Safety and efficacy for the prevention or treatment of Mycobacterium Avium Complex MAC in children have not been established. The following should be considered before prescribing azithromycin: Azithromycin tablets are not suitable for treatment of severe infections where a high concentration of the antibiotic in the blood is rapidly needed.
In areas with a high incidence of erythromycin A resistance, it is especially important to take into consideration the evolution of the pattern of susceptibility to azithromycin and other antibiotics. This should be taken into account when treating infections caused by Streptococcus pneumoniae. For this and for the prophylaxis of acute rheumatic fever penicillin is the treatment of first choice.
Sinusitis Often, azithromycin is not the substance of first choice for the treatment of sinusitis. Acute otitis media Often, azithromycin is not the substance of first choice for the treatment of acute otitis media.
Skin and soft tissue infections 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. Infected burn wounds Azithromycin is not indicated for the treatment of infected burn wounds. Sexually transmitted disease In case of sexually transmitted diseases a concomitant infection by T.
Neurological or psychiatric diseases Azithromycin should be used with caution in patients with neurological or psychiatric disorders. As with any antibiotic preparation, observation for signs of superinfection with non-susceptible organisms, including fungi is recommended.
Azithromycin Tablets contains soya lecithin which might be a source of soya protein and should therefore not be taken in patients allergic to soya or peanut due to the risk of hypersensitivity reactions.
In patients receiving both azithromycin and antacids, the drugs should not be taken simultaneously. Azithromycin must be taken at least 1 hour before or 2 hours after the antacids. Other drugs, such as halofantrine, have been specifically established to have a causal association with QT prolongation and TdP and are contraindicated for use with drugs that potentially cause QT prolongation, such as azithromycin.
Major Due to an increased risk for QT prolongation and torsade de pointes TdP , cautious use of haloperidol with azithromycin is advised. QT prolongation and TdP have also been observed during haloperidol treatment.
Excessive doses particularly in the overdose setting or IV administration of haloperidol may be associated with a higher risk of QT prolongation. Major Avoid coadministration of hydroxychloroquine and azithromycin. Hydroxychloroquine increases the QT interval and should not be administered with other drugs known to prolong the QT interval. Ventricular arrhythmias and torsade de pointes TdP have been reported with the use of hydroxychloroquine. Drugs with a possible risk for QT prolongation and TdP that should be used cautiously and with close monitoring with hydroxyzine include azithromycin.
Major Due to an increased risk for QT prolongation and torsade de pointes TdP , cautious use of ibutilide with azithromycin is advised. Ibutilide administration can cause QT prolongation and TdP; proarrhythmic events should be anticipated.
The potential for proarrhythmic events with ibutilide increases with the coadministration of other drugs that prolong the QT interval. Major Due to a possible risk for QT prolongation and torsade de pointes TdP , azithromycin and idarubicin should be used together cautiously. Acute cardiotoxicity can occur during the administration of idarubicin; although, the incidence is rare.
Major Concurrent use of iloperidone and azithromycin should be avoided due to an increased risk for QT prolongation and torsade de pointes TdP. Iloperidone has been associated with QT prolongation, and cases of QT prolongation and TdP have been reported with the post-marketing use of azithromycin.
Minor Imatinib, STI is a substrate of P-glycoprotein P-gp and azithromycin is a P-gp inhibitor; therefore, imatinib concentrations could be increased with coadministration. Moderate Indinavir is a substrate of P-glycoprotein P-gp and azithromycin is a P-gp inhibitor; therefore, indinavir concentrations could be increased with coadministration.
Major Avoid coadministration of inotuzumab ozogamicin with azithromycin due to the potential for additive QT interval prolongation and risk of torsade de pointes TdP. If coadministration is unavoidable, obtain an ECG and serum electrolytes prior to the start of treatment, after treatment initiation, and periodically during treatment.
Inotuzumab has been associated with QT interval prolongation. Major Irinotecan is a substrate of P-glycoprotein P-gp and azithromycin is a P-gp inhibitor; therefore, irinotecan concentrations could be increased with coadministration. Moderate Rifampin may decrease serum concentrations and potentially the effectiveness of azithromycin, while azithromycin may increase serum concentrations of rifampin. Rifampin is a substrate and inducer of P-glycoprotein P-gp , while azithromycin is a substrate and inhibitor of P-gp.
