Sumycin

GENERIC AVAILABLE: Yes

Tetracycline hydrochloride is a prescription antibiotic used to treat a wide range of infections.

It's effective against a broad spectrum of bacteria, as well as other organisms, including some protozoan parasites.

Tetracycline has commonly been used to treat acne and other skin infections; respiratory tract infections such as pneumonia; genital and urinary infections; and Helicobacter pylori (the bacteria that can lead to stomach ulcers).

It's also sometimes used for treating Lyme disease and for preventing anthrax infections.

The first drug in the tetracycline family, chlortetracycline, was introduced in 1948.

Tetracycline and Antibiotic Resistance

Overuse of tetracycline (and other antibiotics) in humans and farm animals has allowed some bacteria to build up a resistance to antibiotics.

The development of these so-called "superbug" bacteria limits the number of infections that antibiotics such as tetracycline can treat. (Partly as a result of antibiotic resistance, tetracycline is prescribed less often today than other, more effective antibiotics.)

Doctors are now strongly advised to prescribe tetracycline only when there is proof, or a strong suspicion, that bacteria - not a virus - is causing an infection.

Since tetracycline does not work for colds, influenza (flu), or other viral infections, if you take it for these conditions, you may be promoting the development of drug-resistant diseases while doing nothing to help your illness.

Tetracycline for Dogs and Other Animals

Tetracycline is prescribed for dogs, other household pets, and livestock. Low doses are commonly fed to farm animals to promote their growth.

It's often used in dogs and cats to treat leptospirosis, toxoplasmosis, mycoplasma, and psittacosis. Tetracycline is also effective in animals that have tick-borne infections, such as Lyme disease, ehrlichiosis, and Rocky Mountain spotted fever.

Tetracycline Warnings

Before taking tetracycline, you should tell your doctor if you have or have ever had:

• Allergies
• Asthma
• Hay fever
• Hives
• Kidney disease
• Liver disease
• Diabetes

You should tell your physician that you are taking this medication before having any type of surgery, including dental surgery.

Tetracycline can cause false readings on tests for sugar in urine. If you have diabetes, you should talk to your doctor about this possibility before altering your diet or changing your diabetes medication dosage.

You should not take this medication after it expires. Consuming expired tetracycline can lead to a dangerous syndrome that can result in kidney damage.

Tetracycline and Children

When this medication is used to treat children up to age 8, it can cause lifelong tooth discoloration. It can also affect a child's growth.

Tetracycline should therefore not be used in children under age 8 unless directed by a doctor.

Pregnancy and Tetracycline

Tetracycline is a pregnancy category D drug. Studies show the medication can impair the development of bones in infants. Use during pregnancy can also cause lifelong tooth discoloration in your child.

This drug should not be used during pregnancy unless the benefits outweigh the risks.

Tetracycline is secreted in breast milk and may affect bone and tooth development in a nursing infant. Women should not use this medication while breastfeeding.

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.

Tetracycline is an antibiotic that fights bacteria in the body.

Tetracycline is used to treat many different bacterial infections, such as urinary tract infections, acne, gonorrhea, chlamydia, and others.

Tetracycline may also be used for other purposes not listed in this medication guide.

Tetracycline is a prescription medication used to treat various bacterial infections.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Children younger than 8 years old should not take tetracycline.

Using tetracycline during pregnancy could harm the unborn baby or cause permanent tooth discoloration later in the baby's life.

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take tetracycline on an empty stomach, at least 1 hour before or 2 hours after a meal.

Do not take tetracycline with milk or other dairy products, unless your doctor has told you to. Dairy products can make it harder for your body to absorb the medicine.

Shake the oral suspension (liquid) well just before you measure a dose. Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

If you need surgery, tell the surgeon ahead of time that you are using tetracycline.

If you use this medicine long-term, you may need frequent medical tests.

Use this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Tetracycline will not treat a viral infection such as the flu or a common cold.

Do not share this medicine with another person, even if they have the same symptoms you have.

Store this medication at room temperature away from moisture and heat.

Throw away any unused tetracycline after the expiration date on the label has passed. Taking expired tetracycline can cause damage to your kidneys.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• severe blistering, peeling, and red skin rash;

• fever, chills, body aches, flu symptoms;

• pale or yellowed skin, easy bruising or bleeding;

• any signs of a new infection.

Common side effects may include:

• nausea, vomiting, diarrhea, upset stomach, loss of appetite;

• white patches or sores inside your mouth or on your lips;

• swollen tongue, black or "hairy" tongue, trouble swallowing;

• sores or swelling in your rectal or genital area; or

• vaginal itching or discharge.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Storage

Oral

Room temperature in tight, light-resistant container.c Avoid excessive heat.c

<30°C in tight container; protect from light.d

Kit containing tetracycline, metronidazole, and bismuth subsalicylate: 20–25°C.e

REFERENCES

1. National Committee for Clinical Laboratory Standards, Performance 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, Methods 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.

Manufactured by:

Bristol-Myers Squibb Company

Princeton, NJ 08543 USA

Manufactured for:

Par Pharmaceutical, Inc.

