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Tetracycline (Tetracycline Hydrochloride) - Indications and Dosage

 
 



Indications and Usage:

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 Hemophilus 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 Klebsiellasp.)
  • Skin and soft tissue infections caused by Streptococcus pyogenes, Staphylococcus aureaus.
    (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 of ornithosis caused by Chlamydia psittaci.
  • Infections caused by Chlamydia trachomatis such as uncomplicated urethral, endocervical, or rectal infections, inclusion conjunctivitis, trachoma and lymphogranuloma venereum.
  • Granuloma inquinale caused by Calymmatobacterium granulomatis.
  • Relapsing fever caused by Borrelia sp.
  • Bartonellosis caused by Bartonella bacilli-formis.
  • Chancroid caused by Hemophilus 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 pallidumand 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.

Dosage and Administration:

Adults:

Usual daily dose, 1 gram as 500 mg b.i.d. or 250 mg q.i.d. Higher doses such as 500 mg q.i.d. may be required for severe infections or for those infections which do not respond to the smaller doses.

Children above eight years of age:

Usual daily dose, 10 to 20 mg/lb (25 to 50 mg/kg) body weight divided in four equal doses.

Therapy should be continued for at least 24 to 48 hours after symptoms and fever have subsided.

For the treatment of brucellosis, 500 mg tetracycline q.i.d. for three weeks should be 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 q.i.d. for 15 days. Syphilis of more than one year’s duration (except neurosyphilis)—500 q.i.d. for 30 days.

For treatment of gonorrhea, the recommended dose is 500 mg by mouth four times a day for 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, dosage should be gradually reduced 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 Fertilit y).

Concomitant Therapy:

Absorption of tetracyclines is impaired by antacids containing aluminum, calcium or magnesium and preparations containing iron, zinc or sodium bicarbonate.

Food and some dairy products also interfere with absorption.

In the treatment of streptococcal infections, a therapeutic dose of tetracycline should be administered for at least ten days.

In patients with renal impairment (see WARNINGS) total dosage should be decreased by reduction of recommended individual doses and/or by extending time intervals between doses.

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.

Administration of adequate amounts of fluid with the capsule formulation of tetracycline is recommended to wash down the drug and reduce the risk of esophageal irritation and ulceration (see ADVERSE REACTIONS).

How Supplied:

Tetracycline Hydrochloride Capsules, USP are available as:

250 mg: Orange/yellow capsules. Imprinted with barr 011. Available in bottles of:

100 NDC 0555-0011-02

1000 NDC 0555-0011-05

500 mg: Black/yellow capsules. Imprinted with barr 010. Available in bottles of:

100 NDC 0555-0010-02

1000 NDC 0555-0010-05

Dispense with a child-resistant closure in a tight, light-resistant container as defined in the USP/NF.

Store at controlled room temperature 15°-30°C (59°-86°F).

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