Demeclocycline Hydrochloride

INDICATIONS AND USAGE Demeclocycline hydrochloride tablets USP is indicated in the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions below: Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by rickettsiae; Respiratory tract infections caused by Mycoplasma pneumoniae ; Lymphogranuloma venereum due to Chlamydia trachomatis ; Psittacosis (Ornithosis) due to Chlamydia psittaci ; Trachoma due to Chlamydia trachomatis , although the infectious agent is not always eliminated, as judged by immunofluorescence; Inclusion conjunctivitis caused by Chlamydia trachomatis ; Nongonococcal urethritis in adults caused by Ureaplasma urealyticum or Chlamydia trachomatis ; Relapsing fever due to Borrelia recurrentis ; Chancroid caused by Haemophilus ducreyi ; Plague due to Yersinia pestis ; Tularemia due to Francisella tularensis ; Cholera caused by Vibrio cholerae ; Campylobacter fetus infections caused by Campylobacter fetus ; Brucellosis due to Brucella species (in conjunction with streptomycin); Bartonellosis due to Bartonella bacilliformis ; Granuloma inguinale caused by Calymmatobacterium granulomatis ; Demeclocycline hydrochloride tablets USP 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 ; Shigella species; Acinetobacter species; Respiratory tract infections caused by Haemophilus influenzae ; Respiratory tract and urinary tract infections caused by Klebsiella species. Demeclocycline hydrochloride tablets USP is indicated for treatment of infections caused by the following gram-positive microorganisms, when bacteriologic testing indicates appropriate susceptibility to the drug: Upper respiratory infections caused by Streptococcus pneumoniae; Skin and skin structure infections caused by Staphylococcus aureus . (Note: Tetracyclines, including demeclocycline, are not the drugs of choice in the treatment of any type of staphylococcal infection.) When penicillin is contraindicated, tetracyclines, including demeclocycline hydrochloride, are alternative drugs in the treatment of the following infections: Uncomplicated urethritis in men due to Neisseria gonorrhoeae , and for the treatment of other uncomplicated gonococcal infections; Infections in women caused by Neisseria gonorrhoeae ; Syphilis caused by Treponema pallidum subspecies pallidum ; Yaws caused by Treponema pallidum subspecies pertenue ; Listeriosis due to Listeria monocytogenes ; Anthrax due to Bacillus anthracis ; Vincent’s infection caused by Fusobacterium fusiforme ; Actinomycosis caused by Actinomyces israelii ; Clostridial diseases caused by Clostridium species. In acute intestinal amebiasis, demeclocycline hydrochloride tablets USP may be a useful adjunct to amebicides. In severe acne, demeclocycline hydrochloride tablets USP may be a useful adjunctive therapy. To reduce the development of drug-resistant bacteria and maintain the effectiveness of demeclocycline hydrochloride tablets USP and other antibacterial drugs, demeclocycline hydrochloride tablets 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.

DOSAGE AND ADMINISTRATION Therapy should be continued for at least 24 to 48 hours after symptoms and fever have subsided. Concomitant Therapy Absorption of tetracyclines is impaired by antacids containing aluminum, calcium, or magnesium, and by iron-containing preparations. Foods and some dairy products also interfere with absorption. Oral forms of tetracycline should be given at least 1 hour before or 2 hours after meals. In Patients With Renal Impairment (See WARNINGS ). Tetracyclines should be used cautiously in patients with impaired renal function. Total dosage should be decreased by reduction of recommended individual doses and/or by extending time intervals between doses. In Patients With Liver Impairment Tetracyclines should be used cautiously in patients with impaired liver function. Total dosage should be decreased by reduction of recommended individual doses and/or by extending time intervals between doses. Administration of adequate amounts of fluid with the oral formulations of tetracyclines is recommended to wash down the drugs and reduce the risk of esophageal irritation and ulceration. (See ADVERSE REACTIONS ). Adults Usual Daily Dose Four divided doses of 150 mg each or two divided doses of 300 mg each. For Pediatric Patients Above Eight Years of Age Usual daily dose, 7 to 13 mg per kg body weight per day, depending upon the severity of the disease, divided into two to four doses not to exceed adult dosage of 600 mg per day. Gonorrhea patients sensitive to penicillin may be treated with demeclocycline administered as an initial oral dose of 600 mg followed by 300 mg every 12 hours for four days to a total of 3 grams.

CONTRAINDICATIONS This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines or any of the components of the product formulation.

