Country: Bandaríkin
Tungumál: enska
Heimild: NLM (National Library of Medicine)
DOXYCYCLINE (UNII: N12000U13O) (DOXYCYCLINE ANHYDROUS - UNII:334895S862)
Alembic Pharmaceuticals Inc.
DOXYCYCLINE
DOXYCYCLINE ANHYDROUS 75 mg
ORAL
PRESCRIPTION DRUG
To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline capsules, USP and other antibacterial drugs, doxycycline capsules, USP 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 n
Doxycycline capsules USP, 75 mg are opaque brown cap/opaque white body hard gelatin capsules size “2” having imprinting “A” on cap with black ink and “241” on body with black ink filled with yellow to brown granular powder. Each capsule contains doxycycline monohydrate equivalent to 75 mg doxycycline. NDC 62332-249-30 bottle of 30 capsules NDC 62332-249-31 bottle of 100 capsules Doxycycline capsules USP, 100 mg are opaque brown cap/opaque yellow body hard gelatin capsules size “1” having imprinting “A” on cap with white ink and “242” on body with brown ink filled with yellow to brown granular powder. Each capsule contains doxycycline monohydrate equivalent to 100 mg doxycycline. NDC 62332-250-30 bottle of 30 capsules NDC 62332-250-50 bottles of 50 capsules NDC 62332-250-60 bottle of 60 capsules NDC 62332-250-61 bottle of 250 capsules Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight light- resistant container as defined in the USP/NF.
Abbreviated New Drug Application
DOXYCYCLINE - DOXYCYCLINE CAPSULE ALEMBIC PHARMACEUTICALS INC. ---------- DOXYCYCLINE CAPSULES, USP RX ONLY TO REDUCE THE DEVELOPMENT OF DRUG-RESISTANT BACTERIA AND MAINTAIN THE EFFECTIVENESS OF DOXYCYCLINE CAPSULES, USP AND OTHER ANTIBACTERIAL DRUGS, DOXYCYCLINE CAPSULES, USP SHOULD BE USED ONLY TO TREAT OR PREVENT INFECTIONS THAT ARE PROVEN OR STRONGLY SUSPECTED TO BE CAUSED BY BACTERIA. DESCRIPTION Doxycycline, USP is a broad - spectrum antibacterial synthetically derived from oxytetracycline. Doxycycline monohydrate capsules USP, 100 mg and 75 mg contain doxycycline monohydrate equivalent to 100 mg and 75 mg of doxycycline for oral administration. The chemical designation of the light yellow to pale yellow powder is alpha- 6- deoxy- 5- oxytetracycline. Structural formula: C H N O • H O M.W. = 462.45 Doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Inert ingredients: microcrystalline cellulose; sodium starch glycolate; povidone; colloidal silicon dioxide; magnesium stearate; and a hard gelatin capsule which contains iron oxide black, iron oxide red, iron oxide yellow, titanium dioxide, gelatin and sodium lauryl sulphate. The capsule shells of 75 mg are printed with edible black ink containing shellac, propylene glycol, iron oxide black and potassium hydroxide. The cap of 100 mg capsule shells is printed with edible white ink containing shellac, propylene glycol, potassium hydroxide and titanium dioxide. The body of 100 mg capsule shells is printed with edible and brown ink containing shellac, propylene glycol, potassium hydroxide, iron oxide brown and iron oxide black. CLINICAL PHARMACOLOGY Tetracyclines are readily absorbed and are bound to plasma proteins in varying degrees. They are concentrated by the liver in the bile and excreted in the urine and feces at high concentrations in a biologically active form. Doxycycline is virtually completely absorbed after oral admini Lestu allt skjalið