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Vibramycin
Generic Name: Doxycycline
Drug Category: Tetracycline Antibiotic
Litigation Alert Level: Medium
This drug has been approved for use by males and females over the age of 8 years old for a maximum duration of 4 months.
| Approved Uses |
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To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vibramycin and other antibacterial drugs, Vibramycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. Doxycycline is indicated for the treatment of the following infections:
Doxycycline is also indicated for the treatment of infections caused by the following gram-negative microorganisms:
Doxycycline is indicated for treatment of infections caused by the following gram-negative microorganisms, when bacteriologic testing indicates appropriate susceptibility to the drug:
Doxycycline is indicated for treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug:
When penicillin is contraindicated, doxycycline is an alternative drug in the treatment of the following infections:
In acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides. In severe acne, doxycycline may be useful adjunctive therapy. Prophylaxis: • Doxycycline is indicated for the prophylaxis of malaria due to Plasmodium falciparum in short-term travelers (less than 4 months) to areas with chloroquine and/or pyrimethamine-sulfadoxine resistant strains. 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 it has been observed following repeated short-term courses. Enamel hypoplasia has also been reported. Use doxycycline in pediatric patients 8 years of age or less only when the potential benefits are expected to outweigh the risks in severe or life-threatening conditions (e.g., anthrax, Rocky Mountain spotted fever), particularly when there are no alternative therapies. Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Vibramycin, 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. Intracranial hypertension (IH, pseudotumor cerebri) has been associated with the use of tetracyclines including Vibramycin. A decrease in fibula growth rate has been observed in prematures given oral tetracycline in doses of 25 mg/kg every 6 hours. This reaction was shown to be reversible when the drug was discontinued. Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. Severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in patients receiving doxycycline. Vibramycin Syrup contains sodium metabisulfite, a sulfite that may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. Absorption of tetracyclines is impaired by antacids containing aluminum, calcium, or magnesium, and iron-containing preparations. Absorption of tetracyclines is impaired by bismuth subsalicylate. Barbiturates, carbamazepine, and phenytoin decrease the half-life of doxycycline. Concurrent use of tetracycline 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 tetracyclines in conjunction with penicillin. The concurrent use of tetracycline and Penthrane (methoxyflurane) has been reported to result in fatal renal toxicity. False elevations of urinary catecholamine levels may occur due to interference with the fluorescence test. 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 also been noted in animals treated early in pregnancy. If any tetracycline is used during pregnancy or if the patient becomes pregnant while taking this drug, 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 doxycycline, a decision should be made whether to discontinue nursing or to 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 • Adjunctive treatment of multiple sclerosis. GoToSource • Recurrent corneal abrasion syndrome. GoToSource • Subcutaneous nodular sarcoidosis. GoToSource • Meibomian gland dysfunction. GoToSource • Rosacea. GoToSource • Episodic migraine. GoToSource • Diabetic kidney disease. GoToSource • Prevention of acute coronary syndromes. GoToSource • Decreasing hemorrhagic risk in brain vascular malformations. GoToSource • Alzheimer’s disease. GoToSource • Reduction of proteinuria with overt diabetic nephropathy. GoToSource • Crescentic glomerulonephritis. GoToSource • Sjogren’s syndrome. GoToSource • Osteoarthritis of the knee or hip. GoToSource |
| Adverse Events |
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Toxic epidermal necrolysis, stevens-johnson syndrome and erythema multiforme (severe drug reaction). GoToSource Teeth discoloration and permanent staining of teeth. GoToSource Esophageal ulceration. GoToSource Inflammatory bowel disease and crohn’s disease. GoToSource Acute cholestatic liver injury. GoToSource Suicidal ideation and behavior. GoToSource Gastric mucosal necrosis with vascular degeneration. GoToSource Photosensitivity. GoToSource Pancreatitis (inflammation of the pancreas). GoToSource Pseudotumor cerebri (increased pressure within the brain). GoToSource Hyperpigmentation of the skin and nails. GoToSource Hypoglycemia. GoToSource Hypersensitivity reactions. GoToSource Clostridium difficile associated diarrhea. GoToSource |
| Litigation |
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Lawsuits filed for teeth discoloration. |
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