देश: संयुक्त राज्य
भाषा: अंग्रेज़ी
स्रोत: NLM (National Library of Medicine)
Doxycycline Hyclate (UNII: 19XTS3T51U) (DOXYCYCLINE ANHYDROUS - UNII:334895S862)
Alvogen, Inc.
Doxycycline Hyclate
DOXYCYCLINE ANHYDROUS 50 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. 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 Chlamydophila psittaci . - Trachoma caused by Chlamydia trachomatis , although the infectious agent is no
Doxycycline Hyclate Capsules, USP 50 mg are available as a blue and white capsule filled with yellow powder, imprinted with “2984”, containing doxycycline hyclate equivalent to 50 mg doxycycline. NDC 47781-489-50 Bottles of 50 capsules Doxycycline Hyclate Capsules, USP 100 mg are available as a light blue capsule filled with yellow powder, imprinted with “2985”, containing doxycycline hyclate equivalent to 100 mg doxycycline. NDC 47781-490-50 Bottles of 50 capsules NDC 47781-490-05 Bottles of 500 capsules Doxycycline Hyclate Tablets, USP 100 mg are available as a round, orange film-coated tablet engraved with “3626” on one side, and plain on the other side, containing doxycycline hyclate equivalent to 100 mg doxycycline. NDC 47781-491-50 Bottles of 50 tablets NDC 47781-491-05 Bottles of 500 tablets Dispense in a tight, light-resistant container as defined in the USP, with a 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 CAPSULE DOXYCYCLINE HYCLATE- DOXYCYCLINE HYCLATE TABLET, FILM COATED ALVOGEN, INC. ---------- DOXYCYCLINE HYCLATE CAPSULES, USP 50 MG AND 100 MG DOXYCYCLINE HYCLATE TABLETS, USP 100 MG To reduce the development of drug-resistant bacteria and maintain the 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 bacteria. DESCRIPTION Doxycycline is an antibacterial drug 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 is a light-yellow crystalline powder. Doxycycline hyclate is 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 capsule, for oral administration, contains doxycycline hyclate equivalent to 50 mg or 100 mg of doxycycline. In addition, the capsules contain the inactive ingredients anhydrous lactose, colloidal silicon dioxide, magnesium stearate, methylcellulose, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and stearic acid. The 50 mg capsule shell is composed of D&C Yellow #10, FD&C Blue #1, gelatin, and titanium dioxide. The 100 mg capsule shell is composed of FD&C Blue #1, gelatin, and titanium dioxide. The capsule imprinting ink contains butyl alcohol, denatured alcohol, D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, iron oxide पूरा दस्तावेज़ पढ़ें