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Montelukast 10 mg Tablet, Film Coated, 1,000-count — NDC 72865-0175-10 package photo

Montelukast 10 mg Tablet, Film Coated, 1,000-count

by XLCare Pharmaceuticals Inc. · 1000 TABLET, FILM COATED in 1 BOTTLE (72865-175-10)
NDC 72865-0175-10
🏷️ FDA NDC (as labeled) 72865-175-10 billing pads the product segment with a zero
This package
Contains1,000-count Pack sizes3 compare ↓
Also priced by: Part D plans $0.1490/unit — full pricing hub ↓
Also comes in: 30 tablets 72865-0175-30 90 tablets 72865-0175-90
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

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

🆔 Identity & classification

FDA NDC (as labeled) 72865-175-10
Product NDC 72865-175
11-digit billing NDC 72865017510
NCPDP billing unit EA — each (per item)
RxCUI 200224
UNII U1O3J18SFL
UPC 0372865175309
Application # ANDA202843
SPL Set ID 82d65eea-c7c9-4e16-9176-46c43f00f0f6
Established class (EPC) Leukotriene Receptor Antagonist
Mechanism of action Leukotriene Receptor Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-02-11
Route ORAL
Dosage form TABLET, FILM COATED
Substance MONTELUKAST SODIUM
GPI-14 44505050100330
GPI class Montelukast Sodium
GCN Seq No 038451
GCN 94444
HICL code 016911
Ingredient (HICL) Montelukast Sodium
HIC1 code Z
Therapeutic class — broad (HIC1) Body As A Whole
HIC2 code Z4
Therapeutic class — intermediate (HIC2) Eicosanoids
HIC3 code Z4B
Therapeutic class — specific (HIC3) Leukotriene Receptor Antagonists
AHFS code 48:10.24.00
AHFS class Leukotriene Modifiers
FDB label name MONTELUKAST SOD 10 MG TABLET
FDB brand name Montelukast Sodium
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 72865-175-10 — 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 → 72865-0175-10. 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 Leukotriene Receptor Antagonist class.

Pharmacologic class Leukotriene Receptor Antagonist
Drug family (ATC) Leukotriene receptor antagonists
How it works Leukotriene Receptor 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

LabelerXLCare Pharmaceuticals Inc.
Application holderHETERO LABS LTD UNIT V
FDA applicationANDA202843 (ANDA)
Labeler code72865
First marketedFeb 2021
Product typeHuman Prescription Drug
Portfolio67 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 MONTELUKAST SOD 10 MG TABLET Ingredient Montelukast Sodium
📖 What it is MedlinePlus · NLM

Montelukast is used to prevent wheezing, difficulty breathing, chest tightness, and coughing caused by asthma in adults and children 12 months of age and older. Montelukast is also used to prevent bronchospasm (breathing difficulties) during exercise in adults and children 6 years of age and older. Montelukast is also used to treat the symptoms of seasonal (occurs only at certain times of the year), allergic rhinitis (a condition associated with sneezing and stuffy, runny or itchy nose) in adults and children 2 years of age and older, and perennial (occurs all year round) allergic rhinitis in...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It does more than just treat allergies. Montelukast is used to help prevent and control asthma on a daily basis, to prevent breathing problems triggered by exercise, and to relieve...
  • What is montelukast actually used for — is it just for allergies?
  • This is a real and important concern — the FDA has placed its strongest warning on montelukast because of reported mental health side effects. These can include mood changes, agita...
  • I heard montelukast can affect your mood. Should I be worried?
📖 Read our full Montelukast guide →
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 brown
ShapeSquare
Imprint114;I
Size8 mm
ScoringNot scored
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 R12CBM0EIZ
    A natural wax derived from a Brazilian palm tree, used as a coating and polish on tablets and capsules. It creates a smooth, shiny finish that protects the medicine and improves appearance.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII 1K09F3G675
    Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
  • UNII EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII RFW2ET671P
    Hydroxypropyl cellulose is a plant-derived thickening agent made from cellulose. It acts as a binder to hold tablet ingredients together and as a film-former to coat tablets or control how fast the medicine releases.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII 3OWL53L36A
    A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

