Version May 2024
Acne vulgaris (alternative agent):
Note: Reserve for patients who cannot use first-line agents. Use in combination with benzoyl peroxide to reduce the risk for the development of antibiotic resistance (Ref).
Topical: Foam 4% (Amzeeq): Express a small (cherry-sized) amount to fingertips and apply to acne-affected areas once daily; may repeat until all acne-affected areas are treated (Ref).
Rosacea:
Topical: Foam 1.5% (Zilxi): Express a small (cherry-sized) amount to fingertips and apply a thin layer to all areas of the face once daily; may repeat until entire face is covered.
There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.
There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.
Refer to adult dosing.
(For additional information see "Minocycline (topical): Pediatric drug information")
Acne vulgaris: Note: Due to emerging resistance patterns, topical antibiotics should not typically be used as monotherapy for the management of acne vulgaris (Ref).
Children ≥9 years and Adolescents: Topical: Foam 4% (Amzeeq): Apply small amount (eg, cherry sized) to affected area(s) once daily.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%:
Dermatologic: Burning sensation of skin (≤13%), erythema of skin (≤36%), exfoliation of skin (≤16%), hyperpigmentation (≤23%), pruritus (≤20%), stinging of skin (≤13%), telangiectasia (19% to 61%), xeroderma (≤24%)
Nervous system: Flushing sensation (≤39%)
1% to 10%:
Gastrointestinal: Diarrhea (1%)
Nervous system: Headache (3%)
Hypersensitivity to tetracyclines or to any component of the formulation.
Concerns related to adverse effects:
• Autoimmune syndromes: Lupus-like, hepatitis, and vasculitis autoimmune syndromes (including serum sickness [eg, fever, arthralgia, malaise]) have been reported with oral minocycline; immediately discontinue if symptoms occur.
• CNS effects: Lightheadedness, dizziness, and vertigo have been reported with oral minocycline; patients must be cautioned about performing tasks that require mental alertness (eg, operating machinery, driving). Symptoms may disappear with continued therapy and when the drug is discontinued.
• Hepatotoxicity: Serious liver injury, including irreversible drug-induced hepatitis and fulminant hepatic failure (sometimes fatal), have been reported with oral minocycline.
• Hypersensitivity/Skin reaction: Anaphylaxis, rash, erythema multiforme, Stevens Johnson syndrome or eosinophilia, fever, and organ failure including death (drug rash with eosinophilia and systemic symptoms [DRESS] syndrome), have been reported with oral minocycline; discontinue treatment immediately if DRESS syndrome is suspected.
• Intracranial hypertension: Intracranial hypertension (eg, headache, blurred vision, diplopia, vision loss, papilledema) has been associated with use of tetracyclines. Women of childbearing age who are overweight or have a history of intracranial hypertension are at greater risk. Concomitant use of isotretinoin (known to cause intracranial hypertension) and minocycline should be avoided. Intracranial hypertension typically resolves after discontinuation of treatment; however, permanent visual loss is possible. If visual symptoms develop during treatment, prompt ophthalmologic evaluation is warranted. Intracranial pressure can remain elevated for weeks after drug discontinuation; monitor patients until they stabilize.
• Metabolic effects: May be associated with increases in BUN secondary to antianabolic effects of tetracyclines.
• Photosensitivity: Photosensitivity has been reported with oral tetracyclines. Although not reported with topical minocycline, use skin protection, wear loose-fitting clothes that protect skin from sun exposure, and avoid or minimize exposure to natural or artificial sunlight. Discontinue use at first evidence of sunburn.
• Superinfection: Fungal or bacterial superinfection, including Clostridioides difficile–associated diarrhea (CDAD) and pseudomembranous colitis, has been reported with prolonged use of oral minocycline; CDAD has been observed >2 months post antibiotic treatment.
Special populations:
• Pediatric: Tissue hyperpigmentation, tooth enamel hypoplasia, or permanent tooth discoloration have been reported with oral tetracyclines, more common with long-term use, but observed with repeated, short courses. Use of tetracyclines should be avoided during tooth development (infancy and children ≤8 years of age) unless other drugs are not likely to be effective or are contraindicated.
Dosage form specific issues:
• Flammable contents: Foam contains flammable propellants. Avoid fire, flame, and smoking during and immediately following application.
Other warnings/precautions:
• Appropriate use: Acne: The American Academy of Dermatology acne guidelines generally recommend topical antibiotics be used in conjunction with other therapies (not as monotherapy) due to the risk of bacterial resistance (AAD [Zaenglein 2016]).
Zilxi (minocycline 1.5% topical foam): FDA approved May 2020; anticipated availability in the fourth quarter of 2020.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Foam, External, as hydrochloride:
Amzeeq: 4% (30 g) [contains cetostearyl alcohol, coconut oil (copra/cocos nucifera oil), soybean oil]
Zilxi: 1.5% (30 g) [contains cetostearyl alcohol, coconut oil (copra/cocos nucifera oil), soybean oil]
No
Foam (Amzeeq External)
4% (per gram): $19.40
Foam (Zilxi External)
1.5% (per gram): $19.40
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Topical: Not for oral, ophthalmic, or intravaginal use. Shake can well before use. Allow can to warm to room temperature before first use. Apply at approximately the same time each day ≥1 hour before bedtime. Do not bathe, shower, or swim for ≥1 hour after application. Avoid fire, flame, or smoking during or immediately following application.
Topical: Foam: For topical external use only; not for oral, ophthalmic, or intravaginal use. Prior to treatment, thoroughly wash affected area(s) with mild cleanser and pat dry. Allow product to reach room temperature prior to first use. Shake can well before use; express foam from can onto fingertips and then gently rub on acne-affected area(s). Apply at the same time each day, at least 1 hour before bedtime; do not bathe, shower, or swim for at least 1 hour after application. Avoid fire, flame, or smoking during or immediately following application.
Acne vulgaris: Foam 4% (Amzeeq): Topical treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in adults and pediatric patients ≥9 years of age.
Rosacea: Foam 1.5% (Zilxi): Topical treatment of inflammatory lesions of rosacea in adults.
Amzeeq may be confused with Amitiza, Belviq, Pristiq.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Aminolevulinic Acid (Systemic): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Systemic). Risk X: Avoid combination
Aminolevulinic Acid (Topical): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Topical). Risk C: Monitor therapy
Methoxsalen (Systemic): Photosensitizing Agents may enhance the photosensitizing effect of Methoxsalen (Systemic). Risk C: Monitor therapy
Porfimer: Photosensitizing Agents may enhance the photosensitizing effect of Porfimer. Risk C: Monitor therapy
Verteporfin: Photosensitizing Agents may enhance the photosensitizing effect of Verteporfin. Risk C: Monitor therapy
Minocycline crosses the placenta and may cause fetal harm following oral administration. The amount of minocycline available systemically is less following topical application than with oral use. As a class, tetracyclines should be avoided during pregnancy.
Refer to the Minocycline (Systemic) monograph for additional information.
It is not known if minocycline is present in breast milk following topical administration.
Minocycline is present in breast milk following oral administration. However, the amount of minocycline available systemically is less following topical application than with oral administration. Due to the potential for serious adverse reactions in the breastfed infant, breastfeeding is not recommended by the manufacturer.
Refer to the Minocycline (Systemic) monograph for additional information.
The mechanism of action of minocycline for the treatment of acne or rosacea is unknown.
Absorption: Topical: Acne: Steady-state reached after 6 days; pediatric patients (10 to <17 years of age) had a 2.4-fold higher Cmax and a 2.7-fold higher AUC than adult patients. Rosacea: Steady-state reached by day 1.
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