Azithromycin

748.98400

748.98

617-500-5

DTXSID8030760

Amorphous solid

2941500000

180.08000

1.83860

white crystalline powder

1.18 g/cm3

113-115 °C

822.1ºC at 760 mmHg

451ºC

1.536

In water, 2.37 mg/L at 25 °C (est)

Store at -20ºC

2.65X10-24 mm Hg at 25 °C (est)

LD50 oral in rat: > 2gm/kg

Henry's Law constant = 5.3X10-29 atm-cu m/mol at 25 °C (est)

pKa = 8.74

NONH for all modes of transport

2

42/43

22-36/37-45

RN6960000

Xi

Stable. Incompatible with strong oxidizing agents.

P261-P280-P342 + P311

H317-H334

SRP: Expired or waste pharmaceuticals shall carefully take into consideration applicable DEA, EPA, and FDA regulations. It is not appropriate to dispose by flushing the pharmaceutical down the toilet or discarding to trash. If possible return the pharmaceutical to the manufacturer for proper disposal being careful to properly label and securely package the material. Alternatively, the waste pharmaceutical shall be labeled, securely packaged and transported by a state licensed medical waste contractor to dispose by burial in a licensed hazardous or toxic waste landfill or incinerator.|SRP: Wastewater from contaminant suppression, cleaning of protective clothing/equipment, or contaminated sites should be contained and evaluated for subject chemical or decomposition product concentrations. Concentrations shall be lower than applicable environmental discharge or disposal criteria. Alternatively, pretreatment and/or discharge to a permitted wastewater treatment facility is acceptable only after review by the governing authority and assurance that "pass through" violations will not occur. Due consideration shall be given to remediation worker exposure (inhalation, dermal and ingestion) as well as fate during treatment, transfer and disposal. If it is not practicable to manage the chemical in this fashion, it must be evaluated in accordance with EPA 40 CFR Part 261, specifically Subpart B, in order to determine the appropriate local, state and federal requirements for disposal.

The Approved Drug Products with Therapeutic Equivalence Evaluations List identifies currently marketed prescription drug products, incl azithromycin, approved on the basis of safety and effectiveness by FDA under sections 505 of the Federal Food, Drug, and Cosmetic Act.

Langtry HD et al; Azithromycin. A Review of its Use in Pediatric Infectious Diseases; Drugs 56 (2): 273-97 (1998)

|Danger|H317 (98.36%): May cause an allergic skin reaction [Warning Sensitization, Skin]|P260, P261, P264, P270, P272, P273, P280, P285, P302+P352, P304+P341, P314, P321, P333+P313, P342+P311, P363, P391, and P501|Aggregated GHS information provided by 122 companies from 7 notifications to the ECHA C&L Inventory. Each notification may be associated with multiple companies.

Respiratory Protection: Where respirators are deemed necessary to reduce or control occupational exposures, use NIOSH-approved respiratory protection and have an effective respirator program in place. Gloves: Chemically compatible. For handling solutions, ensure that the glove material is protective against the solvent being used. Use handling practices that minimize direct hand contact. Employees who are sensitive to natural rubber (latex) should use nitrile or other synthetic nonlatex gloves. Use of powdered latex gloves should be avoided due to the risk of latex allergy. Eye Protection: Safety glasses with sideshields are recommended. Face shields or goggles may be required if splash potential exists or if corrosive materials are present. Approved eye protection (e.g., bearing the ANSI Z87 or CSA stamp) is preferred. Maintain eyewash facilities in the work area. Protective clothing: For handling of laboratory scale quantities, a cloth lab coat is recommended. Where significant quantities are handled, work clothing may be necessary to prevent take-home contamination.|Engineering controls such as exhaust ventilation are recommended.

As with all fires, evacuate personnel to a safe area. Firefighters should use self-contained breathing equipment and protective clothing.|Water spray, dry chemical, carbon dioxide or foam as appropriate for surrounding fire and materials.

