HomeNDC LookupIngredientsTimolol Maleate › 60758-0801-10
TIMOLOL MALEATE 5 mg/mL Solution/ Drops — NDC 60758-0801-10 package photo

TIMOLOL MALEATE 5 mg/mL Solution/ Drops

by Pacific Pharma, Inc. · 1 BOTTLE, DROPPER in 1 CARTON (60758-801-10) / 10 mL in 1 BOTTLE, DROPPER
NDC 60758-0801-10
🏷️ FDA NDC (as labeled) 60758-801-10 billing pads the product segment with a zero
This package
Contains10 mL in 1 bottle, dropper Cost per mL$0.7316 NADAC Per package$7.32 / 10 ml Pack sizes2 compare ↓
Also priced by: Medicaid pays $1.39/unit · Part D plans $0.8743/unit — full pricing hub ↓
Also comes in: 5 mL 60758-0801-05
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 →
⚠️
Other active recalls for Timolol Maleate (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jul 5, 2025 — Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle. (FDC Limited) · FDA recall D-0543-2025
Class II · Apr 18, 2025 — Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle. (FDC Limited) · FDA recall D-0403-2025
Class II · Jan 23, 2025 — Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle. (FDC Limited) · FDA recall D-0214-2025
Class II · Dec 5, 2024 — Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle. (FDC Limited) · FDA recall D-0114-2025
Class II · Oct 29, 2024 — Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle (FDC Limited) · FDA recall D-0035-2025
Class II · Aug 12, 2024 — Defective Container: patients are unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle. (FDC Limited) · FDA recall D-0642-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 60758-801-10
Product NDC 60758-801
11-digit billing NDC 60758080110
NCPDP billing unit ML — per mL (volume)
RxCUI 1923428, 1992303
UNII P8Y54F701R
Application # ANDA074747
SPL Set ID e16c33fd-aa86-49ad-a767-c79ade4a62c7
Established class (EPC) beta-Adrenergic Blocker
Mechanism of action Adrenergic beta-Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1997-05-20
Route OPHTHALMIC
Dosage form SOLUTION/ DROPS
Substance TIMOLOL MALEATE
GPI-14 86250030102010
GPI class Timolol Maleate
GCN Seq No 007856
GCN 32821
HICL code 002105
Ingredient (HICL) Timolol Maleate
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q6
Therapeutic class — intermediate (HIC2) Ophthalmic Preparations
HIC3 code Q6G
Therapeutic class — specific (HIC3) Miotics And Other Intraocular Pressure Reducers
AHFS code 52:40.08.00
AHFS class Beta-Adrenergic Blocking Agents (52:40)
FDB label name TIMOLOL MALEATE 0.5% EYE DROPS
FDB brand name Timolol Maleate
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AT1 · RLD · RS
Why two NDCs? The FDA registers this code as 60758-801-10 — 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 → 60758-0801-10. 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

LabelerPacific Pharma, Inc.
Application holderPACIFIC PHARMA
FDA applicationANDA074747 (ANDA)
Labeler code60758
First marketedMay 1997
Product typeHuman Prescription Drug
Portfolio9 products on file
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

Label name TIMOLOL MALEATE 0.5% EYE DROPS Ingredient Timolol Maleate
📖 What it is MedlinePlus · NLM

Ophthalmic timolol is used to treat glaucoma, a condition in which increased pressure in the eye can lead to gradual loss of vision. Timolol is in a class of medications called beta-blockers. It works by decreasing the pressure in the eye.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Yes, and this is something your pharmacist and doctor take seriously. Even though you're putting the drops in your eye, a small amount is absorbed into your bloodstream. This can s...
  • I was prescribed timolol eye drops for glaucoma. Can the drops affect my heart or breathing?
  • Please don't stop on your own — this is one of the most important things to know about timolol tablets. Stopping suddenly, especially if you have any heart disease, can cause a dan...
  • I take timolol tablets for high blood pressure. Is it safe to just stop if I feel fine?
📖 Read our full Timolol guide →
1
Nutrient depletion considerations

Timolol may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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.

