Rozamax (latanoprost, timolol) eye drops solution 2.5 ml. vial

Description

Rozamax (latanoprost, timolol) eye drops solution 2.5 ml. vial 

Composition

active substance: latanoprost; timolol;

1 ml of solution contains latanoprost – 0.05 mg and timolol maleate – 6.83 mg, which is equivalent to timolol – 5.00 mg;

excipients: benzalkonium chloride, sodium chloride, sodium dihydrogen phosphate monohydrate, anhydrous sodium hydrogen phosphate, sodium hydroxide and/or dilute hydrochloric acid, water for injections.

Medicinal form

Eye drops, solution.

Main physicochemical properties: transparent, colorless aqueous solution.

Pharmacotherapeutic group

Antiglaucoma drugs and miotic agents.
ATX code S01E D51.

Pharmacological properties

This drug belongs to the group of combined miotic drugs that are used in the treatment of glaucoma.
The main mechanism of action of its main active ingredients is latanoprost and timolol.
The mechanism of the first is the ability to increase uveoscleral outflow. Has shown its effectiveness when used as a monopreparation. It is also active in combination with beta-blockers, in particular timolol.
Latanoprost does not affect the excretion of intraocular fluid by the body. Does not affect the blood-ophthalmic barrier.

Has no effect (or it is insignificant) on the blood circulation inside the eye. At the same time, when applied topically, conjunctivitis and episcleral hyperemia can be observed.
Timolol, in turn, is a non-selective beta-1 and beta-2 adrenergic blocker. Helps to reduce the amount of discharge of aqueous humor.

Indications

This drug is used to treat increased ocular pressure, with insufficient effect from treatment with beta-blockers or local prostaglandin analogs.
Including, for:

• reduction of increased intraocular pressure in patients with open-angle glaucoma and increased intraocular pressure;
• reduction of increased intraocular pressure in pediatric patients with increased intraocular pressure and childhood glaucoma.

Contraindications

Not applicable if the patient has hypersensitivity (allergy) to one of the components that make up the drug.
Contraindicated in:

• reactive diseases of the respiratory organs, including bronchial asthma, COPD;
• sinus bradycardia;
• sick sinus syndrome;
• sinus-auricular block;
• atrioventricular blockade of the 2-3rd degree, which cannot be controlled by a pacemaker;
• heart failure;
• cardiogenic shock.

Not used in pediatrics.

Application during pregnancy and lactation

It is not used to treat pregnant women.
If there is a need to take this drug, then lactation (breastfeeding) should be suspended during treatment.

Method of administration and dosage

The recommended dosage is 1 drop of Rozamax is injected daily into the affected eye, 1 time per day.
The greatest effect is achieved if the drug is used in the evening, before going to bed.
More frequent use reduces the effectiveness of the drug (pressure does not decrease as actively), therefore, increasing the dosage is not recommended.
Missing a dose is not a reason for increasing the dosage or frequency of administration of the drug.
To increase the effectiveness of the effect, after instilling the drug, you need to slightly press down the eyelids, squeezing the lacrimal sac (inner corner of the eye).
Contact lenses are removed before instillation. Their installation is possible only after 15-20 minutes.
If there is a need to instill other eye drops, then the break between their use should be at least 5 minutes.
Children’s dosage and frequency of administration does not differ from that of an adult.
The duration of treatment is determined by the attending physician.

Overdose

An overdose of the drug can cause:

• eye irritation;
• conjunctivitis;
• conjunctival hyperemia;
• bradycardia;
• bronchospasm;
• heart failure;
• arterial hypotension.

Accidental swallowing of the drug in large quantities may cause:

• nausea;
• vomiting;
• abdominal pain;
• increased sweating;
• increased fatigue;
• bronchospasm;
• hot flashes.

In this case, treatment of symptoms, gastric lavage, and intake of enterosorbents is recommended.
Dialysis is ineffective.

Side effects

Therapy with this drug can cause side reactions in the form of:

• herpetic keratitis, keratitis, blepharitis;
• increased pigmentation of the iris;
• changes in eyelashes and vellus hair (increase in length, thickness, pigmentation and quantity);
• mild to moderate conjunctival hyperemia, eye irritation (burning with gritty sensation in the eyes, itching, dryness, tingling and foreign body sensation in the eye);
• point epithelial erosions, often asymptomatic;
• pain in the eyes;
• swelling of the eyelids;
• blurred vision, especially the first 15 minutes after the instillation procedure;
• conjunctivitis;
• iritis, uveitis;
• macular edema, symptomatic edema and corneal erosion;
• periorbital edema,
• the growth of eyelashes in the wrong direction, which can cause eye irritation, as well as the appearance of an additional row of eyelashes in the excretory ducts of the meibomian glands (distichiasis);
• photophobia;
• exacerbation of angina pectoris in patients with concomitant diseases;
• tachycardia;
• bronchial asthma, shortness of breath;
• rashes;
• myalgia, arthralgia;
• extremely rare – corneal calcification due to the intake of eye drops containing phosphate in some patients who have significantly damaged the cornea.