Source: Web Search Revision Year: 2022
Serious allergic reactions, including angio-oedema, anaphylaxis and dermatologic reactions (including acute generalised exanthematous pustulosisn, Stevens-Johnson syndrome, toxic epidermal necrolysis and DRESS syndrome [drug reaction with eosinophilia and systemic symptoms]) have been reported rarely in patients on azithromycin therapy.
Fatalities have been reported. Despite initially successful symptomatic treatment of the allergic symptoms, when symptomatic therapy was discontinued, the allergic symptoms recurred soon thereafter in some patients without further azithromycin exposure. These patients required prolonged periods of observation and symptomatic treatment. The relationship of these episodes to the long tissue half-life of azithromycin and subsequent prolonged exposure to antigen is unknown at present.
If an allergic reaction occurs, the drug should be discontinued and appropriate therapy should be instituted. Physicians should be aware that reappearance of the allergic symptoms may occur when symptomatic therapy is discontinued.
Abnormal liver function, hepatitis, cholestatic jaundice, hepatic necrosis and hepatic failure have been reported, some of which have resulted in death. Discontinue azithromycin immediately if signs and symptoms of hepatitis occur.
Cases of fulminant hepatitis potentially leading to life-threatening liver failure have been reported with azithromycin. Some patients may have had pre-existing hepatic disease or may have been taking other hepatotoxic medicinal products.
In case of signs and symptoms of liver dysfunction, such as rapid developing asthenia associated with jaundice, dark urine, bleeding tendency or hepatic encephalopathy, liver function tests/investigations should be performed immediately. Azithromycin administration should be stopped if liver dysfunction has emerged.
Pseudomembranous colitis has been reported following use of macrolide antibiotics; this diagnosis should, therefore, be taken into consideration in patients who develop diarrhoea after starting treatment with azithromycin.
Following the use of azithromycin in neonates (treatment up to 42 days of life), IHPS has been reported. Direct parents and carers to contact the treating physician if vomiting or irritability with feeding occurs.
The concurrent use of ergot alkaloids and macrolide antibiotics has been found to accelerate the development of ergotism. The interactions between ergot alkaloids and azithromycin have not been studied. The development of ergotism is, however, possible; hence, azithromycin and ergot alkaloid derivatives should not be administered simultaneously.
CDAD has been reported with the use of nearly all antibacterial agents, including azithromycin, and may range in severity from mild diarrhoea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon, leading to overgrowth of Clostridium difficile.
Clostridium difficile produces toxins A and B, which contribute to the development of CDAD. Hypertoxin-producing strains of Clostridium difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhoea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over 2 months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against Clostridium difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of Clostridium difficile, and surgical evaluation should be instituted as clinically indicated.
Prolonged cardiac repolarisation 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
Elderly patients and women may be more susceptible to drug-associated effects on the QT interval.
Exacerbation of symptoms of myasthenia gravis and new onset of myasthenic syndrome have been reported in patients receiving azithromycin therapy.
Azithromycin, at the recommended dose, should not be relied upon to treat syphilis. Antibacterial agents used to treat non-gonococcal urethritis may mask or delay the symptoms of incubating syphilis. All patients with sexually transmitted urethritis or cervicitis should have a serologic test for syphilis and appropriate testing for gonorrhea performed at the time of diagnosis. Appropriate antibacterial therapy and follow-up tests for these diseases should be initiated if infection is confirmed.
As with any antibiotic preparation, observation for signs of superinfection with nonsusceptible organisms, including fungi, is recommended.
Prescribing azithromycin in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
The following should be considered before prescribing azithromycin:
Azithromycin film-coated tablets are not suitable for the treatment of severe infections where a high concentration of the antibiotic in the blood is rapidly needed. As for other macrolides, high resistance rates of Streptococcus pneumoniae have been reported for azithromycin in some European countries. This should be taken into account when treating infections caused by Streptococcus pneumoniae.