Wear approved respiratory protection, chemically compatible gloves and protective clothing. Wipe up spillage or collect spillage using a high efficiency vacuum cleaner. Avoid breathing dust. Place spillage in appropriately labelled container for disposal. Wash spill site.

As a general rule, when handling USP Reference Standards avoid all contact and inhalation of dust, mists, and/or vapors associated with the material. Wash thoroughly after handling.|As with all dry powders it is advisable to ground mechanical equipment in contact with dry material to dissipate the potential buildup of static electricity.|SRP: Local exhaust ventilation should be applied wherever there is an incidence of point source emissions or dispersion of regulated contaminants in the work area. Ventilation control of the contaminant as close to its point of generation is both the most economical and safest method to minimize personnel exposure to airborne contaminants. Ensure that the local ventilation moves the contaminant away from the worker.|SRP: Contaminated protective clothing should be segregated in such a manner so that there is no direct personal contact by personnel who handle, dispose, or clean the clothing. The completeness of the cleaning procedures should be considered before the decontaminated protective clothing is returned for reuse by the workers. Contaminated clothing should not be taken home at the end of shift, but should remain at employee's place of work for cleaning.

Median concentrations of azithromycin were 170 ng/L in raw influents and 160 ng/L in tertiary effluents of conventional wastewater treatment employed in Zurich, Switzerland(1). The compound exhibited a 60% frequency of detection in the Ebro River Basin, Spain, input being traced to wastewater treatment plant effluents. Average concentrations found in June 2005 and November 2005 in river waters downstream from 7 wastewater treatment plants were reported as 68, 16, 9, 2, 23, 17, and 14 ng/L; the method detection limit = 1 ng/L(2). Azithromycin concentrations in sewage water effluents of the Netherlands in 2002 ranged from approximately 170 to 500 ng/L(3). Mean concentrations in effluent from a tertiary wastewater treatment facility located in the Los Angeles, CA metropolitan area were 124, 337, and 304 ng/L in July 2008, May 2009, and October 2009, respectively; reporting limit = 10 ng/L(4). Azithromycin was detected in 5 of 5 influent samples at a concentrations of (ng/L; date): 17, 8/9/02; 6, 9/22/06; 37, 12/18/06; 53, 2/9/07; and detected, not quantified, 3/8/07. The limit of detection was 1 ng/L. Concentrations in effluent samples were (ng/L; date): 6, 8/9/02; 12, 9/22/06; 35, 12/18/06; 30, 2/9/07; and detected, not quantified; 3/8/07. Sampling took place at a wastewater treatment plant in Kentucky serving a local community of approximately 15,000 with an additional influx of approximately 10,000 students, academic year 2006-2007(5).

Because concomitant use of pimozide and other macrolides (e.g., clarithromycin) has increased pimozide concentrations and is associated with a risk of prolonged QT interval and serious cardiovascular effects, the manufacturer of pimozide states that concomitant use of pimozide and macrolides (including azithromycin) is contraindicated.|Although specific drug interaction studies have not been performed with azithromycin, concomitant use with other macrolides has resulted in increased phenytoin concentrations. Therefore, the patient should be carefully monitored if azithromycin and phenytoin are used concomitantly.|Although the single-dose extended-release oral suspension of azithromycin may be taken without regard to antacids containing magnesium hydroxide and/or aluminum hydroxide, conventional oral azithromycin preparations (tablets or oral suspension) should not be administered simultaneously with aluminum- or magnesium-containing antacids. A study using azithromycin capsules (no longer commercially available) indicate that administration of oral azithromycin 500 mg with an aluminum- and magnesium hydroxide-containing antacid resulted in a decreased rate of absorption of azithromycin as evidenced by 24% reduction in peak serum azithromycin concentrations; however, the extent of azithromycin absorption (AUC) was unaffected.|Although specific drug interaction studies have not been performed with azithromycin, concomitant use with other macrolides has resulted in increased concentrations of ergot alkaloids (ergotamine, dihydroergotamine). Therefore, the patient should be carefully monitored if azithromycin and ergot alkaloids are used concomitantly.|For more Interactions (Complete) data for AZITHROMYCIN (14 total), please visit the HSDB record page.

