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Minocycline (systemic): Drug information

Minocycline (systemic): Drug information
(For additional information see "Minocycline (systemic): Patient drug information" and see "Minocycline (systemic): Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • CoreMino [DSC];
  • Minocin;
  • Minolira;
  • Solodyn;
  • Ximino
Brand Names: Canada
  • CO Minocycline;
  • TEVA-Minocycline [DSC]
Pharmacologic Category
  • Antibiotic, Tetracycline Derivative
Dosing: Adult

Usual dosage range:

IV, Oral: 200 mg once, followed by 100 mg every 12 hours (maximum: 400 mg daily). For multidrug-resistant gram-negative infections (eg, carbapenem-resistant Acinetobacter sp., S. maltophilia) and nocardiosis, some experts recommend 200 mg every 12 hours (Ref).

Acinetobacter baumannii infection, multidrug-resistant

Acinetobacter baumannii infection, multidrug-resistant: IV, Oral: 200 mg every 12 hours. For mild infection, may use as monotherapy; for moderate to severe infection, administer as part of an appropriate combination regimen (Ref). Note: Not recommended for urinary tract infection or as monotherapy for bloodstream infections (Ref).

Acne vulgaris, inflammatory, moderate to severe

Acne vulgaris, inflammatory, moderate to severe:

Note: Use in combination with topical acne therapy. Some experts prefer other tetracyclines because of adverse effect profiles (Ref). Treatment should ideally be limited to 3 to 4 months to minimize the risk of resistance (Ref).

Oral:

IR capsule or tablet: 50 to 100 mg once or twice daily; usual dose: 100 mg twice daily (Ref).

ER capsule or tablet: 1 mg/kg once daily, rounded to the nearest dosage form available; maximum dose: 135 mg/day.

ER capsule:

Ximino:

45 to 59 kg: 45 mg once daily.

60 to 90 kg: 90 mg once daily.

91 to 136 kg: 135 mg once daily.

ER tablet:

Minolira:

45 to 59 kg: 52.5 mg (one-half of the 105 mg tablet) once daily.

60 to 89 kg: 67.5 mg (one-half of the 135 mg tablet) once daily.

90 to 125 kg: 105 mg once daily.

126 to 136 kg: 135 mg once daily.

CoreMino, Solodyn:

45 to 49 kg: 45 mg once daily.

50 to 59 kg: 55 mg once daily.

60 to 71 kg: 65 mg once daily.

72 to 84 kg: 80 mg once daily.

85 to 96 kg: 90 mg once daily.

97 to 110 kg: 105 mg once daily.

111 to 125 kg: 115 mg once daily.

126 to 136 kg: 135 mg once daily.

Leprosy

Leprosy (alternative agent) (off-label use): Oral:

Lepromatous (multibacillary): 100 mg once daily for 24 months as part of an appropriate combination regimen (Ref).

Tuberculoid (paucibacillary): 100 mg once daily for 12 months in combination with rifampin (Ref).

Meningococcal disease, chemoprophylaxis after close contact with a patient with invasive disease

Meningococcal disease, chemoprophylaxis after close contact with a patient with invasive disease: Note: CDC recommendations do not mention use of minocycline for eradicating nasopharyngeal carriage of meningococcus (Ref).

Oral: 100 mg every 12 hours for 5 days (Ref).

Mycobacterium marinum

Mycobacterium marinum: Oral: 100 mg every 12 hours for 2 to 3 months (Ref).

Nocardiosis

Nocardiosis (alternative agent) (off-label use): IV, Oral: 100 to 200 mg every 12 hours, generally as part of an appropriate combination regimen (Ref).

Plague

Plague (Yersinia pestis ) (alternative agent):

Note: Consult public health officials for event-specific recommendations.

Postexposure prophylaxis: Oral: 100 mg every 12 hours for 7 days; a 200 mg loading dose is recommended in patients who are pregnant (Ref).

Treatment, bubonic or pharyngeal: Oral, IV: 200 mg initially then 100 mg every 12 hours for 10 to 14 days and for at least a few days after clinical resolution (Ref).

Prosthetic joint infection

Prosthetic joint infection (off-label use):

Treatment: Oral continuation therapy for Staphylococcus (following pathogen-specific IV therapy in patients undergoing 1-stage exchange or debridement with retention of prosthesis): Oral: 100 mg twice daily in combination with rifampin; duration is ≥3 months, depending on patient-specific factors (Ref).

Chronic suppression for staphylococci (methicillin-resistant) and Cutibacterium acnes (alternative agent for C. acnes): Oral: 100 mg twice daily (Ref).

Rheumatoid arthritis

Rheumatoid arthritis (off-label use): Oral: 100 mg twice daily (Ref).

Sexually transmitted infections

Sexually transmitted infections:

Chlamydial or Ureaplasma urealyticum infection, uncomplicated: Note: Clinical practice guidelines do not mention use of minocycline for treatment of chlamydial or U. urealyticum infection (Ref).

Oral, IV: Urethral, endocervical, or rectal: 100 mg every 12 hours for at least 7 days.

Gonococcal infection, uncomplicated (males): Note: Clinical practice guidelines do not recommend tetracyclines for the treatment of gonorrhea because of increased resistance (Ref).

Urethritis: Oral, IV: 100 mg every 12 hours for 5 days.

Without urethritis or anorectal infection: Oral, IV: 200 mg once, followed by 100 mg every 12 hours for at least 4 days (cultures 2 to 3 days post therapy).

Syphilis (alternative agent for nonpregnant patients with penicillin allergy):

Note: Limited data support use of minocycline as an alternative to penicillin, and close serologic and clinical follow-up is warranted; some experts prefer other alternative agents (eg, ceftriaxone, doxycycline) (Ref).

Early syphilis (primary, secondary, and early latent [<1-year duration]): Oral, IV: 200 mg once followed by 100 mg every 12 hours for 28 days (Ref).

