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ZITHROMAX Capsule, hard (2018)

Active ingredients: Azithromycin

Product Name and Form

ZITHROMAX 250 mg CAPSULES.

Pharmaceutical form

Capsule, hard.

White, hard gelatin capsules marked Pfizer and ZTM 250.

Qualitative and Quantitative Composition

Each capsule contains azithromycin dihydrate 262.05 mg equivalent to 250 mg azithromycin base.

Excipients with known effect: Each capsule contains lactose anhydrous, and sulfur dioxide.

For the full list of excipients, see section 6.1.

Chemical substance
Description
Azithromycin

Azithromycin is a macrolide antibiotic belonging to the azalide group. The molecule is constructed by adding a nitrogen atom to the lactone ring of erythromycin A. The mechanism of action of azithromycin is based upon the suppression of bacterial protein synthesis by means of binding to the ribosomal 50S sub-unit and inhibition of peptide translocation.

List of excipients

Capsule content:

Lactose anhydrous
Magnesium stearate
Maize starch
Sodium lauryl sulfate

Capsule shell:

Gelatin
Titanium dioxide (E171)

Printing Ink:

Black iron oxide (E172)
Propylene glycol
Shellac
Sulfur dioxide

Pack sizes and Marketing

Zithromax Capsules are available as:

Packs of 2 capsules. Aluminium/PVC blister strips, 2 capsules per strip, 1 strip in a carton box.

Packs of 4 capsules. Aluminium/PVC blister strips, 4 capsules per strip, 1 strip in a carton box.

Pack of 6 capsules. Aluminium/PVC blister strips, 6 capsules per strip, 1 strip in a carton box.

Polythene capsule container with child resistant cap, 100 capsules per container.

Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

Pfizer Limited, Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

Date of first authorisation: 4 April 1991

Date of latest renewal: 7 September 1996

Marketing authorization number:

PL 00057/0335