minocycline

Minocycline belongs to thetetracyclineclass of antibiotics, used to treat a wide variety ofbacterial infections.Tetracyclines are bacteriostatic antibiotics that prevent the growth of bacteria, but do not directly kill them (bactericidal).

Minocycline is effective against many species of gram-positive and gram-negative bacteria. These two types of bacteria are structurally different and are identified by the Gram stain lab test.

Minocycline works by inhibiting the synthesis of proteins that bacteria require to survive and grow. Minocycline binds to 30S and 50S subunits in the bacterial ribosomes (cellular particles that synthesize proteins) and prevents the formation of protein chains from amino acids. Although minocycline is active against many species of gram-positive and gram-negative bacteria, manystrainshave developed resistance to the drug, and it is recommended to be used only after culture and susceptibility tests.

FDA-approved uses of minocycline include treatment of the following infections from susceptible strains of organisms:

• Rocky Mountain spotted fever,typhusfever, and thetyphusgroup,Q fever,rickettsialpox, and tickfeverscaused byRickettsiae
• Respiratory tract infections caused byMycoplasma pneumoniae, Haemophilus influenzae,and克雷伯氏菌species
• Upper respiratory tract infectionscaused byStreptococcuspneumoniae
• Lymphogranuloma venereumcaused byChlamydia trachomatis
• Psittacosis (ornithosis) due toChlamydiapsittaci
• Trachomacaused byChlamydiatrachomatis
• Inclusionconjunctivitiscaused byChlamydiatrachomatis
• Nongonococcalurethritis, endocervical, or rectal infections in adults caused by Ureaplasma urealyticum, orChlamydia trachomatis
• Relapsingfeverdue toBorrelia recurrentis
• Chancroidcaused byHaemophilus ducreyi
• Plaguedue toYersinia pestis
• Tularemiadue toFrancisella tularensis
• Choleracaused byVibriocholerae
• Campylobacter fetusinfections
• Brucellosisdue toBrucellaspecies (in conjunction with streptomycin)
• Bartonellosisdue toBartonella bacilliformis
• Granuloma inguinale caused byCalymmatobacterium granulomatis
• Skin and skin structure infections caused byStaphylococcus aureus(minocycline is not the drug of choice in the treatment of any type ofstaphylococcal infection)
• To eliminate the meningococci from the nasopharynx of asymptomatic carriers ofNeisseria meningitidis

As an alternative drug whenpenicillinis contraindicated:

• Uncomplicated urethritis in men due toNeisseria gonorrhoeaeand for the treatment of other gonococcal infections
• Infections in women caused byNeisseria gonorrhoeae
• Syphiliscaused byTreponema pallidumsubspeciespallidum
• Yawscaused byTreponema pallidumsubspecies pertenue
• Listeriosisdue toListeriamonocytogenes
• Anthraxdue to芽孢杆菌anthracis
• Vincent’s infection caused byFusobacterium fusiforme
• Actinomycosis caused byActinomyces israelii
• Infections caused byClostridiumspecies.

Adjunctive therapy

• Acne vulgaris
• Acute intestinalamebiasis

Off-label uses include:

• Purulentcellulitis
• Rheumatoid arthritis
• Leprosy
• Nocardiosis
• Prosthetic joint infection
• Infectiveendocarditis
• Sarcoidosis(orphan designation)

Susceptible organisms include the following:

Acinetobacter baumannii, Actinomycesspecies,Afipia felis, Bacteroidesspecies,Bartonella bacilliformis, Borrelia recurrentis, Brucellaspecies,Burkholderia cepacia, Klebsiella granulomatis, Campylobacter jejuni, Chlamydia species, Clostridiumspecies,Coxiella burnetii, Eikenella corrodens,Escherichia coli, Entamoebaspecies,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,Shigellaspecies,MRSA,Streptococcuspneumoniae, Streptococcus pyogenes, Treponema pallidum, Ureaplasma urealyticum,Vibriocholerae, Yersinia pestis, Yersinia enterocolitica, Yersinia pseudotuberculosis,andmycobacteriaother thantuberculosis

