Окупрес-Е - instructions for use, doses, side effects, contraindications

benzalkonium chloride - 0.01% m / v (preservative), disodium hydrogen phosphate dihydrate, sodium dihydrogen phosphate dihydrate, disodium EDTA, sodium chloride, beta-cyclodextrin, propylene glycol, water for injection.

0.5% solution

Active substance:

Timolol - 5 mg (in the form of timolol maleate).

Excipients:

Description:

Transparent colorless or with a light yellow hue solution without

visible mechanical inclusions.

Pharmacotherapeutic group:Antiglaucoma means β-blocker

ATX: & nbsp

S.01.E.D. Beta-blockers

S.01.E.D.01 Timolol

Pharmacodynamics:

Timolol is a non-selective beta-adrenergic blocker. Has no internal sympathomimetic and membrane-stabilizing activity.

With topical application in the form of eye drops reduces both normal and increased intraocular pressure by reducing the formation of intraocular fluid.Does not affect the size of the pupil and accommodation.

The drug appears after 20 minutes after instillation into the conjunctival cavity. The maximum decrease in intraocular pressure occurs in 1-2 hours and persists for 24 hours.

Pharmacokinetics:

When topical application of timolol maleate quickly penetrates through the cornea. After instillation of eye drops, the maximum concentration of timolol in the aqueous humor of the anterior chamber of the eye is achieved after 1-2 hours.

In an insignificant amount gets into the systemic bloodstream by absorption through the vessels of the conjunctiva, the nasal mucosa and the lacrimal tract. The excretion of timolol metabolites is mainly carried out by the kidneys.

In newborns and young children, the concentration of the active substance is significantly higher than its C_max in adult plasma.

Indications:

- Increased intraocular pressure (ocular hypertension);

- open-angle glaucoma;

- aphakic glaucoma and other types of secondary glaucoma;

- as an additional means to reduce intraocular pressure in closed-angle glaucoma (in combination with miotics);

- congenital glaucoma (with insufficient other therapeutic measures).

Contraindications:

Do not use Okupres-E®, if you previously noted increased individual sensitivity to timolol. The drug is also contraindicated in patients who have the following medical history:

- bronchial asthma or other severe chronic obstructive airway disease;

- sinus bradycardia;

- atrioventricular block of II or III degree;

- severe heart failure;

- cardiogenic shock;

- Allergic reactions with generalized skin rashes;

- severe atrophic rhinitis;

corneal dystrophy.

Carefully:Ocupress-E® should be used with caution in patients with pulmonary insufficiency, severe cerebrovascular insufficiency, heart failure, diabetes mellitus, hypoglycaemia, thyrotoxicosis, myasthenia gravis, and simultaneous administration of other beta-blockers.

Pregnancy and lactation:

Sufficient experience in the use of the drug during pregnancy, breast-feeding and in children is not, however it is established that timolol passes the placental barrier, and also enters breast milk. It is possible to use Okupres-E® for the treatment of children, pregnant and lactating mothers, if the expected curative effect exceeds the risk of possible side effects.

If the drug was used immediately before delivery or during breastfeeding, the newborns should be closely monitored for several days after birth and during the entire treatment period of nursing mothers with Ocupres-E®.

Dosing and Administration:

At the beginning of therapy, 1 drop of Ocupres-E® 0.25% and 0.5% in the diseased eye is instilled in the eye twice a day.

If intraocular pressure with normal use is normalized, you should reduce the dosage - one drop once a day.

Treatment with Ocupres-E® is usually carried out for a long time. Interruption or change in dosage is carried out only according to the prescription of the attending physician.

Side effects:

Local Reactions: irritation and congestion hyperemia, eyelid skin, burning and itching in the eyes, lacrimation, photophobia, corneal epithelial edema, spot surface keratopathy, corneal hypostasis, diplopia, ptosis, dry eyes.When performing fistulizing antiglaucomatous operations, it is possible to develop a detachment of the choroid in the postoperative period.

Systemic reactions:

From the side of the cardiovascular system: heart failure, bradycardia, bradyarrhythmia, lowering of arterial pressure, collapse, atrioventricular blockade, cardiac arrest, transient cerebral circulation disorders.

From the respiratory system: shortness of breath, bronchospasm, pulmonary insufficiency.

From the central nervous system: headache, dizziness, weakness, depression, paresthesia.

From the gastrointestinal tract: nausea, diarrhea.

Allergic reactions: urticaria, eczema.

Rhinitis, violation of sexual functions, alopecia.

Local application in newborns can lead to apnea.

In case of side effects, stop using the drug and contact your doctor (ophthalmologist) as soon as possible.

Overdose:

It is possible to develop general-resorptive effects, characteristic for beta-blockers. dizziness, headache, arrhythmia, bradycardia, bronchospasm, nausea, vomiting.

Treatment: immediately wash eyes with water or saline solution, symptomatic therapy.

Interaction:

Co-administration of the preparation "Okupresa-E" with eye drops containing epinephrine, can cause a dilated pupil.

Specific action of the drug - decrease in intraocular pressure - is enhanced with simultaneous use of eye drops containing epinephrine and pilocarpine, bury in the eyes of two beta-blocker should not.

Reduction of blood pressure and slowing of the heart rhythm can be potentiated by joint application of the drug with blockers of slow calcium channels, reserpine and other beta-blockers.

Simultaneous use with insulin or oral antidiabetics can lead to hypoglycemia.

Timolol strengthens the action of peripheral muscle relaxants, therefore, it is necessary to cancel the drug 48 hours before the planned surgical intervention with the use of general anesthesia.

These data can also refer to medicines that were applied shortly before.

Special instructions:

It is necessary to visit the doctor regularly to measure intraocular pressure and examine the cornea.

If the patient wears soft contact lenses, he should not use Okupres-E® eye drops with 0.25% and 0.5%, since the preservative can be deposited in soft contact lenses and adversely affect the eyes.

Strict contact lenses should be removed before instillation of the preparation and they should be worn again only after 15 minutes.

Immediately after instillation of the drug, it is possible to reduce visual clarity and slow mental reactions, which may reduce the ability to actively participate in street traffic, machine maintenance or work without reliable support. In an even greater degree, this is the case with the simultaneous use of the drug with alcohol.

When transferring patients to treatment with timolol, correction of refraction after effects caused by previously used miotics may be necessary.

In the case of an upcoming surgical intervention with general anesthesia, it is necessary to cancel the drug within 48 hours.

Effect on the ability to drive transp. cf. and fur:Immediately after instillation of the drug, it is possible to reduce the clearness of vision and the slowing of mental reactions,which can reduce the ability to actively participate in traffic, machine maintenance or work without reliable support.

Form release / dosage:

Eye drops 0.25% and 0.5%.

Packaging:A polyethylene dropper bottle with a screw cap, packed in a polyethylene film containing 5 ml of the drug, is placed in a pack of cardboard with instructions for use.

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C. Keep away from children.

Shelf life:

2 years.

Use the solution within one month after opening the vial.

Terms of leave from pharmacies:On prescription

Registration number:P N 015583/01

Date of registration:23.07.2009 / 13.04.2017

Expiration Date:Unlimited

The owner of the registration certificate:Cadil Pharmaceuticals Co., Ltd.Cadil Pharmaceuticals Co., Ltd. India

Manufacturer: & nbsp

CADILA PHARMACEUTICALS, Ltd. India

Information update date: & nbsp03.06.2017

Illustrated instructions

Instructions

Okupres-E® (Ocupres-E®)