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Drug Catalog - Product Detail

TETRACYCLINE HCL CP 500MG 100

NDC Mfr Size Str Form
67405-0661-10 HARRIS PHARMACEUTICAL 100 500MG CAPSULE
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Description
DESCRIPTION Tetracycline is a yellow, odorless, crystalline powder. Tetracycline is stable in air, but exposure to strong sunlight causes it to darken. Its potency is affected in solutions of pH below 2 and is rapidly destroyed by alkali hydroxide solutions. Tetracycline is very slightly soluble in water, freely soluble in dilute acid and in alkali hydroxide solutions, sparingly soluble in alcohol, and practically insoluble in chloroform and in ether. The chemical name for tetracycline hydrochloride is 4-(Dimethylamino)- 1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12,-12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecar-boxamide monohydrochloride. Its structural formula is as follows: C 22 H 24 N 2 0 8 ∙HCl M.W. 480.90 Each capsule, for oral administration, contains 250 mg or 500 mg tetracycline hydrochloride. Inactive Ingredients: Lactose, and magnesium stearate. The 250 mg and 500 mg capsule shells contain D&C Yellow No. 10, FD&C yellow No. 6, gelatin, sodium lauryl sulfate, water, and titanium dioxide. The imprinting ink for the 250 mg and 500 mg capsules contain D&C Yellow No. 10, FD&C Blue No.1, FD&C Blue No. 2, FD&C Red No. 40, ferrosoferric oxide, pharmaceutical shellac, propylene glycol, n-butyl alcohol, ethanol and methanol. Product complies with USP Dissolution Test 2. Chemical Structure
How Supplied
HOW SUPPLIED Tetracycline HCl Capsules, USP are available as: 250 mg: Yellow Opaque Cap /Yellow Opaque Body, Cap and Body Imprinted 5225 in Black Ink. Available in bottles of: 20 capsules – NDC 67405-660-02 100 capsules -NDC 67405-660-10 500 capsules -NDC 67405-660-50 500 mg: Orange Opaque Cap/Yellow Opaque Body, Cap and Body Imprinted 5266 in Black Ink. Available in bottles of: 20 capsules – NDC 67405-661-02 100 capsules -NDC 67405-661-10 500 capsules -NDC 67405-661-50 Dispense in a tight, light-resistant containers as defined in the USP. Use child-resistant closure (as required). Store at 20°to 25°C (68°to 77°F) [See USP Controlled Room Temperature]. Call your doctor for medical advice about side effects. You may report side effects to HARRIS Pharmaceutical at 1-800-983-4708 or FDA at 1-800- FDA-1088.
Indications & Usage
INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of Tetracycline HCl Capsules, USP and other antibacterial drugs, Tetracycline HCl Capsules, 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 HCl Capsules, USP is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below: Upper respiratory tract infections caused by Streptococcus pyogenes , Streptococcus pneumoniae and Hemophilus influenzae . Note: Tetracycline HCl Capsules, USP should not be used for streptococcal disease unless the organism has been demonstrated to be susceptible. Lower respiratory tract infections caused by Streptococcus pyogenes , Streptococcus pneumoniae , Mycoplasma pneumoniae (Eaton agent, and Klebsiella sp .) Skin and soft tissue infections caused by Streptococcus pyogenes , Staphylococcus aureaus . (Tetracyclines are not the drugs of choice in the treatment of any type of staphylococcal infections.) Infections caused by rickettsia including Rocky Mountain spotted fever, typhus group infections, Q fever, rickettsialpox. Psittacosis of ornithosis caused by Chlamydia Psittaci . Infections caused by Chlamydia trachomatis such as uncomplicated urethral, endocervical or rectal infections, inclusion conjunctivitis, trachoma, and lymphogranuloma venereum. Granuloma inquinale caused by Calymmatobacterium granulomatis . Relapsing fever caused by Borrelia sp. Bartonellosis caused by Bartonella bacilliformis . Chancroid caused by Hemophilus ducreyi . Tularemia caused by Francisella tularensis . Plaque caused by Yersinia pestis . Cholera caused by Vibrio cholerae . Brucellosis caused by Brucella species (tetracycline may be used in conjunction with an aminoglycoside). Infections due to Campylobacter fetus . As adjunctive therapy in intestinal amebiasis caused by Entamoeba histolytica . Urinary tract infections caused by susceptible strains of Escherichia coli , Klebsiella , etc. Other infections caused by susceptible gram-negative organisms such as E. coli , Enterobacteraerogenes , Shigella sp., Acinetobacter sp ., Klebsiella sp ., and Bacteroides sp. In severe acne, adjunctive therapy with Tetracycline HCl Capsules, USP may be useful. When penicillin is contraindicated, tetracyclines are alternative drugs in the treatment of the following infections: Syphilis and yaws caused by Treponema pallidum and pertenue , respectively, Vincent's infection caused by Fusobacterium fusiforme , Infections caused by Neisseria gonorrhoeae , Anthrax caused by Bacillus anthracis , Infections due to Listeria monocytogenes , Actinomycosis caused by Actinomyces species, Infections due to Clostridium species.
Dosage and Administration
DOSAGE AND ADMINISTRATION Adults Usual daily dose, 1 gram as 500 mg b.i.d. or 250 mg q.i.d. Higher doses such as 500 mg q.i.d. may be required for severe infections or for those infections which do not respond to the smaller doses. Children above eight years of age Usual daily dose, 10 to 20 mg/lb (25 to 50 mg/kg) body weight divided in four equal doses. Therapy should be continued for at least 24 to 48 hours after symptoms and fever have subsided. For treatment of brucellosis, 500 mg Tetracycline HCl Capsules, USP q.i.d. for three weeks should be accompanied by streptomycin, 1 gram intramuscularly twice daily the first week and once daily the second week. For the treatment of syphilis in patients allergic to penicillin, the following dosage of Tetracycline HCl Capsules, USP is recommended: early syphilis (less than one year's duration), 500 mg q.i.d. for 15 days. Syphilis of more than one year's duration (except neurosyphilis), 500 mg q.i.d. for 30 days. For treatment of gonorrhea, the recommended dose is 500 mg by mouth four times a day for seven days. In cases of moderate to severe acne which, in the judgement of the clinician, require long-term treatment, the recommended initial dosage is 1 gram daily in divided doses. When improvement is noted, dosage should be gradually reduced to maintenance levels ranging from 125 mg to 500 mg daily. In some patients it may be possible to maintain adequate remission of lesions with alternate day or intermittent therapy. Tetracycline HCl Capsules, USP therapy of acne should augment the other standard measures known to be of value. Duration of long-term treatment which can safely be recommended has not been established (see WARNINGS and Carcinogenesis, Mutagenesis, Impairment of Fertility ). Concomitant Therapy Absorption of Tetracycline HCl Capsules, USP is impaired by antacids containing aluminum, calcium or magnesium and preparations containing iron, zinc or sodium bicarbonate. Food and some dairy products also interfere with absorption. In the treatment of streptococcal infections, a therapeutic dose of Tetracycline HCl Capsules, USP should be administered for at least ten days. 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. Uncomplicated urethral, endocervical or rectal infections in adults caused by Chlamydia trachomatis : 500 mg, by mouth, four times a day for at least seven days. Administration of adequate amounts of fluid with the capsule formulation of tetracycline is recommended to wash down the drug and reduce the risk of esophageal irritation and ulceration (see ADVERSE REACTIONS ).