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Sumycin for oral administration contains tetracycline, an antibiotic isolated from Streptomyces aureofaciens. Tetracycline is described chemically as 4-(dimethylamino)-1, 4, 4a, 5, 5a, 6, 11, 12a-octa- hydro-3, 6, 10, 12, 12a-pentahydroxy-6-methyl-1, 11-dioxo-2-nap- thacenecarboxamide; its structural formula is:

Sumycin '250' and Sumycin '500' Tablets (Tetracycline Hydrochloride Tablets) are available for oral administration as tablets providing 250 mg and 500 mg tetracycline hydrochloride, respectively. Inactive ingredients: colorants (D&C Red No. 30 Aluminum lake, titanium dioxide), hypromellose, anhydrous lactose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid. In addition, 250 mg contains methylene chloride hydroxypropyl cellulose, triacetin, and 500 mg contains polyethylene glycol, polyparaben, methylparaben, sodium citrate, potassium sorbate, propylparaben, and xanthan gum.

Last updated on RxList: 2/8/2008

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.

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)

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 updated on RxList: 2/8/2008

Gastrointestinal: anorexia, epigastric distress, nausea, vomiting, diarrhea, bulky loose stools, stomatitis, sore throat, glossitis, black hairy tongue, dysphagia, hoarseness, enterocolitis, and inflammatory lesions (with candidal overgrowth) in the anogenital region, including proctitis and pruritus ani. Rare instances of 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 medication immediately before going to bed (see DOSAGE AND ADMINISTRATION). These reactions have been caused by both the oral and parenteral administration of tetracyclines but are less frequent after parenteral use.

Skin and Skin Structures: maculopapular and erythematous rashes. Exfoliative dermatitis has been reported but is uncommon. Onycholysis and discoloration of the nails have been reported rarely. Photosensitivity has occurred. (See WARNINGS).

Renal Toxicity: increases in BUN have been reported and are apparently dose-related. (See WARNINGS.)

Hepatic Cholestasis: has been reported rarely, and is usually associated with high dosage levels of tetracycline.

Hypersensitivity Reactions: Anaphylaxis; serum sickness-like reactions, as fever, rash, and arthralgia; urticaria, angioneurotic edema, anaphylactoid purpura, pericarditis, exacerbation of systemic lupus erythematosus.

Hematological: Blood: anemia, hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, neutropenia and eosinophilia have been reported.

Miscellaneous: Dizziness and headache 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 are known to occur. Bulging fontanels in infants and intracranial hypertension in adults have been reported. (See PRECAUTIONS-General.)

PENICILLIN-Since bacteriostatic drugs like tetracycline may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracycline in conjunction with penicillin.

ANTICOAGULANTS-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.

ANTACIDS AND IRON CONTAINING PRODUCTS-Absorption of tetra- cycline is impaired by antacids containing aluminum, calcium, or magnesium, and iron containing preparations.

ORAL CONTRACEPTIVES-Concurrent use of tetracycline may render oral contraceptives less effective.

METHOXYFLURANE-The concurrent use of tetracycline and methoxyflurane has been reported to result in fatal renal toxicity.

Last updated on RxList: 2/8/2008

TETRACYCLINE-CLASS ANTIBIOTICS CAN CAUSE FETAL HARM WHEN ADMINISTERED TO A PREGNANT WOMAN. IF ANY TETRACYCLINE IS USED DURING PREGNANCY, OR IF THE PATIENT BECOMES PREGNANT WHILE TAKING THESE DRUGS, THE PATIENT SHOULD BE APPRISED OF THE POTENTIAL HAZARD TO THE FETUS.

THE USE OF DRUGS OF THE TETRACYCLINE CLASS DURING TOOTH DEVELOPMENT (LAST HALF OF PREGNANCY, INFANCY AND CHILDHOOD TO AGE OF 8 YEARS) MAY CAUSE PERMANENT DISCOLORATION OF THE TEETH (YELLOWISH-GRAY-BROWN).

