Timolol Ophthalmic

What is Timolol Ophthalmic?

• Timolol Ophthalmic (Betimol;Timoptic) ophthalmic solution, is a non-selective beta-adrenergic receptor blocking agent used to treat increased pressure inside the eye such as in ocular hypertension and glaucoma.

Timolol structure

Timolol

Timolol ball-and-stick

What are the uses of this medicine?

• Timolol Ophthalmic (Betimol;Timoptic) is used in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.

How does this medicine work?

• Timolol maleate is a beta1 and beta2 (non-selective) adrenergic receptor blocking agent that does not have significant intrinsic sympathomimetic, direct myocardial depressant, or local anesthetic (membrane-stabilizing) activity.
• Timolol maleate 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.
• Elevated intraocular pressure is a major risk factor in the pathogenesis of glaucomatous visual field loss.
• The higher the level of intraocular pressure, the greater the likelihood of glaucomatous visual field loss and optic nerve damage.
• Timolol reduces intra ocular pressure possibly by decreasing aqueous humor production by reduction of blood flow to the ciliary processes and camp synthesis.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• bronchial asthma or with a history of bronchial asthma
• severe chronic obstructive pulmonary disease
• sinus bradycardia
• second- and third-degree atrioventricular block
• overt cardiac failure
• cardiogenic shock
• hypersensitivity to this product

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention any of the following:

• beta blockers such as atenolol (Tenormin), carteolol (Cartrol), esmolol (Breviblic), labetalol (Normodyne, Trandate), metoprolol (Lopressor), nadolol (Corgard), propranolol (Inderal), sotalol (Betapace), and timolol (Blocadren)
• quinidine (Quinidex, Quinaglute Dura-Tabs)
• verapamil (Calan, Isoptin)

• If you are using another topical eye medication, instill it at least 10 minutes before or after you instill timolol eye drops or gel-forming solution.

Is this medicine FDA approved?

• Timolol was approved for use in the United States in 1995 and is still in wide use.
• Timolol is available in tablets of 5, 10 and 20 mg in generic forms and formerly under the trade name Blocadren.
• In addition, timolol is available in an ophthalmic formulation for therapy of ocular hypertension and glaucoma.

How should this medicine be used?

Recommended dosage:

• The usual starting dose is one drop of 0.25% timolol maleate ophthalmic solution in the affected eyes twice a day.
• If the clinical response is not adequate, the dosage may be changed to one drop of 0.5% solution in the affected eyes twice a day.
• If the intraocular pressure is maintained at satisfactory levels, the dosage schedule may be changed to one drop once a day in the affected eyes.

Administration:

• Ophthalmic timolol comes as a solution and an extended-release gel-forming solution (liquid that thickens to a gel when instilled in the eye).
• Timolol eye drops are usuallyinstilled once or twice a day, at evenly spaced intervals, until pressure in the eye is controlled (about 4 weeks).
• Then it may be instilled once a day. Timolol gel-forming solution is usually instilled once a day.
• Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye or surrounding structures.
• Contact lenses should be removed prior to administration of the solution.
• Lenses may be reinserted 15 minutes following timolol maleate ophthalmic solution administration.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As a solution (liquid) and an extended-release (long-acting) gel-forming solution

This medicine is available in fallowing brand namesː

• Betimol
• Timoptic
• Timoptic GFS
• Timoptic-XE

Timolol Ophthalmic is also available as combination product:

• Combigan (containing Timolol and Brimonidine)
• Cosopt (containing Timolol and Dorzolamide)

What side effects can this medication cause?

The most common side effects of this medicine include:

• burning and stinging upon instillation
• double vision
• depression
• dizziness
• nausea

The following additional adverse experiences have been reported less frequently with ocular administration of this or other timolol maleate formulations:

• Headache
• asthenia/fatigue
• chest pain

Serious side effects may include:

• slow or irregular heartbeat
• difficulty breathing
• sudden weight gain
• swelling of the feet or lower legs
• fainting

What special precautions should I follow?

• As with many topically applied ophthalmic drugs, this drug is absorbed systemically. The same adverse reactions found with systemic administration of beta-adrenergic blocking agents may occur with topical administration. For example, severe respiratory reactions and cardiac reactions, including death due to bronchospasm in patients with asthma, and rarely death in association with cardiac failure, have been reported following systemic or ophthalmic administration of timolol maleate
• In Patients Without a History of Cardiac Failure continued depression of the myocardium with beta-blocking agents over a period of time can, in some cases, lead to cardiac failure. At the first sign or symptom of cardiac failure, timolol should be discontinued.
• The necessity or desirability of withdrawal of beta-adrenergic blocking agents prior to major surgery is controversial. For these reasons, in patients undergoing elective surgery, some authorities recommend gradual withdrawal of beta-adrenergic receptor blocking agents.
• Beta-adrenergic receptor blocking agents may mask the signs and symptoms of acute hypoglycemia. Beta-adrenergic blocking agents should be administered with caution in patients subject to spontaneous hypoglycemia or to diabetic patients.
• Beta-adrenergic blocking agents may mask certain clinical signs (e.g., tachycardia) of hyperthyroidism.
• Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye or surrounding structures.
• Patients should also be instructed that ocular solutions, if handled improperly or if the tip of the dispensing container contacts the eye or surrounding structures, can become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.
• Patients with bronchial asthma, a history of bronchial asthma, severe chronic obstructive pulmonary disease, sinus bradycardia, second or third degree atrioventricular block, or cardiac failure should be advised not to take this product.
• Patients should be advised that timolol maleate ophthalmic solution contains benzalkonium chloride which may be absorbed by soft contact lenses. Contact lenses should be removed prior to administration of the solution. Lenses may be reinserted 15 minutes following timolol maleate ophthalmic solution administration.
• Timolol has been reported rarely to increase muscle weakness in some patients with myasthenia gravis or myasthenic symptoms.
• Timolol maleate has little or no effect on the pupil. Timolol maleate should not be used alone in the treatment of angle-closure glaucoma.
• If you are having surgery, including dental surgery, tell the doctor or dentist that you are using timolol.
• If you have eye surgery, an eye injury, or develop an eye infection while using timolol eye drops or gel-forming solution, ask your doctor if you can continue using the same container of timolol.
• you should know that your vision may be blurred during your treatment with timolol gel-forming solution. Avoid rubbing your eyes even if your vision is blurred. Do not drive a car or operate machinery if you are unable to see clearly.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• dizziness, headache, shortness of breath, bradycardia, bronchospasm, and cardiac arrest

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

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

Can this medicine be used in children?

• Safety and effectiveness of timolol maleate ophthalmic solution have been established when administered in pediatric patients aged 2 years and older.
• Safety and efficacy in pediatric patients below the age of 2 years have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• TIMOLOL MALEATE

Inactive ingredients:

• BENZALKONIUM CHLORIDE
• SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM
• SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM
• SODIUM HYDROXIDE
• WATER

Who manufactures and distributes this medicine?

Manufactured by:

• Alcon Laboratories, Inc.
• Fort Worth, Texas for
• Sandoz Inc., Princeton, NJ

What should I know about storage and disposal of this medication?

• Store timolol maleate ophthalmic solution at room temperature between 59°F to 86°F (15°C to 30°C) in an upright position.
• Do not freeze timolol maleate ophthalmic solution.
• Keep timolol maleate ophthalmic solution out of light.

• Dailymed label info on Timolol Ophthalmic
• FDA Timolol Ophthalmic

Timolol Ophthalmic Resources
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