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. [1]; Associate Editor(s)-in-Chief: Ammu Susheela, M.D. [2]

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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

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

Minocycline structure.png
Minocycline-from-xtal-PDB-2DRD-3D-balls.png
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
PubChem 24960
DrugBank DB01017
Chemical data
Formula C23H27N3O7 
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) -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

Package and Label Display Panel

This image is provided by the National Library of Medicine.
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This image of the FDA label is provided by the National Library of Medicine.

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

  • MINOCYCLINE HYDROCHLORIDE ®[2]

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.


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