LD50 Mice oral 3000-4000 mg/kg

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; or 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, aminodarone, sotalol) antiarrhythmic agents. Elderly patients may be more susceptible to drug-associated effects on the QT interval.|Because azithromycin is eliminated principally via the liver, the drug should be used with caution in patients with impaired hepatic function. In addition, because of limited data regarding use of azithromycin in patients with renal impairment, the drug should be used with caution in patients with glomerular filtration rates less than 10 mL/minute.|/The investigators/ report the case of a 25-year-old female patient with severe aggravation of myasthenia gravis due to azithromycin which was prescribed for an influenza syndrome. ... The close temporal relationship between the intake of azithromycin and severe worsening of myasthenia gravis in our patient suggests that azithromycin, a new azalid-antibiotic of the macrolid group, can exacerbate myasthenia gravis. /The investigators/ conclude that azithromycin should be added to the list of drugs to be used with caution in patients with myasthenia gravis.

Azithromycin's production and use as an antibiotic(1) may result in its release to the environment through various waste streams(SRC).

TERRESTRIAL FATE: Based on a classification scheme(1), an estimated Koc value of 3100(SRC), determined from a log Kow of 4.02(2) and a regression-derived equation(3), indicates that azithromycin is expected to have slight mobility in soil(SRC). The pKa of azithromycin is 8.74(2), indicating that this compound will exist almost entirely in the cation form in the environment and cations generally adsorb more strongly to soils containing organic carbon and clay than their neutral counterparts(4). Volatilization from moist soil is not expected because the compound exists as an cation and cations do not volatilize. Azithromycin is not expected to volatilize from dry soil surfaces(SRC) based upon an estimated vapor pressure of 2.6X10-24 mm Hg at 25 °C(SRC), determined from a fragment constant method(5). Biodegradation data in soil were not available(SRC, 2012).|AQUATIC FATE: Based on a classification scheme(1), an estimated Koc value of 3100(SRC), determined from a log Kow of 4.02(2) and a regression-derived equation(3), indicates that azithromycin is expected to adsorb to suspended solids and sediment(SRC). A pKa of 8.74(2) indicates azithromycin will exist almost entirely in the cation form at pH values of 5 to 9 and therefore volatilization from water surfaces is not expected to be an important fate process(SRC). According to a classification scheme(4), an estimated BCF of 200(SRC), from its log Kow(2) and a regression-derived equation(3), suggests the potential for bioconcentration in aquatic organisms is high, provided the compound is not metabolized by the organism(SRC). Azithromycin photodegradation followed first-order reaction kinetics in environmental waters under simulated solar radiation; in artificial freshwater (pH 6.8) the half-life was 7 hours(5). Biodegradation data in water were not available(SRC, 2012).|ATMOSPHERIC FATE: According to a model of gas/particle partitioning of semivolatile organic compounds in the atmosphere(1), azithromycin, which has an estimated vapor pressure of 2.6X10-24 mm Hg at 25 °C(SRC), determined from a fragment constant method(2), is expected to exist solely in the particulate phase in the ambient atmosphere. Particulate-phase azithromycin may be removed from the air by wet or dry deposition(SRC).

Azithromycin is expected to undergo hydrolysis in the environment due to the presence of functional groups that hydrolyze under environmental conditions(1). Azithromycin photodegradation followed first-order reaction kinetics in environmental waters under simulated solar radiation. A half-life of 20 hours was measured in HPLC water (pH 5.3), whereas in artificial freshwater (pH 6.8), the half-life was 7 hours. Addition of nitrate, humic acid, and nitrate with humic acid resulted in half-lives of 3.7, 1.2, and 1,1 hours, respectively. Six photoproducts were detected formed in part by the hydrolytic cleavages of the desosamine and/or cladinose residue(2).

