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Drug Information for DOXYCYCLINE HYCLATE CAPSULES, USP (Hikma Pharmaceutical): DESCRIPTION

Doxycycline hyclate is a. broad-spectrurn antibiotic synthetically derived from oxytetracycline. The structural formula is as follows:
with a molecular formula of C₂₂H₂₄N₂O₈•H₂O 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. 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 of 100 mg of doxycycline (anhydrous). Inactive ingredients: lactose monohydrate, microcrystalline cellulose, magnesium stearate.
50 mg gelatin capsule shell contains: FD&C Blue #1, silicon dioxide, sodium lauryl sulfate and titanium dioxide. 100 mg gelatin capsule shell contains: FD&C Blue#1, silicon dioxide, sodium lauryl sulfate and titanium dioxide. The printing ink contains: D&C Yellow #10, FD&C Blue #1, FE&C Blue #2, FE&C Red #40, n-Butyl Alcohol, Pharmaceutical Glaze, Propylene Glycol, SDA-3A, Alcohol and Synthetic Black Iron Oxide.