Brimonidine tartrate and Timolol maleate

Brimonidine tartrate and Timolol maleate
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Deepika Beereddy, MBBS [2]

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Overview

Brimonidine tartrate and Timolol maleate is {{{aOrAn}}} {{{drugClass}}} that is FDA approved for the {{{indicationType}}} of {{{indication}}}. Common adverse reactions include Somnolence (1% to 5% ) Ophthalmic: Allergic conjunctivitis (5% to 15% ), Burning sensation in eye (5% to 15% ), Conjunctival hyperemia (5% to 15% ), Follicular conjunctivitis, acute (5% to 15% ), Itching of eye (5% to 15% ).

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Glaucoma, In patients requiring adjunctive or replacement therapy

• In patients requiring adjunctive or replacement therapy: instill 1 drop in the affected eye(s) twice daily, approximately 12 hr apart

   Ocular hypertension, In patients requiring adjunctive or replacement therapy

• instill 1 drop in the affected eye(s) twice daily, approximately 12 hr apart

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Brimonidine tartrate and Timolol maleate in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Brimonidine tartrate and Timolol maleate in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

the safety and efficacy of brimonidine tartrate and timolol maleate combination have not been established in children under 2 yrs old [1] Glaucoma, In patients requiring adjunctive or replacement therapy: instill 1 drop in the affected eye(s) twice daily, approximately 12 hr apart [1] Ocular hypertension, In patients requiring adjunctive or replacement therapy: instill 1 drop in the affected eye(s) twice daily, approximately 12 hr apart

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Brimonidine tartrate and Timolol maleate in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Brimonidine tartrate and Timolol maleate in pediatric patients.

Contraindications

There is limited information regarding Brimonidine tartrate and Timolol maleate Contraindications in the drug label.

Warnings

There is limited information regarding Brimonidine tartrate and Timolol maleate Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Brimonidine tartrate and Timolol maleate Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Brimonidine tartrate and Timolol maleate Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Brimonidine tartrate and Timolol maleate Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Brimonidine tartrate and Timolol maleate in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Brimonidine tartrate and Timolol maleate in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Brimonidine tartrate and Timolol maleate during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Brimonidine tartrate and Timolol maleate in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Brimonidine tartrate and Timolol maleate in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Brimonidine tartrate and Timolol maleate in geriatric settings.

Gender

There is no FDA guidance on the use of Brimonidine tartrate and Timolol maleate with respect to specific gender populations.

Race

There is no FDA guidance on the use of Brimonidine tartrate and Timolol maleate with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Brimonidine tartrate and Timolol maleate in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Brimonidine tartrate and Timolol maleate in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Brimonidine tartrate and Timolol maleate in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Brimonidine tartrate and Timolol maleate in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Brimonidine tartrate and Timolol maleate Administration in the drug label.

Monitoring

There is limited information regarding Brimonidine tartrate and Timolol maleate Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Brimonidine tartrate and Timolol maleate and IV administrations.

Overdosage

There is limited information regarding Brimonidine tartrate and Timolol maleate overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Brimonidine tartrate and Timolol maleate Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Brimonidine tartrate and Timolol maleate Mechanism of Action in the drug label.

Structure

There is limited information regarding Brimonidine tartrate and Timolol maleate Structure in the drug label.

Pharmacodynamics

There is limited information regarding Brimonidine tartrate and Timolol maleate Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Brimonidine tartrate and Timolol maleate Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Brimonidine tartrate and Timolol maleate Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Brimonidine tartrate and Timolol maleate Clinical Studies in the drug label.

How Supplied

There is limited information regarding Brimonidine tartrate and Timolol maleate How Supplied in the drug label.

Storage

There is limited information regarding Brimonidine tartrate and Timolol maleate Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Brimonidine tartrate and Timolol maleate Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Brimonidine tartrate and Timolol maleate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Combigan

Look-Alike Drug Names

There is limited information regarding Brimonidine tartrate and Timolol maleate Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.