Timolol Maleate IP eq. to Timolol Benzalkonium Chloride 0.02% v/v

Trade Name :
Glunil

Composition :
Each ml of solution contains:
Active ingredient: Timolol maleate IP equivalent to TimololBenzalkonium Chloride 0.02% v/v

Dosage Form :
Eye Drops

Indications :
Increased intraocular pressure;
Open-angle glaucoma;
Secondary glaucoma;
As an additional remedy to reduce intraocular pressure in angle-closure glaucoma (in combination with myotics);
Congenital glaucoma (when failure of other therapeutic measures).
Treatment with Glunilis long-term. Break or change of dosage carried out only by order of a physician.

CLINICAL PHARMACOLOGY :
Mechanism of Action: The precise mechanism of the ocular hypotensive action of Glunil is not clearly established at this time. Tonography and fluorophotometry studies in man suggest that its predominant action may be related to reduce aqueous formation. However, in some studies a slight increase in outflow facility was also observed. Glunil ophthalmic solution, when applied topically on the eye, has the action of reducing elevated as well as normal intraocular pressure, whether or not accompanied by glaucoma. The onset of reduction in intraocular pressure following administration of Glunilcan usually be detected within one-half hour after a single dose. The maximum effect usually occurs in one to two hours and significant lowering of intraocular pressure can be maintained for periods as long as 24 hours with a single dose. Repeated observations over a period of one year indicate that the intraocular pressure lowering effect of Glunil is well maintained. In considering the physicochemical property of timolol as a cationic drug it was found that lipophilicity increased in the presence of an appropriate counterion.

Dosage and Administration :
Glunil ophthalmic solution is available in a concentration of 0.5 percent. The starting dose is one drop of 0.5 percent Glunil in the affected eye(s) once a day in the AM. If the patient's intraocular pressure is not at a satisfactory level on this regimen, concomitant therapy with other agent(s) for lowering intraocular pressure can be instituted. The concomitant use of two topical beta-adrenergic blocking agents is not recommended.

Contraindications :
For patients with individual hypersensitivity to the drug and a history of the following diseases:
asthma or other severe chronic obstructive airways disease;
sinusbradycardia;
atrioventricular block II or III level;
congestive heart failure;
severe chronic heart failure (III – IV functional class);
cardiogenic shock;
allergic reaction with generalized skin rash;
atrophic rhinitis;
degenerative disease of the cornea;
the neonatal period.

Warning and Precautions :
It is necessary to visit a physician regular for to corneal examination and intraocular pressure monitoring. If the patient wears soft contact lenses, then he should not use eye drops as a preservative can be adsorbed by material of soft contact lenses and have an adverse effect on the eye tissues. It is necessary to remove hard contact lenses prior to instillation of the drug and to wear them again only after 15 minutes.
Immediately after instillation of the drug visual acuity may be reduce and mental reactions may become slower, which may reduce the ability to actively participate in road traffic, maintenance of machinery or to perform work without support. While the use of the drug simultaneously with alcohol this takes place with higher probability.
When transferring patients to the treatment with timolol correction after refraction effects caused by myotics used previously may be necessary.
In the case of the upcoming surgery with general anaesthesia withdraw the drug for 48 hours before it.

Side Effect :
Topical reactions :
irritation and conjunctival hyperaemia, eyelid skin, burning and itchy eyes, watery eyes or a decrease in lacrimation, photophobia, oedema of the corneal epithelium, dot the surface keratopathy, corneal hypoesthesia, diplopia, ptosis, dry eyes, short-term disturbance of visual acuity, blepharitis, conjunctivitis , keratitis. In carrying out ant glaucomatous operations may develop choroidal detachment in the postoperative period.
Systemic reactions :
Cardio-vascular system:
congestive heart failure, bradycardia, Brady arrhythmia, lowering blood pressure, collapse, atrioventricular block, heart failure, transient ischemic attacks.
The respiratory system :
shortness of breath, bronchospasm, pulmonary insufficiency.
The central nervous system: headache, dizziness, myasthenia gravis, depression, paraesthesia, drowsiness, hallucinations, tinnitus, slowing of psychomotor responses. On the part of the gastrointestinal tract: nausea, vomiting, diarrhoea.
Allergic reaction: hives, eczema.
Rhinitis, nasal bleeding, chest pain, decreased potency, alopecia. In the case of side effects, discontinue use of the drug as soon as possible contact your doctor.

Drug Interaction :
The simultaneous use of the drug with eye drops containing epinephrine can cause dilatation of the pupil. The specific effect of the drug (reducing the intraocular pressure) increases, while the use of eye drops containing epinephrine and pilocarpine; instilling into the eyes of two beta-adrenergic blocker is not be allowed.
Lowering blood pressure and slowing heart rate may increase when combined with slow calcium channels blocker drugs, reserpine, and other beta-blockers. The simultaneous use of insulin or oral antidiabetic agents may lead to hypoglycaemia. Simultaneous use with the antipsychotic drugs (neuroleptics) and anxiolytic drugs (tranquilizers) is not allowed.
During the treatment it is not recommended intake of ethanol (a sharp decreasing in blood pressure is possible). Timolol increases the effect of peripheral muscle relaxants, and therefore requires removal of the drug for 48 hours before the planned surgery with general anaesthesia.

Over Dosage :
The development of general resorptive effects typical to beta-blockers are possible: dizziness, headache, arrhythmia, bradycardia, bronchospasm, nausea and vomiting.
Treatment: Immediately flush eyes with water or 0.9% sodium chloride solution, symptomatic therapy.

Packaging :
Glunil Ophthalmic Solution, 0.5% supplied in LDPE bottle with white cap in 5 ml size.

STORAGE :
Store below 30 C, protect from light. Do not freeze. Keep out of reach of children’s.

Shelf Life :
15 Months
Do not use after expiration date printed on the packaging
Shelf life after opening the vial is 45 days.