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AZITHROMYCIN DIHYDRATE- azithromycin tablet, film coated


  1. Patient Information
  2. Azithromycin Tablets?
  3. Azithromycin Should Not Be Taken By People Who Cannot Tolerate Oral Medications Because They Are Very Ill Or Have Certain Other Risk Factors Including:
  4. Who Should Not Take Azithromycin Tablets?
  5. Not Take Azithromycin Tablets If You:
  6. I Tell My Healthcare Provider Before Taking Azithromycin Tablets?
  7. Take Azithromycin Tablets, Tell Your Healthcare Provider If You:
  8. Especially Tell Your Healthcare Provider If You Take:
  9. I Take Azithromycin Tablets?
  10. Cause Serious Side Effects, Including:
  11. The Most Common Side Effects Of Azithromycin Tablets Include:
  12. I Store Azithromycin Tablets?

Patient Information 

General Patient Counseling
Azithromycin tablets and oral suspension can be taken with or without food.

Patients should also be cautioned not to take aluminum- and magnesium-containing antacids and azithromycin simultaneously.

The patient should be directed to discontinue azithromycin immediately and contact a physician if any signs of an allergic reaction occur.

Direct parents or caregivers to contact their physician if vomiting and irritability with feeding occurs in the infant.

Patients should be counseled that antibacterial drugs including azithromycin should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When azithromycin is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of the 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 azithromycin or other antibacterial drugs in the future.

Diarrhea is a common problem caused by antibacterials which usually ends when the antibacterial is discontinued. Sometimes after starting treatment with antibacterials 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 the antibacterial drug. If this occurs, patients should contact their physician as soon as possible.

See FDA-approved Patient Labeling

APOTEX CORP.
AZITHROMYCIN TABLETS, USP
250 mg and 500 mg

Manufactured byManufactured for
Apotex Inc.Apotex Corp.
Toronto, OntarioWeston, Florida
Canada M9L 1T933326

Revised: April 2017
Rev. 14a

Azithromycin Tablets? 

Azithromycin tabletsare a macrolide antibiotic prescription medicine used in adults 18 years or older to treat certain infections caused by certain germs called bacteria. These bacterial infections include:

  • acute worsening of chronic bronchitis

  • acute sinus infection

  • community-acquired pneumonia

  • infected throat or tonsils

  • skin infections

  • infections of the urethra or cervix

  • genital ulcers in men

Azithromycintablets are also used in children to treat:

  • ear infections

  • community-acquired pneumonia

  • infected throat or tonsils

Azithromycin Should Not Be Taken By People Who Cannot Tolerate Oral Medications Because They Are Very Ill Or Have Certain Other Risk Factors Including: 

  • have cystic fibrosis
  • have hospital acquired infections
  • have known or suspected bacteria in the blood
  • need to be in the hospital
  • are elderly
  • have any medical problems that can lower the ability of the immune system to fight infections

Azithromycintablets are not for viral infections such as the common cold.

It is not known if azithromycintablets are safe and effective for genital ulcers in women.

It is not known if azithromycintablets are safe and effective for children with ear infections, sinus infections, and community-acquired pneumonia under 6 months of age.

It is not known if azithromycintablets are safe and effective for infected throat or tonsils in children under 2 years of age.

Who Should Not Take Azithromycin Tablets? 

Do

Not Take Azithromycin Tablets If You: 

  • have had a severe allergic reaction to certain antibiotics known as macrolides or ketolides including azithromycin and erythromycin.
  • have a history of cholestatic jaundice or hepatic dysfunction that happened with the use of azithromycin.

Whatshould

I Tell My Healthcare Provider Before Taking Azithromycin Tablets? 

Beforeyou

Take Azithromycin Tablets, Tell Your Healthcare Provider If You: 

  • have pneumonia

  • have cystic fibrosis

  • have known or suspected bacteremia (bacterial infection in the blood)

  • have liver or kidney problems

  • have an irregular heartbeat, especially a problem called QT prolongation

  • have a problem that causes muscle weakness (myasthenia gravis)

  • have any other medical problems

  • are pregnant or plan to become pregnant. It is not known if azithromycin will harm your unborn baby.

  • are breastfeeding or plan to breastfeed. Azithromycin has been reported to pass into breast milk. Talk to your healthcare provider about the best way to feed your baby while you take azithromycin.

Contact your healthcare provider immediately if you are giving azithromycin to a young child (less than 6 weeks of age) and he or she vomits or becomes irritable when fed.

