Edit the instructions. Azithromycin in dosage forms - dispersible tablets, film-coated tablets, capsules, granules for oral suspension, powder for oral suspension, lyophilizate for the preparation of a solution for infusion

October 03, 2016
Active substances:
ICD-10:
I.A30-A49.A31.0    Pulmonary infection caused by Mycobacterium
I.A30-A49.A46    Erys
I.A30-A49.A48.1    Legionnaires' disease
I.A50-A64.A56.0    Chlamydial infections of the lower parts of the genito-urinary tract
I.A50-A64.A56.1    Chlamydial infections of the pelvic organs and other urogenital organs
I.A50-A64.A56.4    Chlamydial pharyngitis
I.A65-A69.A69.2    Lyme disease
VIII.H65-H75.H66    Purulent and unspecified otitis media
X.J00-J06.J00    Acute nasopharyngitis (runny nose)
X.J00-J06.J01    Acute Sinusitis
X.J00-J06.J02    Acute pharyngitis
X.J00-J06.J03    Acute tonsillitis
X.J00-J06.J04    Acute laryngitis and tracheitis
X.J10-J18.J15.9    Bacterial pneumonia, unspecified
X.J10-J18.J16    Pneumonia caused by other infectious agents, not elsewhere classified
X.J10-J18.J16.0    Pneumonia caused by chlamydia
X.J20-J22.J20    Acute bronchitis
X.J30-J39.J31    Chronic rhinitis, nasopharyngitis and pharyngitis
X.J30-J39.J32    Chronic Sinusitis
X.J30-J39.J35.0    Chronic tonsillitis
X.J30-J39.J37    Chronic laryngitis and laryngotracheitis
X.J40-J47.J42    Chronic bronchitis, unspecified
XII.L00-L08.L01    Impetigo
XII.L00-L08.L02    Abscess of skin, boil and carbuncle
XII.L00-L08.L03    Phlegmon
XII.L00-L08.L08.0    Pyoderma
XII.L20-L30.L30.3    Infectious dermatitis
XII.L60-L75.L70    Acne
XIV.N30-N39.N30    Cystitis
XIV.N30-N39.N34    Urethritis and urethral syndrome
XIV.N70-N77.N72    Inflammatory disease of the cervix
Azithromycin, antibiotic-azalide, treatment of chlamydial infections, chlamydia, rhinitis, tonsillitis, otitis media, laryngitis, pharyngitis

In the course of preparation of requirements to safety, efficacy of medicines based on modern scientifically grounded information on the clinical use of medicines containing as active ingredient azithromycin in dosage forms - tablets, dispersible, film-coated tablets, capsules, granules for the preparation of a suspension for ingestion, powder for the preparation of a suspension for oral administration,lyophilizate for the preparation of a solution for infusions, it was found necessary to supplement the instructions for the use of medications with the following information:

1. In the section "Contraindications" remove any information on violations of kidney function.

2. In the "Precautions" section, information on violations of the function kidney present in the following edition: "terminal renal deficiency with GFR (glomerular filtration rate) less than 10 ml / min. "

3. In the section "Method of administration and dose", the information in the section "If the renal function is impaired" is presented in the following edition: "In case of renal dysfunction: in patients with GFR 10-80 ml / min dose adjustment is not required."

4. In the section "Special instructions" information on violations of kidney function should be presented in the following edition: "In case of violations of kidney function: in patients with GFR 10-80 ml / min dose adjustment is not required, drug therapy ... should be conducted with caution under the control of the function kidney ".