An estimated BCF of 200 was calculated in fish for azithromycin(SRC), using a log Kow of 4.02(1) and a regression-derived equation(2). According to a classification scheme(3), this BCF suggests the potential for bioconcentration in aquatic organisms is high(SRC), provided the compound is not metabolized by the organism(SRC).

The Koc of azithromycin is estimated as 3100(SRC), using a log Kow of 4.02(1) and a regression-derived equation(2). According to a classification scheme(3), this estimated Koc value suggests that azithromycin is expected to have slight mobility in soil. The pKa of azithromycin is 8.74(1), indicating that this compound will exist almost entirely in the cation form in the environment and cations generally adsorb more strongly to soils containing organic carbon and clay than their neutral counterparts(4).|Using a 2.4 meter soil column, treated effluent was applied to the top of the column over 23 days, simulating a recharge condition similar to those in arid or semiarid climates. The soil used was a Mohall-Laveen sandy loam from an area northwest of Phoenix, AZ with no known history of cultivation or irrigation. Secondarily treated effluent from a 17.5 million gallon/day municipal waste water treatment plant serving 120,000-150,000 residents near Phoenix, AZ was employed. Azithromycin was not detected in the outflow of the column; reporting limit not determined(1). The compound was shown to absorb to suspended solids and sludge during waste water treatment plant processes; Kd values in activated sludge were 460 and 352 for October 2003 and February 2004, respectively, at municipal treatment facilities in Switzerland (a KD of 376 was reported for an unspecified field study)(2).

A pKa of 8.74(1) indicates azithromycin will exist almost entirely in the cation form at pH values of 5 to 9 and therefore volatilization from water surfaces is not expected to be an important fate process(SRC). Azithromycin is not expected to volatilize from dry soil surfaces(SRC) based upon an estimated vapor pressure of 2.6X10-24 mm Hg(SRC), determined from a fragment constant method(2).

GROUNDWATER: Azithromycin was not detected in a Lower Neosho River subbasin cave stream in northeastern Oklahoma sampled from May through July 2006; detection limit = 1.7 ng analyte/polar organic chemical integrative sampler(1).|SURFACE WATER: Azithromycin was detected at 77 ng analyte/polar organic chemical integrative sampler (POCIS) in an unnamed creek approximately 250 meters downstream from the outfall of a municipal wastewater treatment plant in northeastern Oklahoma sampled from May through July 2006; detection limit = 1.7 ng analyte/POCIS(1). The compound was detected at a concentration of 6 ng/L from a sample from Bee Creek, downstream from a wastewater treatment plant in Kentucky serving a local community of approximately 15,000 with an additional influx of approximately 10,000 students, academic year 2006-2007(2). Azithromycin exhibited a 0% frequency of detection in 16 samples from Canadian waters and the Great Lakes(3). Azithromycin concentrations in surface water of the Netherlands between 1996 and 2005 ranged from approximately 15 to 60 ng/L(4).

Azithromycin has been detected in human milk.

Occupational exposure to azithromycin may occur through inhalation and dermal contact with this compound at workplaces where azithromycin is produced or administered. Monitoring data indicate that the general population may be exposed to azithromycin via dermal contact with water. Exposure to azithromycin among the general population will also occur among those administered the drug, an antibiotic. (SRC)

Anti-Bacterial Agents|Azithromycin is used orally in children for the treatment of acute otitis media (AOM) caused by Haemophilus influenzae, M. catarrhalis, or S. pneumoniae. /Included in US product labeling/|Azithromycin is used orally for the treatment of pharyngitis and tonsillitis caused by Streptococcus pyogenes (group A beta-hemolytic streptococci) in adults and children when first-line therapy (penicillins) cannot be used. /Included in US product labeling/|Although further study is needed, azithromycin has been used in conjunction with an antimalarial agent (e.g., chloroquine, quinine, artesunate [not commercially available in the US]) for the treatment of uncomplicated malaria caused by Plasmodium falciparum, including multidrug-resistant strains. Azithromycin should not be used alone as monotherapy for the treatment of malaria. /NOT included in US product labeling/|For more Therapeutic Uses (Complete) data for AZITHROMYCIN (52 total), please visit the HSDB record page.

