Minocycline

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Minocycline
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [2]; Associate Editor(s)-in-Chief: Ammu Susheela, M.D. [3]

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Overview

Minocycline is a tetracycline antiobiotic that is FDA approved for the treatment of is indicated as an adjunct to scaling and root planing procedures for reduction of pocket depth in patients with adult periodontitis. Minocycline may be used as part of a periodontal maintenance program which includes good oral hygiene, and scaling and root planing.. Common adverse reactions include the most frequently reported nondental treatment-emergent adverse events in the 3 multicenter US trials were headache, infection, flu syndrome, and pain. Dental conditions include peritonitis, gingivitis, stomatitis, pharyngitis.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Minocycline is indicated as an adjunct to scaling and root planing procedures for reduction of pocket depth in patients with adult periodontitis. Minocycline may be used as part of a periodontal maintenance program which includes good oral hygiene, and scaling and root planing.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Minocycline in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Minocycline in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Minocycline FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Minocycline in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Minocycline in pediatric patients.

Contraindications

It should not be used in any patient who has a known sensitivity to tetracyclines.

Warnings

There is limited information regarding Minocycline Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

  • This medication may cause upset stomach, diarrhea, dizziness, unsteadiness, drowsiness, headache or vomiting. If these symptoms persist or worsen, one should notify their doctor. Minocycline increases sensitivity to sunlight. Prolonged sun exposure should be avoided. Wear protective clothing and use a sunscreen if needed. Very unlikely but should be reported: fever, yellowing of the eyes or skin, stomach pain, sore throat, vision changes and mental changes.
  • In those cases where this drug must be used for extended periods, blue-gray skin discoloration may occur. In the unlikely event one has an allergic reaction to this drug, immediate medical attention should be sought. Symptoms of an allergic reaction include rash, itching, swelling, severe dizziness, trouble breathing. Other effects not listed above should be reported to the doctor or pharmacist.

Postmarketing Experience

There is limited information regarding Minocycline Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Minocycline Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Minocycline in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Minocycline in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Minocycline during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Minocycline in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Minocycline in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Minocycline in geriatric settings.

Gender

There is no FDA guidance on the use of Minocycline with respect to specific gender populations.

Race

There is no FDA guidance on the use of Minocycline with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Minocycline in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Minocycline in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Minocycline in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Minocycline in patients who are immunocompromised.

Administration and Monitoring

Administration

  • THE USUAL DOSAGE AND FREQUENCY OF ADMINISTRATION OF MINOCYCLINE DIFFERS FROM THAT OF THE OTHER TETRACYCLINES. EXCEEDING THE RECOMMENDED DOSAGE MAY RESULT IN AN INCREASED INCIDENCE OF SIDE EFFECTS.
  • Minocycline hydrochloride capsules may be taken with or without food.
  • For Pediatric Patients Above 8 Years of Age

The usual dosage of minocycline hydrochloride capsules is 4 mg/kg initially followed by 2 mg/kg every 12 hours. Adults

  • The usual dosage of minocycline hydrochloride is 200 mg initially followed by 100 mg every 12 hours. Alternatively, if more frequent doses are preferred, two or four 50 mg capsules may be given initially followed by one 50 mg capsule four times daily.
  • Uncomplicated gonococcal infections other than urethritis and anorectal infections in men: 200 mg initially, followed by 100 mg every 12 hours for a minimum of four days, with post-therapy cultures within 2 to 3 days.
  • In the treatment of uncomplicated gonococcal urethritis in men, 100 mg every 12 hours for five days is recommended.
  • For the treatment of syphilis, the usual dosage of minocycline hydrochloride capsules should be administered over a period of 10 to 15 days. Close follow-up, including laboratory tests, is recommended.
  • In the treatment of meningococcal carrier state, the recommended dosage is 100 mg every 12 hours for five days.
  • Mycobacterium marinum infections: Although optimal doses have not been established, 100 mg every 12 hours for 6 to 8 weeks have been used successfully in a limited number of cases.
  • Uncomplicated urethral, endocervical, or rectal infections in adults caused by Chlamydia trachomatis or Ureaplasma urealyticum: 100 mg orally, every 12 hours for at least seven days.
  • Ingestion of adequate amounts of fluids along with capsule and tablet forms of drugs in the tetracycline-class is recommended to reduce the risk of esophageal irritation and ulceration.
  • In patients with renal impairment, the total dosage should be decreased by either reducing the recommended individual doses and/or by extending the time intervals between doses.

