DYNACIN SUMMARY
DYNACIN® (MINOCYCLINE HCl TABLETS, USP)
Minocycline hydrochloride, a semisynthetic derivative of tetracycline, is 4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride.
Minocycline hydrochloride tablets are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms:
- Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox and tick fevers caused by Rickettsiae.
- Respiratory tract infections caused by Mycoplasma pneumoniae.
- Lymphogranuloma venereum caused by Chlamydia trachomatis.
- Psittacosis (Ornithosis) due to Chlamydia psittaci.
- Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunoflourescence.
- Inclusion conjunctivitis caused by Chlamydia trachomatis.
- Nongonococcal urethritis, endocervical, or rectal infections in adults caused by Ureaplasma urealyticum or Chlamydia trachomatis.
- Relapsing fever due to Borrelia recurrentis.
- Chancroid caused by Haemophilus ducreyi.
- Plague due to Yersinia pestis.
- Tularemia due to Francisella tularensis.
- Cholera caused by Vibrio cholerae.
- Campylobacter fetus infections caused by Campylobacter fetus.
- Brucellosis due to Brucella species (in conjunction with streptomycin).
- Bartonellosis due to Bartonella bacilliformis.
- Granuloma inguinale caused by Calymmatobacterium granulomatis.
Minocycline is indicated for treatment of infections caused by the following gram-negative microorganisms, when bacteriologic testing indicates appropriate susceptibility to the drug:
- Escherichia coli.
- Enterobacter aerogenes.
- Shigella species.
- Acinetobacter species.
- Respiratory tract infections caused by Haemophilus influenzae.
- Respiratory tract and urinary tract infections caused by Klebsiella species.
Minocycline hydrochloride tablets are indicated for the treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug:
- Upper respiratory tract infections caused by Streptococcus pneumoniae.
- Skin and skin structure infections caused by Staphylococcus aureus.
- (Note: Minocycline is not the drug of choice in the treatment of any type of staphylococcal infection.)
When penicillin is contraindicated, minocycline is an alternative drug in the treatment of the following infections:
- Uncomplicated urethritis in men due to Neisseria gonorrhoeae and for the treatment of other gonococcal infections.
- Infections in women caused by Neisseria gonorrhoeae.
- Syphilis caused by Treponema pallidum subspecies pallidum.
- Yaws caused by Treponema pallidum subspecies pertenue.
- Listeriosis due to Listeria monocytogenes.
- Anthrax due to Bacillus anthracis.
- Vincent's infection caused by Fusobacterium fusiforme.
- Actinomycosis caused by Actinomyces israelii.
- Infections caused by Clostridium species.
In acute intestinal amebiasis, minocycline may be useful adjunct to amebicides.
In severe acne, minocycline may be useful adjunctive therapy.
Oral minocycline is indicated in the treatment of asymptomatic carriers of Neisseria meningitidis to eliminate the meningococci from the nasopharynx. In order to preserve the usefulness of minocycline in the treatment of asymptomatic meningococcal carrier, diagnostic laboratory procedures, including serotyping and susceptibility testing, should be performed to establish the carrier state and the correct treatment. It is recommended that the prophylactic use of minocycline be reserved for situations in which the risk of meningococcal meningitis is high.
Oral minocycline is not indicated for the treatment of meningococcal infection.
Although no controlled clinical efficacy studies have been conducted, limited clinical data show that oral minocycline hydrochloride has been used successfully in the treatment of infections caused by Mycobacterium marinum.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of, minocycline hydrochloride tablets and other antibacterial drugs, minocycline hydrochloride tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antimicrobial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
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NEWS HIGHLIGHTS
Published Studies Related to Dynacin (Minocycline)
Minocycline-EDTA lock solution prevents catheter-related bacteremia in hemodialysis. [2011.10]
There is growing concern about the development of antibacterial resistance with the use of antibiotics in catheter lock solutions...
Minocycline treatment for HIV-associated cognitive impairment: results from a randomized trial. [2011.09.20]
OBJECTIVE: We conducted a study of minocycline to assess its safety, tolerability, and efficacy for the treatment of HIV-associated cognitive impairment... CONCLUSION: Minocycline was safe and well-tolerated in individuals with HIV-associated cognitive impairment, but cognitive improvement was not observed. Classification of evidence. This interventional study provides Class II evidence for the safety, tolerability, and efficacy of minocycline for the treatment of HIV-associated cognitive impairment.