This adverse reaction is more common during long-term use of the drugs but has been observed following repeated short-term courses. Enamel hypoplasia has also been reported. TETRACYCLINE DRUGS, THEREFORE, SHOULD NOT BE USED DURING TOOTH DEVELOPMENT UNLESS OTHER DRUGS ARE NOT LIKELY TO BE EFFECTIVE OR ARE CONTRAINDICATED.

All tetracyclines form a stable calcium complex in any bone forming tissues. A decrease in fibula growth rate has been observed in young animals (rats and rabbits) given oral tetracycline in doses of 25 mg/kg every six hours. This reaction was shown to be reversible when the drug was discontinued.

Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues and can have toxic effects on the developing fetus (often related to retardation of skeletal development). Evidence of embryotoxicity has also been noted in animals treated early in pregnancy.

The antianabolic action of tetracycline may cause an increase in BUN. While this is not a problem in those with normal renal function, in patients with significantly impaired function, higher serum levels of tetracycline may lead to azotemia, hyperphosphatemia, and acidosis. If renal impairment exists, even usual oral or parenteral dose may lead to excessive systemic accumulation of the drug and possible liver toxicity. Under such conditions, lower than usual doses are indicated and, if therapy is prolonged, serum level determinations of the drug may be advisable.

Photosensitivity, manifested by an exaggerated sunburn reaction, has been observed in some individuals taking tetracyclines. Patients apt to be exposed to direct sunlight or ultra-violet light should be advised that this reaction can occur with tetracycline drugs, and treatment should be discontinued at the first evidence of skin erythema.

NOTE: Photosensitization reactions have occurred most frequently with demeclocycline, less with chlortetracycline, and very rarely with oxytetracycline and tetracycline.

General

Prescribing Sumycin '250' and Sumycin '500' Tablets (Tetracycline Hydrochloride Tablets) in the absence of a 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.

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 instituted. NOTE: Superinfection of the bowel by staphylococci may be life-threatening.

Pseudotumor cerebri (benign intracranial hypertension) in adults has been associated with the use of tetracyclines. The usual clinical manifestations are headache and blurred vision. Bulging fon- tanels have been associated with the use of tetracyclines in infants. While both of these conditions and related symptoms usually resolve after discontinuation of the tetracycline, the possibility for permanent sequelae exists.

Since sensitivity reactions are more likely to occur in persons with a history of allergy, asthma, hay fever, or urticaria, the preparation should be used with caution in such individuals.

Cross-sensitization among the various tetracyclines is extremely common.

Incision and drainage or other surgical procedures should be performed in conjunction with antibiotic therapy, when indicated.

Under no circumstances should outdated tetracyclines be administered, as the degradation of tetracyclines are highly nephrotoxic and have, on occasion, produced a Fanconi-like syndrome.

Laboratory Tests

During long-term therapy, periodic laboratory evaluation of organ system function, including renal, hepatic, and hematopoietic systems, should be performed.

All patients with gonorrhea should have a serologic test for syphilis at the time of diagnosis. Patients treated with tetracycline should have a follow-up serologic test for syphilis after 3 months.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies conducted in rats and mice to determine whether tetracycline hydrochloride has carcinogenic potential were negative. Some related antibiotics (oxytetracycline, minocycline) have shown evidence of oncogenic activity in rats. In twoin vitro mammalian cell assay systems (L51784y mouse lymphoma and Chinese hamster lung cells), there was evidence of mutagenicity at tetracycline hydro- chloride concentrations of 60 and 10µg/mL, respectively.

Tetracycline hydrochloride had no effect on fertility when administered in the diet to male and female rats at a daily intake of 25 times the human dose.

Pregnancy: Teratogenic effects: Pregnancy Category D (see WARNINGS.)

Pregnancy: Nonteratogenic effects: (see WARNINGS.)

Labor and Delivery

The effect of tetracyclines on labor and delivery is unknown.

Nursing Mothers

Tetracyclines are present in the milk of lactating women who are taking a drug in this class. Because of the potential for serious adverse reactions in nursing infants from tetracyclines, a decision should be made whether to discontinue nursing or 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.

Last updated on RxList: 2/8/2008

In case of overdosage, treat symptomatically and institute sup- portive measures.