The main causative agent of soft tissue infections, Staphylococcus aureus is frequently resistant to azithromycin. Therefore, susceptibility testing is considered a precondition for treatment of soft tissue infections with azithromycin.
Azithromycin is not the substance of first choice for the treatment of pharyngitis and tonsillitis caused by Streptococcus pyogenes. For this and for the prophylaxis of acute rheumatic fever, penicillin is the treatment of first choice.
Often, azithromycin is not the substance of first choice for the treatment of sinusitis.
Often, azithromycin is not the substance of first choice for the treatment of acute otitis media.
Azithromycin is not indicated for the treatment of infected burn wounds. Sexually Transmitted Diseases In case of sexually transmitted diseases a concomitant infection by T. pallidum should be excluded.
Azithromycin should be administered with caution to patients suffering from neurological or psychiatric diseases.
There is no experience regarding the safety and efficacy of long-term use of azithromycin for the mentioned indications. In case of rapid recurrent infections, treatment with another antibiotic should be considered. Due to cross-resistance existing among macrolides, in areas with a high incidence of erythromycin resistance, it is especially important to take into consideration the evolution of the pattern of susceptibility to azithromycin and other macrolides. Azithromycin is not the first choice for the empirical treatment of infections in areas where the prevalence of resistant isolates is 10% or more.
Safety and efficacy for the prevention or treatment of Mycobacterium avium complex in children have not been established.
This Medicinal Product Contains Soya Oil
Azithromycin contains soya oil. Patients who are allergic to peanut or soya must not use this medicinal product. Azithromycin contains less than 1 mmol sodium (23 mg) per tablet, i.e. it is essentially ‘sodium-free’.
Azithromycin tablets and oral suspension can be taken with or without food.
Patients should also be cautioned not to take aluminium- and magnesium-containing antacids and azithromycin simultaneously.
The patient should be directed to discontinue azithromycin immediately and contact a physician if any signs of an allergic reaction occur.
Patients should be counselled that antibacterial drugs, including azithromycin, should only be used to treat bacterial infections. They do not treat viral infections (e.g. the common cold). When azithromycin is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of the therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment, and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by azithromycin or other antibacterial drugs in the future.
Diarrhoea is a common problem caused by antibiotics, which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as 2 or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.
No studies on the effects on the ability to drive and use machines have been performed. However, the possibility of undesirable effects such as dizziness and convulsions should be taken into account when performing these activities.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice
In clinical trials, most of the reported side effects were mild to moderate in severity and were reversible upon discontinuation of the drug. Potentially serious side effects of angiooedema and cholestatic jaundice were reported rarely. Approximately 0.7% of the patients (adults and paediatric patients) from the 5-day multiple-dose clinical trials discontinued azithromycin therapy because of treatment-related side effects. In adults given 500 mg/day for 3 days, the discontinuation rate due to treatment-related side effects was 0.6%. In clinical trials in paediatric patients given 30 mg/kg, either as a single dose or over 3 days, discontinuation from the trials due to treatment-related side effects was approximately 1%. Most of the side effects leading to discontinuation were related to the gastrointestinal tract, e.g. nausea, vomiting, diarrhoea or abdominal pain.
Other adverse reactions possibly or probably related to azithromycin, based on clinical trial experience and postmarketing surveillance:
Common (>1/100 <1/10): dysgeusia, visual impairment, lymphocyte count decreased, blood bicarbonate decreased.
Uncommon (≥1/1,000 to <1/100): hypersensitivity, vaginal infection, bacterial infection, gastroenteritis, eosinophilia, ear disorder, dyspnoea, epitaxis, dysphagia, abdominal distension, dry mouth, eructation, mouth ulceration, salivary hypersecretion, dry skin, hyperhidrosis, osteoarthritis, back pain, neck pain, dysuria, renal pain, metrorrhagia, testicular disorder, oedema, pyrexia, pain, peripheral oedema, blood urea increased, chloride increased, post procedural complication.
Not Known (cannot be estimated from available data): haemolytic anaemia, anaphylactic reaction, psychomotor hyperactivity, anosmia, ageusia, parosmia, aggression, hallucination, myasthenia gravis, fulminant hepatitis.
