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Minocin
Generic Name: Minocycline Hydrochloride
Drug Category: Tetracycline Antibiotic
Litigation Alert Level: High
This drug has been approved for use by males and females over the age of 8 years old for a maximum duration of week.
| Approved Uses |
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MINOCIN intravenous is indicated in the treatment of the following infections due to susceptible isolates of the designated bacteria:
Minocycline is indicated for the treatment of infections caused by the following Gram-negative bacteria when bacteriologic testing indicates appropriate susceptibility to the drug:
MINOCIN intravenous is indicated for the treatment of infections caused by the following Gram-positive bacteria when bacteriologic testing indicates appropriate susceptibility to the drug:
When penicillin is contraindicated, minocycline is an alternative drug in the treatment of the following infections:
• In acute intestinal amebiasis, minocycline may be a useful adjunct to amebicides. • In severe acne, minocycline may be useful adjunctive therapy. To reduce the development of drug-resistant bacteria and maintain the effectiveness of MINOCIN for Injection and other antibacterial drugs, MINOCIN (minocycline) for Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. Minocycline is not recommended for use in children below 8 years of age unless the expected benefits of therapy outweigh the risks. 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. Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. This has been reported with minocycline. 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 drugs 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. Central nervous system side effects including light-headedness, dizziness or vertigo have been reported. Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including MINOCIN, and may range in severity from mild diarrhea to fatal colitis. 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. Because MINOCIN (minocycline) for Injection contains magnesium close monitoring is recommended in patients with heart block or myocardial damage. MINOCIN for Injection contains magnesium sulfate heptahydrate. Potentially serious drug interactions may occur when intravenous magnesium sulfate heptahydrate is given concomitantly with CNS depressants, neuromuscular blocking agents and cardiac glycosides. Intracranial hypertension (IH, pseudotumor cerebri) has been associated with the use of tetracyclines including Minocin. 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. Concomitant use of isotretinoin and Minocin should be avoided because isotretinoin is also known to cause pseudotumor cerebri. Administration of isotretinoin should be avoided shortly before, during, and shortly after minocycline therapy. Each drug alone has been associated with pseudotumor cerebri. 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 tetracyclines in conjunction with penicillin. The concurrent use of tetracyclines 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. Concurrent use of tetracyclines with oral contraceptives may render oral contraceptives less effective. MINOCIN, like other tetracycline-class antibacterials, 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 drugs 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. 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. Tetracyclines are excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from 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. |
| Off-label Uses |
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• Use in patients under the age of 8. GoToSource • Staphylococcal infections. GoToSource • Rheumatoid arthritis. GoToSource • Dermatitis, periodontitis, atherosclerosis, inflammatory bowel disease, traumatic brain injury, neuropathic pain, rosacea, bullous dermatoses, neutrophilic diseases, pyoderma gangrenosum, sarcoidosis, aortic aneurysms, cancer metastasis, fragile X syndrome, cardiac ischaemia, HIV infection, atherosclerosis, allergic asthma, adjunctive treatment for autistic disorder and osteoporosis. GoToSource • Lyme disease. GoToSource • Cystic fibrosis. GoToSource • Gougerot-carteaud syndrome. GoToSource • Adjunctive therapy for unipolar psychotic depression. GoToSource • Schizophrenia. GoToSource • Lepromatous leprosy. GoToSource • Cerebral ischemia, parkinson disease, huntington disease, alzheimer’s disease, multiple sclerosis, amyotrophic lateral sclerosis, autoimmune encephalomyelitis and spinal cord injury. GoToSource |
| Adverse Events |
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Lupus-erythematosus-like syndrome (autoimmune disorder where the body attacks its own cells), irreversible pigmentation and hepatotoxicity (liver injury). GoToSource Fulminant intracranial hypertension (increased pressure within the brain) and loss of vision. GoToSource Papilledema (optic disc swelling) and diplopia (double vision). GoToSource Anaphylaxis (life-threatening allergic reaction), pneumonitis (inflammation of lung tissue), hepatitis (inflammation of the liver), pancreatitis (inflammation of the pancreas), nephritis (inflammation of the kidneys), polyarthritis (type of arthritis involving five or more joints simultaneously), pruritus (severe itching), urticaria (hives), photosensitive rash and serum sickness-like reaction (hypersensitivity reaction). GoToSource Hemolytic anemia (abnormal breakdown of red blood cells). GoToSource Teeth discoloration. GoToSource Drug rash with eosinophilia and systemic symptoms (severe drug reaction). GoToSource Tinnitus (noise or ringing in the ears) and decreased hearing. GoToSource |
| Litigation |
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Lawsuits filed for loss of vision. |
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