Brimonidine

Name: Brimonidine

Is brimonidine safe to take if I'm pregnant or breastfeeding?

It is not known if brimonidine is secreted in breast milk.

Adverse Effects

Frequency Not Defined

Oral dryness

Conjunctival hyperemia

Allergic conjunctivitis

Eye pruritus

Rash

Photophobia

Headache

Fatigue

Dizziness

Dyspepsia

Blepharitis

Eye discharge

Postmarketing Reports

Skin and subcutaneous disorders: Pallor

Immune system disorders: Angioedema, hypersensitivity, lip swelling, swollen tongue, throat tightness, urticaria

Cardiovascular disorders: bradycardia, hypotension (including orthostatic hypotension)

Brimonidine Precautions

Serious side effects have been reported with brimonidine including the following:

  • Worsening of vascular disease. Brimonidine should be used with caution in patients with depression, cerebral or coronary insufficiency, Raynaud’s phenomenon, orthostatic hypotension, thrombangiitis obliterans, scleroderma, or Sjögren’s syndrome.
  • Cardiovascular disease. Brimonidine may lower blood pressure. It should be used with caution in patients with severe or unstable or uncontrolled heart disease.

Brimonidine can cause blurred vision. Do not drive or operate heavy machinery until you know how brimonidine affects you.

Do not take brimonidine if you are:

  • allergic to brimonidine or to any of its ingredients
  • taking a monoamine oxidase inhibitor

Brimonidine Usage

Use brimonidine exactly as prescribed.

Brimonidine comes in solution form for eye drops and is applied to the affected eye(s) 3 times daily.

Brimonidine comes in topical gel form and is applied once daily for redness associated with rosacea. It is for external use only.

Brimonidine gel should not be applied to irritated skin or open wounds. Avoid contact with the eyes and lips.

Wash your hands immediately after applying the medication.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take 2 doses of brimonidine at the same time.

Other Requirements

Store brimonidine at room temperature.

Keep this and all medicines out of the reach of children.

How is Brimonidine Supplied

Brimonidine Tartrate Ophthalmic Solution 0.2% is supplied sterile in a plastic bottle with a purple cap and controlled drop tip in the following sizes:

5 mL bottles – NDC 24208-411-05

10 mL bottles – NDC 24208-411-10

15 mL bottles – NDC 24208-411-15

Storage: Store between 15° – 25°C (59° – 77°F).

KEEP OUT OF THE REACH OF CHILDREN.

DO NOT USE IF IMPRINTED “Protective Seal” WITH YELLOW IS NOT INTACT.

Revised: July 2016
Bausch + Lomb, a division of Valeant Pharmaceuticals North America LLC
Bridgewater, NJ 08807 USA
©Bausch & Lomb Incorporated

9104703 (Folded) 9104603 (Flat)
Prod. No. 411

Package/label principal display panel

NDC 24208-411-15

Brimonidine Tartrate
Ophthalmic Solution
0.2%
(Sterile)

FOR USE IN
THE EYES ONLY

Rx only
15 mL

BAUSCH + LOMB

Brimonidine TARTRATE 
Brimonidine tartrate solution/ drops
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:24208-411
Route of Administration OPHTHALMIC DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Brimonidine TARTRATE (Brimonidine) Brimonidine TARTRATE 2 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZALKONIUM CHLORIDE  
CITRIC ACID MONOHYDRATE  
HYDROCHLORIC ACID  
WATER  
SODIUM CHLORIDE  
SODIUM CITRATE, UNSPECIFIED FORM  
SODIUM HYDROXIDE  
POLYVINYL ALCOHOL, UNSPECIFIED  
Packaging
# Item Code Package Description
1 NDC:24208-411-05 1 BOTTLE, DROPPER in 1 CARTON
1 5 mL in 1 BOTTLE, DROPPER
2 NDC:24208-411-10 1 BOTTLE, DROPPER in 1 CARTON
2 10 mL in 1 BOTTLE, DROPPER
3 NDC:24208-411-15 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
ANDA ANDA076260 05/28/2003
Labeler - Bausch & Lomb Incorporated (196603781)
Establishment
Name Address ID/FEI Operations
Bausch & Lomb Incorporated 079587625 MANUFACTURE(24208-411)
Revised: 07/2016   Bausch & Lomb Incorporated
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