Classes
DEA Class; Rx
Common Brand Names; Dynacin, Minocin, Minocin Kit, Minolira, Solodyn, Ximino
- Tetracyclines
Minocycline dental (Rx)
- Classes: Antimicrobials, Dental
Minocycline topical (Rx)
- Classes: Acne Agents, Topical
Description
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
Indications
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
Contraindications
Documented hypersensitivity
Hypersensitivity to any tetracycline or other ingredient
Acutely abscessed periodontal pockets
Adverse Effects
- 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%)
Warnings
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 and Lactation
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
Maximum Dosage
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.
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.
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.
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.
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.
Safety and efficacy have not been established.
How supplied
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)
