(azithromycin dihydrate TABLET, SUSPENSION)
2 DOSAGE AND ADMINISTRATION
2 DOSAGE AND ADMINISTRATION
2.1 Adult Patients
[see Indications and Usage (1.1) and Clinical Pharmacology (12.3)]
| Infection* | Recommended Dose/Duration of Therapy |
|---|---|
| |
Community-acquired pneumonia Pharyngitis/tonsillitis (second-line therapy) | 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5 |
Acute bacterial exacerbations of chronic obstructive pulmonary disease | 500 mg once daily for 3 days |
Acute bacterial sinusitis | 500 mg once daily for 3 days |
Genital ulcer disease (chancroid) | One single 1 gram dose |
Non-gonococcal urethritis and cervicitis | One single 1 gram dose |
Gonococcal urethritis and cervicitis | One single 2 gram dose |
ZITHROMAX tablets can be taken with or without food.
2.2 Pediatric Patients1
| Infection* | Recommended Dose/Duration of Therapy |
|---|---|
| 1 see dosing tables below for maximum doses evaluated by indication | |
| |
Acute otitis media | 30 mg/kg as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on Day 1 followed by 5 mg/kg/day on Days 2 through 5. |
Acute bacterial sinusitis | 10 mg/kg once daily for 3 days. |
Community-acquired pneumonia | 10 mg/kg as a single dose on Day 1 followed by 5 mg/kg once daily on Days 2 through 5. |
Pharyngitis/tonsillitis | 12 mg/kg once daily for 5 days. |
ZITHROMAX for oral suspension can be taken with or without food.
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS, AND COMMUNITY-ACQUIRED PNEUMONIA
(Age 6 months and above, [see Use in Specific Populations (8.4)])
Based on Body Weight
| Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5. | ||||||
|---|---|---|---|---|---|---|
| Weight | 100 mg/5 mL | 200 mg/5 mL | Total mL per Treatment Course | Total mg per Treatment Course | ||
| Kg | Day 1 | Days 2–5 | Day 1 | Days 2-5 | ||
| ||||||
5 | 2.5 mL; (½ tsp) | 1.25 mL;(¼ tsp) | 7.5 mL | 150 mg | ||
10 | 5 mL; (1tsp) | 2.5 mL; (½ tsp) | 15 mL | 300 mg | ||
20 | 5 mL; (1 tsp) | 2.5 mL; (½ tsp) | 15 mL | 600 mg | ||
30 | 7.5 mL; (1½ tsp) | 3.75 mL; (¾ tsp) | 22.5 mL | 900 mg | ||
40 | 10 mL; (2 tsp) | 5 mL; (1 tsp) | 30 mL | 1200 mg | ||
50 and above | 12.5 mL; (2½ tsp) | 6.25 mL; (1¼ tsp) | 37.5 mL | 1500 mg | ||
| Dosing Calculated on 10 mg/kg/day. | ||||
|---|---|---|---|---|
| Weight | 100 mg/5 mL | 200 mg/5 mL | Total mL per Treatment Course | Total mg per Treatment Course |
| Kg | Days 1–3 | Days 1–3 | ||
| ||||
5 | 2.5 mL; (1/2 tsp) | 7.5 mL | 150 mg | |
10 | 5 mL; (1 tsp) | 15 mL | 300 mg | |
20 | 5 mL (1 tsp) | 15 mL | 600 mg | |
30 | 7.5 mL (1½ tsp) | 22.5 mL | 900 mg | |
40 | 10 mL (2 tsp) | 30 mL | 1200 mg | |
50 and above | 12.5 mL (2 ½ tsp) | 37.5 mL | 1500 mg | |
| Dosing Calculated on 30 mg/kg as a single dose. | |||
|---|---|---|---|
| Weight | 200 mg/5 mL | Total mL per Treatment Course | Total mg per Treatment Course |
| Kg | 1-Day Regimen | ||
5 | 3.75 mL;(3/4 tsp) | 3.75 mL | 150 mg |
10 | 7.5 mL;(1½ tsp) | 7.5 mL | 300 mg |
20 | 15 mL;(3 tsp) | 15 mL | 600 mg |
30 | 22.5 mL;(4½ tsp) | 22.5 mL | 900 mg |
40 | 30 mL;(6 tsp) | 30 mL | 1200 mg |
50 and above | 37.5 mL;(7½ tsp) | 37.5 mL | 1500 mg |