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

Last updated on RxList: 2/8/2008

Tetracyclines are adequately but incompletely absorbed from the gastrointestinal tract. Approximately 65 percent of a short-acting tetracycline is bound to plasma proteins; the plasma protein binding for intermediate- and long-acting analogues is usually greater.

Penetration of the tetracyclines into most body fluids and tissues is excellent. Tetracyclines are distributed in varying degrees into bile, liver, lung, kidney, prostate, urine, cerebrospinal fluid, synovial fluid, mucosa of the maxillary sinus, brain, sputum, and bone. Tetracyclines cross the placenta and enter the fetal circulation and amniotic fluid.

Following a single oral dose, peak plasma concentrations are achieved in two to four hours.

Tetracyclines are concentrated by the liver in the bile. They are excreted in both the urine and feces at high concentrations in a biologically active form. Since renal clearance of tetracyclines is by glomerular filtration, excretion is significantly affected by the state of renal function. (See WARNINGS.)

Microbiology

The tetracyclines are primarily bacteriostatic and are thought to exert their antimicrobial effect by the inhibition of protein synthesis. The tetracyclines have a similar antimicrobial spectrum of activity against a wide range of gram-positive and gram-negative organism. Crossresistance of these organisms to tetracyclines is common. In addition, gram-negative bacilli made tetracycline-resistant, may also show cross-resistance to chloramphenicol.

GRAM-NEGATIVE BACTERIA:

Bartonella bacilliformis
Brucella species
Calymmatobacterium granulomatis
Campylobacter fetus
Francisella tularensis
Haemophilus ducreyi
Haemophilus influenzae
Listeria monocytogenes
Neisseria gonorrhoeae
Vibrio cholerae
Yersinia pestis

Because many strains of the following groups of gram-negative microorganisms have been shown to be resistant to tetracyclines, culture and susceptibility testing are especially recommended:

Acinetobacter species
Bacteroides species
Enterobacter aerogenes
Escherichia coli
Klebsiella species
Shigella species

GRAM-POSITIVE BACTERIA:

Enterococcus group [Enterococcus faecalis, (formerly Streptococcus faecalis) and Enterococcus faecium (formerly Streptococcus faecium)

Streptococci viridans group
Streptococcus pneumoniae
Streptococcus pyogenes

Because many strains of these gram-positive microorganism have been shown to be resistant to tetracycline, culture and susceptibility testing are recommended. Up to 44 percent of strains of Streptococcus pyogenes and 74 percent of Enterococcus faecalis (formerly Streptococcus faecalis) have been found to be resistant to tetracycline drugs. Therefore, tetracyclines should not be used for treatment of streptococcal disease unless the organism is known to be susceptible.

OTHER MICROORGANISMS:

Actinomyces species
Bacillus anthracis
Balantidium coli
Borrelia recurrentis
Chlamydia psittaci
Chlamydia trachomatis
Clostridium species
Entamoeba species
Fusobacterium fusiforme
Mycoplasma pneumoniae
Rickettsiae
Propionibacterium acnes
Treponema pallidum
Treponema pertenue
Ureaplasma urealyticum

Susceptibility Testing

Diffusion Techniques

Quantitative methods that require measurement of zone diameters give the most precise estimate of the susceptibility of bacteria to antimicrobial agents.

One such standard procedure¹ that has been recommended for use with disks to test susceptibility of microorganisms to tetracycline uses the 30-mcg tetracycline disk. Interpretation involves the correlation of the zone diameters obtained in the disk test with the minimum inhibitory concentration (MIC) for tetracycline.

Reports from the laboratory giving results of the standard single- disk susceptibility test with a 30-mcg tetracycline disk should be interpreted according to the following criteria:

Zone Diameter (mm)	Interpretation
≥ 19	Susceptible
15-18	Intermediate
≤ 14	Resistant

A report of "Susceptible" indicates that the pathogen is likely to be inhibited by generally achievable blood levels. A report of "Intermediate" suggests that the organism would be susceptible if high dosage is used or if the infection is confined to tissues or fluids in which high antibiotic (or antimicrobial) levels are attained. A report of "Resistant" indicates that achievable concentrations are unlikely to be inhibitory and other therapy should be selected.

