Important Safety Information
Indications and Usage
TARGADOX® (doxycycline hyclate tablets) is a tetracycline-class antimicrobial indicated as adjunctive therapy for severe acne. To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of TARGADOX and other antibacterial drugs, TARGADOX should be used only as indicated. The usual dose of oral doxycycline is 200mg on the first day of treatment (administered 100mg every 12 hours), followed by a maintenance dose of 100mg daily. There are no adequate and well-controlled studies on the use of doxycycline in pregnant women.
Contraindications
This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.
Important Safety Information
- TARGADOX tablets are contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.
- The use of tetracycline class drugs during tooth development (last half of pregnancy, infancy, and childhood to 8 years) may cause permanent discoloration of the teeth and should not be used in this group (except for anthrax).
- Clostridium difficile-associated diarrhea (CDAD) has been reported with nearly all antibacterial agents, including doxycycline, and may range from mild diarrhea to fatal colitis.
- Photosensitivity can occur with tetracycline-class drugs. TARGADOX patients should minimize or avoid excessive exposure to natural or artificial sunlight and consider using sunscreen or sunblock.
Advise patients to discontinue therapy at the first evidence of skin erythema.
- Intracranial Hypertension (IH) has been associated with the use of tetracyclines.
- Concurrent use of tetracycline may render oral contraceptives less effective.
- Absorption of tetracyclines is impaired by antacids containing aluminum, calcium, or magnesium, bismuth subsalicylate, and iron-containing preparations.
- Esophagitis has been associated with the use of tetracyclines so patients should be advised to drink fluids liberally along with doxycycline.
- Adverse reactions observed in patients receiving tetracyclines include anorexia, nausea, vomiting, diarrhea, rash, photosensitivity, urticaria, hemolytic anemia, toxic epidermal necrolysis, Stevens-Johnson syndrome, increased blood urea nitrogen (BUN) and hypersensitivity reactions.
To report SUSPECTED ADVERSE REACTIONS, contact Journey Medical Corporation at 1-877-801-1298, or the FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch.
Click here for Full Prescribing Information.
