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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 25°C.
Protect from freezing and light. |