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, 8 patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis: The recommended dose of ZITHROMAX for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS/TONSILLITIS
(Age 2 years and above, [see Use in Specific Populations (8.4)])
Based on Body Weight
| Dosing Calculated on 12 mg/kg/day for 5 days. | |||
|---|---|---|---|
| Weight | 200 mg/5 mL | Total mL per Treatment Course | Total mg per Treatment Course |
| Kg | Day 1–5 | ||
8 | 2.5 mL; (½ tsp) | 12.5 mL | 500 mg |
17 | 5 mL; (1 tsp) | 25 mL | 1000 mg |
25 | 7.5 mL; (1½ tsp) | 37.5 mL | 1500 mg |
33 | 10 mL; (2 tsp) | 50 mL | 2000 mg |
40 | 12.5 mL; (2½ tsp) | 62.5 mL | 2500 mg |
Constituting instructions for ZITHROMAX Oral Suspension 300, 600, 900, 1200 mg bottles. The table below indicates the volume of water to be used for constitution:
| Amount of water to be added | Total volume after constitution (azithromycin content) | Azithromycin concentration after constitution |
|---|---|---|
9 mL (300 mg) | 15 mL (300 mg) | 100 mg/5 mL |
9 mL (600 mg) | 15 mL (600 mg) | 200 mg/5 mL |
12 mL (900 mg) | 22.5 mL (900 mg) | 200 mg/5 mL |
15 mL (1200 mg) | 30 mL (1200 mg) | 200 mg/5 mL |
Shake well before each use. Oversized bottle provides shake space. Keep tightly closed.
After mixing, store suspension at 5° to 30°C (41° to 86°F) and use within 10 days. Discard after full dosing is completed.
PATIENT INFORMATION
Patient Information
ZITHROMAX® (Zith-roe-maks)
(azithromycin)
Tablets
ZITHROMAX®
(azithromycin)
Oral Suspension
Read this Patient Information leaflet before you start taking ZITHROMAX 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 is ZITHROMAX?
ZITHROMAX is 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
ZITHROMAX is 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
ZITHROMAX is not for viral infections such as the common cold.
It is not known if ZITHROMAX is safe and effective for genital ulcers in women.
It is not known if ZITHROMAX is safe and effective for children with ear infections, sinus infections, and community-acquired pneumonia under 6 months of age.
It is not known if ZITHROMAX is safe and effective for infected throat or tonsils in children under 2 years of age.
Who should not take ZITHROMAX?
Do not take ZITHROMAX 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 ZITHROMAX?
Before you take ZITHROMAX, 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 ZITHROMAX will harm your unborn baby.
- •
- are breastfeeding or plan to breastfeed. ZITHROMAX has been reported to pass into breast milk. Talk to your healthcare provider about the best way to feed your baby while you take ZITHROMAX.
Contact your healthcare provider immediately if you are giving ZITHROMAX 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.
ZITHROMAX and other medicines may affect each other causing side effects. ZITHROMAX may affect the way other medicines work, and other medicines may affect how ZITHROMAX works.
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 ZITHROMAX?
- •
- Take ZITHROMAX exactly as your healthcare provider tells you to take it.
- •
- ZITHROMAX can be taken with or without food.
- •
- If you take ZITHROMAX Oral Suspension, shake the bottle well just before you take it.