11 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 systemPer eachPer 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 $0.1490 $149.00 / 1000 tablets
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
Montelukast Sodium 10 mg 00904-6808-06 Major 1 tablet $0.042 AB Availability likely —
Montelukast Sodium 10 mg 13668-0081-05 Torrent 500 tablets $0.042 AB Availability likely —
Montelukast Sodium 10 mg 16571-0100-09 Rising 90 tablets $0.042 AB Availability likely —
Montelukast 10 mg 33342-0102-07 Macleods 30 tablets $0.042 AB Availability likely —
Montelukast 10 mg 50268-0556-15 AvPAK 1 tablet $0.042 AB Availability likely —
Montelukast 10 mg 68001-0361-03 BluePoint 500 tablets $0.042 AB Availability likely —
Montelukast Sodium 10 mg 68084-0875-01 American 1 tablet $0.042 AB Availability likely —
Montelukast Sodium 10 mg 69367-0287-05 Westminster 500 tablets $0.042 AB Availability likely —
Montelukast 10 mg 82009-0009-10 Quallent 1000 tablets $0.042 AB Availability likely —
Montelukast Sodium 10 mg 16729-0119-10 Accord 30 tablets $0.042 AB Availability likely —
Singulair 10 mg 78206-0172-01 Organon 30 tablets $9.212 AB Availability likely —
Montelukast 10 mg 00781-5560-13 Sandoz 10 tablets — AB FDA listed —
Montelukast Sodium 10 mg 27241-0018-03 Ajanta 30 tablets — — FDA listed —
montelukast sodium 10 mg 29300-0220-01 Unichem 100 tablets — AB FDA listed —
Montelukast Sodium 10 mg 31722-0726-01 Camber 100 tablets — AB FDA listed —
Montelukast Sodium 10 mg 43063-0762-30 PD-Rx 30 tablets — AB FDA listed —
Montelukast 10 mg 50090-6108-00 A-S 30 tablets — AB FDA listed —
Montelukast 10 mg 50090-6109-00 A-S 90 tablets — AB FDA listed —
Montelukast Sodium 10 mg 55111-0725-01 Dr. 100 tablets — — FDA listed —
Montelukast Sodium 10 mg 55154-8075-00 Cardinal 1 tablet — AB FDA listed —
Montelukast Sodium 10 mg 57237-0255-30 Rising 30 tablets — AB FDA listed —
Montelukast Sodium 10 mg 63187-0430-30 Proficient 30 tablets — AB FDA listed —
Montelukast Sodium 10 mg 63187-0692-30 Proficient 30 tablets — — FDA listed —
Montelukast Sodium 10 mg 63187-0781-14 Proficient 14 tablets — AB FDA listed —
Montelukast Sodium 10 mg 65162-0732-03 Amneal 30 tablets — AB FDA listed —
Montelukast Sodium 10 mg 65862-0574-10 Aurobindo 10 tablets — AB Discontinued —
Montelukast Sodium 10 mg 67296-1926-03 Redpharm 30 tablets — AB FDA listed —
Montelukast 10 mg 67296-2248-03 Redpharm 30 tablets — AB Discontinued —
Montelukast Sodium 10 mg 68071-3355-09 NuCare 90 tablets — AB FDA listed —
Montelukast 10 mg 68071-3855-03 NuCare 30 tablets — AB FDA listed —
Montelukast 10 mg 68071-4034-09 NuCare 90 tablets — AB FDA listed —
Montelukast Sodium 10 mg 68071-4047-03 NuCare 30 tablets — AB FDA listed —
montelukast sodium 10 mg 68071-5278-03 NuCare 30 tablets — AB FDA listed —
Montelukast 10 mg 68788-8099-03 Preferred 30 tablets — AB FDA listed —
Montelukast Sodium 10 mg 68788-8610-03 Preferred 30 tablets — AB FDA listed —
montelukast sodium 10 mg 68788-8617-03 Preferred 30 tablets — AB FDA listed —
Montelukast 10 mg 70518-3133-00 REMEDYREPACK 90 tablets — AB FDA listed —
montelukast sodium 10 mg 71205-0181-30 Proficient 30 tablets — AB FDA listed —
Montelukast Sodium 10 mg 71205-0778-30 Proficient 30 tablets — AB FDA listed —
Montelukast Sodium 10 mg 71335-0514-01 Bryant 30 tablets — AB FDA listed —
Montelukast 10 mg 71335-1979-01 Bryant 30 tablets — AB FDA listed —
montelukast sodium 10 mg 71335-1995-01 Bryant 30 tablets — AB FDA listed —
Montelukast 10 mg 71610-0563-30 Aphena 30 tablets — AB FDA listed —
Montelukast Sodium 10 mg 72189-0418-30 Direct_Rx 30 tablets — AB FDA listed —
Montelukast Sodium 10 mg 72789-0306-30 PD-Rx 30 tablets — AB FDA listed —
Montelukast 10 mgthis 72865-0175-10 XLCare 1000 tablets — AB FDA listed —
Montelukast 10 mg 67046-2060-03 Coupler 30 tablets — 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

