Medicinal Products

AZITHROMYCIN RANBAXY 250 mg

Generic drug of Zithromax
Therapeutic class: Infectiology - Parasitology
active ingredients: Azithromycin
laboratory: Ranbaxy Pharma Generic

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 AZITHROMYCIN RANBAXY 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 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 impairment (see Warnings and Precautions for Use section ).

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 ).

This medicine is contraindicated in patients with wheat allergy (other than celiac disease).

Azithromycin Ranbaxy side effects

· Cutaneous-mucous and allergic: rash, photosensitivity, arthralgia, urticaria, pruritus, rarely angioedema, anaphylactic reactions. Rare cases of severe skin reactions have been reported.

· Gastrointestinal: nausea, vomiting, dyspepsia, diarrhea (rarely severe), abdominal pain, pancreatitis. Rare cases of pseudomembranous colitis have been reported.

· Hepatic: increased liver enzymes reversible upon discontinuation of treatment. Rare cases of hepatic necrosis and hepatic insufficiency have rarely been life-threatening. However, no causal link could be established.

Isolated cases of cholestatic hepatitis have been reported.

· Neurological: dizziness; rare cases of seizures have been reported.

· Hematologic: isolated cases of thrombocytopenia have been reported.

· Psychiatric: rare cases of aggressive behavior, nervousness, agitation and anxiety have been reported.

· Genitals: vaginitis.

· Hearing aids: rare cases of hearing problems with tinnitus or deafness have been reported.

· General: candidiasis.

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