ZITHROMAX immediate-release oral formulations (tablets or oral suspension) are not bioequivalent and are not interchangeable with azithromycin sustained release due to a different pharmacokinetic profile.
No dose adjustment of oral ZITHROMAX preparations is recommended for patients with mild to moderate hepatic impairment. Azithromycin has not been studied in patients with severe hepatic impairment. Since the liver is the principal route of elimination for azithromycin, the use of oral ZITHROMAX preparations should be undertaken with caution in patients with impaired hepatic function (see 7 WARNINGS AND PRECAUTIONS and 10 CLINICAL PHARMACOLOGY). Due to the lack of data, ZITHROMAX for Injection should be used with caution in patients with hepatic impairment.
No dosage adjustment of oral ZITHROMAX preparations is recommended for subjects with GFR 10-80 mL/min. The mean AUC0-120 increased 35% in subjects with GFR 7 WARNINGS AND PRECAUTIONS and 10 CLINICAL PHARMACOLOGY).
Due to the lack of data, ZITHROMAX for Injection should be used with caution in patients with renal impairment (including patients on dialysis).
TABLETS: ZITHROMAX Tablets can be taken with or without food.
The recommended dose of ZITHROMAX for individuals 16 years of age or older in the treatment of mild to moderate acute bacterial exacerbations of chronic obstructive pulmonary disease due to the indicated organisms is: either 500 mg per day for 3 days or 500 mg as a single dose on the first day followed by 250 mg once daily on days 2 through 5 for a total dose of 1.5 grams.
The recommended dose of ZITHROMAX for the treatment of community-acquired pneumonia of mild severity, uncomplicated skin and skin structure infections, and for pharyngitis/tonsillitis (as second-line therapy) due to the indicated organisms is: 500 mg as a single dose on the first day followed by 250 mg once daily on days 2 through 5 for a total dose of 1.5 grams.
The recommended dose of ZITHROMAX for the treatment of genital ulcer disease due to Haemophilus ducreyi (chancroid) and non-gonococcal urethritis and cervicitis due to C. trachomatis is: a single 1 gram (1000 mg) oral dose of ZITHROMAX. This dose can be administered as four 250 mg tablets.
The recommended dose of ZITHROMAX for the treatment of urethritis and cervicitis due to Neisseria gonorrhoeae is: a single 2 gram (2000 mg) dose of ZITHROMAX. This dose can be administered as eight 250 mg tablets.
The recommended dose of ZITHROMAX for the prevention of disseminated Mycobacterium avium complex (MAC) disease is 1200 mg (two 600 mg tablets) taken once weekly. This dose of ZITHROMAX may be continued with the approved dosage regimen of rifabutin.
POWDER FOR ORAL SUSPENSION: ZITHROMAX Powder for Oral Suspension can be taken with or without food (see 10 CINICAL PHARMACOLOGY).
The recommended total dose for children is 30 mg/kg for otitis media and community acquired pneumonia. For pharyngitis/tonsillitis, the recommended total dose is 60 mg/kg.
| Indication | 1-Day | 3-Day | 5-Day |
|---|---|---|---|
| Acute Otitis Media | 30 mg/kg | 10 mg/kg/day | Day 1: 10 mg/kg Day 2-5: 5 mg/kg |
| Pharyngitis/ Tonsillitis | 12 mg/kg/day | ||
| Community-Acquired Pneumonia | Day 1: 10 mg/kg Day 2-5: 5 mg/kg |
The recommended dose of ZITHROMAX oral suspension for the treatment of children with acute otitis media is 30 mg/kg given as a single dose (not to exceed 1500 mg) or 10 mg/kg once daily for 3 days (not to exceed 500 mg/day) or 10 mg/kg as a single dose on the first day (not to exceed 500 mg/day) followed by 5 mg/kg/day on days 2 through 5 (not to exceed 250 mg/day). (See chart #1, 2 and 3 respectively below).
