Alphagan P

Name: Alphagan P

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

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Descriptions

Brimonidine ophthalmic (eye) drops is used alone or together with other medicines to treat increased pressure in the eye that is caused by open-angle glaucoma or a condition called hypertension of the eye (ocular hypertension). This medicine is an alpha-adrenergic agonist.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

  • Solution

Overdose

This medicine may be harmful if swallowed. If swallowing or overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

How should I use Alphagan P (brimonidine ophthalmic)?

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Wash your hands before using the eye drops.

To apply the eye drops:

  • Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the dropper above the eye with the tip down. Look up and away from the dropper and squeeze out a drop.

  • Close your eyes for 2 or 3 minutes with your head tipped down, without blinking or squinting. Gently press your finger to the inside corner of the eye for about 1 minute, to keep the liquid from draining into your tear duct.

  • Use only the number of drops your doctor has prescribed. If you use more than one drop, wait about 5 minutes between drops.

  • Wait at least 5 minutes before using any other eye drops your doctor has prescribed.

Do not touch the tip of the eye dropper or place it directly on your eye. A contaminated dropper can infect your eye, which could lead to serious vision problems.

Do not use the eye drops if the liquid has changed colors or has particles in it. Call your pharmacist for new medicine.

Tell your doctor right away if you have any eye injury or infection, or if you need to have any type of surgery, especially eye surgery.

Store at room temperature away from moisture and heat. Do not freeze. Keep the bottle tightly closed when not in use.

Before Using Alphagan P

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of brimonidine eye drops in children 2 years of age and older. Because of brimonidine's toxicity, use in children younger than 2 years of age is not recommended.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of brimonidine eye drops in the elderly.

Pregnancy

Pregnancy Category Explanation
All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Depression or
  • Heart attack, history of or
  • Heart disease or
  • Orthostatic hypotension (low blood pressure when standing up) or
  • Raynaud disease (blood vessel disease) or
  • Stroke, history of or
  • Thromboangiitis obliterans (blood vessel disease)—Use with caution. May make these conditions worse.

How is this medicine (Alphagan P) best taken?

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • For the eye only.
  • Some of these products are not for use if you are wearing contact lenses. Be sure you know if you need to avoid wearing contact lenses while using this product.
  • Do not touch the container tip to the eye, lid, or other skin.
  • 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.
  • If more than 1 drug is being used in the same eye, use each drug at least 5 minutes apart.
  • Do not use if the solution is cloudy, leaking, or has particles.
  • Do not use if solution changes color.

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.

How do I store and/or throw out Alphagan P?

  • Store at room temperature.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Warnings and Precautions

Potentiation of Vascular Insufficiency

ALPHAGAN® P may potentiate syndromes associated with vascular insufficiency. ALPHAGAN® P should be used with caution in patients with depression, cerebral or coronary insufficiency, Raynaud's phenomenon, orthostatic hypotension, or thromboangiitis obliterans.

Severe Cardiovascular Disease

Although brimonidine tartrate ophthalmic solution had minimal effect on the blood pressure of patients in clinical studies, caution should be exercised in treating patients with severe cardiovascular disease.

Contamination of Topical Ophthalmic Products After Use

There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products. These containers had been inadvertently contaminated by patients who, in most cases, had a concurrent corneal disease or a disruption of the ocular epithelial surface (see PATIENT COUNSELING INFORMATION, 17).

How Supplied/Storage and Handling

ALPHAGAN® P is supplied sterile, in teal opaque plastic LDPE bottles and tips, with purple high impact polystyrene (HIPS) caps as follows:

0.1%

5 mL in 10 mL bottle              NDC 0023-9321-05
10 mL in 10 mL bottle            NDC 0023-9321-10
15 mL in 15 mL bottle            NDC 0023-9321-15

0.15%

5 mL in 10 mL bottle              NDC 0023-9177-05
10 mL in 10 mL bottle            NDC 0023-9177-10
15 mL in 15 mL bottle            NDC 0023-9177-15

Storage: Store at 15°-25°C (59°-77°F).

Patient Counseling Information

Patients should 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 (see WARNINGS AND PRECAUTIONS, 5.3). Always replace the cap after using. If solution changes color or becomes cloudy, do not use. Do not use the product after the expiration date marked on the bottle.

Patients also should be advised that if they have ocular surgery or develop an intercurrent ocular condition (e.g., trauma or infection), they should immediately seek their physician's advice concerning the continued use of the present multidose container.

If more than one topical ophthalmic drug is being used, the drugs should be administered at least five minutes apart.

As with other similar medications, ALPHAGAN® P may cause fatigue and/or drowsiness in some patients. Patients who engage in hazardous activities should be cautioned of the potential for a decrease in mental alertness.

© 2013 Allergan, Inc.
Irvine, CA 92612, U.S.A.
® marks owned by Allergan, Inc.
Patented. See: www.allergan.com/products/patent_notices
Made in the U.S.A.

