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Voben (Ophthalmic Solution)

COMPOSITION

Each ml contains:
Levobunolol HCl U.S.P. ……… 5.0 mg.
with: Benzalkonium chloride 0.004%, sodium chloride, edetate disodium, sodium metabisulfite, sodium phosphate (dibasic), potassium phosphate (monobasic), polyvinyl alcohol 14 mg and purified water.

CLINICAL PHARMACOLOGY

Levobunolol HCl is a noncardioselective beta-adrenoceptor blocking agent, equipotent at both beta1 and beta2 receptors. Levobunolol is 60 times more potent than its dextro isomer in its beta-blocking activity. In order to obtain the highest degree of beta-blocking potential without increasing the potential for direct myocardial depression, the levo isomer, levobunolol, is used . Levobunolol does not have significant local anesthetic (membrane-stabilizing) or intrinsic sympathomimetic activity.

Levobunolol HCl has been shown to be an active agent in lowering elevated as well as normal intraocular pressure (IOP) whether or not accompanied by glaucoma. Elevated IOP presents a major risk factor in the pathogenesis of glaucomatous field loss. The higher the level of IOP, the greater the likelihood of optic nerve damage and visual field loss.

The exact mechanism of action of levobunolol in reducing intraocular pressure is not known. Levobunolol reduces intraocular pressure with little or no effect on pupil size in contrast to the miosis which cholinergic agents are known to produce. The blurred vision and night blindness often associated with miotics would not be expected with the use of levobunolol. Patients with cataracts avoid the inability to see around lenticular opacities caused by pupil constriction. The onset of action with one drop of levobunolol can be detected within one hour after treatment, with maximum effect seen between 2 – 6 hours. A significant decrease can be maintained for up to 24 hours following a single dose.

INDICATIONS

Voben Ophthalmic Solution is indicated for the control of intraocular pressure in chronic open angle glaucoma and ocular hypertension.

CONTRAINDICATIONS

It is contraindicated in patients with severe chronic obstructive pulmonary disease, bronchospasm, including bronchial asthma and uncontrolled congestive heart failure. It is also contraindicated in those individuals who are hypersensitive to any component of this product.

WARNINGS

As with other topically applied ophthalmic drugs, levobunolol may be absorbed systemically.

PRECAUTIONS

General: It should be used with caution in patient with known contraindications to systemic use of beta adrenoceptor blocking agents. These include abnormally low heart rate and heart block more severe than first degree. Congestive heart failure should be adequately controlled before beginning therapy with levobunolol. In patients with a history of significant cardiac disease, pulse rates should be monitored.

Levobunolol should be used with caution in patients with known hypersensitivity to other beta-adrenoceptor blocking agents. Use with caution in patients with known diminished pulmonary function.

Drug Interactions: Levobunolol may have additive effects in patients taking systemic anti-hypertensive drugs. These possible additive effects may include hypotension, including orthostatic hypotension, bradycardia, dizziness, and/or syncope. Conversely, systemic beta-adrenoceptor blocking agents may potentiate the ocular hypotensive effect of levobunolol.

Pregnancy: There are no adequate and well controlled studies in pregnant women. Levobunolol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers: It is not known whether this drug is excreted in human milk. Systemic beta blockers and topical timolol maleate are known to be excreted in human milk. Because similar drugs are excreted in human milk, caution should be exercised when levobunolol is administered to a nursing woman.
Pediatric Use: Safety and effectiveness in children have not been established.

ADVERSE EFFECTS

Blepharoconjunctivitis and decreases in heart rate and blood pressure have been reported occasionally with the use of levobunolol. Urticaria has been reported rarely with the use of levobunolol. The following adverse effects have been reported rarely and a definite relationship with the use of levobunolol has not been established: change in heart rhythm, headache, dizziness, transient ocular burning, stinging and itching.

DOSAGE AND ADMINISTRATION

The usual dose is one drop once daily. If necessary the dose can be increased to one drop twice daily or as directed by the ophthalmologist.

HOW SUPPLIED

Voben Ophthalmic Solution is available as a sterile solution in 5 ml pilfer proof plastic dropper bottles (Gamma Irradiated).

STORAGE

Protect from sunlight. Keep away from children’s reach. Do not freeze. Store between 15°C to 30°C. After opening the bottle, use within 4 weeks.