Azithromycin Dihydrate
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Questions & Answers
Side Effects & Adverse Reactions
Serious allergic reactions, including angioedema, anaphylaxis, and dermatologic reactions including Stevens Johnson Syndrome and toxic epidermal necrolysis have been reported rarely in patients on azithromycin therapy. Although rare, fatalities have been reported. (See CONTRAINDICATIONS.) Despite initially successful symptomatic treatment of the allergic symptoms, when symptomatic therapy was discontinued, the allergic symptoms recurred soon thereafter in some patients without further azithromycin exposure. These patients required prolonged periods of observation and symptomatic treatment. The relationship of these episodes to the long tissue half-life of azithromycin and subsequent prolonged exposure to antigen is unknown at present.
If an allergic reaction occurs, the drug should be discontinued and appropriate therapy should be instituted. Physicians should be aware that reappearance of the allergic symptoms may occur when symptomatic therapy is discontinued.
Abnormal liver function, hepatitis, cholestatic jaundice, hepatic necrosis, and hepatic failure have been reported, some of which have resulted in death. Discontinue azithromycin immediately if signs and symptoms of hepatitis occur.
In the treatment of pneumonia, azithromycin has only been shown to be safe and effective in the treatment of community-acquired pneumonia due to Chlamydia pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae or Streptococcus pneumoniae in patients appropriate for oral therapy. Azithromycin should not be used in patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors such as any of the following: patients with cystic fibrosis, patients with nosocomially acquired infections, patients with known or suspected bacteremia, patients requiring hospitalization, elderly or debilitated patients, or patients with significant underlying health problems that may compromise their ability to respond to their illness (including immunodeficiency or functional asplenia).
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including azithromycin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
Prolonged cardiac repolarization and QT interval, imparting a risk of developing cardiac arrhythmia and torsades de pointes, have been seen in treatment with macrolides, including azithromycin. Cases of torsades de pointes have been spontaneously reported during postmarketing surveillance in patients receiving azithromycin. Providers should consider the risk of QT prolongation which can be fatal when weighing the risks and benefits of azithromycin for at-risk groups including:
• patients with known prolongation of the QT interval, a history of torsades de pointes, congenital long QT syndrome, bradyarrhythmias or uncompensated heart failure • patients on drugs known to prolong the QT interval • patients with ongoing proarrhythmic conditions such as uncorrected hypokalemia or hypomagnesemia, clinically significant bradycardia, and in patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.Elderly patients may be more susceptible to drug-associated effects on the QT interval.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Azithromycin Tablets, USP are indicated for the treatment of patients with mild to moderate infections (pneumonia: see WARNINGS) caused by susceptible strains of the designated microorganisms in the specific conditions listed below. As recommended dosages, durations of therapy and applicable patient populations vary among these infections, please see DOSAGE AND ADMINISTRATION for specific dosing recommendations.
Acute bacterial exacerbations of chronic obstructive pulmonary disease due to Haemophilus influenzae, Moraxella catarrhalis or Streptococcus pneumoniae.
Acute bacterial sinusitis due to Haemophilus influenzae, Moraxella catarrhalis or Streptococcus pneumoniae.
Community-acquired pneumonia due to Chlamydophila pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae or Streptococcus pneumoniae in patients appropriate for oral therapy.
NOTE: Azithromycin should not be used in patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors such as any of the following:
patients with cystic fibrosis, patients with nosocomially acquired infections, patients with known or suspected bacteremia, patients requiring hospitalization, elderly or debilitated patients, or patients with significant underlying health problems that may compromise their ability to respond to their illness (including immunodeficiency or functional asplenia).Pharyngitis/tonsillitis caused by Streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy.
NOTE: Penicillin by the intramuscular route is the usual drug of choice in the treatment of Streptococcus pyogenes infection and the prophylaxis of rheumatic fever. Azithromycin is often effective in the eradication of susceptible strains of Streptococcus pyogenes from the nasopharynx. Because some strains are resistant to azithromycin, susceptibility tests should be performed when patients are treated with azithromycin. Data establishing efficacy of azithromycin in subsequent prevention of rheumatic fever are not available.Uncomplicated skin and skin structure infections due to Staphylococcus aureus, Streptococcus pyogenes, or Streptococcus agalactiae. Abscesses usually require surgical drainage.
