Azithromycin Dihydrate (Page 7 of 7)

15 REFERENCES

  1. Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard — Tenth Edition. CLSI document M07-A10, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2015.

  2. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Susceptibility Testing; Twenty-sixth Informational Supplement , CLSI document M100-S26. CLSI document M100-S26, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2016.

  3. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Disk Diffusion Susceptibility Tests; Approved Standard – Twelfth Edition CLSI document M02-A12, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2015.

  4. Clinical and Laboratory Standards Institute (CLSI). Methods for Antimicrobial Dilution and Disk Susceptibility Testing for Infrequently Isolated or Fastidious Bacteria: Approved Guidelines—Third Edition CLSI document M45-A3, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2016.

16 HOW SUPPLIED/STORAGE AND HANDLING

Azithromycin Tablets, USP 250 mg are supplied as white, oval, biconvex film coated tablets containing azithromycin dihydrate equivalent to 250 mg of azithromycin.

Azithromycin Tablets, USP 250 mg are engraved “APO” on one side and “AZ250” on the other side. These are packaged in bottles and blister cards of 6 tablets as follows:

Bottles of 30 NDC 60505-2581-3
Bottles of 500 NDC 60505-2581-5
Box of 6 tablets (unit-of-use) NDC 60505-2581-0
Package of 18 tablets [3 boxes of 6 tablets (unit-of-use)] NDC 60505-2581-2

Azithromycin Tablets, USP 500 mg are supplied as white, oval, biconvex film coated tablets containing azithromycin dihydrate equivalent to 500 mg of azithromycin.

Azithromycin Tablets, USP 500 mg are engraved “APO” on one side and “AZ500” on the other. These are packaged in bottles and blister cards of 3 tablets as follows:

Bottles of 30 NDC 60505-2582-3
Bottles of 500 NDC 60505-2582-5
Box of 3 tablets (unit-of-use) NDC 60505-2582-0

Storage: Store at 20ºC to 25ºC (68ºF to 77º F); excursions permitted from 15ºC to 30ºC (59ºF to 86º F) [See USP Controlled Room Temperature].

17 PATIENT COUNSELING 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 by Manufactured for
Apotex Inc. Apotex Corp.
Toronto, Ontario Weston, Florida
Canada M9L 1T9 33326

Revised

: April 2017


Rev. 14a

Patient Information

Azithromycin Tablets
(ay zith” roe mye’ sin)

Read this Patient Information leaflet before you start taking azithromycin tablets 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 your treatment.

What are azithromycin tablets?

Azithromycin tablets are 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

Azithromycin tablets 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

Azithromycin tablets are not for viral infections such as the common cold.

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

It is not known if azithromycin tablets 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 azithromycin tablets 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.

What should I tell my healthcare provider before taking azithromycin tablets?

Before you 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.

Tell your 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.

How should 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. “See What are the possible side effects of azithromycin tablets?” If you skip doses, or do not complete the total course of azithromycin tablets your treatment may not work as well and your infection may be harder to treat. Taking all of your azithromycin tablet doses will help lower the chance that the bacteria will become resistant to azithromycin tablets.
  • If the bacteria becomes resistant to azithromycin, azithromycin tablets and other antibiotic medicines may not work for you in the future.

  • If you take too many azithromycin tablets, call your healthcare provider or get medical help right away.

What are the possible side effects of azithromycin tablets?

Azithromycin tablets can cause serious side effects, including:

  • Serious allergic 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.

  • Liver damage (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).

  • Serious heart rhythm changes (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)
  • Worsening of myasthenia gravis (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.

How should I store azithromycin tablets?

  • Store azithromycin tablets at 20°C to 25°C (68°F to 77°F), excursions permitted from 15ºC to 30ºC (59ºF to 86ºF) [see Controlled Room Temperature].

  • Safely throw away any medicine that is out of date or no longer needed.

Keep azithromycin tablets and all medicines out of the reach of children.

General information about the safe and effective use of azithromycin tablets.

Medicines are sometimes prescribed for purposes other than those listed in the Patient Information leaflet. Do not use azithromycin tablets for a condition for which it was not prescribed. Do not give azithromycin tablets to other people, even if they have the same symptoms you have. It may harm them.

This Patient Information leaflet summarizes the most important information about azithromycin tablets. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about azithromycin tablets that is written for health professionals.

For more information, go to www.apotex.com or call 1-800-706-5575.

What are the ingredients in azithromycin tablets?

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 by Manufactured for
Apotex Inc. Toronto, Ontario Apotex Corp. Weston, Florida
Canada M9L 1T9 33326

Revised: April 2017 Rev. 14a

pdp
(click image for full-size original)

AZITHROMYCIN DIHYDRATE azithromycin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45865-641(NDC:60505-2581)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AZITHROMYCIN DIHYDRATE (AZITHROMYCIN ANHYDROUS) AZITHROMYCIN ANHYDROUS 250 mg
Inactive Ingredients
Ingredient Name Strength
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
HYDROXYPROPYL CELLULOSE (TYPE H)
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
HYPROMELLOSES
LACTOSE MONOHYDRATE
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color white Score no score
Shape OVAL Size 13mm
Flavor Imprint Code APO;AZ250
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45865-641-06 6 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065507 07/18/2011
Labeler — Medsource Pharmaceuticals (833685915)
Establishment
Name Address ID/FEI Operations
Medsource Pharmaceuticals 833685915 repack (45865-641)

Revised: 07/2018 Medsource Pharmaceuticals

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