🏛️
2021
On the market since
Feb 2021
📍
2026
Currently FDA-listed
5 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 Montelukast — the ingredient across all brands.

Top reported reactions

Dyspnoea19,386
Asthma18,795
Fatigue12,128
Cough11,576
Headache10,934
Nausea9,559
Pneumonia9,315

Age at onset

Neonate38
Infant79
Child1,539
Adolescent1,072
Adult20,263
Elderly12,371

Reporter sex

174,997 reports
Male · 30%
Female · 70%
Unknown · 0%

Serious outcomes

Hospitalization47,563
Death7,488
Disabling5,885
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 14,475 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 Marketing startStatus
72865-0175-10 You're viewing this 1000 TABLET, FILM COATED in 1 BOTTLE (72865-175-10) 2021-02-11 Active
72865-0175-30 30 TABLET, FILM COATED in 1 BOTTLE (72865-175-30) 2021-02-11 Active
72865-0175-90 90 TABLET, FILM COATED in 1 BOTTLE (72865-175-90) 2021-02-11 Active

You're viewing the largest of 3 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 72865-0175-10?
NDC 72865-0175-10 is a 1,000-count package — 1000 tablet, film coated in 1 bottle.
What is the difference between NDC 72865-0175-10 and NDC 72865-0175-30?
Both are Montelukast 10 mg Tablet, Film Coated — the drug itself is identical. NDC 72865-0175-10 is the 1,000-count package, while NDC 72865-0175-30 is the 30 tablets package.
What NDC number is used to bill for this package of Montelukast 10 mg Tablet, Film Coated?
Bill NDC 72865-0175-10 — the 11-digit billing format is 72865017510. 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 72865-175-10, 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: 72865-0175-10, written without dashes as 72865017510. 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 72865-0175-10, the first segment (72865) is the labeler code FDA assigned to XLCare Pharmaceuticals Inc.; the middle segment (0175) 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 XLCare Pharmaceuticals Inc.. 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 30 tablets (72865-0175-30), 90 tablets (72865-0175-90). 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?
XLCare Pharmaceuticals Inc. 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.
🚨 Boxed Warning 🎯 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 💬 Medication Guide
🚨 Boxed Warning ~1 min read ▾

WARNING: SERIOUS NEUROPSYCHIATRIC EVENTS Serious neuropsychiatric (NP) events have been reported with the use of montelukast sodium. The types of events reported were highly variable, and included, but were not limited to, agitation, aggression, depression, sleep disturbances, suicidal thoughts and behavior (including suicide). The mechanisms underlying NP events associated with montelukast sodium use are currently not well understood [see Warnings and Precautions (5.1 )].

Because of the risk of NP events, the benefits of montelukast sodium may not outweigh the risks in some patients, particularly when the symptoms of disease may be mild and adequately treated with alternative therapies. Reserve use of montelukast sodium for patients with allergic rhinitis who have an inadequate response or intolerance to alternative therapies [see Indications and Usage ( 1.3 )]. In patients with asthma or exercise-induced bronchoconstriction, consider the benefits and risks before prescribing montelukast sodium.

Discuss the benefits and risks of montelukast sodium with patients and caregivers when prescribing montelukast sodium. Advise patients and/or caregivers to be alert for changes in behavior or new NP symptoms when taking montelukast sodium. If changes in behavior are observed, or if new NP symptoms or suicidal thoughts and/or behavior occur, advise patients to discontinue montelukast sodium and contact a healthcare provider immediately [see Warnings and Precautions (5.1 )].