Urethritis and cervicitis due to Chlamydia trachomatis or Neisseria gonorrhoeae.
Genital ulcer disease in men due to Haemophilus ducreyi (chancroid). Due to the small number of women included in clinical trials, the efficacy of azithromycin in the treatment of chancroid in women has not been established.
Azithromycin, at the recommended dose, should not be relied upon to treat syphilis. Antimicrobial agents used in high doses for short periods of time to treat non-gonococcal urethritis may mask or delay the symptoms of incubating syphilis. All patients with sexually-transmitted urethritis or cervicitis should have a serologic test for syphilis and appropriate cultures for gonorrhea performed at the time of diagnosis. Appropriate antimicrobial therapy and follow-up tests for these diseases should be initiated if infection is confirmed.
Appropriate culture and susceptibility tests should be performed before treatment to determine the causative organism and its susceptibility to azithromycin. Therapy with azithromycin may be initiated before results of these tests are known; once the results become available, antimicrobial therapy should be adjusted accordingly.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin and other antibacterial drugs, azithromycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
(See PRECAUTIONS—Pediatric Use and CLINICAL STUDIES IN PEDIATRIC PATIENTS.)
Acute otitis media caused by Haemophilus influenzae, Moraxella catarrhalis or Streptococcus pneumoniae. (For specific dosage recommendation, see DOSAGE AND ADMINISTRATION.)
Community-acquired pneumonia due to Chlamydophila pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae or Streptococcus pneumoniae in patients appropriate for oral therapy. (For specific dosage recommendation, see DOSAGE AND ADMINISTRATION.)
NOTE: Azithromycin should not be used in pediatric patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors such as any of the following:
patients with cystic fibrosis, patients with nosocomially acquired infections, patients with known or suspected bacteremia, patients requiring hospitalization, or patients with significant underlying health problems that may compromise their ability to respond to their illness (including immunodeficiency or functional asplenia).Pharyngitis/tonsillitis caused by Streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy. (For specific dosage recommendation, see DOSAGE AND ADMINISTRATION.)
NOTE: Penicillin by the intramuscular route is the usual drug of choice in the treatment of Streptococcus pyogenes infection and the prophylaxis of rheumatic fever. Azithromycin is often effective in the eradication of susceptible strains of Streptococcus pyogenes from the nasopharynx. Because some strains are resistant to azithromycin, susceptibility tests should be performed when patients are treated with azithromycin. Data establishing efficacy of azithromycin in subsequent prevention of rheumatic fever are not available.Appropriate culture and susceptibility tests should be performed before treatment to determine the causative organism and its susceptibility to azithromycin. Therapy with azithromycin may be initiated before results of these tests are known; once the results become available, antimicrobial therapy should be adjusted accordingly.
History
There is currently no drug history available for this drug.
Other Information
Azithromycin Tablets, USP contain the active ingredient azithromycin, an azalide, a subclass of macrolide antibiotics, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-‑13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl) oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3- (dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749. Azithromycin has the following structural formula:
Azithromycin, as the dihydrate, is a white crystalline powder with a molecular formula of C38H72N2O12•2H2O and a molecular weight of 785.
Azithromycin is supplied for oral administration as film-coated, white oval shaped biconvex tablets containing azithromycin dihydrate equivalent to either 250 mg or 500 mg azithromycin and the following 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).
Sources
Azithromycin Dihydrate Manufacturers
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Proficient Rx Lp
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Azithromycin Dihydrate | Proficient Rx Lp
(See INDICATIONS AND USAGE and CLINICAL PHARMACOLOGY.)
Adults Infection* Recommended Dose/Duration of Therapy * DUE TO THE INDICATED ORGANISMS (See INDICATIONS AND USAGE.)Community-acquired pneumonia (mild severity)
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 (mild to moderate)500 mg QD × 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 QD × 3 days
Genital ulcer disease (chancroid)
One single 1 gram dose
Non-gonoccocal urethritis and cervicitis
One single 1 gram dose
Gonococcal urethritis and cervicitis
One single 2 gram dose
Azithromycin tablets can be taken with or without food.
