Azyter 15mg/g eye drops 0.25g unit dose

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Azithromycin dihydrate

Available from:

Thea Pharmaceuticals Ltd

ATC code:

S01AA26

INN (International Name):

Azithromycin dihydrate

Dosage:

15mg/1gram

Pharmaceutical form:

Eye drops

Administration route:

Ocular

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 11030100; GTIN: 3662042000294

Summary of Product characteristics

OBJECT 1
AZYTER
Summary of Product Characteristics Updated 10-Sep-2013 | Thea
Pharmaceuticals Ltd
1. Name of the medicinal product
Azyter 15 mg/g, eye drops, solution in single-dose container
2. Qualitative and quantitative composition
Each gram of solution contains 15 mg of azithromycin dihydrate
equivalent to 14.3 mg of azithromycin.
One single-dose container of 250 mg solution contains 3.75 milligrams
of azithromycin dihydrate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Eye drops, solution in single-dose container.
Clear, colourless to slightly yellow, oily liquid.
4. Clinical particulars
4.1 Therapeutic indications
AZYTER 15 mg/g, eye drops, solution in single-dose container is
indicated for the local antibacterial
curative treatment of conjunctivitis caused by susceptible strains
(see sections 4.4 and 5.1):
- Purulent bacterial conjunctivitis in children (aged from birth to 17
years) and adults
- Trachomatous conjunctivitis caused by _Chlamydia trachomatis _in
children (aged from birth to 17 years)
and adults (see section 4.4 “Use in neonates“).
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 Posology and method of administration
_Posology_
Adult population
Instil one drop in the conjunctival fornix twice a day, morning and
evening, during three days.
It is unnecessary to prolong treatment beyond three days.
Adherence to the dosing regimen is important for the success of
treatment.
Elderly patients
No dose adjustment is necessary.
_Paediatric population_
No dose adjustment is necessary (see section 4.4 and 5.1).
_Method of administration_
Ocular use.
The patient should be advised to:
- thoroughly wash hands before and after the instillation,
- avoid touching the eye or eyelids with the dropper tip of the
single-dose container,
- discard the single-dose container after use, and not keep it for
subsequent use.
4.3 Contraindications
Hypersensitivity to azithromycin, to any other macrolide or to the
excipient listed in section