البلد: الولايات المتحدة
اللغة: الإنجليزية
المصدر: NLM (National Library of Medicine)
DOXYCYCLINE HYCLATE (UNII: 19XTS3T51U) (DOXYCYCLINE ANHYDROUS - UNII:334895S862)
Proficient Rx LP
DOXYCYCLINE HYCLATE
DOXYCYCLINE ANHYDROUS 100 mg
ORAL
PRESCRIPTION DRUG
To reduce the development of drug-resistant bacteria and maintain effectiveness of Doxycycline Hyclate Capsules 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: Doxycycline is also indicated for the treatment of infections caused by the following gram-negative microorganisms: Because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended. Doxycycline is indicated for treatment of infections caused by the following gram-negative bacteria, when bacter
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. 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 PROFICIENT RX LP ---------- DOXYCYCLINE HYCLATE CAPSULES, 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 Capsules and Tablets 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. Each capsule for oral administration contains doxycycline hyclate equivalent to 50 mg or 100 mg of doxycycline (anhydrous). Inactive ingredients 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, and other inert ingredients. 100 mg gelatin capsule shell contains: FD&C Blue #1 and other inert ingredients. 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 h اقرأ الوثيقة كاملة