Medskin Zela

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Description

COMPOSITION:
Azelaic acid .......................... 2 g
Excipients q.s   .................. 10 g
(Propylene glycol, glycerin, sepineo, cetyl stearyl alcohol, paraffin oil, isopropyl palmitate, cremophor RH40, potassium sorbate, butyl hydroxy toluene (BHT), laure flavor, ethanol 96%, purified water).
DOSAGE FORM: Dermal cream.
PRESENTATION: Box of 1 tube x 10 g.
PHARMACODYNAMICS: Azelaic acid is a dicarboxylic acid that acts as a mechanism to inhibit the foundation of tyrosinase - an enzyme required for the formation of pigmentation, the normalization of keratinization (reducing the thickness of epidermal keratinocytes, the size and number of keratohyalin granules, and filaggrin). It is active against Propionibacterium acnes and Staphylococcus, which are the causes of acne formation.
PHARMACOKINETICS: After dermal administration of the cream, azelaic acid penetrates into all layers of human skin. The penetration is more rapid into damaged skin than into intact skin. A total of 3.6% of the administered dose was absorbed percutaneously after a single topical administration of 1 g azelaic acid (5 g cream).
A portion of the azelaic acid absorbed through the skin is excreted in unchanged form in the urine. The remaining portion is broken down by beta-oxidation into dicarboxylic acids with shorter chain length (C7, C5), which have likewise been found in the urine.
INDICATIONS:
MedSkinZELA fades scratched acne and is used to treat mild to moderate acne. The drug should be applied as soon as on the newly formed acne; the swelling and itching of acne will be reduced, disappeared without any dark spot.
CONTRAINDICATIONS: Hypersensitivity to any components of the drug.
PRECAUTIONS: Care should be taken to avoid contact with the eyes, mouth and other mucous membranes. 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.
Infants must not come into contact with treated skin/breast. The hands should be washed after each application of MedSkinZELA. Worsening of asthma in patients treated with azelaic acid has been reported.
PREGNANCY AND LACTATION: The drug should be used with caution in pregnant women and nursing mothers.
EFFECTS ON ABLITY TO DRIVE AND USE MACHINES:
The drug has no influence on the ability to drive and use machines.
INTERACTIONS: No document has been reported.
ADVERSE EFFECTS: Temporary skin reactions including itching, burning or tingling can sometimes happen at the beginning treatment. However, these reactions reduce after using the drug for some time.
Inform your physician about any adverse effects occur during the treatment.
OVERDOSAGE: No document has been reported.
DOSAGE AND ADMINISTRATION:
After the skin should be thoroughly cleaned with plain water and dried, the drug should be applied to the affected skin areas twice a day and rubbed in gently. The duration of use of the drug can vary from person to person and also depends on the severity of the skin disorder. In general, a distinct improvement becomes apparent after 4 weeks.
Or as prescribed by the physician.
Read the directions carefully before use.
Consult the physician for more information.
This drug is for prescriptions only.
Shelf-life: 36 months from the manufacturing date.
Storage conditions: Store in dry places, not exceeding 30oC, protect from light.
Specifications: Manufacturer's.

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