For Adverse Events/Complaints: call on Cipla Toll free number (for India)18002677779 or email to drugsafety@cipla.com
By reporting side effects, you can help provide more information on the safety of this product.
Overall, the most common treatment-related side effects in adult patients receiving multiple-dose regimens of azithromycin were related to the gastrointestinal system, with diarrhoea/loose stools (4–5%), nausea (3%), and abdominal pain (2–3%) being the most frequently reported.
No other treatment-related side effects occurred in patients on the multiple-dose regimens of azithromycin with a frequency greater than 1%. Side effects that occurred with a frequency of 1% or less included the following:
Cardiovascular: palpitations, chest pain.
Gastrointestinal: dyspepsia, flatulence, vomiting, melaena and cholestatic jaundice.
Genitourinary: monilia, vaginitis and nephritis.
Nervous System: dizziness, headache, vertigo and somnolence.
General: fatigue.
Allergic: rash, pruritus, photosensitivity and angio-oedema.
Overall, the most common side effects in patients receiving a single-dose regimen of 1 gram of azithromycin were related to the gastrointestinal system and were more frequently reported than in patients receiving the multiple-dose regimen.
Side effects that occurred in patients on the single 1 gm dosing regimen of azithromycin with a frequency of 1% or greater included diarrhoea/loose stools (7%), nausea (5%), abdominal pain (5%), vomiting (2%), dyspepsia (1%), and vaginitis (1%).
Overall, the most common side effects in patients receiving a single 2 gm dose of azithromycin were related to the gastrointestinal system. Side effects that occurred in patients in this study with a frequency of 1% or greater included nausea (18%), diarrhoea/loose stools (14%), vomiting (7%), abdominal pain (7%), vaginitis (2%), dyspepsia (1%) and dizziness (1%). The majority of these complaints were mild in nature.
The types of side effects in paediatric patients were comparable with those seen in adults, with different incidence rates for the dosage regimens recommended in paediatric patients.
For the recommended total dosage regimen of 30 mg/kg, the most frequent side effects (≥1%) attributed to treatment were diarrhoea, abdominal pain, vomiting, nausea and rash.
The incidence, based on dosing regimen, is described in the table below:
| Dosage Regimen | Diarrhoea, % | Abdominal Pain, % | Vomiting, % | Nausea, % | Rash, % |
|---|---|---|---|---|---|
| 1 day | 4.3% | 1.4% | 4.9% | 1.0% | 1.0% |
| 3 days | 2.6% | 1.7% | 2.3% | 0.4% | 0.6% |
| 5 days | 1.8% | 1.2% | 1.1% | 0.5% | 0.4% |
For the recommended dosage regimen of 10 mg/kg on Day 1 followed by 5 mg/kg on Days 2–5, the most frequent side effects attributed to treatment were diarrhoea/loose stools, abdominal pain, vomiting, nausea and rash.
The incidence is described in the table below:
| Dosage Regimen | Diarrhoea/Loose stools, % | Abdominal Pain, % | Vomiting, % | Nausea, % | Rash, % |
|---|---|---|---|---|---|
| 5 days | 5.8% | 1.9% | 1.9% | 1.9% | 1.6% |
For the recommended dosage regimen of 12 mg/kg on Days 1–5, the most frequent side effects attributed to treatment were diarrhoea, vomiting, abdominal pain, nausea and headache.
The incidence is described in the table below:
| Dosage Regimen | Diarrhoea, % | Abdominal Pain, % | Vomiting, % | Nausea, % | Rash, % | Headache, % |
|---|---|---|---|---|---|---|
| 5 days | 5.4% | 3.4% | 5.6% | 1.8% | 0.7% | 1.1% |
With any of the treatment regimens, no other treatment-related side effects occurred in paediatric patients treated with azithromycin with a frequency greater than 1%. Side effects that occurred with a frequency of 1% or less included the following:
Cardiovascular: chest pain.
