ZILXI 15 mg/g

Minocycline · AEROSOL, FOAM · Journey Medical Corporation

No Recall History

Plain English

ZILXI is a aerosol, foam containing minocycline at 15 mg/g, taken topical. Manufactured by Journey Medical Corporation.

Key Facts

Brand Name: ZILXI
Generic Name: Minocycline
NDC Code (Product): 69489-212
Manufacturer: Journey Medical Corporation
Strength: 15 mg/g
Dosage Form: AEROSOL, FOAM
Route: TOPICAL
Marketing Status
Application #: NDA213690
Marketing Start: 10/01/2022

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective1,917 reports

off label use1,421 reports

nausea1,038 reports

pain994 reports

arthralgia966 reports

fatigue920 reports

drug intolerance881 reports

rash877 reports

drug hypersensitivity876 reports

rheumatoid arthritis845 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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. 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 ( 1 ).

Dosage & Administration

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 )

Contraindications

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 )

Drug 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.

Adverse Reactions

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. The majority of subjects were White (97%) and female (70%). Approximately 67% were non-Hispanic/Latino. The mean age was 50.0 years and ages ranged from 18 to 86 years. The most common adverse reaction reported by ≥1% of subjects treated with ZILXI and more frequently than in subjects treated with vehicle was diarrhea (1% vs. 0%), respectively. During the two Phase 3 trials, local tolerability evaluations were cond…

Frequently Asked Questions

What is ZILXI used for?

ZILXI contains Minocycline. It is a aerosol, foam taken topical. Consult your doctor for specific uses.

Is ZILXI a controlled substance?

ZILXI is not classified as a controlled substance by the DEA.

What is the generic name for ZILXI?

The generic name for ZILXI is Minocycline. There are 12 other brand versions of Minocycline.

What is the NDC code for ZILXI 15 mg/g?

The NDC (National Drug Code) for ZILXI 15 mg/g is 69489-212, listed by Journey Medical Corporation.

Product NDC

69489-212

Package NDC

69489-212-03

Other Minocycline Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)