Indications

ADULTS: Treatment of infections of the respiratory tract, chronic obstructive pulmonary disease (COPD), community-acquired pneumonia, Mycobacterium avium complex, pelvic inflammatory disease, skin and skin structure, and sexually-transmitted diseases caused by susceptible organisms.

CHILDREN: Treatment of acute otitis media caused by susceptible organisms; community-acquired pneumonia, treatment of pharyngitis/tonsillitis caused by Streptococcus pyogenes in patients who cannot use first-line therapy.

 Contraindications Hypersensitivity to azithromycin, erythromycin, or to any macrolide antibiotic.

 Route/Dosage

Acute Otitis Media

Children 6 mo and older: PO 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 (not to exceed 500 mg/day) followed by 5 mg/kg on days 2 through 5 (not to exceed 250 mg/day).

Bacterial Infections

Adults: PO 500 mg as single dose on first day, then 250 mg/day on days 2 through 5.

Community-Acquired Pneumonia

Adults and children 16 yr and older: PO 500 mg as a single dose on the first day followed by 250 mg once daily on days 2 through 5.

Adults: IV 500 mg as a single daily dose for greater than or equal to 2 days. Follow IV therapy by the oral route at a single daily dose of 500 mg to complete 7- to 10-day course of therapy.

Children 6 mo and older: PO 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).

Gonorrhea

Adults: PO Single 2 g dose.

Mild to Moderate COPD

Adults and children 16 yr and older: PO 500 mg/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.

Mycobacterium Avium Complex

Adults: PO Prevention: 1.2 g taken weekly. Treatment: 600 mg/day in combination with ethambutol (15 mg/kg).

Pelvic Inflammatory Disease

Adults: IV 500 mg as a single daily dose for 1 to 2 days. Follow IV therapy by the oral route at a single daily dose of 250 mg to complete a 7-day course of therapy.

Pharyngitis/Tonsillitis

Adults and children 16 yr and older: PO 500 mg as a single dose on the first day followed by 250 mg once daily on days 2 through 5.

Children at least 2 yr: PO 12 mg/kg/day for 5 days, not to exceed 500 mg/day.

Genital Ulcer Disease caused by H. ducreyi (chancroid), Nongonococcal Urethritis/Cervicitis caused by C. trachomatis:

Adults: PO Single 1 g dose.

Uncomplicated Skin and Skin Structure Infections

Adults and children 16 yr and older: PO 500 mg as a single dose on the first day followed by 250 mg once daily for 4 days.

 Interactions

HMG-CoA reductase inhibitors (eg, lovastatin):

Increased risk of myopathy and rhabdomyolysis.

Tacrolimus:

Increased tacrolimus plasma levels with increased risk of toxicity.

Warfarin:

The anticoagulant effect may be increased, increasing the risk of hemorrhage.

 Lab Test Interferences None well documented.

 Adverse Reactions

CARDIOVASCULAR: Palpitations; chest pain. CNS: Dizziness; headache; vertigo; somnolence; fatigue. DERMATOLOGIC: Rash; photosensitivity. GI: Diarrhea; nausea; vomiting; abdominal pain; dyspepsia; flatulence; melena. GU: Vaginitis; monilia; nephritis. HEPATIC: Cholestatic jaundice. OTHER: Angioedema; anaphylaxis.

 Precautions

Pregnancy: Category B. Lactation: Undetermined. Cardiac effects: Serious cardiovascular events have occurred with other macrolide antibiotics, especially when given concomitantly with certain antihistamines (eg, terfenadine). Gonorrhea/Syphilis: Ineffective for treatment of these infections. Hepatic/Renal function impairment: Use cautiously. Pneumonia: Only effective for mild community-acquired pneumonia. Pseudomembranous colitis: May be factor in patients who develop diarrhea.

 Administration/Storage

Oral suspension/Tablets

• Administer 1 hr before or 2 hr after meal.
• Tablets can be taken without regard to meals.
• Time doses evenly throughout day for optimal blood levels.
• Do not give antacids for greater than 2 hr after administration of product.
• Do not crush capsules.
• Give patient 6 to 8 oz of water or noncitrus juice with oral medication.
• Store reconstituted oral suspension at room temperature and use within 10 days. Discard after full dosing is completed.
• Store in tightly closed container at room temperature.

