AZITHROMYCIN MG

Transcription

1 AZITHROMYCIN MG Alternatively, the same total dose mg can be administered in a period of 5 days, mg on the first day and mg on day 2 to 5. In the case of uncomplicated Chlamydia trachomatis urethritis and cervicitis, the dosage is mg as a single oral dose. Azithromycin tablets are not suitable for patients under 45 kg body weight. Other dosage forms are available for this group of patients. For elderly patients the same dose as for adults can be applied. Since elderly patients can be patients with ongoing proarrhythmic conditions a particular caution is recommended due to the risk of developing cardiac arrhythmia and torsades de pointes. Dose adjustment is not required for patients with mild to moderate hepatic dysfunction see section 4. Hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide antibiotic, or to any of the excipient listed in section 6. As with erythromycin and other macrolides, rare serious allergic reactions including angioneurotic oedema and anaphylaxis rarely fatal, dermatologic reactions including acute generalised exanthematous pustulosis AGEP, Stevens Johnson syndrome SJS, toxic epidermal necrolysis TEN rarely fatal and drug reaction with eosinophilia and systemic symptoms DRESS have been reported. Some of these reactions with azithromycin have resulted in recurrent symptoms and required a longer period of observation and treatment. 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. Since the liver is the principal route of elimination for azithromycin, the use of azithromycin should be undertaken with caution in patients with significant hepatic disease. Cases of fulminant hepatitis potentially leading to life-threatening liver failure have been reported with azithromycin see section 4. Some patients may have had pre-existing hepatic disease or may have been taking other hepatotoxic medicinal products. Azithromycin administration should be stopped if liver dysfunction has emerged. In patients receiving ergot derivatives, ergotism has been precipitated by coadministration of some macrolide antibiotics. There are no data concerning the possibility of an interaction between ergotamine derivatives and azithromycin. However, because of the theoretical possibility of ergotism, azithromycin and ergot derivatives should not be co-administered see section 4. As with any antibiotic preparation, it is recommended to pay attention to signs of superinfection with non-susceptible micro-organisms like fungi. A superinfection may require an interruption of the azithromycin treatment and initiation of adequate measures. Clostridium difficile associated diarrhoea CDAD has been reported with 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 C. Hypertoxin producing strains of C. 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 two months after the administration of antibacterial agents. Prolonged cardiac repolarisation and QT interval, imparting a risk of developing cardiac arrhythmia and torsades de pointes, have been seen in treatment with other macrolides, including azithromycin see section 4. Therefore as the following situations may lead to an increased risk for ventricular arrhythmias including torsade de pointes which can lead to cardiac arrest, azithromycin should be used with caution in patients with ongoing proarrhythmic conditions especially women and elderly patients such as patients:. Exacerbations of the symptoms of myasthenia gravis and new onset of myasthenia syndrome have been reported in patients receiving azithromycin therapy see section 4. Safety and efficacy for the prevention or treatment of Mycobacterium Avium Complex MAC in children have not been established. Azithromycin is not suitable for treatment of severe infections where a high concentration of the antibiotic in the blood is rapidly needed. The selection of azithromycin to treat an individual patient should take into account the appropriateness of using a macrolide antibacterial agent based on adequate diagnosis to ascertain the bacterial etiology of the infection in the approved indications and the prevalence of resistance to azithromycin or other macrolides. 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. As for other macrolides, high resistance rates of Streptococcus pneumoniae have been reported for azithromycin in some European countries see section 5. This should be taken into account when treating infections caused by Streptococcus pneumoniae. In bacterial pharyngitis the use of azithromycin is recommended only in cases where first line therapy with beta-lactams is not possible. 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. In case of sexually transmitted diseases a concomitant infection by T. Patients with rare hereditary problems of galactose intolerance, the Lapp