Renal InsufficiencyNo dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC0-120 was similar in subjects with GFR 10 to 80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency.)
Hepatic InsufficiencyThe pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency.)
No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY, Special Populations.)
Pediatric PatientsAzithromycin for oral suspension can be taken with or without food.
Acute Otitis MediaThe recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
Acute Bacterial SinusitisThe recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days. (See chart below.)
Community-Acquired PneumoniaThe recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS—Pediatric Use .) Based on Body Weight
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 Lbs. Day 1 Days 2–5 Day 1 Days 2–5 * Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established.5
11
2.5 mL
(½ tsp)1.25 mL
(¼ tsp)7.5 mL
150 mg
10
22
5 mL
(1 tsp)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
(2 tsp)5 mL
(1 tsp)30 mL
1200 mg
50 and above
110 and above
12.5 mL
(2½ tsp)6.25 mL
(1¼ tsp)37.5 mL
1500 mg
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 Lbs. Day 1–3 Day 1–3 * Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.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
OTITIS MEDIA: (1-Day 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 Lbs. Day 15
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
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, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/TonsillitisThe recommended dose of azithromycin 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 PRECAUTIONS—Pediatric Use.) Based on Body Weight
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 Lbs. Day 1–58
18
2.5 mL
(½ tsp)12.5 mL
500 mg
17
37
5 mL
(1 tsp)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
(2½ tsp)62.5 mL
2500 mg
-
Remedyrepack Inc.
Azithromycin Dihydrate | Remedyrepack Inc.
(See INDICATIONS AND USAGE and CLINICAL PHARMACOLOGY.)
Infection* Recommended Dose/Duration of Therapy Community-acquired pneumonia (mild severity)
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 (mild to moderate) 500 mg QD × 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 QD × 3 days Genital ulcer disease (chancroid) One single 1 gram dose Non-gonoccocal urethritis and cervicitis One single 1 gram dose Gonococcal urethritis and cervicitis One single 2 gram dose4
Azithromycin tablets can be taken with or without food.
No dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC0-120 was similar in subjects with GFR 10 to 80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency.)
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency.)
No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY, Special Populations.)
Azithromycin for oral suspension can be taken with or without food.
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days. (See chart below.)
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS—Pediatric Use.) Based on Body Weight
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 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
(1 tsp) 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
(2 tsp) 5 mL
(1 tsp) 30 mL 1200 mg 50 and above 110 and above 12.5 mL
(2½ tsp) 6.25 mL
(1¼ tsp) 37.5 mL 1500 mg5
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 Lbs. Day 1–3 Day 1–3 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 mg6
OTITIS MEDIA: (1-Day 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 Lbs. Day 1 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 mgThe 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, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
The recommended dose of azithromycin 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 PRECAUTIONS—Pediatric Use.) Based on Body Weight
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 Lbs. Day 1–5 8 18 2.5 mL
(½ tsp) 12.5 mL 500 mg 17 37 5 mL
(1 tsp) 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
(2½ tsp) 62.5 mL 2500 mg
4 See 5 Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established. 6 Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established. -
Remedyrepack Inc.
Azithromycin Dihydrate | Remedyrepack Inc.
(See INDICATIONS AND USAGE and CLINICAL PHARMACOLOGY.)
Infection* Recommended Dose/Duration of Therapy Community-acquired pneumonia (mild severity)
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 (mild to moderate) 500 mg QD × 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 QD × 3 days Genital ulcer disease (chancroid) One single 1 gram dose Non-gonoccocal urethritis and cervicitis One single 1 gram dose Gonococcal urethritis and cervicitis One single 2 gram dose4
Azithromycin tablets can be taken with or without food.
No dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC0-120 was similar in subjects with GFR 10 to 80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency.)
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency.)
No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY, Special Populations.)
Azithromycin for oral suspension can be taken with or without food.
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days. (See chart below.)
