Brimonidine Tartrate/Timolol Maleate (Page 5 of 5)

17 PATIENT COUNSELING INFORMATION

Patients with bronchial asthma, a history of bronchial asthma, severe chronic obstructive pulmonary disease, sinus bradycardia, second or third degree atrioventricular block, or cardiac failure should be advised not to take this product [see Contraindications ( 4.1, 4.2)].

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 or by inadvertent contact with the dropper tip [see Warnings and Precautions (5.10)]. 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.

Patients should be advised that brimonidine tartrate/timolol maleate ophthalmic solution contains benzalkonium chloride which may be absorbed by soft contact lenses. Contact lenses should be removed prior to administration of the solution. Lenses may be reinserted 15 minutes following administration of brimonidine tartrate/timolol maleate ophthalmic solution.

As with other similar medications, brimonidine tartrate/timolol maleate ophthalmic solution 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.

Manufactured In India By:
Indoco Remedies Limited
Verna, Goa 403722, India

Manufactured For:
Teva Pharmaceuticals USA, Inc.
Parsippany, NJ 07054

Iss. 2/2022

NDC 0591-2422-26
Brimonidine
Tartrate/
Timolol Maleate
Ophthalmic
Solution
0.2%/0.5%
Sterile
Rx only5 mL

carton 5 mL
(click image for full-size original)
BRIMONIDINE TARTRATE/TIMOLOL MALEATE brimonidine tartrate and timolol maleate solution/ drops
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-2422
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
TIMOLOL MALEATE (TIMOLOL ANHYDROUS) TIMOLOL ANHYDROUS 5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZALKONIUM CHLORIDE
SODIUM PHOSPHATE
WATER
HYDROCHLORIC ACID
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0591-2422-26 1 BOTTLE, DROPPER in 1 CARTON contains a BOTTLE, DROPPER
1 5 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (0591-2422-26)
2 NDC:0591-2422-79 1 BOTTLE, DROPPER in 1 CARTON contains a BOTTLE, DROPPER
2 10 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (0591-2422-79)
3 NDC:0591-2422-12 1 BOTTLE, DROPPER in 1 CARTON contains a BOTTLE, DROPPER
3 15 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (0591-2422-12)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201949 10/07/2022
Labeler — Actavis Pharma, Inc. (119723554)
Establishment
Name Address ID/FEI Operations
INDOCO REMEDIES LIMITED 915851870 label (0591-2422), manufacture (0591-2422), pack (0591-2422)

Revised: 02/2022 Actavis Pharma, Inc.

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