Injection

• The infusate concentration and rate of infusion for azithromycin for injection should be either 1 mg/mL over 3 hr or 2 mg/mL over 1 hr. Do not administer as a bolus or IM injection.

 Assessment/Interventions

• Obtain patient history, including drug history and any known allergies.
• Review C&S report as available.
• Monitor renal, liver, and GI function during therapy. Notify health care provider of any GI side effects.
• Observe for signs of superinfection during therapy (eg, yeast infections, black hairy tongue, itching in groin area).
• Monitor for bleeding in patients receiving concomitant oral anticoagulant therapy.
• Notify health care provider if signs and symptoms of anaphylaxis occur.

 Patient/Family Education

• Instruct patient to time doses for even distribution over a 24-hr period.
• Inform patient that the medication works best on empty stomach, but may be taken with food if there is GI upset.
• Instruct patient to take medication with full glass of water or noncitrus juice.
• Encourage patient to increase fluid intake to 2000 to 3000 mL/day, if not contraindicated.
• Instruct patient to notify health care provider if rash develops or difficult breathing occurs.
• Explain that antacids should be avoided while this medication is being taken.

Indications for Drugs ::

 Action Interferes with microbial protein synthesis.

 Indications

ADULTS: Treatment of infections of the respiratory tract, chronic obstructive pulmonary disease (COPD), community-acquired pneumonia, Mycobacterium avium complex, pelvic inflammatory disease, skin and skin structure, and sexually-transmitted diseases caused by susceptible organisms.

CHILDREN: Treatment of acute otitis media caused by susceptible organisms; community-acquired pneumonia, treatment of pharyngitis/tonsillitis caused by Streptococcus pyogenes in patients who cannot use first-line therapy.

 Contraindications Hypersensitivity to azithromycin, erythromycin, or to any macrolide antibiotic.

 Route/Dosage

Acute Otitis Media

Children 6 mo and older: PO 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 (not to exceed 500 mg/day) followed by 5 mg/kg on days 2 through 5 (not to exceed 250 mg/day).

Bacterial Infections

Adults: PO 500 mg as single dose on first day, then 250 mg/day on days 2 through 5.

Community-Acquired Pneumonia

Adults and children 16 yr and older: PO 500 mg as a single dose on the first day followed by 250 mg once daily on days 2 through 5.

Adults: IV 500 mg as a single daily dose for greater than or equal to 2 days. Follow IV therapy by the oral route at a single daily dose of 500 mg to complete 7- to 10-day course of therapy.

Children 6 mo and older: PO 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).

Gonorrhea

Adults: PO Single 2 g dose.

Mild to Moderate COPD

Adults and children 16 yr and older: PO 500 mg/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.

Mycobacterium Avium Complex

Adults: PO Prevention: 1.2 g taken weekly. Treatment: 600 mg/day in combination with ethambutol (15 mg/kg).

Pelvic Inflammatory Disease

Adults: IV 500 mg as a single daily dose for 1 to 2 days. Follow IV therapy by the oral route at a single daily dose of 250 mg to complete a 7-day course of therapy.

Pharyngitis/Tonsillitis

Adults and children 16 yr and older: PO 500 mg as a single dose on the first day followed by 250 mg once daily on days 2 through 5.

Children at least 2 yr: PO 12 mg/kg/day for 5 days, not to exceed 500 mg/day.

Genital Ulcer Disease caused by H. ducreyi (chancroid), Nongonococcal Urethritis/Cervicitis caused by C. trachomatis:

Adults: PO Single 1 g dose.

Uncomplicated Skin and Skin Structure Infections

Adults and children 16 yr and older: PO 500 mg as a single dose on the first day followed by 250 mg once daily for 4 days.

 Interactions

HMG-CoA reductase inhibitors (eg, lovastatin):

Increased risk of myopathy and rhabdomyolysis.

Tacrolimus:

Increased tacrolimus plasma levels with increased risk of toxicity.