2 lactase deficiency or glucose- galactose malabsorption should not take this medicine. Azithromycin must be taken at least 1 hour before or 2 hours after antacids. In healthy volunteers, coadministration 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. Concomitant administration of macrolide antibiotics, including azithromycin, with P-glycoprotein substrates such as digoxin, 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 mg doses and multiple doses of mg or mg 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 P system. It is not believed to undergo the pharmacokinetic drug interactions as seen with erythromycin and other macrolides. Hepatic cytochrome P induction or inactivation via cytochrome-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 see section 4. Pharmacokinetic studies have been conducted between azithromycin and the following drugs known to undergo significant cytochrome P mediated metabolism. There are no known data on interactions with astemizole or alfentanil. Caution is advised in the co-administration of these medicines with Azithromycin because of the known enhancing effect of these medicines when used concurrently with the macrolid antibiotic erythromycin. Coadministration of atorvastatin 10 mg daily and azithromycin mg daily did not alter the plasma concentrations of atorvastatin based on a HMG CoA-reductase-inhibition assay. However, post-marketing 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 metabolized 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 interaction study, azithromycin did not alter the anticoagulant effect of a single mg dose of warfarin administered to healthy volunteers. There have been reports received in the post-marketing period of potentiated anticoagulation subsequent to coadministration of azithromycin and coumarintype oral anticoagulants. Although a causal relationship has not been established, consideration should be given to the frequency of monitoring prothrombin time when azithromycin is used in patients receiving coumarin-type oral anticoagulants. Consequently, caution should be exercised before considering concurrent administration of these drugs. If coadministration of these drugs is necessary, cyclosporin levels should be monitored and the dose adjusted accordingly. Coadministration of a mg single dose of azithromycin and mg efavirenz daily for 7 days did not result in any clinically significant pharmacokinetic interactions. Coadministration of a single dose of mg azithromycin did not alter the pharmacokinetics of a single dose of mg fluconazole. Coadministration of a single dose of mg azithromycin had no statistically significant effect on the pharmacokinetics of indinavir administered as mg three times daily for 5 days. In a pharmacokinetic interaction study in healthy volunteers, azithromycin had no significant effect on the pharmacokinetics of methylprednisolone. Coadministration of azithromycin mg and nelfinavir at steady state mg three times daily resulted in increased azithromycin concentrations. No clinically significant adverse effects were observed and no dose adjustment is required. Coadministration of azithromycin and rifabutin did not affect the serum concentrations of either drug. Neutropenia was observed in subjects receiving concomitant treatment of azithromycin and rifabutin. Although neutropenia has been associated with the use of rifabutin, a causal relationship to combination with azithromycin has not been established see section 4. In normal healthy male volunteers, there was no evidence of an effect of azithromycin mg daily for 3 days on the AUC and C max 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. As interactions of other macrolides with theophylline have been reported, alertness to signs that indicate a rise in theophylline levels is advised. In 14 healthy volunteers, coadministration of azithromycin mg on Day 1 and mg on Day 2 with 0.

3 Azithromycin serum concentrations were similar to those seen in other studies. There are no adequate data from the use of azithromycin in pregnant women. In reproduction toxicity studies in animals azithromycin was shown to pass the placenta, but no teratogenic effects were observed see section 5. The safety of azithromycin has not been confirmed with regard to the use of the active substance during pregnancy. Therefore Azithromycin should only be used during pregnancy if the benefit outweighs the risk. Azithromycin has been reported to be secreted into human breast milk, but there are no adequate and well-controlled clinical studies in nursing women that have characterized the pharmacokinetics of azithromycin excretion into human breast milk. Because it is not known whether azithromycin may have adverse effects on the breast-fed infant, nursing should be discontinued during treatment with Azithromycin. Among other things diarrhoea, fungus infection of the mucous membrane as well as sensitisation is possible in the nursed infant. It is recommended to discard the milk during treatment and up until 2 days after discontinuation of treatment. Nursing may be resumed thereafter. In fertility studies conducted in rat, reduced pregnancy rates were noted following administration of azithromycin. The relevance of this finding to humans is unknown. No data are available regarding the influence of azithromycin on a patient's ability to drive or operate machinery. However, the possibility of undesirable effects like dizziness and convulsions should be taken into account when performing these activities. The table below lists the adverse reactions identified through clinical trial experience and post-marketing surveillance by system organ class and frequency. Adverse reactions identified from post-marketing experience are included in italics. The frequency grouping is defined using the following convention: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Adverse reactions possibly or probably related to azithromycin based on clinical trial experience and post-marketing surveillance: Candidiasis, oral, candidiasis, vaginal infection, pneumonia, fungal infection, bacterial infection, pharyngitis, gastroenteritis, respiratory disorder, rhinitis. Pseudomembranous colitis see section 4. Anaphylactic reaction see section 4. Dizziness, headache, paraesthesia, dysgeusia. Ear and labyrinth disorders. Torsades de pointes see section 4. Gastritis, constipation, dysphagia, abdominal distension, dry mouth, eructation, mouth ulceration, salivary hypersecretion. Pancreatitis, tongue and teeth discoloration. Hepatic failure which has rarely resulted in death see section 4. Stevens-Johnson syndrome, photosensitivity reaction, urticaria, dermatitis, dry skin, hyperhidrosis. Toxic epidermal necrolysis, erythema multiforme. Renal and urinary disorders. Reproductive system and breast disorders. General disorders and administration site conditions. Lymphocyte count decreased, eosinophil count increased, blood bicarbonate decreased, basophils increased, monocytes increased, neutrophils increased. Aspartate aminotransferase increased, alanine aminotransferase increased, blood bilirubin increased, blood urea increased, blood creatinine increased, blood potassium abnormal, blood alkaline phosphatase increased, chloride increased, glucose increased, platelets increased, hematocrit decreased, bicarbonate increased, abnormal sodium. Adverse reactions possibly or probably related to Mycobacterium Avium Complex prophylaxis and treatment based on clinical trial experience and post-marketing surveillance. These adverse reactions differ from those reported with immediate release or the prolonged release formulations, either in kind or in frequency:. Reporting suspected adverse reactions after authorisation of the medicinal product is important. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme Website: Adverse events experienced in higher than recommended doses were similar to those seen at normal doses. The typical symptoms of an overdose with macrolide antibiotics include reversible loss of hearing, severe nausea, vomiting and diarrhoea. The molecule is constructed by adding a nitrogen atom to the lactone ring of erythromycin A. Azithromycin mg-tev, pink, oblong,. Zithromax mg, red, oval,. Azithromycin mg-apo, white, oval, film coated. Azithromycin mg-tev, white, oval, film coated. Azithromycin mg-myl, blue, round,. Azithromycin mg-gre, white, oval,. Azithromycin mg-myl, blue, oblong,. Azithromycin mg-gg, white, oval,. Azithromycin 1 g Sus-GRE,,,. Azithromycin mg-apo, white, oval,. Zithromax mg, red, oblong, film coated. Zithromax mg, red, oval, film coated. Would an antibiotic, such as azithromycin, interfere with my birth control Necon? Studies have shown that antibiotics such as azithromycin Zithromax, Zmax may decrease hormonal birth control efficacy. There is more evidence of this with tetracycline and ampicillin. Use caution when taking these two medications at the same time. Can both women and men take azithromycin suspension? Azithromycin is approved, by the U. Food and Drug Administration FDA, as a safe and effective treatment, for men and women, to treat various different types of bacterial infections, such as respiratory infections, skin infections, ear infections and sexually transmitted diseases. Azithromycin should be taken exactly as directed by your health care provider. The dose and duration of treatment with

