Azelex

Generic title and potency

Azelex Cream, 20% w/w, is a white to off-white cream with 20 mg of active ingredient per gram.

Inactive substances

methylparaben 0.3%, polyethylene glycol 400 monostearate, propylene glycol, purified water, citric acid anhydrous, cyclomethicone 5 and dimethicone 350, carbomer 940 ceteareth-20, cetearyl alcohol, glycerin, glyceryl stearate SE, and sodium hydroxide solution.

Topical cream called Azelex is used to treat acne. Sebum production, an oily substance that can clog pores and cause breakouts, is decreased as a result of this treatment. Only with a prescription is Azelex available, and it must be taken exactly as prescribed by your doctor.

Azelex works best when combined with other acne medications like Benzaclin or Retin-A. Azelex may take up to eight weeks to produce results when used alone.

For the majority of people, Azelex is a secure and reliable acne treatment. However, there is always a chance for side effects with any medication. Before beginning Azelex treatment, be sure to discuss any concerns you may have with your doctor.

Pharmacokinetics

Following topical application, azelex is quickly absorbed, and mean peak plasma concentrations of nordazepam and its active metabolite desmethyldiazepam happen in just three hours. Both nordazepam and desmethyldiazepam have high plasma protein binding (>99%), but their glucuronides have only moderate binding (60–70%).

Nordazepam and desmethyldiazepam have approximately 50- and 100-hour elimination half-lives, respectively. Less than 1% of the dose of both nordazepam and desmethyldiazepam is excreted unchanged in the urine due to extensive metabolization. Both substances are metabolized primarily by conjugation with glucuronic acid.

Azelex's pharmacokinetics are comparable in both men and women.

Indications

Acne vulgaris is a condition for which Azelex is prescribed.

Contraindications

Patients who have a history of known hypersensitivity to any of the formulation's ingredients should not take Azelex.

Warnings and Precautions

Avoid coming into contact with the mucous membranes, lips, and eyes. If there is contact, thoroughly rinse with water.

Stop using immediately and seek medical advice if severe skin rashes appear.

Teratogenic Effects on Pregnancy. Category C pregnancy. Although there are no adequate and well-controlled human studies and animal reproduction studies have shown a negative effect on the fetus, there may be benefits to using the drug during pregnancy that outweigh any risks.

Moms who are nursing: Whether this medication is excreted in human milk is unknown. When giving Azelex to a nursing mother, caution should be taken because many medications are excreted in human milk.

Use in children under 12 years old has not been proven to be safe or effective.

Geriatric Use: Insufficient elderly participants were enrolled in clinical studies of Azelex to assess whether their responses differed from those of younger participants. The responses of elderly patients and younger patients have not been found to differ in other reported clinical experiences. In general, choosing a dose for an elderly patient should be cautious, usually beginning at the low end of the dosing range. This is because elderly patients are more likely to have decreased hepatic, renal, or cardiac function, as well as concurrent disease or other drug therapy, and these factors are more common.

Adverse reactions

Dry skin is the most typical side effect associated with Azelex Cream (incidence 1%).

Topical retinoids have also been linked to local adverse reactions like erythema, scaling, pruritus, burning/stinging, and contact dermatitis. Although they have been documented in clinical trials and/or postmarketing reports, these reactions do not always happen in patients who receive Azelex Cream. It is not always possible to estimate their frequency with accuracy or establish a causal link to drug exposure because these reactions are voluntary reports from a population of unknown size:

Body as a Whole - Allergic reaction generally, reaction at application site (including edema at application site)

• Blood Pressure: Cardiovascular System
• digestive system: gastroenteritis, motion sickness, and nausea
• Ecchymosis in the hematopoietic and lymphatic system
• Disorders of Metabolism and Nutrition - Peripheral swelling
• Psychiatric/Nervous System - Headache, Insomnia
• Respiratory
• Alopecia, contact dermatitis, erythema, exfoliation, peeling skin, photosensitivity reaction, pruritus, skin reaction (including erythema multiforme), and urticaria are some conditions that affect the skin and appendages.

Side Effects

Dry skin, redness, itching, and burning are a few of the side effects of Azelex. Usually minor, these side effects will disappear on their own over time. However, stop using the cream and call your doctor right away if you experience any serious side effects.

Dosage and Administration

After washing the skin, use Azelex Cream once daily as part of your morning or evening skincare routine. Apply cream evenly all over the face, avoiding the eyes and lips, using a pea-sized amount.

The potential for additional local irritation when using Azelex Cream with other potentially irritating topical products should be avoided or minimized. Reduce application to once every other day or once every third day if bothersome dryness or peeling develops.

When going outside, use sunscreen with an SPF of 15 or higher and cover treated areas with protective clothing when exposure cannot be avoided. When using Azelex Cream and for at least four weeks, it is advised to wear protective clothing over treated areas and daily use of sunscreen lotions.

Overdose

Azelex Cream topical overdose is unlikely to result in clinically significant side effects. The patient should receive counseling and be referred to a doctor if large amounts are consumed or if it is suspected that topical doses above those advised have been used.

Storage

The 40 g tubes of Azelex (azelaic acid) Cream, 20%, have the NDC 56258-438-40. Store between 68° and 77°F (20° to 25°C). Keep away from temperatures below freezing and those above 40 °C (104 °F). Keep this carton on hand for future use. Keep out of children's reach.