Warfarin:

The anticoagulant effect may be increased, increasing the risk of hemorrhage.

 Lab Test Interferences None well documented.

 Adverse Reactions

CARDIOVASCULAR: Palpitations; chest pain. CNS: Dizziness; headache; vertigo; somnolence; fatigue. DERMATOLOGIC: Rash; photosensitivity. GI: Diarrhea; nausea; vomiting; abdominal pain; dyspepsia; flatulence; melena. GU: Vaginitis; monilia; nephritis. HEPATIC: Cholestatic jaundice. OTHER: Angioedema; anaphylaxis.

 Precautions

Pregnancy: Category B. Lactation: Undetermined. Cardiac effects: Serious cardiovascular events have occurred with other macrolide antibiotics, especially when given concomitantly with certain antihistamines (eg, terfenadine). Gonorrhea/Syphilis: Ineffective for treatment of these infections. Hepatic/Renal function impairment: Use cautiously. Pneumonia: Only effective for mild community-acquired pneumonia. Pseudomembranous colitis: May be factor in patients who develop diarrhea.

 Administration/Storage

Oral suspension/Tablets

• Administer 1 hr before or 2 hr after meal.
• Tablets can be taken without regard to meals.
• Time doses evenly throughout day for optimal blood levels.
• Do not give antacids for greater than 2 hr after administration of product.
• Do not crush capsules.
• Give patient 6 to 8 oz of water or noncitrus juice with oral medication.
• Store reconstituted oral suspension at room temperature and use within 10 days. Discard after full dosing is completed.
• Store in tightly closed container at room temperature.

Injection

• The infusate concentration and rate of infusion for azithromycin for injection should be either 1 mg/mL over 3 hr or 2 mg/mL over 1 hr. Do not administer as a bolus or IM injection.

 Assessment/Interventions

• Obtain patient history, including drug history and any known allergies.
• Review C&S report as available.
• Monitor renal, liver, and GI function during therapy. Notify health care provider of any GI side effects.
• Observe for signs of superinfection during therapy (eg, yeast infections, black hairy tongue, itching in groin area).
• Monitor for bleeding in patients receiving concomitant oral anticoagulant therapy.
• Notify health care provider if signs and symptoms of anaphylaxis occur.

 Patient/Family Education

• Instruct patient to time doses for even distribution over a 24-hr period.
• Inform patient that the medication works best on empty stomach, but may be taken with food if there is GI upset.
• Instruct patient to take medication with full glass of water or noncitrus juice.
• Encourage patient to increase fluid intake to 2000 to 3000 mL/day, if not contraindicated.
• Instruct patient to notify health care provider if rash develops or difficult breathing occurs.
• Explain that antacids should be avoided while this medication is being taken.

Drug Dose ::

 Action Interferes with microbial protein synthesis.

 Indications

ADULTS: Treatment of infections of the respiratory tract, chronic obstructive pulmonary disease (COPD), community-acquired pneumonia, Mycobacterium avium complex, pelvic inflammatory disease, skin and skin structure, and sexually-transmitted diseases caused by susceptible organisms.

CHILDREN: Treatment of acute otitis media caused by susceptible organisms; community-acquired pneumonia, treatment of pharyngitis/tonsillitis caused by Streptococcus pyogenes in patients who cannot use first-line therapy.

 Contraindications Hypersensitivity to azithromycin, erythromycin, or to any macrolide antibiotic.

 Route/Dosage

Acute Otitis Media

Children 6 mo and older: PO 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 (not to exceed 500 mg/day) followed by 5 mg/kg on days 2 through 5 (not to exceed 250 mg/day).

Bacterial Infections

Adults: PO 500 mg as single dose on first day, then 250 mg/day on days 2 through 5.

Community-Acquired Pneumonia

Adults and children 16 yr and older: PO 500 mg as a single dose on the first day followed by 250 mg once daily on days 2 through 5.

Adults: IV 500 mg as a single daily dose for greater than or equal to 2 days. Follow IV therapy by the oral route at a single daily dose of 500 mg to complete 7- to 10-day course of therapy.

Children 6 mo and older: PO 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).

Gonorrhea

Adults: PO Single 2 g dose.

