Country: United States
Language: English
Source: NLM (National Library of Medicine)
DOXYCYCLINE HYCLATE (UNII: 19XTS3T51U) (DOXYCYCLINE ANHYDROUS - UNII:334895S862)
Chartwell RX LLC
DOXYCYCLINE HYCLATE
DOXYCYCLINE ANHYDROUS 50 mg
ORAL
PRESCRIPTION DRUG
To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline and other antibacterial drugs, doxycycline 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 Chlamydophila psittaci . - Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as j
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; 100 mg are available as a light blue capsule filled with yellow powder imprinted with "2985" containing doxycycline hyclate, equivalent to 100 mg of doxycycline. NDC 62135-984-50 50 mg capsules - Bottles of 50 capsules NDC 62135-985-50 100 mg capsules -Bottles of 50 capsules NDC 62135-985-05 100 mg capsules -Bottles of 500 capsules Doxycycline Hyclate Tablets, USP equivalent to 100 mg doxycycline: Round, orange film-coated tablet engraved with "3626" on one side, and plain on the other side. NDC 62135-626-20 Bottles of 20 tablets NDC 62135-626-28 Bottles of 28 tablets NDC 62135-626-50 Bottles of 50 tablets NDC 62135-626-12 Bottles of 120 tablets NDC 62135-626-23 Bottles of 210 tablets NDC 62135-626-31 Bottles of 300 tablets NDC 62135-626-40 Bottles of 400 tablets NDC 62135-626-05 Bottles of 500 tablets NDC 62135-626-10 Bottles of 1000 tablets NDC 62135-626-96 Bottles of 2000 tablets Doxycycline for Oral Suspension USP is available as a raspberry-flavored, pink dry powder for oral suspension. When reconstituted, each teaspoonful (5 mL) contains doxycycline monohydrate equivalent to 25 mg of doxycycline in a 2 oz (60 mL) bottle. NDC 62135-417-46 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 CAPSULE CHARTWELL RX LLC ---------- DOXYCYCLINE HYCLATE CAPSULES, USP DOXYCYCLINE FOR ORAL SUSPENSION, USP DOXYCYCLINE HYCLATE TABLETS, USP To reduce the development of drug-resistant bacteria and maintain the effectiveness of Doxycycline and other antibacterial drugs, doxycycline 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 Tablets and Capsules and Doxycycline for Oral Suspension; for oral administration. The structural formula of doxycycline monohydrate is with a molecular formula of C H N O ·H O and a molecular weight of 462.46. The chemical designation for doxycycline 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 monohydrate. The molecular formula for doxycycline hydrochloride hemiethanolate hemihydrate is (C H N O ·HCl) ·C H O·H O and the molecular weight is 1025.89. Doxycycline is a light-yellow crystalline powder. 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. Inactive ingredients in the capsule formulations are: colloidal silicon dioxide, lactose anhydrous, magnesium stearate, methylcellulose, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and stearic acid. 50 mg gelatin capsule shell contains: FD&C Blue #1, D&C Yellow #10, titanium dioxide and gelatin. 100 mg gelatin capsule shell contains: FD&C Blue #1, titanium dioxide and gelatin. Black ink contains shellac glaze in SD-45, black iron oxide, propylene glycol, FD&C Blue #2, FD&C Red # 40, FD&C Blue # 1, D&C Yellow # 10, butyl alcohol, denatured alcohol. Each capsu Read the complete document