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Generic Name
Minocycline
Brand Names
Amzeeq, Arestin, Emrosi, Minocin, ZILXI
FDA approval date: December 30, 1991
Classification: Tetracycline-class Drug
Form: Injection, Aerosol, Tablet, Powder, Capsule
What is Amzeeq (Minocycline)?
AMZEEQ is indicated for the topical treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in adults and pediatric patients 9 years of age and older. Limitations of Use This formulation of minocycline has not been evaluated in the treatment of infections. To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, AMZEEQ should be used only as indicated [ see Warnings and Precautions.
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Brand Information
AMZEEQ (Minocycline)
1INDICATIONS AND USAGE
AMZEEQ is indicated for the topical treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in adults and pediatric patients 9 years of age and older [
Limitations of Use
This formulation of minocycline has not been evaluated in the treatment of infections. To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, AMZEEQ should be used only as indicated [
2DOSAGE AND ADMINISTRATION
For topical use only, not for oral, ophthalmic or intravaginal use [
After shaking the can well, a small amount of topical foam (e.g. a cherry-sized amount) should be expressed from the can onto the fingertips of the hand and then rubbed into acne-affected parts of the face. This should be repeated as needed until all acne-affected parts of the face are treated. If acne is present on other parts of the patient’s body (neck, shoulders, arms, back or chest), additional amounts of topical foam should also be applied to these areas. The topical foam should be applied at approximately the same time each day at least 1 hour before bedtime. The patient should not bathe, shower or swim for at least 1 hour after application of the product.
3DOSAGE FORMS AND STRENGTHS
Topical foam, 4%
Each gram of AMZEEQ contains 40 mg of minocycline equivalent to 43 mg of minocycline hydrochloride and is supplied as a yellow suspension in a pressurized aluminum aerosol container (can).
4CONTRAINDICATIONS
This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines or any other ingredients within AMZEEQ.
5DESCRIPTION
Minocycline hydrochloride, a semi-synthetic derivative of tetracycline, is [4S‑ (4α,4aα,5aα,12aα)]-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a‑ tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide mono hydrochloride. The structural formula is represented below:
C
Each gram of AMZEEQ contains micronized minocycline 40 mg equivalent to 43 mg minocycline hydrochloride in a yellow suspension foam.
In addition, the 4% AMZEEQ topical foam contains the following inactive ingredients: soybean oil, coconut oil, light mineral oil, cyclomethicone, cetostearyl alcohol, stearic acid, myristyl alcohol, hydrogenated castor oil, white wax (beeswax), stearyl alcohol, docosanol. AMZEEQ topical foam is dispensed from an aluminum container (can) pressurized with propellant (butane + isobutane + propane).
6CLINICAL STUDIES
The safety and efficacy of AMZEEQ was assessed in three 12-week, multicenter, randomized, double-blind, vehicle-controlled studies (Study 1 [NCT02815267], Study 2 [NCT02815280], and Study 3 [NCT03271021]) in subjects with moderate to severe acne vulgaris. Efficacy was assessed in a total of 2,418 subjects 9 years of age and older. AMZEEQ or its vehicle were applied once daily for 12 weeks; no other topical or systemic medication affecting the course of acne vulgaris was permitted for use during these studies.
Subjects were required to have an inflammatory and non-inflammatory lesion count in the range 20-50 lesions and 25-100 lesions respectively, and an Investigator Global Assessment (IGA) score of 3 (“moderate”) or 4 (“severe”) at baseline.
Overall, 74% were Caucasian and 61% were female. Forty-two (2%) subjects were 9 to 11 years of age, 1,139 (47%) subjects were 12 to 17 years of age, and 1,237 (51%) subjects were 18 years or older. At baseline, subjects had a mean inflammatory lesion count of 31.2 and a mean non-inflammatory lesion count of 49.3. Additionally, approximately 85% of subjects had an IGA score of 3 (“moderate”).
The co-primary efficacy endpoints were the absolute change from baseline in inflammatory lesion counts at Week 12 and the proportion of subjects with treatment success at Week 12, defined as an IGA score of 0 (“clear”) or 1 (“almost clear”), and at least a two-grade improvement (decrease) from baseline at Week 12. The efficacy results are presented in
7HOW SUPPLIED/STORAGE AND HANDLING
How Supplied
AMZEEQ
NDC 69489-201-30 30 g Can
Storage
AMZEEQ must be stored at 2ºC - 8ºC (36ºF - 46ºF) until dispensed to the patient.