The safety of re-dosing azithromycin in children 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, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
The recommended dose of ZITHROMAX for oral suspension for the treatment of children with community-acquired pneumonia is 10 mg/kg as a single dose on the first day (not to exceed 500 mg/day) followed by 5 mg/kg on days 2 through 5 (not to exceed 250 mg/day). (See chart #3 below).
Effectiveness of the 3-day or 1-day regimen in children with community-acquired pneumonia has not been established.
The recommended dose for children with pharyngitis and tonsillitis is 12 mg/kg once daily for 5 days (not to exceed 500 mg/day). (See chart #4 below).
PEDIATRIC DOSAGE GUIDELINES
BASED on BODY Weight
OTITIS MEDIA: (1-Day Regimen)* Dosing Calculated on 30 mg/kg as a single dose Age 6 months and above, see 7.1.3 Pediatrics | ||||
|---|---|---|---|---|
| Weight | 200 mg/5 mL Day 1 | Total mL per Treatment Course | Total mg per Treatment Course | |
| Kg | Lbs. | |||
| 5 | 11 | 3.75 mL (3/4 tsp) | 3.75 mL | 150 mg |
| 10 | 22 | 7.5 mL (1 ½ tsp) | 7.5 mL | 300 mg |
| 20 | 44 | 15 mL (3 tsp) | 15 mL | 600 mg |
| 30 | 66 | 22.5 mL (4 ½ tsp) | 22.5 mL | 900 mg |
| 40 | 88 | 30 mL (6 tsp) | 30 mL | 1200 mg |
| 50 and above | 110 and above | 37.5 mL (7 ½ tsp) | 37.5 mL | 1500 mg |
| ||||
OTITIS MEDIA: (3-Day Regimen)* Dosing Calculated on 10 mg/kg/day Age 6 months and above, see 7.1.3 Pediatrics | |||||
|---|---|---|---|---|---|
| Weight | 100 mg/5 mL Day 1-3 | 200 mg/5 mL Day 1-3 | Total mL per Treatment Course | Total mg per Treatment Course | |
| Kg | Lbs. | ||||
| 5 | 11 | 2.5 mL (1/2 tsp) | 7.5 mL | 150 mg | |
| 10 | 22 | 5 mL (1 tsp) | 15 mL | 300 mg | |
| 20 | 44 | 5 mL (1 tsp) | 15 mL | 600 mg | |
| 30 | 66 | 7.5 mL (1 ½ tsp) | 22.5 mL | 900 mg | |
| 40 | 88 | 10 mL (2 tsp) | 30 mL | 1200 mg | |
| 50 and above | 110 and above | 12.5 mL (2 ½ tsp) | 37.5 mL | 1500 mg | |
| |||||
ACUTE OTITIS MEDIA OR COMMUNITY-ACQUIRED PNEUMONIA Age 6 months and above, see 7.1.3 Pediatrics 5-Day Regimen | |||||||
|---|---|---|---|---|---|---|---|
Dosing Calculated on 10 mg/kg on Day 1 dose, followed by 5 mg/kg on Days 2 to 5 | |||||||
| Weight | 100 mg/5 mL Suspension | 200 mg/5 mL Suspension | Total mL per Treatment Course | Total mg per Treatment Course | |||
| Kg | lbs | Day 1 | Days 2-5 | Day 1 | Days 2-5 | ||
| 5 | 11 | 2.5 mL (½ tsp) | 1.25 mL (¼ tsp) | 7.5 mL | 150 mg | ||
| 10 | 22 | 5 mL (1tsp) | 2.5 mL (½ tsp) | 15 mL | 300 mg | ||
| 20 | 44 | 5 mL (1 tsp) | 2.5 mL (½ tsp) | 15 mL | 600 mg | ||
| 30 | 66 | 7.5 mL (1½ tsp) | 3.75 mL (¾ tsp) | 22.5 mL | 900 mg | ||
| 40 | 88 | 10 mL (2tsp) | 5 mL (1tsp) | 30 mL | 1200 mg | ||
| 50 and above | 110 and above | 12.5mL (2½ tsp) | 6.25 mL (1¼ tsp) | 37.5 mL | 1500 mg | ||
PHARYNGITIS AND TONSILLITIS: (5-Day Regimen) (Age 2 years and above see 7.1.3 Pediatrics) | ||||
|---|---|---|---|---|
Dosing Calculated on 12 mg/kg once daily Days 1 to 5 | ||||
| Weight | 200 mg/5 mL Suspension | Total mL per Treatment Course | Total mg per Treatment Course | |
| Kg | Lbs | Day 1-5 | ||
| 8 | 18 | 2.5 mL (½ tsp) | 12.5 mL | 500 mg |
