Generic Name: tetracycline
Dosage Form: Syrup
TETRACYCLINE ORAL SUSPENSION, USP
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Sumycin Syrup (Tetracycline Oral Suspension, USP) and other antibacterial drugs, Sumycin Syrup (Tetracycline Oral Suspension, USP) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
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-octahydro-3, 6, 10, 12, 12a-pentahydroxy-6-methyl-1, 11-dioxo-2-napthacenecarboxamide; its structural formula is:
Sumycin Syrup (Tetracycline Oral Suspension, USP) is a suspension containing, in each 5 mL teaspoonful, tetracycline equivalent to 125 mg tetracycline hydrochloride. Inactive ingredients: citric acid, colorant (D&C Yellow No. 10), flavor, potassium citrate, potassium metaphosphate, purified water, saccharin sodium, sodium benzoate, sodium citrate, sodium metabisulfite, sorbitol solution, sucrose, and tragacanth.
Sumycin - Clinical Pharmacology
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.
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.)
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 organisms. Cross-resistance of these organisms to tetracyclines is common. In addition, gram-negative bacilli made tetracycline-resistant, may also show cross-resistance to chloramphenicol.
Because many strains of these gram-positive microorganisms 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.
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.
|Zone diameter (mm)||Interpretation|
|15 – 18||Intermediate|
A report of “Susceptible” indicates that the pathogen is likely to be inhibited by generally achievableblood levels. A report of “Intermediate” suggests that the organism would be susceptible if high dosage isused 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.
|Organism||-||Zone Diameter (mm)|
|E. coli||ATCC25922||18 – 25|
|S. aureus||ATCC25923||19 - 18|
|> 4.0 < 16||Intermediate|
|Organism||-||Zone Diameter (mm)|
|E. coli||ATCC25922||1 – 4|
|S. aureus||ATCC29213||0.25 – 1|
|E. faecalis||ATCC29212||8 – 32|
|P. aeruginosa||ATCC27853||8 - 32|
Indications and Usage for Sumycin
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Sumycin Syrup (Tetracycline Oral Suspension, USP) and other antibacterial drugs, Sumycin Syrup (Tetracycline Oral Suspension, USP) 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-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 (YELLOW-GRAY-BROWN).
This adverse reaction is more common during long term use of the drug 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.
Sumycin Syrup (Tetracycline Oral Suspension, USP) contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
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.
Prescribing Sumycin Syrup (Tetracycline Oral Suspension, USP) 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 fontanels 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.
Information for Patients
Patients should be counseled that antibacterial drugs including Sumycin Syrup (Tetracycline Oral Suspension, USP) should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Sumycin Syrup (Tetracycline Oral Suspension, USP) 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 Syrup (Tetracycline Oral Suspension, USP) or other antibacterial drugs in the future.
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.
Carcinogenesis and Mutagenesis and 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 two in vitro mammalian cell assay systems (L51784y mouse lymphoma and Chinese hamsterlung cells), there was evidence of mutagenicity at tetracycline hydrochloride concentrations of 60 and 10 μg/mL, respectively.
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.)
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.
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.)
Sumycin Dosage and Administration
|20 lbs||2.5 mL||(1/2 teaspoonful)|
|40 lbs||5 mL||(1 teaspoon)|
|60 lbs||7.5 mL||(1–1/2 teaspoonfuls)|
|80 lbs||10 Ml||(2 teaspoonfuls)|
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.
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 alternate-day or intermittent therapy. Tetracycline therapy of acne should augment the other standard measures known to be of value.
How is Sumycin Supplied
Sumycin Syrup (Tetracycline Oral Suspension, USP) is available as a fruit-flavored suspension containing, in each 5 mL teaspoonful, tetracycline equivalent to 125 mg tetracycline hydrochloride. NDC 49884-799-33 Bottles of 473 mL (16 fl. oz.)
ANIMAL PHARMACOLOGY AND/OR 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.
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.
|Labeler - Par Pharmaceutical, Inc.|