Clinical and biochemical efficacy of minocycline in nonsurgical periodontal therapy: a randomized controlled pilot study. [2011.06]
The present study evaluated the effects of systemic minocycline on clinical and biochemical parameters of chronic periodontitis, which is a common inflammatory disorder of the periodontium initiated by the presence of bacteria in the gingival sulcus...
Non-surgical periodontal therapy with and without subgingival minocycline administration in patients with poorly controlled type II diabetes: a randomized controlled clinical trial. [2011.03.18]
The aim of this study was to evaluate changes in clinical parameters and levels of inflammatory biomarkers in plasma in periodontal patients with poorly controlled type 2 diabetes mellitus (T2DM) after non-surgical periodontal therapy. Twenty-eight poorly controlled T2DM patients were randomly assigned to treatment with scaling and root planning (SRP) and SRP + subgingival minocycline administration...
A randomised controlled trial assessing the effect of adding clarithromycin to rifampicin, ofloxacin and minocycline in the treatment of single lesion paucibacillary leprosy in Agra District, India. [2011.03]
AIM: To assess if there is any additional short and long-term effect of adding clarithromycin to rifampicin, ofloxacin and minocycline (ROM), the combination here after called C-ROM, in treating single lesion PB leprosy detected in the field... CONCLUSION: The study shows that addition of clarithromycin to ROM does not significantly improve the efficacy as measured in terms of cure rates and relapse rates in single skin lesion leprosy patients.
Clinical Trials Related to Dynacin (Minocycline)
Pilot Study of Minocycline in Huntington's Disease [Active, not recruiting]
This study is being conducted to assess the impact of minocycline on the progression of
symptoms of HD. The study will also assess whether it is reasonable to continue with further
study of minocycline in HD. We will measure the effect of minocycline on HD by measuring the
change in Huntington's disease symptoms.
A Study for Reducing Symptom Burden Produced by Chemoradiation Treatment for Non Small Cell Lung Cancer by Minocycline and Armodafinil [Recruiting]
The goal of this clinical research study is to compare armodafinil and minocycline when
given alone or in combination to learn which is better for controlling symptoms, such as the
side effects of chemoradiation, when given to treat lung cancer.
Adjunctive Minocycline in Clozapine Treated Schizophrenia Patients [Recruiting]
Schizophrenia is a devastating and costly illness. One-third to one-half of people with
schizophrenia do not respond to the most current drugs leaving clozapine as the best
alternative for treatment. However, over 60% of people treated with clozapine continue to
have persistent symptoms and cognitive impairments. Little data is available to support
evidence-based recommendations to guide clinicians in treating these patients. Preliminary
data has suggested that adjunct treatment with minocycline may offer robust symptom
improvement in patients with schizophrenia, including those taking clozapine. Minocycline
has had interesting effects; including suggesting it may have a significant role in
treatment of neurologic and psychiatric disorders. Minocycline is currently available
generically; its side effects are well-described and minimal. The proposed double-blind
treatment study seeks to demonstrate that adjunctive minocycline offers patients superior
efficacy for persistent positive symptoms, cognitive impairments, and/or other components of
schizophrenia pathology. This knowledge could lead to the more effective treatment of
patients with schizophrenia. The research itself may lead to a better understanding of the
pathophysiology of positive symptoms and cognitive impairments, which could contribute to
improved treatments in the future.
Minocycline and Aspirin in the Treatment of Bipolar Depression [Not yet recruiting]
The purpose of this study is to determine whether Minocycline and aspirin are effective in
the treatment of depression in Bipolar patients.
Minocycline in Clinically Isolated Syndromes (CIS) [Recruiting]
The aim of the trial is to demonstrate that 100 mg of oral minocycline twice daily reduces
the conversion of CIS to McDonald Criteria MS (McDMS) by an absolute 25% as compared to
placebo, over a 6 month follow-up period (primary outcome).
A key secondary outcome is to confirm that this early treatment benefit is maintained at two
years.
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