| 17 | 37 | 5 mL (1tsp) | 25 mL | 1000 mg |
| 25 | 55 | 7.5 mL (1½ tsp) | 37.5 mL | 1500 mg |
| 33 | 73 | 10 mL (2 tsp) | 50 mL | 2000 mg |
| 40 | 88 | 12.5 mL (2 ½ tsp) | 62.5 mL | 2500 mg |
ZITHROMAX for Injection must be reconstituted and diluted, as directed, and administered as an intravenous infusion over at least 60 minutes. Do not administer as an intravenous bolus or an intramuscular injection (see 7 WARNINGS AND PRECAUTIONS). Intravenous therapy should be followed by oral ZITHROMAX. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response.
The infusate concentration and rate of infusion for ZITHROMAX should be either 1 mg/mL over 3 hours, or 2 mg/mL over 1 hour.
COMMUNITY-ACQUIRED PNEUMONIA: in patients who require initial intravenous therapy:
The recommended dose is 500 mg I.V. as a single daily infusion for at least 2 days followed by oral therapy at 500 mg daily to complete a 7-10 day course of therapy.
The recommended dose is 500 mg I.V. as a single daily infusion for at least 1 day followed by oral therapy at 250 mg daily to complete a 7-day course of therapy. Note: If anaerobic organisms are suspected of contributing to the infection, an antimicrobial agent with anaerobic activity should be administered in combination with ZITHROMAX.
Tap bottle to loosen powder. Add the directed volume of water. Shake well before each use. Oversized bottle provides shake space. Keep tightly closed. The table below indicates the volume of water to be used for reconstitution:
| Amount of water to be added | Nominal volume after reconstitution (azithromycin content) | Azithromycin concentration after reconstitution |
|---|---|---|
| 9 mL (300 mg bottle) | 15 mL (300 mg bottle) | 100 mg/5 mL |
| 9 mL (600 mg bottle) | 15 mL (600 mg bottle) | 200 mg/5 mL |
| 12 mL (900 mg bottle) | 22.5 mL (900 mg bottle) | 200 mg/5 mL |
Use only the dosing device provided to measure the correct amount of suspension (see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING). The dosing device may need to be filled multiple times to provide the complete dose prescribed. Rinse the device with water after the complete daily dose has been administered.
Following constitution, and for use with the oral syringe, the supplied plastic stopper should be inserted into the neck of the bottle then sealed with the original closure.
ZITHROMAX for Injection:
| Strength | Reconstitution Solution | Volume to be Added | Approximate Volume Available | Nominal Concentration |
|---|---|---|---|---|
| 500 mg | Sterile Water for Injection | 4.8 mL | 5 mL | 100 mg/mL |
Prepare the initial solution of ZITHROMAX for Injection by adding 4.8 mL of Sterile Water for Injection to the 500 mg vial. Shake the vial until all of the drug is dissolved. Since the vial is evacuated, it is recommended that a standard 5 mL (non-automated) syringe be used to ensure that the exact volume of 4.8 mL is dispensed. Each mL of reconstituted solution contains azithromycin dihydrate equivalent to 100 mg azithromycin. Reconstituted solution is stable for 24 hours when stored below 30°C. The reconstituted solution must be further diluted prior to administration.
