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Brimonidine Tartrate and Timolol Maleate 2 mg/mL; 5 mg/mL Solution/ Drops

by Alembic Pharmaceuticals Limited · 1 BOTTLE, DROPPER in 1 CARTON (46708-706-10) / 10 mL in 1 BOTTLE, DROPPER

NDC 46708-0706-10

🏷️ FDA NDC (as labeled) 46708-706-10 billing pads the product segment with a zero

This package

Contains10 mL in 1 bottle, dropper Pack sizes3 compare ↓

Also priced by: Part D plans $10.33/unit — full pricing hub ↓

Also comes in: 5 mL 46708-0706-05 15 mL 46708-0706-15

Rx only Generic On market Non-controlled

🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm

📋 All sources & update times →

This page is curated, coded, and maintained by Dr. Brian Staiger, PharmD

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️

Other active recalls for Brimonidine Tartrate And Timolol Maleate (different manufacturers) — 3 · tap to view

These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.

Class II · Mar 5, 2026 — Lack of Assurance of Sterility (Apotex Corp.) · FDA recall D-0407-2026

Class II · Sep 5, 2025 — Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns (Apotex Corp.) · FDA recall D-0676-2025

Class II · May 28, 2025 — Lack of Assurance of Sterility (Apotex Corp.) · FDA recall D-0496-2025

Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 46708-706-10

Product NDC 46708-706

11-digit billing NDC 46708070610

RxCUI 861635

UNII 4S9CL2DY2H, P8Y54F701R

Application # ANDA215230

SPL Set ID b5d560b6-847e-4f09-b1ef-22e4deb8a206

Established class (EPC) alpha-Adrenergic Agonist; beta-Adrenergic Blocker

Mechanism of action Adrenergic alpha-Agonists; Adrenergic beta-Antagonists

DEA schedule Non-controlled

Marketing category ANDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2023-08-25

Route OPHTHALMIC

Dosage form SOLUTION/ DROPS

Substance BRIMONIDINE TARTRATE; TIMOLOL MALEATE

TE code (Orange Book) AB · RLD · RS

Why two NDCs? The FDA registers this code as 46708-706-10 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 46708-0706-10. Same drug, same package — only the format differs.

Where does this data come from?

Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the beta-Adrenergic Blocker class.

Pharmacologic class beta-Adrenergic Blocker

Drug family (ATC) Beta blocking agents, non-selective, Beta blocking agents

How it works Adrenergic beta-Antagonists

Where does this data come from?

Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerAlembic Pharmaceuticals Limited

Application holderALEMBIC PHARMACEUTICALS LTD

FDA applicationANDA215230 (ANDA)

Labeler code46708

First marketedAug 2023

Product typeHuman Prescription Drug

Portfolio502 products on file

🔎 All NDCs from Alembic Pharmaceuticals Limited

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).

Where does this data come from?

Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

📖 What it is MedlinePlus · NLM

Ophthalmic brimonidine is used to lower pressure in the eyes in patients who have glaucoma (a condition in which increased pressure in the eye can lead to gradual loss of vision) or ocular hypertension (increased pressure in the eyes). Brimonidine is in a class of drugs called alpha adrenergic agonists. Brimonidine works by decreasing the amount of fluid in the eyes.

Read the full MedlinePlus article ↗

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →

Where does this data come from?

Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

UNII F5UM2KM3W7
Benzalkonium chloride is a chemical compound that works as a preservative and antimicrobial agent in medications. It prevents bacterial and fungal growth in liquid formulations to keep the product safe during storage and use.
UNII QTT17582CB
A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
UNII 70WT22SF4B
A mineral salt that acts as a buffer to maintain the pH balance of the medication. It helps stabilize the drug's potency and prevents unwanted chemical changes during storage.
UNII 593YOG76RN
A salt made from sodium and phosphate that helps regulate acidity and maintain proper pH balance in the medicine. It also acts as a buffer to keep the product stable.
UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

6 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?

Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?

No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.

Why might an inactive ingredient be missing?

Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.

Can inactive ingredients matter?

Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price system	Per mL	Per package
Retail pharmacies payNADAC · weekly	Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo	No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026	$10.33	$103.27 / 10 ml

Where does this data come from?

NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 2 mg/mL; 5 mg/mL 65145-0164-01	Caplin	1 bottle	$1.839	AB	Availability likely	—
Brimonidine Tartrate and Timolol Maleate 2 mg/mL; 5 mg/mL 70069-0653-01	Somerset	1 bottle	$1.839	AB	Availability likely	—
Brimonidine Tartrate and Timolol Maleate 2 mg/mL; 5 mg/mL 00781-7186-70	Sandoz	10 ml	$2.461	AB	Availability likely	—
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 2 mg/mL; 5 mg/mL 65145-0163-01	Caplin	1 bottle	$2.461	AB	Availability likely	—
Brimonidine Tartrate/Timolol Maleate 2 mg/mL; 5 mg/mL 68462-0281-32	Glenmark	1 bottle	$2.461	AB	Availability likely	—
Brimonidine Tartrate and Timolol Maleate 2 mg/mL; 5 mg/mL 70069-0652-01	Somerset	1 bottle	$2.461	AB	Availability likely	—
Brimonidine Tartrate and Timolol Maleate 2 mg/mL; 5 mg/mL 00832-1425-05	Upsher-Smith	1 bottle	$2.795	AB	Availability likely	—
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 2 mg/mL; 5 mg/mL 60505-0589-01	Apotex	1 bottle	$2.795	AB	Availability likely	—
Brimonidine Tartrate and Timolol Maleate 2 mg/mL; 5 mg/mL 62332-0706-05	Alembic	1 bottle	$2.795	AB	Availability likely	—
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 2 mg/mL; 5 mg/mL 65145-0162-01	Caplin	1 bottle	$2.795	AB	Availability likely	—
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 2 mg/mL; 5 mg/mL 69315-0330-05	Leading	1 bottle	$2.795	AB	Availability likely	—
Brimonidine Tartrate and Timolol Maleate 2 mg/mL; 5 mg/mL 70069-0651-01	Somerset	1 bottle	$2.795	AB	Availability likely	—
Brimonidine Tartrate And Timolol Maleate 2 mg/mL; 5 mg/mL 71921-0188-05	Florida	1 bottle	$2.795	AB	Availability likely	—
Brimonidine tartrate and Timolol maleate 2 mg/mL; 5 mg/mL 72603-0931-05	NorthStar	1 bottle	$2.795	AB	Availability likely	—
Combigan 2 mg/mL; 5 mg/mL 00023-9211-03	Allergan,	1 bottle	—	AB	FDA listed	—
Brimonidine Tartrate and Timolol Maleate 2 mg/mL; 5 mg/mLthis 46708-0706-10	Alembic	1 bottle	—	AB	FDA listed	—
Brimonidine Tartrate and Timolol maleate Ophthalmic Solution 2 mg/mL; 5 mg/mL 68083-0624-01	Gland	1 bottle	—	AB	FDA listed	—
Brimonidine Tartrate and Timolol maleate Ophthalmic Solution 2 mg/mL; 5 mg/mL 68083-0625-01	Gland	1 bottle	—	AB	FDA listed	—
Brimonidine Tartrate and Timolol maleate Ophthalmic Solution 2 mg/mL; 5 mg/mL 68083-0664-01	Gland	1 bottle	—	AB	FDA listed	—
Brimonidine Tartrate/Timolol Maleate 2 mg/mL; 5 mg/mL 72485-0634-05	ARMAS	1 bottle	—	AB	FDA listed	—
Brimonidine Tartrate and Timolol maleate Ophthalmic Solution 2 mg/mL; 5 mg/mL 73043-0029-01	Devatis	1 bottle	—	AB	FDA listed	—

About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.

Where does this data come from?

Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️

2023

On the market since

Aug 2023

📍

2026

Currently FDA-listed

3 years listed

🔓

Generic on the market

this product is a generic

✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?

Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Brimonidine Tartrate and Timolol Maleate — the ingredient across all brands.

Top reported reactions

Eye Pain28

Eye Irritation27

Ocular Hyperaemia25

Fatigue23

Visual Impairment21

Headache19

Nausea17

Age at onset

Adult24

Elderly40

Reporter sex

Male · 40%

Female · 58%

Unknown · 2%

Serious outcomes

Hospitalization65

Disabling13

Death13

Life-threatening6

Reports over time (by year) — tap or hover for the count & year

Most recent year is provisional (FAERS lags ~3 months).

Where does this data come from?

Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
46708-0706-05	1 BOTTLE, DROPPER in 1 CARTON (46708-706-05) / 5 mL in 1 BOTTLE, DROPPER	2023-08-25	Active
46708-0706-10 You're viewing this	1 BOTTLE, DROPPER in 1 CARTON (46708-706-10) / 10 mL in 1 BOTTLE, DROPPER	2023-08-25	Active
46708-0706-15	1 BOTTLE, DROPPER in 1 CARTON (46708-706-15) / 15 mL in 1 BOTTLE, DROPPER	2023-08-25	Active

Pack size FAQ

What quantity is in NDC 46708-0706-10?

NDC 46708-0706-10 is listed by the FDA — 1 bottle, dropper in 1 carton / 10 ml in 1 bottle, dropper.

What NDC number is used to bill for this package of Brimonidine Tartrate and Timolol Maleate 2 mg/mL; 5 mg/mL Solution/ Drops?

Bill NDC 46708-0706-10 — the 11-digit billing format is 46708070610. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product

What data is (and isn’t) available for this NDC — tap to expand

NDC identity (package / product / labeler codes)	✓ Available
Labeler	✓ Available
Product & package description	✓ Available
Marketing category & status	✓ Available
Active ingredient / dosage form / route	✓ Available
FDA label (SPL via DailyMed)	✓ Available
Package photos	✓ Available
Inactive ingredients (structured)	✓ Available
NADAC pharmacy acquisition price (CMS)	— Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data	✓ Available
HCPCS J-code billing crosswalk	— Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD)	— Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.

“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?

The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.

Is the NDC printed on the package the same as the 11-digit billing NDC?

Yes, they identify this exact package in different formats. The FDA registers it as 46708-706-10, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 46708-0706-10, written without dashes as 46708070610. The Identity section at the top of this page lists every form of this code.

What do the three segments of this NDC mean?

In 46708-0706-10, the first segment (46708) is the labeler code FDA assigned to Alembic Pharmaceuticals Limited; the middle segment (0706) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (10) identifies this exact package size and type. Together they name one specific package of one specific product.

Is this package still being marketed?

Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Alembic Pharmaceuticals Limited. Listing status can change — the directory data on this page refreshes weekly.

Does this product come in other package sizes?

Yes — the FDA directory lists 2 other package presentations of this same product, including 1 bottle (46708-0706-05), 1 bottle (46708-0706-15). Each has its own NDC and its own page — see the package list near the top of this page.

Who lists this product with the FDA?

Alembic Pharmaceuticals Limited is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.

Do I need a prescription for this product?

This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.

This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.

Where does this data come from?

Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.

🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients

🎯 Indications and Usage 184 words ▾

1 INDICATIONS & USAGE Brimonidine tartrate and timolol maleate ophthalmic solution 0.2% /0.5% is an alpha-adrenergic receptor agonist with a beta-adrenergic receptor inhibitor indicated for the reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP; the IOP-lowering of brimonidine tartrate and timolol maleate ophthalmic solution dosed twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol maleate ophthalmic solution dosed twice a day and 0.2% brimonidine tartrate ophthalmic solution dosed three times per day.

Brimonidine tartrate and timolol maleate ophthalmic solution is an alpha-adrenergic receptor agonist with a beta-adrenergic receptor inhibitor indicated for the reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP; the IOP-lowering of brimonidine tartrate and timolol maleate ophthalmic solution dosed twice a day was slightly less than that seen with the concomitant administration of timolol maleate ophthalmic solution, 0.5% dosed twice a day and brimonidine tartrate ophthalmic solution, 0.2% dosed three times per day.

⏱️ Dosage and Administration 62 words ▾

2 DOSAGE & ADMINISTRATION The recommended dose is one drop of brimonidine tartrate and timolol maleate ophthalmic solution in the affected eye(s) twice daily approximately 12 hours apart. If more than one topical ophthalmic product is to be used, the different products should be instilled at least 5 minutes apart. One drop in the affected eye(s), twice daily approximately 12 hours apart.

💊 Dosage Forms and Strengths 29 words ▾

3 DOSAGE FORMS & STRENGTHS Solution containing 2 mg/mL brimonidine tartrate and 5 mg/mL timolol (6.8 mg/mL timolol maleate). Solution containing 2 mg/mL brimonidine tartrate and 5 mg/mL timolol.

⛔ Contraindications 216 words ▾

4 CONTRAINDICATIONS Bronchial asthma, a history of bronchial asthma, severe chronic obstructive pulmonary disease. ( 4.1 , 5.1 , 5.3 ) Sinus bradycardia, atrioventricular block, overt cardiac failure, cardiogenic shock. ( 4.2 , 5.2 ) Neonates and infants (under the age of 2 years). ( 4.3 ) Hypersensitivity to any component of this product. ( 4.4 )

4.1Reactive Airway Disease Including Asthma, COPD Brimonidine tartrate and timolol maleate ophthalmic solution is contraindicated in patients with reactive airway disease including bronchial asthma; a history of bronchial asthma; severe chronic obstructive pulmonary disease [see Warnings and Precautions (5.1, 5.3)] .

4.2Sinus Bradycardia, AV Block, Cardiac Failure, Cardiogenic Shock Brimonidine tartrate and timolol maleate ophthalmic solution is contraindicated in patients with sinus bradycardia; second or third degree atrioventricular block; overt cardiac failure [see Warnings and Precautions (5.2)] ; cardiogenic shock.

4.3Neonates and Infants (Under the Age of 2 Years) Brimonidine tartrate and timolol maleate ophthalmic solution is contraindicated in neonates and infants (under the age of 2 years).

4.4Hypersensitivity Reactions Local hypersensitivity reactions have occurred following the use of different components of brimonidine tartrate and timolol maleate ophthalmic solution. Brimonidine tartrate and timolol maleate ophthalmic solution is contraindicated in patients who have exhibited a hypersensitivity reaction to any component of this medication in the past.

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Potential for Severe Respiratory or Cardiac Reactions ( 5.1 ) Cardiac Failure ( 5.2 ) Obstructive Pulmonary Disease ( 5.3 ) Potentiation of Vascular Insufficiency ( 5.4 ) Increased Reactivity to Allergens ( 5.5 ) Potentiation of Muscle Weakness ( 5.6 ) Masking of Hypoglycemic Symptoms in Patients with Diabetes Mellitus ( 5.7 ) Masking of Thyrotoxicosis ( 5.8 ) Ocular Hypersensitivity ( 5.9 )

5.1Potential for Severe Respiratory or Cardiac Reactions Brimonidine tartrate and timolol maleate ophthalmic solution contains timolol maleate; and although administered topically can be absorbed systemically. Therefore, the same types of adverse reactions found with systemic administration of beta-adrenergic blocking agents may occur with topical administration. For example, severe respiratory reactions and cardiac reactions including death due to bronchospasm in patients with asthma, and rarely death in association with cardiac failure have been reported following systemic or ophthalmic administration of timolol maleate [see Contraindications (4.1)] .

Additionally, ophthalmic beta-blockers may impair compensatory tachycardia and increase risk of hypotension.

5.2Cardiac Failure Sympathetic stimulation may be essential for support of the circulation in individuals with diminished myocardial contractility, and its inhibition by beta-adrenergic receptor blockade may precipitate more severe failure. In patients without a history of cardiac failure, continued depression of the myocardium with beta-blocking agents over a period of time can, in some cases, lead to cardiac failure. At the first sign or symptom of cardiac failure, brimonidine tartrate and timolol maleate ophthalmic solution should be discontinued [see Contraindications (4.2)] .

