Data from FDA - Curated by EPG Health - Last updated 01 June 2018

Indication(s)

INDICATIONS AND USAGE 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: 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 Klebsiella sp .) 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 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 bacilliformis . 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 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.

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Advisory information

contraindications
CONTRAINDICATIONS This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.
Special warnings and precautions
PRECAUTIONS General As with other antibacterials, use of this drug may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, discontinue antibacterial and institute appropriate therapy. Treat all infections due to Group A beta-hemolytic streptococci for at least ten days. Perform incision and drainage or other surgical procedures in conjunction with antibacterial therapy, when indicated. Prescribing tetracycline in the absence of proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. Information for Patients Counsel patients that antibacterial drugs including tetracycline should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When tetracycline is prescribed to treat a bacterial infection, tell patients that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by tetracycline or other antibacterial drugs in the future. Laboratory Tests In sexually transmitted infections, when coexistent syphilis is suspected, perform dark field examinations e before treatment is started and the blood serology repeated monthly for at least four months. Drug Interactions Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracycline in conjunction with penicillin or other bactericidal antibacterials. 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. Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal studies are currently being conducted to determine whether tetracycline hydrochloride has carcinogenic potential. Some related antibacterials (oxytetracycline, minocycline) have shown evidence of oncogenic activity in rats. In two in vitro mammalian cell assay systems (L 51784y mouse lymphoma and Chinese hamster lung cells), there was evidence of mutagenicity with tetracycline hydrochloride. Tetracycline hydrochloride had no effect on fertility when administered in the diet to male and female rats at a daily intake of approximately 400 mg/kg/day, roughly 8 times the highest recommended human dose based on body surface area. Pregnancy Teratogenic Effects Pregnancy Category D (see WARNINGS ) Nonteratogenic Effects (see WARNINGS ) Pregnant women with renal disease may be more prone to develop tetracycline-associated liver failure. Labor and Delivery The effect of tetracyclines on labor and delivery is unknown. Nursing Mothers Because of 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 (see WARNINGS ). Pediatric Use See WARNINGS and DOSAGE AND ADMINISTRATION .
Adverse reactions
ADVERSE REACTIONS Gastrointestinal: anorexia, nausea, epigastric distress, vomiting, diarrhea, glossitis, black hairy tongue, dysphagia, enterocolitis, and inflammatory lesions (with Candida overgrowth) in the anogenital region. Esophagitis and esophageal ulceration have been reported in patients receiving particularly the capsule and also the tablet forms of tetracyclines. Most of the patients were reported to have taken medication immediately before going to bed (see DOSAGE AND ADMINISTRATION ). Teeth: permanent discoloration of teeth may be caused during tooth development. Enamel hypoplasia has been reported (see WARNINGS ). Skin: maculopapular and erythrematous rashes. Exfoliative dermatitis has been reported. Onycholysis and discoloration of the nails have been reported. Photosensitivity is discussed in WARNINGS . Renal Toxicity: an increase in BUN has been reported and is dose related. Liver: hepatotoxicity and liver failure have been observed in patients receiving tetracycline and 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.

Usage information

Dosing and administration
DOSAGE AND ADMINISTRATION 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 (25mg/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 Chlamydiatrachomatis : 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.
Pregnancy and lactation
Nursing Mothers Because of 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 (see WARNINGS ).

Interactions

Drug Interactions Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracycline in conjunction with penicillin or other bactericidal antibacterials. 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.

More information

Category Value
Authorisation number NDA050278
Agency product number P6R62377KV
Orphan designation No
Product NDC 23155-017,23155-018
Date Last Revised 16-05-2018
Type HUMAN PRESCRIPTION DRUG
RXCUI 198250
Marketing authorisation holder Heritage Pharmaceuticals Inc.