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Minocycline

    Brands

    DEA Class; Rx

    Common Brand Names; Dynacin, Minocin, Minocin Kit, Minolira, Solodyn, Ximino

    • Tetracyclines

    Minocycline dental (Rx)

    Brand and Other Names:Arestin
    • Classes: Antimicrobials, Dental

    Minocycline topical (Rx)

    Brand and Other Names: Amzeeq, Zilxi
    • Classes: Acne Agents, Topical

    Tetracycline antibiotic available in oral, intravenous, periodontal, and topical formulations
    Used to treat acne vulgaris, rosacea, rickettsial infections, cholera, respiratory tract infections, urinary tract infections, sexually transmitted diseases, periodontitis
    Associated with permanent tooth discoloration

    Indicated for Acne Vulgaris

    Indicated for the treatment of Purulent Cellulitis (Off-label)

    Indicated for Chlamydial or Ureaplasma Urealyticum, Gonococcal Infection, Meningococcal Carrier State, Urethral, Endocervical, or Rectal Infections, Mycobacterium marinum, Syphilis, Rheumatoid Arthritis (Off-label), Infective Endocarditis.

    Indicated for Periodontitis

    Indicated for treatment of inflammatory lesions of non-nodular moderate-to-severe acne vulgaris

    Indicated to treat inflammatory lesions of rosacea in adults

    Dyspepsia

    Mouth ulceration

    Mucous membrane disorder

    Pharyngitis

    Documented hypersensitivity

    Hypersensitivity to any tetracycline or other ingredient

    Acutely abscessed periodontal pockets

    • To report suspected adverse reactions, contact Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
    • Discoloration of teeth (in children)
    • Vestibular symptoms (>30%)
    • Pericarditis
    • Myocarditis
    • Vasculitis
    • Angioedema
    • Alopecia
    • Erythema nodosum
    • Erythematous rash
    • Exfoliative dermatitis
    • Pruritus
    • Toxic epidermal necrolysis
    • Urticaria
    • Dizziness
    • Fever
    • Fatigue
    • Somnolence
    • Angioedema
    • Hyperpigmentation of nails
    • Pigmentation of skin and mucous membranes
    • Thyroid dysfunction
    • Thyroid discoloration
    • Thyroid cancer
    • Vulvovaginitis
    • Hemolytic anemia
    • Neutropenia
    • Thrombocytopenia
    • Agrunolocytosis
    • Pancytopenia
    • Hepatic cholestasis
    • Hepatitis
    • Hyperbilirubinemia
    • Jaundice
    • CNS effects
    • Clostridium difficile diarrhea
    • Erythema (14.2%)
    • Hyperpigmentation (12.4%)

    Caution in significant renal impairment (may lead to azotemia, hyperphosphatemia, and acidosis; monitor BUN)

    Adjust dose if renal impairment occurs

    Anaphylaxis reported; discontinue use and institute supportive therapy

    Prolonged use may result in fungal or bacterial superinfection

    Lupus, hepatitis, and vasculitis autoimmune syndromes reported with use; discontinue if lupus symptoms occur and assess liver function tests; ANA and CBC

    Discontinue therapy if pseudomembranous colitis occurs

    Risk of vestibular reactions

    Caution in hepatic impairment; discontinue if liver injury occurs

    Photosensitivity may occur with prolonged exposure to sunlight or tanning equipment; use skin protection and avoid prolonged exposure to sunlight

    Reduce dose in renal impairment; consider drug serum level determinations in prolonged therapy

    Tetracycline use during tooth development (last half of pregnancy through age 8 years) can cause tooth enamel hypoplasia or permanent teeth discoloration; more common with long-term use and with repeated, short courses; during pregnancy, may retard skeletal development and reduce bone growth

    Fanconi-like syndrome may occur with outdated tetracyclines

    Lightheadedness and vertigo may occur; use caution when performing tasks that require mental alertness or operating heavy machinery

    May increase BUN secondary to antianabolic effects

    Cases of drug rash with eosinophilia and systemic symptoms (DRESS) reported, some fatal; discontinue immediately

    May cause tooth discoloration in utero

    Flammable; caution patient to avoid fire, flame, and smoking during and immediately following application; do not puncture or incinerate containers

    Pregnancy category: D

    Lactation: Enters breast milk, some manufacturers say do not nurse; however AAP considers nursing compatible due to calcium chelation of drug and prevention of its absorption; long-term safety of prolonged exposure unknown

    Adults

    Intravenous formulation: 400 mg/day IV.
    Immediate-release oral formulations: 300 mg PO on day 1, then 200 mg/day PO.
    Extended-release oral formulations: 1 mg/kg/day (Max: 135 mg/day) PO.
    Subgingival formulation: Up to 122 unit-dose cartridges have been used in a single visit.
    Topical foam: 1 application/day.

