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 Klebsiella 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.

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.

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 antianabolic 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). 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.

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.

Intracranial hypertension (IH, pseudotumor cerebri) has been associated with the use of tetracyclines including minocycline hydrochloride. Clinical manifestations of IH include headache, blurred vision, diplopia, and vision loss; papilledema can be found on fundoscopy. Women of childbearing age who are overweight or have a history of IH are at greater risk for developing tetracycline associated IH.

Hepatotoxicity has been reported with minocycline; therefore, minocycline should be used with caution in patients with hepatic dysfunction and in conjunction with other hepatotoxic drugs.

Concomitant use of isotretinoin and minocycline hydrochloride should be avoided because isotretinoin is also known to cause pseudotumor cerebri.

Concurrent use of tetracycline with oral contraceptives may render oral contraceptives less effective.

Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage.

Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracycline-class drugs in conjunction with penicillin.

Absorption of tetracyclines is impaired by antacids containing aluminum, calcium, or magnesium, and iron-containing preparations.

The concurrent use of tetracycline and methoxyflurane has been reported to result in fatal renal toxicity.

Increased risk of ergotism when ergot alkaloids or their derivatives are given with tetracyclines.

False elevations of urinary catecholamine levels may occur due to interference with the fluorescence test.

Minocycline hydrochloride, 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.

Tetracyclines are excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from the tetracyclines, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

GoToSource

• Adult dosage greater than 200 mg in 24 hours. GoToSource

• Use in patients under 8 years of age. GoToSource

• Mild blast-induced traumatic brain injury. GoToSource

• Acute viral encephalitis, preventing human immunodeficiency virus (HIV) infections and improving cognitive deficiencies associated with neuroAIDS. GoToSource

• Diabetic macular edema. GoToSource

• Adjunctive therapy for symptoms in early schizophrenia. GoToSource

• Adjunctive treatment for psychotic symptoms, bipolar depression, addiction and mood disorders. GoToSource

• Rheumatoid arthritis. GoToSource

• Fragile X syndrome. GoToSource

• Cerebral ischemia, chemically induced parkinson’s disease, huntington’s disease, alzheimer’s disease, amyotrophic lateral sclerosis and multiple sclerosis. GoToSource

• Regressive autism. GoToSource

• Adjunctive therapy for brain vascular malformations. GoToSource

• Melkersson-rosenthal syndrome. GoToSource

• Rosacea, bullous dermatoses, neutrophilic diseases, pyoderma gangrenosum, sarcoidosis, aortic aneurysms, cancer metastasis, periodontitis rheumatoid arthritis and scleroderma. GoToSource

• Malignant pleural effusion. GoToSource

Vestibular disturbances (dizziness, vertigo, tinnitus and decreased hearing). GoToSource 

Depersonalization disorder. GoToSource

Esophageal ulceration. GoToSource

Hyperpigmentation of the skin. GoToSource

Intracranial hypertension (increased pressure around the brain). GoToSource

Staining of the teeth and oral cavity. GoToSource

Acute hepatitis (liver inflammation) with jaundice. GoToSource

Decreased effectiveness of oral contraceptives. GoToSource

Hypersensitivity pneumonitis (inflammation of the lungs). GoToSource

Black bone disease. GoToSource 

Loss of vision. GoToSource

Lupus erythematosus. GoToSource

Autoimmune hepatitis (immune system attacks liver cells). GoToSource

Drug rash with eosinophilia and systemic symptoms (potentially life-threatening hypersensitivity reaction), autoimmune hyperthyroidism and type I diabetes mellitus. GoToSource

Candidiasis (infection caused by a yeast), photosensitivity and hypersensitivity reactions. GoToSource

Black thyroid (black discoloration of thyroid gland). GoToSource

Lawsuits filed for vision loss, drug-induced lupus and inflammatory bowel disease.