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Basic Drug Info
Drug Name:Sumycin
Manufacturer:Par Pharmaceutical, Inc.
Other Info:



Clinical Trials:


Indications and Usage

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 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 fevers caused by RickettsiaeRespiratory tract infections caused by Mycoplasma pneumoniaeLymphogranuloma venereum caused by Chlamydia trachomatisPsittacosis and ornithosis due to Chlamydia psittaciTrachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescenceInclusion conjunctivitis caused by Chlamydia trachomatisTetracycline hydrochloride is indicated for the treatment of uncomplicated urethral, endocervical or rectal infections in adults caused by Chlamydia trachomatisNongonococcal urethritis caused by Ureaplasma urealyticumRelapsing fever due to Borrelia recurrentisTetracycline hydrochloride is also indicated for the treatment of infections caused by the following gramnegative microorganisms:Chancroid caused by Haemophilus ducreyiPlague 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 bacilliformisGranuloma inguinale caused by Calymmatobacterium granulomatisBecause 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 (formally Mima species and Herellea species)Respiratory tract infections caused by Haemophilus influenzaeRespiratory tract and urinary tract infections caused by Klebsiella speciesTetracycline 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 gonorrhoeaeSyphilis caused by Treponema pallidumYaws caused by Treponema pertenueListeriosis due to Listeria monocytogenesAnthrax due to Bacillus anthracisVincent’s infection caused by Fusobacterium fusiformeActinomycosis caused by Actinomyces israeliiInfections caused by Clostridia speciesIn acute intestinal amebiasis, the tetracycline hydrochlorides may be a useful adjunctive therapy to amebicides.In severe acne the tetracycline hydrochlorides may be useful adjunctive therapy.
Infection -- Invasion of the host organism by microorganisms that can cause pathological conditions or diseases.

Rocky Mountain Spotted Fever -- An acute febrile illness caused by RICKETTSIA RICKETTSII. It is transmitted to humans by bites of infected ticks and occurs only in North and South America. Characteristics include a sudden onset with headache and chills and fever lasting about two to three weeks. A cutaneous rash commonly appears on the extremities and trunk about the fourth day of illness.

TYPHUS -- group of acute, arthropod borne infections caused by rickettsiae; includes epidemic (classic or louse-borne) typhus, its recrudescent form, and murine (endemic or flea-borne) typhus; all are characterized by severe headache, chills, high fever, stupor, and rash.

Q Fever -- An acute infectious disease caused by COXIELLA BURNETII. It is characterized by a sudden onset of FEVER; HEADACHE; malaise; and weakness. In humans, it is commonly contracted by inhalation of infected dusts derived from infected domestic animals (ANIMALS, DOMESTIC).

Rickettsialpox --

Bovine Anaplasmosis -- A disease of cattle caused by parasitization of the red blood cells by bacteria of the genus ANAPLASMA.

Infection by Babesia bovis --

Tick fever --

Psittacosis -- Infection with CHLAMYDOPHILA PSITTACI (formerly Chlamydia psittaci), transmitted to humans by inhalation of dust-borne contaminated nasal secretions or excreta of infected BIRDS. This infection results in a febrile illness characterized by PNEUMONITIS and systemic manifestations.

Conjunctivitis -- inflammation of the mucous membrane that lines the inner surface of the eyelids and the anterior part of the sclera; also called pinkeye and redeye.

Nongonococcal urethritis [NGU] due to Chlamydia trachomatis --

Chancroids -- Acute, localized autoinoculable infectious disease usually acquired through sexual contact. Caused by HAEMOPHILUS DUCREYI, it occurs endemically almost worldwide, especially in tropical and subtropical countries and more commonly in seaports and urban areas than in rural areas.

Tularemia -- A plague-like disease of rodents, transmissible to man. It is caused by FRANCISELLA TULARENSIS and is characterized by fever, chills, headache, backache, and weakness.

Cholera -- An acute diarrheal disease endemic in India and Southeast Asia whose causative agent is VIBRIO CHOLERAE. This condition can lead to severe dehydration in a matter of hours unless quickly treated.

Brucellosis -- Infection caused by bacteria of the genus BRUCELLA mainly involving the MONONUCLEAR PHAGOCYTE SYSTEM. This condition is characterized by fever, weakness, malaise, and weight loss.

Bartonella Infections -- Infections by the genus BARTONELLA. Bartonella bacilliformis can cause acute febrile anemia, designated Oroya fever, and a benign skin eruption, called verruga peruana. BARTONELLA QUINTANA causes TRENCH FEVER, while BARTONELLA HENSELAE is the etiologic agent of bacillary angiomatosis (ANGIOMATOSIS, BACILLARY) and is also one of the causes of CAT-SCRATCH DISEASE in immunocompetent patients.

respiratory infection -- Invasion of the host RESPIRATORY SYSTEM by microorganisms, usually leading to pathological processes or diseases.

Urinary tract infection -- Inflammatory responses of the epithelium of the URINARY TRACT to microbial invasions. They are often bacterial infections with associated BACTERIURIA and PYURIA.

Upper Respiratory Infections --

Lobar Pneumonia --

skin infection -- Skin diseases caused by bacteria, fungi, parasites, or viruses.

SPONDYLOMETAEPIPHYSEAL DYSPLASIA, SHORT LIMB-HAND TYPE --

Staphylococcal Infections -- Infections with bacteria of the genus STAPHYLOCOCCUS.

Gonorrhea -- Acute infectious disease characterized by primary invasion of the urogenital tract. The etiologic agent, NEISSERIA GONORRHOEAE, was isolated by Neisser in 1879.

Amebic colitis -- DYSENTERY caused by intestinal PROTOZOA infection, chiefly with ENTAMOEBA HISTOLYTICA. This condition may be associated with amebic infection of the LIVER and other distant sites.

Acne -- chronic inflammatory disease of the pilosebaceous apparatus marked by an increase in sebum secretions causing lesions most frequently occurring on the face, chest, and back; the inflamed glands may form small pink papules, which sometimes surround comedones so that they have black centers (blackheads), or form pustules or cysts (whiteheads).

Acne Vulgaris -- A chronic disorder of the pilosebaceous apparatus associated with an increase in sebum secretion. It is characterized by open comedones (blackheads), closed comedones (whiteheads), and pustular nodules. The cause is unknown, but heredity and age are predisposing factors.

Contraindications
This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Warnings

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.

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