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Azithromycin information from DrugsUpdate Reviews / Comments See Available Brands of Azithromycin in India P - Caution when used during

pregnancy. L - Caution when used during lactation FI - Food * Page Contents Pharmacodynamics Pharmacokinetics Azithromycin Uses Azithromycin Side Effects Precautions Special Precautions Other drug interactions Other interactions Dosage Food List of Contraindications Azithromycin and Pregnancy Azithromycin and Lactation Azithromycin and Children Azithromycin and Geriatic Azithromycin and Other Contrandications Storage Lab interference Azithromycin is an azalide, a subclass of macrolide antibiotics. Azithromycin is one of the world's best-selling antibiotics, and is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl -substituted nitrogen atom is incorporated into the lactone ring, thus making th e lactone ring 15-membered. Azithromycin is used to treat or prevent certain bacterial infections, most ofte n those causing middle ear infections, tonsillitis, throat infections, laryngiti s, bronchitis, pneumonia, Typhoid, and sinusitis. In recent years it has primari ly been used to prevent bacterial infections in infants and those with weaker im mune systems. It is also effective against certain urinary tract infections, suc h as non-gonococcal urethritis and cervicitis. Recent studies have also indicate d it to be effective against late-onset asthma, but these findings are controver sial and not widely accepted. Pharmacodynamics Pharmacokinetics Azithromycin blocks transpeptidation by binding to 50s ribosomal subunit of susc eptible organisms and disrupting RNA-dependent protein synthesis at the chain el ongation step. Absorption Reduced by food (capsule formulation); peak plasma concentrations after 2-3 hour s. Distribution Extensive into the tissues (concentrations higher than those in blood), WBC (hig h concentrations), CSF (small amounts). Metabolism Liver (demethylation). Excretion

Via the bile (as unchanged drug and metabolites); via the urine (6% of the dose) . Elimination half-life About 68 hours. Azithromycin Indications / Azithromycin Uses Information Not Available Azithromycin Adverse Reactions / Azithromycin Side Effects Mild to moderate nausea, vomiting, abdominal pain, dyspepsia, flatulence, diarrh oea, cramping; angioedema, cholestatic jaundice; dizziness, headache, vertigo, s omnolence; transient elevations of liver enzyme values. Precautions Monitor Sensitivity Review results of culture and sensitivity testing as appropriate. STD testing Ensure patient being treated for sexually transmitted urethritis or cervicitis h as serologic test for syphilis and cultures for gonorrhea performed at time of d iagnosis and that appropriate antimicrobial therapy and follow-up tests are init iated if infection is confirmed. Therapy response Monitor patient's response to therapy. Special Precautions Impaired liver and renal function; pregnancy and lactation; children. Other Drug Interactions Antacids containing aluminium and magnesium salts reduce rate of absorption. Inc reased risk of ergot toxicity. Potentially Fatal Increased serum concentrations of digoxin and ciclosporin. Other Interactions Food interactions Food may alter absorption. Dosage Oral Skin and soft tissue infections. Adult: 500 mg once daily for 3 days. Alternatively, 500 mg as a single dose on t he 1st day followed by 250 mg once daily for 4 days. Child: >6 mth: 10 mg/kg; 15 25 kg: 200 mg; 26 35 kg: 300 mg; 36 45 kg: 400 mg. Doses t o be taken once daily for 3 days Oral Respiratory tract infections Adult: 500 mg once daily for 3 days. Alternatively, 500 mg as a single dose on t he 1st day followed by 250 mg once daily for 4 days. Child: >6 mth: 10 mg/kg; 15 25 kg: 200 mg; 26 35 kg: 300 mg; 36 45 kg: 400 mg. Doses t o be taken once daily for 3 days Oral Uncomplicated genital infections due to Chlamydia trachomatis Adult: 1 g as a single dose. Oral Uncomplicated gonorrhoea Adult: 2 g as a single dose.

Oral Prophylaxis of disseminated Mycobacterium avium complex (MAC) infections Adult: 1.2 g once every wk. For treatment or secondary prophylaxis: 500 mg once daily with other antimycobacterials. Child: >6 mth: 10 mg/kg once daily for 3 days. Oral Granuloma inguinale Adult: Initially, 1 g followed by 500 mg daily. Alternatively, 1 g once a wk for at least 3 wk, until all lesions have completely healed. Intravenous Active immunisation against typhoid fever caused by Salmonella typhi Adult: 500 mg once daily for 7 days. Food(before/after) Tab May be taken with or without food. (May be taken w/ meals to reduce GI discomfor t.) Susp May be taken with or without food. (May be taken w/ meals to reduce GI discomfor t.) Cap Should be taken on an empty stomach. (Take on an empty stomach 1 hour before or 2 hour after meals.) List of Contraindications Azithromycin and Pregnancy Caution when used during pregnancy. Category B: Either animal-reproduction studies have not demonstrated a foetal ri sk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that w as not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters). Azithromycin and Lactation Caution when used during lactation Azithromycin and Children Acute bacterial sinusitis, acute otitis media, community-acquired pneumonia Safety and efficacy not established in children younger than 6 mo of age. Pharyngitis/Tonsillitis Safety and efficacy not established in children younger than 2 years of age. Ophthalmic solution Safety and efficacy not established in children younger than 1 years of age. IV infusion Safety and efficacy not established in children younger than 16 years of age. Azithromycin and Geriatic Information Not Available Azithromycin and Other Contraindications Hypersensitivity. Storage Intravenous Store below 30C. Oral

Store below 30C. Lab interference None well documented.

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