Minocycline
Generic Name: minocycline
Brand Names:
Zilxi
11 DESCRIPTION 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 monohydrochloride. The structural formula is represented below: C 23 H 27 N 3 O 7 •HClM. W. 493.94 Each gram of ZILXI contains micronized 15 mg minocycline equivalent to 16 mg minocycline hydrochloride in a yellow suspension foam.
Overview
11 DESCRIPTION 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 monohydrochloride. The structural formula is represented below: C 23 H 27 N 3 O 7 •HClM. W. 493.94 Each gram of ZILXI contains micronized 15 mg minocycline equivalent to 16 mg minocycline hydrochloride in a yellow suspension foam.
Uses
1 INDICATIONS AND USAGE ZILXI is indicated for the treatment of inflammatory lesions of rosacea in adults [see Clinical Studies ( 14 )] . 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, ZILXI should be used only as indicated [see Warnings and Precautions ( 5.14 )] . ZILXI is a tetracycline-class drug indicated for the treatment of inflammatory lesions of rosacea in adults. ( 1 ) Limitations of Use This formulation of minocycline has not been evaluated in the treatment of infections.
Dosage
2 DOSAGE 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 applied as a thin layer over all areas of the face. Additional ZILXI foam may be used as needed to ensure the entire face is treated. 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. Apply ZILXI over all areas of the face once daily. ZILXI should be gently rubbed into the skin. ( 2 )
Side Effects
6 ADVERSE REACTIONS The most commonly observed adverse reaction (incidence ≥1%) is diarrhea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Journey Medical Corporation at 1-855-531-1859 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In three (two Phase 3 and one Phase 2) multicenter, randomized, double-blind, vehicle-controlled trials, adult subjects applied ZILXI or vehicle once daily for 12 weeks. A total of 1,087 subjects were treated with ZILXI and 591 with vehicle.
Interactions
7 DRUG INTERACTIONS • Patients on anticoagulant therapy may require downward adjustment of their anticoagulant dosage. ( 7.1 ) • Penicillin: avoid coadministration. ( 7.2 ) 7.1 Anticoagulants Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage. 7.2 Penicillin Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracycline-class drugs in conjunction with penicillin. 7.3 Drug/Laboratory Test Interactions False elevations of urinary catecholamine levels may occur due to interference with the fluorescence test.
Warnings
5 WARNINGS AND PRECAUTIONS • The propellant in ZILXI is flammable. Instruct the patient to avoid fire, flame, and smoking during and immediately following application. ( 5.1 ) • The use of tetracycline-class of drugs orally during the second and third trimesters of pregnancy, infancy and childhood up to the age of 8 years may cause permanent discoloration of the teeth (yellow-gray-brown) and reversible inhibition of bone growth. ( 5.2 , 5.3 , 5.4 , 8.4 ) • If Clostridioides difficile associated diarrhea occurs, discontinue ZILXI. ( 5.5 ) • If liver injury is suspected, discontinue ZILXI. ( 5.6 ) • If renal impairment exists, oral minocycline doses may need to be adjusted to avoid excessive systemic accumulations of the drug and possible liver toxicity. 4 CONTRAINDICATIONS This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines or any other ingredients in ZILXI. This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines or any of the ingredients in ZILXI. ( 4 )
Pregnancy
8.1 Pregnancy Risk Summary Available data with ZILXI 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 of ZILXI in humans is low following once daily topical administration of ZILXI under maximal clinical use conditions [see Clinical Pharmacology ( 12.3 )] . Because of low systemic exposure, it is not expected that maternal use of ZILXI will result in significant fetal exposure to the drug.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied ZILXI ® (minocycline) topical foam, 1.5% is a yellow suspension supplied in a pressurized aluminum aerosol container (can).
Frequently Asked Questions
What is Minocycline used for?▼
1 INDICATIONS AND USAGE ZILXI is indicated for the treatment of inflammatory lesions of rosacea in adults [see Clinical Studies ( 14 )] . 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, ZILXI should be used only as indicated [see Warnings and Precautions ( 5.14 )] . ZILXI is a tetracycline-class drug indicated for the treatment of inflammatory lesions of rosacea in adults. ( 1 ) Limitations of Use This formulation of minocycline has not been evaluated in the treatment of infections.
What are the side effects of Minocycline?▼
6 ADVERSE REACTIONS The most commonly observed adverse reaction (incidence ≥1%) is diarrhea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Journey Medical Corporation at 1-855-531-1859 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In three (two Phase 3 and one Phase 2) multicenter, randomized, double-blind, vehicle-controlled trials, adult subjects applied ZILXI or vehicle once daily for 12 weeks. A total of 1,087 subjects were treated with ZILXI and 591 with vehicle.
Can I take Minocycline during pregnancy?▼
8.1 Pregnancy Risk Summary Available data with ZILXI 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 of ZILXI in humans is low following once daily topical administration of ZILXI under maximal clinical use conditions [see Clinical Pharmacology ( 12.3 )] . Because of low systemic exposure, it is not expected that maternal use of ZILXI will result in significant fetal exposure to the drug.
What are the important warnings for Minocycline?▼
5 WARNINGS AND PRECAUTIONS • The propellant in ZILXI is flammable. Instruct the patient to avoid fire, flame, and smoking during and immediately following application. ( 5.1 ) • The use of tetracycline-class of drugs orally during the second and third trimesters of pregnancy, infancy and childhood up to the age of 8 years may cause permanent discoloration of the teeth (yellow-gray-brown) and reversible inhibition of bone growth. ( 5.2 , 5.3 , 5.4 , 8.4 ) • If Clostridioides difficile associated diarrhea occurs, discontinue ZILXI. ( 5.5 ) • If liver injury is suspected, discontinue ZILXI. ( 5.6 ) • If renal impairment exists, oral minocycline doses may need to be adjusted to avoid excessive systemic accumulations of the drug and possible liver toxicity. 4 CONTRAINDICATIONS This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines or any other ingredients in ZILXI. This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines or any of the ingredients in ZILXI. ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.