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Timman 0.25% 5 ml eye drop.

$3.70

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Description

The instruction for medical use

of TIMMAL® medicine

Trade name
ТИММАЛ®

the International unlicensed

name Timololum Dosage Form
Eye drops of 0.25% and 0.5% 5 ml

Structure
of 1 ml of solution contain
active agent – Timololum of 2.5 mg or 5.0 mg (in the form of Timololum of a maleate of 3.4 mg or 6.8 mg),
excipients: a benzalkoniya chloride of 50% solution (in terms of 100% substance), dihydrophosphate sodium a dihydrate, phosphate dinatrium dodecahydrate (for correction rn solution), water for injections.

Description
Colourless or slightly yellowish transparent liquid. Weak opalescence of solution is allowed.

Pharmacotherapeutic group
Drugs for treatment of diseases of eyes. Protivoglaukomny drugs and miotik. Beta blockers.
ATH Timololum S01ED01 code

The pharmacological

Pharmacokinetics At properties topical administration of Timololum a maleate in insignificant degree is exposed to system absorption, quickly gets through an eye cornea. In insignificant quantity gets to a system blood stream due to absorption through vessels of a conjunctiva, mucous membranes of a nose and a plaintive path. After instillation of eye drops the maximum concentration (Cmax) of active agent of Timololum in watery moisture of an anterior chamber of an eye is reached in 1-2 h. Linking with proteins of plasma – less than 10%. Gets into breast milk, there passes the blood-brain barrier and a placental barrier. It Biotransformirutsya in a liver. It is excreted by kidneys and intestines in not changed look and in the form of metabolites.

Timololum pharmacodynamics a maleate – active component of eye drops Timmal® – is a non-selective blocker of beta and adrenergic receptors, not having mestnoanesteziruyushchy and cardiodepressive effect, internal sympathomimetic and membrane stabilizing activity. Does not influence the size of a pupil and accommodation. Prevents the stimulating influence of catecholamines on beta adrenoceptors.
At topical administration the blockade of beta and adrenergic receptors causes reduction of products of watery moisture and improves its outflow. The effect is observed with the normal initial and, especially, increased intraocular pressure.
Usually the effect occurs in 20 minutes after instillation eye drops of Timmal® in a conjunctival sac, reaches a maximum in 1-2 h and proceeds during 24 h.

Indications
– the increased intraocular pressure (oftalmogipertenziya)
– a chronic open angle glaucoma
– as an additional tool for decrease in intraocular
pressure in closed-angle glaucoma (in a combination from miotika)
– secondary glaucoma, including afakichesky, uveal, posttraumatic
– congenital glaucoma (at inefficiency of other therapeutic actions)

the Route of administration and doses
to Adults and children are more senior than 18 years 2 times a day dig in on 1 drop 0.25% of solution, at insufficient efficiency – on 1 drop of 0.5% of solution 2 times a day. At normalization of intraocular pressure a maintenance dose – 1 drop of 0.25% of solution once a day.
Treatment is carried out, as a rule, for an appreciable length of time. Duration of a course of treatment depends on a course of the disease and is defined by the doctor. Having rummaged in use of drug or change of a dosage are carried out only according to the instruction of the attending physician.
In closed-angle glaucoma the use is possible only together with miotocs. It is recommended to Instillirovat other drugs not less than in 10 min. prior to Timololum use.

Side effects
– irritation and hyperaemia of a conjunctiva, an eyelid skin, burning and an itching of eyes, dacryagogue, a photophobia, swelled a cornea epithelium, a dot superficial keratopathy, a cornea giposteziya, a diplopia, a ptosis, xerophthalmus
– amotio of a choroid in the postoperative period at fistuliziruyushchy antiglaukomatozny operations
– heart failure, bradycardia, bradyarrhythmia, a lowering of arterial pressure, collapse, atrioventricular block, cardiac arrest, passing disturbances of cerebral circulation
– an asthma, a bronchospasm, pulmonary insufficiency
– a headache, dizziness, weakness, a depression, paresthesias, hallucinations, dreadful dreams, confusion of consciousness, an asthenia
– nausea, diarrhea
– urticaria, eczema
– rhinitis
– disturbance of sexual function,

the Contraindication alopecia
– the increased individual sensitivity to drug components
– bronchial asthma, hyperreactivity of bronchial tubes, a serious chronic obstructive illness of lungs
– sinus bradycardia (reduction of heart rate)
– disturbances of atrioventricular conductivity of II and III degree
– heart failure of the II-III degree
– cardiogenic shock
– heavy atrophic rhinitis
– cornea dystrophy
– the lactation period
– children’s and teenage age up to 18 years