💊 What it looks like

Color white
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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 GR686LBA74
    Sodium phosphate, dibasic is a salt derived from phosphoric acid. It acts as a buffer to help maintain the medicine's pH balance and may serve as a binder or filler in tablets and capsules.
  • UNII 3980JIH2SW
    A salt form of phosphoric acid that acts as a buffer and pH adjuster in medicines. It helps keep the product at the correct acidity level for stability and effectiveness.
  • 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 DailyMedingredient 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 systemPer mLPer package
Retail pharmacies payNADAC · weekly $0.732 $7.32 / 10 ml
Medicaid paysCMS SDUD · 12 mo $1.39 $13.88 / 10 ml
Medicare drug plans payPart D · Q2 2026 $0.8743 $8.74 / 10 ml
NADAC price history (per mL) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $1.048 $0.732
▼ Down 30% over the last 24 months.
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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Timolol Maleate 5 mg/mLthis 60758-0801-10 Pacific 1 bottle $0.732 AT1 Availability likely
Timolol Maleate 5 mg/mL 64980-0514-01 Rising 1 bottle $0.732 AT1 Availability likely
Timolol Maleate 5 mg/mL 65145-0153-01 Caplin 1 bottle $0.732 AT1 Availability likely
Timolol maleate 5 mg/mL 70069-0707-01 Somerset 1 bottle $0.732 AT1 Availability likely
timolol maleate 5 mg/mL 70756-0657-30 Lifestar 1 bottle $0.732 AT1 Availability likely
Timolol Maleate 5 mg/mL 65145-0154-01 Caplin 1 bottle $0.760 AT1 Availability likely +4%
Timolol maleate 5 mg/mL 70069-0708-01 Somerset 1 bottle $0.760 AT1 Availability likely +4%
Timolol Maleate 5 mg/mL 42571-0404-21 Micro 5 ml $1.059 AT1 Availability likely +45%
Timolol Maleate 5 mg/mL 61314-0227-05 Sandoz 5 ml $1.059 AT1 Availability likely +45%
Timolol Maleate 5 mg/mL 65145-0152-01 Caplin 1 bottle $1.059 AT1 Availability likely +45%
Timolol Maleate 5 mg/mL 69315-0325-05 Leading 5 ml $1.059 AT1 Availability likely +45%
Timolol maleate 5 mg/mL 70069-0706-01 Somerset 1 bottle $1.059 AT1 Availability likely +45%
timolol maleate 5 mg/mL 70756-0656-15 Lifestar 1 bottle $1.059 AT1 Availability likely +45%
timolol maleate 5 mg/mL 72603-0540-01 NorthStar 1 bottle $1.059 AT1 Availability likely +45%
Timolol Maleate 5 mg/mL 82260-0813-05 Bausch 1 bottle $1.059 AT1 Availability likely +45%
Timoptic in Ocudose 5 mg/mL 69918-0601-60 Nordic 60 pouches $1.187 AT3 Availability likely +62%
Timolol Maleate 5 mg/mL 82260-0819-05 Bausch 1 bottle $10.066 AB Availability likely +1276%
Timolol Maleate 5 mg/mL 82260-0045-05 Bausch 1 bottle $23.655 AT2 Availability likely +3133%
Timolol Maleate 5 mg/mL 68682-0045-25 Oceanside 1 bottle $26.378 AT2 Discontinued +3506%
Istalol 5 mg/mL 24208-0004-01 Bausch 1 bottle $79.763 AT2 Availability likely +10803%
Timoptic 5 mg/mL 24208-0813-05 Bausch 1 bottle AT1 FDA listed
Timolol Maleate 5 mg/mL 50090-3441-00 A-S 10 ml AT1 FDA listed
Timolol Maleate 5 mg/mL 50090-5769-00 A-S 1 bottle AT1 FDA listed
Timolol Maleate 5 mg/mL 50090-7837-00 A-S 1 bottle AT1 FDA listed
timolol maleate 5 mg/mL 81469-0210-05 First 1 bottle AT1 FDA listed
Timoptic-XE 5 mg/mL 24208-0816-05 Bausch 1 bottle AB FDA listed
Timolol Maleate 5 mg/mL 59651-0313-05 Aurobindo 1 bottle AB FDA listed
Timolol Maleate 5 mg/mL 50090-1852-00 A-S 1 bottle AT1 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

