Drug Catalog - Product Detail
DOXYCYCLINE HYCLATE 100MG TABLETS 500CT
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00591-5553-05 | ACTAVIS PHARMA | 500 | 100MG | TABLET |
PACKAGE FILES
Generic Name
Substance Name
Product Type
Route
Application Number
Description
DESCRIPTION Doxycycline is a broad-spectrum antibiotic synthetically derived from oxytetracycline, and is available as doxycycline hyclate (doxycycline hydrochloride hemiethanolate hemihydrate) for oral administration. The structural formula of doxycycline hyclate is with a molecular formula of (C H N O •HCl) •C H O•H O and a molecular weight of 1025.89. The chemical designation for doxycycline hyclate is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline hyclate is a yellow crystalline powder which is soluble in water. 22 24 2 8 2 2 6 2 Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each capsule, for oral administration, contains Doxycycline Hyclate, equivalent to 50 mg or 100 mg of Doxycycline. Each tablet, for oral administration, contains Doxycycline Hyclate, equivalent to 100 mg of Doxycycline. Doxycycline Hyclate Capsules USP 50 mg and 100 mg contain the following inactive ingredients: magnesium stearate and microcrystalline cellulose. The capsule shells contain: FD&C Blue No. 1, gelatin, silicon dioxide, sodium lauryl sulfate and titanium dioxide. Doxycycline Hyclate Tablets USP 100 mg contain the following inactive ingredients: croscarmellose sodium, FD&C Red No. 40, FD&C Yellow No. 6, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium lauryl sulfate and titanium dioxide. structural formula of doxycycline hyclate
How Supplied
HOW SUPPLIED NDC:64725-5440-1 in a BOTTLE of 50 CAPSULES Recommended storage: Store below 30°C (86°F). ANIMAL PHARMACOLOGY AND ANIMAL TOXICOLOGY Hyperpigmentation of the thyroid has been produced by members of the tetracycline class in the following species: in rats by oxytetracycline, doxycycline, tetracycline PO , and methacycline; in minipigs by doxycycline, minocycline, tetracycline PO , and methacycline; in dogs by doxycycline and minocycline; in monkeys by minocycline. 4 4 Minocycline, tetracycline PO , 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. 4 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.
Indications & Usage
INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate 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. Treatment : Doxycycline is indicated for the treatment of the following infections: 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 caused by . Chlamydia trachomatis Psittacosis (ornithosis) caused by . Chlamydia psittaci Trachoma caused by , although the infectious agent is not always eliminated, as judged by immunofluorescence. Chlamydia trachomatis Inclusion conjunctivitis caused by . Chlamydia trachomatis Uncomplicated urethral, endocervical, or rectal infections in adults caused by . Chlamydia trachomatis Nongonococcal urethritis caused by . Ureaplasma urealyticum Relapsing fever due to . Borrelia recurrentis Doxycycline is also indicated for the treatment of infections caused by the following gram-negative microorganisms: Chancroid caused by . Haemophilus ducreyi Plague due to (formerly ). Yersinia pestis Pasteurella pestis Tularemia due to (formerly ). Francisella tularensis Pasteurella tularensis Cholera caused by (formerly ). Vibrio cholerae Vibrio comma Campylobacter fetus infections caused by (formerly ). Campylobacter fetus Vibrio fetus Brucellosis due to species (in conjunction with streptomycin). Brucella Bartonellosis due to . Bartonella bacilliformis Granuloma inguinale caused by . Calymmatobacterium granulomatis Because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended. Doxycycline is indicated for treatment of infections caused by the following gram- negative microorganisms, when bacteriologic testing indicates appropriate susceptibility to the drug: Escherichia coli. (formerly ). Enterobacter aerogenes Aerobacter aerogenes species. Shigella species (formerly species and species). Acinetobacter Mima He rellea Respiratory tract infections caused by . Haemophilus influenzae Respiratory tract and urinary tract infections caused by species. Klebsiella Doxycycline 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 (formerly ). Streptococcus pneumoniae Diplococcus pneumoniae Anthrax due to , including inhalational anthrax (post-exposure): to reduce the incidence or progression of disease following exposure to aerosolized . Bacillus anthracis Bacillus anthracis When penicillin is contraindicated, doxycycline is an alternative drug in the treatment of the following infections: Uncomplicated gonorrhea caused by . Neisseria gonorrhoeae Syphilis caused by . Treponema pallidum Yaws caused by . Treponema pertenue Listeriosis due to . Listeria monocytogenes Vincent’s infection caused by . Fusobacterium fusiforme Actinomycosis caused by . Actinomyces isr aelii Infections caused by species. Clostridium In acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides. In severe acne, doxycycline may be useful adjunctive therapy. Prophylaxis: Doxycycline is indicated for the prophylaxis of malaria due to in short-term travelers (<4 months) to areas with chloroquine and/or pyrimethamine-sulfadoxine resistant strains. (See section and subsection of the section.) Plasmodium falciparum DOSAGE AND ADMINISTRATION Information for Patients PRECAUTIONS
Dosage and Administration
DOSAGE AND ADMINISTRATION THE USUAL DOSAGE AND FREQUENCY OF ADMINISTRATION OF DOXYCYCLINE DIFFERS FROM THAT OF THE OTHER TETRACYCLINES. EXCEEDING THE RECOMMENDED DOSAGE MAY RESULT IN AN INCREASED INCIDENCE OF SIDE EFFECTS. Adults: The usual dose of oral doxycycline is 200 mg on the first day of treatment (administered 100 mg every 12 hours) followed by a maintenance dose of 100 mg/day. In the management of more severe infections (particularly chronic infections of the urinary tract), 100 mg every 12 hours is recommended. For children above eight years of age: The recommended dosage schedule for children weighing 100 pounds or less is 2 mg/lb of body weight divided into two doses on the first day of treatment, followed by 1 mg/lb of body weight given as a single daily dose or divided into two doses, on subsequent days. For more severe infections up to 2 mg/lb of body weight may be used. For children over 100 lb the usual adult dose should be used. The therapeutic antibacterial serum activity will usually persist for 24 hours following recommended dosage. When used in streptococcal infections, therapy should be continued for 10 days. Administration of adequate amounts of fluid along with capsule and tablet forms of drugs in the tetracycline class is recommended to wash down the drugs and reduce the risk of esophageal irritation and ulceration. (See ) ADVERSE REACTIONS. If gastric irritation occurs, it is recommended that doxycycline be given with food or milk. The absorption of doxycycline is not markedly influenced by simultaneous ingestion of food or milk. Studies to date have indicated that administration of doxycycline at the usual recommended doses does not lead to excessive accumulation of the antibiotic in patients with renal impairment. Uncomplicated gonococcal infections in adults (except anorectal infections in men): 100 mg, by mouth, twice a day for 7 days. As an alternate single visit dose, administer 300 mg stat followed in one hour by a second 300 mg dose. The dose may be administered with food, including milk or carbonated beverage, as required. Uncomplicated urethral, endocervical, or rectal infection in adults caused by : 100 mg, by mouth, twice a day for 7 days. Chlamydia trachomatis Nongonococcal urethritis (NGU) caused by or : 100 mg, by mouth, twice a day for 7 days. C. trachomatis U. urealyticum Syphilis–early: Patients who are allergic to penicillin should be treated with doxycycline 100 mg, by mouth, twice a day for 2 weeks. Syphilis of more than one year’s duration: Patients who are allergic to penicillin should be treated with doxycycline 100 mg, by mouth, twice a day for 4 weeks. Acute epididymo-orchitis caused by : 100 mg, by mouth, twice a day for at least 10 days. N. gonorrhoeae Acute epididymo-orchitis caused by : 100 mg, by mouth, twice a day for at least 10 days. C. trachomatis For the prophylaxis of malaria: For adults, the recommended dose is 100 mg daily. For children over 8 years of age, the recommended dose is 2 mg/kg given once daily up to the adult dose. Prophylaxis should begin 1 to 2 days before travel to the malarious area. Prophylaxis should be continued daily during travel in the malarious area and for 4 weeks after the traveler leaves the malarious area. Inhalational anthrax (post-exposure): ADULTS: 100 mg of doxycycline, by mouth, twice a day for 60 days. CHILDREN: weighing less than 100 lb (45 kg); 1 mg/lb (2.2 mg/kg) of body weight, by mouth, twice a day for 60 days. Children weighing 100 lb or more should receive the adult dose.