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ORACEA
Rosacea
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Drug Name:

ORACEA Rx

Generic Name and Formulations:
Doxycycline 40mg (30mg immediate-release beads, 10mg delayed-release beads); caps.

Company:
Galderma Laboratories, Inc.

Therapeutic Use:

Indications for ORACEA:

Treatment of inflammatory lesions (papules and pustules) of rosacea. Limitations of use: this formulation has not been evaluated in the treatment or prevention of infections. Efficacy >16 weeks and safety >9 months have not been established.

Adult:

Take on empty stomach in the morning with sufficient amount of fluids. 40mg once daily.

Children:

Not recommended.

Warnings/Precautions:

Do not substitute with other doxycycline products. Renal impairment. Hepatic insufficiency. Monitor blood, renal and hepatic function. Achlorhydria. GI surgery. Predisposition to candidiasis overgrowth. Avoid sun and UV light. Discontinue if pseudomembranous colitis or superinfection occurs and treat appropriately. Monitor for autoimmune syndromes. Labor & delivery. Pregnancy (Cat.D), nursing mothers: not recommended. Not recommended for either gender if conception is planned.

Interactions:

Avoid concomitant methoxyflurane, penicillins, photosensitizers, oral retinoids. Reduced absorption with bismuth subsalicylate, acid pump inhibitors, antacids, calcium, magnesium, iron. May potentiate anticoagulants (eg, warfarin). May antagonize hormonal contraceptives (use back-up contraception). May be antagonized by metabolic enzyme inducers (eg, barbiturates, carbamazepine, phenytoin).

Pharmacological Class:

Tetracycline antibiotic.

Adverse Reactions:

Nasopharyngitis, sinusitis, superinfection, diarrhea, dry mouth, hypertension, blood glucose increase, elevated liver enzymes or BUN; pseudomembranous colitis, autoimmune syndromes (discontinue if occurs), hyperpigmentation, photosensitivity; benign intracranial hypertension, teeth discoloration, others (see full labeling).

How Supplied:

Caps—30

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