🏛️
1997
On the market since
May 1997
📍
2026
Currently FDA-listed
29 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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 60758-0801-10, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
1.1K
Units reimbursed last 4 qtrs
11.2K
Gross reimbursed last 4 qtrs
$15.5K
Avg / prescription
$14.20
Avg / unit
$1.3878
Latest quarter Q4 2025
253Rx
Medicaid pays / mL
$1.3878
gross reimbursed
vs
NADAC / mL
$0.7316
acquisition cost
=
Spread
+$0.6562
+90% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care
40% FFS 60% MCO
Fee-for-service · 436 Rx Managed care · 656 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 120 units · 1.5 per 100k residents WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: 505 units · 8.5 per 100k residents WI Michigan: 565 units · 5.6 per 100k residents MI New York: 590 units · 3.0 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 1,255 units · 10.0 per 100k residents IL Indiana: 430 units · 6.3 per 100k residents IN Ohio: 520 units · 4.4 per 100k residents OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 3,140 units · 8.1 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: 230 units · 3.7 per 100k residents MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: 130 units · 1.5 per 100k residents VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: 660 units · 8.9 per 100k residents AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: 990 units · 9.1 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 440 units · 9.6 per 100k residents LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 795 units · 2.6 per 100k residents TX Florida: 800 units · 3.5 per 100k residents FL
Units reimbursed · per 100k residents
1.510.0
gray = no data reported
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Illinois 10.0 /100k
2 Louisiana 9.6 /100k
3 North Carolina 9.1 /100k
4 Arizona 8.9 /100k
5 Wisconsin 8.5 /100k
6 California 8.1 /100k
7 Indiana 6.3 /100k
8 Michigan 5.6 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 bottle60758-0801-05 2,370 Rx · $29,010
1 bottle this page60758-0801-10 1,092 Rx · $15,502
Drug total (last 4 qtrs): 3,462 Rx · 25,049 units · $44,512 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Timolol Maleate — the program that covers self-administered drugs. 17 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Timolol Maleate. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$11.78M
Claims incl. refills
718.9K
Beneficiaries
526.4K
Spend / beneficiary
$22.38
Spend / claim
$16.39
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 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 Timolol Maleate — the ingredient across all brands.

Top reported reactions

Eye Irritation1,810
Ocular Hyperaemia1,498
Eye Pain1,495
Treatment Failure1,450
Fatigue1,209
Vision Blurred1,029
Intraocular Pressure Increased978

Age at onset

Neonate3
Infant6
Child11
Adolescent5
Adult692
Elderly2,143

Reporter sex

24,869 reports
Male · 40%
Female · 59%
Unknown · 0%

Serious outcomes

Hospitalization4,956
Death1,555
Disabling695
Life-threatening560
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 3,277 0
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 NDCDescription Per unit Per pack Marketing startStatus
60758-0801-05 1 BOTTLE, DROPPER in 1 CARTON (60758-801-05) / 5 mL in 1 BOTTLE, DROPPER $1.06 / mL $5.30 1997-05-20 Active
60758-0801-10 You're viewing this 1 BOTTLE, DROPPER in 1 CARTON (60758-801-10) / 10 mL in 1 BOTTLE, DROPPER $0.7316 / mL $7.32 1997-05-20 Active

This pack has the lowest per-mL cost of the 2 priced pack sizes ($0.7316 NADAC).

This pack accounts for about 32% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓

Pack size FAQ

What quantity is in NDC 60758-0801-10?
NDC 60758-0801-10 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 TIMOLOL MALEATE 5 mg/mL Solution/ Drops?
Bill NDC 60758-0801-10 — the 11-digit billing format is 60758080110. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 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 24 words

INDICATIONS AND USAGE Timolol Maleate ophthalmic solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.

⏱️ Dosage and Administration 214 words

DOSAGE AND ADMINISTRATION Timolol Maleate ophthalmic solution is available in concentrations of 0.25% and 0.5%. The usual starting dose is one drop of the 0.25% Timolol solution in the affected eye(s) twice a day. If the clinical response is not adequate, the dosage may be changed to one drop of 0.5% solution in the affected eye(s) twice a day.

Since in some patients the pressure-lowering response to timolol may require a few weeks to stabilize, evaluation should include a determination of intraocular pressure after approximately 4 weeks of treatment with timolol. If the intraocular pressure is maintained at satisfactory levels, the dosage schedule may be changed to one drop once a day in the affected eye(s). Because of diurnal variations in intraocular pressure, satisfactory response to the once-a-day dose is best determined by measuring the intraocular pressure at different times during the day.