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; or 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, aminodarone, sotalol) antiarrhythmic agents. Elderly patients may be more susceptible to drug-associated effects on the QT interval.|Pregnancy risk category: B /NO EVIDENCE OF RISK IN HUMANS. Adequate, well controlled studies in pregnant women have not shown increased risk of fetal abnormalities despite adverse findings in animals, or, in the absents of adequate human studies, animal studies show no fetal risk. The chance of fetal harm is remote but remains a possibility./|The most frequent adverse effects of azithromycin involve the GI tract (i.e., diarrhea/loose stools, nausea, abdominal pain). While these adverse effects generally are mild to moderate in severity and occur less frequently than with oral erythromycin, adverse GI effects are the most frequent reason for discontinuing azithromycin therapy. Administration of conventional azithromycin tablets or oral suspension with food may improve GI tolerability.|Azithromycin has been detected in human milk. The drug should be used with caution in nursing women.|For more Drug Warnings (Complete) data for AZITHROMYCIN (30 total), please visit the HSDB record page.

Streptococci and staphylococci that are resistant to erythromycin also are resistant to azithromycin and clarithromycin. MAC isolates resistant to azithromycin also are resistant to clarithromycin and complete cross-resistance occurs between these anti-infectives for this organism. Cross-resistance in these isolates appears to be the result of a single point mutation at the position that is homologous to the Escherichia coli positions 2058 or 2059 on the 23S rRNA gene.10 MAC isolates exhibiting cross-resistance generally have an increase in azithromycin MICs to 128 ug/mL or greater or clarithromycin MICs to 32 ug/mL or greater (determined using a radiometric broth dilution susceptibility test with Middlebrook 7H12 medium). Although the clinical importance of cross-resistance between azithromycin and clarithromycin is not fully understood, preclinical data suggest that reduced activity to both drugs will occur after MAC isolates produce the 23S rRNA mutation.|Macrolide-resistant Mycobacterium avium complex (MAC) isolates have been detected in patients with disseminated MAC infections receiving macrolide (i.e., azithromycin, clarithromycin) therapy. In studies evaluating prevention of disseminated MAC disease, drug-resistant isolates were detected in 29-58% of individuals in whom disease developed while receiving clarithromycin and 11% of those receiving azithromycin.|In 1999, Neisseria gonorrhoeae with reduced susceptibility to azithromycin were isolated from a cluster of 12 men with gonorrhea in Kansas City, MO. These isolates had a median azithromycin MIC of 2 ug/mL (range: 1-4 ug/mL) and also were resistant to tetracycline (MIC 1-2 ug/mL); however, they were susceptible to ceftriaxone, cefixime, spectinomycin, ciprofloxacin, and penicillin. A mutation in Treponema pallidum that confers resistance to macrolides (including azithromycin) has been identified. T. pallidum containing this mutation has been isolated from several syphilis patients in San Francisco who failed to respond to azithromycin treatment. The overall prevalence of this mutation in T. pallidum has not been determined, but it has been found in specimens obtained in the US (Baltimore, San Francisco, Seattle) and Ireland (Dublin).|The overall incidence of macrolide-resistant Streptococcus pyogenes (group A beta-hemolyte streptococci) in the US is reported to be 3-9%.309 In one US study, about 7% of S. pyogenes isolates (principally pharyngeal isolates) were resistant to azithromycin.