Mild to Moderate COPD

Adults and children 16 yr and older: PO 500 mg/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.

Mycobacterium Avium Complex

Adults: PO Prevention: 1.2 g taken weekly. Treatment: 600 mg/day in combination with ethambutol (15 mg/kg).

Pelvic Inflammatory Disease

Adults: IV 500 mg as a single daily dose for 1 to 2 days. Follow IV therapy by the oral route at a single daily dose of 250 mg to complete a 7-day course of therapy.

Pharyngitis/Tonsillitis

Adults and children 16 yr and older: PO 500 mg as a single dose on the first day followed by 250 mg once daily on days 2 through 5.

Children at least 2 yr: PO 12 mg/kg/day for 5 days, not to exceed 500 mg/day.

Genital Ulcer Disease caused by H. ducreyi (chancroid), Nongonococcal Urethritis/Cervicitis caused by C. trachomatis:

Adults: PO Single 1 g dose.

Uncomplicated Skin and Skin Structure Infections

Adults and children 16 yr and older: PO 500 mg as a single dose on the first day followed by 250 mg once daily for 4 days.

 Interactions

HMG-CoA reductase inhibitors (eg, lovastatin):

Increased risk of myopathy and rhabdomyolysis.

Tacrolimus:

Increased tacrolimus plasma levels with increased risk of toxicity.

Warfarin:

The anticoagulant effect may be increased, increasing the risk of hemorrhage.

 Lab Test Interferences None well documented.

 Adverse Reactions

CARDIOVASCULAR: Palpitations; chest pain. CNS: Dizziness; headache; vertigo; somnolence; fatigue. DERMATOLOGIC: Rash; photosensitivity. GI: Diarrhea; nausea; vomiting; abdominal pain; dyspepsia; flatulence; melena. GU: Vaginitis; monilia; nephritis. HEPATIC: Cholestatic jaundice. OTHER: Angioedema; anaphylaxis.

 Precautions

Pregnancy: Category B. Lactation: Undetermined. Cardiac effects: Serious cardiovascular events have occurred with other macrolide antibiotics, especially when given concomitantly with certain antihistamines (eg, terfenadine). Gonorrhea/Syphilis: Ineffective for treatment of these infections. Hepatic/Renal function impairment: Use cautiously. Pneumonia: Only effective for mild community-acquired pneumonia. Pseudomembranous colitis: May be factor in patients who develop diarrhea.

 Administration/Storage

Oral suspension/Tablets

• Administer 1 hr before or 2 hr after meal.
• Tablets can be taken without regard to meals.
• Time doses evenly throughout day for optimal blood levels.
• Do not give antacids for greater than 2 hr after administration of product.
• Do not crush capsules.
• Give patient 6 to 8 oz of water or noncitrus juice with oral medication.
• Store reconstituted oral suspension at room temperature and use within 10 days. Discard after full dosing is completed.
• Store in tightly closed container at room temperature.

Injection

• The infusate concentration and rate of infusion for azithromycin for injection should be either 1 mg/mL over 3 hr or 2 mg/mL over 1 hr. Do not administer as a bolus or IM injection.

 Assessment/Interventions

• Obtain patient history, including drug history and any known allergies.
• Review C&S report as available.
• Monitor renal, liver, and GI function during therapy. Notify health care provider of any GI side effects.
• Observe for signs of superinfection during therapy (eg, yeast infections, black hairy tongue, itching in groin area).
• Monitor for bleeding in patients receiving concomitant oral anticoagulant therapy.
• Notify health care provider if signs and symptoms of anaphylaxis occur.

 Patient/Family Education

• Instruct patient to time doses for even distribution over a 24-hr period.
• Inform patient that the medication works best on empty stomach, but may be taken with food if there is GI upset.
• Instruct patient to take medication with full glass of water or noncitrus juice.
• Encourage patient to increase fluid intake to 2000 to 3000 mL/day, if not contraindicated.
• Instruct patient to notify health care provider if rash develops or difficult breathing occurs.
• Explain that antacids should be avoided while this medication is being taken.

Contraindication ::

 Action Interferes with microbial protein synthesis.

