1. Name Of The Medicinal Product
Finacea 15 % Gel
2. Qualitative And Quantitative Composition
1 g Finacea 15 % Gel contains 150 mg azelaic acid.
Excipients:
1 mg Benzoic acid /g Gel
0.12 g Propylene glycol /g Gel
For a full list of excipients, see section 6.1.
3. Pharmaceutical Form
Gel.
White to yellowish-white opaque gel.
4. Clinical Particulars
4.1 Therapeutic Indications
For the relief of mild to moderate papular-pustular acne of the facial area.
For the topical treatment of papulopustular rosacea.
4.2 Posology And Method Of Administration
Finacea 15 % Gel is intended for cutaneous use only. Before Finacea 15 % Gel is applied, the skin should be thoroughly cleaned with water and dried. A mild skin-cleansing agent may be used.
Finacea 15 % Gel should be applied sparingly to the affected skin areas twice a day (in the morning and in the evening) and massaged gently into the skin. Approximately 0.5 g = 2.5 cm of gel is sufficient for the entire facial area.
Occlusive dressing or wrappings should not be used, and hands should be washed after applying the gel.
It is important to use Finacea 15 % Gel continuously over the entire period of treatment.
In the event of irritation of the skin (see “4.8 Undesirable effects“), the amount of gel per application should be reduced or the frequency of use of Finacea 15 % Gel should be reduced to once a day until the irritation ceases. If required, the treatment should be temporarily interrupted for a few days.
The duration of use of Finacea 15 % Gel can vary from person to person and also depends on the severity of the skin disorder.
Acne: In general, a distinct improvement becomes apparent within 4 weeks.To obtain optimum results, Finacea 15 % Gel can be used over several months in accordance with the clinical outcome. In case of no improvement after 1 month or exacerbation of acne, Finacea 15 % Gel should be discontinued and other therapeutic options should be considered.
Rosacea: Significant initial therapeutic effects have been observed after 4–8 weeks of treatment. To obtain optimum results, Finacea 15 % Gel can be used over several months in accordance with the clinical outcome.
In case of no improvement after 2 month or exacerbation of rosacea, Finacea 15 % Gel should be discontinued and other therapeutic options should be considered.
Finacea 15 % Gel is not recommended for use in children below age 12 due to a lack of data on safety and efficacy.
4.3 Contraindications
Hypersensitivity to active substance or to any of the excipients.
4.4 Special Warnings And Precautions For Use
For external use only.
Finacea 15 % Gel contains benzoic acid which is mildly irritant to the skin, eyes and mucous membranes and propylene glycol which may cause skin irritation.
Care should be taken to avoid contact with the eyes, mouth and other mucous membranes, and patients should be instructed accordingly (see “5.3 Preclinical safety data”). In the event of accidental contact, the eyes, mouth and/or affected mucous membranes should be washed with large amounts of water. If eye irritation persists, patients should consult a physician. The hands should be washed after each application of the Finacea 15 % Gel.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
No interaction studies have been performed. The composition of Finacea 15 % Gel gives no indication of any undesired interactions of the single components that could adversely affect the safety of the product. No drug-specific interactions were noted during any of the controlled clinical trials.
4.6 Pregnancy And Lactation
Data on a limited number of exposed pregnancies (n=2) indicate no adverse effects of azelaic acid on pregnancy or on the health of the foetus/newborn child. To date, no other relevant epidemiological data are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development.
Caution should be exercised when prescribing azelaic acid to pregnant women.
Infants must not come into contact with treated skin/breast.
The amount of azelaic acid potentially transferred per day during breast-feeding is negligible and should not imply any risk to the infant.
4.7 Effects On Ability To Drive And Use Machines
Finacea 15 % Gel has no influence on the ability to drive and use machines.
4.8 Undesirable Effects
Only cutaneous treatment-related adverse events were reported in clinical trials comprising 269 acne patients treated with Finacea 15 % Gel for up to 4 months and 457 rosacea patients treated with Finacea 15 % Gel for up to 15 weeks. In the great majority of cases the symptoms were mild or moderate; the frequency of cutaneous adverse events gradually decreased during the course of therapy.
The spectrum of undesirable cutaneous effects related to Finacea 15 % Gel was similar in acne and rosacea.
Rosacea:
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4.9 Overdose
Due to the very low local and systemic toxicity of azelaic acid intoxication is unlikely.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Pharmacotherapeutic group: Other anti-acne preparations for topical use.