71816US16

ALLERGAN

NDC 0023-9321-10

Alphagan® P

(brimonidine tartrate
ophthalmic solution)

0.1%

Rx only

10 mL sterile

ALLERGAN

NDC 0023-9177-10

Alphagan® P

(brimonidine tartrate
ophthalmic solution)

0.15%

Rx only

10 mL sterile

Alphagan P  
brimonidine tartrate solution/ drops
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0023-9321
Route of Administration OPHTHALMIC DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
brimonidine tartrate (brimonidine) brimonidine tartrate 1 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
boric acid  
calcium chloride  
magnesium chloride  
potassium chloride  
water  
sodium borate  
carboxymethylcellulose sodium  
sodium chloride  
hydrochloric acid  
sodium hydroxide  
Packaging
# Item Code Package Description
1 NDC:0023-9321-03 1 BOTTLE, DROPPER in 1 CARTON
1 3 mL in 1 BOTTLE, DROPPER
2 NDC:0023-9321-05 1 BOTTLE, DROPPER in 1 CARTON
2 5 mL in 1 BOTTLE, DROPPER
3 NDC:0023-9321-10 1 BOTTLE, DROPPER in 1 CARTON
3 10 mL in 1 BOTTLE, DROPPER
4 NDC:0023-9321-15 1 BOTTLE, DROPPER in 1 CARTON
4 15 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021770 01/25/2006
Alphagan P  
brimonidine tartrate solution/ drops
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0023-9177
Route of Administration OPHTHALMIC DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
brimonidine tartrate (brimonidine) brimonidine tartrate 1.5 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
boric acid  
calcium chloride  
magnesium chloride  
potassium chloride  
water  
sodium borate  
carboxymethylcellulose sodium  
sodium chloride  
hydrochloric acid  
sodium hydroxide  
Packaging
# Item Code Package Description
1 NDC:0023-9177-05 1 BOTTLE, DROPPER in 1 CARTON
1 5 mL in 1 BOTTLE, DROPPER
2 NDC:0023-9177-10 1 BOTTLE, DROPPER in 1 CARTON
2 10 mL in 1 BOTTLE, DROPPER
3 NDC:0023-9177-15 1 BOTTLE, DROPPER in 1 CARTON
3 15 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021262 07/10/2001
Labeler - Allergan, Inc. (144796497)
Establishment
Name Address ID/FEI Operations
Allergan Sales, LLC 362898611 MANUFACTURE(0023-9321, 0023-9177)
Revised: 10/2013   Allergan, Inc.

Warnings

Contraindications

Hypersensitivity to product or components

Children <2 years

Concurrent MAO inhibitors

Cautions

Wait 15 min before inserting soft contact lenses

Use caution in severe cardiovascular disease, cerebral insufficiency, depression, hepatic impairment, orthostatic hypotension, renal impairment, thromboangiitis obliterans

May cause CNS depression, which may impair mental abilities

Children are at higher risk of adverse effects

Bradycardia, hypotension (including orthostatic hypotension) and dizziness reported

Avoid applying topical gel to skin or open wounds

Some patients have experienced erythema involving areas of face that were previously not affected by erythema and in areas (e.g., neck and chest) outside of treatment sites

Some patients have experienced increased frequency of flushing and/or increased depth of erythema with flushing; some patients reported new onset of flushing

Some patients have experienced pallor or excessive whitening at or outside application site following therapy

Allergic contact dermatitis was reported for topical gel

Adverse events reported for topical gel include angioedema, throat tightening, tongue swelling, and urticarial; institute appropriate therapy and discontinue therapy, if clinically significant hypersensitivity reaction occurs

Dosing & Uses

Dosage Forms & Strengths

ophthalmic solution

  • 0.1% (Alphagan P)
  • 0.15% (Alphagan P, Qoliana)
  • 0.2% (Alphagan P)

Open-Angle Glaucoma or Ocular Hypertension

1 gtt in affected eye(s) q8hr

Ocular Redness

Pending FDA approval for ocular redness

Optic Neuropathy (Orphan)

Treatment of anterior ischemic optic neuropathy

Orphan indication sponsor

  • Allergan, Inc; 2525 Dupont Drive, P.O. Box 19534; Irvine, CA 92713

Graft vs Host Disease (Orphan)

Orphan designation for ocular GVHD

Sponsor

  • Ocugen, Inc; 5 Great Valley Parkway, Suite 160; Malvern, Pennsylvania 19355

Dosage Forms & Strengths

ophthalmic solution

  • 0.1% (Alphagan P)
  • 0.15% (Alphagan P, Qoliana)
  • 0.2% (Alphagan P)

Open-Angle Glaucoma or Ocular Hypertension

<2 years

  • Contraindicated

≥2 years

  • 1 gtt in affected eye(s) q8hr

Pregnancy & Lactation

Pregnancy Category: B

Lactation: It is not known whether this drug is excreted in milk. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

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