Combigan

DRUG DESCRIPTION

COMBIGAN™ (brimonidine tartrate, timolol maleate ophthalmic solution .2%/.5%) (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5%, sterile, is a relatively selective alpha-2 adrenergic receptor agonist with a non-selective beta-adrenergic receptor inhibitor (topical intraocular pressure lowering agent).

The structural formulae are: Brimonidine tartrate:

Brimonidine tartrate structural formula illustration

5-bromo-6-(2-imidazolidinylideneamino) quinoxaline L-tartrate; MW= 442.24

Timolol maleate:

Timolol maleate structural formula illustration

(-)-1 -(tert-butylamino)-3-[(4-morpholino-l ,2,5-thiadiazol-3-yl)-oxy]-2-propanol maleate (1:1) (salt); MW= 432.50 as the maleate salt

In solution, COMBIGAN™ (brimonidine tartrate, timolol maleate ophthalmic solution .2%/.5%) (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5% has a clear, greenish-yellow color. It has an osmolality of 260-330 mOsmol/kg and a pH during its shelf life of 6.5-7.3.

Brimonidine tartrate appears as an off-white, or white to pale-yellow powder and is soluble in both water (1.5 mg/mL) and in the product vehicle (3.0 mg/mL) at pH 7.2. Timolol maleate appears as a white, odorless, crystalline powder and is soluble in water, methanol, and alcohol.

Each mL of COMBIGAN™ (brimonidine tartrate, timolol maleate ophthalmic solution .2%/.5%) contains the active ingredients brimonidine tartrate 0.2% and timolol 0.5% with the inactive ingredients benzalkonium chloride 0.005%; sodium phosphate, monobasic; sodium phosphate, dibasic; purified water; and hydrochloric acid and/or sodium hydroxide to adjust pH.

What are the possible side effects of brimonidine and timolol ophthalmic (Combigan)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • severe swelling, itching, burning, redness, pain, or discomfort in or around your eye;
  • bronchospasm (wheezing, chest tightness, trouble breathing);
  • pounding heartbeats or fluttering in your chest;
  • slow heart rate, weak pulse, fainting,...

Read All Potential Side Effects and See Pictures of Combigan »

What are the precautions when taking brimonidine tartrate, timolol maleate ophthalmic solution .2%/.5% (Combigan)?

Before using this product, tell your doctor or pharmacist if you are allergic to brimonidine or timolol; or to apraclonidine; or if you have any other allergies. This product may contain inactive ingredients (such as preservatives like benzalkonium chloride), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: lung disease (e.g., current or past asthma, severe chronic obstructive pulmonary disease-COPD), certain types of irregular heartbeats (sinus bradycardia, second- or third-degree AV block), certain types of heart disease (severe heart failure, cardiogenic shock).

Before using...

Read All Potential Precautions of Combigan »


Combigan Consumer (continued)

SIDE EFFECTS: Temporary blurred vision, temporary burning/stinging/itching/redness of the eye, watery eyes, dry eyes, dry mouth, feeling as if something is in the eye, headache, dizziness, or drowsiness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: vision changes, eye sensitivity to light, eye pain/swelling/discharge, slow/irregular heartbeat, muscle weakness, unusual tiredness, mental/mood changes, coldness/numbness/pain in the hands or feet, swelling ankles/feet, sudden unexplained weight gain, shortness of breath.

Seek immediate medical attention if any of these rare but very serious side effects occur: trouble breathing, chest pain, weakness on one side of the body, slurred speech, confusion, persistent dizziness, fainting.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using this product, tell your doctor or pharmacist if you are allergic to brimonidine or timolol; or to apraclonidine; or if you have any other allergies. This product may contain inactive ingredients (such as preservatives like benzalkonium chloride), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: lung disease (e.g., current or past asthma, severe chronic obstructive pulmonary disease-COPD), certain types of irregular heartbeats (sinus bradycardia, second- or third-degree AV block), certain types of heart disease (severe heart failure, cardiogenic shock).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, heart disease, blood vessel disease (e.g., thromboangiitis obliterans, Raynaud's phenomenon), blood circulation disorders (cerebral/coronary insufficiency), dizziness after standing (orthostatic hypotension), diabetes, depression, overactive thyroid (hyperthyroidism), muscle weakness disorders (e.g., myasthenia gravis), severe allergies.