Biliary excretion of azithromycin, predominantly as unchanged drug is a major route of elimination following oral administration.|Azithromycin is rapidly absorbed from the GI tract after oral administration; absorption of the drug is incomplete but exceeds that of erythromycin. The absolute oral bioavailability of azithromycin is reported to be approximately 34-52% with single doses of 500 mg to 1.2 g administered as various oral dosage forms. Limited evidence indicates that the low bioavailability of zithromycin results from incomplete GI absorption rather acid degradation of the drug or extensive first-pss metabolism.|Azithromycin appears to be distributed into most body tissues and fluids after oral or IV administration. The extensive tissue uptake of azithromycin has been attributed to cellular uptake of this basic antibiotic into relatively acidic lysosomes as a result of iron trapping and to an energy-dependent pathway associated with the nucleoside transport system.|Because of rapid distribution into tissues and high intracellular concentrations of azithromycin, tissue concentrations of the drug generally exceed plasma concentrations by 10- to 100-fold following single dose administration; with multiple dosing, the tissue-to-plasma ratio increases.|For more Absorption, Distribution and Excretion (Complete) data for AZITHROMYCIN (10 total), please visit the HSDB record page.

The principal route of biotransformation involves N-demethylation of the desosamine sugar or at the 9a position on the macrolide ring. Other metabolic pathways include O-demethylation and hydrolysis and/or hydroxylation of the cladinose and desosamine sugar moieties and the macrolide ring. Up to 10 metabolites of azithromycin have been identified, and all are microbiologically inactive. While short-term administration of azithromycin produces hepatic accumulation of the drug and increases azithromycin demethylase activity, current evidence indicates that hepatic cytochrome p450 induction of inactivation via cytochrome-metabolite complex formation does not occur. In contrast to erythromycin, azithromycin does not inhibit its own metabolism via this pathway.

An elimination half-life of 54.5 hours has been reported in children 4 months to 15 years of age receiving single or multiple oral doses of azithromycin.|Plasma azithromycin concentrations following a single 500-mg oral or IV dose decline in a polyphasic manner with a terminal elimination half-life averaging 68 hours. The high values for apparent steady-state volume of distribution (31.3-33.3 L/kg) and plasma clearance (630 mL/minute, 10.18 mL/minute per kg) of azithromycin suggest that the prolonged half-life is related to extensive uptake and subsequent release of the drug from tissues. The average tissue half-life of azithromycin is estimated to be 1-4 days. The half-life of the drug in peripheral leukocytes ranges from 34-57 hours.

Azithromycin usually is bacteriostatic, although the drug may be bactericidal in high concentrations against selected organisms. Bactericidal activity has been observed in vitro against Streptococcus pyogenes, S. pneumoniae, and Haemophilus influenzae. Azithromycin inhibits protein synthesis in susceptible organisms by penetrating the cell wall and binding to 50S ribosomal subunits, thereby inhibiting translocation of aminoacyl transfer-RNA and inhibiting polypeptide synthesis. The site of action of azithromycin appears to be the same as that of the macrolides (i.e., erythromycin, clarithromycin), clindamycin, lincomycin, and chloramphenicol. The antimicrobial activity of azithromycin is reduced at low pH. Azithromycin concentrates in phagocytes, including polymorphonuclear leukocytes, monocytes, macrophages, and fibroblasts. Penetration of the drug into phagocytic cells is necessary for activity against intracellular pathogens (e.g., Staphylococcus aureus, Legionella pneumophila, Chlamydia trachomatis, Salmonella typhi).

Emergency and supportive measures: Maintain an open airway and assist ventilation if necessary. Treat coma, seizures, hypotension, anaphylaxis, and hemolysis if they occur. Replace fluid losses resulting from gastroenteritis with intravenous crystalloids. /Antibacterial agents/|Decontamination: Administer activated charcoal orally if conditions are appropriate. Gastric lavage is not necessary after small to moderate ingestions if activated charcoal can be given promptly. /Antibacterial agents/|Enhanced elimination: Most antibiotics are excreted unchanged in the urine, so maintenance of adequate urine flow is important. The role of forced diuresis is unclear. Hemodialysis is not usually indicated, except perhaps in patients with renal dysfunction and a high level of a toxic agent. /Antibacterial agents/|/SRP:/ Immediate first aid: Ensure that adequate decontamination has been carried out. If patient is not breathing, start artificial respiration, preferably with a demand valve resuscitator, bag-valve-mask device, or pocket mask, as trained. Perform CPR if necessary. Immediately flush contaminated eyes with gently flowing water. Do not induce vomiting. If vomiting occurs, lean patient forward or place on the left side (head-down position, if possible) to maintain an open airway and prevent aspiration. Keep patient quiet and maintain normal body temperature. Obtain medical attention. /Poisons A and B/|For more Antidote and Emergency Treatment (Complete) data for AZITHROMYCIN (6 total), please visit the HSDB record page.