5.3Obstructive Pulmonary Patients with chronic obstructive pulmonary disease (e.g., chronic bronchitis, emphysema) of mild or moderate severity, bronchospastic disease, or a history of bronchospastic disease (other than bronchial asthma or a history of bronchial asthma, in which brimonidine tartrate and timolol maleate ophthalmic solution is contraindicated [see Contraindications (4.1)] ) should, in general, not receive beta-blocking agents, including brimonidine tartrate and timolol maleate ophthalmic solution.

5.4Potentiation of Vascular Insufficiency Brimonidine tartrate and timolol maleate ophthalmic solution may potentiate syndromes associated with vascular insufficiency. Brimonidine tartrate and timolol maleate ophthalmic solution should be used with caution in patients with depression, cerebral or coronary insufficiency, Raynaud’s phenomenon, orthostatic hypotension, or thromboangiitis obliterans.

5.5Increased Reactivity to Allergens While taking beta-blockers, patients with a history of atopy or a history of severe anaphylactic reactions to a variety of allergens may be more reactive to repeated accidental, diagnostic, or therapeutic challenge with such allergens. Such patients may be unresponsive to the usual doses of epinephrine used to treat anaphylactic reactions.

5.6Potentiation of Muscle Weakness Beta-adrenergic blockade has been reported to potentiate muscle weakness consistent with certain myasthenic symptoms (e.g., diplopia, ptosis, and generalized weakness). Timolol has been reported rarely to increase muscle weakness in some patients with myasthenia gravis or myasthenic symptoms.

5.7Masking of Hypoglycemic Symptoms in Patients with Diabetes Mellitus Beta-adrenergic blocking agents should be administered with caution in patients subject to spontaneous hypoglycemia or to diabetic patients (especially those with labile diabetes) who are receiving insulin or oral hypoglycemic agents. Beta-adrenergic receptor blocking agents may mask the signs and symptoms of acute hypoglycemia.

5.8Masking of Thyrotoxicosis Beta-adrenergic blocking agents may mask certain clinical signs (e.g., tachycardia) of hyperthyroidism. Patients suspected of developing thyrotoxicosis sh…

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS Most common adverse reactions occurring in approximately 5 to 15% of patients included allergic conjunctivitis, conjunctival folliculosis, conjunctival hyperemia, eye pruritus, ocular burning, and stinging. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceutical, Inc. at 1-866-210-9797 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Brimonidine tartrate and timolol maleate ophthalmic solution In clinical trials of 12 months duration with brimonidine tartrate and timolol maleate ophthalmic solution, the most frequent reactions associated with its use occurring in approximately 5% to 15% of the patients included: allergic conjunctivitis, conjunctival folliculosis, conjunctival hyperemia, eye pruritus, ocular burning, and stinging.

The following adverse reactions were reported in 1% to 5% of patients: asthenia, blepharitis, corneal erosion, depression, epiphora, eye discharge, eye dryness, eye irritation, eye pain, eyelid edema, eyelid erythema, eyelid pruritus, foreign body sensation, headache, hypertension, oral dryness, somnolence, superficial punctate keratitis, and visual disturbance. Other adverse reactions that have been reported with the individual components are listed below. Brimonidine Tartrate (0.1% - 0.2%) Abnormal taste, allergic reaction, blepharoconjunctivitis, blurred vision, bronchitis, cataract, conjunctival blanching, conjunctival edema, conjunctival hemorrhage, conjunctivitis, cough, dizziness, dyspepsia, dyspnea, fatigue, flu syndrome, follicular conjunctivitis, gastrointestinal disorder, hypercholesterolemia, hypotension, infection (primarily colds and respiratory infections), hordeolum, insomnia, keratitis, lid crusting, lid disorder, muscular pain, nasal dryness, ocular allergic reaction, pharyngitis, photophobia, rash, rhinitis, sinus infection, sinusitis, superficial punctate keratopathy, tearing, upper respiratory symptoms, visual field defect, vitreous detachment, vitreous disorder, vitreous floaters, and worsened visual acuity.

Timolol (Ocular Administration) Body as a whole : chest pain; Cardiovascular : Arrhythmia, bradycardia, cardiac arrest, cardiac failure, cerebral ischemia, cerebral vascular accident, claudication, cold hands and feet, edema, heart block, palpitation, pulmonary edema, Raynaud’s phenomenon, syncope, and worsening of angina pectoris; Digestive : anorexia, diarrhea, nausea; Immunologic : Systemic lupus erythematosus; Nervous System/Psychiatric : Increase in signs and symptoms of myasthenia gravis, insomnia, nightmares, paresthesia, behavioral changes and psychic disturbances including confusion, hallucinations, anxiety, disorientation, nervousness, and memory loss; Skin : Alopecia, psoriasiform rash or exacerbation of psoriasis; Hypersensitivity : Signs and symptoms of systemic allergic reactions, including anaphylaxis, angioedema, urticaria, and generalized and localized rash; Respiratory : Bronchospasm (predominantly in patients with pre-existing bronchospastic disease) [see Contraindications (4.1)] , dyspnea, nasal congestion, respiratory failure, upper respiratory infections; Endocrine : Masked symptoms of hypoglycemia in diabetes patients [see Warnings and Precautions (5.7)] ; Special Senses : diplopia, choroidal detachment following filtration surgery, cystoid macular edema, decreased corneal sensitivity, pseudopemphigoid, ptosis, refractive changes, tinnitus; Urogenital : Decreased libido, impotence, Peyronie’s disease, retroperitoneal fibrosis.