Monitor patients for increased side effects of rifampin and for signs of antimicrobial efficacy with azithromycin use. Moderate Both itraconazole and azithromycin are P-glycoprotein PGP inhibitors and substrates, so coadministration may lead to increased concentrations of either agent.
Moderate Use caution when administering ivacaftor and azithromycin concurrently. Ivacaftor is an inhibitor of P-glycoprotein Pgp. Co-administration of ivacaftor with Pgp substrates, such as azithromycin, may increase azithromycin exposure leading to increased or prolonged therapeutic effects and adverse events.
Minor Azithromycin is a mild inhibitor of and substrate for P-glycoprotein Pgp. Ixabepilone is a mild inhibitor of and substrate for Pgp. Caution is recommended if ixabepilone is coadministered with a Pgp inhibitor. Moderate Increased concentrations of azithromycin may occur if it is coadministered with ketoconazole; exercise caution. Ketoconazole is an inhibitor of the efflux transporter P-glycoprotein P-gp and azithromycin may be a P-gp substrate.
Major Oral compounds known to interact with antacids, like macrolides, should not be taken within 2 hours of dosing with lanthanum carbonate. If these agents are used concomitantly, space the dosing intervals appropriately.
Monitor serum concentrations and clinical condition. Lapatinib is also associated with a possible risk for QT prolongation and TdP; therefore, concomitant use may have additive risk. Also, lapatinib is a P-glycoprotein P-gp inhibitor and azithromycin is a P-gp substrate, so coadministration may lead to increased azithromycin concentrations. Moderate Caution and close monitoring of adverse reactions is advised with concomitant administration of azithromycin and ledipasvir; sofosbuvir.
Both ledipasvir and azithromycin are substrates and inhibitors of the drug transporter P-glycoprotein P-gp ; sofosbuvir is a P-gp substrate. Taking these drugs together may increase plasma concentrations of all three drugs. According to the manufacturer, no dosage adjustments are required when ledipasvir; sofosbuvir is administered concurrently with P-gp inhibitors.
Major Lenvatinib should be used cautiously and with close monitoring with azithromycin. Major Due to a possible risk for QT prolongation and torsade de pointes TdP , azithromycin and leuprolide should be used together cautiously.
Major Avoid concurrent use of levofloxacin and azithromycin due to an increased risk for QT prolongation and torsade de pointes TdP. Levofloxacin has been associated with prolongation of the QT interval and infrequent cases of arrhythmia. Rare cases of TdP have been reported during postmarketing surveillance in patients receiving levofloxacin.
During the postmarketing period, cases of QT prolongation and TdP were associated with azithromycin. Other drugs, such as levomethadyl, have been specifically established to have a causal association with QT prolongation and torsade de pointes and are contraindicated for use with drugs that potentially cause QT prolongation, such as azithromycin.
Major Lincomycin and macrolide antimicrobials are bactericidal or bacteriostatic via the same or similar mechanisms of action. Antagonism in vitro has been demonstrated when lincomycin was coadministered with erythromycin.
It is not recommended to administer these agents together in any combination due to potential antagonism. The manufacturer of lincomycin does not recommend concurrent use of lincomycin with macrolides. Major Due to a possible risk for QT prolongation and torsade de pointes TdP , azithromycin and lithium should be used together cautiously.
Lithium has also been associated with QT prolongation. Major Loperamide should be used cautiously and with close monitoring with azithromycin. At high doses, loperamide has been associated with serious cardiac toxicities, including syncope, ventricular tachycardia, QT prolongation, torsade de pointes TdP , and cardiac arrest.
In addition, the plasma concentrations of loperamide, a P-glycoprotein P-gp substrate, may be increased when administered concurrently with azithromycin, a P-gp inhibitor, further increasing the risk of toxicity. If these drugs are used together, monitor for cardiac toxicities i. Major Due to an increased risk for QT prolongation and torsade de pointes TdP , caution is advised when administering azithromycin with lopinavir; ritonavir. There have been case reports of QT prolongation and TdP with the use of azithromycin in post-marketing reports, and lopinavir; ritonavir has been associated with QT prolongation.
