Brimonidine tartrate and Timolol maleate: Difference between revisions
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{{DrugProjectFormSinglePage | {{DrugProjectFormSinglePage | ||
|authorTag={{DB}} | |authorTag={{DB}} | ||
|adverseReactions= | |genericName=Brimonidine tartrate and Timolol maleate | ||
|aOrAn=an | |||
|drugClass=an alpha-adrenergic receptor agonist with a beta-adrenergic receptor inhibitor | |||
|indicationType=treatment | |||
|indication=glaucoma, ocular hypertension; in patients requiring adjunctive or replacement therapy | |||
|adverseReactions=somnolence, allergic conjunctivitis, burning sensation in eye, conjunctival hyperemia, acute follicular conjunctivitis, itching of the eye | |||
|blackBoxWarningTitle=<b><span style="color:#FF0000;">TITLE</span></b> | |blackBoxWarningTitle=<b><span style="color:#FF0000;">TITLE</span></b> | ||
|blackBoxWarningBody=<i><span style="color:#FF0000;">Condition Name:</span></i> (Content) | |blackBoxWarningBody=<i><span style="color:#FF0000;">Condition Name:</span></i> (Content) | ||
|fdaLIADAdult= | |fdaLIADAdult=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 | :*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 | Ocular hypertension, In patients requiring adjunctive or replacement therapy | ||
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|fdaLIADPed=the safety and efficacy of brimonidine tartrate and timolol maleate combination have not been established in children under 2 yrs old [1] | |fdaLIADPed=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] | 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 | Ocular hypertension, In patients requiring adjunctive or replacement therapy: instill 1 drop in the affected eye(s) twice daily, approximately 12 hr apart | ||
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Brimonidine tartrate and Timolol maleate in pediatric patients. | |offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Brimonidine tartrate and Timolol maleate in pediatric patients. | ||
|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Brimonidine tartrate and Timolol maleate in pediatric patients. | |offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Brimonidine tartrate and Timolol maleate in pediatric patients. | ||
Revision as of 16:48, 19 September 2014
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 an an alpha-adrenergic receptor agonist with a beta-adrenergic receptor inhibitor that is FDA approved for the treatment of glaucoma, ocular hypertension; in patients requiring adjunctive or replacement therapy. Common adverse reactions include somnolence, allergic conjunctivitis, burning sensation in eye, conjunctival hyperemia, acute follicular conjunctivitis, itching of the eye.
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
{{#ask: Label Page::Brimonidine tartrate and Timolol maleate |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}
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.