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ACTICLATE- doxycycline hyclate tablet, coated


  1. Patient Information
  2. Advise Patients Taking Acticlate And Acticlate Cap For Malaria Prophylaxis:
  3. That Doxycycline Prophylaxis:- Should Begin 1 Day 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 Acticlate And Acticlate Cap:
  4. Acticlate Tablets Are Marked With Scored Lines And May Be Broken At These Scored Lines To Provide The Following Doses:
  5. How To Break Your Acticlate Tablet:

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Instructions for Use).

Advise Patients Taking Acticlate And Acticlate Cap 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 Day 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 Acticlate And Acticlate Cap: 

  • that ACTICLATE Tablets (150 mg) can be broken into two-thirds or one-third at the scored lines to provide 100 mg or 50 mg strength doses, respectively.
  • that they must swallow ACTICLATE CAP whole. They must not break, open, crush, dissolve or chew the capsule [see Dosage and Administration (2.2)].
  • 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[see Warnings and Precautions (5.3)].
  • to drink fluids liberally along with ACTICLATE and ACTICLATE CAP to reduce the risk of esophageal irritation and ulceration[see Adverse Reactions (6)].
  • that the absorption of tetracyclines is reduced when taken with foods, especially those that contain calcium[see Drug Interactions (7.3)]. However, the absorption of doxycycline is not markedly influenced by simultaneous ingestion of food or milk[see Clinical Pharmacology (12.3)].
  • that if gastric irritation occurs, ACTICLATE and ACTICLATE CAP may be given with food or milk[see Clinical 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[see Drug 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 ACTICLATE and ACTICLATE CAP should only be used to treat bacterial infections. They do not treat viral infections (for example, the common cold). When ACTICLATE and ACTICLATE CAP are 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 ACTICLATE and ACTICLATE CAP or other antibacterial drugs in the future.

    Manufactured by Catalent Pharma Solutions, Winchester, KY 40391
    For Aqua Pharmaceuticals, an Almirall Company Exton, PA 19341

    AQUA PHARMACEUTICALS
    an Almirall company



    FDA-Approved Patient Labeling

    Instructions for Use
    ACTICLATE( akt kl t)
    (doxycycline hyclate)
    tablets
    for oral use

    Read this Instructions for Use before you start using ACTICLATE and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

    Note:

    • Your healthcare provider may need to change your dose of ACTICLATE during treatment as needed.
    • ACTICLATE tablets can be taken whole or broken at scored lines.

    Acticlate Tablets Are Marked With Scored Lines And May Be Broken At These Scored Lines To Provide The Following Doses: 

    150 mg treatment (take the entire whole tablet)

    150mg treatment

    100 mg treatment (take two-thirds of the tablet)

    150mg treatment

    50 mg treatment (take one-third of the tablet)

    150mg treatment

    How To Break Your Acticlate Tablet: 

    • Hold the tablet between your thumb and index finger close to the scored line for your dose of ACTICLATE as shown above.
    • Apply enough pressure to break the tablet at the scored line.
    • Do notbreak the ACTICLATE tablet in any other way.

    AQUA PHARMACEUTICALS
    an Almirall company

    Manufactured by Catalent Pharma Solutions, Winchester, KY 40391
    For Aqua Pharmaceuticals, an Almirall Company Exton, PA 19341


    This Instructions for Use has been approved by the U.S. Food and Drug Administration.
    Revised: 06/2018
    Rx only




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