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Sumycin

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Sumycin

Sumycin

INDICATIONS

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Sumycin '250' and Sumycin '500' Tablets (Tetracycline Hydrochloride Tablets) and other antibacterial drugs, Sum- ycin '250' and Sumycin '500' Tablets (Tetracycline Hydrochloride Tablets) should be used only to treat or prevent 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 hydrochloride is indicated for the treatment of the following infections:

Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsial pox and tick fever caused by Rickettsiae.

Respiratory tract infections caused by Mycoplasma pneumoniae

Lymphogranuloma venereum caused by Chlamydia trachomatis

Psittacosis and ornithosis due to Chlamydia psittaci

Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immuno- fluorescence

Inclusion conjunctivitis caused by Chlamydia trachomatis

Tetracycline hydrochloride is indicated for the treatment of uncomplicated urethral, endocervical or rectal infections in adults caused by Chlamydia trachomatis

Nongonococcal urethritis caused by Ureaplasma urealyticum Relapsing fever due to Borrelia recurrentis

Tetracycline hydrochloride is also indicated for the treatment of infections caused by the following gram-negative microorganisms:

Chancroid caused by Haemophilus ducreyi

Plague due to Yersinia pestis (formerly Pasteurella pestis)

Tularemia due to Francisella tularensis (formerly Pasteurella tularensis)

Cholera caused by Vibrio cholerae (formerly Vibrio comma)

Campylobacter fetus infections caused by Campylobacter fetus (formerly Vibrio fetus)

Brucellosis due to Brucella species (in conjunction with streptomycin)

Bartonellosis due to Bartonella bacilliformis

Granuloma inguinale caused by Calymmatobacterium granulomatis

Because many strains of the following groups of microorganisms have been shown to be resistant to tetracycline hydrochloride, culture and susceptibility testing are recommended.

Tetracycline hydrochloride is indicated for treatment of infections caused by the following gram-negative microorganisms, when bacteriologic testing indicates appropriate susceptibility to the drug:

Escherichia coli

Enterobacter aerogenes (formerly Aerobacter aerogenes)

Shigella species

Acinetobacter species [formerly Mima species and Herellea species]

Respiratory tract infections caused by Haemophilus influenzae

Respiratory tract and urinary tract infections caused by Klebsiella species

Tetracycline hydrochloride is indicated for treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicated appropriate susceptibility to the drug:

For upper respiratory infections caused by Streptococcus pneumoniae (formerly Diplococcus pneumoniae)

Skin and skin structure infections caused by Staphylococcus aureus. Tetracyclines are not the drugs of choice in the treatment of any type of staphylococcal infections

When penicillin is contraindicated, tetracycline hydrochloride is an alternative drug in the treatment of the following infections:

Uncomplicated gonorrhea caused by Neisseria gonorrhoeae

Syphilis caused by Treponema pallidum

Yaws caused by Treponema pertenue

Listeriosis due to Listeria monocytogenes

Anthrax due to Bacillus anthracis

Vincent's infection caused by Fusobacterium fusiforme

Actinomycosis caused by Actinomyces israelii

Infections caused by Clostridia species

In acute intestinal amebiasis, the tetracycline hydrochlorides may be a useful adjunctive therapy to amebicides.

In severe acne the tetracycline hydrochlorides may be useful ad- junctive therapy.

DOSAGE AND ADMINISTRATION

Adults: usual daily dose is 1 to 2 g: for mild to moderate infections: 500 mg bid or 250 mg qid; higher dosages such as 500 mg qid may be required for severe infections.

For children above eight years of age: usual daily dose is 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.

The treatment of brucellosis, 500 mg tetracycline four times daily for three weeks should be accompanied by streptomycin, 1 g intramuscularly twice daily the first week and once daily the second week.

For treatment of uncomplicated gonorrhea, 500 mg every six hours for seven days.

For treatment of syphilis, a total of 30 to 40 g in equally divided doses over a period of 10 to 15 days should be given. Close follow up, including laboratory tests, is recommended.

Uncomplicated urethral, endocervical, or rectal infection in adults caused by Chlamydia trachomatis: 500 mg by mouth, four times a day for at least seven days.

In cases of severe acne which in the judgment of the clinician, requires long-term treatment, the recommended initial dosage is 1 g daily in divided doses. When improvement is noted, usually within one week, dosage should be gradually reduced to maintenance levels ranging from 125 to 500 mg daily. In some patients it may be possible to maintain adequate remission of lesions with alternateday or intermittent therapy. Tetracycline therapy of acne should augment the other standard measures known to be of value.

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.

In the treatment of streptococcal infections, a therapeutic dose of tetracycline should be administered for at least 10 days.

Concomitant therapy: Absorption of tetracyclines is impaired by antacids containing aluminum, calcium, or magnesium, and iron containing preparations.

Food and some dairy products also interfere with absorption.

Administration of adequate amounts of fluid with the tablet and especially capsule formulations of tetracycline is recommended to wash down the drug and reduce the risk of esophageal irrita- tion and ulceration (see ADVERSE REACTIONS)

HOW SUPPLIED

Sumycin® Tablets (Tetracycline Hydrochloride Tablets USP)

250 mg/tablet
bottles of 100
NDC 49884-797-01 Each light pink, biconvex, capsule-shaped tablet is imprinted with 663.
500 mg/tablet
bottles of 100
NDC 49884-798-01 Each pink, biconvex, capsule-shaped tablet is imprinted with 603.

Storage

Store the tablets at room temperature; avoid excessive heat. Dis- pense in tight, light-resistant containers.

Manufactured by: Bristol-Myers Squibb Company, Princeton, NJ 08543 USA. Manufactured for: Par Pharmaceutical, Inc. Spring Valley, NY 10977. USA. Revised 03/04. FDA Rev date: 7/22/1997

Last reviewed on RxList: 2/8/2008
This monograph has been modified to include the generic and brand name in many instances.

A A A

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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