Sumycin (Syrup)

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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. Representative pediatric dosages for the syrup on a qid basis are as follows: 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 alternate-day 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.

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 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. 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 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 treatmentof 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 Tests 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 procedurethat 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: 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. Standardized procedures require the use of laboratory control organisms. The 30-mcg tetracycline disk should give the following zone diameters: DILUTION TECHNIQUES: Use a standardized dilution method(broth, agar, microdilution) or equivalent with tetracycline powder. The MIC values obtained should be interpreted according to the following criteria: As with standard diffusion techniques, dilution methods require the use of laboratory control organisms. Standard tetracycline powder should provide the following MIC values:

This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.

http://www4.wiwiss.fu-berlin.de/drugbank/resource/drugs/DB00759

dailymed-ingredient:Cherry_Flavor, dailymed-ingredient:Citric_Acid, dailymed-ingredient:D&C_Yellow_#_10, dailymed-ingredient:Grape_Flavor, dailymed-ingredient:Potassium_Citrate, dailymed-ingredient:Potassium_Metaphosphate, dailymed-ingredient:Sodium_Benzoate, dailymed-ingredient:Sodium_Citrate, dailymed-ingredient:Sodium_Metabisulfate, dailymed-ingredient:Sodium_Saccharin, dailymed-ingredient:Sorbitol_Solution, dailymed-ingredient:Sucrose, dailymed-ingredient:Tragacanth_Powder, dailymed-ingredient:Tutti_Frutti_Flavor, dailymed-ingredient:Water

In case of overdosage, treat symptomatically and institute supportive measures.

Sumycin (Syrup)

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.

http://www4.wiwiss.fu-berlin.de/dailymed/resource/organization/Par_Pharmaceutical,_Inc.

Sumycin