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Doryx
Generic Name: Doxycycline Hyclate
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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Indicated for: Rickettsial Infections: • Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae. Sexually Transmitted Infections:
Respiratory Tract Infections: • Respiratory tract infections caused by Mycoplasma pneumoniae. Psittacosis (ornithosis) caused by Chlamydophila psittaci. Because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended. Doxycycline is indicated for treatment of infections caused by the following microorganisms, when bacteriological testing indicates appropriate susceptibility to the drug:
Specific Bacterial Infections:
Because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended. Doxycycline is indicated for treatment of infections caused by the following gram-negative microorganisms, when bacteriological testing indicates appropriate susceptibility to the drug:
Ophthalmic Infections:
Anthrax Including Inhalational Anthrax (post-exposure): • Anthrax due to Bacillus anthracis, including inhalational anthrax (post-exposure): to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. Alternative Treatment for Selected Infections when Penicillin is Contraindicated:
Adjunctive Therapy for Acute Intestinal Amebiasis and Severe Acne:
Prophylaxis of Malaria: • 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.
Doxycycline offers substantial but not complete suppression of the asexual blood stages of Plasmodium strains. Doxycycline does not suppress P. falciparum’s sexual blood stage gametocytes. Subjects completing this prophylactic regimen may still transmit the infection to mosquitoes outside endemic areas. 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. Doxycycline should not be used in this age group, except for anthrax, including inhalational anthrax (post-exposure), unless other drugs are not likely to be effective or are contraindicated. Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including DORYX Tablets, 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. 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. As with other antibacterial preparations, use of DORYX may result in overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, the antibacterial should be discontinued and appropriate therapy institute. Intracranial hypertension (IH, pseudotumor cerebri) has been associated with the use of tetracycline including DORYX. 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. Avoid concomitant use of isotretinoin and Doryx because isotretinoin is also known to cause pseudotumor cerebri. All tetracyclines form a stable calcium complex in any bone-forming tissue. A decrease in fibula growth rate has been observed in prematures given oral tetracycline in doses of 25 mg/kg every six hours. This reaction was shown to be reversible when the drug was discontinued. The antianabolic action of the tetracyclines may cause an increase in BUN. Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage. Absorption of tetracyclines is impaired by antacids containing aluminum, calcium, or magnesium, bismuth subsalicylate, and iron-containing preparations. Concurrent use of tetracycline may render oral contraceptives less effective. Barbiturates, carbamazepine, and phenytoin decrease the half-life of doxycycline. 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. There are no adequate and well-controlled studies on the use of doxycycline in pregnant women. 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 also has been noted in animals treated early in pregnancy. 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, however, the extent of absorption of tetracyclines including doxycycline, by the breastfed infant is not known. |
| Off-label Uses |
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• Glioma. GoToSource • Creutzfeldt-jakob disease. GoToSource • Rheumatoid arthritis. GoToSource • Animal bite wounds. GoToSource • Rosacea. GoToSource • Red scrotum syndrome. GoToSource • Pelvic inflammatory disease. GoToSource • Chronic inflammatory lung diseases. GoToSource • Human ehrlichiosis. GoToSource • Legionnaires’ disease. GoToSource • Mediterranean spotted fever. GoToSource • Chronic leg ulceration. GoToSource • Leptospirosis. GoToSource |
| Adverse Events |
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Intracranial hypertension (increased pressure around the brain). GoToSource Pancreatitis (inflammation of the pancreas). GoToSource Drug fever. GoToSource Esophageal ulcers and herpes simplex virus infection. GoToSource Acute respiratory failure. GoToSource Anosmia (loss of the sense of smell). GoToSource Photo-onycholysis (separation of nail from the nail bed). GoToSource Solar urticaria (exposure to light induces hives). GoToSource Dizziness. GoToSource Hepatotoxicity (liver damage). GoToSource Autoimmune hepatitis (liver inflammation). GoToSource Hypoglycemia (low blood sugar). GoToSource Candidiasis (yeast infection) and uncontrolled hypertension. GoToSource Suicidal ideation and behavior. GoToSource Maculopapular and erythematous rashes, stevens-johnson syndrome, toxic epidermal necrolysis, erythema multiforme, exfoliative dermatitis (severe drug reactions), teeth discoloration,retardation of skeletal development in the fetus when administered to pregnant women. GoToSource |
| Litigation |
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Lawsuits filed for teeth staining. |
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