Minocycline

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
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
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	J01AA08 (WHO) A01AB23 (WHO)
Legal status
Legal status	AU: S4 (Prescription only)
Pharmacokinetic data
Bioavailability	100%
Metabolism	liver
Elimination half-life	11-22 hours
Excretion	mostly fecal, rest renal
Identifiers
IUPAC name 2-(amino-hydroxy-methylidene)-4,7- bis(dimethylamino)-10,11,12a-trihydroxy-4a,5,5a, 6-tetrahydro-4H-tetracene-1,3,12-trione (synonym 7-Dimethylamino-6-demethyl- 6-deoxytetracycline)
CAS Number	10118-90-8
PubChem CID	24960
DrugBank	APRD00547
E number	{{#property:P628}}
ECHA InfoCard	{{#property:P2566}}
Chemical and physical data
Formula	C23H27N3O7
Molar mass	457.477

WikiDoc Resources for Minocycline
Articles
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Evidence Based Medicine
Cochrane Collaboration on Minocycline Bandolier on Minocycline TRIP on Minocycline
Clinical Trials
Ongoing Trials on Minocycline at Clinical Trials.gov Trial results on Minocycline Clinical Trials on Minocycline at Google
Guidelines / Policies / Govt
US National Guidelines Clearinghouse on Minocycline NICE Guidance on Minocycline NHS PRODIGY Guidance FDA on Minocycline CDC on Minocycline
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News
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Commentary
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Definitions
Definitions of Minocycline
Patient Resources / Community
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Healthcare Provider Resources
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International
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Experimental / Informatics
List of terms related to Minocycline

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.

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.

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.

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%).

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

• Acne
• Amoebic dysentery
• Anthrax
• Cholera
• Gonorrhea (when penicillin cannot be given)
• Bubonic plague
• Respiratory infections such as pneumonia
• Rocky Mountain spotted fever
• Syphilis (when penicillin cannot be given)
• Urinary tract infections, rectal infections, and infections of the cervix caused by certain microbes

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, amongst others neurodegenerative diseases.

The neuroprotective action of minocycline may include its inhibitory effect on 5-lipoxygenase, an inflammatory enzyme associated with brain aging, and is being studied for use in Alzheimer's disease patients. 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 . 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.

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.

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.

External links

• British National Formulary 45 March 2003
• New Zealand Datasheet May 2002
• Minocycline on drugs.com
• Minocycline on medicinenet.com