If you develop an eye infection or injury, or have eye surgery, check with your doctor about whether you should continue to use your current bottle of this medication. You may be advised to start using a new bottle.

Before having surgery, tell your doctor or dentist that you are using this medication.

This drug may make you dizzy or drowsy or cause temporary blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This medication passes into breast milk, but is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.


Combigan Patient Information Including Side Effects

Brand Names: Combigan

Generic Name: brimonidine and timolol ophthalmic (Pronunciation: bri MOE ni deen and TIM oh lol)

  • What is brimonidine and timolol ophthalmic (Combigan)?
  • What are the possible side effects of brimonidine and timolol ophthalmic (Combigan)?
  • What is the most important information I should know about brimonidine and timolol ophthalmic (Combigan)?
  • What should I discuss with my healthcare provider before using brimonidine and timolol ophthalmic (Combigan)?
  • How should I use brimonidine and timolol ophthalmic (Combigan)?
  • What happens if I miss a dose (Combigan)?
  • What happens if I overdose (Combigan)?
  • What should I avoid while using brimonidine and timolol ophthalmic (Combigan)?
  • What other drugs will affect brimonidine and timolol ophthalmic (Combigan)?
  • Where can I get more information?

What is brimonidine and timolol ophthalmic (Combigan)?

Brimonidine reduces the amount of fluid in the eye, which decreases pressure inside the eye.

Timolol also reduces pressure inside the eye.

The combination of brimonidine and timolol ophthalmic (for the eyes) is used to treat glaucoma or ocular hypertension (high pressure inside the eye).

Brimonidine and timolol ophthalmic may also be used for other purposes not listed in this medication guide.

What are the possible side effects of brimonidine and timolol ophthalmic (Combigan)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • severe swelling, itching, burning, redness, pain, or discomfort in or around your eye;
  • bronchospasm (wheezing, chest tightness, trouble breathing);
  • pounding heartbeats or fluttering in your chest;
  • slow heart rate, weak pulse, fainting, slow breathing (breathing may stop);
  • feeling like you might pass out;
  • numbness, tingling, or cold feeling in your hands or feet;
  • muscle weakness; or
  • confusion, hallucinations, unusual thoughts or behavior.

Less serious side effects may include:

  • mild burning, stinging, or itching of your eyes;
  • dry eyes, blurred vision;
  • mildly swollen or puffy eyes;
  • feeling like something is in your eye;
  • weakness, tired feeling;
  • cough, sore throat;
  • nausea, upset stomach;
  • headache;
  • drowsiness;
  • unusual or unpleasant taste in your mouth;
  • sensitivity to light;
  • dry nose;

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about brimonidine and timolol ophthalmic (Combigan)?

Do not use brimonidine and timolol ophthalmic if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days.

You should not use this medication if you are allergic to brimonidine (Alphagan) or timolol (Timoptic, Cosopt), or if you have certain conditions. Be sure your doctor knows if you have asthma, or severe chronic obstructive pulmonary disease (COPD), heart disease or heart failure, slow heartbeats, or a heart condition called "AV block."

Before using this medication, tell your doctor if you have diabetes, overactive thyroid, circulation problems, allergies, low blood pressure, myasthenia gravis, or a history of depression

Do not use this medication while you are wearing contact lenses. This medication may contain a preservative that can be absorbed by soft contact lenses. Wait at least 15 minutes after using brimonidine and timolol ophthalmic before putting your contact lenses in.

Do not allow the dropper tip to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

Related Drug Centers
  • Combigan


Related Drugs Index: