minocycline topical (Rx)

Brand and Other Names:Amzeeq, Zilxi
  • Print

Dosing & Uses

AdultPediatric

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
Next:

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%)
Previous
Next:

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

Previous
Next:

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.

Previous
Next:

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

Previous
Next:

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

Previous
Next:

Images

Previous
Next:

Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
  • Manage and view all your plans together – even plans in different states.
  • Compare formulary status to other drugs in the same class.
  • Access your plan list on any device – mobile or desktop.

The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
Additional Offers
Email to Patient

From:

To:

The recipient will receive more details and instructions to access this offer.

By clicking send, you acknowledge that you have permission to email the recipient with this information.

Email Forms to Patient

From:

To:

The recipient will receive more details and instructions to access this offer.

By clicking send, you acknowledge that you have permission to email the recipient with this information.

Previous
Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.