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Oracea Generic Name & Formulations
Legal Class
Rx
General Description
Doxycycline 40mg (30mg immediate-release beads, 10mg delayed-release beads); caps.
Pharmacological Class
Tetracycline antibiotic.
How Supplied
Caps—30
Manufacturer
Oracea Indications
Indications
Treatment of only inflammatory lesions (papules and pustules) of rosacea.
Limitations of Use
This formulation has not been evaluated in the treatment or prevention of infections. Not been evaluated for the treatment of erythematous, telangiectatic, or ocular components of rosacea.
Oracea Dosage and Administration
Adult
Take on empty stomach in the morning with sufficient amount of fluids. 40mg once daily.
Children
Not recommended.
Oracea Contraindications
Not Applicable
Oracea Boxed Warnings
Not Applicable
Oracea Warnings/Precautions
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 superinfection occurs; treat appropriately. Monitor for autoimmune syndromes, visual disturbances. Labor & delivery. Pregnancy (during 2nd & 3rd trimester): avoid. Nursing mothers: not recommended (during and for 5 days after the last dose).
Oracea Pharmacokinetics
See Literature
Oracea Interactions
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).
Oracea Adverse Reactions
Adverse Reactions
Nasopharyngitis, sinusitis, superinfection, diarrhea, dry mouth, hypertension, blood glucose increase, elevated liver enzymes or BUN; C.difficile-associated diarrhea, autoimmune syndromes (discontinue if occurs), hyperpigmentation, photosensitivity, teeth discoloration, pseudotumor cerebri, others (see full labeling).
Oracea Clinical Trials
See Literature
Oracea Note
Not Applicable
Oracea Patient Counseling
See Literature
