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Oracea

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ORACEA®
(doxycycline, USP) Capsules 40 mg*
*30 mg Immediate Release & 10 mg Delayed Release beads

KEEP OUT OF REACH OF CHILDREN

The dosage of ORACEA differs from that of doxycycline used to treat infections. To reduce the development of resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, ORACEA should be used only as indicated.

ORACEA is indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients.

This formulation of doxycycline has not been evaluated as an antibacterial in the treatment of infections.

DRUG DESCRIPTION

ORACEA (doxycycline, USP) capsules 40 mg are hard gelatin capsule shells filled with two types of doxycycline beads (30 mg immediate release and 10 mg delayed-release) that together provide a dose of 40 mg of anhydrous doxycycline (C22H24N2O8).

The structural formula of doxycycline, USP is:

with an empirical formula of C22H24N2O8• H2O and a molecular weight of 462.46. The chemical designation for doxycycline is 2-Naphthacenecarboxamide, 4-(dimethylamino)- 1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-, [4S-(4aa, 4aa, 5a, 5aa, 6a,12aa)]-, monohydrate. It is very slightly soluble in water.

Inert ingredients in the formulation are: hypromellose, iron oxide red, iron oxide yellow, methacrylic acid copolymer, polyethylene glycol, Polysorbate 80, sugar spheres, talc, titanium dioxide, and triethyl citrate. Active ingredients: Each capsule contains doxycycline, USP in an amount equivalent to 40 mg of anhydrous doxycycline.

Brand Name: Oracea
Generic Name: Doxycycline

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