azithromycin (Rx)

Brand and Other Names:Zithromax, Zmax
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

powder for solution

  • 500mg
  • 2.5g

suspension reconstituted

  • 100mg/5mL
  • 200mg/5mL

packet

  • 1g

tablet

  • 250mg
  • 500mg
  • 600mg
more...

Acute Bacterial Exacerbations of Chronic Obstructive Pulmonary Disease

500 mg PO once, then 250 mg once daily for 4 days

Alternatively, 500 mg PO qDay for 3 days

Acute Otitis Media

500 mg PO once, then 250 mg once daily for 4 days

Genital Ulcer Disease (Chancroid)

1 g PO once

Acute Bacterial Sinusitis

500 mg/day PO for 3 days or 2 g PO once

Community-Acquired Pneumonia

500 mg PO once, then 250 mg once daily for 4 days

2 g extended release suspension PO once

500 mg IV as single dose for at least 2 days; follow with oral therapy with single dose of 500 mg to complete 7-10 days course of therapy

Pharyngitis/Tonsillitis

500 mg PO once, then 250 mg once daily for 4 days

Alternatively, 12 mg/kg PO; not to exceed 500 mg on day 1 followed by 6 mg/kg; not to exceed 250 mg on days 2 through 5

Uncomplicated Skin/Skin Structure Infections

500 mg PO once, then 250 mg once daily for 4 days

Cat Scratch Disease

>45.5 kg: 500 mg PO once, then 250 mg once daily for 4 days

Pertussis (Off-label)

500 mg PO once, then 250 mg once daily for 4 days

Acute Pelvic Inflammatory Disease

500 mg IV over 1 hour once daily for 1-2 days; follow therapy by oral route with 250 mg qDay for 5 days to complete a 7 day therapy

Uncomplicated Gonococcal Infections

Infection of pharynx, cervix, urethra, or rectum: Ceftriaxone 250 mg IM once plus azithromycin 1 g PO once (preferred) or alternatively doxycycline 100 mg PO q12hr for 7 days

CDC STD guidelines: MMWR Recomm Rep. June 5, 2015:64(RR3);1-137

Sexual assault

  • Prophylaxis of sexually transmitted diseases (STDs) such as gonorrhea after sexual assault per CDC guidelines includes the following 3-drug regimen:
  • Ceftriaxone 250 mg IM once PLUS
  • Azithromycin 1 g PO once PLUS
  • Metronidazole or tinidazole 2 g PO once
  • If alcohol has been recently ingested or emergency contraception is provided, metronidazole or tinidazole can be taken by the victim at home rather than as directly observed therapy to avoid drug interactions

Mycobacterium Avium Complex Infection

Prevention

  • Primary prophylaxis: 1.2 g PO once weekly or 600 mg PO twice weekly; with or without rifabutin 300 mg once daily
  • Secondary prophylaxis: 500-600 mg PO qDay in combination with ethambutol

Treatment

  • 250 mg PO once daily in combination with ethambutol 15 mg/kg/day with or without rifabutin 300 mg/day
  • Alternative regimen: 500 mg PO 3 times weekly in combination with ethambutol 15 mg/kg/day with or without rifabutin 300 mg/day

Endocarditis (Off-label)

Prophylaxis

500 mg PO 30-60 min before procedure

Current American Heart Association (AHA) guidelines recommend only for high-risk patients

Dosing Considerations

Not for use in patients with pneumonia judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors

Susceptible organisms

  • Actinobacillus actinomycetemcomitans, Actinomyces israelii, Actinomyces naeslundii, Actinomyces odontolyticus, Afipia felis, Arachnia propionica, Arcanobacterium (Corynebacterium) haemolyticum, Bartonella henselae, Bartonella quintana, Bordetella pertussis, Borrelia burgdorferi, Borrelia recurrentis, Klebsiella granulomatis, Campylobacter jejuni, Chlamydia pneumoniae (TWAR agent), Chlamydia trachomatis, Haemophilus ducreyi, Haemophilus influenzae, Legionella spp, Mycobacterium simiae, Mycobacterium scrofulaceum, Mycobacterium xenopi, Mycoplasma pneumoniae, Moraxella (Branhamella) catarrhalis, Neisseria gonorrhoeae, Staphylococcus aureus, Streptococcus (group C and G), Streptococcus agalactiae (group B), Streptococcus bovis (group D), Streptococcus intermedius group (Streptococcus anginosus, Streptococcus intermedius, Streptococcus constellatus), Streptococcus pneumoniae, Streptococcus pyogenes (group A), viridans streptococci
  • First-line therapy: A felis, B henselae, B quintana, B pertussis, C jejuni, C pneumoniae (TWAR agent), C trachomatis, H ducreyi, H influenzae, Legionella spp, M scrofulaceum, M simiae, M xenopi, N gonorrhoeae

Dosage Forms & Strengths

oral suspension

  • 100mg/5mL
  • 200mg/5mL

powder for solution

  • 500mg
  • 2.5g

suspension reconstituted

  • 100mg/5mL
  • 200mg/5mL

packet

  • 1g

tablet

  • 250mg
  • 500mg
  • 600mg
more...