• Do not use to treat patients with hypersensitivity to any tetracycline antibiotics, minocycline or any of its components.
• Use duringpregnancycan cause fetal harm and affect skeletal growth. Ifpregnancytakes place during therapy, patient should be apprised of potential hazard to the fetus.
• Use of tetracyclines including minocycline during fetal and childhood tooth development stage (last half of pregnancy and up to 8 years of age) may permanently discolorteeth, and may also impair enamel growth (enamel hypoplasia).
• A decrease in the rate of fibula growth has been observed with use in premature infants, which reversed with discontinuation of the drug.
• Drugrashwith eosinophilia and systemic symptoms (DRESS), sometimes fatal, have been reported with minocycline use. The drug should be discontinued immediately if DRESS symptoms develop.
• Lupus-like,hepatitisandvasculitisautoimmune syndromes includingserum sicknessmay occur. Discontinue minocycline if such symptoms occur, and evaluateliver function, antinuclear antibodies (ANA), andcomplete blood count(CBC).
• Minocycline can increase blood urea nitrogen (BUN) levels. Use with caution and adjust dosage in patients with impaired kidney function.
• Use with caution in patients with impairedliverfunction. Discontinue minocycline if liver injury occurs.
• Prolonged use may result in bacterial or fungal superinfections.
• Discontinue minocycline if the patient hassevere allergic reaction(anaphylaxis) and initiate appropriate treatment.
• Photosensitivitymay occur with prolonged exposure to sunlight or tanning equipment.
• May causedizzinessorvertigoin some patients, which can impair the ability to engage in activities such as driving or operating heavy machinery. Advise patients appropriately.
• As with most antibiotics, minocycline use can alter gut flora and lead toClostridium difficileassociateddiarrhea, even up to two months after discontinuation. Monitor patients for signs of colon inflammation (colitis) anddiarrhea, and treat promptly.
• Minocycline may causebenign intracranial hypertension(pseudotumor cerebri) with symptoms such asheadacheandblurred vision, which usually resolve with discontinuation of the drug.
• In the absence of a proven or strongly suspected bacterial infection or a prophylactic indication, minocycline is unlikely to be beneficial and increases the risk of development of drug-resistant bacteria.

Common side effects of minocycline include:

• Fatigue
• Dizziness
• Vertigo
• Headache
• Fatigue
• Drowsiness (somnolence)
• Convulsions
• Intracranial hypertension
• Fever
• Discoloration of secretions
• Tooth and oralcavitydiscoloration
• Deficient enamel growth in tooth development stage (enamel hypoplasia)
• Nausea
• Vomiting
• Diarrhea
• Clostridium difficileassociated diarrhea (CDAD)
• Highbilirubinlevels in blood (hyperbilirubinemia)
• Liver inflammation (hepatitis)
• Impaired bile flow (cholestasis)
• Jaundice
• Elevatedliver enzymes
• Liver failure
• Reducedhearing
• Ringing in ears (tinnitus)
• Cough
• Bronchospasm
• Shortness of breath(dyspnea)
• Exacerbation ofasthma
• Lung inflammation (pneumonitis)
• Inflammation in the kidney (interstitial nephritis)
• Increase in the blood urea nitrogen (BUN) levels
• Acutekidney failure
• Joint pain(arthralgia)
• Joint inflammation(arthritis)
• Joint stiffness
• Joint swelling
• Bone discoloration
• Muscle pain(肌痛)
• Thyroid dysfunction
• Thyroid discoloration
• Thyroid cancer
• Swelling oflymph nodes(lymphadenopathy)
• Inflammation of the membrane around theheart(pericarditis)
• Inflammation of the heart muscle (myocarditis)
• Blood disordersincluding:
  • Low red blood cell countdue to rapid destruction (hemolyticanemia)
  • Low count of granulocyte immune cells (agranulocytosis)
  • Low count of leukocyte immune cells (leukopenia)
  • Low count of neutrophil immune cells (neutropenia)
  • High levels of eosinophil immune cells (eosinophilia)
  • Low platelet levels (thrombocytopenia)
  • Low count of all types of blood cells (pancytopenia)
• Hypersensitivity reactions such as:
  • Hives(urticaria)
  • Itching(pruritus)
  • Photosensitivity
  • Swelling of tissue under the skin and mucous membranes (angioedema)
  • Blood vessel inflammation (vasculitis)
  • Serum sickness
  • Lupus式综合症
  • Severeallergic reaction(anaphylaxis)
• Severe skin reactions such as:
  • Erythematousrashes
  • Erythema nodosum
  • Erythema multiforme
  • Exfoliativedermatitis
  • Toxic epidermal necrolysis
  • Stevens-Johnson syndrome
• Hyperpigmentationof nails
• Pigmentation of skin and mucous membranes
• Hair loss(alopecia)
• Inflammation of the penis head (balanitis)
• Inflammation of vulva and vagina (vulvovaginitis)

