Source: FDA, National Drug Code (US) Revision Year: 2023
To reduce the development of drug-resistant bacteria and maintain the effectiveness of tetracycline hydrochloride and other antibacterial drugs, tetracycline hydrochloride should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Tetracycline is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below:
When penicillin is contraindicated, tetracyclines are alternative drugs in the treatment of the following infections:
Adults: Usual daily dose, 1 gram as 500 mg twice a day or 250 mg four times a day. Higher doses such as 500 mg four times a day may be required for severe infections or for those infections which do not respond to the smaller doses.
For pediatric patients above eight years of age: Usual daily dose, 10 mg/lb to 20 mg/lb (25 mg/kg to 50 mg/kg) body weight divided in four equal doses.
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).
Absorption of tetracycline 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.
When used in streptococcal infections, therapy should be continued for 10 days.
For treatment of brucellosis, 500 mg tetracycline four times a day for three weeks 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).
In patients with renal impairment (see WARNINGS): decrease total dosage by reduction of recommended individual doses and/or by extending time intervals between doses.
In case of overdosage, discontinue medication, treat symptomatically and institute supportive measures. Tetracycline is not dialyzable.
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