DORYX® MPC Delayed-Release Tablets

Prescribing information doryx.com Savings card

DORYX® MPC (doxycycline hyclate delayed-release tablets) for the Adjunctive Treatment of Severe Acne*

  • A tetracycline-class antimicrobial indicated as adjunctive therapy for severe acne available in 60 mg and 120 mg dosage strengths for flexible dosing options1
  • Similar to standard DORYX®, DORYX® MPC contains pH-sensitive enteric-coated pellets of doxycycline hyclate1
  • The modified polymer coat (MPC) of DORYX® MPC delays the absorption of doxycycline by approximately 15 to 20 minutes farther into the GI tract when compared to standard DORYX®1-3
    – This minimizes doxycycline exposure in the upper GI tract, including the esophagus and stomach
  • DORYX® MPC 120 tablets were proven bioequivalent to 100 mg of doxycycline
    – The further delayed release of DORYX® MPC results in approximately 86% bioavailability of doxycycline1

*The usual dose of oral doxycycline is 240 mg on the first day of treatment (administered 120 mg every 12 hours), followed by a maintenance dose of 120 mg daily. In the management of more severe infections (particularly chronic infections of the urinary tract), 120 mg every 12 hours is recommended.

For additional information please visit the website for Doryx® MPC Delayed-Release Tablets.

Indication and Usage

DORYX® MPC (doxycycline hyclate delayed-release 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 DORYX® MPC and other antibacterial drugs, DORYX® MPC should be used only as indicated.

Selected Safety Information about DORYX® MPC (doxycycline hyclate delayed-release tablets)

Doxycycline is contraindicated in patients who have shown hypersensitivity to any of the tetracyclines. Tetracycline-class drugs, like DORYX® MPC (doxycycline hyclate delayed-release tablets), can cause fetal harm when administered to a pregnant woman. DORYX® MPC should be avoided if possible by nursing mothers, taking into account the importance of the drug to the mother. DORYX® MPC should not be used in children during tooth development (up to the age of 8 years). Concurrent use of tetracycline-class antibiotics with oral contraceptives may reduce their effectiveness.

Clostridium difficile associated diarrhea (CDAD) has been reported with nearly all antibacterial agents including doxycycline, and may range from mild diarrhea to fatal erythema.

Photosensitivity can occur with tetracycline-class drugs. DORYX® MPC 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.

Overgrowth of non-susceptible organisms, including fungi, may occur. DORYX® MPC should be discontinued if superinfection occurs and appropriate therapy instituted. Adverse reactions observed in patients receiving tetracyclines include anorexia, nausea, vomiting, diarrhea, rash, photosensitivity, urticaria and hemolytic anemia.

Intracranial Hypertension (IH) has been associated with the use of tetracyclines. Women of childbearing age who are overweight or have a history of IH are at greater risk for developing tetracycline-associated IH.

Adverse reactions observed in patients receiving tetracyclines include anorexia,  nausea, vomiting, diarrhea, rash, photosensitivity, urticaria, and hemolytic anemia.

For additional safety and other information, please see Prescribing Information

To report SUSPECTED ADVERSE REACTIONS, contact Mayne Pharma at 1-844-825-8500 or FDA at 1 800-FDA-1088 or www.fda.gov/medwatch.

 

1. DORYX MPC [package insert]. Greenville, NC: Mayne Pharma; 2016. 2. Kircik LH, Bikowski JB. Enteric-coated doxycycline pellets, delayed release, in tablets. Pract Dermatol. 2010;(suppl):5-8. 3. Data on file. Greenville, NC; Mayne Pharma.