Once dispensed, the patient is to store AMZEEQ at room temperature below 25ºC (77ºF) for 90 days. Do not store in the refrigerator.
Handling
Allow the can to warm to room temperature before first use.
Shake can well before use.
WARNING: Flammable. Avoid fire, flame, or smoking during and immediately following application. Contents under pressure. Do not puncture or incinerate. Do not expose to heat or temperatures above 49
8PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
Inform patients using AMZEEQ (minocycline) topical foam, 4% of the following information and instructions:
Flammability
The propellant in AMZEEQ is flammable. Instruct the patient to avoid fire, flame, and smoking during and immediately following application.
Tooth Discoloration
Advise caregivers of pediatric patients that AMZEEQ may cause permanent discoloration of deciduous and permanent teeth during tooth development (generally up to the age of 8 years) based on observations with oral tetracycline.
Lactation
Advise women that breastfeeding is not recommended during AMZEEQ therapy.
Tissue Hyperpigmentation
Inform patients that AMZEEQ may cause discoloration of skin, scars, teeth or gums based on observations with oral minocycline.
Clostridioides difficileAssociated Diarrhea
Advise patients that
Hepatotoxicity
Inform patients about the possibility of hepatotoxicity reported with oral minocycline. Advise patients to seek medical advice if they experience symptoms or signs of hepatotoxicity, including loss of appetite, tiredness, diarrhea, jaundice, increased bleeding tendencies, confusion, and sleepiness.
Central Nervous System Effects
Inform patients that central nervous system adverse reactions including dizziness or vertigo have been reported with oral minocycline therapy. Caution patients about driving vehicles or using hazardous machinery if they experience such symptoms while on AMZEEQ.
Intracranial Hypertension
Inform patients that intracranial hypertension can occur with minocycline therapy. Advise patients to seek medical attention if they develop unusual headache, visual symptoms, such as blurred vision, diplopia, and vision loss.
Photosensitivity
Inform patients that photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking oral tetracyclines, including minocycline. Advise patients to minimize or avoid exposure to natural or artificial UV light (tanning beds or UVA/B treatment) while using AMZEEQ. Discuss other sun protection measures, if patients need to be outdoors while using AMZEEQ. Advise patients to discontinue treatment at the first evidence of sunburn.
Autoimmune Syndromes
Inform patients that autoimmune syndromes, including drug-induced lupus-like syndrome, autoimmune hepatitis, vasculitis and serum sickness have been observed with oral tetracycline-class drugs, including minocycline. Symptoms may be manifested by arthralgia, fever, rash and malaise. Advise patients who experience such symptoms to stop the drug immediately and seek medical help.
Other Information
AMZEEQ should be applied exactly as directed.
AMZEEQ may stain fabric.
Manufactured by: ASM Aerosol-Service AG, Mohlin, Switzerland
AMZ-P01-R01
AMZEEQ is a registered trademark of Journey Medical Corporation
9PACKAGE/LABEL PRINCIPAL DISPLAY PANEL - 30g Trade (69489-201-30)
AMZEEQ Trade Label
NDC 69489-
amzeeq
(minocycline)
For topical use only, not for oral, ophthalmic or intravaginal use
Rx only
[logo -Journey Medical Corporation]
30 g
NDC 69489-
amzeeq
(minocycline)
For topical use only,
not for oral, ophthalmic
or intravaginal use
Rx only
[logo -Journey Medical Corporation]
30 g
10PACKAGE/LABEL PRINCIPAL DISPLAY PANEL - 3 g Sample (69489-201-03)
AMZEEQ Sample Labels
NDC 69489-
Physician Sample Not for Sale
amzeeq
(minocycline)
For topical use only, not for oral,
ophthalmic or intravaginal use
Rx only
[logo -Journey Medical Corporation]
3 g
NDC 69489-
Physician Sample
Not for Sale
amzeeq
(minocycline)
For topical use only,
not for oral, ophthalmic
or intravaginal use
Rx only
[logo -Journey Medical Corporation]
3 g
