Rozenta Dosage/Direction for Use

Oral azithromycin should be administered as a single daily dose. The period of dosing with regard to infection is given as follows.
Tablet: Azithromycin tablets should only be administered to children weighing more than 45 kg.
The safety and efficacy of intravenous azithromycin for the treatment of infections in children have not been established. Safety and efficacy for the prevention or treatment of MAC in children have not been established. Based on pediatric pharmacokinetic data, a dose of 20 mg/kg would be similar to the adult dose of 1,200 mg but with a ^higherCmax.
Elderly: The same dosage as in adult patients is used in the elderly. Elderly patients may be more susceptible to the development of Torsades de pointes arrhythmia than younger patients.
In Patients with Renal Impairment: No dose adjustment is necessary in patients with mild to moderate renal impairment (GFR 10-80 mL/min). Caution should be exercised when azithromycin is administered to patients with severe renal impairment (GFR <10 mL/min).
In Patients with Hepatic Impairment: The same dosage as in patients with normal hepatic function may be used in patients with mild to moderate hepatic impairment.
Or as prescribed by the physician.
Administration: Azithromycin tablets can be taken with or without food. The tablets should be swallowed whole.
Suspension: Azithromycin tablets, powder for oral suspension can be taken with or without food.
In adults: For the treatment of sexually transmitted diseases caused by Chlamydia trachomatis and Hemophilus ducreyi, the dose is 1,000 mg as a single oral dose. For susceptible Neisseria gonorrhoeae, the recommended dose is 1,000 mg or 2,000 mg of azithromycin in combination with 250 mg or 500 mg of ceftriaxone according to local clinical treatment guidelines. For patients who are allergic to penicillin and/or cephalosporins, prescribers should consult local treatment guidelines. For prophylaxis against MAC infections in patients infected with HIV, the dose is 1,200 mg once per week. For the treatment of DMAC infections in patients with advanced HIV infection, the recommended dose is 600 mg once a day. Azithromycin should be administered in combination with other antimycobacterial agents that have shown in vitro activity against MAC, such as ethambutol, at the approved dose. For the treatment of adult patients with CAP due to the indicated organisms, the recommended dose of IV azithromycin is 500 mg as a single daily dose by the IV route for at least 2 days. IV therapy should be followed by oral azithromycin at a single daily dose of 500 mg to complete a 7- to 10-day course of therapy. The timing of the conversion to oral therapy should be done at the discretion of the physician and in accordance with clinical response.
For the treatment of adult patients with PID due to the indicated organisms, the recommended dose of IV azithromycin is 500 mg as a single dose by the IV route for 1 or 2 days. IV therapy should be followed by oral azithromycin at a single daily dose of 250 mg to complete a 7-day course of therapy. The timing of the conversion to oral therapy should be done at the discretion of the physician and in accordance with clinical response. If anaerobic microorganisms are suspected of contributing to the infection, an antimicrobial anaerobic agent may be administered in combination with azithromycin. For all other indications in which the oral formulation is administered, the total dosage of 1,500 mg should be given as 500 mg daily for 3 days. As an alternative, the same total dose can be given over 5 days with 500 mg given on Day 1, then 25 mg daily on Days 2 to 5.
In children: The maximum recommended total dose for any treatment is 1,500 mg for children. In general, the total dose in children is 30 mg/kg. Treatment for pediatric streptococcal pharyngitis should be dosed at a different regimen (see as follows). The total dose of 30 mg/kg should be given as a single daily dose of 10 mg/kg daily for 3 days, or given over 5 days with a single daily dose of 10 mg/kg on Day 1, then 5 mg/kg on Days 2-5. As an alternative to the previously mentioned dosing, treatment for children with acute otitis media can be given as a single dose of 30 mg/kg. For pediatric streptococcal pharyngitis, azithromycin given as a single dose of 10 mg/kg or 20 mg/kg for 3 days has been shown to be effective; however, a daily dose of 500 mg must not be exceeded. In clinical trials comparing these two dosage regimens, similar clinical efficacy was observed but greater bacteriologic eradication was evident at the 20 mg/kg/day dose. However, penicillin is the usual drug of choice for the treatment of Streptococcus pyogenes pharyngitis, including prophylaxis of rheumatic fever.
For children weighing less than 15 kg, azithromycin suspension should be measured as closely as possible. For children weighing 15 kg or more, azithromycin suspension should be administered according to the guide provided as follows: (See Table 5.)

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Special populations: In the Elderly: The same dosage as in adult patients is used in the elderly. Elderly patients may be more susceptible to the development of Torsades de pointes arrhythmia than younger patients (see Precautions).
In Patients with Renal Impairment: No dose adjustment is necessary in patients with mild to moderate renal impairment (GFR 10-80 mL/min). Caution should be exercised when azithromycin is administered to patients with severe renal impairment (GFR <10 mL/min) (see Precautions and Pharmacology: Pharmacokinetics under Actions).
In Patients with Hepatic Impairment: The same dosage as in patients with normal hepatic function may be used in patients with mild to moderate hepatic impairment (see Precautions).