    Geriatric

    Intravenous formulation: 400 mg/day IV.
    Immediate-release oral formulations: 300 mg PO on day 1, then 200 mg/day PO.
    Extended-release oral formulations: 1 mg/kg/day (Max: 135 mg/day) PO.
    Subgingival formulation: Up to 122 unit-dose cartridges have been used in a single visit.
    Topical foam: 1 application/day.

    Adolescents

    Intravenous formulation: 6 mg/kg/day (Max: 300 mg/day) IV on day 1, then 4 mg/kg/day (Max: 200 mg/day) IV.
    Immediate-release oral formulations: 6 mg/kg/day (Max: 300 mg/day) PO on day 1, then 4 mg/kg/day (Max: 200 mg/day) PO.
    Extended-release oral formulations: 1 mg/kg/day (Max: 135 mg/day) PO.
    Subgingival formulation: Safety and efficacy have not been established.
    Topical foam: 1 application/day.

    Children

    12 years:
    Intravenous formulation: 6 mg/kg/day (Max: 300 mg/day) IV on day 1, then 4 mg/kg/day (Max: 200 mg/day) IV.
    Immediate-release oral formulations: 6 mg/kg/day (Max: 300 mg/day) PO on day 1, then 4 mg/kg/day (Max: 200 mg/day) PO.
    Extended-release oral formulations: 1 mg/kg/day (Max: 135 mg/day) PO.
    Subgingival formulation: Safety and efficacy have not been established.
    Topical foam: 1 application/day.
     
    9 to 11 years:
    Intravenous formulation: 6 mg/kg/day (Max: 300 mg/day) IV on day 1, then 4 mg/kg/day (Max: 200 mg/day) IV.
    Immediate-release oral formulations: 6 mg/kg/day (Max: 300 mg/day) PO on day 1, then 4 mg/kg/day (Max: 200 mg/day) PO.
    Extended-release oral formulations: Safety and efficacy have not been established.
    Subgingival formulation: Safety and efficacy have not been established.
    Topical foam: 1 application/day.
     
    8 years:
    Intravenous formulation: 6 mg/kg/day (Max: 300 mg/day) IV on day 1, then 4 mg/kg/day (Max: 200 mg/day) IV.
    Immediate-release oral formulations: 6 mg/kg/day (Max: 300 mg/day) PO on day 1, then 4 mg/kg/day (Max: 200 mg/day) PO.
    Extended-release oral formulations: Safety and efficacy have not been established.
    Subgingival formulation: Safety and efficacy have not been established.
    Topical foam: Safety and efficacy have not been established.
     
    1 to 7 years:
    Intravenous formulation: Safety and efficacy have not been established; however, doses up to 6 mg/kg/day IV on day 1, then 4 mg/kg/day IV have been used off-label.
    Immediate-release oral formulations: Safety and efficacy have not been established; however, doses up to 6 mg/kg/day PO on day 1, then 4 mg/kg/day PO have been used off-label.
    Extended-release oral formulations: Safety and efficacy have not been established.
    Subgingival formulation: Safety and efficacy have not been established.
    Topical foam: Safety and efficacy have not been established.

    Infants

    Intravenous formulation: Safety and efficacy have not been established; however, doses up to 6 mg/kg/day IV on day 1, then 4 mg/kg/day IV have been used off-label.
    Immediate-release oral formulations: Safety and efficacy have not been established; however, doses up to 6 mg/kg/day PO on day 1, then 4 mg/kg/day PO have been used off-label.
    Extended-release oral formulations: Safety and efficacy have not been established.
    Subgingival formulation: Safety and efficacy have not been established.
    Topical foam: Safety and efficacy have not been established.

    Neonates

    Safety and efficacy have not been established.

    Minocycline hydrochloride

    tablet/capsule

    • 50mg
    • 75mg
    • 100mg

    tablet, extended-release

    • 45mg (Solodyn)
    • 55mg (Solodyn)
    • 65mg (Solodyn)
    • 80mg (Solodyn)
    • 90mg (Solodyn)
    • 105mg (Minolira, Solodyn)
    • 135mg (Minolira, Solodyn)

    injection, intravenous

    • 100mg/vial

    cartridge

    • 1mg

    topical foam

    • 1.5% (15mg/g) (Zilxi)
    • 4% (40mg/g) (Amzeeq)