/SIGNS AND SYMPTOMS/ Serious hypersensitivity reactions, including angioedema, anaphylaxis, and dermatologic reactions, have occurred rarely in patients receiving azithromycin. Fatalities have been reported.|/CASE REPORTS/ /The investigators/ report the case of a 25-year-old female patient with severe aggravation of myasthenia gravis due to azithromycin which was prescribed for an influenza syndrome. One hour after the intake of 500 mg azithromycin the patient developed weakness of the legs and respiratory distress due to respiratory muscle failure. She was hospitalized in a comatose state and required intubation and mechanical ventilation for six days. Acute worsening of myasthenia gravis was observed in this patient in 1986 after parenteral administration of erythromycin. Erythromycin causing aggravation of myasthenia gravis by interfering with neuromuscular transmission is reported in the literature. The close temporal relationship between the intake of azithromycin and severe worsening of myasthenia gravis in our patient suggests that azithromycin, a new azalid-antibiotic of the macrolid group, can exacerbate myasthenia gravis. /The investigators/ conclude that azithromycin should be added to the list of drugs to be used with caution in patients with myasthenia gravis.|/CASE REPORTS/ Vanishing bile duct syndrome is a severe cholestatic disease associated with toxic effects of medications. Stevens-Johnson syndrome is a hypersensitivity disorder that may also be caused by medications. We present a case of a 62-year-old male patient who developed vanishing bile duct syndrome a month after Stevens-Johnson syndrome. These adverse drug reactions were associated with the use of azithromycin (500 mg daily for 3 days). The patient was initially treated for Stevens-Johnson syndrome with steroids, antihistamines and proton pump inhibitors and fully recovered. However, a month after the beginning of Stevens-Johnson syndrome, he developed vanishing bile duct syndrome and was treated with steroids, ursodeoxycholic acid, antihistamines and tacrolimus. Unfortunately, the treatment was unsuccessful and he was listed for liver transplantation which was performed 7 months after the beginning of jaundice. ...|/CASE REPORTS/ ... A case of an elderly patient with idiopathic dilated cardiomyopathy who developed a significative prolongation of the QT interval after two days of treatment with azithromycin for a community-acquired pneumonia /is reported/. QT prolongation is associated with a high risk of serious ventricular tachyarrhythmias. Three days after discontinuation of azithromycin, QT interval returned to the normal value.|For more Human Toxicity Excerpts (Complete) data for AZITHROMYCIN (6 total), please visit the HSDB record page.

Table: Azithromycin Dihydrate Preparations [Table#6834]

Analyte: Azithromycin; matrix: tears; procedure: high performance liquid chromatography|Analyte: Azithromycin; matrix: blood, tissue; procedure: high performance liquid chromatography; limit of detection: 100 ng/g (tissue)|Analyte: Azithromycin; matrix: blood, gastric juice, gastric mucosa, saliva, vitreous humor; procedure: high performance liquid chromatography; limit of detection: 10 ng/mL|Analyte: Azithromycin; matrix: blood, bronchoalveolar lavage fluid; procedure: high performance liquid chromatography; limit of detection: 2 ng/ml (BAL and leucocytes), 10 ng/mL (serum)|For more Analytic Laboratory Methods (Complete) data for AZITHROMYCIN (16 total), please visit the HSDB record page.