Active Substance: Azithromycin (as dihydrate).
Overview
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This medicine contains an important and useful components, as it consists of
Azithromycin (as dihydrate)is available in the market in concentration
Azithromycin
- **Liver Disease**: Azithromycin should be used with caution in patients with liver disease, including those with a history of jaundice or hepatic dysfunction, as it is primarily metabolized in the liver. Liver function tests should be monitored during treatment in these individuals. - **Cardiac Arrhythmias**: Azithromycin has been associated with QT prolongation, which can lead to life-threatening arrhythmias such as torsades de pointes. It should be used cautiously in patients with a history of cardiac arrhythmias, electrolyte disturbances, or those on other medications that prolong the QT interval. - **Renal Impairment**: While azithromycin is mainly excreted in the bile, it should be used with caution in patients with severe renal impairment. Monitoring renal function is recommended during prolonged treatment. - **Superinfection**: Prolonged or repeated use of azithromycin can lead to the overgrowth of non-susceptible organisms, including fungi, which can result in superinfections. Any signs of new infections should be closely monitored. - **Pregnancy and Breastfeeding**: Azithromycin is generally considered safe during pregnancy, classified as a Category B drug by the FDA, meaning there is no evidence of risk to the fetus in human studies. It is also considered safe for breastfeeding, as only small amounts pass into breast milk. - **Elderly Patients**: Older adults may be at higher risk of cardiovascular side effects, such as arrhythmias. Therefore, azithromycin should be used at lower doses or with close monitoring in elderly patients, especially those with pre-existing heart conditions.
- **Respiratory Tract Infections**: Azithromycin is commonly used to treat bacterial infections of the respiratory tract, including acute bacterial sinusitis, bacterial pharyngitis, and community-acquired pneumonia. - **Skin and Soft Tissue Infections**: It is indicated for skin infections caused by susceptible organisms, including cellulitis, impetigo, and soft tissue abscesses. - **Ear Infections**: Azithromycin is often prescribed to treat otitis media (middle ear infections) in children and adults. - **Sexually Transmitted Infections**: Azithromycin is used in the treatment of sexually transmitted diseases, including chlamydia, gonorrhea, and syphilis (often in combination with other antibiotics). - **Gastrointestinal Infections**: It can be used for certain gastrointestinal infections, such as traveler's diarrhea caused by *Campylobacter* or *Shigella* species. - **Helicobacter Pylori Eradication**: Azithromycin is sometimes used as part of a combination therapy to eradicate *Helicobacter pylori*, a bacterium associated with peptic ulcers. - **Chronic Obstructive Pulmonary Disease (COPD)**: Azithromycin may be prescribed for the prevention of exacerbations of COPD, particularly in patients with a history of frequent flare-ups.
- **Hypersensitivity**: Azithromycin is contraindicated in patients who have a known hypersensitivity or allergic reaction to azithromycin, other macrolide antibiotics, or any of the excipients in the formulation. - **History of Jaundice**: Azithromycin is contraindicated in patients with a history of jaundice or hepatic dysfunction related to previous use of azithromycin, as this may worsen liver function. - **Prolonged QT Interval**: Azithromycin is contraindicated in patients with a history of QT prolongation or those taking other medications that can prolong the QT interval, such as certain antiarrhythmic drugs. - **Severe Renal Impairment**: Azithromycin is contraindicated in patients with severe renal impairment (CrCl <10 mL/min), as the drug is primarily cleared by the liver, and impaired renal function could lead to accumulation. - **Infants**: Azithromycin should be used with caution in infants and young children, particularly in those less than 6 months old, due to the risk of side effects like diarrhea or stomach upset.
- **Gastrointestinal Issues**: Common side effects of azithromycin include nausea, vomiting, abdominal pain, diarrhea, and indigestion. These are usually mild and transient but may be bothersome. - **QT Prolongation**: Azithromycin can cause QT prolongation, which increases the risk of serious arrhythmias, particularly in patients with underlying heart conditions. Monitoring of the ECG is recommended in at-risk individuals. - **Liver Toxicity**: In rare cases, azithromycin can cause liver toxicity, manifesting as elevated liver enzymes, jaundice, and hepatic failure. Liver function should be monitored in patients receiving long-term therapy. - **Rash and Allergic Reactions**: Some patients may experience skin rashes, which could be a sign of an allergic reaction. Severe allergic reactions, including anaphylaxis, are rare but possible. - **Hearing Loss**: High doses of azithromycin or prolonged use have been associated with reversible hearing loss, especially in patients with pre-existing hearing issues. - **Candidiasis**: Use of azithromycin can lead to fungal overgrowth, including oral or vaginal candidiasis (thrush or yeast infections), especially with prolonged use. - **Fatigue and Dizziness**: Some patients may experience dizziness, headache, or a general feeling of tiredness during treatment. - **Clostridium difficile-associated Diarrhea**: Long-term or inappropriate use of azithromycin can lead to the overgrowth of *Clostridium difficile* in the colon, causing severe diarrhea (pseudomembranous colitis). This requires prompt medical attention.