Dilution of reconstituted solution: To provide azithromycin over a concentration range of 1.0 - 2.0 mg/mL, transfer 5 mL of the 100 mg/mL azithromycin solution into the appropriate amount of the following diluents:
| Final Infusion Concentration (mg/mL) | Amount of Diluent (mL) |
|---|---|
| 1.0 mg/mL | 500 mL |
| 2.0 mg/mL | 250 mL |
| Appropriate Diluents | |
| 0.9% Sodium Chloride Injection 5% Dextrose in Water for Injection 0.45% Sodium Chloride Injection Lactated Ringer’s Injection 5% Dextrose in 0.45% Sodium Chloride Injection with 20 mEq Potassium Chloride 5% Dextrose in Lactated Ringer’s Injection 5% Dextrose in 0.3% Sodium Chloride Injection 5% Dextrose in 0.45% Sodium Chloride Injection Normosol-M in 5% Dextrose | |
Diluted solutions prepared in this manner are stable for 24 hours at or below room temperature (30°C), or for 72 hours if stored under refrigeration (2-8°C). As with all parenteral drug products, intravenous admixtures should be inspected visually for clarity, particulate matter, precipitate, discoloration and leakage prior to administration, whenever solution and container permit. Solutions showing haziness, particulate matter, precipitate, discoloration or leakage should be discarded.
Only limited data are available on the compatibility of ZITHROMAX for Injection with other intravenous substances, therefore additives or other medications should not be added to ZITHROMAX for Injection or infused simultaneously through the same intravenous line. If the same intravenous line is used for sequential infusion of several different drugs, the line should be flushed before and after infusion of ZITHROMAX for Injection with an infusion solution compatible with ZITHROMAX for Injection and with any other drug(s) administered via the common line. If ZITHROMAX for Injection is to be given concomitantly with another drug, each drug should be given separately in accordance with the recommended dosage and route of administration for each drug.
In case of missed dose, patients should not double the next dose.
)ZITHROMAX immediate-release oral formulations (tablets or oral suspension) are not bioequivalent and are not interchangeable with azithromycin sustained release due to a different pharmacokinetic profile.
No dose adjustment of oral ZITHROMAX preparations is recommended for patients with mild to moderate hepatic impairment. Azithromycin has not been studied in patients with severe hepatic impairment. Since the liver is the principal route of elimination for azithromycin, the use of oral ZITHROMAX preparations should be undertaken with caution in patients with impaired hepatic function (see 7 WARNINGS AND PRECAUTIONS and 10 CLINICAL PHARMACOLOGY). Due to the lack of data, ZITHROMAX for Injection should be used with caution in patients with hepatic impairment.
No dosage adjustment of oral ZITHROMAX preparations is recommended for subjects with GFR 10-80 mL/min. The mean AUC0-120 increased 35% in subjects with GFR 7 WARNINGS AND PRECAUTIONS and 10 CLINICAL PHARMACOLOGY).
Due to the lack of data, ZITHROMAX for Injection should be used with caution in patients with renal impairment (including patients on dialysis).
TABLETS: ZITHROMAX Tablets can be taken with or without food.
The recommended dose of ZITHROMAX for individuals 16 years of age or older in the treatment of mild to moderate acute bacterial exacerbations of chronic obstructive pulmonary disease due to the indicated organisms is: either 500 mg per day for 3 days or 500 mg as a single dose on the first day followed by 250 mg once daily on days 2 through 5 for a total dose of 1.5 grams.
The recommended dose of ZITHROMAX for the treatment of community-acquired pneumonia of mild severity, uncomplicated skin and skin structure infections, and for pharyngitis/tonsillitis (as second-line therapy) due to the indicated organisms is: 500 mg as a single dose on the first day followed by 250 mg once daily on days 2 through 5 for a total dose of 1.5 grams.
