AZIDERM 10% GEL 15 GM

Name

Brand Name: AZIDERM 10% GEL Common Name: Azelaic Acid Gel 10%

Composition

AZIDERM 10% GEL contains Azelaic Acid (10% w/w) as its active ingredient.

Uses

AZIDERM 10% GEL is prescribed for the treatment of various skin conditions, primarily:

• Acne (Pimples): It treats mild to moderate papulopustular acne, helping to reduce inflamed pimples, pustules, blackheads, and whiteheads by killing acne-causing bacteria and reducing keratin production that clogs pores.
• Rosacea: It is used for mild to moderate papulopustular rosacea on the face, reducing inflammatory papules and pustules, and calming redness. It also helps to reduce dark spots and hyperpigmentation, improve skin clarity, and soothe irritation and inflammation.

Dosage and Administration

This medicine is for external use only.

• Cleanse and dry the affected area thoroughly before application.
• Apply a thin layer of the gel to the affected skin, gently massaging it in.
• Typically, it is applied twice daily (morning and evening), unless otherwise advised by a doctor.
• For individuals with very sensitive skin, it may be recommended to apply once daily (in the evening) for the first week before increasing to twice daily.
• Wash hands thoroughly after applying the gel, unless the hands are the affected area.
• Do not use more than the prescribed amount, as it will not clear the condition faster and may increase side effects.
• Avoid contact with eyes, eyelids, lips, mouth, nose, and other mucous membranes. In case of accidental contact, rinse immediately with water.

Side Effects

Common side effects may include:

• Burning sensation
• Skin irritation, itching, or redness (erythema)
• Dryness (xerosis) or peeling
• Tingling and numbness at the application site
• Dermatitis If side effects persist or worsen, medical advice should be sought.

Precautions

• Allergy: Do not use if allergic to azelaic acid or any other ingredients in the gel.
• Sensitive Skin: People with sensitive skin should start with once-daily application.
• Sun Exposure: The gel can make skin change color, especially darker skin. Avoid tanning booths and sunlamps.
• Irritated Skin: Do not apply to irritated, sunburned, open wounds, cuts, scrapes, or damaged skin.
• Other Products: Limit the use of products containing high amounts of alcohol, hair removal products, and products with lime or spices while using AZIDERM 10% GEL.
• Pregnancy and Breastfeeding: Consult a doctor before use if pregnant or breastfeeding. While generally considered safe, caution is advised, and it should not be applied to breast areas that may come into contact with an infant.
• Asthma: Consult a doctor if asthma worsens while using the gel.
• Children: Not recommended for children below 12 years for acne and below 18 years for rosacea due to lack of safety data.

Storage

Store in a cool, dry place, protected from direct sunlight, moisture, and heat. Keep it out of sight and reach of children. Store at temperatures between 10ºC and 25ºC or below 30ºC. Do not use expired medicine.

AZIDERM 10% GEL contains Azelaic Acid, a dicarboxylic acid known for its antibacterial, keratolytic, comedolytic (inhibiting blemish formation), and antioxidant properties. It is primarily used topically for various inflammatory skin conditions affecting the face.

What is AZIDERM 10% GEL used for?

AZIDERM 10% GEL is predominantly used to treat mild to moderate papulopustular acne (pimples) and papulopustular rosacea (a skin condition causing facial redness and bumps). It helps reduce inflamed pimples and pustules, calms redness, and can improve skin clarity. It is also useful in reducing post-inflammatory hyperpigmentation and may be prescribed for melasma.

How does AZIDERM 10% GEL work?

The active ingredient, Azelaic Acid, works by killing acne-causing bacteria like Propionibacterium acnes (now Cutibacterium acnes) and inhibiting the synthesis of microbial cellular proteins. It also reduces inflammation and swelling of the skin, normalizes the shedding of skin cells, and decreases keratin production, which helps prevent clogged pores (comedones), blackheads, and whiteheads.

What is the usual dosage?

AZIDERM 10% GEL is for external use only. It should be applied as a thin layer to the clean, dry affected area twice daily, typically in the morning and evening, or as directed by your doctor. For individuals with sensitive skin, it may be recommended to apply it once a day for the first week before increasing to twice daily. Improvement may be noticeable within 4-8 weeks, and treatment duration can extend up to 6 months.

What are the possible side effects?

Common side effects of AZIDERM 10% GEL include application site reactions such as dryness, peeling, burning, irritation, itching, and redness (erythema). These side effects are often mild and temporary, especially during the first few weeks of treatment. If side effects persist or worsen, consult your doctor. More severe but less common side effects can include stinging, tingling, pain, crusting, soreness, severe redness, swelling, scaliness, and skin discoloration, particularly in dark-skinned individuals.

Is it safe during pregnancy or breastfeeding?

During pregnancy, AZIDERM 10% GEL is generally considered safe if prescribed by a doctor. Animal studies have shown low or no adverse effects, though human studies are limited. For breastfeeding mothers, it is probably safe to use, with limited human data suggesting no significant risk to the baby. However, it is always recommended to consult your doctor before using this medication during pregnancy or breastfeeding, and avoid applying it to breast areas that may come into contact with an infant.

Can it be taken with other medications?

AZIDERM 10% GEL is for topical use. There have been no formal studies on interactions with other drugs. However, concomitant use with other topical acne medications like salicylic acid or benzoyl peroxide may increase the risk of skin irritation. It's advisable to inform your doctor about all medicines, including prescription and over-the-counter topical preparations, to avoid undesired side effects. If using other treatments, apply them on different days than AZIDERM 10% GEL to minimize irritation.

What precautions should be taken?

AZIDERM 10% GEL is for external use only. Avoid contact with eyes, eyelids, lips, mouth, nose, or other mucous membranes. If accidental contact occurs, rinse immediately and thoroughly with water. Do not apply it to open wounds, cuts, scrapes, irritated, windburned, sunburned, or damaged skin. Patients with sensitive skin may need to start with once-daily application. Products containing large amounts of alcohol, astringents, shaving creams, hair removal products, or those with lime or spices should be limited or avoided while using this gel. In rare cases, Azelaic Acid may worsen asthma; consult your doctor if this occurs. Monitor for skin color changes, especially if you have dark skin.

What happens if a dose is missed?

If you miss a dose of AZIDERM 10% GEL, apply it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed one and continue with your regular schedule. Do not double the dose to compensate for a missed one, as this can increase the risk of side effects.

How should it be stored?

AZIDERM 10% GEL should be stored in a cool and dry place, protected from direct sunlight, moisture, and heat. The optimal temperature range for storage is typically 10ºC to 25ºC or below 30ºC. Keep it out of the sight and reach of children and pets. Do not use the medicine after its expiry date.