Tetracycline

What is Tetracycline?

• Tetracycline is an oral, broad-spectrum antibiotic used to treat mild-to-moderate infections due to susceptible microbial organisms.

Tetracycline

What are the uses of this medicine?

Tetracycline is indicated in the treatment of infections caused by susceptible strains as below:

• Upper respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae and Hemophilus influenzae.
• 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, rickettsial pox.
• Psittacosis or 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 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.

How does this medicine work?

• Tetracycline is an oral, broad-spectrum antibiotic and semisynthetic derivative of Streptomyces actinobacteria.
• Tetracycline acts by inhibition of protein synthesis by binding to the 30S subunit of microbial ribosomes.
• Human cells are less susceptible to this inhibition.
• Currently, tetracycline is most frequently used for upper respiratory and skin and soft tissue infection and more than 2 million prescriptions are filled yearly.
• Chronic therapy with tetracycline is effective in ameliorating acne, but because of their better absorption and tissue penetration, minocycline and doxycycline have largely replaced tetracycline for this indication.
• Tetracycline is also active against infections with several rickettsial, spirochetal, chlamydial and mycoplasmas infections and are often used for therapy of nonspecific urethritis and several Rickettsia diseases, such as Rocky Mountain spotted fever and Lyme disease.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• have shown hypersensitivity to any of the tetracyclines.

What drug interactions can this medicine cause?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Be sure to mention any of the following:

• anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven), and penicillin.

• Tell your healthcare provider if you are taking antacids containing magnesium, aluminum, calcium, or sodium bicarbonate, calcium supplements, zinc products, iron products, and laxatives containing magnesium interfere with tetracycline, making it less effective.
• Take tetracycline 2 hours before or 6 hours after antacids, calcium supplements, zinc products, and laxatives containing magnesium.
• Take tetracycline 2 hours before or 4 hours after iron preparations and vitamin products that contain iron.
• Take tetracycline 2 hours before or after zinc containing products.

Is this medicine FDA approved?

• Tetracycline was first approved for use in the United States in 1957 and was one of several oral tetracyclines used at that time (oxytetracycline, chlortetracycline), many of which are no longer available or are used in veterinary medicine only.
• More modern forms of tetracycline include doxycycline and minocycline which are much more commonly used and have similar indications.

How should this medicine be used?

Recommended dosage: 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 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 mg 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.
• 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 patients with renal impairment:

• Total dosage should be decreased by reduction of recommended individual doses and/or by extending time intervals between doses.

Administration:

• Tetracycline comes as a capsule to take by mouth.
• It is usually taken two or four times daily.
• Tetracycline should be taken on an empty stomach, at least 1 hour before or 2 hours after meals or snacks.
• Drink a full glass of water with each dose of tetracycline.
• Do not take tetracycline with food, especially dairy products such as milk, yogurt, cheese, and ice cream.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tetracycline Hydrochloride Capsules USP, 250 mg
• Tetracycline Hydrochloride Capsules USP, 500 mg
• Pediatric formulations as oral suspension are also available.

This medicine is available in fallowing brand namesː

• Achromycin V
• Sumycin

What side effects can this medication cause?

The most common side effects of this medicine include:

• gastrointestinal upset, nausea, poor appetite, diarrhea, glossitis, rash, hypersensitivity reactions hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, neutropenia and eosinophilia

• Tetracycline can cause staining of developing teeth (in children or when taken by a pregnant mother).
• Hepatotoxicity and liver failure have been observed in patients receiving large doses of tetracycline and in tetracycline-treated patients with renal impairment.

Tetracycline may cause serious side effects, including:

• swelling of the face, throat, tongue, lips, and eyes
• difficulty breathing or swallowing
• joint stiffness or swelling
• headache
• unusual bleeding or bruising
• chest pain
• blurred vision, seeing double, or loss of vision
• skin rash
• hives
• a return of fever, sore throat, chills, or other signs of infection
• watery or bloody stools , stomach cramps, or fever during treatment or for up to two or more months after stopping treatment

What special precautions should I follow?

• As with other antibiotics, use of this drug may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, the antibiotic should be discontinued and appropriate therapy should be instituted.
• 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.
• Patients should be counseled that antibacterial drugs including tetracycline should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold).
• 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.
• If you become pregnant while taking tetracycline, call your doctor immediately. Tetracycline can harm the fetus.
• Plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen. Tetracycline may make your skin sensitive to sunlight. Tell your doctor right away if you get a sunburn.
• when tetracycline is used during pregnancy or in babies or children up to age 8, it can cause the teeth to become permanently stained. Tetracycline should not be used in children under age 8 unless your doctor decides it is needed.
• High doses of several forms of tetracycline given intravenously have been associated with acute fatty liver that can be severe and result in liver failure and death. Oral tetracycline use has been rarely and not very convincingly linked to acute hepatic injury.

What to do in case of emergency/overdose?

Management of overdosage:

• In case of overdosage, discontinue medication, treat symptomatically and institute supportive measures.
• Tetracycline is not dialyzable.

Can this medicine be used in pregnancy?

• Pregnancy Category D.
• Tetracycline drugs should not be used during pregnancy unless absolutely necessary.
• If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

Can this medicine be used in children?

THE USE OF DRUGS OF THE TETRACYCLINE CLASS DURING TOOTH DEVELOPMENT (LAST HALF OF PREGNANCY, INFANCY AND CHILDHOOD TO THE AGE OF 8 YEARS) MAY CAUSE PERMANENT DISCOLORATION OF THE TEETH (YELLOW - GRAY - BROWN). TETRACYCLINE DRUGS, THEREFORE, SHOULD NOT BE USED IN THIS AGE GROUP UNLESS OTHER DRUGS ARE NOT LIKELY TO BE EFFECTIVE OR ARE CONTRAINDICATED.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• TETRACYCLINE HYDROCHLORIDE

Inactive ingredients:

• D&C YELLOW NO. 10
• FD&C BLUE NO. 1
• FD&C BLUE NO. 2
• FD&C RED NO. 40
• FD&C YELLOW NO. 6
• FERROSOFERRIC OXIDE
• GELATIN
• PROPYLENE GLYCOL
• SHELLAC
• SILICON DIOXIDE
• STARCH, CORN
• STEARIC ACID
• TITANIUM DIOXIDE

Who manufactures and distributes this medicine?

• TEVA PHARMACEUTICALS USA
• Sellersville, PA

What should I know about storage and disposal of this medication?

• Store at 20° to 25°C (68° to 77°F).

List of tetracyclines

• Demeclocycline
• Doxycycline
• Minocycline
• Tetracycline
• Tigecycline

• Dailymed label info on Tetracycline
• FDA Tetracycline

Tetracycline Resources
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