Monitoring

There is limited information regarding Minocycline Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Minocycline and IV administrations.

Overdosage

There is limited information regarding Minocycline overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

Template:Px
Template:Px
Minocycline
Systematic (IUPAC) name
(2E,4S,4aR,5aS,12aR)- 2-(amino-hydroxy-methylidene)- 4,7-bis(dimethylamino)- 10,11,12a-trihydroxy-4a,5,5a,6- tetrahydro-4H-tetracene- 1,3,12-trione[1]
Identifiers
CAS number 10118-90-8
ATC code J01AA08 A01AB23 (WHO)
PubChem 24960
DrugBank DB01017
Chemical data
Formula Template:OrganicBox atomTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox 
Mol. mass 457.477
SMILES eMolecules & PubChem
Pharmacokinetic data
Bioavailability 100%
Metabolism liver
Half life 11–22 hours
Excretion mostly fecal, rest renal
Therapeutic considerations
Licence data

US

Pregnancy cat.

D(US)

Legal status

Prescription Only (S4)(AU) [[Prescription drug|Template:Unicode-only]](US)

Routes oral

Mechanism of Action

There is limited information regarding Minocycline Mechanism of Action in the drug label.

Structure

There is limited information regarding Minocycline Structure in the drug label.

Pharmacodynamics

There is limited information regarding Minocycline Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Minocycline Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Minocycline Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Minocycline Clinical Studies in the drug label.

How Supplied

  • Minocycline equivalent to 50 mg minocycline are opaque white capsules imprinted "0487" and "DYNACIN® 50 mg" and are supplied as follows:

NDC 99207-487-10 Bottles of 100 NDC 99207-487-11 Bottle of 1000.

  • Minocycline equivalent to 75 mg minocycline are light gray opaque capsules imprinted "0489" and "DYNACIN® 75 mg" and are supplied as follows:

NDC 99207-489-10 Bottles of 100 NDC 99207-489-11 Bottle of 1000.

  • Minocycline equivalent to 100 mg minocycline are opaque dark gray and opaque white capsules imprinted "0488" and "DYNACIN® 100 mg" and are supplied as follows:

NDC 99207-488-05 Bottles of 50 NDC 99207-488-11 Bottle of 1000.

  • Dispense in tight, light-resistant container with child-resistant closure.
  • Store at 20º–25ºC (68º–77ºF).
  • Protect from light, moisture and excessive heat.

Storage

There is limited information regarding Minocycline Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Minocycline Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Minocycline interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Minomycin Minocin Arestin Akamin Aknemin Solodyn Dynacin Sebomin

Look-Alike Drug Names

There is limited information regarding Minocycline Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

Minocycline
Clinical data
Routes of
administration
oral
ATC code
Legal status
Legal status
  • AU: S4 (Prescription only)
Pharmacokinetic data
Bioavailability100%
Metabolismliver
Elimination half-life11-22 hours
Excretionmostly fecal, rest renal
Identifiers
CAS Number
PubChem CID
DrugBank
E number{{#property:P628}}
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Chemical and physical data
FormulaC23H27N3O7
Molar mass457.477

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Clinical Trials

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Guidelines / Policies / Govt

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International

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Minocycline hydrochloride, also known as minocycline, is a member of the broad spectrum tetracycline antibiotics, and has a broader spectrum than the other members. It is a bacteriostatic antibiotic. As a result of its long half-life it generally has serum levels 2-4 times that of most other tetracyclines (150 mg giving 16 times the activity levels compared to 250 mg of tetracycline at 24-48 hours). Minocycline was originally discovered by Lederle Laboratories and marketed under the brand name Minocin.[1]

Indications

It is primarily used to treat acne and other skin infections as the one pill twice daily 100 mg dosage is far easier for patients than the four times a day required with tetracycline or oxytetracycline.