The recommended dose of ZITHROMAX for the treatment of genital ulcer disease due to Haemophilus ducreyi (chancroid) and non-gonococcal urethritis and cervicitis due to C. trachomatis is: a single 1 gram (1000 mg) oral dose of ZITHROMAX. This dose can be administered as four 250 mg tablets.
The recommended dose of ZITHROMAX for the treatment of urethritis and cervicitis due to Neisseria gonorrhoeae is: a single 2 gram (2000 mg) dose of ZITHROMAX. This dose can be administered as eight 250 mg tablets.
The recommended dose of ZITHROMAX for the prevention of disseminated Mycobacterium avium complex (MAC) disease is 1200 mg (two 600 mg tablets) taken once weekly. This dose of ZITHROMAX may be continued with the approved dosage regimen of rifabutin.
POWDER FOR ORAL SUSPENSION: ZITHROMAX Powder for Oral Suspension can be taken with or without food (see 10 CINICAL PHARMACOLOGY).
The recommended total dose for children is 30 mg/kg for otitis media and community acquired pneumonia. For pharyngitis/tonsillitis, the recommended total dose is 60 mg/kg.
| Indication | 1-Day | 3-Day | 5-Day |
|---|---|---|---|
| Acute Otitis Media | 30 mg/kg | 10 mg/kg/day | Day 1: 10 mg/kg Day 2-5: 5 mg/kg |
| Pharyngitis/ Tonsillitis | 12 mg/kg/day | ||
| Community-Acquired Pneumonia | Day 1: 10 mg/kg Day 2-5: 5 mg/kg |
The recommended dose of ZITHROMAX oral suspension for the treatment of children with acute otitis media is 30 mg/kg given as a single dose (not to exceed 1500 mg) or 10 mg/kg once daily for 3 days (not to exceed 500 mg/day) or 10 mg/kg as a single dose on the first day (not to exceed 500 mg/day) followed by 5 mg/kg/day on days 2 through 5 (not to exceed 250 mg/day). (See chart #1, 2 and 3 respectively below).
The safety of re-dosing azithromycin in children 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, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
The recommended dose of ZITHROMAX for oral suspension for the treatment of children with community-acquired pneumonia is 10 mg/kg as a single dose on the first day (not to exceed 500 mg/day) followed by 5 mg/kg on days 2 through 5 (not to exceed 250 mg/day). (See chart #3 below).
Effectiveness of the 3-day or 1-day regimen in children with community-acquired pneumonia has not been established.
The recommended dose for children with pharyngitis and tonsillitis is 12 mg/kg once daily for 5 days (not to exceed 500 mg/day). (See chart #4 below).
PEDIATRIC DOSAGE GUIDELINES
BASED on BODY Weight
OTITIS MEDIA: (1-Day Regimen)* Dosing Calculated on 30 mg/kg as a single dose Age 6 months and above, see 7.1.3 Pediatrics | ||||
|---|---|---|---|---|
| Weight | 200 mg/5 mL Day 1 | Total mL per Treatment Course | Total mg per Treatment Course | |
| Kg | Lbs. | |||
| 5 | 11 | 3.75 mL (3/4 tsp) | 3.75 mL | 150 mg |
| 10 | 22 | 7.5 mL (1 ½ tsp) | 7.5 mL | 300 mg |
| 20 | 44 | 15 mL (3 tsp) | 15 mL | 600 mg |
