Tetracid

Tetracid is a bacteriostatic broad-spectrum antibiotic, active against a wide variety of Gram-positive and Gram-negative organisms.

Infections caused by Tetracid-sensitive organisms include:

1) Respiratory tract infections: Pneumonia and other lower respiratory tract infections due to susceptible strains of Streptococcus pneumoniae, Haemophilus influenzae, Klebsiella pneumoniae and other organisms. Mycoplasma pneumoniae pneumonia. Treatment of chronic bronchitis (including the prophylaxis of acute exacerbations) and whooping cough.

2) Urinary tract infections: Caused by susceptible strains of the Klebsiella species. Enterobacter species, Escherichia coli, Streptococcus faecalis and other organisms.

3) Sexually transmitted diseases: Infections due to Chlamydia trachomatis including uncomplicated urethral, endocervical or rectal infections. Non-gonococcal urethritis caused by Ureaplasma urealyticum. Tetracid is also indicated in chancroid, granuloma inguinale and lymphogranuloma venereum.

Tetracid is an alternative drug in the treatment of penicillin resistant gonorrhoea and syphilis.

4) Skin Infections: Acne vulgaris when antibiotic therapy is considered necessary and severe rosacea.

5) Ophthalmic infections: Trachoma, although the infectious agent, as judged by immunofluorescence, is not always eliminated. Inclusion conjunctivitis may be treated with oral Tetracid alone or in combination with topical agents.

6) Rickettsial infections: Rocky Mountain spotted fever, typhus group, Q fever and Coxiella endocarditis and tick fevers.

7) Other infections: Stagnant loop syndrome. Psittacosis, brucellosis (in combination with streptomycin), cholera, bubonic plague, louse and tick-borne relapsing fever, tularaemia, glanders, melioidosis and acute intestinal amoebiasis (as an adjunct to amoebicides).

Tetracid is an alternative drug in the treatment of leptospirosis, gas-gangrene and tetanus.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Tetracid '250' and Tetracid '500' Tablets (Tetracycline Hydrochloride Tablets) and other antibacterial drugs, Sum- ycin '250' and Tetracid '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.

Posology

Tetracid should be given one hour before or two hours after meals, since food and some dairy products interfere with absorption. Therapy should be continued for up to three days after symptoms have subsided.

All infections due to Group A beta-haemolytic streptococci should be treated for at least 10 days.

Adults (including the elderly) and children over 12 years: The minimum recommended dosage is 250mg every six hours. Therapeutic levels are attained more rapidly by the administration of 500mg initially, followed by 250mg every six hours. For severe infections, the dosage may be increased to 500mg every six hours.

Children under 12 years: Contraindicated in this age group.

Elderly: Usual adult dose. Caution should be observed as subclinical renal insufficiency may lead to drug accumulation.

Renal impairment: In general Tetracids are contraindicated in renal impairment and the dosing recommendations only apply if use of this class of drug is deemed absolutely essential. Total dosage should be decreased by reduction of recommended individual doses and/or by extending time intervals between doses.

Dosage recommendations in specific infections:

Skin infections: 250-500mg daily in single or divided doses should be administered for at least three months in the treatment of acne vulgaris and severe rosacea.

Streptococcal infections: A therapeutic dose of Tetracid should be administered for at least 10 days.

Brucellosis: 500mg Tetracid four times daily accompanied by streptomycin.

Sexually transmitted diseases: 500mg four times daily for seven days is recommended in the following infections: Uncomplicated gonococcal infections (except anorectal infections in man); uncomplicated urethral, endocervical or rectal infection caused by Chlamydia trachomatis; non-gonococcal urethritis caused by Ureaplasma urealyticum. Acute epididymo-orchitis caused by Chlamydia trachomatis, or Neisseria gonorrhoea, 500mg four times daily for 10 days. Primary and secondary syphilis: 500mg four times daily for 15 days. Syphilis of more than one year's duration, (latent syphilis of uncertain or more than one year's duration, cardiovascular or late benign syphilis) except neurosyphilis, should be treated with 500mg, four times daily for 30 days. Patient compliance with this regimen may be difficult so care should be taken to encourage optimal compliance. Close follow-up including laboratory tests, is recommended.

Method of Administration

For oral 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)

- Chronic renal/hepatic dysfunction;

- Renal impairment, particularly if severe;

- Systemic lupus erythematosus;

- Children under 12 years ;

- Pregnancy and breastfeeding women.

- Benign intracranial hypertension has been reported following the concomitant use of Tetracids and Vitamin A or retinoids and therefore concurrent use should be contraindicated.

This drug is contraindicated in persons who have shown hyper- sensitivity to any of the tetracyclines.