Medicinal interactions
Timololum at topical administration is compatible to miotocs and inhibitors of a karboangidraza. Simultaneous use of the eye drops containing epinephrine or Norepinephrinum can cause mydriasis. Specific effect of drug – decrease in intraocular pressure – amplifies at simultaneous use of the eye drops containing epinephrine and pilocarpine. It is not recommended to dig in two drugs of group of beta blockers at the same time. At simultaneous system and topical administration of beta blockers perhaps mutual strengthening of severity of side effects.
Timololum increases (mutually) the probability of disturbances of automatism, conductivity and contractility of heart against the background of Amiodaronum, sympatholytics, diltiazem, verapamil, hinidinovy drugs, risk of hypotension and a decompensation of warm activity – against the background of antagonists of calcium (dihydropyridine derivatives), cardiac glycosides, inhalation anesthetics, strengthens action of muscle relaxants therefore drug withdrawal for 48 h before the planned surgical intervention using the general anesthesia is necessary. At simultaneous use with reserpine the development of the profound bradycardia, hypotonias is possible. Simultaneous use with insulin or oral antidiabetic means can lead to a hypoglycemia.
Combined use of the drug Timmal® with Taufon® medicine, leads to more significant and long decrease in intraocular pressure.

Special instructions
Hypotensive effect of drug develops gradually and decrease in intraocular pressure happens at prolonged use of drug therefore it is regularly necessary to control intraocular pressure (in 3-4 weeks after the beginning of therapy) for selection of the optimum mode of dosing of eye drops of Timmal®, glucose level in blood serum, a slezootdeleniye, integrity of a cornea and a field of vision each 6 months.
With extra care drug is used at patients with emphysema of lungs, heart failure in compensation stage, arterial hypotension, not allergic chronic allergic bronchitis, vasomotorial rhinitis, a Raynaud’s disease, a pheochromocytoma, acidosis, heavy cerebrovascular insufficiency, diabetes (especially labile course), a hypoglycemia, a hyperthyroidism, a myasthenia.
With care apply at patients of advanced age. At use of Timololum for these categories of patients the careful medical control is necessary.
If the patient carries soft contact lenses, he should not apply eye drops of Timmal® as the preservative which is contained in them can be laid in soft contact lenses and have negative effect on eye tissues. Lenses should be removed before burying drug and to put on them not earlier than in 15 minutes.
Simultaneous alcohol intake can lead to delay of speed of psychomotor reactions.
Use in pediatrics
the Data on efficiency and safety of medicine at children up to 18 years are absent.
Pregnancy
Eye drops of Timmal® should not be used during pregnancy.
Timololum gets through a placenta, is excreted in breast milk. Because of a possibility of serious side reactions on Timololum at babies, the decision on the termination either feedings by maternal milk, or drug uses, taking into account its importance for the nursing mother has to be made.
If drug was used just before childbirth, then newborns have to be under careful observation within several days after the birth.
The feature of influence on ability of control of motor transport and potentially dangerous mechanisms
Within 30 minutes after use of drug should abstain from occupations potentially dangerous types of activity requiring special attention.

Overdose
Symptoms: development of the all-resorptive effects characteristic of blockers of β-adrenoceptors – dizzinesses, a headache, arrhythmia, bradycardia, a bronchospasm, nausea, vomiting.
Treatment: immediate washing of eyes water or isotonic solution of sodium of chloride, if necessary symptomatic therapy.

A form of release and packing
On 5 ml in bottles droppers polyethylene, hermetically corked by the screwing-up covers with control of the first opening.
On 1 bottle together with the instruction for medical use in the state and Russian languages place in a pack from cardboard.

To Store storage conditions at a temperature from 15 wasps up to 25 wasps, in the place protected from light.
To store out of children’s reach!

Prescription status from drugstore
According to the prescription

the Period of storage
2.5 years
a drug Period of storage after opening of a bottle – 4 weeks.
Not to apply after an expiration date.

LeKos LLP producer 050000, Almaty, Kabangbai St. of the batyr, 114-13, ph.: 308-10-67.

The owner of the registration certificate
of LeKos LLP, the Republic of Kazakhstan

the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products
050000, Almaty, Kabangbai St. of the batyr, 114-13, ph.: 308-10-67.
e-mail: lecos1@mail.ru, www.lecos.kz

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