- •
- Do not skip any doses of ZITHROMAX 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 ZITHROMAX. "See What are the possible side effects of ZITHROMAX?" If you skip doses, or do not complete the total course of ZITHROMAX your treatment may not work as well and your infection may be harder to treat. Taking all of your ZITHROMAX doses will help lower the chance that the bacteria will become resistant to ZITHROMAX.
- •
- If the bacteria becomes resistant to ZITHROMAX, ZITHROMAX and other antibiotic medicines may not work for you in the future.
- •
- If you take too much ZITHROMAX, call your healthcare provider or get medical help right away.
What are the possible side effects of ZITHROMAX?
ZITHROMAX can cause serious side effects, including:
- •
- Serious allergic reactions. Allergic reactions can happen in people taking azithromcyin the active ingredient in ZITHROMAX, even after only 1 dose. Stop taking ZITHROMAX and get emergency medical help right away if you have any of the following symptoms of a severe allergic reaction:
- o
- trouble breathing or swallowing
- o
- swelling of the lips, tongue, face
- o
- throat tightness, hoarseness
- o
- rapid heartbeat
- o
- faintness
- o
- skin rash (hives)
- o
- new onset of fever and swollen lymph nodes
- Stop taking ZITHROMAX 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 ZITHROMAX.
- •
- Liver damage (hepatotoxicity). Hepatotoxicity can happen in people who take ZITHROMAX. Call your healthcare provider right away if you have unexplained symptoms such as:
|
|
- Stop taking ZITHROMAX 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 ZITHROMAX (a liver problem).
- •
- Serious heart rhythm changes that can be life-threatening, including heart stopping (cardiac arrest), QT prolongation, torsades de pointes, feeling that your heart is pounding or racing (palpitations), chest discomfort, or irregular heartbeat.
Tell your healthcare provider right away if you or your child feel a fast or irregular heartbeat, get dizzy or faint. ZITHROMAX 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:- o
- who are elderly
- o
- with a family history of prolonged QT interval
- o
- with low blood potassium
- o
- who take certain medicines to control heart rhythm (antiarrhythmics)
- •
- Worsening of myasthenia gravis (a problem that causes muscle weakness). Certain antibiotics like ZITHROMAX 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 ZITHROMAX.
The most common side effects of ZITHROMAX include:- o
- nausea
- o
- stomach pain
- o
- vomiting
These are not all the possible side effects of ZITHROMAX. 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 ZITHROMAX?
- •
- Store ZITHROMAX Tablets at 59°F to 86°F (15°C to 30°C).
- •
- Store ZITHROMAX Oral Suspension at 41°F to 86°F (5°C to 30°C).
- •
- Keep ZITHROMAX Oral Suspension in a tightly closed container.
- •
- Safely throw away any medicine that is out of date or no longer needed.
Keep ZITHROMAX and all medicines out of the reach of children.
General information about the safe and effective use of ZITHROMAX.
Medicines are sometimes prescribed for purposes other than those listed in the Patient Information leaflet. Do not use ZITHROMAX for a condition for which it was not prescribed.
Do not give ZITHROMAX 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 ZITHROMAX. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about ZITHROMAX that is written for health professionals.
For more information, go to www.zithromax.com or call 1-800-438-1986.
What are the ingredients in ZITHROMAX Tablets and Oral Suspension?
ZITHROMAX Tablets and Oral Suspension
Active ingredient: azithromycin dehydrate
ZITHROMAX Tablets:
Inactive ingredients: dibasic calcium phosphate anhydrous, pregelatinized starch, sodium croscarmellose, magnesium stearate, sodium lauryl sulfate, hypromellose, lactose, titanium dioxide, triacetin, and D&C Red #30 aluminum lake.
ZITHROMAX Oral Suspension:
Inactive ingredients: sucrose; sodium phosphate, tribasic, anhydrous; hydroxypropyl cellulose; xanthan gum; FD&C Red #40; and spray dried artificial cherry, creme de vanilla, and banana flavors.
This Patient Information has been approved by the U.S. Food and Drug Administration.
LAB-0372-7.0
Revised November 2021
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