Skin and soft tissue infection

Skin and soft tissue infection:

Cellulitis, nonpurulent with risk for methicillin-resistant S. aureus: Oral: 100 mg twice daily in combination with an additional agent (eg, amoxicillin, cephalexin) for coverage of beta-hemolytic streptococci (Ref). Some experts give an initial 200 mg loading dose (Ref).

Cellulitis, purulent or abscess: Oral: 100 mg twice daily (Ref). Some experts give an initial 200 mg loading dose (Ref). Note: Systemic antibiotics only indicated for abscess in certain instances (eg, immunocompromised patients, signs of systemic infection, large or multiple abscesses, indwelling device, high risk for adverse outcome with endocarditis). If at risk for gram-negative bacilli, use in combination with an appropriate agent (Ref).

Duration: Treat for ≥5 days but may extend up to 14 days depending on severity and clinical response (Ref).

Stenotrophomonas maltophilia infection, multidrug-resistant

Stenotrophomonas maltophilia infection, multidrug-resistant (alternative agent) (off-label use): IV, Oral: 200 mg every 12 hours. For mild infection, may use as monotherapy; for moderate to severe infection, administer as part of an appropriate combination regimen. Note: Not recommended for urinary tract infection or as monotherapy for bloodstream infections (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason A. Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.

Altered kidney function:

Oral, IV: No dosage adjustment necessary for any degree of kidney dysfunction (Ref). Note: Theoretically, minocycline doses >200 mg/day may increase plasma urea concentrations due to antianabolic effects. Therefore, patients with kidney impairment requiring doses >200 mg/day should be frequently monitored for increased BUN, serum creatinine, and/or signs and symptoms of uremia (Ref).

Augmented renal clearance (measured urinary CrCl ≥130 mL/minute/1.73 m2):

Note: Augmented renal clearance (ARC) is a condition that occurs in certain critically ill patients without organ dysfunction and with normal serum creatinine concentrations. Younger patients (<55 years of age) admitted post trauma or major surgery are at highest risk for ARC, as well as those with sepsis, burns, or hematologic malignancies. An 8- to 24-hour measured urinary CrCl is necessary to identify these patients (Ref).

Oral, IV: No dosage adjustment necessary (Ref).

Hemodialysis, intermittent (thrice weekly): Not dialyzable (Ref):

Oral, IV: No dosage adjustment necessary (Ref).

Peritoneal dialysis: Not dialyzable (Ref):

Oral, IV: No dosage adjustment necessary (Ref).

CRRT: Oral, IV: No dosage adjustment necessary (Ref).

PIRRT (eg, sustained, low-efficiency diafiltration): Oral, IV: No dosage adjustment necessary (Ref).

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling; however, hepatotoxicity has been reported. Use with caution.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Minocycline (systemic): Pediatric drug information")

General dosing, susceptible infection: Children >8 years and Adolescents:

Oral: Immediate-release formulations: Initial: 4 mg/kg once (maximum dose: 200 mg), then 2 mg/kg/dose every 12 hours (maximum dose: 100 mg/dose).

IV: Initial: 4 mg/kg once (maximum dose: 200 mg), then 2 mg/kg/dose (maximum dose: 100 mg/dose) every 12 hours; maximum daily dose: 400 mg/day.

Acne vulgaris, inflammatory, non-nodular, moderate to severe

Acne vulgaris, inflammatory, non-nodular, moderate to severe: Note: Higher doses do not confer greater efficacy and may be associated with more acute vestibular side effects. Due to emerging resistance patterns, should not typically be used as monotherapy for the management of acne vulgaris (Ref).

Immediate-release formulations: Children ≥8 years and Adolescents: Oral: 50 to 100 mg 1 to 2 times daily in conjunction with topical therapy (eg, benzoyl peroxide); duration of 4 to 8 weeks of therapy usually necessary to evaluate initial clinical response with a longer duration for a maximum effect (3 to 6 months) (Ref).

Extended-release formulations: Children ≥12 years and Adolescents: Oral: ~1 mg/kg/dose once daily for 12 weeks.

Product-specific dosing:

Extended-release capsule: Ximino: Oral:

45 to 59 kg: 45 mg once daily.

60 to 90 kg: 90 mg once daily.

91 to 136 kg: 135 mg once daily.

Extended-release tablet:

Minolira: Oral:

45 to 59 kg: 52.5 mg (one-half of the 105 mg tablet) once daily.

60 to 89 kg: 67.5 mg (one-half of the 135 mg tablet) once daily.

90 to 125 kg: 105 mg once daily.

126 to 136 kg: 135 mg once daily.

CoreMino, Solodyn: Oral:

45 to 49 kg: 45 mg once daily.

50 to 59 kg: 55 mg once daily.

60 to 71 kg: 65 mg once daily.

72 to 84 kg: 80 mg once daily.

85 to 96 kg: 90 mg once daily.

97 to 110 kg: 105 mg once daily.

111 to 125 kg: 115 mg once daily.

126 to 136 kg: 135 mg once daily.

Skin and soft tissue infection, community-acquired MRSA

Skin and soft tissue infection (ie, purulent cellulitis), community-acquired MRSA: Note: Treatment duration based on clinical response; usual duration is 5 to 10 days for outpatient cellulitis (Ref).

Children >8 years and Adolescents: Immediate-release formulations: Oral: Initial: 4 mg/kg (maximum dose: 200 mg), then 2 mg/kg/dose (maximum dose: 100 mg/dose) every 12 hours (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Pediatric

Immediate release: IV, Oral: There are no pediatric-specific recommendations; based on experience in adult patients; dosing adjustment suggested. Hemodialysis: Not dialyzable (Ref).

Extended-release formulations: Children ≥12 years and Adolescents: There are no specific dosage adjustments provided in the manufacturer's labeling. Consider decreasing dose or increasing dosing interval.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling; however, hepatotoxicity has been reported. Use with caution.

Adverse Reactions (Significant): Considerations
Bone growth suppression

Bone growth suppression, as evidenced by growth retardation (fibula), has been reported in premature infants treated with tetracycline; growth restriction up to 40% has been associated with oral tetracycline therapy but is reversible when short-term treatment is discontinued. Upon discontinuation of tetracycline, rapid compensatory bone growth is observed (Ref). There are limited/no data with minocycline; therefore, the risk for bone growth suppression is extrapolated from data with tetracycline.

Mechanism: Dose-related; tetracycline binds to calcium in growing bones and negatively affects calcium orthophosphate metabolism (Ref).

Onset: Intermediate; deposition of tetracycline in bone has been shown after one dose and treatment with tetracycline for 9 to 12 days has resulted in restricted bone growth (Ref).

Risk factors:

• Dose; tetracycline 25 mg/kg/dose every 6 hours in premature infants (Ref)

• Age: Premature infants (Ref)

CNS effects

Minocycline is associated with dizziness, tinnitus, and vertigo, which are often mild and reversible within 48 hours after discontinuation (Ref).

Mechanism: Unknown; readily crosses the blood-brain barrier, impacts microglia activation and cytokine expression (Ref). Peak minocycline serum concentrations correlate with the peak onset of adverse reactions; however, lower doses do not appear to improve adverse reaction profile with short treatment courses (Ref).

Onset: Rapid; usually within 2 to 3 days of initiation (Ref).

Idiopathic intracranial hypertension

Idiopathic intracranial hypertension (ie, pseudotumor cerebri) has been associated with minocycline (Ref). Symptoms include headache (predominant symptom), blurred vision, diplopia, vision loss, and/or papilledema. Intracranial hypertension is typically benign and resolves with discontinuation; however, permanent vision loss is possible (Ref). Intracranial pressure may remain elevated for 2 to 5 weeks after discontinuation (Ref). Idiopathic intracranial hypertension has been reported in infants following tetracycline exposure, manifested by bulging fontanel (Ref).

Mechanism: Unknown; proposed that minocycline reduces cerebrospinal fluid absorption at the arachnoid villi, leading to increased intracranial pressure (Ref).

Onset: Varied; generally within 8 weeks of initiation (range <1 week to 1 year) (Ref).

Risk factors:

• Concurrent isotretinoin (Ref)

• Females of childbearing age (especially those who are overweight, obese, have experienced recent weight gain, or have a history of intracranial hypertension) (Ref)

Hepatotoxicity

Minocycline may cause hepatotoxicity (ranging from mild elevations in serum aminotransferase levels to hepatic failure [including fatal cases]) (Ref). Liver injury may present as an acute hepatitis-like syndrome, or a chronic autoimmune hepatitis, usually with hepatocellular pattern of enzyme elevation (Ref). Autoantibodies are usually present with autoimmune hepatitis, typically antinuclear antibody (ANA) at titers of >1:160 (Ref). Most cases of hepatotoxicity resolve within 3 months after discontinuation of therapy (Ref). Some cases may require treatment; persistent and severe injury has been reported (Ref). Hepatic failure is rare (Ref).

Mechanism: Non–dose-related; not clearly established, immunologic (Ref).

Onset: Varied; acute hepatitis: 3 to 4 weeks after initiation (Ref). Autoimmune hepatitis: generally occurs with prolonged therapy (average within 2 years but may occur within a few months after initiation) (Ref).

Risk factors:

• First month of use (Ref)

Hypersensitivity reactions (immediate and delayed) and autoimmune syndromes

Hypersensitivity reactions include immediate (eg, anaphylaxis) (Ref) and delayed reactions. Drug reaction with eosinophilia and systemic symptoms (DRESS) has been reported (Ref). Although the liver is the main organ affected, meningitis, myocarditis, and pneumonitis may also occur (Ref). DRESS may have a prolonged course with development of autoimmune syndromes, including diabetes mellitus, hepatitis, thyroiditis, and vasculitis (Ref). Other cutaneous reactions that have been associated with minocycline include serum sickness-like reaction (Ref), Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) (Ref), Sweet syndrome (Ref), fixed drug eruption (Ref) and lupus-like syndrome, usually with positive ANA antibodies (Ref).

Mechanism: Non–dose-related; immunologic (Ref). Immediate hypersensitivity reactions (eg, anaphylaxis, urticaria) are IgE-mediated. Delayed hypersensitivity reactions are T-cell mediated (Ref), triggered by minocycline or a reactive metabolite (Ref). Prolonged courses of DRESS may be the result of accumulation of melanin-minocycline complex in patients with pigmented skin (Ref).

Onset: Immediate hypersensitivity reactions: Rapid; occur within 1 hour of administration but may occur up to 6 hours after exposure (Ref). Delayed hypersensitivity reactions: Varied; DRESS has been reported 16 to 60 days after initiation (mean 23.7 days) (Ref), and serum sickness-like reactions approximately 16 days (Ref). Lupus-like syndrome occurs from 3 months to 6 years (median 22.5 months) (Ref).

Risk factors:

• Longer duration of use (for autoimmune syndromes) (Ref)

• African or West Indian origin (Ref)

• Females (for lupus-like syndrome) (Ref)

• Cross-reactivity between minocycline and other tetracyclines is unknown (Ref)

• Viral reactivation, in particular human herpesvirus 6 (HHV-6) has been associated with DRESS (Ref)

• Increased risk with minocycline for DRESS and autoimmune syndromes compared to other tetracyclines (Ref)

• Genetic variants (for lupus-like syndrome) (Ref)

Photosensitivity

Minocycline may cause skin photosensitivity reactions ranging from mild sunburn-like reactions to photodermatitis. However, minocycline is less phototoxic than other tetracyclines (eg, doxycycline) (Ref). Reactions have not been reported with topical minocycline (Ref). Phototoxic reactions are restricted to exposed skin, usually develop shortly after sun exposure, and appear to be dose-related (Ref). Photo-onycholysis has also been reported, which may take up to 6 months to resolve after discontinuation (Ref).

Mechanism: Dose-related; minocycline absorbs light energy resulting in subsequent photochemical reactions in living tissues (Ref).

Onset: Varied; photosensitivity occurs <24 hours after sun exposure (Ref). Photo-onycholysis may occur weeks after sun exposure (Ref).

Skin hyperpigmentation/dental discoloration

Minocycline may induce diffuse skin hyperpigmentation (brown, bluish-grey, and/or black discoloration) including nails, skin of face, arms, legs, or around scars and dental discoloration (staining of tooth) (Ref). Hyperpigmentation may be more prevalent with minocycline than doxycycline and associated with a greater variety of tissues (eg, bone, conjunctiva and sclera, ear tympanic membrane, internal organs, nails, subcutaneous fat, teeth and oral mucosa, and thyroid) (Ref). Minocycline hyperpigmentation and dental discoloration may be partially reversible, but permanent in some cases (Ref). Discoloration may be amenable to vital bleaching (Ref). Minocycline may affect fully erupted teeth compared to tetracycline, which may cause dental staining and enamel hypoplasia in unerupted, uncalcified teeth. Furthermore, the gingival third of the crown tends to be spared in minocycline staining compared with tetracycline (Ref).

Mechanism: Dose- and time-related; minocycline may mineralize tissue as it binds to calcium/iron to form a tetracycline-calcium/iron orthophosphate complex and/or activate melanocytes in the upper dermis (Ref).

Onset: Delayed; months to years (Ref).

Risk factors:

• Higher doses (≥100 mg daily) (Ref)

• Long-term use (>1 to 2 months) (Ref)

• Sun-exposed areas of skin with higher density of melanocytes (Ref)

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

1% to 10%:

Dermatologic: Pruritus (5%), urticaria (2%)

Nervous system: Dizziness (9%) (table 1), drowsiness (2%), fatigue (9%), malaise (4%)

Minocycline (Systemic): Adverse Reaction: Dizziness

Drug (Minocycline [Systemic])

Placebo

Dose

Dosage Form

Number of Patients (Minocycline [Systemic])

Number of Patients (Placebo)

9%

5%

1 mg/kg

Extended-release tablets

674

364

Neuromuscular & skeletal: Arthralgia (1%)

Otic: Tinnitus (2%) (table 2)

Minocycline (Systemic): Adverse Reaction: Tinnitus

Drug (Minocycline [Systemic])

Placebo

Dose

Dosage Form

Number of Patients (Minocycline [Systemic])

Number of Patients (Placebo)

2%

1%

1 mg/kg

Extended-release tablets

674

364

Postmarketing:

Cardiovascular: Myocarditis (Shaughnessy 2010), pericarditis (Davey 2000), vasculitis (including polyarteritis nodosa [Agur 2014])

Dermatologic: Erythema multiforme (Knowles 1996), exfoliative dermatitis (Davies 1989), fixed drug eruption (Correia 1999), onycholysis (McCarthy 2019), skin hyperpigmentation (Rok 2021, Wang 2021), skin photosensitivity (Odorici 2021), skin pigmentation (Shute 2020), skin rash, Stevens-Johnson syndrome (Yoon 2010), Sweet syndrome (Khanna 2020), toxic epidermal necrolysis (Dominic 2021)

Endocrine & metabolic: Abnormal thyroid function test (Millington 2019), diabetes mellitus (Brown 2009), malignant neoplasm of thyroid (Kandil 2010), microscopic thyroid discoloration (Azuma 2010, Kandil 2010), thyroiditis (Millington 2019)

Gastrointestinal: Clostridioides difficile colitis, Clostridioides difficile-associated diarrhea, diarrhea, dysphagia, enamel hypoplasia, enterocolitis, glossitis, mucous membrane hyperpigmentation (Eisen 1998), pancreatitis (Shapiro 1997), parotitis (bilateral) (Yoon 2010), staining of tooth (Johnston 2013)

Genitourinary: Balanitis

Hematologic & oncologic: Eosinophilia, hemolytic anemia (Kudoh 1994), Henoch-Schonlein purpura, lymphadenopathy (Bando 1994), thrombocytopenia (Dominic 2021)

Hepatic: Autoimmune hepatitis (Harmon 2018), hepatic failure (Lan 2016), hepatitis, hepatotoxicity (Chalasani 2018)

Hypersensitivity: Anaphylaxis (Jang 2010), angioedema (Jang 2010), drug reaction with eosinophilia and systemic symptoms (Eshki 2009), nonimmune anaphylaxis (Okana 1996), serum sickness (Elkayam 1999), serum sickness-like reaction (Lucido 2021)

Nervous system: Bulging fontanel (Fields 1961), intracranial hypertension (Tan 2019), meningitis (Lefebvre 2007), vertigo

Neuromuscular & skeletal: Arthritis, exacerbation of systemic lupus erythematosus (Elkayam 1999), joint stiffness, joint swelling, lupus-like syndrome (Clark 2017), myalgia, polyarthralgia

Otic: Hearing loss, vestibular ototoxicity (Jacobson 1975)

Renal: Acute kidney injury (Dominic 2021), nephritis (including acute intestinal nephritis [Sharma 2020])

Respiratory: Pneumonitis (including eosinophilic pneumonitis [Dykhuizen 1995]), pulmonary infiltrates (Dykhuizen 1995), respiratory failure (Oddo 2003)

Miscellaneous: Fever

Contraindications

Hypersensitivity to minocycline, other tetracyclines, or any component of the formulation

Canadian labeling: Additional contraindications (not in the US labeling): Severe liver disease; complete renal failure; myasthenia gravis; use in children <13 years of age; pregnancy; breastfeeding

Warnings/Precautions

Concerns related to adverse effects:

• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.

Disease-related concerns:

• Hepatic impairment: Use with caution in patients with hepatic impairment or in conjunction with other hepatotoxic drugs.

• Renal impairment: Use with caution in patients with kidney impairment. see "Dosing: Altered Kidney Function" for additional information.

Special populations:

• Pediatric: May cause tissue hyperpigmentation, tooth enamel hypoplasia, or permanent tooth discoloration; more common with long-term use, but observed with repeated, short courses; use of tetracyclines should be avoided during tooth development (infancy and children ≤8 years of age) unless other drugs are not likely to be effective or are contraindicated.

Dosage form specific issues:

• Magnesium content: Parenteral (IV) formulation contains magnesium; monitor serum magnesium in patients with renal impairment and signs of magnesium intoxication (eg, flushing, sweating, hypotension, depressed reflexes, flaccid paralysis, hypothermia, circulatory collapse, cardiac and CNS depression leading to respiratory paralysis). Also use with caution and closely monitor patients with heart block or myocardial damage.

Dosage Forms Considerations

Minocin Kit contains minocycline oral capsules packaged with T3 Calming Wipes

Minocin for injection contains magnesium 2.2 mEq per vial

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Capsule, Oral:

Minocin: 50 mg [DSC] [contains fd&c blue #1 (brilliant blue), quinoline yellow (d&c yellow #10)]

Generic: 50 mg, 75 mg, 100 mg

Capsule Extended Release 24 Hour, Oral:

Ximino: 90 mg [contains fd&c blue #1 (brilliant blue)]

Ximino: 135 mg [contains fd&c blue #1 (brilliant blue), fd&c yellow #6 (sunset yellow)]

Ximino: 45 mg [contains fd&c blue #1 (brilliant blue), fd&c yellow #6 (sunset yellow), quinoline yellow (d&c yellow #10)]

Generic: 135 mg, 45 mg, 90 mg

Solution Reconstituted, Intravenous [preservative free]:

Minocin: 100 mg (1 ea)

Tablet, Oral:

Generic: 50 mg, 75 mg, 100 mg

Tablet Extended Release 24 Hour, Oral:

CoreMino: 45 mg [DSC], 90 mg [DSC], 135 mg [DSC]

Minolira: 105 mg, 135 mg [scored]

Solodyn: 55 mg [contains fd&c red #40 (allura red ac dye)]

Solodyn: 65 mg [contains fd&c blue #1 (brilliant blue), fd&c blue #2 (indigotine,indigo carmine), quinoline yellow (d&c yellow #10)]

Solodyn: 80 mg [contains fd&c blue #2 (indigotine,indigo carmine), fd&c red #40 (allura red ac dye), fd&c yellow #6 (sunset yellow)]

Solodyn: 105 mg [contains fd&c blue #1 (brilliant blue)]

Solodyn: 115 mg [contains fd&c blue #1 (brilliant blue), fd&c blue #2 (indigotine,indigo carmine), quinoline yellow (d&c yellow #10)]

Generic: 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg, 135 mg

Generic Equivalent Available: US

May be product dependent

Pricing: US

Capsule ER 24 Hour Therapy Pack (Minocycline HCl ER Oral)

45 mg (per each): $21.00

90 mg (per each): $21.00

135 mg (per each): $21.00

Capsule ER 24 Hour Therapy Pack (Ximino Oral)

45 mg (per each): $33.04

90 mg (per each): $33.04

135 mg (per each): $33.04

Capsules (Minocycline HCl Oral)

50 mg (per each): $1.70

75 mg (per each): $1.98

100 mg (per each): $1.38 - $3.40

Solution (reconstituted) (Minocin Intravenous)

100 mg (per each): $301.08

Tablet, 24-hour (Minocycline HCl ER Oral)

45 mg (per each): $20.17 - $24.16

55 mg (per each): $39.01 - $43.89

65 mg (per each): $39.01 - $43.88

80 mg (per each): $39.01 - $43.89

90 mg (per each): $20.17 - $24.16

105 mg (per each): $39.01 - $43.89

115 mg (per each): $39.01 - $43.88

135 mg (per each): $20.17 - $24.16

Tablet, 24-hour (Minolira Oral)

105 mg (per each): $29.58

135 mg (per each): $29.58

Tablet, 24-hour (Solodyn Oral)

55 mg (per each): $2.50

65 mg (per each): $2.50

80 mg (per each): $2.50

105 mg (per each): $2.50

115 mg (per each): $2.50

Tablets (Minocycline HCl Oral)

50 mg (per each): $3.43 - $4.35

75 mg (per each): $5.04 - $6.39

100 mg (per each): $6.02

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Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule, Oral:

Generic: 50 mg, 100 mg

Administration: Adult

IV: Infuse over 60 minutes; avoid rapid administration. The injectable route should be used only if the oral route is not feasible or adequate. Prolonged intravenous therapy may be associated with thrombophlebitis.

Oral: May be administered with or without food. Administer with adequate fluid to decrease the risk of esophageal irritation and ulceration. Swallow pellet-filled capsule and ER tablet or capsule whole; do not chew, crush, or split. Minolira 105 mg and 135 mg ER tablets may be split on the score line.

Bariatric surgery: Capsule and tablet, extended release: Some institutions may have specific protocols that conflict with these recommendations; refer to institutional protocols as appropriate. ER capsule (Ximino) and tablet (CoreMino, Solodyn) should be swallowed whole. Do not chew, crush, or split. ER tablet (Minolira) may be split on the score line. IR tablet, capsule, and injectable formulations are available. If safety and efficacy can be effectively monitored, no change in formulation or administration is required after bariatric surgery; however, consideration should be given to conversion to IR formulations for high-risk labeled and off-label indications.

Administration: Pediatric

IV: Infuse over 60 minutes; avoid rapid administration; the injectable route should be used only if the oral route is not feasible or adequate; prolonged intravenous therapy may be associated with thrombophlebitis.

Oral: Administer with plenty of fluids with or without food. Ingestion of adequate amounts of fluid and food may reduce the risk of esophageal irritation and ulceration. Swallow pellet-filled capsule and extended-release tablet whole; do not chew, crush, or split. Minolira 105 mg and 135 mg extended-release tablets may be split on the score line. Administer antacids, calcium supplements, iron supplements, magnesium-containing laxatives, and cholestyramine 2 hours before or after minocycline.

Use: Labeled Indications

Acute intestinal amebiasis: Adjunctive therapy to amebicides in the treatment of acute intestinal amebiasis.

Acne vulgaris, inflammatory, moderate to severe:

Oral (immediate release) and IV: Adjunctive therapy for the treatment of severe acne.

Oral (extended-release): Treatment of only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years and older.

Actinomycosis: Treatment of actinomycosis caused by Actinomyces israelii when penicillin is contraindicated.

Anthrax: Treatment of anthrax caused by Bacillus anthracis when penicillin is contraindicated.

Campylobacter: Treatment of infections caused by Campylobacter fetus.

Cholera: Treatment of cholera caused by Vibrio cholerae.

Clostridium: Treatment of infections caused by Clostridium spp when penicillin is contraindicated.

Gram-negative infections: Treatment of infections caused by Acinetobacter spp, Escherichia coli, Klebsiella aerogenes (formerly Enterobacter. aerogenes), Shigella spp.

Listeriosis: Treatment of listeriosis due to Listeria monocytogenes when penicillin is contraindicated.

Meningitis: Treatment of meningitis due to Neisseria meningitidis when penicillin is contraindicated.

Meningococcal disease, chemoprophylaxis after close contact with a patient with invasive disease : Oral (immediate-release): To prevent meningococcal disease after exposure to a close contact with N. meningitidis infection. Note: CDC recommendations do not mention minocycline for eradicating nasopharyngeal carriage of meningococcus (CDC [McNamara 2022]).

Mycobacterial infection: Treatment of infection caused by Mycobacterium marinum.

Ophthalmic infections: Treatment of inclusion conjunctivitis or trachoma caused by Chlamydia trachomatis.

Relapsing fever: Treatment of relapsing fever caused by Borrelia recurrentis.

Respiratory tract infections: Treatment of respiratory tract infections caused by Haemophilus influenzae, Klebsiella spp, or Mycoplasma pneumonia. For the treatment of upper respiratory tract infections caused by Streptococcus pneumoniae.

Rickettsial infections: Treatment of Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae.

Sexually transmitted infections: Treatment of lymphogranuloma venereum caused by C. trachomatis; nongonococcal urethritis, endocervical, or rectal infections in adults caused by Ureaplasma urealyticum or C. trachomatis; donovanosis (granuloma inguinale) caused by Klebsiella granulomatis; syphilis caused by Treponema pallidum subspecies pallidum, when penicillin is contraindicated. Treatment of uncomplicated urethritis in males due to Neisseria gonorrhoeae and other gonococcal infections are FDA-approved uses in the manufacturer’s prescribing information, but clinical practice guidelines do not recommend tetracyclines for the treatment of gonorrhea because of increased resistance (CDC [Workowski 2021]).

Skin and soft tissue infections: Treatment of skin and soft tissue infections caused by Staphylococcus aureus (not considered a first-line agent for any staphylococcal infection).

Urinary tract infections: Treatment of urinary tract infections caused by Klebsiella species.

Vincent infection: Treatment of Vincent infection caused by Fusobacterium fusiforme when penicillin is contraindicated.

Yaws: Treatment of yaws caused by T. pallidum subspecies pertenue when penicillin is contraindicated.

Zoonotic infections: Treatment of psittacosis (ornithosis) due to Chlamydia psittaci; plague due to Yersinia pestis; tularemia due to Francisella tularensis; brucellosis due to Brucella spp (in conjunction with streptomycin); bartonellosis due to Bartonella bacilliformis.

Use: Off-Label: Adult

Leprosy; Nocardiosis; Prosthetic Joint Infection; Rheumatoid arthritis; Stenotrophomonas maltophilia infection

Medication Safety Issues
Sound-alike/look-alike issues:

Dynacin may be confused with Dyazide, Dynapen

Minocin may be confused with Indocin, Lincocin, Minizide, niacin

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Aminolevulinic Acid (Systemic): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Systemic). Risk X: Avoid combination

Aminolevulinic Acid (Topical): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Topical). Risk C: Monitor therapy

Antacids: May decrease the absorption of Tetracyclines. Management: Separate administration of antacids and oral tetracycline derivatives by several hours when possible to minimize the extent of this potential interaction. Monitor for decreased therapeutic effects of tetracyclines. Risk D: Consider therapy modification

Atazanavir: Minocycline (Systemic) may decrease the serum concentration of Atazanavir. Risk C: Monitor therapy

Bacillus clausii: Antibiotics may diminish the therapeutic effect of Bacillus clausii. Management: Bacillus clausii should be taken in between antibiotic doses during concomitant therapy. Risk D: Consider therapy modification

BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination

BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Risk C: Monitor therapy

Bile Acid Sequestrants: May decrease the absorption of Tetracyclines. Risk C: Monitor therapy

Bismuth Subcitrate: May decrease the serum concentration of Tetracyclines. Management: Avoid administration of oral tetracyclines within 30 minutes of bismuth subcitrate administration. This is of questionable significance for at least some regimens intended to treat H. pylori infections. Risk D: Consider therapy modification

Bismuth Subsalicylate: May decrease the serum concentration of Tetracyclines. Management: Consider dosing tetracyclines 2 hours before or 6 hours after bismuth. The need to separate doses during Helicobacter pylori eradication regimens is questionable. Risk D: Consider therapy modification