Dosages above one drop of a 0.5% Timolol solution twice a day generally have not been shown to produce further reduction in intraocular pressure. If the patient’s intraocular pressure is still not at a satisfactory level on this regimen, concomitant therapy with other agent(s) for lowering intraocular pressure can be instituted. The concomitant use of two topical beta-adrenergic blocking agents is not recommended (see PRECAUTIONS, Drug Interactions, Beta-adrenergic blocking agents ).

Contraindications 55 words

CONTRAINDICATIONS Timolol Maleate is contraindicated in patients with (1) bronchial asthma; (2) a history of bronchial asthma; (3) severe chronic obstructive pulmonary disease (see WARNINGS ); (4) sinus bradycardia; (5) second or third degree atrioventricular block; (6) overt cardiac failure (see WARNINGS ); (7) cardiogenic shock; or (8) hypersensitivity to any component of this product.

⚠️ Warnings ~2 min read

WARNINGS As with many topically applied ophthalmic drugs, this drug is absorbed systemically. The same adverse reactions found with systemic administration of beta-adrenergic blocking agents may occu r 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 T imolol M aleate (see CONTRAINDICATIONS ).

Cardiac Failure : Sympathetic stimulation may be essential for support of the circulation in individuals with diminished myocardial contractility, and its inhibition of 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, timolol should be discontinued.

Obstructive Pulmonary Disease : 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 timolol is contraindicated [see CONTRAINDICATIONS ]) should, in general, not receive beta-blockers, including timolol. Major Surgery : The necessity or desirability of withdrawal of beta-adrenergic blocking agents prior to major surgery is controversial.

Beta-adrenergic receptor blockade impairs the ability of the heart to respond to beta-adrenergically mediated reflex stimuli. This may augment the risk of general anesthesia in surgical procedures. Some patients receiving beta-adrenergic receptor blocking agents have experienced protracted severe hypotension during anesthesia.

Difficulty in restarting and maintaining the heartbeat has also been reported. For these reasons, in patients undergoing elective surgery, some authorities recommend gradual withdrawal of beta-adrenergic receptor blocking agents. If necessary during surgery, the effects of beta-adrenergic blocking agents may be reversed by sufficient doses of adrenergic agonists.

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. Thyrotoxicosis : Beta-adrenergic blocking agents may mask certain clinical signs (e.g., tachycardia) of hyperthyroidism.

Patients suspected of developing thyrotoxicosis should be managed carefully to avoid abrupt withdrawal of beta-adrenergic blocking agents that might precipitate a thyroid storm.

🤒 Adverse Reactions ~2 min read

ADVERSE REACTIONS The most frequently reported adverse experiences have been burning and stinging upon instillation (approximately one in eight patients). The following additional adverse experiences have been reported less frequently with ocular administration of this or other Timolol Maleate formulations: BODY AS A WHOLE: Headache, asthenia/fatigue, and chest pain. CARDIOVASCULAR: Bradycardia, arrhythmia, hypotension, hypertension, syncope, heart block, cerebral vascular accident, cerebral ischemia, cardiac failure, worsening of angina pectoris, palpitation, cardiac arrest, pulmonary edema, edema, claudication, Raynaud’s phenomenon, and cold hands and feet.

DIGESTIVE: Nausea, diarrhea, dyspepsia, anorexia, and dry mouth. IMMUNOLOGIC: Systemic lupus erythematosus. NERVOUS SYSTEM/PSYCHIATRIC: Dizziness, increase in signs and symptoms of myasthenia gravis, paresthesia, somnolence, insomnia, nightmares, behavioral changes and psychic disturbances including depression, confusion, hallucinations, anxiety, disorientation, nervousness, and memory loss.

SKIN: Alopecia and psoriasiform rash or exacerbation of psoriasis. HYPERSENSITIVITY: Signs and symptoms of systemic allergic reactions, including anaphylaxis, angioedema, urticaria, and localized and generalized rash. RESPIRATORY: Bronchospasm (predominantly in patients with pre-existing bronchospastic disease), respiratory failure, dyspnea, nasal congestion, cough and upper respiratory infections.

ENDOCRINE: Masked symptoms of hypoglycemia in diabetic patients (see WARNINGS ). SPECIAL SENSES: Signs and symptoms of ocular irritation including conjunctivitis, blepharitis, keratitis, ocular pain, discharge (e.g., crusting), foreign body sensation, itching and tearing, and dry eyes; ptosis; decreased corneal sensitivity; cystoid macular edema; visual disturbances including refractive changes and diplopia; pseudopemphigoid; choroidal detachment following filtration surgery (see PRECAUTIONS, General ); and tinnitus.