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS—Pediatric Use.) Based on Body Weight
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 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
(1 tsp) 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
(2 tsp) 5 mL
(1 tsp) 30 mL 1200 mg 50 and above 110 and above 12.5 mL
(2½ tsp) 6.25 mL
(1¼ tsp) 37.5 mL 1500 mg5
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 Lbs. Day 1–3 Day 1–3 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 mg6
OTITIS MEDIA: (1-Day 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 Lbs. Day 1 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 mgThe 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, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
The recommended dose of azithromycin 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 PRECAUTIONS—Pediatric Use.) Based on Body Weight
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 Lbs. Day 1–5 8 18 2.5 mL
(½ tsp) 12.5 mL 500 mg 17 37 5 mL
(1 tsp) 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
(2½ tsp) 62.5 mL 2500 mg
4 See 5 Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established. 6 Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established. -
Remedyrepack Inc.
Azithromycin Dihydrate | Remedyrepack Inc.
(See INDICATIONS AND USAGE and CLINICAL PHARMACOLOGY.)
Infection* Recommended Dose/Duration of Therapy Community-acquired pneumonia (mild severity)
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 (mild to moderate) 500 mg QD × 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 QD × 3 days Genital ulcer disease (chancroid) One single 1 gram dose Non-gonoccocal urethritis and cervicitis One single 1 gram dose Gonococcal urethritis and cervicitis One single 2 gram dose4
Azithromycin tablets can be taken with or without food.
No dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC0-120 was similar in subjects with GFR 10 to 80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency.)
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency.)
No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY, Special Populations.)
Azithromycin for oral suspension can be taken with or without food.
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days. (See chart below.)
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS—Pediatric Use.) Based on Body Weight
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 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
(1 tsp) 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
(2 tsp) 5 mL
(1 tsp) 30 mL 1200 mg 50 and above 110 and above 12.5 mL
(2½ tsp) 6.25 mL
(1¼ tsp) 37.5 mL 1500 mg5
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 Lbs. Day 1–3 Day 1–3 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 mg6
OTITIS MEDIA: (1-Day 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 Lbs. Day 1 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 mgThe 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, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
The recommended dose of azithromycin 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 PRECAUTIONS—Pediatric Use.) Based on Body Weight
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 Lbs. Day 1–5 8 18 2.5 mL
(½ tsp) 12.5 mL 500 mg 17 37 5 mL
(1 tsp) 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
(2½ tsp) 62.5 mL 2500 mg
4 See 5 Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established. 6 Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established. -
Remedyrepack Inc.
Azithromycin Dihydrate | Remedyrepack Inc.
(See INDICATIONS AND USAGE and CLINICAL PHARMACOLOGY.)
Infection* Recommended Dose/Duration of Therapy Community-acquired pneumonia (mild severity)
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 (mild to moderate) 500 mg QD × 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 QD × 3 days Genital ulcer disease (chancroid) One single 1 gram dose Non-gonoccocal urethritis and cervicitis One single 1 gram dose Gonococcal urethritis and cervicitis One single 2 gram dose4
Azithromycin tablets can be taken with or without food.
No dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC0-120 was similar in subjects with GFR 10 to 80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency.)
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency.)
No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY, Special Populations.)
Azithromycin for oral suspension can be taken with or without food.
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days. (See chart below.)
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS—Pediatric Use.) Based on Body Weight
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 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
(1 tsp) 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
(2 tsp) 5 mL
(1 tsp) 30 mL 1200 mg 50 and above 110 and above 12.5 mL
(2½ tsp) 6.25 mL
(1¼ tsp) 37.5 mL 1500 mg5
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 Lbs. Day 1–3 Day 1–3 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 mg6
OTITIS MEDIA: (1-Day 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 Lbs. Day 1 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 mgThe 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, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
The recommended dose of azithromycin 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 PRECAUTIONS—Pediatric Use.) Based on Body Weight
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 Lbs. Day 1–5 8 18 2.5 mL
(½ tsp) 12.5 mL 500 mg 17 37 5 mL
(1 tsp) 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
(2½ tsp) 62.5 mL 2500 mg
4 See 5 Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established. 6 Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established. -
American Health Packaging
Azithromycin Dihydrate | Paramesh Banerji Life Sciences Llc
Adult or child: Take three pills daily. Leaving a gap of 30 minutes after any food or as advised by your physician.
-
Pd-rx Pharmaceuticals, Inc.