 Indications

ADULTS: Treatment of infections of the respiratory tract, chronic obstructive pulmonary disease (COPD), community-acquired pneumonia, Mycobacterium avium complex, pelvic inflammatory disease, skin and skin structure, and sexually-transmitted diseases caused by susceptible organisms.

CHILDREN: Treatment of acute otitis media caused by susceptible organisms; community-acquired pneumonia, treatment of pharyngitis/tonsillitis caused by Streptococcus pyogenes in patients who cannot use first-line therapy.

 Contraindications Hypersensitivity to azithromycin, erythromycin, or to any macrolide antibiotic.

 Route/Dosage

Acute Otitis Media

Children 6 mo and older: PO 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 (not to exceed 500 mg/day) followed by 5 mg/kg on days 2 through 5 (not to exceed 250 mg/day).

Bacterial Infections

Adults: PO 500 mg as single dose on first day, then 250 mg/day on days 2 through 5.

Community-Acquired Pneumonia

Adults and children 16 yr and older: PO 500 mg as a single dose on the first day followed by 250 mg once daily on days 2 through 5.

Adults: IV 500 mg as a single daily dose for greater than or equal to 2 days. Follow IV therapy by the oral route at a single daily dose of 500 mg to complete 7- to 10-day course of therapy.

Children 6 mo and older: PO 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).

Gonorrhea

Adults: PO Single 2 g dose.

Mild to Moderate COPD

Adults and children 16 yr and older: PO 500 mg/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.

Mycobacterium Avium Complex

Adults: PO Prevention: 1.2 g taken weekly. Treatment: 600 mg/day in combination with ethambutol (15 mg/kg).

Pelvic Inflammatory Disease

Adults: IV 500 mg as a single daily dose for 1 to 2 days. Follow IV therapy by the oral route at a single daily dose of 250 mg to complete a 7-day course of therapy.

Pharyngitis/Tonsillitis

Adults and children 16 yr and older: PO 500 mg as a single dose on the first day followed by 250 mg once daily on days 2 through 5.

Children at least 2 yr: PO 12 mg/kg/day for 5 days, not to exceed 500 mg/day.

Genital Ulcer Disease caused by H. ducreyi (chancroid), Nongonococcal Urethritis/Cervicitis caused by C. trachomatis:

Adults: PO Single 1 g dose.

Uncomplicated Skin and Skin Structure Infections

Adults and children 16 yr and older: PO 500 mg as a single dose on the first day followed by 250 mg once daily for 4 days.

 Interactions

HMG-CoA reductase inhibitors (eg, lovastatin):

Increased risk of myopathy and rhabdomyolysis.

Tacrolimus:

Increased tacrolimus plasma levels with increased risk of toxicity.

Warfarin:

The anticoagulant effect may be increased, increasing the risk of hemorrhage.

 Lab Test Interferences None well documented.

 Adverse Reactions

CARDIOVASCULAR: Palpitations; chest pain. CNS: Dizziness; headache; vertigo; somnolence; fatigue. DERMATOLOGIC: Rash; photosensitivity. GI: Diarrhea; nausea; vomiting; abdominal pain; dyspepsia; flatulence; melena. GU: Vaginitis; monilia; nephritis. HEPATIC: Cholestatic jaundice. OTHER: Angioedema; anaphylaxis.

 Precautions

Pregnancy: Category B. Lactation: Undetermined. Cardiac effects: Serious cardiovascular events have occurred with other macrolide antibiotics, especially when given concomitantly with certain antihistamines (eg, terfenadine). Gonorrhea/Syphilis: Ineffective for treatment of these infections. Hepatic/Renal function impairment: Use cautiously. Pneumonia: Only effective for mild community-acquired pneumonia. Pseudomembranous colitis: May be factor in patients who develop diarrhea.

 Administration/Storage

Oral suspension/Tablets

• Administer 1 hr before or 2 hr after meal.
• Tablets can be taken without regard to meals.
• Time doses evenly throughout day for optimal blood levels.
• Do not give antacids for greater than 2 hr after administration of product.
• Do not crush capsules.
• Give patient 6 to 8 oz of water or noncitrus juice with oral medication.
• Store reconstituted oral suspension at room temperature and use within 10 days. Discard after full dosing is completed.
• Store in tightly closed container at room temperature.