UROGENITAL: Retroperitoneal fibrosis, decreased libido, impotence, and Peyronie’s disease. The following additional adverse effects have been reported in clinical experience with ORAL Timolol Maleate or other ORAL beta-blocking agents and may be considered potential effects of ophthalmic Timolol Maleate: Allergic : Erythematous rash, fever combined with aching and sore throat, laryngospasm with respiratory distress; Body as a Whole : Extremity pain, decreased exercise tolerance, weight loss; Cardiovascular : Worsening of arterial insufficiency, vasodilatation; Digestive : Gastrointestinal pain, hepatomegaly, vomiting, mesenteric arterial thrombosis, ischemic colitis; Hematologic : Non thrombocytopenic purpura, thrombocytopenic purpura, agranulocytosis; Endocrine : Hyperglycemia, hypoglycemia; Skin : Pruritus, skin irritation, increased pigmentation, sweating; Musculoskeletal : Arthralgia; Nervous System/Psychiatric : Vertigo, local weakness, diminished concentration, reversible mental depression progressing to catatonia, an acute reversible syndrome characterized by disorientation for time and place, emotional lability, slightly clouded sensorium, and decreased performance on neuropsychometrics; Respiratory : Rales, bronchial obstruction; Urogenital : Urination difficulties.

🔄 Drug Interactions ~1 min read

Drug Interactions Although timolol used alone has little or no effect on pupil size, mydriasis resulting from concomitant therapy with timolol and epinephrine has been reported occasionally. Beta-adrenergic blocking agents : Patients who are receiving a beta-adrenergic blocking agent orally and timolol 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.

Calcium antagonists : Caution should be used in the coadministration of beta-adrenergic blocking agents, such as timolol, and oral or intravenous calcium antagonists because of possible atrioventricular conduction disturbances, left ventricular failure, and hypotension. In patients with impaired cardiac function, coadministration should be avoided. Catecholamine-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.

Digitalis 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. CYP2D6 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. Clonidine : Oral beta adrenergic blocking agents may exacerbate the rebound hypertension which can follow the withdrawal of clonidine.

There have been no reports of exacerbation of rebound hypertension with ophthalmic Timolol Maleate. Injectable Epinephrine : (see PRECAUTIONS, General, Anaphylaxis )

🤰 Pregnancy 144 words

Pregnancy Teratogenic Effects Teratogenicity studies with timolol in mice, rats, and rabbits at oral doses up to 50 mg/kg/day (7,000 times the systemic exposure following the maximum recommended human ophthalmic dose) 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 1000 mg/kg/day (142,000 times the systemic exposure following the maximum recommended human ophthalmic dose) were maternotoxic in mice and resulted in an increased number of fetal resorptions.

Increased fetal resorptions were also seen in rabbits at doses of 14,000 times the systemic exposure following the maximum recommended human ophthalmic dose, in this case without apparent maternotoxicity. There are no adequate and well-controlled studies in pregnant women. Timolol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

🧒 Pediatric Use 62 words

Pediatric Use Safety and effectiveness of timolol maleate ophthalmic solution have been established when administered in pediatric patients aged 2 years and older. Use of timolol maleate ophthalmic solution in these children is supported by evidence from adequate and well controlled studies in children and adults. Safety and efficacy in pediatric patients below the age of 2 years have not been established.

🧓 Geriatric Use 17 words

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

🆘 Overdosage 144 words

OVERDOSAGE There have been reports of inadvertent overdosage with Timolol Maleate 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 (see also ADVERSE REACTIONS ). Overdosage has been reported with Timolol Maleate tablets. A 30 year old female ingested 650 mg of Timolol Maleate tablets (maximum recommended oral daily dose is 60 mg) and experienced second and third degree heart block.

She recovered without treatment but approximately two months later developed irregular heartbeat, hypertension, dizziness, tinnitus, faintness, increased pulse rate, and borderline first degree heart block. An in vitro hemodialysis study, using 14 C timolol added to human plasma or whole blood, showed that timolol was readily dialyzed from these fluids; however, a study of patients with renal failure showed that timolol did not dialyze readily.

