Avita

Avita is a prescription medication used to control acne. Avita belongs to a group of drugs called retinoids. These work to promote peeling of affected skin areas and work to unclog pores. 

Avita comes in a gel and cream and is applied to the face once a day.

Common side effects of Avita include peeling, dry skin, and redness of the skin.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• thiazide diuretics
• tetracycline antibiotics such as demeclocycline (Declomycin), doxycycline (Monodox, Vibramycin, others), minocycline (Minocin), oxytetracycline (Terramycin), and tetracycline (Sumycin, Tetrex, others)
• fluoroquinolone antibiotics
• ketoconazole (Nizoral)
• phenothiazine medications
• sulfonamide-containing medications
• aminocaproic acid (Amicar)
• certain calcium channel blockers such as diltiazem (Cardizem, Dilacor, Tiazac, others) and verapamil (Calan, Covera, Isoptin, Verelan)
• cimetidine (Tagamet)
• cyclosporine (Sandimmune, Gengraf, Neoral)
• erythromycin (E.E.S., Erythrocin, E-Mycin)
• hydroxyurea (Droxia)
• pentobarbital
• phenobarbital
• rifampin (Rifadin, Rimactane)
• oral steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), and prednisone (Deltasone)
• tranexamic acid (Cyklokapron)
• vitamin A

This is not a complete list of all drug interactions. Ask your doctor or pharmacist for more information.

You should avoid using skin products that can dry or irritate your skin because skin dryness and irritation are increased with Avita. Skin products that can dry and irritate your skin include:

• products that contain alcohol, astringents, or spices
• acne medicines that contain benzoyl peroxide, sulfur, resorcinol, or salicylic acid
• medicated soap or skin cleansers

This is not a complete list of all drug interactions. Ask your doctor or pharmacist for more information.

• Avita: store below 86˚F

Tretinoin is a form of vitamin A that helps the skin renew itself.

Tretinoin topical (for the skin) is used to treat acne, to smooth rough facial skin, and to reduce the appearance of fine wrinkles and mottled skin discoloration.

Tretinoin topical may also be used for purposes not listed in this medication guide.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Do not take by mouth. Tretinoin topical is for use only on the skin. Do not use this medicine on open wounds or on sunburned, windburned, dry, chapped, or irritated skin.

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Using more medicine or applying it more often than prescribed will not make it work any faster, and may increase side effects.

Wash your hands before and after applying tretinoin topical. Before applying, clean and dry the skin area to be treated.

Applying tretinoin topical to wet skin may cause skin irritation. If you use Renova, wait at least 20 minutes after washing your face before applying a thin layer of the medication.

Do not wash the treated area for at least 1 hour after applying tretinoin topical. Avoid the use of other skin products on the treated area for at least 1 hour following application of tretinoin topical.

Applying an excessive amount of tretinoin gel may result in "pilling" of the medication. If this occurs, use a thinner layer of gel with the next application.

Tretinoin topical should be used as part of a complete skin care program that includes avoiding sunlight and using an effective sunscreen and protective clothing.

Use this medication for the full prescribed length of time, even if you think it is not working.

It may take up to several weeks before you notice improvement in your skin. Keep using the medication as directed and tell your doctor if your symptoms do not improve. If you are using tretinoin topical to treat acne, your condition may get slightly worse for a short time when you first start using the medication.

Call your doctor if skin irritation becomes severe or if your acne does not improve within 8 to 12 weeks.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

Tretinoin topical gel is flammable. Do not use near high heat or open flame. Do not smoke until the gel has completely dried on your skin.

Avita® Gel, a topical retinoid, contains tretinoin 0.025% by weight in a gel vehicle of butylated hydroxytoluene, hydroxypropyl cellulose, polyolprepolymer-2, and ethanol (denatured with tert-butyl alcohol and brucine sulfate) 83% w/w. Chemically, tretinoin is all-trans-retinoic acid (C20H28O2; molecular weight 300.44 vitamin A acid) and has the following structural formula:

Although the exact mode of action of tretinoin is unknown, current evidence suggests that topical tretinoin decreases cohesiveness of follicular epithelial cells with decreased microcomedo formation. Additionally, tretinoin stimulates mitotic activity and increased turnover of follicular epithelial cells causing extrusion of the comedones.

Pharmacokinetics

In vitro and in vivo pharmacokinetic studies with Avita® Gel indicate that less than 0.3% of the topically applied dose is bioavailable. Circulating plasma levels of both tretinoin and isotretinoin are only slightly elevated above those found in healthy normal controls.

CLINICAL STUDIES

In two large vehicle-controlled clinical trials, Avita® (tretinoin gel) Gel 0.025%, applied once daily was more effective than vehicle in the treatment of facial acne vulgaris of mild to moderate severity. Percent reductions in lesion counts after treatment for 12 weeks in these studies are shown in the following Tables:

GELS ARE FLAMMABLE. Note: Keep away from heat and flame. Keep tube tightly closed.

Applies to tretinoin topical: topical cream, topical gel, topical kit, topical liquid

Dermatologic

Cream:
Very common (10% or more): Severe skin irritation (Up to 32%)
Frequency not reported: Mild irritation, peeling/skin exfoliation, erythema, pruritus, blistering, pain, crusting, tenderness, dry skin, burning/warmth/stinging, photosensitivity/increased sensitivity to light
Postmarketing reports: Temporary hyper/hypopigmentation, rash, skin atrophy

Gel:
Very common (10% or more): Dry skin (Up to 16%), peeling/scaling/flaking skin (Up to 12%)
Common (1% to 10%): Burning sensation, erythema, pruritus, skin pain, sunburn
Frequency not reported: Blistering/crusting skin
Postmarketing reports: Temporary hypo/hyperpigmentation, increased susceptibility to sunlight

Microsphere Gel:
Common (1% to 10%): Skin irritation, skin burning, erythema, dermatitis
Frequency not reported: Peeling, dryness, stinging, itching
Postmarketing reports: Temporary hypo/hyperpigmentation[Ref]

Erythema, peeling, dryness, burning/stinging, and/or itching occurred most frequently during the first 2 weeks of therapy.

Most of the dermatologic side effects were mild in severity (approximately 63%), and approximately 34% were of moderate severity.

Dry, peeling, scaling, and/or flaking skin occurred most often in the gel formulation.[Ref]

Hepatic

Cream:
Frequency not reported: Reversible liver function test changes (bilirubin, alkaline phosphatase, ALT, AST)[Ref]

Metabolic

Cream:
Frequency not reported: Thymol turbidity elevations, increased flocculation[Ref]

Cardiovascular

Cream:
Postmarketing reports: Edema/swelling of application site[Ref]

Hypersensitivity

Cream:
Frequency not reported: Allergic contact dermatitis
Postmarketing reports: Allergic reaction[Ref]

Some side effects of Avita may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.