Injection

• The infusate concentration and rate of infusion for azithromycin for injection should be either 1 mg/mL over 3 hr or 2 mg/mL over 1 hr. Do not administer as a bolus or IM injection.

 Assessment/Interventions

• Obtain patient history, including drug history and any known allergies.
• Review C&S report as available.
• Monitor renal, liver, and GI function during therapy. Notify health care provider of any GI side effects.
• Observe for signs of superinfection during therapy (eg, yeast infections, black hairy tongue, itching in groin area).
• Monitor for bleeding in patients receiving concomitant oral anticoagulant therapy.
• Notify health care provider if signs and symptoms of anaphylaxis occur.

 Patient/Family Education

• Instruct patient to time doses for even distribution over a 24-hr period.
• Inform patient that the medication works best on empty stomach, but may be taken with food if there is GI upset.
• Instruct patient to take medication with full glass of water or noncitrus juice.
• Encourage patient to increase fluid intake to 2000 to 3000 mL/day, if not contraindicated.
• Instruct patient to notify health care provider if rash develops or difficult breathing occurs.
• Explain that antacids should be avoided while this medication is being taken.

Drug Precautions ::

 Action Interferes with microbial protein synthesis.

 Indications

ADULTS: Treatment of infections of the respiratory tract, chronic obstructive pulmonary disease (COPD), community-acquired pneumonia, Mycobacterium avium complex, pelvic inflammatory disease, skin and skin structure, and sexually-transmitted diseases caused by susceptible organisms.

CHILDREN: Treatment of acute otitis media caused by susceptible organisms; community-acquired pneumonia, treatment of pharyngitis/tonsillitis caused by Streptococcus pyogenes in patients who cannot use first-line therapy.

 Contraindications Hypersensitivity to azithromycin, erythromycin, or to any macrolide antibiotic.

 Route/Dosage

Acute Otitis Media

Children 6 mo and older: PO 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 (not to exceed 500 mg/day) followed by 5 mg/kg on days 2 through 5 (not to exceed 250 mg/day).

Bacterial Infections

Adults: PO 500 mg as single dose on first day, then 250 mg/day on days 2 through 5.

Community-Acquired Pneumonia

Adults and children 16 yr and older: PO 500 mg as a single dose on the first day followed by 250 mg once daily on days 2 through 5.

Adults: IV 500 mg as a single daily dose for greater than or equal to 2 days. Follow IV therapy by the oral route at a single daily dose of 500 mg to complete 7- to 10-day course of therapy.

Children 6 mo and older: PO 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).

Gonorrhea

Adults: PO Single 2 g dose.

Mild to Moderate COPD

Adults and children 16 yr and older: PO 500 mg/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.

Mycobacterium Avium Complex

Adults: PO Prevention: 1.2 g taken weekly. Treatment: 600 mg/day in combination with ethambutol (15 mg/kg).

Pelvic Inflammatory Disease

Adults: IV 500 mg as a single daily dose for 1 to 2 days. Follow IV therapy by the oral route at a single daily dose of 250 mg to complete a 7-day course of therapy.

Pharyngitis/Tonsillitis

Adults and children 16 yr and older: PO 500 mg as a single dose on the first day followed by 250 mg once daily on days 2 through 5.

Children at least 2 yr: PO 12 mg/kg/day for 5 days, not to exceed 500 mg/day.

Genital Ulcer Disease caused by H. ducreyi (chancroid), Nongonococcal Urethritis/Cervicitis caused by C. trachomatis:

Adults: PO Single 1 g dose.

Uncomplicated Skin and Skin Structure Infections

Adults and children 16 yr and older: PO 500 mg as a single dose on the first day followed by 250 mg once daily for 4 days.

 Interactions

HMG-CoA reductase inhibitors (eg, lovastatin):

Increased risk of myopathy and rhabdomyolysis.

Tacrolimus:

Increased tacrolimus plasma levels with increased risk of toxicity.

Warfarin:

The anticoagulant effect may be increased, increasing the risk of hemorrhage.