6.2Postmarketing Experience The following reactions have been identified during post-marketing use of brimonidine tartrate ophthalmic solutions, timolol ophthalmic solutions, or both in combina…

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Antihypertensives/cardiac glycosides may lower blood pressure. ( 7.1 ) Concomitant use with systemic beta-blockers may potentiate systemic beta-blockade. ( 7.2 ) Oral or intravenous calcium antagonists may cause atrioventricular conduction disturbances, left ventricular failure, and hypotension.

( 7.3 ) Catecholamine-depleting drugs may have additive effects and produce hypotension and/or marked bradycardia. ( 7.4 ) Use with CNS depressants may result in an additive or potentiating effect.( 7.5 ) Digitalis and calcium antagonists may have additive effects in prolonging atrioventricular conduction time. ( 7.6 ) CYP2D6 inhibitors may potentiate systemic beta-blockade.

( 7.7 ) Tricyclic antidepressants may potentially blunt the hypotensive effect of systemic clonidine. ( 7.8 ) Monoamine oxidase inhibitors may result in increased hypotension. ( 7.9 )

7.1Antihypertensives/Cardiac Glycosides Because brimonidine tartrate and timolol maleate ophthalmic solution may reduce blood pressure, caution in using drugs such as antihypertensives and/or cardiac glycosides with brimonidine tartrate and timolol maleate ophthalmic solution is advised.

7.2Beta-adrenergic Blocking Agents Patients who are receiving a beta-adrenergic blocking agent either orally or intravenously and brimonidine tartrate and timolol maleate ophthalmic solution should be observed for potential additive effects of beta-blockade, both systemic and on intraocular pressure. The concomitant use of two topical beta-adrenergic blocking agents is not recommended.

7.3Calcium Antagonists Caution should be used in the co-administration of beta-adrenergic blocking agents, such as brimonidine tartrate and timolol maleate ophthalmic solution, and oral or intravenous calcium antagonists because of possible atrioventricular conduction disturbances, left ventricular failure, and hypotension. In patients with impaired cardiac function, co-administration should be avoided.

7.4Catecholamine-depleting Drugs Close observation of the patient is recommended when a beta blocker is administered to patients receiving catecholamine-depleting drugs such as reserpine, because of possible additive effects and the production of hypotension and/or marked bradycardia, which may result in vertigo, syncope, or postural hypotension.

7.5CNS Depressants Although specific drug interaction studies have not been conducted with brimonidine tartrate and timolol maleate ophthalmic solution, the possibility of an additive or potentiating effect with CNS depressants (alcohol, barbiturates, opiates, sedatives, or anesthetics) should be considered.

7.6Digitalis and Calcium Antagonists The concomitant use of beta-adrenergic blocking agents with digitalis and calcium antagonists may have additive effects in prolonging atrioventricular conduction time.

7.7CYP2D6 Inhibitors Potentiated systemic beta-blockade (e.g., decreased heart rate, depression) has been reported during combined treatment with CYP2D6 inhibitors (e.g., quinidine, SSRIs) and timolol.

7.8Tricyclic Antidepressants Tricyclic antidepressants have been reported to blunt the hypotensive effect of systemic clonidine. It is not known whether the concurrent use of these agents with brimonidine tartrate and timolol maleate ophthalmic solution in humans can lead to resulting interference with the IOP-lowering effect. Caution, however, is advised in patients taking tricyclic antidepressants which can affect the metabolism and uptake of circulating amines.

7.9Monoamine Oxidase Inhibitors Monoamine oxidase (MAO) inhibitors may theoretically interfere with the metabolism of brimonidine and potentially result in an increased systemic side effect such as hypotension. Caution, however, is advised in patients taking MAO inhibitors which can affect the metabolism and uptake of circulating amines.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Not for use in children below the age of 2 years. Use with caution in children ≥ 2 years of age. ( 8.4 )

8.1Pregnancy Teratogenicity studies have been performed in animals. Brimonidine tartrate was not teratogenic when given orally during gestation days 6 through 15 in rats and days 6 through 18 in rabbits. The highest doses of brimonidine tartrate in rats (2.5 mg/kg/day) and rabbits (5 mg/kg/day) achieved AUC exposure values 580 and 37-fold higher, respectively, than similar values estimated in humans treated with brimonidine tartrate and timolol maleate ophthalmic solution, 1 drop in both eyes twice daily.

Teratogenicity studies with timolol in mice, rats, and rabbits at oral doses up to 50 mg/kg/day [4,200 times the maximum recommended human ocular dose of 0.012 mg/kg/day on a mg/kg basis (MRHOD)] demonstrated no evidence of fetal malformations. Although delayed fetal ossification was observed at this dose in rats, there were no adverse effects on postnatal development of offspring. Doses of 1,000 mg/kg/day (83,000 times the MRHOD) were maternotoxic in mice and resulted in an increased number of fetal resorptions.