Gastrointestinal: dyspepsia, constipation, anorexia, enteritis, flatulence, gastritis, jaundice, loose stools, and oral moniliasis.
Haematologic and Lymphatic: anaemia and leucopaenia.
Nervous System: headache (otitis media dosage), hyperkinesia, dizziness, agitation, nervousness and insomnia.
General: fever, face oedema, fatigue, fungal infection, malaise and pain.
Allergic: rash and allergic reaction.
Respiratory: cough increased, pharyngitis, pleural effusion and rhinitis.
Skin and Appendages: eczema, fungal dermatitis, pruritus, sweating, urticaria and vesiculobullous rash.
Special Senses: conjunctivitis.
Clinically significant abnormalities (irrespective of drug relationship) occurring during the clinical trials were reported as follows:
With an Incidence of Greater Than 1%: decreased haemoglobin, haematocrit, lymphocytes, neutrophils and blood glucose; elevated serum creatine phosphokinase, potassium, ALT, GGT, AST, BUN, creatinine, blood glucose, platelet count, lymphocytes, neutrophils and eosinophils.
With an Incidence of Less Than 1%: leucopaenia, neutropaenia, decreased sodium, potassium, platelet count, elevated monocytes, basophils, bicarbonate, serum alkaline phosphatase, bilirubin, LDH and phosphate. The majority of subjects with elevated serum creatinine also had abnormal values at baseline.
When follow-up was provided, changes in laboratory tests appeared to be reversible.
In multiple-dose clinical trials involving more than 5,000 patients, 4 patients discontinued therapy because of treatment-related liver enzyme abnormalities and 1 because of a renal function abnormality.
Laboratory data collected from comparative clinical trials employing two 3-day regimens (30 mg/kg or 60 mg/kg in divided doses over 3 days), or two 5-day regimens (30 mg/kg or 60 mg/kg in divided doses over 5 days) were similar for regimens of azithromycin and all comparators combined, with most clinically significant laboratory abnormalities occurring at incidences of 1–5%. Laboratory data for patients receiving 30 mg/kg as a single dose were collected in one single-centre trial. In that trial, an absolute neutrophil count between 500 and 1,500 cells/mm³ was observed in 10/64 patients receiving 30 mg/kg as a single dose, 9/62 patients receiving 30 mg/kg given over 3 days, and 8/63 comparator patients. No patient had an absolute neutrophil count <500 cells/mm³.
In multiple-dose clinical trials involving approximately 4,700 paediatric patients, no patients discontinued therapy because of treatment-related laboratory abnormalities.
The following adverse reactions have been identified during post-approval use of azithromycin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Adverse events reported with azithromycin during the postmarketing period in adult and/or paediatric patients for which a causal relationship may not be established included the following:
Allergic: arthralgia, oedema, urticaria and angio-oedema.
Cardiovascular: arrhythmias, including ventricular tachycardia and hypotension. There have been rare reports of QT prolongation and torsades de pointes.
Gastrointestinal: anorexia, constipation, dyspepsia, flatulence, vomiting/diarrhoea, pseudomembranous colitis, pancreatitis, oral candidiasis, pyloric stenosis, and rare reports of tongue discolouration.
General: asthenia, paraesthesia, fatigue, malaise and anaphylaxis (rarely fatal).
Genitourinary: interstitial nephritis and acute renal failure and vaginitis.
Haematopoietic: thrombocytopaenia.
Liver/Biliary: abnormal liver function, hepatitis, cholestatic jaundice, hepatic necrosis, and hepatic failure.
Nervous System: convulsions, dizziness/vertigo, headache, somnolence, hyperactivity, nervousness, agitation and syncope.
Psychiatric: aggressive reaction and anxiety.
Skin/Appendages: pruritus; serious skin reactions, including erythema multiforme, AGEP, Stevens-Johnson syndrome and toxic epidermal necrolysis and DRESS.
Special Senses: hearing disturbances, including hearing loss, deafness and/or tinnitus, and reports of taste/smell perversion and/or loss.