Acute Otitis Media

<6 months: Safety and efficacy not established

≥6 months: 30 mg/kg of oral suspension once or 10 mg/kg PO once daily for 3 days or 10 mg/kg once on day 1 followed by 5 mg/kg on days 2-5 

Community-Acquired Pneumonia

<6 months: Safety and efficacy not established

≥6 months: 10 mg/kg PO on day 1, followed by 5 mg/kg PO on days 2 through 5 

≥6 months (Zmax): 60 mg/kg PO once; not to exceed 2 g

Cat Scratch Disease (Off-label)

<45.5 kg: 10 mg/kg PO as single dose; then 5 mg/kg PO qDay on days 2 through 5

>45.5 kg: 500 mg PO once, then 250 mg once daily for 4 days

Acute Bacterial Sinusitis

Zmax: 2g PO once

10 mg/kg of oral suspension PO once daily for 3 days 

Pharyngitis/Tonsillitis

<2 years: Safety and efficacy not established

≥2 years: 12 mg/kg PO once daily for 5 days; not to exceed 500 mg/day 

Chlamydia Trachomatis Infection (Off-label)

>45 mg/kg: 1 g PO as single dose

Mycobacterium Avium Complex Infection

Prophylaxis

<6 years: Safety and efficacy not established

≥6 years primary prophylaxis: 20 mg/kg PO once weekly; not to exceed 1200 mg or 5mg/kg/day qDay; not to exceed 250 mg/day

≥6 years secondary prophylaxis: 5 mg/kg/day PO qDay; not to exceed 250 mg/day in cimbination with ethambutol with or without rifabutin

Treatment: 10-12 mg/kg/day PO; not to exceed 500 mg; used in combination with ethambutol; if severe disease patient should also receive rifabutin

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Interactions

Interaction Checker

and azithromycin

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    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            High single dose therapy

            • Diarrhea (52.8%)
            • Nausea (32.6%)
            • Abdominal pain (27%)
            • Loose stool (19.1%)

            1-10%

            Cramping (2-10%)

            Vaginitis (2-10%)

            Dyspepsia (9% with single high dose therapy)

            Flatulence (9% with single high dose therapy)

            Vomiting (6.7% with single high dose therapy)

            Malaise (1.1%)

            <1%

            Agitation

            Allergic reaction

            Anemia

            Anorexia

            Candidiasis

            Chest pain

            Conjunctivitis

            Constipation

            Dermatitis (fungal)

            Dizziness

            Eczema

            Edema

            Enteritis

            Facial edema

            Fatigue

            Gastritis

            Headache

            Hyperkinesia

            Hypotension

            Increased cough

            Insomnia

            Leukopenia

            Malaise

            Melena

            Mucositis

            Nervousness

            Oral candidiasis

            Pain

            Palpitations

            Pharyngitis

            Pleural effusion

            Pruritus

            Pseudomembranous colitis

            Rash

            Rhinitis

            Seizures

            Somnolence

            Urticaria

            Vertigo

            Postmarketing Reports

            Anaphylaxis

            Angioedema

            Anorexia

            Bronchospasm

            Constipation

            Dermatologic reactions

            Dyspepsia

            Elevated liver enzymes

            Erythema multiforme

            Flatulence

            Oral candidiasis

            Pancreatitis

            Pseudomembranous colitis

            Pyloric stenosis, rare reports of tongue discoloration

            Stevens-Johnson syndrome

            Torsades de pointes

            Toxic epidermal necrolysis

            Vomiting/diarrhea, rarely resulting in dehydration

            Neutropenia

            Elevated bilirubin, AST, ALT, BUN, creatinine

            Alterations in potassium

            Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)

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            Warnings

            Contraindications

            Documented hypersensitivity

            History of cholestatic jaundice or hepatic impairment associated with prior azithromycin use

            Coadministration with pimozide

            Cautions

            Use with caution in 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

            Injection-site reactions can occur with IV route

            In treatment of gonorrhea or syphilis, perform susceptibility culture tests before initiating azithromycin therapy; may mask or delay symptoms of incubating gonorrhea or syphilis.