🧬 Clinical Pharmacology ~2 min read

CLINICAL PHARMACOLOGY Mechanism of Action: Timolol Maleate is a beta 1 and beta 2 (non-selective) adrenergic receptor blocking agent that does not have significant intrinsic sympathomimetic, direct myocardial depressant, or local anesthetic (membrane-stabilizing) activity. Beta-adrenergic receptor blockade reduces cardiac output in both healthy subjects and patients with heart disease. In patients with severe impairment of myocardial function, beta-adrenergic receptor blockade may inhibit the stimulatory effect of the sympathetic nervous system necessary to maintain adequate cardiac function.

Beta-adrenergic receptor blockade in the bronchi and bronchioles results in increased airway resistance from unopposed parasympathetic activity. Such an effect in patients with asthma or other bronchospastic conditions is potentially dangerous. Timolol Maleate ophthalmic solution, when applied topically on the eye, has the action of reducing elevated as well as normal intraocular pressure, whether or not accompanied by glaucoma.

Elevated intraocular pressure is a major risk factor in the pathogenesis of glaucomatous visual field loss. The higher the level of intraocular pressure, the greater the likelihood of glaucomatous visual field loss and optic nerve damage. The onset of reduction in intraocular pressure following administration of Timolol Maleate ophthalmic solution can usually be detected within one-half hour after a single dose.

The maximum effect usually occurs in one to two hours and significant lowering of intraocular pressure can be maintained for periods as long as 24 hours with a single dose. Repeated observations over a period of one year indicate that the intraocular pressure-lowering effect of timolol is well maintained. The precise mechanism of the ocular hypotensive action of timolol is not clearly established at this time.

Tonography and fluorophotometry studies in man suggest that its predominant action may be related to reduced aqueous formation. However, in some studies a slight increase in outflow facility was also observed. Pharmacokinetics: In a study of plasma drug concentration in six subjects, the systemic exposure to timolol was determined following twice daily administration of Timolol Maleate ophthalmic solution 0.5%.

The mean peak plasma concentration following morning dosing was 0.46 ng/mL and following afternoon dosing was 0.35 ng/mL. Clinical Studies: In controlled multiclinic studies in patients with untreated intraocular pressures of 22 mmHg or greater, Timolol Maleate ophthalmic solution 0.25% or 0.5% administered twice a day produced a greater reduction in intraocular pressure than 1, 2, 3, or 4% pilocarpine solution administered four times a day or 0.5, 1, or 2% epinephrine hydrochloride solution administered twice a day.

In these studies, timolol was generally well tolerated and produced fewer and less severe side effects than either pilocarpine or epinephrine. A slight reduction of resting heart rate in some patients receiving timolol (mean reduction 2.9 beats/minute standard deviation 10.2) was observed.

📦 How Supplied / Storage and Handling 172 words

HOW SUPPLIED Timolol Maleate ophthalmic solution, USP is a clear, colorless to light yellow solution. Timolol Maleate ophthalmic solution, 0.25% timolol equivalent, is supplied sterile in opaque white LDPE plastic bottles with droppers with yellow high impact polystyrene (HIPS) caps as follows: Timolol Maleate ophthalmic solution, 0.5% timolol equivalent, is supplied sterile in opaque white LDPE plastic bottles with droppers with yellow high impact polystyrene (HIPS) caps as follows: 5 mL in 10 mL bottle NDC 60758-801-05 10 mL in 15 mL bottle NDC 60758-801-10 Storage: Store at 15˚-25˚C (59˚-77˚F).

Protect from freezing. Protect from light. Revised: 0 3 /2024 Distributed by: AbbVie Inc.

North Chicago, IL 60064 © 2024 AbbVie. All rights reserved. PACIFIC PHARMA and its design are trademarks of Allergan, Inc., an AbbVie company.

PHARMACIST - DETACH AND GIVE INSTRUCTIONS TO PATIENT Please detach at the perforation to separate the patient information. Timolol Maleate ophthalmic solution, 0.25% timolol equivalent, is supplied sterile in opaque white LDPE plastic bottles with droppers with yellow high impact polystyrene (HIPS) caps as follows:

📋 Description ~1 min read

DESCRIPTION Timolol Maleate ophthalmic solution is a non-selective beta-adrenergic receptor blocking agent. Its chemical name is (-)-1-( tert -Butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol Maleate possesses an asymmetric carbon atom in its structure and is provided as the levo-isomer.

