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Deriva Aqueous Gel

 

COMPOSITION
Adapalene 0.1 in a aqueous gel base


Preservatives
Methyl hydroxybenzoate BP 0.1% w/w

Phenoxyethanol BP 0.25% w/w


Description
Aluminium collapsible tube containing opaque white smooth gel.


THERAPEUTIC CLASS

T0900


PHARMACOLOGY
Adapalene is a retinoid-like compound for the treatment of acne vulgaris. It is a naphthoic derivative with a methoxyphenyl adamantyl side chain. 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.

 

Adapalene binds to specific retinoic acid nuclear receptors but does not bind to the cytosolic receptor protein. It has been suggested that topical adapalene may normalize the differentiation of follicular epithelial cells resulting in decreased microcomedone formation.


Analysis of cryosections, radioactive tracing and fluorescence studies in excised human skin have shown that adapalene gel penetrates into the epidermis and dermis (especially the pilosebaceous units).


PHARMACOKINETICS
The pharmacokinetics of topical adapalene has not been extensively studied. Therapeutic effects of the drug usually appear within 8 to 12 weeks of initiation of treatment. The transdermal absorption of adapalene is low. Only trace amounts of the parent substance (<0.25 ng/mL) have been found in the plasma of acne patients following chronic topical application of adapalene gel in controlled clinical trials. Excretion appears to be primarily by the biliary route.


INDICATIONS
Deriva Aqueous Gel is indicated for the topical treatment of acne vulgaris.


CONTRAINDICATIONS
Deriva Aqueous Gel should not be administered to individuals who are hypersensitive to Adapalene or any of the components in the vehicle gel.


SIDE EFFECTS/ADVERSE REACTIONS
Some adverse effects such as erythema, scaling, dryness, pruritus and burning occur in 10-40% of patients. Pruritus or burning immediately after application also occurs frequently. In approximately 1% or less of patients, skin irritation, burning/stinging, erythema, sunburn and acne flares have also been reported. 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 Adapalene Gel during clinical trials were reversible upon discontinuation of therapy.


PRECAUTIONS/ WARNINGS

General


FOR EXTERNAL USE ONLY
Cutaneous signs and symptoms such as erythema, dryness, scaling, burning or pruritus may be experienced during treatment.
Avoid contact with the eyes, lips, angles of the nose and mucous membranes
Avoid excessive exposure to sunlight, including sun lamps
Concomitant use of topical products that may dry or irritate the skin, such as medicated or abrasive soaps or cleansers, soaps and cosmetics with a strong drying effect, and products with high concentrations of alcohol, astringents, spices or lime; local imitation may occur.
In case of hypersensitivity to any of the ingredients, discontinue the therapy.
Do not apply to cuts, eczematous, sunburnt or abraded skin
Avoid exposure to UV light
 

DRUG INTERACTION
As Deriva Aqueous Gel 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 concentration of alcohol, astringents, spices or lime) should be used with caution. Particular caution should be exercised in using preparations containing sulfur, resorcinol or salicylic acid in combination with Deriva Aqueous Gel. If these preparations have been used, it is advisable not to start therapy with Deriva Aqueous Gel, until the effects of such preparations in the skin have subsided.


USE IN PREGNANCY AND LACTATION
Pregnancy:
Category C
No teratogenic effects were seen in animal studies. There are no adequate and well controlled studies in pregnant women. Hence use of adapalene is not recommended during pregnancy. Adapalene should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.


Lactation:
It is not known whether adalapene is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Deriva Aqueous Gel is administered to nursing mothers.


RECOMMENDED DOSAGE, DOSAGE SCHEDULE AND ROUTE OF ADMINISTRATION
Adults:
Deriva Aqueous Gel is used in the topical treatment of mild to moderate acne where comedones, papules and pustules predominate. Deriva Aqueous Gel is applied once daily at night as a 0.1 % Gel to the skin that has been cleansed and dried. Other topical preparations that may cause irritation should not be used concomitantly.


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.


Pediatric Population
The safety and efficacy of adapalene in pediatric patients under the age of 12 years have not been established.


Route of administration: Topical


SYMPTOMS AND TREATMENT FOR OVERDOSAGE AND ANTIDOTE (S)
No overdosage has been reported with Adapalene gel in human beings. Deriva Aqueous Gel is intended for topical 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 Gel 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.


In case of accidental ingestion, appropriate method of gastric emptying should be considered.


PACKING/ PACK SIZES

Tube of 15 g


SHELF LIFE

36 months


STORAGE CONDITIONS, USER INSTRUCTIONS AND PHARMACEUTICAL PRECAUTIONS
Store below 25C.

Protect from freezing and light.

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