ZITHROMAX® TABLET, SUSPENSION (azithromycin dihydrate TABLET, SUSPENSION) 2 DOSAGE AND ADMINISTRATION

(azithromycin dihydrate TABLET, SUSPENSION)

Prescribing Information

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage for Adult Patients

Recommended dosages and durations of therapy in adult patient populations vary by indications [see Indications and Usage (1.1) and Clinical Pharmacology (12.3)].

ZITHROMAX tablets and ZITHROMAX for oral suspension can be taken with or without food.

Table 1. Recommended dosage for Adult Patients by Indication
Infection*	Recommended Dose/Duration of Therapy
* Due to the indicated microorganisms [see Indications and Usage (1.1)].
Community-acquired pneumonia Pharyngitis/tonsillitis (second-line therapy) Skin/skin structure (uncomplicated)	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 OR 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5
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

2.2 Recommended Dosage for Pediatric Patients

Recommended dosages and durations of therapy in pediatric patient populations vary by indications [see Indications and Usage (1.2) and Clinical Pharmacology (12.3)].

ZITHROMAX for oral suspension can be taken with or without food.

* Due to the indicated microorganisms [see Indications and Usage (1.2) and Use in Specific Populations (8.4)]. † see dosing tables below for maximum doses evaluated by indication.
Table 2. Recommended dose for Pediatric Patients by Indication
Infection*	Recommended Dose/Duration of Therapy†
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.

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

* Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established [see Use in Specific Populations (8.4)].
Table 3. Otitis Media and Community-Acquired Pneumonia: (5-Day Regimen)*
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	Total mL per Treatment Course	Total mg per Treatment Course
5	2.5 mL; (½ tsp)	1.25 mL; (¼ tsp)			7.5 mL	150 mg
10	5 mL; (1 tsp)	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

* Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established [see Use in Specific Populations (8.4)].
Table 4. Otitis Media and Acute Bacterial Sinusitis: (3-Day Regimen)*
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	Total mL per Treatment Course	Total mg per Treatment Course
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

Table 5. Otitis Media: (Single-dose Regimen)*
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	Total mL per Treatment Course	Total mg per Treatment Course
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.

2.3 Pediatric Dosage Guidelines for Pharyngitis/Tonsillitis

The recommended dose of ZITHROMAX for pediatric patients 2 years of age and older with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days [see Use in Specific Populations (8.4)]

PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS/TONSILLITIS

(Age 2 years and above, [see Use in Specific Populations (8.4)])

Based on Body Weight

Table 6. Pharyngitis/Tonsillitis: (5-Day Regimen)
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	Total mL per Treatment Course	Total mg per Treatment Course
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

2.4 Preparation Instructions for ZITHROMAX for Oral Suspension

Constituting instructions for ZITHROMAX for Oral Suspension 300, 600, 900, 1200 mg bottles are described in table 7 below.

Table 7. Preparation of Zithromax for Oral Suspension: Volume of Water to add, Total Volume and Azithromycin Concentration After Constitution
Volume 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 constituted ZITHROMAX for oral suspension at 5° to 30°C (41° to 86°F) and use within 10 days. Discard after full dosing is completed.

Medication Guide

MEDICATION GUIDE

Patient Information ZITHROMAX® (Zith-roe-maks) (azithromycin) tablets, for oral use ZITHROMAX® (azithromycin) for 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 of age 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 used in children 6 months of age and older to treat: • ear infections • community-acquired pneumonia ZITHROMAX is used in children 2 years of age and older to treat: • infected throat or tonsils ZITHROMAX is not recommended for use in people who cannot tolerate oral medicines 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 (bacterial infection 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 ear infections, sinus infections and community-acquired pneumonia in children 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 about all your medical conditions including if you: • have pneumonia. • have cystic fibrosis. • have known or suspected bacteremia (bacterial infection in the blood). • have liver or kidney problems. • have heart problems, including a slow or irregular heartbeat, a heart problem called “QT prolongation”, or heart failure. • have a problem that causes muscle weakness (myasthenia gravis). • 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 can 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 breastfeeding a young child (less than 6 weeks of age) and he or she vomits, has diarrhea, develops a rash, or becomes irritable when fed. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter 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 azithromycin 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:
	o nausea or vomiting o stomach pain o abdominal pain or tenderness o itching o unusual tiredness o loss of appetite o fever o weakness o change in the color of your bowel movements o dark colored urine o yellowing of your skin or the white part of your eyes
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)
• 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 as late as 2 or more months after you have finished your treatment with ZITHROMAX. • 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. The most common side effects of ZITHROMAX include: • nausea • stomach pain • 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 between 59°F to 86°F (15°C to 30°C). • Store ZITHROMAX oral suspension between 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.
What are the ingredients in ZITHROMAX tablets and oral suspension? ZITHROMAX tablets and oral suspension Active ingredient: azithromycin dihydrate ZITHROMAX tablets: Inactive ingredients: D&C Red #30 aluminum lake, dibasic calcium phosphate anhydrous, hypromellose, lactose, magnesium stearate, pregelatinized starch, sodium croscarmellose, sodium lauryl sulfate, titanium dioxide, and triacetin. ZITHROMAX oral suspension: Inactive ingredients: FD&C Red #40, hydroxypropyl cellulose, sodium phosphate tribasic anhydrous, sucrose, xanthan gum, and spray dried artificial banana, cherry and creme de vanilla flavors. LAB-0372-8.0 This product’s labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com Revised 7/2026

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