WARNING: SERIOUS NEUROPSYCHIATRIC EVENTS See full prescribing information for complete boxed warning. • Serious neuropsychiatric events have been reported in patients taking montelukast sodium (5.1). • Discuss benefits and risks of montelukast sodium with patients and caregivers (5.1). • Monitor for neuropsychiatric symptoms in patients taking montelukast sodium (5.1). • Discontinue montelukast sodium immediately if neuropsychiatric symptoms occur (5.1). • Because the benefits of montelukast sodium may not outweigh the potential risk of neuropsychiatric symptoms in patients with allergic rhinitis, reserve use for patients who have an inadequate response or intolerance to alternative therapies ( 1.3 , 5.1).

🎯 Indications and Usage ~1 min read ▾

1 INDICATIONS AND USAGE Montelukast sodium tablets are a leukotriene receptor antagonist indicated for: • Prophylaxis and chronic treatment of asthma in patients 15 years of age and older (1.1). • Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older (1.2). • Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 15 years of age and older, and perennial allergic rhinitis (PAR) in patients 15 years of age and older. Reserve use for patients who have an inadequate response or intolerance to alternative therapies (1.3).

1.1Asthma Montelukast sodium tablets are indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 15 years of age and older.

1.2Exercise-Induced Bronchoconstriction (EIB) Montelukast sodium tablets are indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older.

1.3Allergic Rhinitis tablets are indicated for the relief of symptoms of seasonal allergic rhinitis in patients 15 years of age and older and perennial allergic rhinitis in patients of age and older. Because the benefits of montelukast sodium tablets may not outweigh the risk of neuropsychiatric symptoms in patients with reserve use for patients who have an inadequate response or intolerance to alternative therapies. Montelukast sodium tablets are indicated for the relief of symptoms of seasonal allergic rhinitis in patients 15 years of age and older and perennial allergic rhinitis in patients 15 years of age and older.

Because the benefits of montelukast sodium tablets may not outweigh the risk of neuropsychiatric symptoms in patients with allergic rhinitis [see warnings and precautions (5.1)], reserve use for patients who have an inadequate response or intolerance to alternative therapies.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Administration (by indications): • Asthma (2.1): Once daily in the evening for patients 15 years and older. • Acute prevention of EIB (2.2): One tablet at least 2 hours before exercise for patients 15 years of age and older. • Seasonal allergic rhinitis (2.3): Once daily for patients 15 years and older. • Perennial allergic rhinitis (2.3): Once daily for patients 15 years and older. Dosage (by age) (2): • 15 years and older: one 10 mg tablet. Patients with both asthma and allergic rhinitis should take only one dose daily in the evening (2.4).

2.1Asthma Montelukast sodium tablets should be taken once daily in the evening. The following doses are recommended: For adults and adolescents 15 years of age and older: one 10 mg tablet. Safety and effectiveness in pediatric patients less than 12 months of age with asthma have not been established. who miss a dose should take the next dose at their regular time and should not take 2 doses at the same time.

There have been no clinical trials in patients with asthma to evaluate the relative efficacy of morning versus evening dosing. The pharmacokinetics of montelukast are similar whether dosed in the morning or evening. Efficacy has been demonstrated for asthma when montelukast was administered in the evening without regard to time of food ingestion.

Montelukast sodium tablets should be taken once daily in the evening. The following doses are recommended: For adults and adolescents 15 years of age and older: one 10 mg tablet. Safety and effectiveness in pediatric patients less than 12 months of age with asthma have not been established.

Patients who miss a dose should take the next dose at their regular time and should not take 2 doses at the same time. There have been no clinical trials in patients with asthma to evaluate the relative efficacy of morning versus evening dosing. The pharmacokinetics of montelukast are similar whether dosed in the morning or evening.

Efficacy has been demonstrated for asthma when montelukast was administered in the evening without regard to time of food ingestion.

2.2Exercise-Induced Bronchoconstriction (EIB) For prevention of EIB, a single dose of montelukast sodium tablets should be taken at least 2 hours before exercise. The following doses are recommended: For adults and adolescents 15 years of age and older: one 10 mg tablet. An additional dose of montelukast sodium tablets should not be taken within 24 hours of a previous dose.

Patients already taking montelukast sodium tablets daily for another indication (including chronic asthma) should not take an additional dose to prevent EIB. All patients should have available for rescue a short-acting β-agonist. Safety and efficacy in patients younger than 6 years of age have not been established.

