Ruzit Dosage/Direction for Use

Azithromycin differs from other antibiotics by its high tissue affinity. Azithromycin reaches levels up to 50 times higher in tissue than in plasma and tissue elimination half-life ranges between 2 to 4 days. Thus, azithromycin dose regimen differs from other that of other antibiotics.
Dosage: Children and adolescents up to 45 kg body weight: The dosage in children and adolescents up to 45 kg body weight (KG) is based on the body weight (BW), taking either 10 mg once a day for 3 days in a 3-day regimen.
Azithromycin per kg BW or alternatively in a 5-day therapy schedule on the first day 10 mg/kg BW and 5 mg/kg BW on days 2 to 5 (exception: see streptococcal pharyngitis).
Depending on the body weight, dosing is carried out using the examples in the following tables. (See Tables 3 and 4.)

Click on icon to see table/diagram/image


Click on icon to see table/diagram/image

Acute otitis media: In acute otitis media, the total dose is also 30 mg/kg BW azithromycin. This total dose can be administered as a single dose, 3-day therapy or 5-day therapy (according to the previously mentioned dosing schedule).
Streptococcal pharyngitis: For streptococcal pharyngitis, 10 mg/kg BW or 20 mg/kg BW azithromycin should be administered daily for 3 days. However, the daily dose must not exceed 500 mg. In clinical trials, both doses showed comparable clinical efficacy. With 20 mg/kg BW, however, a higher bacteriological eradication rate can be achieved. Nevertheless, penicillin remains the first choice of treatment for pharyngitis caused by Streptococcus pyogenes. This also applies to the prevention of rheumatic fever.
A maximum total dose in children corresponds to the usual adult dose of 1500 mg azithromycin in all indications.
Adults and adolescents over 45 kg body weight: Adults and adolescents over 45 kg body weight (KG) usually receive a total dose of 1500 mg azithromycin, which can be taken either according to the 3-day therapy schedule or the 5-day therapy schedule: 3-day therapy schedule: 500 mg azithromycin once daily for 3 days, corresponding to 12.5 mL of the prepared suspension once daily.
5-day therapy schedule: Alternatively, a 5-day therapy can be carried out: Day 1: 500 mg azithromycin (corresponding to 12.5 mL suspension) all at once and; Days 2 to 5: 250 mg azithromycin each day (corresponding to 6.25 mL suspension).
Uncomplicated genital infections from Chlamydia trachomatis or sensitive Neisseria gonorrhoeae: Deviating from the previously-mentioned dosages, a simple dose of 1000 mg azithromycin, corresponding to 25 mL of the prepared suspension, is taken for uncomplicated genital infections from Chlamydia trachomatis or sensitive Neisseria gonorrhoeae.
For adults and adolescents over 45 kg body weight, other suitable dosage forms such as film-coated tablets are also available.
A 5-day treatment regimen of azithromycin was shown to have sufficient efficacy in the treatment of pneumonia. In most cases, use of a 3-day treatment regimen also seems to be sufficient.
Older people: The same dose as in adult patients is used in older people. Since older 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 (see Precautions).
In patients with renal impairment: No dose adjustment is necessary in patients with mild to moderate renal impairment with (Glomerular Filtration Rate [GFR] of 10-80 mL/min) (see Precautions and Pharmacology: Pharmacokinetics under Actions).
In patients with hepatic impairment: A dose adjustment is not necessary for patients with mild to moderately impaired liver function (see Precautions and Pharmacology: Pharmacokinetics under Actions).
Method of administration: For oral use after preparation of the suspension (see Preparation of suspension under Cautions for Usage). Preparation yields a white to off-white or slightly yellowish, homogeneous suspension.
Azithromycin can be taken with meals. The bottle must be shaken vigorously before each use.
The daily dose can be measured as described as follows using the included 10 mL dosing syringe with millilitre scale: Place the dosing syringe in the stopper on the bottle.
Rotate the bottle with the dosing syringe in place.
Withdraw the appropriate number of milliliters of the prescribed daily dose into the syringe.
Stand the bottle upright again before removing the dosing syringe.
The measured amount of the suspension can be emptied directly into the child's mouth: As slowly as possible against the inside of the cheek so that the child does not choke; or first put on a spoon.
After each dose, the bottle should be closed well and the dosing syringe cleaned with water.