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Achromycin V
Generic Name: Tetracycline HCL
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 30 days.
| Approved Uses |
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Tetracycline is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below: • Upper respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae and Haemophilus influenzae. Note: Tetracycline should not be used for streptococcal disease unless the organism has been demonstrated to be susceptible. • Lower respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae, Mycoplasma pneumoniae (Eaton agent, and Klebsiella sp.) • Skin and soft tissue infections caused by Streptococcus pyogenes, Staphylococcus aureus. (Tetracyclines are not the drugs of choice in the treatment of any type of staphylococcal infections.) • Infections caused by rickettsia including Rocky Mountain spotted fever, typhus group infections, Q fever, rickettsialpox. • Psittacosis caused by Chlamydophila psittaci. • Infections caused by Chlamydia trachomatis such as uncomplicated urethral, endocervical or rectal infections, inclusion conjunctivitis, trachoma, and lymphogranuloma venereum. • Granuloma inguinale caused by Klebsiella granulomatis. • Relapsing fever caused by Borrelia sp. • Bartonellosis caused by Bartonella bacill iformis. • Chancroid caused by Haemophilus ducreyi. • Tularemia caused by Francisella tularensis. • Plaque caused by Yersinia pestis. • Cholera caused by Vibrio cholerae. • Brucellosis caused by Brucella species (Tetracycline may be used in conjunction with an aminoglycoside). • Infections due to Campylobacter fetus. • As adjunctive therapy in intestinal amebiasis caused by Entamoeba histolytica. • Urinary tract infections caused by susceptible strains of Escherichia coli, Klebsiella, etc. • Other infections caused by susceptible gram-negative organisms such as E. coli, Enterobacter aerogenes, Shigella sp., Acinetobacter sp., Klebsiella sp., and Bacteroides sp. • In severe acne, adjunctive therapy with tetracycline may be useful. When penicillin is contraindicated, tetracyclines are alternative drugs in the treatment of the following infections: • Syphilis and yaws caused by Treponema pallidum and pertenue, respectively, • Vincent’s infection caused by Fusobacterium fusiforme, • Infections caused by Neisseria gonorrhoeae, • Anthrax caused by Bacillus anthracis, • Infections due to Listeria monocytogenes, • Actinomycosis caused by Actinomyces species, • Infections due to Clostridium species. Tetracycline should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). 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 in this age group 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 tetracyclines, 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 Achromycin V. 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 tetracycline should be avoided because isotretinoin, a systemic retinoid, is also known to cause pseudotumor cerebri. Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. Advise patients apt to be exposed to direct sunlight or ultraviolet lights that this reaction can occur with tetracycline drugs. Discontinue treatment at the first evidence of skin erythema. Hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, neutropenia and eosinophilia have been reported. A decrease in fibula growth rate has been observed in premature 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. 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 renal function, higher serum levels of tetracycline may lead to azotemia, hyperphosphatemia and acidosis. Hepatotoxicity and liver failure have been observed in patients receiving tetracycline and in tetracycline-treated patients with renal impairment. Because the tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage. The concurrent use of tetracycline and methoxyflurane has been reported to result in fatal renal toxicity. Absorption of tetracyclines is impaired by antacids containing aluminum, calcium or magnesium and preparations containing iron, zinc, or sodium bicarbonate. Concurrent use of tetracycline may render oral contraceptives less effective. Pregnant women with renal disease may be more prone to develop tetracycline associated liver failure. 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 this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to the fetus. Tetracycline drugs should not be used during pregnancy unless absolutely necessary. Because of the potential for serious adverse reaction in nursing infants from tetracyclines, a decision should be made whether 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 • Use longer than 30 days. GoToSource • Use as anti-angiogenic therapy. GoToSource • Meibomian gland dysfunction. GoToSource • Recurrent corneal erosion. GoToSource • Malignant pleural effusions. GoToSource • Lyme disease. GoToSource • Rosacea. GoToSource • Rheumatoid arthritis. GoToSource |
| Adverse Events |
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Pancreatitis (inflammation of the pancreas). GoToSource Liver damage. GoToSource Inflammatory bowel disease. GoToSource Tooth discoloration. GoToSource Pseudotumor cerebri (high pressure in the brain) and vision loss. GoToSource Pseudomembranous colitis (inflammation (swelling, irritation) of the large intestine). GoToSource |
| Litigation |
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Lawsuits filed for inflammatory bowel disease. |
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