Call your doctor immediately if you experience any of the following symptoms or serious side effects while using this drug:

• Seriousheart symptomsinclude fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness;
• Severeheadache,confusion, slurred speech, severeweakness,vomiting, loss of coordination, feeling unsteady;
• Severe nervous system reaction with very stiff muscles, high fever,sweating, confusion, fast or uneven heartbeats,tremors, and feeling like you might pass out; or
• Serious eye symptoms include blurred vision,tunnel vision,eye painor swelling, or seeing halos around lights.

This is not a complete list of all side effects or adverse reactions that may occur from the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may also report side effects or health problems to the FDA at 1-800-FDA-1088.

Tablet/Capsule

• 50 mg
• 75 mg
• 100 mg

Tablet

• 45 mg
• 55 mg
• 65 mg
• 80 mg
• 90 mg
• 105 mg
• 115 mg
• 135 mg

Injection, Intravenous

• 100 mg/vial

Adult:

AcneVulgaris

• 50-100 mg orally twice daily
• Solodyn, Minolira (extended-release tablet): 1 mg/kg orally once/day
• Administer therapy for 12 weeks

Extended-release tablets

Solodyn

• 45-49 kg: 45 mg once/day (1-0.92 mg/kg)
• 50-59 kg: 55 mg once/day (1.1-0.93 mg/kg)
• 60-71 kg: 65 mg once/day (1.08-0.92 mg/kg)
• 72-84 kg: 80 mg once/day (1.11-0.95 mg/kg)
• 85-96 kg: 90 mg once/day (1.06-0.94 mg/kg)
• 97-110 kg: 105 mg once/day (1.08-0.95 mg/kg)
• 111-125 kg: 115 mg once/day (1.04-0.92 mg/kg)
• 126-136 kg: 135 mg once/day (1.07-0.99 mg/kg)

Minolira

• 45-59 kg: 52.5 mg once/day (half of the 105 mg tab)
• 60 - 89公斤:67.5 mg /天(一半的135 mg tab)
• 90-125 kg: 105 mg once/day
• 126-136 kg: 135 mg once/day

Chlamydial or Ureaplasma Urealyticum

• Uncomplicated infection: 100 mg orally every 12 hours for at least 7 days

Gonococcal Infection

• Uncomplicated infection in males (no anorectal infections or presence of urethritis: 200 mg orally initially)
• Maintenance: 100 mg orally twice daily for at least 4 days
• Uncomplicated gonococcal urethritis in men: 100 mg orally every 12 hours for 5 days

我ningococcal Carrier State

• 100 mg orally every 12 hours for 5 days

Urethral, Endocervical, or Rectal Infections

• Caused byc . trachomatisorU. urealyticum(uncomplicated infection): 100 mg orally every 12 hours for 7 days

Mycobacterium marinum

• 100 mg orally every 12 hours for 6-8 weeks

Syphilis

• 200 mg orally initially, followed by 100 mg every 12 hours for 10-15 days

Infective Endocarditis

• 100 mg intravenously (IV) twice daily for at least 5 weeks

Infections, General Dosing

• 200 mg orally/IV initially, THEN 100 mg orally/IV every 12 hours; not to exceed 400 mg/day, OR
• Alternatively, 200 mg orally initially, THEN 100 mg orally every 12 hours; OR 100-200 mg initially; THEN 50 mg orally every 6 hours

Purulent Cellulitis (Off-label)

• Community acquiredMRSA: 200 mg orally initially
• Maintenance: 100 mg orally twice daily for 5-10 days

Rheumatoid Arthritis(Off-label)

• 100 mg orally twice daily

Dosing Modifications

• Renal impairment: Reduce dose and/or frequency

Pediatric:

AcneVulgaris

• Children under 12 years: Safety and efficacy not established
• Immediate-release products: 4 mg/kg orally initially (not to exceed 200 mg), THEN 2 mg/kg/day orally every 12 hours; not to exceed 400 mg/day
• Solodyn (extended-release tablet): 1 mg/kg orally once/day
• Administer therapy for 12 weeks

Extended-release tablets

Solodyn

• 45-49 kg: 45 mg once/day (1-0.92 mg/kg)
• 50-59 kg: 55 mg once/day (1.1-0.93 mg/kg)
• 60-71 kg: 65 mg once/day (1.08-0.92 mg/kg)
• 72-84 kg: 80 mg once/day (1.11-0.95 mg/kg)
• 85-96 kg: 90 mg once/day (1.06-0.94 mg/kg)
• 97-110 kg: 105 mg once/day (1.08-0.95 mg/kg)
• 111-125 kg: 115 mg once/day (1.04-0.92 mg/kg)
• 126-136 kg: 135 mg once/day (1.07-0.99 mg/kg)

Monolira

• 45-59 kg: 52.5 mg once/day (half of the 105 mg tab)
• 60 - 89公斤:67.5 mg /天(一半的135 mg tab)
• 90-125 kg: 105 mg once/day
• 126-136 kg: 135 mg once/day

c . trachomatisorU. Urealyticum

• 100 mg orally every 12 hours for at least 7 days

Infections, General Dosing

• Children 8 years and under: Not recommended, unless unable to take other, alternate antibiotics
• Children over 8 years: 4 mg/kg orally/IV initially; not to exceed 200 mg; THEN 2 mg/kg orally/IV every 12 hours; not to exceed adult dose; not to exceed 100 mg orally/IV every 12 hours for 5-10 days

The most common symptoms of minocycline overdose are dizziness,nauseaand vomiting. There is no known specific antidote for minocycline. Overdose treatment includes symptomatic and supportive care.

Inform your doctor of all medications you are currently taking, who can advise you on any possible药物的相互作用. Never begin taking, suddenly discontinue, or change the dosage of any medication without your doctor’s recommendation.

• Severe Interactions of minocycline include:
  • acitretin
  • tretinoin
• Minocycline has serious interactions with at least 57 differentdrugs.
• Minocycline has moderate interactions with at least 35 different drugs.
• Minocycline has mild interactions with at least 23 different drugs.

The drug interactions listed above are not all of the possible interactions or adverse effects. For more information on drug interactions, visit the RxList Drug Interaction Checker.

It is important to always tell your doctor, pharmacist, or health care provider of all prescription andover-the-countermedications you use, as well as the dosage for each, and keep a list of the information. Check with your doctor or health care provider if you have any questions about the medication.

• Minocycline may cause fetal harm, limit use during pregnancy only for life-threatening emergencies when no safer alternative is available.
• Minocycline is present inbreast milk. Taking into account the maternal need for the drug,breastfeedingor minocycline should be discontinued, because of the potential risk of adverse reactions in thebreastfedinfant.

• Take minocycline exactly as directed by your physician.
• Complete the prescribed antibiotic therapy; do not skip doses or discontinue therapy if you feel better; it can decrease effectiveness of treatment and can also lead to development of drug-resistant bacteria.
• Discard unused tablets by the expiration date.
• Minocycline is used only for bacterial infections. Do not use for viral infections.
• Avoid prolonged exposure to sunlight or tanning equipment, minocycline may cause photosensitivity. If you develop skin redness, report to your physician.
• Some may experience dizziness andvertigo. Avoid engaging in hazardous tasks such as driving and operating heavy machinery until the drug effects can be determined.
• Concurrent use of tetracycline antibiotics including minocycline withoral contraceptivesmay render oral contraceptives less effective.
• Diarrhea is a common problem with antibiotic treatments which should resolve with the completion of the therapy. Seek medical help if you have watery or bloody stools, with or withoutstomach crampsand fever. Symptoms can develop even up to two months after the last dose of antibiotic.
• Store safely out of reach of children.
• In case of overdose, seek medical help or contactPoison Control.