Although minocycline's broader spectrum of activity, compared to other members of the group, includes activity against Neisseria meningitidis, its use as a prophylaxis is no longer recommended because of side effects (dizziness and vertigo).

It may be used to treat certain strains of MRSA infection and disease caused by drug resistant Acinetobacter.

For other uses of minocycline see Tetracycline antibiotics and oxytetracycline as the uses are much the same between Tetracyclines with only minor exceptions.

Cautions

Contrary to all the other tetracycline antibiotics (Doxycyclin excluded), minocycline may be used in renal impairment, but may be aggravating systemic lupus erythematosus.[2]

Also, more so than other tetracyclines, minocycline can cause the rare condition of secondary intracranial hypertension which has initial symptoms of headache, visual disturbances, and confusion. Meningitis and cerebral edema are rare side effects of minocycline.[3]

Minocycline, like all tetracyclines, becomes dangerous past its expiration date. While most prescription drugs lose potency after their expiration dates, tetracyclines are known to become toxic over time; expired tetracyclines can cause serious damage to the kidneys.

Minocycline's absorption is impaired if taken at the same time of day as calcium or iron supplements. Unlike some of the other tetracycline group antibiotics, it can be taken with calcium rich foods such as milk, although this does reduce the absorption slightly (by ~5%).[citation needed]

Side effects

This medication may cause upset stomach, diarrhea, dizziness, unsteadiness, drowsiness, headache or vomiting. If these symptoms persist or worsen, one should notify their doctor. Minocycline increases sensitivity to sunlight. Prolonged sun exposure should be avoided. Wear protective clothing and use a sunscreen if needed. Very unlikely but should be reported: fever, yellowing of the eyes or skin, stomach pain, sore throat, vision changes and mental changes.

In those cases where this drug must be used for extended periods, blue-gray skin discoloration may occur. In the unlikely event one has an allergic reaction to this drug, immediate medical attention should be sought. Symptoms of an allergic reaction include rash, itching, swelling, severe dizziness, trouble breathing. Other effects not listed above should be reported to the doctor or pharmacist.

Uses

Anti-inflammatory and neuroprotective

Current research is examining the possible neuroprotective and anti-inflammatory effects of minocycline against progression of a group of neurodegenerative disorders including multiple sclerosis (MS), rheumatoid arthritis (RA), amyotrophic lateral sclerosis (ALS), Huntington's disease, and Parkinsons disease,[4] amongst others neurodegenerative diseases.[5][6][7]

The neuroprotective action of minocycline may include its inhibitory effect on 5-lipoxygenase,[8] an inflammatory enzyme associated with brain aging, and is being studied for use in Alzheimer's disease patients.[9] It also has been used as a "last ditch" treatment for toxoplasmosis in AIDS patients. Minocycline is neuroprotective in mouse models of amyotrophic lateral sclerosis (ALS) and Huntington's disease and has been recently shown to stabilize the course of Huntington's disease in humans over a 2-year period.

As an anti-inflammatory, minocycline inhibits apoptosis (cell death) via attenuation of TNF-alpha, downregulating pro-inflammatory cytokine output. This effect is mediated by a direct action of minocycline on the activated T cells and on microglia, which results in the decreased ability of T cells to contact microglia which impairs cytokine production in T cell-microglia signal transduction .[10] Minocycline also inhibits microglial activation, through blockade of NF-kappa B nuclear translocation.

It is thought that minocycline exerts neuroprotective effects independent of its anti-inflammatory properties.[11]

A recent study reported the impact of the antibiotic minocycline on clinical and magnetic resonance imaging (MRI) outcomes and serum immune molecules in MS patients over 24 months of open-label minocycline treatment. Despite a moderately high pretreatment relapse rate in patients in the study prior to treatment, no relapses occurred between months 6 and 24. The only patient with gadolinium-enhancing lesions on MRI at 12 and 24 months was on half-dose minocycline. Levels of interleukin-12 (IL-12), which at high levels might antagonize the proinflammatory IL-12 receptor, were elevated over 18 months of treatment, as were levels of soluble vascular cell adhesion molecule-1 (VCAM-1). The activity of matrix metalloproteinase-9 was decreased by treatment. Clinical and MRI outcomes in this study were supported by systemic immunological changes and call for further investigation of minocycline in MS.[12][13][11][14]

Trade names and availability

Minocycline is no longer covered by patent and is therefore marketed under several trade names:

  • Minomycin
  • Minocin
  • Arestin
  • Akamin
  • Aknemin
  • Solodyn
  • Dynacin
  • Sebomin

StoneBridge Pharma also markets Minocycline as Cleeravue-M in combination with SteriLid eyelid cleanser in the treatment of rosacea blepharitis.