Increased fetal resorptions were also seen in rabbits at doses 8,300 times the MRHOD without apparent maternotoxicity. There are no adequate and well-controlled studies in pregnant women; however, in animal studies, brimonidine crossed the placenta and entered into the fetal circulation to a limited extent. Because animal reproduction studies are not always predictive of human response, brimonidine tartrate and timolol maleate ophthalmic solution should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus.

8.3Nursing Mothers Timolol has been detected in human milk following oral and ophthalmic drug administration. It is not known whether brimonidine tartrate is excreted in human milk, although in animal studies, brimonidine tartrate has been shown to be excreted in breast milk. Because of the potential for serious adverse reactions from brimonidine tartrate and timolol maleate ophthalmic solution in nursing infants, 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.

8.4Pediatric Use Brimonidine tartrate and timolol maleate ophthalmic solution is contraindicated in children under the age of 2 years [see Contraindications (4.3)] . During post-marketing surveillance, apnea, bradycardia, coma, hypotension, hypothermia, hypotonia, lethargy, pallor, respiratory depression, and somnolence have been reported in infants receiving brimonidine. The safety and effectiveness of brimonidine tartrate and timolol maleate have not been studied in children below the age of 2 years.

The safety and effectiveness of brimonidine tartrate and timolol maleate ophthalmic solution have been established in the age groups 2 to 16 years of age. Use of brimonidine tartrate and timolol maleate ophthalmic solution in these age groups is supported by evidence from adequate and well-controlled studies of brimonidine tartrate and timolol maleate ophthalmic solution in adults with additional data from a study of the concomitant use of brimonidine tartrate ophthalmic solution 0.2% and timolol maleate ophthalmic solution in pediatric glaucoma patients (ages 2 to 7 years).

In this study, brimonidine tartrate ophthalmic solution 0.2% was dosed three times a day as adjunctive therapy to beta-blockers. The most commonly observed adverse reactions were somnolence (50% to 83% in patients 2 to 6 years) and decreased alertness. In pediatric patients 7 years of age or older (>20 kg), somnolence appears to occur less frequently (25%).

Approximately 16% of patients on brimonidine tartrate ophthalmic solution discontinued from the study due to somnolence.

8.5Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and other adult patient…

🤰 Pregnancy ~1 min read ▾

🧒 Pediatric Use ~1 min read ▾

Approximately 16% of patients on brimonidine tartrate ophthalmic solution discontinued from the study due to somnolence.

🧓 Geriatric Use 19 words ▾

8.5Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and other adult patients.

🆘 Overdosage 106 words ▾

10 OVERDOSAGE There have been reports of inadvertent overdosage with timolol ophthalmic solution resulting in systemic effects similar to those seen with systemic beta-adrenergic blocking agents such as dizziness, headache, shortness of breath, bradycardia, bronchospasm, and cardiac arrest. With the exception of hypotension, very limited information exists on accidental ingestion of brimonidine in adults. Symptoms of brimonidine overdose have been reported in neonates, infants, and children receiving brimonidine ophthalmic solutions as part of medical treatment of congenital glaucoma or by accidental oral ingestion [see Use in Specific Populations (8.4)] .

Treatment of an oral overdose includes supportive and symptomatic therapy; a patent airway should be maintained.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Brimonidine tartrate and timolol maleate ophthalmic solution is comprised of two components: brimonidine tartrate and timolol. Each of these two components decreases elevated intraocular pressure, whether or not associated with glaucoma. Elevated intraocular pressure is a major risk factor in the pathogenesis of optic nerve damage and glaucomatous visual field loss.

The higher the level of intraocular pressure, the greater the likelihood of glaucomatous field loss and optic nerve damage. Brimonidine tartrate and timolol maleate ophthalmic solution is a relatively selective alpha-2 adrenergic receptor agonist with a non-selective beta-adrenergic receptor inhibitor. Both brimonidine and timolol have a rapid onset of action, with peak ocular hypotensive effect seen at two hours post-dosing for brimonidine and one to two hours for timolol.

Fluorophotometric studies in animals and humans suggest that brimonidine tartrate has a dual mechanism of action by reducing aqueous humor production and increasing uveoscleral outflow. Timolol maleate is a beta 1 and beta 2 adrenergic receptor inhibitor that does not have significant intrinsic sympathomimetic, direct myocardial depressant, or local anesthetic (membrane-stabilizing) activity.

12.3Pharmacokinetics Absorption Systemic absorption of brimonidine and timolol was assessed in healthy volunteers and patients following topical dosing with brimonidine tartrate and timolol maleate ophthalmic solution. Normal volunteers dosed with one drop of brimonidine tartrate and timolol maleate ophthalmic solution twice daily in both eyes for seven days showed peak plasma brimonidine and timolol concentrations of 30 pg/mL and 400 pg/mL, respectively. Plasma concentrations of brimonidine peaked at 1 to 4 hours after ocular dosing.

Peak plasma concentrations of timolol occurred approximately 1 to 3 hours post-dose. In a crossover study of brimonidine tartrate and timolol maleate ophthalmic solution, brimonidine tartrate 0.2%, and timolol 0.5% administered twice daily for 7 days in healthy volunteers, the mean brimonidine area-under-the-plasma-concentration-time curve (AUC) for brimonidine tartrate and timolol maleate ophthalmic solution was 128 ± 61 pg•hr/mL versus 141 ± 106 pg•hr/mL for the respective monotherapy treatments; mean C max values of brimonidine were comparable following bimonidine tartrate and timolol maleate ophthalmic solution treatment versus monotherapy (32.7 ± 15 pg/mL versus 34.7 ± 22.6 pg/mL, respectively).

