Minocycline Hydrochloride

Minocycline Hydrochloride

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Questions & Answers

Side Effects & Adverse Reactions

MINOCYCLINE HYDROCHLORIDE CAPSULES, LIKE OTHER TETRACYCLINE-CLASS ANTIBIOTICS, CAN CAUSE FETAL HARM WHEN ADMINISTERED TO A PREGNANT WOMAN. IF ANY TETRACYCLINE IS USED DURING PREGNANCY OR IF THE PATIENT BECOMES PREGNANT WHILE TAKING THESE DRUGS, THE PATIENT SHOULD BE APPRISED OF THE POTENTIAL HAZARD TO THE FETUS. THE USE OF DRUGS OF THE TETRACYCLINE CLASS DURING TOOTH DEVELOPMENT (LAST HALF OF PREGNANCY, INFANCY, AND CHILDHOOD TO THE AGE OF 8 YEARS) MAY CAUSE PERMANENT DISCOLORATION OF THE TEETH (YELLOW-GRAY-BROWN).

This adverse reaction is more common during long-term use of the drug but has been observed following repeated short-term courses. Enamel hypoplasia has also been reported. TETRACYCLINE DRUGS, THEREFORE, SHOULD NOT BE USED DURING TOOTH DEVELOPMENT UNLESS OTHER DRUGS ARE NOT LIKELY TO BE EFFECTIVE OR ARE CONTRAINDICATED.

All tetracyclines form a stable calcium complex in any bone-forming tissue. A decrease in the fibula growth rate has been observed in premature human infants given oral tetracycline in doses of 25 mg/kg every six hours. This reaction was shown to be reversible when the drug was discontinued.

Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can have toxic effects on the developing fetus (often related to retardation of skeletal development). Evidence of embryotoxicity has been noted in animals treated early in pregnancy.

Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) including fatal cases have been reported with minocycline use. If this syndrome is recognized, the drug should be discontinued immediately.

The anti-anabolic action of the tetracyclines may cause an increase in BUN. While this is not a problem in those with normal renal function, in patients with significantly impaired function, higher serum levels of tetracycline may lead to azotemia, hyperphosphatemia, and acidosis. Under such conditions, monitoring of creatinine and BUN is recommended, and the total daily dosage should not exceed 200 mg in 24 hours. (See DOSAGE AND ADMINISTRATION.) If renal impairment exists, even usual oral or parenteral doses may lead to systemic accumulation of the drug and possible liver toxicity.

Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. This has been reported with minocycline.

Central nervous system side effects including light-headedness, dizziness, or vertigo have been reported with minocycline therapy. Patients who experience these symptoms should be cautioned about driving vehicles or using hazardous machinery while on minocycline therapy. These symptoms may disappear during therapy and usually disappear rapidly when the drug is discontinued.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including minocycline hydrochloride, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. 

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

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Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

Minocycline hydrochloride capsules, USP 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 immunofluorescence.
  • 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 the 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 capsules, USP 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 a 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 meningococci from the nasopharynx. In order to preserve the usefulness of minocycline in the treatment of asymptomatic meningococcal carriers, 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 capsules, USP and other antibacterial drugs, minocycline hydrochloride capsules, USP 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 antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

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History

There is currently no drug history available for this drug.

Other Information

Minocycline hydrochloride, USP, is a semisynthetic derivative of tetracycline, 4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride.

Its structural formula is:

image description

Minocycline hydrochloride capsules, USP for oral administration contain minocycline hydrochloride, USP equivalent to 50 mg, 75 mg or 100 mg of minocycline. The capsule also contains the following inactive ingredients: corn starch and magnesium stearate. The empty hard gelatin capsule shells contain titanium dioxide, sodium lauryl sulfate, and gelatin. In addition, the 50 mg capsule shells contain FD&C Red #3, D&C Red #33, and FD&C Yellow #6; the 75 mg capsule shells contain black iron oxide; and the 100 mg capsule shells contain FD&C Blue #1, D&C Red #28, FD&C Red #40, and red iron oxide. The capsules are printed with edible ink containing shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, and potassium hydroxide.

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Minocycline Hydrochloride Manufacturers


