Azelaic acid 15% gel — Membership Pricing

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Also listed for Rosacea

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• Metronidazole

About Azelaic acid 15% gel

Struggling with rosacea or acne can be frustrating, but azelaic acid 15 gel offers a powerful solution for clearer, calmer skin. This effective prescription medication targets inflammation and blemishes, helping you achieve a healthier complexion. And with TheDrugClub, managing your skin health doesn't have to break the bank – discover how members save significantly on this essential treatment.

Azelaic acid 15 gel is a prescription topical medication primarily used to treat the inflammatory papules and pustules (bumps and pimples) associated with mild to moderate rosacea. It's also highly effective in combating acne vulgaris, helping to clear existing breakouts and prevent new ones. Its multi-faceted approach makes it a go-to for dermatologists addressing various skin concerns, from persistent redness to stubborn blemishes.

This remarkable gel works its magic through several key mechanisms. Firstly, it possesses anti-inflammatory properties, which are crucial for reducing the redness and swelling characteristic of rosacea and inflamed acne lesions. Secondly, azelaic acid has antibacterial effects, targeting the bacteria (like *Propionibacterium acnes* for acne) that contribute to breakouts. It also helps normalize the keratinization process, preventing dead skin cells from clogging pores and forming comedones (blackheads and whiteheads). By gently exfoliating and promoting

The information above is for educational purposes only and does not constitute medical advice. Consult your healthcare provider before making medication decisions.

What Azelaic acid 15% gel is approved for (FDA label)

Azelaic acid gel, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. Azelaic acid gel, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea ( 1 ). Limitations of Use Efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated. ( 1 ) Limitations of Use Although some reduction of erythema which was present in patients with papules and pustules of rosacea occurred in clinical studies, efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated.

Source: Read the full FDA label on DailyMed. Label effective date: November 11, 2021.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Dosage forms and strengths for Azelaic acid 15% gel (FDA label)

Azelaic acid gel, 15% is a white to yellowish white opaque gel. Each gram of azelaic acid gel contains 0.15 gm of azelaic acid (15% w/w). Gel, 15% ( 3 )

Source: FDA prescribing information (DailyMed). Set ID: 66178511-5c1a-4ecd-bc98-2ceb54e710ac. SPL document ID: d6c8343f-d169-4924-9fa2-4fbf097a32a7. Label effective date: November 11, 2021. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Adverse reactions for Azelaic acid 15% gel (FDA label)

The most common adverse reactions are burning/stinging/tingling (29%), pruritus (11%), scaling/dry skin/xerosis (8%) and erythema/irritation (4%). ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact LEO Pharma Inc. at 1-877-494-4536 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In two vehicle-controlled and one active-controlled U.S. clinical trials, treatment safety was monitored in 788 subjects who used twice-daily azelaic acid gel for 12 weeks (N=333) or 15 weeks (N=124), or the gel vehicle (N=331) for 12 weeks.

Source: FDA prescribing information (DailyMed). Set ID: 66178511-5c1a-4ecd-bc98-2ceb54e710ac. SPL document ID: d6c8343f-d169-4924-9fa2-4fbf097a32a7. Label effective date: November 11, 2021. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Contraindications for Azelaic acid 15% gel (FDA label)

None. None. ( 4 )

Source: FDA prescribing information (DailyMed). Set ID: 66178511-5c1a-4ecd-bc98-2ceb54e710ac. SPL document ID: d6c8343f-d169-4924-9fa2-4fbf097a32a7. Label effective date: November 11, 2021. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Warnings and precautions for Azelaic acid 15% gel (FDA label)

Hypersensitivity : Hypersensitivity reactions, including cases of angioedema, eye swelling, facial swelling, dyspnea, urticaria, and adverse skin reactions, have been reported. In case of known hypersensitivity to any component of the gel, avoid the use of azelaic acid gel. If hypersensitivity develops, discontinue treatment and institute appropriate therapy. ( 5.1 ) Skin Reactions: Skin irritation (i.e. pruritus, burning or stinging) may occur, usually during the first few weeks of treatment. If sensitivity or severe irritation develops and persists, discontinue treatment and institute appropriate therapy. ( 5.2 ) Hypopigmentation: Isolated cases of hypopigmentation occurred after azelaic acid use. Monitor patients with dark complexion for early signs of hypopigmentation ( 5.2 ) Eye and Mucous Membrane Irritation: azelaic acid gel has been reported to cause irritation of the eyes.

Source: FDA prescribing information (DailyMed). Set ID: 66178511-5c1a-4ecd-bc98-2ceb54e710ac. SPL document ID: d6c8343f-d169-4924-9fa2-4fbf097a32a7. Label effective date: November 11, 2021. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.