Azithromycin Dihydrate | Pd-rx Pharmaceuticals, Inc.
(See INDICATIONS AND USAGE and CLINICAL PHARMACOLOGY.)
Adults Infection* Recommended Dose/Duration of Therapy * DUE TO THE INDICATED ORGANISMS (See INDICATIONS AND USAGE.) Community-acquired pneumonia (mild severity)
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 (mild to moderate) 500 mg QD × 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 QD × 3 days Genital ulcer disease (chancroid) One single 1 gram dose Non-gonoccocal urethritis and cervicitis One single 1 gram dose Gonococcal urethritis and cervicitis One single 2 gram doseAzithromycin tablets can be taken with or without food.
Renal InsufficiencyNo dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC0-120 was similar in subjects with GFR 10 to 80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency.)
Hepatic InsufficiencyThe pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency.)
No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY, Special Populations.)
Pediatric PatientsAzithromycin for oral suspension can be taken with or without food.
Acute Otitis MediaThe recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
Acute Bacterial SinusitisThe recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days. (See chart below.)
Community-Acquired PneumoniaThe recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS—Pediatric Use.) Based on Body Weight
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 Lbs. Day 1 Days 2–5 Day 1 Days 2–5 * Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established. 5 11 2.5 mL
(½ tsp) 1.25 mL
(¼ tsp) 7.5 mL 150 mg 10 22 5 mL
(1 tsp) 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
(2 tsp) 5 mL
(1 tsp) 30 mL 1200 mg 50 and above 110 and above 12.5 mL
(2½ tsp) 6.25 mL
(1¼ tsp) 37.5 mL 1500 mg 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 Lbs. Day 1–3 Day 1–3 * Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established. 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 OTITIS MEDIA: (1-Day 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 Lbs. Day 1 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 mgThe 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, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/TonsillitisThe recommended dose of azithromycin 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 PRECAUTIONS—Pediatric Use.) Based on Body Weight
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 Lbs. Day 1–5 8 18 2.5 mL
(½ tsp) 12.5 mL 500 mg 17 37 5 mL
(1 tsp) 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
(2½ tsp) 62.5 mL 2500 mg -
Direct Rx
Azithromycin Dihydrate | Direct Rx
Adults
Infection* Recommended Dose/Duration of Therapy *DUE TO THE INDICATED ORGANISMS (See INDICATIONS AND USAGE.) Community-acquired pneumonia (mild severity)
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 (mild to moderate) 500 mg QD × 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 QD × 3 days Genital ulcer disease (chancroid) One single 1 gram dose Non-gonoccocal urethritis and cervicitis One single 1 gram dose Gonococcal urethritis and cervicitis One single 2 gram doseAzithromycin tablets can be taken with or without food.
Renal Insufficiency
No dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC0-120 was similar in subjects with GFR 10 to 80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency.)
Hepatic Insufficiency
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency.)
No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY, Special Populations.)
Pediatric Patients
Azithromycin for oral suspension can be taken with or without food.
Acute Otitis Media
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
Acute Bacterial Sinusitis
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days. (See chart below.)
Community-Acquired Pneumonia
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS—Pediatric Use.) Based on Body Weight
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 Lbs. Day 1 Days 2–5 Day 1 Days 2–5 *Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established. 5 11 2.5 mL
(½ tsp) 1.25 mL
(¼ tsp) 7.5 mL 150 mg 10 22 5 mL
(1 tsp) 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
(2 tsp) 5 mL
(1 tsp) 30 mL 1200 mg 50 and above 110 and above 12.5 mL
(2½ tsp) 6.25 mL
(1¼ tsp) 37.5 mL 1500 mg 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 Lbs. Day 1–3 Day 1–3 *Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established. 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 OTITIS MEDIA: (1-Day 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 Lbs. Day 1 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 mgThe 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, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis
The recommended dose of azithromycin 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 PRECAUTIONS—Pediatric Use.) Based on Body Weight
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 Lbs. Day 1–5 8 18 2.5 mL
(½ tsp) 12.5 mL 500 mg 17 37 5 mL
(1 tsp) 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
(2½ tsp) 62.5 mL 2500 mg -
Remedyrepack Inc.