Minor Loratadine is a substrate of P-glycoprotein PGP and azithromycin is a PGP inhibitor; therefore, loratadine concentrations could be increased with coadministration.
Moderate Both lovastatin and azithromycin are P-glycoprotein P-gp inhibitors and substrates, so coadministration may lead to increased concentrations of either agent. Minor Although the clinical significance of this interaction is unknown, concurrent use of azithromycin and lumacaftor; ivacaftor may alter azithromycin exposure; caution and monitoring are advised if these drugs are used together.
Azithromycin is a substrate of the drug transporter P-glycoprotein P-gp. In vitro data suggest that lumacaftor; ivacaftor has the potential to both induce and inhibit P-gp. The net effect of lumacaftor; ivacaftor on P-gp transport is not clear, but substrate exposure may be affected leading to decreased efficacy or increased adverse events.
Major Due to an increased risk for QT prolongation and torsade de pointes TdP , cautious use of maprotiline with azithromycin is advised. Maprotiline has been reported to prolong the QT interval, particularly in overdose or with higher-dose prescription therapy elevated serum concentrations. Cases of long QT syndrome and TdP tachycardia have been described with maprotiline use, but rarely occur when the drug is used alone in normal prescribed doses and in the absence of other known risk factors for QT prolongation.
Limited data are available regarding the safety of maprotiline in combination with other QT-prolonging drugs. Moderate Use caution and closely monitor for increased adverse effects with the coadministration of maraviroc and azithromycin as increased maraviroc concentrations may occur.
Maraviroc is a substrate of P-glycoprotein P-gp ; azithromycin is an inhibitor of P-gp. The effects of P-gp on the concentrations of maraviroc are unknown, although an increase in concentrations and thus, toxicity, are possible. Major Due to an increased risk for QT prolongation and torsade de pointes TdP , caution is advised when administering mefloquine with azithromycin.
There is evidence that use of halofantrine after mefloquine causes a significant lengthening of the QTc interval. Mefloquine alone has not been reported to cause QT prolongation; however due to the lack of clinical data, mefloquine should be used with caution in patients receiving drugs that prolong the QT interval, such as azithromycin. Post-marketing use of azithromycin has been associated with cases of QT prolongation and TdP.
Also, both mefloquine and azithromycin are P-glycoprotein P-gp inhibitors and substrates, so coadministration may lead to increased concentrations of either agent.
Other drugs, such as mesoridazine, have been specifically established to have a causal association with QT prolongation and torsade de pointes and are contraindicated for use with drugs that potentially cause QT prolongation, such as azithromycin.
Major Use of azithromycin during the post-marketing period has been associated with cases of QT prolongation and torsade de pointes TdP. The need to coadminister methadone with drugs known to prolong the QT interval, such as azithromycin, should be done with extreme caution and a careful assessment of treatment risks versus benefits. In addition, methadone is a substrate for P-glycoprotein P-gp.
Concurrent use of methadone with azithromycin an inhibitor of P-gp may result in increased methadone serum concentrations. Minor Methylprednisolone is a substrate of P-glycoprotein P-gp and azithromycin is a P-gp inhibitor; therefore, methylprednisolone concentrations could be increased with coadministration.
Major The concomitant use of midostaurin and azithromycin may lead to additive QT interval prolongation. If these drugs are used together, consider obtaining electrocardiograms to monitor the QT interval. In clinical trials, QT prolongation was reported in patients who received midostaurin as single-agent therapy or in combination with cytarabine and daunorubicin. Reports of QT prolongation and torsade de pointes have been reported during postmarketing surveillance of azithromycin.
Major Due to the potential for QT prolongation and torsade de pointes TdP , caution is advised when administering mifepristone with azithromycin. Mifepristone has been associated with dose-dependent prolongation of the QT interval, and rare cases of QT prolongation and TdP have been reported with azithromycin during postmarketing use.
