Brimonidine and Timolol

Use brimonidine and timolol as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• For the eye only.
• Take out contact lenses before using this medicine. Lenses may be put back in 15 minutes after brimonidine and timolol is given. Do not put contacts back in if your eyes are irritated or infected.
• Do not touch the container tip to the eye, lid, or other skin.
• Wash your hands before and after use.
• Tilt your head back and drop drug into the eye.
• After use, keep your eyes closed. Put pressure on the inside corner of the eye. Do this for 1 to 2 minutes. This keeps the drug in your eye.
• Blot extra solution from the eyelid.
• If more than 1 drug is being used in the same eye, use each drug at least 5 minutes apart.
• Keep taking this medicine as you have been told by your doctor or other health care provider, even if you feel well.
• Take brimonidine and timolol at the same time of day.

What do I do if I miss a dose?

• Use a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not use 2 doses or extra doses.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Eye irritation.
• Itching.
• Burning.
• Stinging.
• Feeling sleepy.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

(bri MOE ni deen & TIM oh lol)

Elevated intraocular pressure: Children ≥2 years: Ophthalmic: Instill 1 drop into affected eye(s) twice daily

Note: In the Canadian labeling, use in children (at any age) is not recommended

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Percentages as reported with combination product. Also see individual agents.

>15%: Central nervous system: Drowsiness (children 25% to 83%)

5% to 15%: Ophthalmic: Allergic conjunctivitis, burning sensation of eyes, conjunctival hyperemia, eye pruritus, follicular conjunctivitis, stinging of eyes

1% to 5%:

Cardiovascular: Hypertension

Central nervous system: Depression, foreign body sensation of eye, headache

Dermatologic: Erythema of eyelid

Gastrointestinal: Xerostomia

Neuromuscular & skeletal: Weakness

Ophthalmic: Blepharitis, blurred vision, corneal erosion, dry eye syndrome, epiphora, eye discharge, eye irritation, eye pain, eyelid edema, eyelid pruritus, superficial punctate keratitis

Concerns related to adverse effects:

• Anaphylactic reactions: Use caution with history of severe anaphylaxis to a variety of allergens; patients taking beta-blockers may become more sensitive to repeated challenges. Treatment of anaphylaxis (eg, epinephrine) in patients taking beta-blockers may be ineffective or promote undesirable effects.

• Bacterial keratitis: Inadvertent contamination of multiple-dose ophthalmic solutions has the potential to cause bacterial keratitis.

• CNS depression: May cause CNS depression, which may impair physical or mental abilities; patients must be cautioned about performing tasks that require mental alertness (eg, operating machinery or driving).

• Hypersensitivity: Ocular hypersensitivity reactions have been reported with brimonidine; reactions may cause an increase in intraocular pressure.

• Ocular effects: Use of agents that reduce/suppress aqueous humor production has been associated with choroidal detachment after filtration procedures.

Disease-related concerns:

• Angle-closure glaucoma: Appropriate use: Not for use alone to treat acute angle-closure glaucoma (has no effect on papillary constriction).

• Cardiovascular disease: Use with caution in patients with compensated heart failure or coronary insufficiency. Contraindicated in patients with overt heart failure. Monitor for signs/symptoms of heart failure and discontinue use immediately if suspected. May impair compensatory tachycardia and increase hypotension risk. Use with caution in patients with orthostatic hypotension.

• Cerebrovascular disease: Use with caution in cerebrovascular insufficiency; consider alternative therapy for patients with signs/symptoms of decreased cerebral blood flow after therapy initiation.

• Depression: Use with caution in patients with depression.

• Diabetes: Use with caution in patients with diabetes mellitus; may potentiate hypoglycemia and/or mask signs and symptoms.

• Hepatic impairment: Use with caution in patients with hepatic impairment; has not been studied.

• Myasthenia gravis: Use with caution in patients with myasthenia gravis; may worsen disease or other myasthenic symptoms (diplopia, ptosis, and generalized weakness).

• Renal impairment: Use with caution in patients with renal impairment; has not been studied.

• Respiratory disease: In general, patients with mild to moderate chronic obstructive pulmonary disease (COPD) or bronchospastic disease should not receive beta-blockers; if used at all, should be used cautiously with close monitoring. Use is contraindicated in patients with asthma or severe COPD.

• Thyroid disease: May mask signs of hyperthyroidism (eg, tachycardia). If thyrotoxicosis is suspected, carefully manage and monitor; abrupt withdrawal may exacerbate symptoms of hyperthyroidism or precipitate thyroid storm.

• Vascular insufficiency: Can precipitate or aggravate symptoms of arterial insufficiency in patients with PVD, Raynaud disease, and thromboangiitis obliterans. Use with caution and monitor for progression of arterial obstruction.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

• Contact lens wearers: Product contains benzalkonium chloride which may be absorbed by soft contact lenses; remove lens prior to administration and wait 15 minutes before reinserting.

• Pediatric: Safety and efficacy have not been established in children <2 years of age; use is contraindicated in children <2 years of age. Note: In the Canadian labeling, use in children (at any age) is not recommended.

Other warnings/precautions:

• Surgery: May block systemic effects of beta agonists (eg, epinephrine, norepinephrine); notify anesthesiologist if patient is receiving ophthalmic beta-blocker therapy. Patients undergoing planned major surgery should be gradually tapered off therapy (if possible) prior to procedure. If necessary during surgery, effects of beta-blocker therapy may be reversed by adrenergic agonists.

Intraocular pressure; monitor for systemic effect of beta-blockade with ophthalmic administration; blood pressure