            Bacterial or fungal superinfection may result from prolonged use

            Prolonged QT interval: Cases of torsades de pointes have been reported during postmarketing surveillance; use with caution in patients with known QT prolongation, history of torsades de pointes, congenital long QT syndrome, bradyarrhythmias, or uncompensated heart failure; also use with caution if coadministering with drugs that prolong QT interval or proarrhythmic conditions (eg, hypokalemia, hypomagnesemia); elderly patients may be more susceptible to drug-associated effects on QT interval

            Pneumonia: PO azithromycin is safe and effective only for community-acquired pneumonia (CAP) due to C pneumoniae, H influenzae, M pneumoniae, or S pneumoniae

            Cases of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) reported; despite successful symptomatic treatment of allergic symptoms, when symptomatic therapy was discontinued, allergic symptoms recurred soon thereafter in some patients without further azithromycin exposure; if allergic reaction occurs, the drug should be discontinued and appropriate therapy instituted; physicians should be aware that allergic symptoms may reappear when symptomatic therapy discontinued

            Endocarditis prophylaxis: Indicated only for high-risk patients, per current AHA guidelines

            Use caution in renal impairment (CrCl <10 mL/min)

            Use with caution in patients with myasthenia gravis (exacerbation may occur)

            Immediate release and extended release suspensions are not interchangeable

            Use extended release suspension only for treatment of infections that are proven or strongly suspected to be caused by susceptible bacteria

            Clostridium difficile associated diarrhea (CDAD) reported and may range in severity from mild diarrhea to fatal colitis; treatment with antibacterial agents alters the normal flora of colon leading to overgrowth of Clostridium difficile

            Serious allergic reactions, including angioedema, anaphylaxis, and dermatologic reactions including Stevens-Johnson Syndrome, and toxic epidermal reported ; if allergic reaction occurs, drug should be discontinued and appropriate therapy instituted; physicians should be aware that allergic symptoms may reappear after symptomatic therapy has been discontinued

            Following use in neonates (treatment up to 42 days of life), infantile hypertrophic pyloric stenosis reported; direct parents and caregivers to contact physician if vomiting or irritability with feeding occurs

            Prescribing antibiotics in absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to patient and increases risk of development of drug-resistant bacteria

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            Pregnancy & Lactation

            Pregnancy category: B

            Lactation: Unknown whether drug is excreted into breast milk; use with caution

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Binds to 50S ribosomal subunit of susceptible microorganisms and blocks dissociation of peptidyl tRNA from ribosomes, causing RNA-dependent protein synthesis to arrest; does not affect nucleic acid synthesis

            Concentrates in phagocytes and fibroblasts, as demonstrated by in vitro incubation techniques; in vivo studies suggest that concentration in phagocytes may contribute to drug distribution to inflamed tissues

            Absorption

            Rapidly absorbed

            Bioavailability: 37%; variable effect with food (increased with oral suspension, unchanged with tablet)

            Peak serum time: 2-3 hr (immediate release); 5 hr (extended release)

            Distribution

            Extensively distributed into skin, lungs, sputum, tonsils, and cervix; penetrates cerebrospinal fluid (CSF) poorly

            Protein bound: 7-50% (concentration dependent)

            Vd: 33.3 L/kg (PO); 31.1 L/kg (IV)

            Metabolism

            Metabolized in liver

            Elimination

            Half-life: ~70 hr (immediate release); 59 hr (extended release)

            Excretion: Feces (50% as unchanged drug), urine (5-12%)

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            Administration

            IV Incompatibilities

            Y-site: Amikacin, aztreonam, cefotaxime, ceftazidime, ceftriaxone, cefuroxime, ciprofloxacin, clindamycin, droperidol, famotidine, fentanyl, furosemide, gentamicin, imipenem, cilastatin, ketorolac, levofloxacin, morphine, piperacillin-tazobactam, ondansetron(?), potassium chloride, ticarcillin-clavulanate, tobramycin

            IV Compatibilities

            Solution (partial list): SWI, D5W, LR, D5/LR, D5/½NS, NS, ½NS

            Y-site: Bivalirudin, dexmedetomidine, diphenhydramine, dolasetron, droperidol

            IV Preparation

            Dilute 500-mg vial in 4.8 mL of SWI (100 mg/mL)

            Dilute further in NS to 1 mg/mL (500 mL) or 2 mg/mL (250 mL)

            IV Administration

            Use standard syringe

            1 mg/mL solution: Infuse over 3 hours

            2 mg/mL solution: Infuse over 1 hour

            Oral Administration

            Tablet: Take tablets without regard to food; however, food may enhance tolerability

            Oral suspension

            • Conventional oral suspension (100 mg/5 mL, 200 mg/5 mL) may be stored for 10 days after reconstitution and taken without regard to food
            • Conventional 1 g package must be taken immediately after reconstitution
            • Extended-release oral suspension must be taken on empty stomach within 12 hours of reconstitution; given only in single dose; not interchangeable with immediate release formulation
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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

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            • View the formulary and any restrictions for each plan.
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            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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