuclear receptors but does not bind to the cytosolic receptor protein. Although the exact mode of action is unknown, it is suggested that topical adapalene may normalize the differentiation of follicular epithelial cells resulting in decreased microcomedone formation.

Non-Clinical Toxicology

Adapalene Topical Solution 0.1% should not be administered to individuals who are hypersensitive to adapalene or any of the components in the vehicle solution.

Use of Adapalene Topical Solution 0.1% should be discontinued if hypersensitivity to any of the ingredients is noted. Patients with sunburn should be advised not to use the product until fully recovered.

As Adapalene Topical Solution 0.1% has the potential to produce local irritation in some patients, concomitant use of other potentially irritating topical products (medicated or abrasive soaps and cleansers, soaps and cosmetics that have a strong drying effect, and products with high concentrations of alcohols, astringents, spices or lime) should be approached with caution. Particular caution should be exercised in using preparations containing sulfur, resorcinol, or salicylic acid in combination with Adapalene Topical Solution 0.1%. If these preparations have been used, it is advisable not to start therapy with Adapalene Topical Solution 0.1% until the effects of such preparations in the skin have subsided.

If a reaction suggesting sensitivity or chemical irritation occurs, use of the medication should be discontinued. Exposure to sunlight, including sunlamps, should be minimized during the use of adapalene. Patients who normally experience high levels of sun exposure, and those with inherent sensitivity to sun, should be warned to exercise caution. Use of sunscreen products and protective clothing over treated areas is recommended when exposure cannot be avoided. Weather extremes, such as wind or cold, also may be irritating to patients under treatment with adapalene.

Avoid contact with the eyes, lips, angles of the nose, and mucous membranes. The product should not be applied to cuts, abrasions, eczematous skin, or sunburned skin.

Certain cutaneous signs and symptoms such as erythema, dryness, scaling, burning, or pruritus may be experienced during treatment. These are most likely to occur during the first two to four weeks and will usually lessen with continued use of the medication. Depending upon the severity of adverse events, patients should be instructed to reduce the frequency of application or discontinue use.

Some adverse effects such as erythema, scaling, dryness, pruritus, and burning will occur in 30-60% of patients. Pruritus or burning immediately after application also occurs in approximately 30% of patients. The following additional adverse experiences were reported in approximately 1% or less of patients: skin irritation, burning/stinging, erythema, sunburn, and acne flares. These are most commonly seen during the first month of therapy and decrease in frequency and severity thereafter. All adverse effects with the use of similar products during clinical trials were reversible upon discontinuation of therapy.

To report , contact Rochester Pharmaceuticals at 1-866-458-1772 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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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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