Dosing & Uses
Dosage Forms & Strengths
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
Acne Vulgaris
50-100 mg PO twice daily
Solodyn, Minolira (extended-release tablets): 1 mg/kg PO qDay
Administer therapy for 12 weeks
Extended-release tablets
Solodyn
- 45-49 kg: 45 mg qDay (1-0.92 mg/kg)
- 50-59 kg: 55 mg qDay (1.1-0.93 mg/kg)
- 60-71 kg: 65 mg qDay (1.08-0.92 mg/kg)
- 72-84 kg: 80 mg qDay (1.11-0.95 mg/kg)
- 85-96 kg: 90 mg qDay (1.06-0.94 mg/kg)
- 97-110 kg: 105 mg qDay (1.08-0.95 mg/kg)
- 111-125 kg: 115 mg qDay (1.04-0.92 mg/kg)
- 126-136 kg: 135 mg qDay (1.07-0.99 mg/kg)
Minolira
- 45-59 kg: 52.5 mg qDay (half of the 105-mg tab)
- 60-89 kg: 67.5 mg qDay (half of the 135-mg tab)
- 90-125 kg: 105 mg qDay
- 126-136 kg: 135 mg qDay
Purulent Cellulitis (Off-label)
Community acquired MRSA: 200 mg PO initially
Maintenance: 100 mg PO twice daily for 5-10 days
Chlamydial or Ureaplasma Urealyticum
Uncomplicated infection: 100 mg PO q12hr for at least 7 days
Gonococcal Infection
Uncomplicated infection in males (no anorectal infections or presence of urethritis: 200 mg PO initially)
Maintenance: 100 mg PO twice daily for at least 4 days
Uncomplicated gonococcal urethritis in men: 100 mg PO q12hr for 5 days
Meningococcal Carrier State
100 mg PO q12hr for 5 days
Urethral, Endocervical, or Rectal Infections
Caused by C. trachomatis or U. urealyticum (uncomplicated infection): 100 mg PO q12hr for 7 days
Mycobacterium marinum
100 mg PO q12hr for 6-8 weeks
Syphilis
200 mg PO initially, followed by 100 mg q12hr for 10-15 days
Rheumatoid Arthritis (Off-label)
100 mg PO twice daily
Infective Endocarditis
100 mg IV twice daily for at least 5 weeks
Infections, General Dosing
200 mg PO/IV initially, THEN 100 mg PO/IV q12hr; not to exceed 400 mg/day, OR
Alternatively, 200 mg PO initially, THEN 100 mg PO q12hr; OR 100-200 mg initially; THEN 50 mg PO q6hr
Dosage Modifications
Renal impairment: Reduce dose and/or frequency
Dosing Considerations
Susceptible organisms
- Acinetobacter baumannii, Actinomyces spp, Afipia felis, Bacteroides spp, Bartonella bacilliformis, Borrelia recurrentis, Brucella spp, Burkholderia cepacia, Klebsiella granulomatis, Campylobacter jejuni, Chlamydia spp, Clostridium spp, Coxiella burnetii, Eikenella corrodens, Escherichia coli, Entamoeba spp, Francisella tularensis, Haemophilus ducreyi, Legionella pneumophila, Leptospira interrogans, Listeria monocytogenes, Mycoplasma hominis, Mycoplasma pneumoniae, Neisseria meningitidis, Neisseria gonorrhoeae, Nocardia asteroides, Prevotella melaninogenica, Propionibacterium acnes, Rickettsiae, Shigella spp, MRSA, Streptococcus pneumoniae, Streptococcus pyogenes, Treponema pallidum, Ureaplasma urealyticum, Vibrio cholerae, Yersinia pestis, Yersinia enterocolitica, Yersinia pseudotuberculosis, mycobacteria other than tuberculosis
Sarcoidosis (Orphan)
Orphan indication sponsor
- Autoimmunity Research Foundation; Autoimmunity Research, Inc; Thousand Oaks, CA 91360
Dosage Forms & Strengths
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
Acne Vulgaris
<12 years: Safety and efficacy not established
Immediate-release products: 4 mg/kg PO initially (not to exceed 200 mg), THEN 2 mg/kg/day PO q12hr; not to exceed 400 mg/day
Solodyn, Minolira (extended-release tablets): 1 mg/kg PO qDay
Administer therapy for 12 weeks
Extended-release tablets
Solodyn
- 45-49 kg: 45 mg qDay (1-0.92 mg/kg)
- 50-59 kg: 55 mg qDay (1.1-0.93 mg/kg)
- 60-71 kg: 65 mg qDay (1.08-0.92 mg/kg)
- 72-84 kg: 80 mg qDay (1.11-0.95 mg/kg)
- 85-96 kg: 90 mg qDay (1.06-0.94 mg/kg)
- 97-110 kg: 105 mg qDay (1.08-0.95 mg/kg)
- 111-125 kg: 115 mg qDay (1.04-0.92 mg/kg)
- 126-136 kg: 135 mg qDay (1.07-0.99 mg/kg)
Minolira
- 45-59 kg: 52.5 mg qDay (half of the 105-mg tab)
- 60-89 kg: 67.5 mg qDay (half of the 135-mg tab)
- 90-125 kg: 105 mg qDay
- 126-136 kg: 135 mg qDay
C. trachomatis or U. urealyticum
100 mg PO q12hr for 7 days
Infections, General Dosing
≤8 years: Not recommended, unless unable to take other, alternate antibiotics
>8 years: 4 mg/kg PO/IV initially; not to exceed 200 mg; THEN 2 mg/kg PO/IV q12hr; not to exceed adult dose; not to exceed 100 mg PO/IV q12hr for 5-10 days
Dosing Considerations
Susceptible organisms
- Acinetobacter baumannii, Actinomyces spp, Afipia felis, Bacteroides spp, Bartonella bacilliformis, Borrelia recurrentis, Brucella spp, Burkholderia cepacia, Klebsiella granulomatis, Campylobacter jejuni, Chlamydia spp, Clostridium spp, Coxiella burnetii, Eikenella corrodens, Escherichia coli, Entamoeba spp, Francisella tularensis, Haemophilus ducreyi, Legionella pneumophila, Leptospira interrogans, Listeria monocytogenes, Mycoplasma hominis, Mycoplasma pneumoniae, Neisseria meningitidis, Neisseria gonorrhoeae, Nocardia asteroides, Prevotella melaninogenica, Propionibacterium acnes, Rickettsiae, Shigella spp, MRSA, Streptococcus pneumoniae, Streptococcus pyogenes, Treponema pallidum, Ureaplasma urealyticum, Vibrio cholerae, Yersinia pestis, Yersinia enterocolitica, Yersinia pseudotuberculosis, mycobacteria other than tuberculosis
