Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
DOXYCYCLINE HYCLATE (UNII: 19XTS3T51U) (DOXYCYCLINE ANHYDROUS - UNII:334895S862)
Zydus Pharmaceuticals (USA) Inc.
ORAL
PRESCRIPTION DRUG
To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate capsules 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 infectiou
Doxycycline hyclate capsules, USP contain doxycycline hyclate equivalent to doxycycline 50 mg or 100 mg. Doxycycline hyclate capsules USP, 50 mg are yellowish powder filled in size '3' hard gelatin capsule with light blue opaque cap imprinted with 'CHL' in white ink and white opaque body imprinted with 'D75' in black ink. NDC 68382-221-18 in bottle of 50 capsules with child-resistant closure NDC 68382-221-01 in bottle of 100 capsules NDC 68382-221-05 in bottle of 500 capsules NDC 68382-221-10 in bottle of 1000 capsules NDC 68382-221-77 in cartons of 100 capsules (10 x 10 unit-dose) Doxycycline hyclate capsules USP, 100 mg contains yellowish powder filled in size '1' hard gelatin capsule with light blue opaque cap imprinted with 'CHL' in white ink and light blue opaque body imprinted with 'D76' in black ink. NDC 68382-222-18 in bottle of 50 capsules with child-resistant closure NDC 68382-222-01 in bottle of 100 capsules NDC 68382-222-05 in bottle of 500 capsules NDC 68382-222-10 in bottle of 1000 capsules NDC 68382-222-77 in cartons of 100 capsules (10 x 10 unit-dose) Storage Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Dispense in tight, light-resistant containers (USP).
Abbreviated New Drug Application
DOXYCYCLINE HYCLATE- DOXYCYCLINE HYCLATE CAPSULE ZYDUS PHARMACEUTICALS (USA) INC. ---------- DOXYCYCLINE HYCLATE CAPSULES 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 hyclate is an antibacterial drug synthetically derived from oxytetracycline, and is available as doxycycline hyclate capsules for oral administration. The chemical designation for doxycyclin is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro- 3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacene-carboxamide monohydrate. The structural formula of doxycycline hyclate is Doxycycline hyclate, USP is yellow to light yellow powder. It is freely soluble in water and methanol, sparingly soluble in alcohol; practically insoluble in chloroform and in ether. It dissolves in aqueous solution of alkali hydroxides and carbonates. 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 contains doxycycline hyclate equivalent to doxycycline 50 mg or 100 mg and inactive ingredients: anhydrous lactose, croscarmellose sodium, D&C red 28, FD & C blue 1, gelatin, microcrystalline cellulose, magnesium stearate and sodium lauryl sulfate and titanium dioxide. Each capsule cap is printed with white pharmaceutical ink and capsule body is printed with black pharmaceutical ink which contains following ingredient butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, strong ammonia solution, and shellac. Additionally black pharmaceutical ink also contains black iron oxide. 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 t Lees het volledige document