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- **Bacteriostatic Action**: Azithromycin is a macrolide antibiotic that works by inhibiting bacterial protein synthesis. It binds to the 50S ribosomal subunit of the bacterial cell, preventing the elongation of protein chains and effectively halting bacterial growth. This action is bacteriostatic, meaning it prevents bacteria from multiplying, allowing the immune system to eliminate the infection. - **Broad-spectrum Activity**: Azithromycin is effective against a wide range of bacteria, including both Gram-positive and Gram-negative organisms, atypical bacteria, and some parasites. This broad-spectrum activity makes it effective for treating a variety of infections, from respiratory tract infections to sexually transmitted diseases. - **Long Half-life**: Azithromycin has a long half-life, which allows for once-daily dosing and shorter treatment durations. Its ability to remain in the body for an extended period helps to maintain therapeutic levels for longer, making it effective even with a brief course of treatment.
- **Antacids**: Azithromycin may interact with antacids containing aluminum or magnesium, which can reduce the absorption of azithromycin. It is recommended to take azithromycin at least 1 hour before or 2 hours after taking an antacid. - **CYP450 Inhibitors**: Azithromycin is metabolized by the liver enzyme CYP3A4, so medications that inhibit this enzyme (e.g., ketoconazole, erythromycin) may increase azithromycin levels in the blood, increasing the risk of side effects. - **Warfarin**: Azithromycin may interact with anticoagulants like warfarin, enhancing the effects of warfarin and increasing the risk of bleeding. Regular monitoring of INR is recommended when these drugs are taken together. - **Statins** : Combining azithromycin with statins (such as simvastatin or atorvastatin) may increase the risk of muscle toxicity, including rhabdomyolysis. If these drugs are used together, patients should be closely monitored for muscle pain, weakness, or tenderness. - **Cyclosporine**: Co-administration of azithromycin and cyclosporine may increase cyclosporine levels and the risk of nephrotoxicity. Dosage adjustments of cyclosporine may be necessary. - **Digoxin**: Azithromycin may increase the serum concentration of digoxin, increasing the risk of digoxin toxicity. Monitoring of digoxin levels is advised when used together.
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- **Respiratory Infections**: For adults with infections like pneumonia, bronchitis, or sinusitis, azithromycin is typically dosed as a 500 mg loading dose on day 1, followed by 250 mg daily for 4 more days (total of 5 days). - **Skin and Soft Tissue Infections**: The typical dosage for skin infections is 500 mg once daily for 3 to 5 days, depending on the severity of the infection. - **Chlamydia**: For the treatment of uncomplicated genital chlamydia, the usual dose is a single 1 gram (1000 mg) dose, taken as a single oral dose. - **Sexually Transmitted Infections (STIs)**: For gonorrhea, a single dose of 2 grams (2000 mg) may be administered along with other antibiotics, depending on the local resistance patterns and clinical guidelines. - **Acute Sinusitis**: For acute bacterial sinusitis, the recommended dose is 500 mg once daily for 3 days. - **COPD Exacerbation**: For prevention of COPD exacerbations, a typical dose is 250 mg once daily for 3 days, taken during flare-ups.
- **Respiratory Infections**: For children aged 6 months and older, the typical dose for respiratory infections is 10 mg/kg on the first day (up to 500 mg), followed by 5 mg/kg daily for the next 4 days. This is equivalent to a total 5-day course. - **Otitis Media**: For children with otitis media, a common dose is 10 mg/kg on day 1, followed by 5 mg/kg daily for 4 days. - **Chlamydia**: For pediatric patients with chlamydia, the dose is generally 20 mg/kg per day (max 1 gram) for 3 days. - **Skin and Soft Tissue Infections**: For children with skin infections, the usual dosage is 10 mg/kg on the first day, followed by 5 mg/kg daily for the remainder of the treatment course.
- **Renal Impairment**: In patients with mild to moderate renal impairment, no dosage adjustment is necessary for azithromycin, as it is primarily excreted through the liver. However, in cases of severe renal impairment (CrCl <10 mL/min), caution should be exercised due to limited data, and alternative antibiotics may be considered if necessary. - **Renal Monitoring**: For patients with renal conditions, regular monitoring of kidney function is advised, particularly when azithromycin is used for extended periods or in high doses.
Information not available