Alphagan-P

DRUG DESCRIPTION

ALPHAGAN® P (brimonidine tartrate ophthalmic solution) 0.1% or 0.15%, sterile, is a relatively selective alpha-2 adrenergic receptor agonist (topical intraocular pressure lowering agent).

The structural formula of brimonidine tartrate is:

ALPHAGAN® P (brimonidine tartrate)  Structural Formula Illustration

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

In solution, ALPHAGAN® P (brimonidine tartrate ophthalmic solution) has a clear, greenish-yellow color. It has an osmolality of 250-350 mOsmol/kg and a pH of 7.4-8.0 (0.1%) or 6.6-7.4 (0.15%).

Brimonidine tartrate appears as an off-white to pale-yellow powder and is soluble in both water (0.6 mg/mL) and in the product vehicle (1.4 mg/mL) at pH 7.7.

Each mL of ALPHAGAN® P (brimonidine tartrate) contains the active ingredient brimonidine tartrate 0.1% (1.0 mg/mL) or 0.15% (1.5 mg/mL) with the inactive ingredients sodium carboxymethylcellulose; sodium borate; boric acid; sodium chloride; potassium chloride; calcium chloride; magnesium chloride; PURITE® 0.005% (0.05 mg/mL) as a preservative; purified water; and hydrochloric acid and/or sodium hydroxide to adjust pH.

What are the possible side effects of brimonidine ophthalmic (Alphagan P)?

Stop using brimonidine and 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:

  • slow or uneven heart rate;
  • pounding heartbeats or fluttering in your chest;
  • shallow breathing, feeling like you might pass out;
  • severe swelling, redness, or discomfort in or around your eye;
  • eye pain or...

Read All Potential Side Effects and See Pictures of Alphagan-P »

What are the precautions when taking brimonidine tartrate (Alphagan-P)?

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to apraclonidine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood vessel diseases (thromboangiitis obliterans), blood circulation disorders (cerebral or coronary insufficiency), depression, severe heart disease, kidney disease, liver disease, Raynaud's disease, low blood pressure upon standing (orthostatic hypotension).

This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness...

Read All Potential Precautions of Alphagan-P »


Alphagan-P Consumer (continued)

SIDE EFFECTS: Eye discomfort/itching/redness, blurred vision, dizziness, dry mouth, drowsiness, or tiredness may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that 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: fast/pounding heartbeats, persistent headache, eye pain/burning/swelling, extreme sensitivity to light, vision changes.

Tell your doctor immediately if any of these rare but very serious side effects occur: fainting, slow/irregular heartbeats.

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 medication, tell your doctor or pharmacist if you are allergic to it; or to apraclonidine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood vessel diseases (thromboangiitis obliterans), blood circulation disorders (cerebral or coronary insufficiency), depression, severe heart disease, kidney disease, liver disease, Raynaud's disease, low blood pressure upon standing (orthostatic hypotension).

This drug may make you dizzy or drowsy or cause 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.

Caution is advised when using this medication in children because they may be more sensitive to its side effects, especially drowsiness. See also Uses section.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.


Alphagan-P Patient Information Including Side Effects

Brand Names: Alphagan P

Generic Name: brimonidine ophthalmic (Pronunciation: bri MO ni deen)

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

What is brimonidine ophthalmic (Alphagan-P)?

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

Brimonidine ophthalmic is used to treat open-angle glaucoma or ocular hypertension (high pressure inside the eye).

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

What are the possible side effects of brimonidine ophthalmic (Alphagan-P)?

Stop using brimonidine and 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:

  • slow or uneven heart rate;
  • pounding heartbeats or fluttering in your chest;
  • shallow breathing, feeling like you might pass out;
  • severe swelling, redness, or discomfort in or around your eye;
  • eye pain or increased watering; or
  • numbness or tingly feeling in your hands or feet.

Less serious side effects may include:

  • burning, stinging, or itching of your eyes;
  • feeling like something is in your eye;
  • blurred vision;
  • redness of the eye or eyelid;
  • mildly swollen or puffy eyes;
  • sensitivity to light;
  • nausea, upset stomach;
  • headache, dizziness;
  • muscle pain;
  • tired feeling;
  • sleep problems (insomnia);
  • dry nose or mouth; or
  • unusual or unpleasant taste in your mouth.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about brimonidine ophthalmic (Alphagan-P)?

Do not use brimonidine 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.

Before using brimonidine ophthalmic, tell your doctor if you have kidney or liver disease, heart disease, high blood pressure, circulation problems such as Raynaud's or Buerger's disease, or a history of fainting or low blood pressure.

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 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.

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