Calcium Salts: May decrease the serum concentration of Tetracyclines. Management: If coadministration of oral calcium with oral tetracyclines cannot be avoided, consider separating administration of each agent by several hours. Risk D: Consider therapy modification

Cholera Vaccine: Antibiotics may diminish the therapeutic effect of Cholera Vaccine. Management: Avoid cholera vaccine in patients receiving systemic antibiotics, and within 14 days following the use of oral or parenteral antibiotics. Risk X: Avoid combination

CNS Depressants: Minocycline (Systemic) may enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Fecal Microbiota (Live) (Oral): May diminish the therapeutic effect of Antibiotics. Risk X: Avoid combination

Fecal Microbiota (Live) (Rectal): Antibiotics may diminish the therapeutic effect of Fecal Microbiota (Live) (Rectal). Risk X: Avoid combination

Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies): Antibiotics may diminish the therapeutic effect of Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies). Risk C: Monitor therapy

Iron Preparations: Tetracyclines may decrease the absorption of Iron Preparations. Iron Preparations may decrease the serum concentration of Tetracyclines. Management: Avoid this combination if possible. Administer oral iron preparations at least 2 hours before, or 4 hours after, the dose of the oral tetracycline derivative. Monitor for decreased therapeutic effect of oral tetracycline derivatives. Risk D: Consider therapy modification

Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Risk C: Monitor therapy

Lanthanum: May decrease the serum concentration of Tetracyclines. Management: Administer oral tetracycline antibiotics at least 2 hours before or after lanthanum. Risk D: Consider therapy modification

Lithium: Tetracyclines may increase the serum concentration of Lithium. Risk C: Monitor therapy

Magnesium Dimecrotate: May interact via an unknown mechanism with Tetracyclines. Risk C: Monitor therapy

Magnesium Salts: May decrease the absorption of Tetracyclines. Only applicable to oral preparations of each agent. Management: Avoid coadministration of oral magnesium salts and oral tetracyclines. If coadministration cannot be avoided, administer oral magnesium at least 2 hours before, or 4 hours after, oral tetracyclines. Monitor for decreased tetracycline therapeutic effects. Risk D: Consider therapy modification

Mecamylamine: Tetracyclines may enhance the neuromuscular-blocking effect of Mecamylamine. Risk X: Avoid combination

Methoxsalen (Systemic): Photosensitizing Agents may enhance the photosensitizing effect of Methoxsalen (Systemic). Risk C: Monitor therapy

Methoxyflurane: Tetracyclines may enhance the nephrotoxic effect of Methoxyflurane. Risk X: Avoid combination

Mipomersen: Tetracyclines may enhance the hepatotoxic effect of Mipomersen. Risk C: Monitor therapy

Multivitamins/Minerals (with ADEK, Folate, Iron): May decrease the serum concentration of Tetracyclines. Management: Avoid this combination if possible. If coadministration cannot be avoided, administer the polyvalent cation-containing multivitamin at least 2 hours before or 4 hours after the tetracycline derivative. Monitor for decreased tetracycline effects. Risk D: Consider therapy modification

Multivitamins/Minerals (with AE, No Iron): May decrease the serum concentration of Tetracyclines. Management: If coadministration of a polyvalent cation-containing multivitamin with oral tetracyclines cannot be avoided, administer the polyvalent cation-containing multivitamin either 2 hours before or 4 hours after the tetracycline product. Risk D: Consider therapy modification

Neuromuscular-Blocking Agents: Minocycline (Systemic) may enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents. Risk C: Monitor therapy

Penicillins: Tetracyclines may diminish the therapeutic effect of Penicillins. Risk C: Monitor therapy

Polyethylene Glycol-Electrolyte Solution: May decrease the absorption of Tetracyclines. Management: Give oral tetracyclines at least 2 hours before or at least 6 hours after polyethylene glycol-electrolyte solutions that contain magnesium sulfate (Suflave brand). Other products without magnesium do not require dose separation. Risk D: Consider therapy modification

Porfimer: Photosensitizing Agents may enhance the photosensitizing effect of Porfimer. Risk C: Monitor therapy

Quinapril: May decrease the serum concentration of Tetracyclines. Risk C: Monitor therapy

Retinoic Acid Derivatives: Tetracyclines may enhance the adverse/toxic effect of Retinoic Acid Derivatives. The development of pseudotumor cerebri is of particular concern. Risk X: Avoid combination

Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Risk D: Consider therapy modification

Strontium Ranelate: May decrease the serum concentration of Tetracyclines. Management: In order to minimize any potential impact of strontium ranelate on tetracycline antibiotic concentrations, it is recommended that strontium ranelate treatment be interrupted during tetracycline therapy. Risk X: Avoid combination

Sucralfate: May decrease the absorption of Tetracyclines. Management: Administer most tetracycline derivatives at least 2 hours prior to sucralfate in order to minimize the impact of this interaction. Administer oral omadacycline 4 hours prior to sucralfate. Risk D: Consider therapy modification

Sucroferric Oxyhydroxide: May decrease the serum concentration of Tetracyclines. Management: Administer oral/enteral doxycycline at least 1 hour before sucroferric oxyhydroxide. Specific dose separation guidelines for other tetracyclines are not presently available. No interaction is anticipated with parenteral administration of tetracyclines. Risk D: Consider therapy modification

Sulfonylureas: Tetracyclines may enhance the hypoglycemic effect of Sulfonylureas. Risk C: Monitor therapy

Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Avoid use of live attenuated typhoid vaccine (Ty21a) in patients being treated with systemic antibacterial agents. Postpone vaccination until 3 days after cessation of antibiotics and avoid starting antibiotics within 3 days of last vaccine dose. Risk D: Consider therapy modification

Verteporfin: Photosensitizing Agents may enhance the photosensitizing effect of Verteporfin. Risk C: Monitor therapy

Vitamin K Antagonists (eg, warfarin): Tetracyclines may enhance the anticoagulant effect of Vitamin K Antagonists. Risk C: Monitor therapy

Zinc Salts: May decrease the absorption of Tetracyclines. Only a concern when both products are administered orally. Management: Separate administration of oral tetracycline derivatives and oral zinc salts by at least 2 hours to minimize this interaction. Risk D: Consider therapy modification

Food Interactions

Minocycline serum concentrations are not significantly altered if taken with food or dairy products. Management: Administer without regard to food.

