Ocumed eye drops 0.5% vials 10 ml
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Active ingredients
Timolol
Release form
Drops
Composition
In 1 ml of timolol (in the form of maleate) 5 mg. Excipients: benzalkonium chloride (0.1 mg / ml), sodium hydrogen phosphate, sodium dihydrogen phosphate, water d / and
Pharmacological effect
Non-selective beta-blocker for local use in ophthalmology. Does not possess internal sympathomimetic and membrane stabilizing activity. The drug reduces both normal and increased intraocular pressure by reducing the formation of intraocular fluid. No effect on pupil size and accommodation. The effect of the drug appears 20 minutes after instillation into the conjunctival sac. The maximum reduction in intraocular pressure develops after 1-2 hours and persists for 24 hours.
Pharmacokinetics
Absorption When applied locally, timolol quickly penetrates the cornea. After instillation of Cmax timolol eye drops in the aqueous humor of the anterior chamber of the eye is achieved in 1-2 hours. A small amount enters the systemic circulation by absorption through the vessels of the conjunctiva, the nasal mucosa and the lacrimal tract. Withdrawal Timolol metabolites are excreted primarily by the kidneys. Pharmacokinetics in special clinical situations In newborns and young children, Cmax in the blood plasma is much higher than that in adults
Indications
Increased intraocular pressure (ophthalmic hypertension); - open-angle glaucoma; - secondary glaucoma; - to reduce intraocular pressure with angle-closure glaucoma (as an additional agent in combination with myotics); - congenital glaucoma (with other therapeutic measures insufficiency)
Contraindications
Bronchial asthma or other severe chronic obstructive respiratory diseases; sinus bradycardia; AV block II and III; acute heart failure; severe chronic heart failure (III and IV functional class according to the NYHA classification); cardiogenic shock; allergic reactions with generalized skin rashes; - atrophic rhinitis; - dystrophic diseases of the cornea; - newborn period; - hypersensitivity to the components of the preparation. to patients with pulmonary insufficiency,emphysema, severe cerebrovascular insufficiency, heart failure (NYHA class I and II functional class), sinoatrial blockade, arterial hypertension, diabetes mellitus, hypoglycemia, thyrotoxicosis, myasthenia syndrome, Reye syndrome, while co-administering other beta block blockers
Precautionary measures
The patient should be warned about the need for regular measurement of intraocular pressure and examination of the cornea, as well as the need to stop using the drug and consult a doctor if any side effects occur. When wearing soft contact lenses, do not use Ocumed eye drops, since The preservative in their composition can be deposited in soft contact lenses and adversely affect the eye tissue. Hard contact lenses should be removed before instillation of the drug and install them again after 15 minutes. When transferring patients to treatment by Ocumed, a correction of refraction may be needed (after the effects of the miotik used previously disappeared). Ocumed must be canceled 48 hours before surgery with general anesthesia. Ocumed can not be used simultaneously with antipsychotic (neuroleptics) and anxiolytic (tranquilizers) drugs. During the period of use of the drug is not recommended to drink alcohol (possibly a sharp decrease in blood pressure). Use in pediatrics There is no sufficient experience in the use of the drug in children, so the prescription of the drug is possible only in cases where the intended use of therapy outweighs the potential risk of side effects. Impact on the ability to drive vehicles and control mechanisms. Immediately after using the drug, it is possible to reduce the clarity of vision and slow down psychomotor reactions, which can reduce the ability to engage in potentially hazardous activities that require increased attention (especially while drinking alcohol)
Use during pregnancy and lactation
There is no sufficient experience in the use of the drug during pregnancy and lactation (breastfeeding), so the drug can be prescribed only in cases where the intended benefit of therapy for the mother outweighs the potential risk to the fetus or child. It is established that timolol penetrates the placental barrier and is excreted in breast milk. During treatment should stop breastfeeding.
Dosage and administration
Adults and children over 10 years old are buried in 1 drop (0.25% eye drops) in the conjunctival sac of the affected eye 2 times / day, with insufficient efficiency - 1 drop (0.5% eye drops) 2 times / day. When the intraocular pressure is normalized, the maintenance dose is 1 drop (0.25% eye drops) 1 time / day. Children up to 10 years old are prescribed 1 drop (0.25% eye drops) 2 times / day. The drug is intended for long-term continuous use. The patient should be warned that only a doctor can change the dose or temporarily cancel the drug
Side effects
On the part of the organ of vision: irritation and hyperemia of the conjunctiva, skin of the eyelids, burning and itching in the eyes, tearing or reduction of tearing, photophobia, corneal epithelium, punctate keratopathy, corneal hypesthesia, diplopia, ptosis, dry eye, short-term violation of the sharpness of the cornea, visual acuity, hypothesis , conjunctivitis, keratitis. When conducting surgical interventions for glaucoma, the postoperative detachment of the choroid is possible. On the part of the cardiovascular system: chest pain, heart failure, bradycardia, bradyarrhythmia, reduction of blood pressure, collapse, AV-blockade, cardiac arrest, transient cerebral disorders. blood circulation. On the part of the respiratory system: rhinitis, shortness of breath, bronchospasm, pulmonary insufficiency. On the side of the central nervous system and peripheral nervous system: headache, dizziness, weakness, depression, parestitis ezii, myasthenia gravis, drowsiness, hallucinations, ringing in the ears, slowing down the speed of psychomotor reaction. On the part of the digestive system: nausea, vomiting, diarrhea. Allergic reactions: urticaria, eczema. Others: nasal bleeding, reduction of potency, alopecia
Overdose
Symptoms: due to local absorption may develop systemic effects characteristic of beta-blockers (dizziness, headache, arrhythmia, bradycardia, bronchospasm, nausea, vomiting). Treatment: immediately flush eyes with water or saline. Symptomatic therapy is performed.
Interaction with other drugs
The combined use of the drug Ocumed with eye drops containing epinephrine can cause pupil dilation. The reduction in intraocular pressure is enhanced while the eye drops containing epinephrine and pilocarpine are used simultaneously.Two beta-blockers should not be instilled into the eyes. Reducing blood pressure and slowing the heart rate can be enhanced when the drug is used together with slow calcium channel blockers, reserpine and other beta-blockers. Simultaneous use with insulin or oral antidiabetic agents can lead to hypoglycemia. Thymol. the action of peripheral muscle relaxants (requires the abolition of the drug 48 hours before the planned surgical intervention using general anesthesia).
special instructions
The patient should be warned about the need for regular measurement of intraocular pressure and examination of the cornea, as well as the need to discontinue use of the drug and consult a doctor if any side effects occur. When wearing soft contact lenses, do not use Ocumed eye drops, because The preservative in their composition can be deposited in soft contact lenses and adversely affect the eye tissue. Hard contact lenses should be removed before the instillation of the drug and installed again after 15 minutes. When transferring patients for treatment with Ocumed, a refraction correction may be necessary (after the effects of previously miotics). Okumet must be canceled 48 hours before surgery with general anesthesia. Okumet can not be used simultaneously with antipsychic otic (neuroleptics) and anxiolytic (tranquilizers) drugs. During the period of use of the drug alcohol is not recommended (perhaps a sharp decrease in blood pressure). Use in pediatrics There is no sufficient experience in the use of the drug in children, so the drug may be prescribed only in cases where the intended benefit of therapy outweighs the potential risk of side effects. The effect on the ability to drive a motor vehicle and control mechanisms izhenie visual acuity and slowing of psychomotor reactions, which may reduce the ability to engage in potentially hazardous activities that require attention (especially with simultaneous use of alcohol)