4 azithromycin suspension differs depending on the type of infection being treated. According to the prescribing information, the most commonly reported side effects associated with treatment with azithromycin include diarrhea, nausea, abdominal pain, vomiting and vaginitis. Azithromycin should only be taken as prescribed by your health care provider. For more information regarding azithromycin suspension, you may want to visit our website or check with your health care provider or local pharmacist. Is it safe to use tanning beds while on a Z-pack? Z-Pak azithromycin is a macrolide antibiotic which is used to treat various bacterial infections. The most common side effects with Z-Pak are diarrhea and nausea. Other side effects with Z-Pak include photosensitivity or sensitivity to the sun and UV radiation. It is important to use sunscreen with an SPF of at least 15 and avoid unnecessary UV radiation tanning beds while on Z-Pak to avoid sunburn and skin damage. Tanning beds are never recommended as they can lead to skin cancer as well as premature aging of the skin. Self or spray tans are the better option. This is not a complete list of the side effects associated with Z-Pak. Patients should also be cautioned not to take aluminumand magnesium-containing antacids and azithromycin simultaneously. After bariatric or weight-loss surgery, patients may no longer be able to take whole pills or tablets. So, these patients often need medications that come in formulations that are chewable, liquid, or are able to be crushed. Bariatric patients will not be able to take extended-release formulations or medications that are enteric-coated. Azithromycin is an antibiotic that helps the body fight bacteria. It is used to treat bacterial infections, including respiratory infections, ear infections, sinus infections, certain sexually transmitted diseases STDs, skin infections, pelvic inflammatory disease PID, and Strep throat. Azithromycin: MedlinePlus Drug Information. Azithromycin mg side effects of azithromycin in cats azithromycin mylan og alkohol azithromycin for strep b azithromycin related to erythromycin azithromycin and getting pregnant what does azithromycin 500mg treat take aspirin with azithromycin how should azithromycin be taken for chlamydia drug interaction with azithromycin what std is azithromycin 500mg used for azithromycin time to work chlamydia azithromycin 250 for strep throat azithromycin 250 mg chlamydia side effects oral thrush after azithromycin azithromycin 250 mg treatment for toothache relief reviews is azithromycin good for toothache diarrhea 2 hours after taking azithromycin incidence c diff azithromycin 250 mg can you take azithromycin and clindamycin at the same time bactrim and azithromycin therapy dog training doxycycline vs azithromycin chlamydia can azithromycin be cut in half azithromycin side effects triglycerides acne treatments azithromycin for oily skin azithromycin making me feel sick can u drink wine with azithromycin azithromycin stability and degradation difference between azithromycin and doxycycline is azithromycin 100 effective for chlamydia azithromycin for cryptogenic organizing pneumonia azithromycin 250 mg cost for 4 tablespoons to cups flour azithromycin in 3rd trimester pregnancy can you take fluconazole and azithromycin is azithromycin good for fever high fever after taking azithromycin azithromycin 250mg tablets uti is azithromycin a steroid drug azithromycin clear up nasy phlegm cough can azithromycin cure a bladder infection penicillin allergy and azithromycin azithromycin 250mg enough to cure chlamydia azithromycin and coughing blood clot azithromycin tablets ip 500mg hhazi 500 mg tablet cefixime & azithromycin tablets in hindi 2 g azithromycin for gonorrhea efficacy solubility profile of azithromycin

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