Azithromycin
Azithromycin
Azithromycin
Zithromax, Zmax
Classification
Therapeutic: agents for atypical mycobacterium, anti-infectives
Pharmacologic: macrolides
Pregnancy Category B
= Genetic implication.
= Canadian drug name.
Copyright © 2011 by F.A. Davis Company
Indications
Treatment of the following infections due to susceptible organisms: Upper respiratory tract infections, including
streptococcal pharyngitis, acute bacterial exacerbations of chronic bronchitis and tonsillitis, Lower respiratory tract
infections, including bronchitis and pneumonia, Acute otitis media, Skin and skin structure infections, Nongonococcal
urethritis, cervicitis, gonorrhea, and chancroid. Prevention of disseminated Mycobacterium avium complex (MAC)
infection in patients with advanced HIV infection. Extended-release suspension (ZMax)Acute bacterial sinusitis and
community-acquired pneumonia in adults. Unlabelled Use: Prevention of bacterial endocarditis. Treatment of cystic
fibrosis lung disease.
Action
Inhibits protein synthesis at the level of the 50S bacterial ribosome. Therapeutic Effects: Bacteriostatic action against
susceptible bacteria. Spectrum: Active against the following gram-positive aerobic bacteria: : Staphylococcus aureus,
Streptococcus pneumoniae, Streptococcus pyogenes (group A strep). Active against these gram-negative aerobic
bacteria: Haemophilus influenzae , Moraxella catarrhalis , Neisseria gonorrhoeae . Also active against: : Mycoplasma,
Legionella, Chlamydia pneumoniae, Ureaplasma urealyticum, Borrelia burgdorferi, M. avium. Not active against
methicillin-resistantS. aureus.
Pharmacokinetics
Absorption: Rapidly absorbed (40%) after oral administration. IV administration results in complete bioavailability.
Distribution: Widely distributed to body tissues and fluids. Intracellular and tissue levels exceed those in serum; low
CSF levels.
Metabolism and Excretion: Mostly excreted unchanged in bile; 4.5% excreted unchanged in urine.
Half-life: 11–14 hr after single dose; 2–4 days after several doses; 59 hr after extended release suspension.
Contraindications/Precautions
Contraindicated in: Hypersensitivity to azithromycin, erythromycin, or other macrolide anti-infectives.
Use Cautiously in: Severe liver impairment (dose adjustment may be required); Severe renal impairment (CCr <10
mL/min); Myasthenia gravis (may worsen symptoms); OB/Lactation: Safety not established; Pedi: Safety not
established in children <5 yr.
Interactions
Drug-Drug: Aluminum- and magnesium-containing antacids ↓ peak levels. Nelfinavir ↑ levels (monitor carefully);
azithromycin also ↓ nelfinavir levels. Efavirenz ↑ levels. May ↑ the effects and risk of toxicity of warfarin and
zidovudine. Other macrolide anti-infectives have been known to ↑ levels and effects of digoxin, theophylline,
ergotamine, dihydroergotamine, triazolam, carbamazepine, cyclosporine, tacrolimus, and phenytoin; careful
monitoring of concurrent use is recommended.
Route/Dosage
Most Respiratory and Skin Infections
PO (Adults): 500 mg on 1st day, then 250 mg/day for 4 more days (total dose of 1.5 g); Acute bacterial sinusitis—500
mg once daily for 3 days or single 2 g dose of extended-release suspension (Zmax).
PO (Children ≥ 6 months): 10 mg/kg (not >500 mg/dose) on 1st day, then 5 mg/kg (not >250 mg/dose) for 4 more
days. Pharyngitis/tonsilitis—12 mg/kg once daily for 5 days (not >500 mg/dose); Acute bacterial sinusitis—10
mg/kg/day for three days.
Otitis media
PO (Children ≥6 mo): 30 mg/kg single dose (not >1500 mg/dose) or 10 mg/kg/day as a single dose (not >500
mg/dose) for 3 days or 10 mg/kg as a single dose (not >500 mg/dose) on 1st day, then 5 mg/kg as a single dose (not
>250 mg/dose)daily for 4 more days.
Acute bacterial exacerbations of chronic bronchitis
PO (Adults): 500 mg on 1st day, then 250 mg/day for 4 more days (total dose of 1.5 g) or 500 mg daily for 3 days.
Community-Acquired Pneumonia
IV, PO (Adults): More severe—500 mg IV q 24 hr for at least 2 doses, then 500 mg PO q 24 hr for a total of 7–10
days; less severe—500 mg PO, then 250 mg/day PO for 4 more days or 2 g single dose as extended-release suspension
(Zmax).
PO (Children >6 mo): 10 mg/kg on 1st day, then 5 mg/kg for 4 more days.
Pelvic Inflammatory Disease
IV, PO (Adults): 500 mg IV q 24 hr for 1–2 days, then 250 mg PO q 24 hr for a total of 7 days.
Endocarditis Prophylaxis
PO (Adults): 500 mg 1 hr before procedure.
PO (Children): 15 mg/kg 1 hr before procedure.
Nongonococcal Urethritis, Cervicitis, Chancroid, Chlamydia
PO (Adults): Single 1-g dose.
PO (Children): Chancroid: Single 20 mg/kg dose (not >1000 mg/dose).Urethritis or cervicitis:Single 10 mg/kg dose
(not >1000 mg/dose).
