Azithromycin Dihydrate (Page 7 of 8)

16 HOW SUPPLIED/STORAGE AND HANDLING

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

Azithromycin Tablets USP, 250 mg are debossed “OE” on one side and “250” on the other side. These are packaged in bottles of 4 tablets and blister cards of 6 tablets:

Bottles of 4 tablets with child-resistant closure

Cartons of 1 blister card with child-resistant package (6 tablets per blister card)

NDC 71205-430-04

NDC 71205-430-06

Store at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Dispense in tight containers (USP).

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

General Patient Counseling

Azithromycin tablets 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

Manufactured by:
CSPC Ouyi Pharmaceutical Co., Ltd.
Shijiazhuang, Hebei, China, 052160

Manufactured for:
TAGI Pharma, Inc.
South Beloit, IL 61080

Relabeled and Repackaged by:
Proficient Rx LP
Thousand Oaks, CA 91320

Patient Information Azithromycin Tablets, USP [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 tablets.

Contact your healthcare provider immediately if you are giving azihtromycin tablets 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
colchicine
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 Error! Hyperlink reference not valid.” 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 tablets doses will help lower the chance that the bacteria will become resistant to azithromycin tablets.
If the bacteria becomes resistant to azithromycin tablets, azithromycin tablets and other antibiotic medicines may not work for you in the future.
If you take too much 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 azithromcyin 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: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.
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
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: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).
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
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 59ºF to 86ºF (15ºC to 30ºC).
Azithromycin tablets come in a child-resistant package.
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, call 1-855-225-8244.

What are the ingredients in azithromycin tablets?

Active ingredient: azithromycin dihydrate

Inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, FD&C Blue #1 aluminum lake and lecithin, FD&C Red #40 aluminum Lake, FD&C Yellow #6 aluminum Lake, macrogol/PEG, magnesium stearate, polyvinyl alcohol, pregelatinized starch, talc, and titanium dioxide.

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

Manufactured by:
CSPC Ouyi Pharmaceutical Co., Ltd.
Shijiazhuang, Hebei, China, 052160

Manufactured for:
TAGI Pharma, Inc.
South Beloit, IL 61080

Relabeled and Repackaged by:
Proficient Rx LP
Thousand Oaks, CA 91320

Revised May 2019

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