Azioptic eye drops 15 mg/g 250 mg No. 6




"Azioptic Rompharm" is intended for local antibacterial therapy of conjunctivitis caused by strains sensitive to it, in children from the first days of life and adults, namely:
purulent bacterial conjunctivitis; trachomatous conjunctivitis caused by Chlamydia trachomatis.Composition
Active ingredient: azithromycin;
1 g of solution contains 15 mg of azithromycin dihydrate, which is equivalent to 14.3 mg of azithromycin;
1 single-dose container (250 mg solution) contains 3.75 mg of azithromycin dihydrate;
Excipients: medium chain triglycerides.
Contraindication
Hypersensitivity to azithromycin or to any other macrolide or to any other component of the drug.
Methods of application
The drug is used for instillation into the eyes.
It is necessary for the doctor to provide the patient with recommendations on the proper use of the antibacterial agent.
Application features
The drug is not intended for oral or injectable use, including periocular or intraocular injection.
Pregnancy
Since the systemic effects of azithromycin are clinically insignificant, the drug can be used during pregnancy and breastfeeding.
Children
Comparative efficacy and safety studies of the use of Azioptic Rompharm eye drops for the treatment of trachomatous conjunctivitis in children under 1 year of age have not been conducted. However, there are no known safety concerns or differences in the pathophysiology of the disease that would preclude its use in children under 1 year of age for this indication, taking into account clinical experience in children over 1 year of age and experience in children from birth for the treatment of purulent bacterial conjunctivitis.
Drivers
Temporary loss of visual acuity may occur after instillation. In this case, the patient should wait until normal vision returns before driving or operating machinery.
Overdose
The total amount of azithromycin intended to treat both eyes is too small to cause symptoms of overdose if the contents of a single-dose container are administered intravenously or orally.
Adverse reactions
On the part of the immune system:
uncommon: angioedema, hypersensitivity reactions.From the side of the organs of vision (at the injection site):
very common: eye discomfort (itching, burning, stinging). common: blurred vision, feeling of sticking of the eyelids, foreign body sensation. uncommon: conjunctivitis, allergic conjunctivitis, keratitis, eyelid eczema, eyelid oedema, eye allergy, conjunctival hyperaemia, increased lacrimation, eyelid erythema.Interaction
No specific studies have been conducted on the interaction with the drug Azioptic Rompharm.
Storage conditions
Store in the original package at a temperature not exceeding 25 °C. Keep out of the reach of children. Store single-dose containers in the sachet in order to protect from light.
Shelf life - 18 months.
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