ATC code: D10A X03
Acne:
An antimicrobial action and a direct influence on follicular hyperkeratosis are assumed to be the basis for the therapeutic efficacy of azelaic acid in acne.
In vitro and in vivo, azelaic acid inhibits the proliferation of keratinocytes and normalizes the disturbed terminal epidermal differentiation processes in acne.
Clinically, a significant reduction of the colonization density of Propionibacterium acnes and a significant reduction in the fraction of free fatty acids in the skin surface lipids are observed.
In two double blind randomized clinical studies Finacea 15 % Gel was significantly superior to its vehicle in the median reduction of the sum of papules and pustules, and was 6 % less effective than benzoyl peroxide 5 % (p=0.056).
In these studies effectiveness of Finacea 15 % Gel on comedones has been evaluated as a secondary parameter. Finacea 15 % Gel was more effective than its vehicle in the median relative reduction of comedones, and was less effective in comparison to benzoyl peroxide 5 %.
Rosacea:
The mechanism by which azelaic acid interferes with the pathogenic events in rosacea is unknown. Several in vitro and ex vivo investigations indicate that azelaic acid may exert an anti-inflammatory effect by reducing the formation of pro-inflammatory, reactive oxygen species.
In the two vehicle controlled 12 week clinical studies in papulopustular rosacea,Finacea 15 % Gel was statistically significantly superior to its vehicle with regard to the reduction in inflammatory lesions, Investigator's Global Assessment, overall rating of improvement and with regard to improvement of erythema.
In the clinical study with the active comparator metronidazole 0.75 % gel in papulopustular rosacea, Finacea 15 % Gel showed significant superiority with regard to lesion count reduction (72.7 % versus 55.8 %), overall rating of improvement and with regard to improvement of erythema (56 % versus 42 %). The rate of cutaneous adverse events, which in most cases were mild to moderate, was 25.8 % with Finacea 15 % Gel and 7.1 % with metronidazole 0.75 % gel.
There was no noticeable effect on the teleangiectasias in the three clinical studies.
5.2 Pharmacokinetic Properties
Azelaic acid penetrates into all layers of the skin after topical application of the gel. Penetration is faster into damaged skin than into intact skin. A total of 3.6 % of the dose applied was absorbed percutaneously after a single topical application of 1 g azelaic acid (administered as 5 g Skinoren 20 % Cream). Clinical investigations in acne patients indicated similar absorption rates of azelaic acid from Finacea 15 % Gel and Skinoren 20 % Cream.
A portion of the azelaic acid absorbed through the skin is excreted in unchanged form with the urine. The remaining portion is broken down by β-oxidation into dicarboxylic acids with shorter chain length (C7, C5), which have likewise been found in the urine.
Steady-state plasma levels of azelaic acid in rosacea patients after 8 weeks twice daily treatment with Finacea 15 % Gel were within the range also observed in volunteers and acne patients on normal diets. This indicates that the extent of percutaneous absorption of azelaic acid following twice daily application of Finacea 15 % Gel does not alter the systemic burden of azelaic acid derived from dietary and endogenous sources.
5.3 Preclinical Safety Data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and toxicity to reproduction.
If azelaic acid came into contact with the eyes of monkeys and rabbits, signs of moderate to severe irritation became evident. Therefore, contact with the eyes should be avoided.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Lecithin
Triglycerides (medium chain)
Polysorbate 80
Propylene glycol
Carbomer 980
Sodium hydroxide
Disodium edetate
Purified water
Benzoic acid (E210)
6.2 Incompatibilities
Not applicable.
6.3 Shelf Life
3 years.
6.4 Special Precautions For Storage
This medicinal product does not require any special storage conditions.
6.5 Nature And Contents Of Container
Standard aluminium tube with membrane closure, internal coating with epoxide resin, white coloured outside, with screw cap made of high-density polyethylene.
Tubes of 5, 30, 50, 2 x 50g.
Not all pack sizes may be marketed
6.6 Special Precautions For Disposal And Other Handling
No special requirements.
7. Marketing Authorisation Holder
Intendis GmbH
Max-Dohrn-Straße 10
10589 Berlin
Germany
8. Marketing Authorisation Number(S)
PL 28428/0001
9. Date Of First Authorisation/Renewal Of The Authorisation
03/07/2007
10. Date Of Revision Of The Text
Jul 2009
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