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DORYX MPC- doxycycline hyclate tablet, delayed release

  1. Advise Patients Taking Doryx Mpc For Malaria Prophylaxis:
  2. That Doxycycline Prophylaxis:
  3. Advise All Patients Taking Doryx Mpc:

Advise Patients Taking Doryx Mpc For Malaria Prophylaxis: 

  • that no present-day antimalarial agent, including doxycycline, guarantees protection against malaria.
  • to avoid being bitten by mosquitoes by using personal protective measures that help avoid contact with mosquitoes, especially from dusk to dawn (for example, staying in well-screened areas, using mosquito nets, covering the body with clothing, and using an effective insect repellent).

That Doxycycline Prophylaxis: 

should begin 1 to 2 days before travel to the malarious area,
should be continued daily while in the malarious area and after leaving the malarious area,
should be continued for 4 further weeks to avoid development of malaria after returning from an endemic area,
should not exceed 4 months.

Advise All Patients Taking Doryx Mpc: 

  • to avoid excessive sunlight or artificial ultraviolet light while receiving doxycycline and to discontinue therapy if phototoxicity (for example, skin eruptions, etc.) occurs. Sunscreen or sunblock should be considered [seeWarnings and Precautions (5.3)]
  • to drink fluids liberally along with DORYX MPC to reduce the risk of esophageal irritation and ulceration [seeAdverse Reactions (6)]
  • that the absorption of tetracyclines is reduced when taken with foods, especially those that contain calcium. [seeDrug Interactions (7.3)]
  • that if gastric irritation occurs, DORYX MPC may be given with food or milk [seeClinical Pharmacology (12.3)]
  • that the absorption of tetracyclines is reduced when taken with antacids containing aluminum, calcium or magnesium, bismuth subsalicylate, and iron-containing preparations [seeDrug Interactions (7.3)].
  • that the use of doxycycline might increase the incidence of vaginal candidiasis.

Advise patients that diarrhea is a common problem caused by antibacterial drugs which usually ends when the antibacterial is discontinued. Sometimes after starting treatment with antibacterial drugs, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of antibacterial. If this occurs, patients should contact their physician as soon as possible.

Counsel patients that antibacterial drugs including DORYX MPC should only be used to treat bacterial infections. They do not treat viral infections (for example, the common cold). When DORYX MPC is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by DORYX MPC or other antibacterial drugs in the future.

Manufactured by:
Mayne Pharma International Pty Ltd
1538 Main North Road
Salisbury South, SA 5106 Australia

Distributed by:
Mayne Pharma USA
Greenville, NC 27834

Rev. 07/2018

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