Mean timolol AUC for brimonidine tartrate and timolol maleate ophthalmic solution was similar to that of the respective monotherapy treatment (2919 ± 1679 pg•hr/mL versus 2909 ± 1231 pg•hr/mL, respectively); mean C max of timolol was approximately 20% lower following brimonidine tartrate and timolol maleate ophthalmic solution treatment versus monotherapy. In a parallel study in patients dosed twice daily with brimonidine tartrate and timolol maleate ophthalmic solution, twice daily with timolol 0.5%, or three times daily with brimonidine tartrate 0.2%, one-hour post dose plasma concentrations of timolol and brimonidine were approximately 30-40% lower with brimonidine tartrate and timolol maleate ophthalmic solution than their respective monotherapy values.

The lower plasma brimonidine concentrations with brimonidine tartrate and timolol maleate ophthalmic solution appears to be due to twice-daily dosing for brimonidine tartrate and timolol maleate ophthalmic solution versus three-times dosing with brimonidine tartrate 0.2%. Distribution The protein binding of timolol is approximately 60%. The protein binding of brimonidine has not been studied.

Metabolism In humans, brimonidine is extensively metabolized-by the liver. Timolol is partially metabolized by the liver. Excretion In the crossover study in healthy volunteers, the plasma concentration of brimonidine declined with a systemic half-life of approximately 3 hours.

The apparen…

🧬 Mechanism of Action 176 words ▾

📦 How Supplied / Storage and Handling 69 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Brimonidine tartrate and timolol maleate ophthalmic solution is supplied sterile, in white opaque plastic LDPE bottles and nozzles, with blue high density polyethylene (HDPE) caps as follows: 5 mL in 10 mL bottle NDC 46708-706-05 10 mL in 10 mL bottle NDC 46708-706-10 15 mL in 15 mL bottle NDC 46708-706-15 Storage : Store at 15° to 25°C (59° to 77°F). Protect from light.

📋 Description 183 words ▾

11 DESCRIPTION Brimonidine tartrate and timolol maleate ophthalmic solution 0.2%/0.5%, sterile, is a relatively selective alpha-2 adrenergic receptor agonist with a non-selective beta-adrenergic receptor inhibitor (topical intraocular pressure lowering agent). The structural formulae are: Brimonidine tartrate: 5-bromo-6-(2-imidazolidinylideneamino) quinoxaline L-tartrate; MW= 442.24 Timolol maleate: (-)-1-( tert -butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)-oxy]-2-propanol maleate (1:1) (salt); MW= 432.50 as the maleate salt In solution, brimonidine tartrate and timolol maleate ophthalmic solution 0.2% /0.5% has a clear, greenish-yellow color.

It has an osmolality of 260 to 330 mOsmol/kg and a pH during its shelf life of 6.5 to 7.3. Brimonidine tartrate appears as an off-white, or white to pale-yellow powder and is soluble in both water (1.5 mg/mL) and in the product vehicle (3 mg/mL) at pH 7.2. Timolol maleate appears as a white, odorless, crystalline powder and is soluble in water, methanol, and alcohol.

Each mL of brimonidine tartrate and timolol maleate ophthalmic solution contains the active ingredients brimonidine tartrate 0.2% and timolol 0.5% with the inactive ingredients benzalkonium chloride 0.005%; sodium phosphate, monobasic; sodium phosphate, dibasic; purified water; and hydrochloric acid and/or sodium hydroxide to adjust pH. brimo-timo-structure-brimonidine brimo-timo-struc-timolol

💬 Information for Patients ~1 min read ▾

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 and 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 and timolol maleate ophthalmic solution.

As with other similar medications, brimonidine tartrate and 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. Made in India.

Manufactured by: Alembic Pharmaceuticals Limited Karkhadi 391450, Gujarat, India Revised: June 2023

Glossary — plain-language definitions of medical terms used in this label:

contraindicated: Should not be used in that situation, because the risk is considered too high.

exacerbation: A flare-up or worsening of a condition.

systemic lupus erythematosus: A long-term autoimmune disease in which the immune system attacks the body's own tissues, affecting joints, skin, kidneys, and other organs.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

adjunctive therapy: A medicine added alongside a main treatment to help it work better.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

agonist: A substance that switches on a specific target in the body to produce an effect, the way a key turns a lock.

alopecia: Loss of hair from the scalp or body.

anaphylaxis: A sudden, severe, whole-body allergic reaction that can cause trouble breathing, swelling, and a drop in blood pressure, needing emergency care.

angina pectoris: Chest pain or a squeezing feeling that happens when the heart muscle does not get enough blood and oxygen.

angioedema: Rapid swelling deep under the skin, often around the eyes, lips, tongue, or throat.

animal reproduction studies: Tests in pregnant animals used to check whether a medicine might harm a developing baby.

anorexia: Loss of appetite, or not feeling hungry (on a drug label this means reduced appetite, not the eating disorder).

anxiety: A feeling of worry, nervousness, or unease, sometimes along with a racing heart or restlessness.

apnea: A pause or temporary stop in breathing.

arrhythmia: A heartbeat that is too fast, too slow, or irregular instead of steady.

asthenia: Unusual weakness or lack of physical strength and energy.

atrioventricular block: A slowing or blocking of the electrical signals traveling between the heart's upper and lower chambers, which can slow the heartbeat.

