国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
Doxycycline Hyclate (UNII: 19XTS3T51U) (Doxycycline Anhydrous - UNII:334895S862)
Aphena Pharma Solutions (Formerly TestPak)
Doxycycline Hyclate
Doxycycline Hyclate 100 mg
ORAL
PRESCRIPTION DRUG
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. 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 Chlamydia trachomatis , although the infectious agent is not always elimi
Available as a blue and white capsule with yellow powder, imprinted with company logo and 2984, containing doxycycline hyclate, equivalent to 50 mg doxycycline, packaged in bottles of 50 capsules; as a light blue capsule with yellow powder, imprinted with company logo and 2985, containing doxycycline hyclate, equivalent to 100 mg doxycycline, packaged in bottles of 50 and 500 capsules and unit dose boxes of 100 capsules; and as an orange film-coated tablet, debossed with company logo and 3626, containing doxycycline hyclate, equivalent to 100 mg doxycycline, packaged in bottles of 20, 50, 100, 200 and 500 tablets, and unit dose boxes of 100 tablets. PHARMACIST: Dispense in a tight, light-resistant container 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].
Abbreviated New Drug Application
DOXYCYCLINE HYCLATE- DOXYCYCLINE HYCLATE TABLET APHENA PHARMA SOLUTIONS (FORMERLY TESTPAK) ---------- DOXYCYCLINE DESCRIPTION Doxycycline is a broad-spectrum antibiotic synthetically derived from oxytetracycline. The chemical designation of this light-yellow crystalline powder 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 soluble in water, while doxycycline monohydrate is very slightly soluble in water. 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 tablet, for oral administration, contains doxycycline hyclate equivalent to 100 mg doxycycline. Each capsule for oral administration contains doxycycline hyclate equivalent to 50 mg or 100 mg doxycycline. In addition, each tablet and capsule contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, methylcellulose, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, stearic acid, and titanium dioxide. In addition, the 100 mg tablet contains FD&C Yellow No. 6, FD&C Red No. 40, and hypromellose; the 50 mg capsule contains FD&C Blue No. 1, and D&C Yellow No. 10; the 100 mg capsule contains FD&C Blue No. 1. The structural formula is as follows: (C22H24N2O8 • HCl)2 • C2H6O • H2O M.W. 1025.89 CLINICAL PHARMACOLOGY Tetracyclines are readily absorbed and are bound to plasma proteins in varying degree. They are concentrated by the liver in the bile, and excreted in the urine and feces at high concentrations and in a biologically active form. Doxycycline is virtually completely absorbed after oral administration. Following a 200 mg dose, normal adult volunteers averaged peak serum levels of 2.6 mcg/mL of doxycycline at 2 hours decreasing to 1.45 mcg/mL at 24 hours. Excretion of doxycycline 阅读完整的文件