Azithromycin Dihydrate | Remedyrepack Inc.
(See INDICATIONS AND USAGE and CLINICAL PHARMACOLOGY.)
Infection* Recommended Dose/Duration of Therapy Community-acquired pneumonia (mild severity)
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 (mild to moderate) 500 mg QD × 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 QD × 3 days Genital ulcer disease (chancroid) One single 1 gram dose Non-gonoccocal urethritis and cervicitis One single 1 gram dose Gonococcal urethritis and cervicitis One single 2 gram dose4
Azithromycin tablets can be taken with or without food.
No dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC0-120 was similar in subjects with GFR 10 to 80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency.)
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency.)
No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY, Special Populations.)
Azithromycin for oral suspension can be taken with or without food.
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days. (See chart below.)
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS—Pediatric Use.) Based on Body Weight
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 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
(1 tsp) 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
(2 tsp) 5 mL
(1 tsp) 30 mL 1200 mg 50 and above 110 and above 12.5 mL
(2½ tsp) 6.25 mL
(1¼ tsp) 37.5 mL 1500 mg5
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 Lbs. Day 1–3 Day 1–3 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 mg6
OTITIS MEDIA: (1-Day 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 Lbs. Day 1 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 mgThe 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, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
The recommended dose of azithromycin 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 PRECAUTIONS—Pediatric Use.) Based on Body Weight
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 Lbs. Day 1–5 8 18 2.5 mL
(½ tsp) 12.5 mL 500 mg 17 37 5 mL
(1 tsp) 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
(2½ tsp) 62.5 mL 2500 mg
4 See 5 Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established. 6 Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established. -
Apotex Corp.
Azithromycin Dihydrate | Apotex Corp.
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)
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 *DUE TO THE INDICATED ORGANISMS [see Indications and Usage (1.1)]Azithromycin tablets can be taken with or without food.
2.2 Pediatric Patients 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. *DUE TO THE INDICATED ORGANISMS [see Indications and Usage (1.2)]
1see dosing tables below for maximum doses evaluated by indication
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
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 Lbs. Day 1 Days 2 to 5 Day 1 Days 2 to 5 5 11 2.5 mL; (½ tsp) 1.25 mL;(¼ tsp) 7.5 mL 150 mg 10 22 5 mL; (1 tsp) 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; (2 tsp) 5 mL; (1 tsp) 30 mL 1200 mg 50 and above 110 and above 12.5 mL; (2½ tsp) 6.25 mL; (1¼ tsp) 37.5 mL 1500 mg*Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established.
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 Lbs. Days 1 to 3 Days 1 to 3 5 11 2.5 mL;
(½ 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;
(1½ 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;
(2½ 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.
OTITIS MEDIA: (1-Day 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 Lbs. 1-Day Regimen 5 11 3.75 mL;
(3/4 tsp) 3.75 mL 150 mg 10 22 7.5 mL;
(1½ tsp) 7.5 mL 300 mg 20 44 15 mL;
(3 tsp) 15 mL 600 mg 30 66 22.5 mL;
(4½ 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;
(7½ tsp) 37.5 mL 1500 mgThe 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, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis
The recommended dose of azithromycin 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 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 Lbs. Day 1 to 5 8 18 2.5 mL;
(½ tsp) 12.5 mL 500 mg 17 37 5 mL;
(1 tsp) 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;
(2½ tsp) 62.5 mL 2500 mg -
Cardinal Health
Azithromycin Dihydrate | Cardinal Health
(See INDICATIONS AND USAGE and CLINICAL PHARMACOLOGY.)
Adults Infection* Recommended Dose/Duration of Therapy * DUE TO THE INDICATED ORGANISMS (See INDICATIONS AND USAGE.)Community-acquired pneumonia (mild severity)
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 (mild to moderate)500 mg QD × 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 QD × 3 days
Genital ulcer disease (chancroid)
One single 1 gram dose
Non-gonoccocal urethritis and cervicitis
One single 1 gram dose
Gonococcal urethritis and cervicitis
One single 2 gram dose
Azithromycin tablets can be taken with or without food.
Renal InsufficiencyNo dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC0-120 was similar in subjects with GFR 10 to 80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency.)
Hepatic InsufficiencyThe pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency.)