AUC: A measure of total drug exposure over time, showing how much medicine the blood is exposed to overall.

AV block: A slowing or blocking of the electrical signals traveling between the heart's upper and lower chambers, which can slow the heartbeat.

bradycardia: A slower-than-normal heart rate, usually under 60 beats per minute.

bronchospasm: A sudden tightening of the muscles around the airways in the lungs that narrows them and makes breathing harder.

cardiac arrest: A sudden stop of the heart's pumping that cuts off blood flow to the body, which is a medical emergency.

cataract: A clouding of the eye's normally clear lens that can blur or dim vision.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

conjunctivitis: Redness and irritation of the thin lining over the white of the eye, often called pink eye.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

crossover: A study design in which each person takes one treatment for a time, then switches to the other, acting as their own comparison.

CYP2D6: A liver enzyme that breaks down many medicines; people inherit different versions, so it works faster in some and slower in others.

depression: A lasting low mood with loss of interest that affects everyday life.

diarrhea: Loose, watery bowel movements that happen more often than normal.

diplopia: Double vision, or seeing two images of a single object.

Distribution: How a medicine spreads from the blood into the body's tissues and organs after it is absorbed.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

dyspepsia: Discomfort, fullness, or a burning feeling in the upper belly, commonly called indigestion.

dyspnea: The medical word for shortness of breath, or the feeling that you cannot get enough air.

edema: Swelling caused by extra fluid trapped in the body's tissues.

erythema: Redness of the skin caused by increased blood flow, often from irritation or inflammation.

Excretion: How the body removes a medicine or its leftover pieces, mainly through the urine or stool.

glaucoma: An eye condition, often linked to high pressure inside the eye, that can slowly damage vision.

Half-life: The time it takes for the amount of medicine in the blood to drop by half.

hemorrhage: Bleeding, especially heavy or uncontrolled bleeding, either inside the body or from an outside wound.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hypercholesterolemia: A higher-than-normal level of cholesterol, a type of fat, in the blood.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hypertension: Blood pressure that stays higher than normal, commonly called high blood pressure.

hyperthyroidism: A condition where the thyroid gland makes too much thyroid hormone, which can speed the body up.

hypoglycemia: Low blood sugar, when the amount of glucose (sugar) in the blood drops below the normal range.

hypotension: Blood pressure that is lower than normal, which can cause dizziness or fainting.

inhibitor: A substance that blocks an enzyme or transporter, which can raise the levels of drugs it normally handles.

insomnia: Trouble falling asleep, staying asleep, or getting restful sleep.

intraocular pressure: The fluid pressure inside the eye.

intravenous: Given directly into a vein through a needle or thin tube; often written as IV.

IOP: The fluid pressure inside the eye.

ischemia: Reduced blood flow to a part of the body, so that area does not get enough oxygen.

lethargy: A state of tiredness and sluggishness, often with slowed thinking or movement.

macular edema: Swelling from fluid build-up in the central part of the retina, which can blur central vision.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

monotherapy: Treatment using a single medicine by itself.

myasthenia gravis: A long-term condition where muscles tire and grow weak easily, often affecting the eyes, face, and swallowing.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

orthostatic hypotension: A drop in blood pressure when you stand up from sitting or lying down, which can cause brief dizziness.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

pallor: Unusual paleness of the skin.

paresthesia: A tingling, prickling, or "pins and needles" feeling in the skin, often in the hands or feet.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

photophobia: Discomfort or pain in the eyes when exposed to light.

plasma concentration: The amount of medicine measured in the liquid part of the blood at a given time.

potentiate: To make the effect of one medicine stronger by taking another substance along with it.

protein binding: How much of a medicine sticks to proteins in the blood instead of moving freely through the body.

pruritus: Itching of the skin.

pulmonary edema: A buildup of fluid in the lungs' air sacs that makes it hard to breathe.

receptor: A special docking spot on a cell that a medicine or natural body chemical attaches to in order to trigger an effect.

respiratory depression: Breathing that becomes too slow or too shallow to move enough air, so the body may not get enough oxygen.

respiratory failure: A serious condition in which the lungs cannot get enough oxygen into the blood or remove enough carbon dioxide.

somnolence: Feeling very sleepy or drowsy, with trouble staying awake during the day.

syncope: The medical term for fainting, a brief loss of consciousness from a temporary drop in blood flow to the brain.

tachycardia: A faster-than-normal heart rate, usually over 100 beats per minute.

teratogenic: Able to cause physical birth defects in a developing baby when a medicine is taken during pregnancy.

tinnitus: Ringing, buzzing, or other noise in the ears that is not coming from an outside sound.

topical: Applied onto the skin, eyes, or another body surface to work mainly where it is placed.

urticaria: Raised, itchy welts on the skin, commonly called hives.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

vertigo: A spinning sensation that makes you feel like you or the room around you is moving.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

← 46708-0694-25 · Alembic 46708-0707-31 · Alembic →

For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.

Brimonidine Tartrate and Timolol Maleate 2 mg/mL; 5 mg/mL Solution/ Drops

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