  • Direct Rx
    Minocycline Hydrochloride Capsule [Direct Rx]
  • Avpak
    Minocycline Hydrochloride (Minocycline Hydrochloride) Capsule [Avpak]
  • Indicus Pharma Llc
    Minocycline Hydrochloride (Minocycline Hydrochloride) Tablet, Film Coated [Indicus Pharma Llc]
  • Dr. Reddy’s Laboratories Limited
    Minocycline Hydrochloride Tablet, Film Coated [Dr. Reddy’s Laboratories Limited]
  • Lake Erie Medical Dba Quality Care Products Llc
    Minocycline Hydrochloride Capsule [Lake Erie Medical Dba Quality Care Products Llc]
  • Rebel Distributors Corp.
    Minocycline Hydrochloride Capsule [Rebel Distributors Corp.]
  • Global Pharmaceuticals, Division Of Impax Laboratories Inc.
    Minocycline Hydrochloride Capsule [Global Pharmaceuticals, Division Of Impax Laboratories Inc.]
  • Remedyrepack Inc.
    Minocycline Hydrochloride Capsule [Remedyrepack Inc. ]
  • American Health Packaging
    Minocycline Hydrochloride Capsule [American Health Packaging]
  • Ranbaxy Pharmaceuticals Inc.
    Minocycline Hydrochloride (Minocycline Hydrochloride) Tablet, Film Coated [Ranbaxy Pharmaceuticals Inc.]
  • Physicians Total Care, Inc.
    Minocycline Hydrochloride Capsule [Physicians Total Care, Inc.]
  • Pd-rx Pharmaceuticals, Inc.
    Minocycline Hydrochloride Capsule [Pd-rx Pharmaceuticals, Inc.]
  • Avkare, Inc.
    Minocycline Hydrochloride (Minocycline Hydrochloride) Capsule [Avkare, Inc.]
  • Bryant Ranch Prepack
    Minocycline Hydrochloride Capsule [Bryant Ranch Prepack]
  • Cardinal Health
    Minocycline Hydrochloride Capsule [Cardinal Health]
  • Global Pharmaceuticals, Division Of Impax Laboratories Inc.
    Minocycline Hydrochloride Tablet, Extended Release [Global Pharmaceuticals, Division Of Impax Laboratories Inc.]
  • Teva Pharmaceuticals Usa Inc
    Minocycline Hydrochloride Capsule [Teva Pharmaceuticals Usa Inc]
  • Cardinal Health
    Minocycline Hydrochloride Capsule [Cardinal Health]
  • Lake Erie Medical Dba Quality Care Products Llc
    Minocycline Hydrochloride Capsule [Lake Erie Medical Dba Quality Care Products Llc]
  • Caraco Pharmaceutical Laboratories, Ltd.
    Minocycline Hydrochloride Capsule Minocycline Hydrochloride (Minocycline Hydrochloride ) Capsule [Caraco Pharmaceutical Laboratories, Ltd.]
  • Preferred Pharmaceuticals, Inc
    Minocycline Hydrochloride Capsule [Preferred Pharmaceuticals, Inc]
  • Remedyrepack Inc.
    Minocycline Hydrochloride Capsule [Remedyrepack Inc. ]
  • Dispensing Solution, Inc.
    Minocycline Hydrochloride Capsule [Dispensing Solution, Inc.]
  • Clinical Solutions Wholesale
    Minocycline Hydrochloride Capsule [Clinical Solutions Wholesale]
  • Remedyrepack Inc.
    Minocycline Hydrochloride Capsule [Remedyrepack Inc. ]
  • Kaiser Foundation Hospitals
    Minocycline Hydrochloride Capsule [Kaiser Foundation Hospitals]
  • Aurobindo Pharma Limited
    Minocycline Hydrochloride Tablet, Film Coated, Extended Release [Aurobindo Pharma Limited]
  • Liberty Pharmaceuticals, Inc.
    Minocycline Hydrochloride Capsule [Liberty Pharmaceuticals, Inc.]
  • Unit Dose Services
    Minocycline Hydrochloride Capsule [Unit Dose Services]
  • Sandoz Inc
    Minocycline Hydrochloride Tablet, Extended Release [Sandoz Inc]
  • American Health Packaging
    Minocycline Hydrochloride Capsule [American Health Packaging]
  • Aidarex Pharmaceuticals Llc
    Minocycline Hydrochloride Capsule [Aidarex Pharmaceuticals Llc]
  • Lupin Pharmaceuticals, Inc.
    Minocycline Hydrochloride Tablet, Extended Release [Lupin Pharmaceuticals, Inc.]
  • Aurobindo Pharma Limited
    Minocycline Hydrochloride Capsule [Aurobindo Pharma Limited]
  • Unit Dose Services
    Minocycline Hydrochloride Capsule [Unit Dose Services]
  • Direct Rx
    Minocycline Hydrochloride Capsule [Direct Rx]
  • Bryant Ranch Prepack
    Minocycline Hydrochloride Capsule [Bryant Ranch Prepack]
  • Proficient Rx Lp
    Minocycline Hydrochloride Capsule [Proficient Rx Lp]
  • Mylan Pharmaceuticals Inc.
    Minocycline Hydrochloride Tablet, Film Coated, Extended Release [Mylan Pharmaceuticals Inc.]
  • Pd-rx Pharmaceuticals, Inc.
    Minocycline Hydrochloride Capsule [Pd-rx Pharmaceuticals, Inc.]
  • Ranbaxy Pharmaceuticals Inc.
    Minocycline Hydrochloride Capsule [Ranbaxy Pharmaceuticals Inc.]
  • Carilion Materials Management
    Minocycline Hydrochloride Capsule [Carilion Materials Management]
  • Bryant Ranch Prepack
    Minocycline Hydrochloride Capsule [Bryant Ranch Prepack]
  • Northwind Pharmaceuticals, Llc
    Minocycline Hydrochloride Capsule [Northwind Pharmaceuticals, Llc]
  • Actavis Pharma, Inc.
    Minocycline Hydrochloride Capsule [Actavis Pharma, Inc.]
  • Clinical Solutions Wholesale, Llc
    Minocycline Hydrochloride Capsule [Clinical Solutions Wholesale, Llc]

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