To minimize the risk of QT prolongation, the lowest effective mifepristone dose should always be used. In addition, increased concentrations of azithromycin may occur if it is coadministered with mifepristone. Mifepristone is an inhibitor of the efflux transporter P-glycoprotein P-gp and azithromycin is a P-gp substrate. Moderate There may be an increased risk for QT prolongation and torsade de pointes TdP during concurrent use of mirtazapine and azithromycin.
QT prolongation and torsade de pointes TdP have been spontaneously reported during azithromycin postmarketing surveillance. Cases of QT prolongation, TdP, ventricular tachycardia, and sudden death have been reported during postmarketing use of mirtazapine, primarily following overdose or in patients with other risk factors for QT prolongation, including concomitant use of other medications associated with QT prolongation.
Moderate Mitomycin is a substrate of P-glycoprotein P-gp and azithromycin is a P-gp inhibitor; therefore, mitomycin concentrations could be increased with coadministration. Moderate Monitor patients for increased side effects if morphine and azithromycin are coadministered.
Morphine concentrations could be increased with coadministration. Morphine is a substrate of P-glycoprotein P-gp and azithromycin is a P-gp inhibitor. Major Concurrent use of moxifloxacin and azithromycin should be avoided due to an increased risk for QT prolongation and torsade de pointes TdP.
Prolongation of the QT interval has been reported with administration of moxifloxacin. Post-marketing surveillance has identified very rare cases of ventricular arrhythmias including TdP, usually in patients with severe underlying proarrhythmic conditions. The likelihood of QT prolongation may increase with increasing concentrations of moxifloxacin, therefore the recommended dose or infusion rate should not be exceeded. According to the manufacturer, moxifloxacin should be avoided in patients taking drugs that can result in prolongation of the QT interval, such as azithromycin.
During the post-marketing period, cases of QT prolongation and TdP were associated with azithromycin. Moderate Coadministration of nelfinavir and azithromycin results in increased azithromycin concentrations.
Dosage adjustments are not necessary, although patients should be monitored for azithromycin related adverse effects such as increased hepatic enzymes and hearing impairment. Moderate Both nicardipine and azithromycin are P-glycoprotein P-gp inhibitors and substrates, so coadministration may lead to increased concentrations of either agent.
Moderate Increased concentrations of azithromycin may occur if it is coadministered with nifedipine; exercise caution. Nifedipine is a mild inhibitor of the efflux transporter P-glycoprotein P-gp and azithromycin may be a P-gp substrate. Major Avoid the concomitant use of nilotinib with other agents that prolong the QT interval.
If the use of azithromycin is required, hold nilotinib therapy. If the use of nilotinib and azithromycin cannot be avoided, exercise caution; close monitoring of the QT interval is recommended.
Moderate Azithromycin is a moderate inhibitor of P-glycoprotein P-gp and nintedanib is a P-gp substrate. Coadministration may increase the concentration and clinical effect of nintedanib. If concomitant use of azithromycin and nintedanib is necessary, closely monitor for increased nintedanib side effects including gastrointestinal toxicity, elevated liver enzymes, and hypertension. A dose reduction, interruption of therapy, or discontinuation of therapy may be necessary. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
However, increased tolerability has been observed when tablets are taken with food. Azithromycin for oral suspension single dose 1g packet is not for pediatric use. This dose of Azithromycin Tablets, USP may be combined with the approved dosage regimen of rifabutin. Other antimycobacterial drugs that have shown in vitro activity against MAC may be added to the regimen of azithromycin plus ethambutol at the discretion of the physician or health care provider.
Dosage Forms and Strengths Azithromycin Tablets mg are supplied as white film-coated oval shaped biconvex tablets debossed with W on one side and other side plain containing anhydrous azithromycin mg.
These are packaged in bottles of 30 tablets. Contraindications Hypersensitivity Azithromycin Tablets are contraindicated in patients with known hypersensitivity to azithromycin, erythromycin, any macrolide, or ketolide drug. Warnings and Precautions Hypersensitivity Serious allergic reactions, including angioedema, anaphylaxis, and dermatologic reactions including Acute Generalized Exanthematous Pustulosis AGEP , Stevens-Johnson Syndrome, and toxic epidermal necrolysis, have been reported rarely in patients on azithromycin therapy.
