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Dynacin (Minocycline Hydrochloride) - Summary

 



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)

Glatiramer Acetate in Combination with Minocycline in Patients with Relapsing-Remitting Multiple Sclerosis: Results of a Canadian, Multicenter, Double-Blind, Placebo-Controlled Trial. [2009.09.23]
Minocycline is proposed as an add-on therapy to improve the efficacy of glatiramer acetate in relapsing-remitting multiple sclerosis. The effect of minocycline plus glatiramer acetate was evaluated in this double-blind, placebo-controlled study by determining the total number of T1 gadolinium-enhanced lesions at months 8 and 9 in patients who were starting glatiramer acetate and had at least one T1 gadolinium-enhanced lesion on screening magnetic resonance imaging...

Local minocycline as an adjunct to surgical therapy in moderate to severe, chronic periodontitis. [2008.06]
CONCLUSION: Applications of local minocycline as an adjunct to surgery in adults with moderate to severe, chronic periodontitis were associated with statistically significant greater reductions in probing depth than surgery alone.

Randomized double-blind trial of prophylactic oral minocycline and topical tazarotene for cetuximab-associated acne-like eruption. [2007.12.01]
PURPOSE: To evaluate the ability of either oral minocycline, topical tazarotene or both, to reduce or prevent cetuximab-related acneiform rash when administered starting on day 1 of cetuximab therapy... CONCLUSION: Prophylaxis with oral minocycline may be useful in decreasing the severity of the acneiform rash during the first month of cetuximab treatment. Topical tazarotene is not recommended for management of cetuximab-related rash.

Topical minocycline and tetracycline rinses in treatment of recurrent aphthous stomatitis: a randomized cross-over study. [2007.05.01]
Recurrent aphthous stomatitis (RAS) is a common ulcerative condition of the oral mucosa. We assessed minocycline and tetracycline oral rinses in patients with frequent episodes of RAS in a clinical randomized crossover trial...

Effect of treatment of rosacea in females by Chibixiao Recipe in combination with minocycline and spironolactone. [2006.12]
OBJECTIVE: To observe the clinical efficacy of Chibixiao Recipe (CBX) in combination with minocycline and spironolactone in treating rosacea in females... CONCLUSION: CBX in combination with Western medicine has effect in treating rosacea superior to that of Western medicine alone, and could effectively reduce recurrent rate and the serum level of testosterone. female rosacea, testosterone, Chibixiao Recipe, minocycline, spironolactone

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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.

Treatment of Early RA: Minocycline in Combination With Methotrexate vs Methotrexate Alone [Completed]
The purpose of this study is to determine if a combination of methotrexate and minocycline works better than methotrexate alone in early Rheumatoid Arthritis

Comparison of Tazarotene and Minocycline Therapies for Maintenance of Facial Acne Vulgaris [Completed]

Minocycline for HIV+ Cognitive Impairment in Uganda [Recruiting]
Purpose: The purpose of the study is to assess the safety and effectiveness of minocycline, an antibiotic, in the treatment of HIV-associated cognitive impairment in Uganda.

Study Design: Treatment, 24-week Randomized, Placebo-Controlled, Double-Blind Phase with Optional 24-week Open Label Phase for Subjects with a CD4 Count in the 251-350 Range

- Arm 1: Minocycline 100 mg orally every 12 hours (50 subjects)

- Arm 2: Matching placebo orally every 12 hours (50 subjects)

Primary Outcome Measure:

ยท To examine whether minocycline treatment will improve cognitive performance after 24 weeks compared to baseline

Secondary Outcome Measures:

- To examine whether minocycline treatment for 24 weeks is safe and well-tolerated in

individuals with HIV-associated cognitive impairment

- To examine whether minocycline treatment for 48 weeks is safe and well-tolerated in

individuals with HIV-associated cognitive impairment

- To examine whether minocycline treatment for 24 weeks improves functional impairment

Intrapleural Minocycline After Simple Aspiration for the Prevention of Primary Spontaneous Pneumothorax [Recruiting]
The estimated recurrence rate of primary spontaneous pneumothorax is 23-50% after the first episode, and the optimal treatment remains unknown. In the recently published British Thoracic Society (BTS) guidelines, simple aspiration is recommended as first line treatment for all primary pneumothoraces requiring intervention. However, the 1 year recurrence rate of this procedure was as high as 25-30%, making it inappropriate as a standard of care.

Intrapleural instillation of a chemical irritant (chemical pleurodesis) is an effective way to shorten the duration of air leaks and reduce the rates of recurrent spontaneous pneumothorax in surgical and non-surgical patients. Many chemical irritants (tetracycline, talc, and minocycline) have been used to decrease the rate of recurrence in spontaneous pneumothorax. Tetracycline, which was the most commonly used irritant, is no longer available. Talc insufflation of the pleural cavity is safe and effective for primary spontaneous pneumothorax. However, it should be applied either with surgical or medical thoracoscopy. Minocycline, a derivative of tetracycline, is as effective as tetracycline in inducing pleural fibrosis in rabbits. In the previous studies, we have shown that additional minocycline pleurodesis is a safe and convenient procedure to decrease the rates of ipsilateral recurrence after thoracoscopic treatment of primary spontaneous pneumothorax. In the present study, additional minocycline pleurodesis will be randomly administered in patients with first episode of primary spontaneous pneumothorax after simple aspiration to test if it can reduce the rate of recurrence.

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Page last updated: 2009-10-20

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