No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY, Special Populations.)
Pediatric PatientsAzithromycin for oral suspension can be taken with or without food.
Acute Otitis MediaThe recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
Acute Bacterial SinusitisThe recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days. (See chart below.)
Community-Acquired PneumoniaThe recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS—Pediatric Use .) Based on Body Weight
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 Lbs. Day 1 Days 2–5 Day 1 Days 2–5 * Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established.5
11
2.5 mL
(½ tsp)1.25 mL
(¼ tsp)7.5 mL
150 mg
10
22
5 mL
(1 tsp)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
(2 tsp)5 mL
(1 tsp)30 mL
1200 mg
50 and above
110 and above
12.5 mL
(2½ tsp)6.25 mL
(1¼ tsp)37.5 mL
1500 mg
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 Lbs. Day 1–3 Day 1–3 * Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.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
OTITIS MEDIA: (1-Day 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 Lbs. Day 15
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
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, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/TonsillitisThe recommended dose of azithromycin 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 PRECAUTIONS—Pediatric Use.) Based on Body Weight
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 Lbs. Day 1–58
18
2.5 mL
(½ tsp)12.5 mL
500 mg
17
37
5 mL
(1 tsp)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
(2½ tsp)62.5 mL
2500 mg
-
Apotex Corp.
Azithromycin Dihydrate | Apotex Corp.
For pediatric suspension, please refer to the INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION section of the prescribing information for azithromycin for oral suspension 100 mg/5 mL and 200 mg/5 mL bottles.-
[See Indications and Usage (1)].
2.2 Mycobacterial InfectionsPrevention of Disseminated MAC Infections
The recommended dose of azithromycin for the prevention of disseminated Mycobacterium avium complex (MAC) disease is: 1200 mg taken once weekly. This dose of azithromycin may be combined with the approved dosage regimen of rifabutin.Treatment of Disseminated MAC Infections
Azithromycin should be taken at a daily dose of 600 mg, in combination with ethambutol at the recommended daily dose of 15 mg/kg. Other antimycobacterial drugs that have shown in vitro activity against MAC may be added to the regimen of azithromycin plus ethambutol at the discretion of the physician or health care provider. -
Avpak
Azithromycin Dihydrate | Avpak
(See INDICATIONS AND USAGE and CLINICAL PHARMACOLOGY.)
Adults Infection* Recommended Dose/Duration of Therapy * DUE TO THE INDICATED ORGANISMS (See INDICATIONS AND USAGE.) Community-acquired pneumonia (mild severity)
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 (mild to moderate) 500 mg QD × 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 QD × 3 days Genital ulcer disease (chancroid) One single 1 gram dose Non-gonoccocal urethritis and cervicitis One single 1 gram dose Gonococcal urethritis and cervicitis One single 2 gram doseAzithromycin tablets can be taken with or without food.
Renal InsufficiencyNo dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC0-120 was similar in subjects with GFR 10 to 80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency.)
Hepatic InsufficiencyThe pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency.)
No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY, Special Populations.)
Pediatric PatientsAzithromycin for oral suspension can be taken with or without food.
Acute Otitis MediaThe recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
Acute Bacterial SinusitisThe recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days. (See chart below.)
Community-Acquired PneumoniaThe recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS—Pediatric Use.) Based on Body Weight
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 Lbs. Day 1 Days 2–5 Day 1 Days 2–5 * Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established. 5 11 2.5 mL
(½ tsp) 1.25 mL
(¼ tsp) 7.5 mL 150 mg 10 22 5 mL
(1 tsp) 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
(2 tsp) 5 mL
(1 tsp) 30 mL 1200 mg 50 and above 110 and above 12.5 mL
(2½ tsp) 6.25 mL
(1¼ tsp) 37.5 mL 1500 mg 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 Lbs. Day 1–3 Day 1–3 * Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established. 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 OTITIS MEDIA: (1-Day 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 Lbs. Day 1 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 mgThe 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, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/TonsillitisThe recommended dose of azithromycin 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 PRECAUTIONS—Pediatric Use.) Based on Body Weight
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 Lbs. Day 1–5 8 18 2.5 mL
(½ tsp) 12.5 mL 500 mg 17 37 5 mL
(1 tsp) 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
(2½ tsp) 62.5 mL 2500 mg -
Preferred Pharmaceuticals, Inc.