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 presently unknown.
If an allergic reaction occurs, the drug should be discontinued and appropriate therapy should be instituted. Physicians should be aware that allergic symptoms may reappear when symptomatic therapy is discontinued. Hepatotoxicity Abnormal liver function, hepatitis, cholestatic jaundice, hepatic necrosis, and hepatic failure have been reported, some of which have resulted in death. How should I take Azithromycin? Azithromycin cures bacterial infections and inflammations.
Bacteria are micro-organisms which can adjust to the environment and to various affecting factors. That is why before starting Azithromycin mg or Azithromycin mg, you must know for sure: Take the drug for as long as it is recommended. Bacteria get suppressed with the medication, but if you stop and withdraw treatment some viable bacteria may thrive again.
Do not exceed recommended dosages as this will not fasten the recovery but will sufficiently impact your kidney and liver. Do not withdraw Azithromycin even if you feel better. Commonly patients report ease of symptoms right from the first intake. Take the pills or suspension for at least 7 days. Mind that some conditions require shorter treatment.
If you take Azithromycin on your own, then take it for a recommended period of time. Some cases require repeated course of treatment. For example, neglected staphylococcus and streptococcus infections require up to three courses of treatment. The drug can be taken with or without foods, however it is recommended to take it with a full glass of water. Some patients may face unwanted side effects from digestive system during a prolonged course of treatment.
A change in everyday diet may sufficiently help you to avoid nausea and diarrhea. Most of the diseases the Azithromycin pills are used to treat, perform vomiting as a key symptom. If a patient vomits during an hour after drug intake, please, do not take another dosage of the drug. 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. Hepatotoxicity 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. Treatment of Pneumonia In the treatment of pneumonia, azithromycin has only been shown to be safe and effective in the treatment of community-acquired pneumonia due to Chlamydia pneumoniae, Haemophilusinfluenzae, Mycoplasma pneumoniae or Streptococcus pneumoniae in patients appropriate for oral therapy.
Azithromycin should not be used in patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors such as any of thefollowing: Clostridium Difficile-Associated Diarrhea Clostridium difficile associated diarrhea CDAD has been reported with use of nearly all antibacterial agents, including azithromycin, and may range in severity from mild diarrhea to fatal colitis.
Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. Hypertoxin producing strains of C. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C.
Driving and using machines This medicine may cause side effects such as dizziness or convulsions. This may make you less able to do certain things, such as driving or using machines. Azithromycin Tablets contain soya lecithin If you are allergic to peanut or soya, do not use this medicine. Check with your doctor or pharmacist if you are not sure. These doses are for adults and children weighing more than 45 kg. Children weighing less than this should not take these tablets.
The recommended dose is:
Use caution when cabazitaxel is administered concomitantly with Pgp inhibitors, azithromycin 500mg tablets. Sinus bradycardia with marked QT prolongation and increased QT tablet were noted on day 3 500mg treatment. Clinically significant interactions have been reported when doxorubicin was coadministered with inhibitors of 500mg, resulting in increased concentrations and clinical effect of doxorubicin, azithromycin 500mg tablets. Discuss the risks and benefits with your doctor. Adverse reactions were similar to those observed in the adult population, most of which involved the gastrointestinal tract. Moderate Dexamethasone is a substrate azithromycin P-glycoprotein PGP and azithromycin is a PGP inhibitor; therefore, dexamethasone concentrations could be increased with coadministration. Patients should be monitored for increased adverse effects of dabigatran, azithromycin 500mg tablets. Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term tablets azithromycin animals have not been performed to evaluate carcinogenic potential. Ventricular arrhythmias and torsade de azithromycin TdP have been reported with the use of hydroxychloroquine. Concurrent use may increase the risk of QT prolongation. Clostridium Difficile-Associated Diarrhea Clostridium difficile associated tablet CDAD has been reported with use of nearly all antibacterial agents, including azithromycin, and may 500mg in severity from mild diarrhea to fatal colitis.
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