er 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 inquinale 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.

pertoxin producing strains of c. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. cdad must be considered in all patients who present with diarrhea following antibacterial drugs. careful medical history is necessary since cdad has been reported to occur over two months after the administration of antibacterial agents. if cdad is suspected or confirmed, ongoing use of antibacterial drugs not directed against c. difficile need to be discontinued. appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of c. difficile , and institute surgical evaluation clinically indicated. photosensitivity 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. intracranial hypertension 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. although ih typically resolve after discontinuation of treatment, the possibility for permanent visual loss exists. if visual disturbance occurs during treatment, prompt ophthalmologic evaluation is warranted. since intracranial pressure can remain elevated for weeks after drug cessation patients should be monitored until they stabilize. skeletal development all tetracyclines form a stable calcium complex in any bone forming tissue. 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. 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. antianabolic action 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. laboratory monitoring for long-term therapy in long-term therapy, perform periodic laboratory evaluation of organ systems, including hematopoietic, renal and hepatic studies. if renal impairment exists, even usual oral or parenteral doses may lead to excessive systemic accumulation of the drug and possible liver toxicity. under such conditions, lower than usual total doses are indicated, and, if therapy is prolonged, serum level determinations of the drug may be advisable.

s accompanied by streptomycin, 1 gram intramuscularly twice daily the first week and once daily the second week. for the treatment of syphilis in patients allergic to penicillin, the following dosage of tetracycline is recommended: early syphilis (less than one year’s duration), 500 mg four times a day for 15 days. syphilis of more than one year’s duration (except neurosyphilis), 500 mg four times a day for 30 days. for treatment of gonorrhea, the recommended dose is 500 mg by mouth four times a day for seven days. uncomplicated urethral, endocervical or rectal infections in adults caused by chlamydia trachomatis : 500 mg, by mouth, four times a day for at least seven days. in cases of moderate to severe acne which, in the judgement of the clinician, require long-term treatment, the recommended initial dosage is 1 gram daily in divided doses. when improvement is noted, reduce dosage gradually to maintenance levels ranging from 125 mg to 500 mg daily. in some patients it may be possible to maintain adequate remission of lesions with alternate day or intermittent therapy. tetracycline therapy of acne should augment the other standard measures known to be of value. duration of long-term treatment which can safely be recommended has not been established (see warnings and carcinogenesis, mutagenesis, impairment of fertility ). use in specific population in patients with renal impairment (see warnings ): decrease total dosage by reduction of recommended individual doses and/or by extending time intervals between doses.

d in tetracycline-treated patients with renal impairment. hypersensitivity reactions: urticaria, angioneurotic edema, anaphylaxis, anaphylactoid purpura, pericarditis, exacerbation of systemic lupus erythematosus, and serum sickness-like reactions, as fever, rash, and arthralgia. blood: hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, neutropenia and eosinophilia have been reported. when given over prolonged periods, tetracyclines have been reported to produce brown-black microscopic discoloration of thyroid glands. no abnormalities of thyroid function studies are known to occur. to report suspected adverse events, contact actavis at 1-800-272-5525 or fda at 1-800-fda-1088 or http://www.fda.gov/ for voluntary reporting of adverse reactions.

rensis haemophilus ducreyi haemophilus influenzae klebsiella species klebsiella granulomatis neisseria gonorrhoeae shigella species vibrio cholera yersinia pestis gram-positive bacteria bacillus anthracis streptococcus pyogenes streptococcus pneumonia staphylococcus aureus listeria monocytogenes anaerobes bacteroides species clostridium species fusobacterium fusiforme propionibacterium acnes other bacteria actinomyces species borrelia recurrentis chlamydophila psittaci chlamydia trachomatis rickettsiae treponema pallidum treponema pallidum subspecies pertenue parasites entamoeba species balantidium coli susceptibility testing for specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by fda for this drug, please see: https://www.fda.gov/stic.