Generic drug of the therapeutic class: Infectiology - Parasitology
active ingredients: Azithromycin
laboratory: Pfizer Holding France
Box of 8
Azadose is indicated for the prophylaxis of Mycobacterium avium-intracellular (MAC) infections in human immunodeficiency virus (HIV) infected patients with a CD4 count below 100 / mm 3 .
Official recommendations concerning the appropriate use of antibacterials should be taken into account.
Dosage AZADOSE 600 mg Film-coated tablet Box of 8
Azadose will be given as a single dose. The tablets can be taken during or outside meals. However, administration before a meal may improve the gastrointestinal tolerance of the product.
For the prophylaxis of MAC infections in HIV-infected patients the dosage is 1200 mg once a week.
The same dosage will be recommended.
The same dosage will be used in case of mild renal insufficiency (creatine clearance> 40ml / min).
There is no data available for patients with more severe renal impairment (see Warnings and Precautions section ).
The 1200 mg weekly dose will be used in mild to moderate hepatic impairment (see Warnings and Precautions ).
The efficacy and safety of azithromycin in the prophylaxis of MAC infections has not been studied in children. Based on available pharmacokinetic data in children, a dose of 20 mg / kg should represent the same exposure as the 1200 mg dose in adults, but with a higher maximum concentration.
This medicine MUST NEVER BE USED in case of:
· A history of allergic reaction to azithromycin, erythromycin, any other macrolide or any of the excipients,
· Combination with alkaloids of ergot: dihydroergotamine, ergotamine (see sections Warnings and precautions for use and Interactions with other medicinal products and other forms of interaction ),
· Combination with cisapride (see section Interactions with other medicinal products and other forms of interaction ),
· Combination with colchicine (see section Interactions with other medicinal products and other forms of interaction ),
· Severe hepatic impairment (see Warnings and Precautions section ).
Azadose side effects
The table below presents the undesirable effects identified during the clinical trials and after the placing on the market by organ systems and frequency. Adverse effects reported post-marketing are shown in italics. Group frequencies are defined according to the following convention: very common (³ 1/10); frequent (³ 1/100 to <1/10); uncommon (1/ 1/1000 to <1/100); rare (1/10000 to <1/1000); very rare (<1/10000); and indeterminate (can not be estimated from the available data). Within each group frequency, adverse effects are presented in descending order of severity.
Adverse effects possibly or probably related to azithromycin based on experience in clinical trials and post-marketing surveillance:
Classes of organ systems
Infections and Infestations
Candidiasis, Oral candidiasis, vaginitis
Pseudomembranous colitis (see section Warnings and precautions for use )
Hematological disorders and
of the lymphatic system
Thrombocytopenia, hemolytic anemia
Anaphylactic reactions (see section Warnings and precautions for use )
Metabolism and nutrition disorders
Hypoesthesia, drowsiness, insomnia
Syncope, convulsion, psychomotor hyperactivity, anosmia, ageusie, parosmie, myasthenia gravis (see section Warnings and precautions for use )
Affections of the ear and
Hearing disorders, tinnitus
Torsades de pointes (see section Warnings and precautions for use ), arrhythmia (see section Warnings and precautions for use ) including ventricular tachycardia
Diarrhea, abdominal pain, nausea,
Pancreatitis, discolouration of the tongue
Liver function disorders
Hepatic insufficiency (see Warnings and precautions for use ), fulminant hepatitis, hepatic necrosis, cholestatic jaundice
Affections of the skin and
Skin rash, pruritus
Lyell syndrome, erythema multiforme
Musculoskeletal and systemic disorders
Kidney disorders and pathways
Acute renal failure, nephritis
General disorders and abnormalities
at the administration site
Chest pain, edema, malaise,
Decreased lymphocyte count, increased count of eosinophils, decreased blood bicarbonate concentration
Increase of aspartate aminotransferase, increase of alanine aminotransferase, increase of bilirubinemia, increase of uremia, increase of serum creatinine, abnormal concentration of potassium in the blood
QT prolongation on the electrocardiogram (see section Warnings and precautions for use )