Gonorrhea
PO (Adults): Single 2-g dose.
Prevention of Disseminated MAC Infection
PO (Adults): 1.2 g once weekly (alone or with rifabutin).
PO (Children): 5 mg/kg once daily (not >250 mg/dose) or 20 mg/kg (not >1200 mg/dose) once weekly (alone or with
rifabutin).
Cystic Fibrosis
PO (Children ≥6 yrs, weight ≥25 kg to <40 kg): 250 mg q MWF. ≥40 kg: 500 mg q MWF.
NURSING IMPLICATIONS
Assessment
Assess patient for infection (vital signs; appearance of wound, sputum, urine, and stool; WBC) at beginning of
and throughout therapy.
Obtain specimens for culture and sensitivity before initiating therapy. First dose may be given before receiving
results.
Observe for signs and symptoms of anaphylaxis (rash, pruritus, laryngeal edema, wheezing). Notify health care
professional immediately if these occur.
Assess patient for skin rash frequently during therapy. Discontinue azithromycin at first sign of rash; may be
life-threatening. Stevens-Johnson syndrome or toxic epidermal necrolysis may develop. Treat symptomatically;
may recur once treatment is stopped.
Lab Test Considerations: May cause ↑ serum bilirubin, AST, ALT, LDH, and alkaline phosphatase
concentrations.
May cause ↑ creatine phosphokinase, potassium, prothrombin time, BUN, serum creatinine, and blood glucose
concentrations.
May occasionally cause ↓ WBC and platelet count.
Implementation
Do not confuse azithromycin with erythromycin.
Zmax extended release oral suspension is not bioequivalent or interchangeable with azithromycin oral
suspension .
PO: Administer 1 hr before or 2 hr after meals.
For administration of single 1-g packet, thoroughly mix entire contents of packet with 2 oz (60 mL) of water.
Drink entire contents immediately; add an additional 2 oz of water, mix and drink to assure complete
consumption of dose. Do not use the single packet to administer doses other than 1000 mg of azithromycin.
Pedi: 1-g packet is not for pediatric use.
For Zmax shake suspension well and drink entire contents of bottle. Use within 12 hrs of reconstitution. If
patient vomits within 1 hr of administration, contact prescriber for instructions. Zmax may be taken without
regard to antacids containing magnesium or aluminum hydroxide .
IV Administration
Intermittent Infusion: Diluent: Reconstitute each 500-mg vial with 4.8 mL of sterile water for injection to
achieve a concentration of 100 mg/mL. Reconstituted solution is stable for 24 hr at room temperature. Further
dilute the 500-mg dose in 250 mL or 500 mL of 0.9% NaCl, 0.45% NaCl, D5W, LR, D5/0.45% NaCl, or
D5/LR. Infusion is stable for 24 hr at room temperature or for 7 days if refrigeratedConcentration: Final
concentration of infusion is 1–2 mg/mL.
Rate: Administer the 1 mg/mL solution over 3 hr or the 2 mg/mL solution over 1 hr. Do not administer as a
bolus.
Y-Site Compatibility: amphotericin B liposome, bivalirudin, carboplatin, cisplatin, daptomycin,
dexmedetomidine, diphenhydramine, docetaxel, dolasetron, doripenem, droperidol, ertapenem, fenoldopam,
fluorouracil, hetastarch, mechlorethamine, meperidine, nesiritide, octreotide, ondansetron, oxaliplatin, oxytocin,
palonosetron, pantoprazole, pemetrexed, rocuronium, sodium acetate, thiotepa, tigecycline, tirofiban,
vasopressin, vincristine, voriconazole.
Y-Site Incompatibility: amikacin, aztreonam, cefotaxime, ceftazidime, ceftriaxone, cefuroxime, ciprofloxacin,
clindamycin, epirubicin, famotidine, fentanyl, furosemide, gentamicin, imipenem-cilastatin, ketorolac,
mitoxantrone, morphine, piperacillin-tazobactam, potassium chloride, quinupristin/dalfopristin, ticarcillin-
clavulanate, tobramycin.
Patient/Family Teaching
Instruct patients to take medication as directed and to finish the drug completely, even if they are feeling better.
Take missed doses as soon as possible unless almost time for next dose; do not double doses. Advise patients
that sharing of this medication may be dangerous.
Instruct patient not to take azithromycin with food or antacids.
May cause drowsiness and dizziness. Caution patient to avoid driving or other activities requiring alertness until
response to medication is known.
Advise patient to use sunscreen and protective clothing to prevent photosensitivity reactions.
Advise patient to report symptoms of chest pain, palpitations, yellowing of skin or eyes, or signs of
superinfection (black, furry overgrowth on the tongue; vaginal itching or discharge; loose or foul-smelling
stools) or rash.
Instruct patient to notify health care professional if fever and diarrhea develop, especially if stool contains blood,
pus, or mucus. Advise patient not to treat diarrhea without advice of health care professional.
Advise patients being treated for nongonococcal urethritis or cervicitis that sexual partners should also be treated.
Instruct parents, caregivers, or patient to notify health care professional if symptoms do not improve.
Pedi: Tell parents or caregivers that medication is generally well tolerated in children. Most common side effects
in children are mild diarrhea and rash. Tell parents to notify health care practitioner if these occur.
Evaluation/Desired Outcomes
Resolution of the signs and symptoms of infection. Length of time for complete resolution depends on the
organism and site of infection.