Azithromycin Dihydrate | Preferred Pharmaceuticals, Inc.
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)
Skin/skin structure (uncomplicated)500 mg as a single-dose on Day 1, followed by
250 mg once daily on Days 2 through 5Acute 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 5Acute 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
*DUE TO THE INDICATED ORGANISMS [see Indications and Usage (1.1)]
Azithromycin tablets can be taken with or without food.
2.2 Pediatric Patients1Infection*
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.
*DUE TO THE INDICATED ORGANISMS [see Indications and Usage (1.2)]
1see dosing tables below for maximum doses evaluated by indicationPEDIATRIC 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 WeightOTITIS 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
Lbs.
Day 1
Days 2 to 5
Day 1
Days 2 to 5
5
11
2.5 mL; (½ tsp)
1.25 mL;(¼ tsp)
7.5 mL
150 mg
10
22
5 mL; (1 tsp)
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; (2 tsp)
5 mL; (1 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL; (2½ tsp)
6.25 mL; (1¼ tsp)
37.5 mL
1500 mg
*Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established.
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
Lbs.
Days 1 to 3
Days 1 to 3
5
11
2.5 mL;
(½ 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;
(1½ 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;
(2½ 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.
OTITIS MEDIA: (1-Day 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
Lbs.
1-Day Regimen
5
11
3.75 mL;
(3/4 tsp)3.75 mL
150 mg
10
22
7.5 mL;
(1½ tsp)7.5 mL
300 mg
20
44
15 mL;
(3 tsp)15 mL
600 mg
30
66
22.5 mL;
(4½ 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;
(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, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis
The recommended dose of azithromycin 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 WeightPHARYNGITIS/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
Lbs.
Day 1 to 5
8
18
2.5 mL;
(½ tsp)12.5 mL
500 mg
17
37
5 mL;
(1 tsp)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;
(2½ tsp)62.5 mL
2500 mg
-
Cardinal Health
Azithromycin Dihydrate | Cardinal Health
(See INDICATIONS AND USAGE and CLINICAL PHARMACOLOGY.)
Adults Infection* Recommended Dose/Duration of Therapy * DUE TO THE INDICATED ORGANISMS (See INDICATIONS AND USAGE.)Community-acquired pneumonia (mild severity)
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 (mild to moderate)500 mg QD × 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 QD × 3 days
Genital ulcer disease (chancroid)
One single 1 gram dose
Non-gonoccocal urethritis and cervicitis
One single 1 gram dose
Gonococcal urethritis and cervicitis
One single 2 gram dose
Azithromycin tablets can be taken with or without food.
Renal InsufficiencyNo dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC0-120 was similar in subjects with GFR 10 to 80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency.)
Hepatic InsufficiencyThe pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency.)
No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY, Special Populations.)
Pediatric PatientsAzithromycin for oral suspension can be taken with or without food.
Acute Otitis MediaThe recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
Acute Bacterial SinusitisThe recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days. (See chart below.)
Community-Acquired PneumoniaThe recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS—Pediatric Use .) Based on Body Weight
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 Lbs. Day 1 Days 2–5 Day 1 Days 2–5 * Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established.5
11
2.5 mL
(½ tsp)1.25 mL
(¼ tsp)7.5 mL
150 mg
10
22
5 mL
(1 tsp)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
(2 tsp)5 mL
(1 tsp)30 mL
1200 mg
50 and above
110 and above
12.5 mL
(2½ tsp)6.25 mL
(1¼ tsp)37.5 mL
1500 mg
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 Lbs. Day 1–3 Day 1–3 * Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.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
OTITIS MEDIA: (1-Day 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 Lbs. Day 15
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
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, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/TonsillitisThe recommended dose of azithromycin 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 PRECAUTIONS—Pediatric Use.) Based on Body Weight
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 Lbs. Day 1–58
18
2.5 mL
(½ tsp)12.5 mL
500 mg
17
37
5 mL
(1 tsp)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
(2½ tsp)62.5 mL
2500 mg
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