ADVERSE REACTIONS The following reactions have been reported in patients receiving tetracyclines: Gastrointestinal: Anorexia, nausea, vomiting, diarrhea, glossitis, dysphagia, enterocolitis, pancreatitis, and inflammatory lesions (with monilial overgrowth) in the anogenital region, increases in liver enzymes, and hepatic toxicity have been reported rarely. Rarely, hepatitis and liver failure have been reported. These reactions have been caused by both the oral and parenteral administration of tetracyclines. Instances of esophageal ulcerations have been reported in patients receiving oral tetracyclines. Most of the patients were reported to have taken the medication immediately before lying down. (See DOSAGE AND ADMINISTRATION ) Skin: Maculopapular and erythematous rashes, erythema multiforme. Exfoliative dermatitis has been reported but is uncommon. Fixed drug eruptions and Stevens-Johnson syndrome have been reported rarely. Lesions occurring on the glans penis have caused balanitis. Pigmentation of the skin and mucous membranes has also been reported. Photosensitivity is discussed above. (See WARNINGS ). Renal toxicity: Acute renal failure. Rise in BUN has been reported and is apparently dose related. Nephrogenic diabetes insipidus. (See WARNINGS .) Hypersensitivity reactions: Urticaria, angioneurotic edema, polyarthralgia, anaphylaxis, anaphylactoid purpura, pericarditis, exacerbation of systemic lupus erythematosus, lupus-like syndrome, pulmonary infiltrates with eosinophilia. Hematologic: Hemolytic anemia, thrombocytopenia, neutropenia and eosinophilia have been reported. CNS: Pseudotumor cerebri (benign intracranial hypertension) in adults and bulging fontanels in infants (see PRECAUTIONS, General ). Dizziness, headache, tinnitus, and visual disturbances have been reported. Myasthenic syndrome has been reported rarely. Other: When given over prolonged periods, tetracyclines have been reported to produce brown-black microscopic discoloration of thyroid glands. No abnormalities of thyroid function studies are known to occur. Very rare cases of abnormal thyroid function have been reported. Tooth discoloration has occurred in pediatric patients less than 8 years of age (see WARNINGS ), and has been reported rarely in adults.

Drug Interactions Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage. Since bacteriostatic drugs may interfere with the bactericidal action of penicillins, it is advisable to avoid giving tetracycline-class drugs in conjunction with penicillin. Concurrent use of tetracyclines with oral contraceptives may render oral contraceptives less effective. The concurrent use of tetracyclines and methoxyflurane has been reported to result in fatal renal toxicity. Absorption of tetracyclines is impaired by antacids containing aluminum, calcium or magnesium, and by iron-containing preparations.

DESCRIPTION Demeclocycline hydrochloride, USP is an antibiotic isolated from a mutant strain of Streptomyces aureofaciens. Chemically it is 7- Chloro-4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12, 12a-pentahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. Its structural formula is: Each film-coated tablet for oral administration contains 150 mg or 300 mg of demeclocycline hydrochloride, USP and has the following inactive ingredients: carnauba wax, colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, hypromelloses, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, talc, titanium dioxide, triacetin, D&C Red No. 27 Aluminum Lake, D&C Red No. 30 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake. demeclocycline-hcl-structural-formula

OVERDOSAGE In case of overdosage, discontinue medication, treat symptomatically and institute supportive measures. Tetracyclines are not removed in significant quantities by hemodialysis or peritoneal dialysis.

HOW SUPPLIED Adults Usual Daily Dose Four divided doses of 150 mg each or two divided doses of 300 mg each. For Pediatric Patients Above Eight Years of Age Usual daily dose, 7 to 13 mg per kg body weight per day, depending upon the severity of the disease, divided into two to four doses not to exceed adult dosage of 600 mg per day. Gonorrhea patients sensitive to penicillin may be treated with demeclocycline administered as an initial oral dose of 600 mg followed by 300 mg every 12 hours for four days to a total of 3 grams. Demeclocycline Hydrochloride Tablets USP, 150 mg, are red, round, biconvex, film-coated tablets, debossed with "Є" above "143" on one side and plain on the other side. They are supplied as follows: NDC 24658-710-01 - Bottle of 100 Tablets Demeclocycline Hydrochloride Tablets USP, 300 mg, are red, round, biconvex, film-coated tablets, debossed with "Є" above "144" on one side and plain on the other side. They are supplied as follows: NDC 24658-711-48 - Bottle of 48 Tablets Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense contents in a tight, light-resistant container as defined in the USP, with a child-resistant closure as required . KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.