Medicinal Products

AZADOSE 600 mg

Generic drug of the therapeutic class: Infectiology - Parasitology
active ingredients: Azithromycin
laboratory: Pfizer Holding France

Coated tablet
Box of 8
All forms

Indication

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

Administration mode

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.

Dosage

In adults:

For the prophylaxis of MAC infections in HIV-infected patients the dosage is 1200 mg once a week.

Elderly:

The same dosage will be recommended.

Renal failure:

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 ).

Hepatic insufficiency:

The 1200 mg weekly dose will be used in mild to moderate hepatic impairment (see Warnings and Precautions ).

children:

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.

Against indications

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

Undesirable effect

Frequency

Infections and Infestations

Candidiasis, Oral candidiasis, vaginitis

Rare

Pseudomembranous colitis (see section Warnings and precautions for use )

Undetermined

Hematological disorders and

Leukopenia, neutropenia

Rare

of the lymphatic system

Thrombocytopenia, hemolytic anemia

Undetermined

System conditions

Angioedema, hypersensitivity

Rare

immune

Anaphylactic reactions (see section Warnings and precautions for use )

Undetermined

Metabolism and nutrition disorders

Anorexia

Frequent

Psychiatric disorders

Nervousness

Rare

agitation

Rare

Aggressiveness, anxiety

Undetermined

System conditions

Dizziness, headache,

Frequent

nervous

paresthesia, dysgeusia

Hypoesthesia, drowsiness, insomnia

Rare

Syncope, convulsion, psychomotor hyperactivity, anosmia, ageusie, parosmie, myasthenia gravis (see section Warnings and precautions for use )

Undetermined

Eye disorders

Visual disorders

Frequent

Affections of the ear and

Deafness

Frequent

labyrinth

Hearing disorders, tinnitus

Rare

Dizziness

Rare

Heart conditions

palpitations

Rare

Torsades de pointes (see section Warnings and precautions for use ), arrhythmia (see section Warnings and precautions for use ) including ventricular tachycardia

Undetermined

Vascular disorders

hypotension

Undetermined

Gastrointestinal disorders

Diarrhea, abdominal pain, nausea,

Very common

flatulence

Vomiting, dyspepsia

Frequent

Gastritis, constipation

Rare

Pancreatitis, discolouration of the tongue

Undetermined

Hepatobiliary disorders

Hepatitis

Rare

Liver function disorders

Rare

Hepatic insufficiency (see Warnings and precautions for use ), fulminant hepatitis, hepatic necrosis, cholestatic jaundice

Undetermined

Affections of the skin and

Skin rash, pruritus

Frequent

subcutaneous tissue

Stevens-Johnson Syndrome,

Rare

photosensitivity, urticaria

Lyell syndrome, erythema multiforme

Undetermined

Musculoskeletal and systemic disorders

arthralgia

Frequent

Kidney disorders and pathways

Acute renal failure, nephritis

Undetermined

urinary

interstitial

General disorders and abnormalities

Tired

Frequent

at the administration site

Chest pain, edema, malaise,

Rare

asthenia

investigations

Decreased lymphocyte count, increased count of eosinophils, decreased blood bicarbonate concentration

Frequent

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

Rare

QT prolongation on the electrocardiogram (see section Warnings and precautions for use )

Undetermined

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