 Lab Test Interferences None well documented.

 Adverse Reactions

CARDIOVASCULAR: Palpitations; chest pain. CNS: Dizziness; headache; vertigo; somnolence; fatigue. DERMATOLOGIC: Rash; photosensitivity. GI: Diarrhea; nausea; vomiting; abdominal pain; dyspepsia; flatulence; melena. GU: Vaginitis; monilia; nephritis. HEPATIC: Cholestatic jaundice. OTHER: Angioedema; anaphylaxis.

 Precautions

Pregnancy: Category B. Lactation: Undetermined. Cardiac effects: Serious cardiovascular events have occurred with other macrolide antibiotics, especially when given concomitantly with certain antihistamines (eg, terfenadine). Gonorrhea/Syphilis: Ineffective for treatment of these infections. Hepatic/Renal function impairment: Use cautiously. Pneumonia: Only effective for mild community-acquired pneumonia. Pseudomembranous colitis: May be factor in patients who develop diarrhea.

 Administration/Storage

Oral suspension/Tablets

• Administer 1 hr before or 2 hr after meal.
• Tablets can be taken without regard to meals.
• Time doses evenly throughout day for optimal blood levels.
• Do not give antacids for greater than 2 hr after administration of product.
• Do not crush capsules.
• Give patient 6 to 8 oz of water or noncitrus juice with oral medication.
• Store reconstituted oral suspension at room temperature and use within 10 days. Discard after full dosing is completed.
• Store in tightly closed container at room temperature.

Injection

• The infusate concentration and rate of infusion for azithromycin for injection should be either 1 mg/mL over 3 hr or 2 mg/mL over 1 hr. Do not administer as a bolus or IM injection.

 Assessment/Interventions

• Obtain patient history, including drug history and any known allergies.
• Review C&S report as available.
• Monitor renal, liver, and GI function during therapy. Notify health care provider of any GI side effects.
• Observe for signs of superinfection during therapy (eg, yeast infections, black hairy tongue, itching in groin area).
• Monitor for bleeding in patients receiving concomitant oral anticoagulant therapy.
• Notify health care provider if signs and symptoms of anaphylaxis occur.

 Patient/Family Education

• Instruct patient to time doses for even distribution over a 24-hr period.
• Inform patient that the medication works best on empty stomach, but may be taken with food if there is GI upset.
• Instruct patient to take medication with full glass of water or noncitrus juice.
• Encourage patient to increase fluid intake to 2000 to 3000 mL/day, if not contraindicated.
• Instruct patient to notify health care provider if rash develops or difficult breathing occurs.
• Explain that antacids should be avoided while this medication is being taken.

Drug Side Effects ::

 Action Interferes with microbial protein synthesis.

 Indications

ADULTS: Treatment of infections of the respiratory tract, chronic obstructive pulmonary disease (COPD), community-acquired pneumonia, Mycobacterium avium complex, pelvic inflammatory disease, skin and skin structure, and sexually-transmitted diseases caused by susceptible organisms.

CHILDREN: Treatment of acute otitis media caused by susceptible organisms; community-acquired pneumonia, treatment of pharyngitis/tonsillitis caused by Streptococcus pyogenes in patients who cannot use first-line therapy.

 Contraindications Hypersensitivity to azithromycin, erythromycin, or to any macrolide antibiotic.

 Route/Dosage

Acute Otitis Media

Children 6 mo and older: PO 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 (not to exceed 500 mg/day) followed by 5 mg/kg on days 2 through 5 (not to exceed 250 mg/day).

Bacterial Infections

Adults: PO 500 mg as single dose on first day, then 250 mg/day on days 2 through 5.

Community-Acquired Pneumonia

Adults and children 16 yr and older: PO 500 mg as a single dose on the first day followed by 250 mg once daily on days 2 through 5.

Adults: IV 500 mg as a single daily dose for greater than or equal to 2 days. Follow IV therapy by the oral route at a single daily dose of 500 mg to complete 7- to 10-day course of therapy.

Children 6 mo and older: PO 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).

Gonorrhea

Adults: PO Single 2 g dose.