In a pharmacokinetic study investigating the effects of simultaneous administration of antacid with azithromycin, no effect on overall bioavailability was seen, although peak serum concentrations were reduced by approximately 24%. In patients receiving both azithromycin and antacids, the drugs should not be taken simultaneously.
In healthy volunteers, co-administration of a 5-day regimen of azithromycin with cetirizine 20 mg at steady-state resulted in no pharmacokinetic interaction and no significant changes in the QT interval.
Co-administration of 1,200 mg/day azithromycin with 400 mg/day didanosine in 6 HIV-positive subjects did not appear to affect the steady-state pharmacokinetics of didanosine as compared with placebo.
Concomitant administration of macrolide antibiotics, including azithromycin, with Pglycoprotein substrates such as digoxin and colchicine, has been reported to result in increased serum levels of the P-glycoprotein substrate. Therefore, if azithromycin and P-gp substrates such as digoxin are administered concomitantly, the possibility of elevated serum concentrations of the substrate should be considered.
Single 1,000 mg doses and multiple 1,200 mg or 600 mg doses of azithromycin had little effect on the plasma pharmacokinetics or urinary excretion of zidovudine or its glucuronide metabolite. However, administration of azithromycin increased the concentrations of phosphorylated zidovudine, the clinically active metabolite, in peripheral blood mononuclear cells. The clinical significance of this finding is unclear, but it may be of benefit to patients. Azithromycin does not interact significantly with the hepatic cytochrome (CY) P450 system. It is not believed to undergo the pharmacokinetic drug interactions as seen with erythromycin and other macrolides. Hepatic CYP450 induction or inactivation via CY-metabolite complex does not occur with azithromycin.
Due to the theoretical possibility of ergotism, the concurrent use of azithromycin with ergot derivatives is not recommended. Pharmacokinetic studies have been conducted between azithromycin and the following drugs known to undergo significant CYP450-mediated metabolism:
Co-administration of atorvastatin (10 mg daily) and azithromycin (500 mg daily) did not alter the plasma concentrations of atorvastatin (based on a HMG CoAreductase inhibition assay). However, postmarketing cases of rhabdomyolysis in patients receiving azithromycin with statins have been reported.
In a pharmacokinetic interaction study in healthy volunteers, no significant effect was observed on the plasma levels of carbamazepine or its active metabolite in patients receiving concomitant azithromycin.
Cisapride is metabolised in the liver by the enzyme CYP 3A4. Because macrolides inhibit this enzyme, concomitant administration of cisapride may cause the increase of QT interval prolongation, ventricular arrhythmias and torsades de pointes.
In a pharmacokinetic study investigating the effects of a single dose of cimetidine (given 2 hours before azithromycin) on the pharmacokinetics of azithromycin, no alteration of azithromycin pharmacokinetics was seen.
In a pharmacokinetic study with healthy volunteers that were administered a 500 mg/day oral dose of azithromycin for 3 days and were then administered a single 10 mg/kg oral dose of ciclosporine, the resulting ciclosporine Cmax and AUC0-5 were found to be significantly elevated. Consequently, caution should be exercised before considering concurrent administration of these drugs. If co-administration of these drugs is necessary, ciclosporine levels should be monitored and the dose adjusted accordingly.
Co-administration of a 600 mg single dose of azithromycin and 400 mg efavirenz daily for 7 days did not result in any clinically significant pharmacokinetic interactions.
Co-administration of a single dose of 1,200 mg azithromycin did not alter the pharmacokinetics of a single dose of 800 mg fluconazole. Total exposure and half-life of azithromycin were unchanged by the co-administration of fluconazole; however, a clinically insignificant decrease in Cmax (18%) of azithromycin was observed.
Co-administration of a single dose of 1,200 mg azithromycin had no statistically significant effect on the pharmacokinetics of indinavir administered as 800 mg three times daily for 5 days.
Interactions with digoxin or phenytoin have not been reported in clinical trials with azithromycin; however, no specific drug interaction studies have been performed to evaluate potential drug–drug interactions. However, drug interactions have been observed with other macrolide products. Until further data are developed regarding drug interactions when digoxin or phenytoin is used concomitantly with azithromycin, careful monitoring of patients is advised.
In a pharmacokinetic interaction study in healthy volunteers, azithromycin had no significant effect on the pharmacokinetics of methylprednisolone.
In healthy volunteers, co-administration of azithromycin 500 mg/day for 3 days did not cause clinically significant changes in the pharmacokinetics and pharmacodynamics of a single 15 mg dose of midazolam.
Co-administration of azithromycin (1,200 mg) and nelfinavir at steady state (750 mg three times daily) resulted in increased azithromycin concentrations. Although a dose adjustment of azithromycin is not recommended when administered in combination with nelfinavir, close monitoring for known adverse reactions of azithromycin, such as liver enzyme abnormalities and hearing impairment, is warranted.
Co-administration of azithromycin and rifabutin did not affect the serum concentrations of either drug. Neutropaenia was observed in subjects receiving concomitant treatment of azithromycin and rifabutin. Although neutropaenia has been associated with the use of rifabutin, a causal relationship to combination with azithromycin has not been established.
In normal healthy male volunteers, there was no evidence of an effect of azithromycin (500 mg daily for 3 days) on the AUC and Cmax, of sildenafil or its major circulating metabolite.
Pharmacokinetic studies have reported no evidence of an interaction between azithromycin and terfenadine. There have been rare cases reported where the possibility of such an interaction could not be entirely excluded; however, there was no specific evidence that such an interaction had occurred.
There is no evidence of a clinically significant pharmacokinetic interaction when azithromycin and theophylline are co-administered to healthy volunteers.
In 14 healthy volunteers, co-administration of azithromycin 500 mg on Day 1 and 250 mg on Day 2 with 0.125 mg triazolam on Day 2 had no significant effect on any of the pharmacokinetic variables for triazolam compared to triazolam and placebo.
Co-administration of trimethoprim/sulfamethoxazole DS (160 mg/800 mg) for 7 days with azithromycin 1200 mg on Day 7 had no significant effect on peak concentrations, total exposure or urinary excretion of either trimethoprim or sulfamethoxazole. Azithromycin serum concentrations were similar to those seen in other studies.
Spontaneous postmarketing reports suggest that concomitant administration of azithromycin may potentiate the effects of oral anticoagulants such as warfarin, although the prothrombin time was not affected in the dedicated drug interaction study with azithromycin and warfarin. Prothrombin times should be carefully monitored while patients are receiving azithromycin and oral anticoagulants concomitantly.
Pregnancy Category B.
There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, azithromycin should be used during pregnancy only if clearly needed.
Azithromycin has been reported to be excreted in human breast milk in small amounts. Caution should be exercised when azithromycin is administered to a nursing mother.
Safety and effectiveness in the treatment of paediatric patients with acute otitis media, acute bacterial sinusitis and community-acquired pneumonia under 6 months of age have not been established. Use of azithromycin for the treatment of acute bacterial sinusitis and community-acquired pneumonia in paediatric patients (6 months of age or older) is supported by adequate and well-controlled trials in adults. Safety and effectiveness in the treatment of paediatric patients with pharyngitis/tonsillitis under 2 years of age have not been established.
In multiple-dose clinical trials of oral azithromycin, 9% of patients were at least 65 years of age (458/4,949) and 3% of patients (144/4,949) were at least 75 years of age. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in response between the elderly and younger patients, but the greater sensitivity of some older individuals cannot be ruled out.
Elderly patients may be more susceptible to the development of torsades de pointes arrhythmia than younger patients.
No dosage adjustment is recommended for subjects with mild-to-moderate renal impairment (GFR 30–80 ml/min). Caution should be exercised when azithromycin is administered to subjects with severe renal impairment (GFR <10 ml/min) as a 33% increase in systemic exposure to azithromycin was observed.
A dose adjustment is not necessary for patients with mild to moderately impaired liver function.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