Reproductive Considerations

Minocycline is excreted in seminal fluid (Saivin 1988). Minocycline is not recommended for the treatment of acne in males or females attempting to conceive a child.

Pregnancy Considerations

Minocycline crosses the placenta.

Tetracycline-class antibiotics may cause fetal harm following maternal use in pregnancy. Rare spontaneous reports of congenital anomalies, including limb reduction, have been reported following maternal minocycline use. Due to limited information, a causal association cannot be established. Tetracyclines accumulate in developing teeth and long tubular bones (Mylonas 2011). Permanent discoloration of teeth (yellow, gray, brown) can occur following in utero exposure and is more likely to occur following long-term or repeated exposure.

As a class, tetracyclines are generally considered second-line antibiotics in pregnant patients and their use should be avoided (Mylonas 2011).

Untreated plague (Yersinia pestis) infection in pregnant patients may result in hemorrhage (including postpartum hemorrhage), maternal and fetal death, preterm birth, and stillbirth. Limited data suggest maternal-fetal transmission of Y. pestis can occur if not treated. Pregnant patients should be treated for Y. pestis; parenteral antibiotics are preferred for initial treatment when otherwise appropriate. Minocycline may be used as an alternative antibiotic for pre- and postexposure prophylaxis in pregnant patients exposed to Y. pestis (CDC [Nelson 2021]).

Minocycline is not recommended for the treatment of Rocky Mountain Spotted Fever (Biggs 2016), Q fever (Anderson 2012), or anthrax infection (Meaney-Delman 2014) in pregnant patients. Agents other than minocycline are recommended when systemic antibiotics are needed to treat acne during pregnancy (AAD [Zaenglein 2016]).

Breastfeeding Considerations

Minocycline is present in breast milk (Brogden 1975).

Oral absorption is not affected by dairy products; therefore, oral absorption of minocycline by the breastfed infant would not be expected to be diminished by the calcium in the maternal milk. There have been case reports of black discoloration of breast milk in women taking minocycline (Basler 1985; Hunt 1996).

According to the manufacturer, the decision to continue or discontinue breastfeeding during therapy should consider the risk of exposure to the infant and the benefits of treatment to the mother. As a class, tetracyclines have generally been avoided in breastfeeding women due to theoretical concerns that they may permanently stain the teeth of the breastfeeding infant (Chung 2002). Some sources note that breastfeeding can continue during tetracycline therapy (Chung 2002; WHO 2002) but recommend use of alternative medications when possible (WHO 2002). In general, antibiotics that are present in breast milk may cause nondose-related modification of bowel flora. Monitor infants for GI disturbances (Chung 2002; WHO 2002). Long-term use of tetracyclines (eg for the treatment of acne) is not recommended in breastfeeding women (AAD [Zaenglein 2016]).

Monitoring Parameters

Mental alertness; LFTs, BUN, renal function with long-term treatment, serum magnesium in patients with renal impairment; if symptomatic for autoimmune disorder, include ANA, CBC; ophthalmologic evaluation if visual disturbances occur; intracranial pressure until stabilization in patients with idiopathic intracranial hypertension. If used for syphilis, obtain follow up serologic tests 3 months after treatment.

Mechanism of Action

Inhibits bacterial protein synthesis by binding with the 30S and possibly the 50S ribosomal subunit(s) of susceptible bacteria; cell wall synthesis is not affected.

Pharmacokinetics (Adult Data Unless Noted)

Absorption: Oral: Well absorbed

Distribution: Widely distributed to most body fluids, bile, and tissues; poor CNS penetration; deposits in fat for extended periods; Vd: 0.14 to 0.7 L/kg (Zhanel 2004)

Protein binding: 55% to 96% (Zhanel 2004)

Metabolism: Hepatic to inactive metabolites

Bioavailability: 90% to 100% (Zhanel 2004)

Half-life elimination: IV: 15 to 23 hours; 11 to 16 hours (hepatic impairment); 18 to 69 hours (renal impairment); Oral: 16 hours (range: 11 to 17 hours)

Time to peak: Capsule, pellet filled: 1 to 4 hours; Tablet: 1 to 3 hours; Extended release tablet: 3.5 to 4 hours

Excretion: Urine (5% to 12% excreted unchanged) (Brogden 1975; Zhanel 2004); feces (20% to 34%) (Brogden 1975)

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

Anti-infective considerations:

Parameters associated with efficacy: Time and concentration dependent, associated with free 24-hour area under the curve (fAUC24)/minimum inhibitory concentration (MIC) (Agwuh 2006; Ambrose 2007; Cunha 2000; Lashinsky 2017).

Acinetobacter baumannii: fAUC24/MIC goal: ≥20 to 25 (1-log kill) (Alfouzan 2017; Tarazi 2019).

Expected drug exposure in normal renal function:

AUC:

Adults:

Oral:

100 mg single dose: AUC0-11: 9.64 ± 3.73 mg•hour/L (range: 3.8 to 19 mg•hour/L) (Maesen 1989).

200 mg, single dose: AUC0-24: ~47 mg•hour/L (Cartwright 1975).

IV:

200 mg, single dose: AUC0-7: 67 mg•hour/L (Agwuh 2006).

Postantibiotic effect: ~2 to 3 hours (B. anthracis) (Athamna 2004).

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (TW) Taiwan: Menocik
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