| 30 | 66 | 22.5 mL (4 ½ tsp) | 22.5 mL | 900 mg |
| 40 | 88 | 30 mL (6 tsp) | 30 mL | 1200 mg |
| 50 and above | 110 and above | 37.5 mL (7 ½ tsp) | 37.5 mL | 1500 mg |
| ||||
OTITIS MEDIA: (3-Day Regimen)* Dosing Calculated on 10 mg/kg/day Age 6 months and above, see 7.1.3 Pediatrics | |||||
|---|---|---|---|---|---|
| Weight | 100 mg/5 mL Day 1-3 | 200 mg/5 mL Day 1-3 | Total mL per Treatment Course | Total mg per Treatment Course | |
| Kg | Lbs. | ||||
| 5 | 11 | 2.5 mL (1/2 tsp) | 7.5 mL | 150 mg | |
| 10 | 22 | 5 mL (1 tsp) | 15 mL | 300 mg | |
| 20 | 44 | 5 mL (1 tsp) | 15 mL | 600 mg | |
| 30 | 66 | 7.5 mL (1 ½ tsp) | 22.5 mL | 900 mg | |
| 40 | 88 | 10 mL (2 tsp) | 30 mL | 1200 mg | |
| 50 and above | 110 and above | 12.5 mL (2 ½ tsp) | 37.5 mL | 1500 mg | |
| |||||
ACUTE OTITIS MEDIA OR COMMUNITY-ACQUIRED PNEUMONIA Age 6 months and above, see 7.1.3 Pediatrics 5-Day Regimen | |||||||
|---|---|---|---|---|---|---|---|
Dosing Calculated on 10 mg/kg on Day 1 dose, followed by 5 mg/kg on Days 2 to 5 | |||||||
| Weight | 100 mg/5 mL Suspension | 200 mg/5 mL Suspension | Total mL per Treatment Course | Total mg per Treatment Course | |||
| Kg | lbs | Day 1 | Days 2-5 | Day 1 | Days 2-5 | ||
| 5 | 11 | 2.5 mL (½ tsp) | 1.25 mL (¼ tsp) | 7.5 mL | 150 mg | ||
| 10 | 22 | 5 mL (1tsp) | 2.5 mL (½ tsp) | 15 mL | 300 mg | ||
| 20 | 44 | 5 mL (1 tsp) | 2.5 mL (½ tsp) | 15 mL | 600 mg | ||
| 30 | 66 | 7.5 mL (1½ tsp) | 3.75 mL (¾ tsp) | 22.5 mL | 900 mg | ||
| 40 | 88 | 10 mL (2tsp) | 5 mL (1tsp) | 30 mL | 1200 mg | ||
| 50 and above | 110 and above | 12.5mL (2½ tsp) | 6.25 mL (1¼ tsp) | 37.5 mL | 1500 mg | ||
PHARYNGITIS AND TONSILLITIS: (5-Day Regimen) (Age 2 years and above see 7.1.3 Pediatrics) | ||||
|---|---|---|---|---|
Dosing Calculated on 12 mg/kg once daily Days 1 to 5 | ||||
| Weight | 200 mg/5 mL Suspension | Total mL per Treatment Course | Total mg per Treatment Course | |
| Kg | Lbs | Day 1-5 | ||
| 8 | 18 | 2.5 mL (½ tsp) | 12.5 mL | 500 mg |
| 17 | 37 | 5 mL (1tsp) | 25 mL | 1000 mg |
| 25 | 55 | 7.5 mL (1½ tsp) | 37.5 mL | 1500 mg |
| 33 | 73 | 10 mL (2 tsp) | 50 mL | 2000 mg |
| 40 | 88 | 12.5 mL (2 ½ tsp) | 62.5 mL | 2500 mg |
ZITHROMAX for Injection must be reconstituted and diluted, as directed, and administered as an intravenous infusion over at least 60 minutes. Do not administer as an intravenous bolus or an intramuscular injection (see 7 WARNINGS AND PRECAUTIONS). Intravenous therapy should be followed by oral ZITHROMAX. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response.
The infusate concentration and rate of infusion for ZITHROMAX should be either 1 mg/mL over 3 hours, or 2 mg/mL over 1 hour.
COMMUNITY-ACQUIRED PNEUMONIA: in patients who require initial intravenous therapy:
The recommended dose is 500 mg I.V. as a single daily infusion for at least 2 days followed by oral therapy at 500 mg daily to complete a 7-10 day course of therapy.
