Dosing & Uses
Dosage Forms & Strengths
topical foam
- 1.5% (15mg/g) (Zilxi)
- 4% (40mg/g) (Amzeeq)
Acne Vulgaris
Amzeeq only
Indicated for treatment of inflammatory lesions of non-nodular moderate-to-severe acne vulgaris
Apply to acne-affected areas qHS; repeat application until all affected areas are treated
Apply additional amounts of topical foam if acne is present on other parts of the patient’s body (neck, shoulders, arms, back, or chest)
Rosacea
Zilxi only
Indicated to treat inflammatory lesions of rosacea in adults
Apply small amount (eg, cherry-sized) as thin layer over all facial areas; additional foam may be used as needed to ensure entire face is treated
Dosing Considerations
Limitations of use
- Has not been evaluated in treatment of infections
- To reduce development of drug-resistant bacteria and to maintain effectiveness of other antibacterial drugs, use only as indicated
Dosage Forms & Strengths
topical foam
- 4% (40mg/g) (Amzeeq)
Acne Vulgaris
Amzeeq only
Indicated for treatment of inflammatory lesions of non-nodular moderate-to-severe acne vulgaris in patients aged ≥9 years
<9 years: Safety and efficacy not established
≥9 years
- Apply to acne-affected areas qHS; repeat application until all affected areas are treated
- Apply additional amounts of topical foam if acne is present on other parts of the patient’s body (neck, shoulders, arms, back, or chest)
Dosing Considerations
Limitations of use
- Has not been evaluated in treatment of infections
- To reduce development of drug-resistant bacteria and to maintain effectiveness of other antibacterial drugs, use only as indicated
Adverse Effects
>10%
Mild (Amzeeq)
- Erythema (14.2%)
- Hyperpigmentation (12.4%)
Mild (Zilxi)
- Telangiectasia (61%)
- Flushing/blushing (39%)
- Erythema (36.2%)
- Dryness (23.9%)
- Hyperpigmentation (22.5%)
- Itching (20%)
- Skin peeling (16.1%)
- Burning/stinging (13.3%)
Moderate (Zilxi)
- Telangiectasia (18.8%)
- Erythema (18.3%)
1-10%
Mild (Amzeeq)
- Dryness (6.8%)
- Itching (5.1%)
- Skin peeling (3.2%)
Moderate (Amzeeq)
- Hyperpigmentation (2.8%)
- Erythema (1.5%)
Moderate (Zilxi)
- Flushing/blushing (9.6%)
- Dryness (4%)
- Itching (3.3%)
- Burning/stinging (2.8%)
- Hyperpigmentation (2.8%)
- Skin peeling (1.9%)
<1%
Moderate (Amzeeq)
- Itching (0.8%)
- Dryness (0.6%)
- Skin peeling (0.2%)
Severe (Amzeeq)
- Hyperpigmentation (0.1%)
- Itching (0.1%)
Severe (Zilxi)
- Flushing/blushing (0.9%)
- Erythema (0.7%)
- Dryness (0.1%)
- Skin peeling (0.1%)
Warnings
Contraindications
Hypersensitivity to any tetracycline or other ingredient
Cautions
Flammable; caution patient to avoid fire, flame, and smoking during and immediately following application; do not puncture or incinerate containers
Adverse effects associated with oral minocycline
- Systemic absorption is low from topical minocycline; however, consider adverse effects associated with oral minocycline/tetracyclines listed below
- May inhibit fetal bone growth when administered orally during pregnancy
- May inhibit bone growth in children aged <9 years
- Tetracyclines may cause permanent tooth discoloration during tooth development (eg, second/third pregnancy trimesters, infancy, childhood up to age 8 yr); enamel hypoplasia also reported
- As with most antibacterials, may cause Clostridium difficile-associated diarrhea by altering normal GI flora
- Serious liver injury, including irreversible hepatitis and fulminant hepatic failure (including fatalities), reported
- Antianabolic action of the tetracyclines may increase BUN
- CNS effects (eg, light-headedness, dizziness, vertigo) reported
- Intracranial hypertension reported; symptoms include headache, blurred vision, diplopia, and vision loss
- Autoimmune syndromes reported
- Photosensitivity manifested by exaggerated sunburn reaction may occur
- Cases of anaphylaxis, serious skin reactions (eg, Stevens-Johnson syndrome), erythema multiforme, and DRESS (drug rash with eosinophilia and systemic sympotoms) syndrome reported
- Skin hyperpigmentation may appear; may induce hyperpigmentation in many organs, including nails, bone, skin, eyes, thyroid, visceral tissue, oral cavity, sclerae, and heart valves
- Bacterial resistance to tetracyclines may develop
- Superinfection and potential for microbial overgrowth, including fungi, reported
Drug interaction overview
- Tetracyclines have been shown to depress plasma prothrombin activity; patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage
- Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracycline-class drugs in conjunction with penicillin
- False elevations of urinary catecholamine levels may occur owing to interference with the fluorescence test
Pregnancy & Lactation
Pregnancy
Available data with topical minocycline use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes
Systemic absorption in humans is low following once-daily topical administration for 21 days
Because of low systemic exposure, it is not expected that maternal use of topical minocycline will result in significant fetal exposure
Tetracycline-class drugs may cause permanent discoloration of teeth and reversible inhibition of bone growth when administered orally during pregnancy
Lactation
Tetracycline-class drugs, including minocycline, are present in breast milk following oral administration
Unknown whether minocycline is present in human milk after topical administration to breastfeeding women
There are no data on the effects of minocycline on milk production
Owing to the potential for serious adverse reactions, advise patients that breastfeeding is not recommended during treatment
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Precise mechanism of action by which topical minocycline exerts its affects for acne is unknown
Absorption
Peak plasma concentration (day 21): 1.3 ng/mL
AUC (day 21): 23 ng⋅h/mL
Steady-state reached: Day 6
Administration
Topical Administration
For topical use only; not for oral, ophthalmic, or intravaginal use
Shake can well and measure small amount of topical foam (eg, cherry-sized amount) from can onto fingertips and rub into acne-affected areas
Repeat this process until all acne-affected areas are treated
Apply at approximately the same time each day at least 1 hr before bedtime
Do not to bathe, shower, or swim for at least 1 hr after application
Foam may stain fabric
Storage
Store at 2-8ºC (36-46ºF) until dispensed to the patient
Once dispensed, store foam at room temperature <25ºC (77ºF) for 90 days
Do not refrigerate after dispensing
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Formulary
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