The nominal optical rotation of Timolol Maleate is: Its molecular formula is C 13 H 24 N 4 O 3 S • C 4 H 4 O 4 and its structural formula is: Timolol Maleate has a molecular weight of 432.50. It is a white, odorless, crystalline powder which is soluble in water, methanol, and alcohol. Timolol Maleate ophthalmic solution is stable at room temperature.

Timolol Maleate ophthalmic solution is supplied as a sterile, isotonic, buffered, aqueous solution of Timolol Maleate in two dosage strengths: Each mL, for ophthalmic administration, of 0.25% solution contains 2.5 mg of timolol (3.4 mg of Timolol Maleate). The pH of the solution is approximately 7.0. Each mL, for ophthalmic administration, of 0.5% solution contains 5 mg of timolol (6.8 mg of Timolol Maleate).

Inactive ingredients: monobasic and dibasic sodium phosphate; hydrochloric acid and/or sodium hydroxide to adjust pH; and purified water. Benzalkonium chloride 0.01% is added as preservative. Timolol Maleate ophthalmic solution is a non-selective beta-adrenergic receptor blocking agent.

Its chemical name is (-)-1-(tert-Butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol Maleate possesses an asymmetric carbon atom in its structure and is provided as the levo-isomer. The nominal optical rotation of Timolol Maleate is: The structural formula for Timolol Maleate has a molecular weight of 432.50.

It is a white, odorless, crystalline powder which is soluble in water, methanol, and alcohol. Timolol Maleate ophthalmic solution is stable at room temperature.

💬 Information for Patients ~3 min read

Information for Patients Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye or surrounding structures. Patients should also 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 (see PRECAUTIONS, General ).

Patients should also 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. 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 ). Patients should be advised that 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 Timolol Maleate ophthalmic solution administration.

Information for the Patient TIMOLOL MALEATE ophthalmic solution , USP 0.25% and 0.5% sterile Please follow these instructions carefully when using Timolol Maleate. Use Timolol Maleate ophthalmic solution as prescribed by your doctor. 1.

If you use other topically applied ophthalmic medications, they should be administered at least 10 minutes before or after Timolol Maleate. 2. Thoroughly wash your hands before each use.

3. Before using the medication for the first time be sure the safety celloseal around the cap and top of the bottle neck is unbroken. 4.

Remove safety seal (Figure 1). Figure 1 5. To open the bottle, unscrew the cap by turning as indicated by the arrow (Figure 2).

Figure 2 6. Sit or stand comfortably, with your head tilted back (Figure 3). Figure 3 7.

Open eyes, look up, and draw the lower lid of your eye down gently with your index finger to form a pocket between your eyelid and your eye (Figure 4). Figure 4 8. Hold the Timolol Maleate bottle upside down.

Place dropper tip as close as possible to the lower eyelid and gently squeeze until a single drop is dispensed into the eye as directed by your doctor (Figure 5). Figure 5 DO NOT TOUCH YOUR EYE OR EYELID WITH THE DROPPER TIP. 9.

Blink a few times to make sure the eye is covered with the solution. 10. Close your eye and remove any excess solution with a clean tissue.

11. Repeat steps 6 through 10 with the other eye if instructed to do so by your doctor. 12.

Replace the cap by turning until it is snug. Do not overtighten the cap. 13.

Do not enlarge the hole of the dispenser tip. SPECIAL TIPS 1. DO NOT TOUCH YOUR EYE OR EYELID WITH THE DROPPER TIP.

Ophthalmic medications, if handled improperly, can become contaminated by common bacteria known to cause eye infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated ophthalmic medications. If you think your medication may be contaminated, or if you develop an eye infection, contact your doctor immediately concerning continued use of this bottle.

2. Store at 15-25°C (59-77°F). Protect from freezing.

Protect from light. 3. Keep tightly closed when not in use.

WARNING: KEEP OUT OF THE REACH OF CHILDREN. If you have any questions about the use of Timolol Maleate ophthalmic solution, please contact your doctor. Revised: 0 3 /2024 Distributed by: AbbVie Inc.

North Chicago, IL 60064 © 2024 AbbVie. All rights reserved. PACIFIC PHARMA and its design are trademarks of Allergan, Inc., an AbbVie company.

71633PY12 Remove safety seal (Figure 1). To open the bottle, unscrew the cap by turning as indicated by the arrow (Figure 2). Sit or stand com…

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