Footnotes

  1. [1]Lin, DW The Tetracyclines March 2005
  2. Gough A, Chapman S, Wagstaff K, Emery P, Elias E (1996). "Minocycline induced autoimmune hepatitis and systemic lupus erythematosus-like syndrome". BMJ. 312 (7024): 169–72. PMID 8563540.
  3. Lefebvre N, Forestier E, Farhi D; et al. (2007). "Minocycline-induced hypersensitivity syndrome presenting with meningitis and brain edema: a case report". Journal of Medical Case Reports. 1: 22.
  4. "Preliminary Study Shows Creatine and Minocycline May Warrant Further Study In Parkinson's Disease" (Press release). National Institute of Health. February 23, 2006.
  5. Chen M, Ona VO, Li M, Ferrante RJ, Fink KB, Zhu S, Bian J, Guo L, Farrell LA, Hersch SM, Hobbs W, Vonsattel JP, Cha JH, Friedlander RM (2000). "Minocycline inhibits caspase-1 and caspase-3 expression and delays mortality in a transgenic mouse model of Huntington disease". Nat Med. 6 (7): 797–801. PMID 10888929.
  6. Tikka TM, Koistinaho JE (2001). ["Minocycline provides neuroprotection against N-methyl-D-aspartate neurotoxicity by inhibiting microglia" Check |url= value (help). J Immunol. 166 (12): 7527–33. PMID 11390507.
  7. Nirmalananthan N, Greensmith L (2005). "Amyotrophic lateral sclerosis: recent advances and future therapies". Curr. Opin. Neurol. 18 (6): 712–9. PMID 16280684.
  8. Song Y, Wei EQ, Zhang WP, Zhang L, Liu JR, Chen Z (2004). "Minocycline protects PC12 cells from ischemic-like injury and inhibits 5-lipoxygenase activation". Neuroreport. 15 (14): 2181–4. PMID 15371729.
  9. Uz T, Pesold C, Longone P, Manev H (1998). "Aging-associated up-regulation of neuronal 5-lipoxygenase expression: putative role in neuronal vulnerability". FASEB J. 12 (6): 439–49. PMID 9535216.
  10. Giuliani F, Hader W, Yong VW (2005). "Minocycline attenuates T cell and microglia activity to impair cytokine production in T cell-microglia interaction". J. Leukoc. Biol. 78 (1): 135–43. doi:10.1189/jlb.0804477. PMID 15817702.
  11. 11.0 11.1 Maier K, Merkler D, Gerber J, Taheri N, Kuhnert AV, Williams SK, Neusch C, Bähr M, Diem R (2007). "Multiple neuroprotective mechanisms of minocycline in autoimmune CNS inflammation". Neurobiol. Dis. 25 (3): 514–25. doi:10.1016/j.nbd.2006.10.022. PMID 17239606.
  12. Zabad RK, Metz LM, Todoruk TR, Zhang Y, Mitchell JR, Yeung M, Patry DG, Bell RB, Yong VW (2007). "The clinical response to minocycline in multiple sclerosis is accompanied by beneficial immune changes: a pilot study". Mult. Scler. 13 (4): 517–26. doi:10.1177/1352458506070319. PMID 17463074.
  13. Zemke D, Majid A (2004). "The potential of minocycline for neuroprotection in human neurologic disease". Clinical neuropharmacology. 27 (6): 293–8. PMID 15613934.
  14. Popovic N, Schubart A, Goetz BD, Zhang SC, Linington C, Duncan ID (2002). "Inhibition of autoimmune encephalomyelitis by a tetracycline". Ann. Neurol. 51 (2): 215–23. PMID 11835378.

External links

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