Standardized procedures require the use of laboratory control organisms. The 30-mcg tetracycline disk should give the following zone diameters:

Organism		Zone Diameter (mm)
E. coli	ATCC 25922	18-25
S. aureus	ATCC 25923	19-28

Dilution Techniques

Use a standardized dilution method² (broth, agar, microdilution) or equivalent with tetracycline powder. The MIC values obtained should be interpreted according to the following criteria:

MIC (mcg/mL)	Interpretation
≤ 4.0	Susceptible
> 4.0 < 16	Intermediate
≥ 16	Resistant

As with standard diffusion techniques, dilution methods require the use of laboratory control organisms. Standard tetracycline pow- der should provide the following MIC values:

Organism		MIC (mcg/mL)
E. coli	ATCC 25922	1-4
S. aureus	ATCC 29213	0.25-1
E. faecalis	ATCC 29212	8-32
P. aeruginosa	ATCC 27853	8-32

Animal Pharmacology and Animal Toxicology

Hyperpigmentation of the thyroid has been produced by members of the tetracycline class in the following species: in rats by oxytetracycline, doxycycline, tetracycline PO₄ and methacycline; in minipigs by doxycycline, minocycline, tetracycline PO₄ and methacycline; in dogs by doxycycline and minocycline; in monkeys by minocycline.

Minocycline, tetracycline PO₄, methacycline, doxycycline, tetracycline base, oxytetracycline HCl and tetracycline HCl were goitrogenic in rats fed a low iodine diet. This goitrogenic effect was accompanied by high radioactive iodine uptake. Administration of minocycline also produced a large goiter with high radioiodine uptake in rats fed a relatively high iodine diet.

Treatment of various animal species with this class of drugs has also resulted in the induction of thyroid hyperplasia in the following: in rats and dogs (minocycline), in chickens (chlortetracycline), and in rats and mice (oxytetracycline). Adrenal gland hyperplasia has been observed in goats and rats treated with oxytetracycline.

REFERENCE

1. National Committee for Clinical Laboratory Standards, Perfor- mance Standards for Antimicrobial Disk Susceptibility Tests- Fourth Edition. Approved Standard NCCLS Document M2-A4, Vol. 10, No. 7 NCCLS, Villanova, PA, April 1990.

2. National Committee for Clinical Laboratory Standards, Meth- ods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically-Second Edition. Approved Standard NCCLS Document M7-A2, Vol. 10, No. 8 NCCLS, Villanova, PA, April 1990.

Last updated on RxList: 2/8/2008

Patients should be counseled that antibacterial drugs including Sumycin '250' and Sumycin '500' Tablets (Tetracycline Hydrochloride Tablets) should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Sumycin '250' and Sumycin '500' Tablets (Tetracycline Hydrochloride Tablets) is prescribed to treat a bacterial infection, patients should be told 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 Sumycin '250' and Sumycin '500' Tablets (Tetracycline Hydrochloride Tablets) or other antibacterial drugs in the future.

Last updated on RxList: 2/8/2008

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

TETRACYCLINE - ORAL

(te-tra-SYE-kleen)

COMMON BRAND NAME(S): Achromycin V, Sumycin

USES: Tetracycline is used to treat a wide variety of infections, including acne. It is an antibiotic that works by stopping the growth of bacteria.

This antibiotic treats only bacterial infections. It will not work for viral infections (e.g., common cold, flu). Unnecessary use or overuse of any antibiotic can lead to its decreased effectiveness.

HOW TO USE: Tetracycline works best when taken on an empty stomach 1 hour before or 2 hours after meals. If stomach upset occurs, ask your doctor if you can take this medication with food. Take each dose with a full glass of water (8 ounces or 240 milliliters) unless your doctor directs you otherwise. Do not lie down for 30 minutes after taking this medication. For this reason, do not take it right before bedtime.