Interactions
Interaction Checker
No Results

Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor

Adverse Effects
Frequency Not Defined
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
Postmarketing Reports
Anaphylaxis
Angioneurotic edema
Eosinophilia
Pneumonitis
Nephritis
Myocarditis
Swelling of the face
Lymphadenopathy
Warnings
Contraindications
Documented hypersensitivity
Cautions
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
Intracranial hypertension (pseudotumor cerebri) has been associated with use of tetracyclines including minocycline; avoid concomitant use of isotretinoin and minocycline; isotretinoin is also known to cause pseudotumor cerebri; although intracranial hypertension typically resolves after discontinuation of treatment, risk of permanent visual loss exists; seek ophthalmologic evaluation if visual disturbance occurs during treatment; since intracranial pressure can remain elevated for weeks after drug cessation, monitor until patient stabilizes
A decrease in fibula growth rate observed in premature human infants given oral tetracycline in doses of 25 mg/kg q6hr
Hyperpigmentation may occur in nails, bone, skin (including scars), eyes, sclerae, thyroid, oral cavity, visceral tissue, and heart valves
Increased risk of ergotism when coadministered with ergot alkaloids
Sporadic cases of serum sickness-like reaction have presented shortly after oral minocycline use, manifested by fever, rash, arthralgia, lymphadenopathy and malaise
Pregnancy & 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
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Infection: Inhibits protein synthesis and thus bacterial growth by binding to 30S and possibly 50S ribosomal subunits of susceptible bacteria
Rheumatoid arthritis: Mechanism not fully understood; may play immunomodulatory, anti-inflammatory, or chondroprotective effects; thought to be a potent inhibitor of metalloproteinases, which are active in rheumatoid arthritis joint destruction
Absorption
Absorption: 90-100%
Peak plasma time: 1-4 hr (immediate release); 3.5-4 hr (extended release tablet)
Peak plasma concentration (200 mg dose): 2-3.5 mcg/mL
Distribution
Majority deposits for extended periods in fat; crosses placenta; enters breast milk
Protein bound: 70-75%
Metabolism
Liver (partially)
Elimination
Half-life, elimination: 15-23 hr (PO/IV)
Excretion: Feces and urine
Administration
Incompatibilities
IV solutions: Calcium containing solutions (precipitant may form, particularly with alkaline solutions)
Y-site: Adrenocorticotropic hormone (ACTH), aminophylline, amobarbital sodium, amphotericin B, bicarbonate infusion mixtures, calcium gluconate or chloride, carbenicillin, cephalothin sodium, cefazolin sodium, chloramphenicol succinate, colistin sulfate, heparin sodium, hydrocortisone sodium succinate, iodine sodium, methicillin sodium, novobiocin, penicillin, pentobarbital, phenytoin sodium, polymyxin, prochlorperazine, sodium ascorbate, sulfadiazine, sulfisoxazole, thiopental sodium, vitamin K (sodium bisulfate or sodium salt), whole blood
Compatibilities
IV solutions: 0.9% NaCl, dextrose solutions, dextrose and NaCl solutions, Ringer Injection, or Lactated Ringer
IV Preparation
Reconstitute cryodessicated powder with 5 mL sterile water for injection
Immediately dilute further with 500-1000 mL of 0.9% NaCl, dextrose solutions, dextrose and NaCl solutions, Ringer Injection, or Lactated Ringer
Reformulated Minocin IV
- Allows for dilution with lower fluid volume
- After vial reconstitution, dilute further with 100-1000 mL of 0.9% NaCl, dextrose solutions, dextrose and NaCl solutions, or 250-1000 mL of Ringer or Lactated Ringer injections
IV Administration
Avoid rapid IV infusion
Infuse over one hour
Not to exceed 400mg in 24 hours
Oral Administration
May take with or without food
Ingestion of food along with may help reduce the risk of esophageal irritation and ulceration
Extended-release tablets (ie, Solodyn) or capsules: Swallow whole without chewing, crushing, or splitting
Extended-release tablet (Minolira): These tablets are scored and intended to split to give precise dose
Storage
Unreconstituted vial: Store at controlled room temperature 20-25 degrees C (68-77 degrees F)
Final dilutions: Store at controlled room temperature or refrigerated for up to 24 hr
May be stored at room temperature for up to 4 hours
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Formulary
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