Spring Valley, NY 10977 USA

1016513A3 03/04

Applies to tetracycline: compounding powder, oral capsule, oral suspension, oral tablet

Gastrointestinal

Gastrointestinal side effects have included anogenital lesions with monilial overgrowth, anorexia, black hairy tongue, dysphagia, enamel hypoplasia, enterocolitis, epigastric distress, diarrhea, glossitis, nausea, permanent tooth discoloration, and vomiting. Rarely, esophageal ulceration has been reported with oral tablets and capsules.[Ref]

There have been several cases of esophageal ulcers associated with oral tetracycline therapy. In each case, the patient had taken the medication just before bedtime with only small amounts of liquid and reported severe retrosternal pain and painful swallowing shortly thereafter. The ulcers resolved spontaneously after discontinuation of tetracycline therapy. To minimize esophageal irritation, patients should be advised to avoid taking tetracycline just before retiring and to take the medication with plenty of water.

Oral ulcers have also occurred in a patient who gargled with a tetracycline solution made by emptying the contents of a 250 mg capsule into water.[Ref]

Renal

Renal side effects generally occurred in patients with preexisting renal disease and have been the result of accumulation of tetracycline (the active ingredient contained in Sumycin) Increases in BUN commonly occur because of tetracycline's anti-anabolic effect but do not necessarily indicate renal dysfunction.

Fanconi's syndrome is characterized by renal glycosuria, phosphaturia, aminoaciduria, and acidosis with or without proteinuria and rickets. It is associated with the ingestion of outdated or degraded tetracycline. Additionally, previous formulations of tetracycline contained citric acid which may contribute to metabolic acidosis; however, current formulations of the drug do not. Patients generally require hospitalization with intravenous medication to correct the accompanying metabolic abnormalities. Most cases resolve over time after discontinuation of tetracycline without permanent sequelae. Patients should be instructed to discard any unused portions of tetracycline at the end of therapy and to never use tetracycline remaining from a previous prescription.[Ref]

Renal side effects have included increased BUN and Fanconi's syndrome. In patients with preexisting renal impairment, tetracycline may cause azotemia, hyperphosphatemia, and acidosis. Patients with dehydration are particularly vulnerable.[Ref]

Dermatologic

Dermatologic side effects have included exfoliative dermatitis, maculopapular and erythematous rashes, nail discoloration, onycholysis, and photosensitivity.[Ref]

Musculoskeletal

Musculoskeletal side effects have included adult tooth discoloration, enamel hypoplasia, and a decrease in linear skeletal growth rate. Tetracycline (the active ingredient contained in Sumycin) should not be administered to pregnant women or children less than 12 years of age.[Ref]

Tetracycline deposits into calcium-rich developing osseous tissue thereby causing the discoloration of permanent teeth, decreased rate of enamel growth, and a decrease in linear skeletal growth rate.[Ref]

Nervous system

There have been several cases of benign intracranial hypertension (pseudotumor cerebri) associated with tetracycline (the active ingredient contained in Sumycin) therapy. In most cases, the patient was female and was prescribed tetracycline to treat acne. Symptoms commonly occurring in these cases consisted of severe headaches, nausea, and blurred vision. Physical examination revealed papilledema in all cases, and several had significantly increased pressure on lumbar puncture. All patients recovered over time after discontinuation of tetracycline therapy. The mechanism for development of increased intracranial pressure is unknown.[Ref]

Nervous system side effects have included benign intracranial hypertension (pseudotumor cerebri) in adults and bulging fontanels in infants.[Ref]

Hematologic

Hematologic side effects have included hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, neutropenia, and eosinophilia.[Ref]

At least two cases of tetracycline-induced hemolytic anemia have been reported. In both cases, the anemia resolved over time after discontinuation of the medication and reoccurred 1 to 2 years later following another course of tetracycline therapy. The mechanism for development of hemolytic anemia is unknown.[Ref]

Hypersensitivity

Hypersensitivity side effects have included urticaria, angioneurotic edema, anaphylaxis, anaphylactoid purpura, exacerbation of systemic lupus erythematosus, hypersensitivity myocarditis, and serum sickness-like reactions (fever, rash, arthralgia).[Ref]

Hepatic

Hepatic side effects have included increased liver enzyme levels, hepatotoxicity, liver failure, and bile duct paucity with prolonged cholestasis. These may be dose-related.[Ref]

Other

Other side effects have included superinfection due to overgrowth of resistant organisms. The long-term use of tetracyclines has been associated with microscopic brown-black discoloration of the thyroid gland; however, abnormal thyroid function has not been reported.[Ref]

Metabolic

Metabolic side effects have included azotemia, hyperphosphatemia, and metabolic acidosis. Increases in serum BUN levels may occur as a result of the anti-anabolic action of tetracycline (the active ingredient contained in Sumycin) and not necessarily indicate renal disease.[Ref]

These metabolic side effects have occurred more commonly in the presence of preexisting renal disease, and occur as a result of the accumulation of tetracycline.[Ref]

Some side effects of Sumycin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.