Medicinal Products

AZITHROMYCINE PFIZER 250 mg

Generic drug of Zithromax
Therapeutic class: Infectiology - Parasitology
active ingredients: Azithromycin
laboratory: Pfizer Holding France

Coated tablet
Box of 6
All forms

Indication

They arise from the antibacterial activity and pharmacokinetic characteristics of azithromycin. They take into account both the clinical studies that gave rise to this drug and its place in the range of antibacterial products currently available.

They are limited to infections due to germs defined as sensitive:

· Documented angina at beta-hemolytic streptococcus A, as an alternative to beta-lactam therapy, especially when it can not be used.

· Superinfections of acute bronchitis,

· Exacerbations of chronic bronchitis,

· Stomatological infections.

Official recommendations concerning the appropriate use of antibacterials should be taken into account.

Dosage AZITHROMYCINE PFIZER 250 mg Film-coated tablet Box of 6

Dosage

Adult

· Tonsillitis, stomatologic infections: 500 mg (2 tablets) daily for 3 days.

This dosage, with a short duration of administration of 3 days, is explained by the particular pharmacokinetic properties of azithromycin and the maintenance of the activity, in these indications, several days after the last dose.

· Superinfections of acute bronchitis, exacerbations of chronic bronchitis: 500 mg (2 tablets) the first day then 250 mg (1 tablet) the following 4 days. The duration of treatment will be 5 days.

· No dosage modification in the elderly.

· Same dosage in patients with moderate to moderate hepatic insufficiency (see section 4.4 Special warnings and precautions for use ).

Administration mode

The tablets can be taken during or after meals, in a single daily dose.

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 ).

Adverse effects Azithromycin Pfizer

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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