Take this medication 2-3 hours before or after taking any products containing magnesium, aluminum, or calcium. Some examples include antacids, quinapril, certain forms of didanosine (chewable/dispersible buffered tablets or pediatric oral solution), vitamins/minerals, and sucralfate. Follow the same instructions with dairy products (e.g., milk, yogurt), calcium-enriched juice, bismuth subsalicylate, iron, and zinc. These products bind with tetracycline, preventing its full absorption.

Dosage is based on your medical condition and response to therapy. For use in children older than 8 years of age, the dosage is also based on weight.

Antibiotics work best when the amount of medicine in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals.

Continue to take this medication until the full-prescribed amount is finished even if symptoms disappear after a few days. Stopping the medication too early may allow bacteria to continue to grow, which may result in a relapse of the infection.

Inform your doctor if your condition persists or worsens.

SIDE EFFECTS: Nausea, vomiting, diarrhea, loss of appetite, mouth sores, black hairy tongue, sore throat, dizziness, headache, or rectal discomfort may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: sunburn (sun sensitivity), nail discoloration, muscle pain, difficult or painful swallowing, change in the amount of urine, brown/gray tooth discoloration, numbness/tingling of the hands/feet, unusual fatigue, new signs of infection (e.g., persistent sore throat, fever, chills).

Tell your doctor immediately if any of these rare but very serious side effects occur: hearing changes (e.g., ringing in the ears, decreased hearing), persistent or severe headache, vision changes (e.g., blurred vision), easy bruising/bleeding, severe stomach/abdominal pain, yellowing eyes/skin, dark urine.

This medication may rarely cause a severe intestinal condition (pseudomembranous colitis) due to a resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped.. Do not use anti-diarrhea products or narcotic pain medications if you have the following symptoms because these products may make them worse. Tell your doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool..

Use of this medication for prolonged or repeated periods may result in oral thrush or a new yeast infection (oral or vaginal fungal infection). Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge or other new symptoms.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, skin lesions/sores, itching, swelling, severe dizziness, trouble breathing, new or worsening swelling/pain in the joints, chest pain, fast/irregular heartbeat.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking tetracycline, tell your doctor or pharmacist if you are allergic to it; or to other tetracyclines (e.g., doxycycline, minocycline), or if you have any other allergies. Because some tetracycline products may contain tartrazine, a yellow coloring dye, report any allergy to tartrazine, or to aspirin (some aspirin-allergic people are also allergic to tartrazine).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, problems swallowing, esophagus problems (e.g., hiatal hernia, reflux disease-GERD).

This drug may make you dizzy; use caution engaging in activities requiring alertness such as driving or using machinery. Limit alcoholic beverages.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths or sunlamps. Use a sunscreen and wear protective clothing when outdoors.

Before having surgery, tell your doctor or dentist that you are using tetracycline.

Caution is advised when using this drug in the elderly because they may be more sensitive to its effects.

This medication should not be used in children younger than 8 years of age because it may cause permanent tooth discoloration and other problems. Tooth discoloration has also occurred in older children and young adults. Consult your doctor for more information.

This medication is not recommended for use during pregnancy because of possible harm to an unborn baby. Women of child-bearing age should use effective birth control while taking this medication. Consult your doctor for more details.

This medication passes into breast milk in very small amounts. While there have been no reports of harm to nursing infants, consult your doctor before breast-feeding.

DRUG INTERACTIONS: See also How to Use.

Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop, or change the dosage of any medicine before checking with them first.

This drug should not be used with the following medications because very serious interactions may occur: acitretin, isotretinoin, strontium, tretinoin taken by mouth.

If you are currently using any of these medications, tell your doctor or pharmacist before starting tetracycline.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: digoxin, kaolin pectin, live bacterial vaccines, penicillins, warfarin.

This medication may decrease the effectiveness of combination-type birth control pills. This can result in pregnancy. You may need to use an additional form of reliable birth control while using this medication. Consult your doctor or pharmacist for details.

This product can affect the results of certain lab tests. Make sure laboratory personnel and your doctors know you use this drug.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly.

NOTES: Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it later for another infection unless told to do so by your doctor. A different medication may be necessary in those cases.

Laboratory and/or medical tests may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light, moisture, and excessive heat. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Taking outdated tetracycline can result in serious illness. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.