Mild to Moderate COPD

Adults and children 16 yr and older: PO 500 mg/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.

Mycobacterium Avium Complex

Adults: PO Prevention: 1.2 g taken weekly. Treatment: 600 mg/day in combination with ethambutol (15 mg/kg).

Pelvic Inflammatory Disease

Adults: IV 500 mg as a single daily dose for 1 to 2 days. Follow IV therapy by the oral route at a single daily dose of 250 mg to complete a 7-day course of therapy.

Pharyngitis/Tonsillitis

Adults and children 16 yr and older: PO 500 mg as a single dose on the first day followed by 250 mg once daily on days 2 through 5.

Children at least 2 yr: PO 12 mg/kg/day for 5 days, not to exceed 500 mg/day.

Genital Ulcer Disease caused by H. ducreyi (chancroid), Nongonococcal Urethritis/Cervicitis caused by C. trachomatis:

Adults: PO Single 1 g dose.

Uncomplicated Skin and Skin Structure Infections

Adults and children 16 yr and older: PO 500 mg as a single dose on the first day followed by 250 mg once daily for 4 days.

 Interactions

HMG-CoA reductase inhibitors (eg, lovastatin):

Increased risk of myopathy and rhabdomyolysis.

Tacrolimus:

Increased tacrolimus plasma levels with increased risk of toxicity.

Warfarin:

The anticoagulant effect may be increased, increasing the risk of hemorrhage.

 Lab Test Interferences None well documented.

 Adverse Reactions

CARDIOVASCULAR: Palpitations; chest pain. CNS: Dizziness; headache; vertigo; somnolence; fatigue. DERMATOLOGIC: Rash; photosensitivity. GI: Diarrhea; nausea; vomiting; abdominal pain; dyspepsia; flatulence; melena. GU: Vaginitis; monilia; nephritis. HEPATIC: Cholestatic jaundice. OTHER: Angioedema; anaphylaxis.

 Precautions

Pregnancy: Category B. Lactation: Undetermined. Cardiac effects: Serious cardiovascular events have occurred with other macrolide antibiotics, especially when given concomitantly with certain antihistamines (eg, terfenadine). Gonorrhea/Syphilis: Ineffective for treatment of these infections. Hepatic/Renal function impairment: Use cautiously. Pneumonia: Only effective for mild community-acquired pneumonia. Pseudomembranous colitis: May be factor in patients who develop diarrhea.

 Administration/Storage

Oral suspension/Tablets

• Administer 1 hr before or 2 hr after meal.
• Tablets can be taken without regard to meals.
• Time doses evenly throughout day for optimal blood levels.
• Do not give antacids for greater than 2 hr after administration of product.
• Do not crush capsules.
• Give patient 6 to 8 oz of water or noncitrus juice with oral medication.
• Store reconstituted oral suspension at room temperature and use within 10 days. Discard after full dosing is completed.
• Store in tightly closed container at room temperature.

Injection

• The infusate concentration and rate of infusion for azithromycin for injection should be either 1 mg/mL over 3 hr or 2 mg/mL over 1 hr. Do not administer as a bolus or IM injection.

 Assessment/Interventions

• Obtain patient history, including drug history and any known allergies.
• Review C&S report as available.
• Monitor renal, liver, and GI function during therapy. Notify health care provider of any GI side effects.
• Observe for signs of superinfection during therapy (eg, yeast infections, black hairy tongue, itching in groin area).
• Monitor for bleeding in patients receiving concomitant oral anticoagulant therapy.
• Notify health care provider if signs and symptoms of anaphylaxis occur.

 Patient/Family Education

• Instruct patient to time doses for even distribution over a 24-hr period.
• Inform patient that the medication works best on empty stomach, but may be taken with food if there is GI upset.
• Instruct patient to take medication with full glass of water or noncitrus juice.
• Encourage patient to increase fluid intake to 2000 to 3000 mL/day, if not contraindicated.
• Instruct patient to notify health care provider if rash develops or difficult breathing occurs.
• Explain that antacids should be avoided while this medication is being taken.

Drug Mode of Action ::  

 Action Interferes with microbial protein synthesis.