Tellyour healthcare provider about all the medicines you take,including prescription and non-prescription medicines, vitamins, and herbal supplements.

Azithromycin tablets and other medicines may affect each other causing side effects. Azithromycin tablets may affect the way other medicines work, and other medicines may affect how azithromycin tablets work.

Especially Tell Your Healthcare Provider If You Take: 

  • nelfinavir

  • a blood thinner (warfarin)

  • digoxin

  • phenytoin

  • an antacid that contains aluminum or magnesium

Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.

Howshould

I Take Azithromycin Tablets? 

  • Take azithromycin tablets exactly as your healthcare provider tells you to take it.

  • Azithromycin tablets can be taken with or without food.

  • Do not skip any doses of azithromycin tablets or stop taking it, even if you begin to feel better, until you finish your prescribed treatment unless you have a serious allergic reaction or your healthcare provider tells you to stop taking azithromycin tablets.

    Azithromycin tablets can

Cause Serious Side Effects, Including: 

  • Seriousallergic reactions.Allergic reactions can happen in people taking azithromycin the active ingredient in azithromycin tablets, even after only 1 dose. Stop taking azithromycin tablets and get emergency medical help right away if you have any of the following symptoms of a severe allergic reaction:

    • trouble breathing or swallowing

    • swelling of the lips, tongue, face

    • throat tightness, hoarseness

    • rapid heartbeat

    • faintness

    • skin rash (hives)

    • new onset of fever and swollen lymph nodes

Stop taking azithromycin tablets at the first sign of a skin rash and call your healthcare provider. Skin rash may be a sign of a more serious reaction to azithromycin tablets.

  • Liverdamage(hepatotoxicity).Hepatotoxicity can happen in people who take azithromycin tablets. Call your healthcare provider right away if you have unexplained symptoms such as:

    • nausea or vomiting
    • stomach pain
    • fever
    • weakness
    • abdominal pain or tenderness
    • itching
    • unusual tiredness
    • loss of appetite
    • change in the color of your bowel movements
    • dark colored urine
    • yellowing of your skin or of the whites of your eyes

Stop taking azithromycin tablets and tell your healthcare provider right away if you have yellowing of your skin or white part of your eyes, or if you have dark urine. These can be signs of a serious reaction to azithromycin tablets (a liver problem).

  • Seriousheart rhythmchanges(QT prolongation and torsades de pointes).

    Tell your healthcare provider right away if you have a change in your heartbeat (a fast or irregular heartbeat), or if you feel faint and dizzy. Azithromycin tablets may cause a rare heart problem known as prolongation of the QT interval. This condition can cause an abnormal heartbeat and can be very dangerous. The chances of this happening are higher in people:

    • who are elderly
    • with a family history of prolonged QT interval
    • with low blood potassium
    • who take certain medicines to control heart rhythm (antiarrhythmics)
  • Worseningof myastheniagravis(a problem that causes muscle weakness).Certain antibiotics like azithromycin tablets may cause worsening of myasthenia gravis symptoms, including muscle weakness and breathing problems. Call your healthcare provider right away if you have any worsening muscle weakness or breathing problems.

  • Diarrhea.Tell your healthcare provider right away if you have watery diarrhea, diarrhea that does not go away, or bloody stools. You may experience cramping and a fever. This could happen after you have finished your azithromycin tablets.

The Most Common Side Effects Of Azithromycin Tablets Include: 

  • nausea
  • stomach pain
  • vomiting

These are not all the possible side effects of azithromycin tablets. Tell your healthcare provider about any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Howshould

I Store Azithromycin Tablets? 

  • Store azithromycin tablets at 20 C to 25 C (68 F to 77 F), excursions permitted from 15 Cto 30 C (59 Fto 86 F) [

    Active ingredient: azithromycin dihydrate

    Inactive ingredients: dibasic calcium phosphate dihydrate, hydroxypropyl cellulose, croscarmellose sodium, magnesium stearate and Opadry II white (Opadry II white contains the following components: hypromellose, lactose monohydrate, titanium dioxide and triacetin).

    This Patient Information has been approved by the U.S. Food and Drug Administration.

    APOTEX CORP.
    AZITHROMYCIN TABLETS, USP
    250 mg and 500 mg

    Manufactured byManufactured for
    Apotex Inc.
    Toronto, Ontario
    Apotex Corp.
    Weston, Florida
    Canada M9L 1T933326
    Revised: April 2017
    Rev. 14a



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