The recommended dose is 500 mg I.V. as a single daily infusion for at least 1 day followed by oral therapy at 250 mg daily to complete a 7-day course of therapy. Note: If anaerobic organisms are suspected of contributing to the infection, an antimicrobial agent with anaerobic activity should be administered in combination with ZITHROMAX.
Tap bottle to loosen powder. Add the directed volume of water. Shake well before each use. Oversized bottle provides shake space. Keep tightly closed. The table below indicates the volume of water to be used for reconstitution:
| Amount of water to be added | Nominal volume after reconstitution (azithromycin content) | Azithromycin concentration after reconstitution |
|---|---|---|
| 9 mL (300 mg bottle) | 15 mL (300 mg bottle) | 100 mg/5 mL |
| 9 mL (600 mg bottle) | 15 mL (600 mg bottle) | 200 mg/5 mL |
| 12 mL (900 mg bottle) | 22.5 mL (900 mg bottle) | 200 mg/5 mL |
Use only the dosing device provided to measure the correct amount of suspension (see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING). The dosing device may need to be filled multiple times to provide the complete dose prescribed. Rinse the device with water after the complete daily dose has been administered.
Following constitution, and for use with the oral syringe, the supplied plastic stopper should be inserted into the neck of the bottle then sealed with the original closure.
ZITHROMAX for Injection:
| Strength | Reconstitution Solution | Volume to be Added | Approximate Volume Available | Nominal Concentration |
|---|---|---|---|---|
| 500 mg | Sterile Water for Injection | 4.8 mL | 5 mL | 100 mg/mL |
Prepare the initial solution of ZITHROMAX for Injection by adding 4.8 mL of Sterile Water for Injection to the 500 mg vial. Shake the vial until all of the drug is dissolved. Since the vial is evacuated, it is recommended that a standard 5 mL (non-automated) syringe be used to ensure that the exact volume of 4.8 mL is dispensed. Each mL of reconstituted solution contains azithromycin dihydrate equivalent to 100 mg azithromycin. Reconstituted solution is stable for 24 hours when stored below 30°C. The reconstituted solution must be further diluted prior to administration.
Dilution of reconstituted solution: To provide azithromycin over a concentration range of 1.0 - 2.0 mg/mL, transfer 5 mL of the 100 mg/mL azithromycin solution into the appropriate amount of the following diluents:
| Final Infusion Concentration (mg/mL) | Amount of Diluent (mL) |
|---|---|
| 1.0 mg/mL | 500 mL |
| 2.0 mg/mL | 250 mL |
| Appropriate Diluents | |
| 0.9% Sodium Chloride Injection 5% Dextrose in Water for Injection 0.45% Sodium Chloride Injection Lactated Ringer’s Injection 5% Dextrose in 0.45% Sodium Chloride Injection with 20 mEq Potassium Chloride 5% Dextrose in Lactated Ringer’s Injection 5% Dextrose in 0.3% Sodium Chloride Injection 5% Dextrose in 0.45% Sodium Chloride Injection Normosol-M in 5% Dextrose | |
Diluted solutions prepared in this manner are stable for 24 hours at or below room temperature (30°C), or for 72 hours if stored under refrigeration (2-8°C). As with all parenteral drug products, intravenous admixtures should be inspected visually for clarity, particulate matter, precipitate, discoloration and leakage prior to administration, whenever solution and container permit. Solutions showing haziness, particulate matter, precipitate, discoloration or leakage should be discarded.
Only limited data are available on the compatibility of ZITHROMAX for Injection with other intravenous substances, therefore additives or other medications should not be added to ZITHROMAX for Injection or infused simultaneously through the same intravenous line. If the same intravenous line is used for sequential infusion of several different drugs, the line should be flushed before and after infusion of ZITHROMAX for Injection with an infusion solution compatible with ZITHROMAX for Injection and with any other drug(s) administered via the common line. If ZITHROMAX for Injection is to be given concomitantly with another drug, each drug should be given separately in accordance with the recommended dosage and route of administration for each drug.
In case of missed dose, patients should not double the next dose.
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