Daily administration of montelukast sodium tablets for the chronic treatment of asthma has not been established to prevent acute episodes of EIB.

2.3Allergic Rhinitis For allergic rhinitis, montelukast sodium tablets should be taken once daily. Efficacy was demonstrated for seasonal allergic rhinitis when montelukast was administered in the morning or the evening without regard to time of food ingestion. The time of administration may be individualized to suit patient needs.

The following doses for the treatment of symptoms of seasonal allergic rhinitis are recommended: For adults and adolescents 15 years of age and older: one 10 mg tablet. Safety and effectiveness in pediatric patients younger than 2 years of age with seasonal allergic rhinitis have not been established. The following doses for the treatment of symptoms of perennial allergic rhinitis are recommended: For adults and adolescents 15 years of age and older: one 10 mg tablet.

Safety and effectiveness in pediatric patients younger than 6 months of age with perennial allergic rhinitis have not been established. who miss a dose should take the next dose at their regular time and should not take 2 doses at the same time. For al…

💊 Dosage Forms and Strengths 37 words ▾

3 DOSAGE FORMS AND STRENGTHS • Montelukast sodium film-coated tablets, USP 10 mg are beige, rounded square-shaped, film- coated tablets debossed with 'I' on one side and '114' on the other side. • Tablets: 10 mg (3)

⛔ Contraindications 19 words ▾

4 CONTRAINDICATIONS • Hypersensitivity to any component of this product. • Hypersensitivity to any component of this product (4).

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS • Do not prescribe montelukast sodium to treat an acute asthma attack (5.2). • Advise patients to have appropriate rescue medication available (5.2). • Inhaled corticosteroid may be reduced gradually. Do not abruptly substitute montelukast sodium for inhaled or oral corticosteroids (5.3). • Patients with known aspirin sensitivity should continue to avoid aspirin or non-steroidal anti-inflammatory agents while taking montelukast sodium (5.4). • Systemic eosinophilia, sometimes presenting with clinical features of vasculitis consistent with Churg-Strauss syndrome, has been reported.

These events have been sometimes associated with the reduction of oral corticosteroid therapy (5.5 and 6.2).

5.1Neuropsychiatric Events neuropsychiatric (NP) events have been reported with use of montelukast sodium. These postmarketing reports have been highly variable and included, but were not limited to, agitation, aggressive behavior or hostility, anxiousness, depression, disorientation, disturbance in attention, dream dysphemia (stuttering), hallucinations, insomnia, irritability, memory impairment, obsessive-compulsive symptoms, restlessness, , suicidal thoughts and behavior (including suicide), tic, and tremor. NP events have been reported in adult, adolescent, and pediatric patients with and without a history of psychiatric disorder.

NP events have been reported mostly during montelukast sodium treatment, but some were reported after sodium discontinuation. Animal studies showed that montelukast distributes into the brain in rats however, the mechanisms underlying montelukast sodium-associated NP events are currently not well understood. Based upon the available data, it is difficult to identify risk for or quantify the risk of NP events with montelukast sodium use. of the risk of NP events, the benefits of montelukast sodium may not outweigh the risks in some patients, particularly when the symptoms of disease may be and adequately treated with alternative therapies.

Reserve use of montelukast sodium for patients with allergic rhinitis who have an inadequate or intolerance to alternative therapies In patients with asthma or exercise-induced bronchoconstriction, consider the benefits and before prescribing montelukast sodium. the benefits and risks of montelukast sodium use with patients and caregivers when prescribing montelukast sodium. Advise patients and/or caregivers to be for changes in behavior or for new NP symptoms when taking montelukast sodium. If changes in behavior are observed, or if new NP symptoms or suicidal thoughts behavior occur, advise patients to discontinue montelukast sodium and contact a healthcare provider immediately.

In many cases, resolved after stopping montelukast sodium therapy; however, in some cases symptoms persisted after discontinuation of montelukast sodium. continue to monitor and provide supportive care until symptoms resolve. Re-evaluate the benefits and risks of restarting treatment with sodium if such events occur. Serious neuropsychiatric (NP) events have been reported with use of montelukast sodium.

These postmarketing reports have been highly variable and included, but were not limited to, agitation, aggressive behavior or hostility, anxiousness, depression, disorientation, disturbance in attention, dream abnormalities, dysphemia (stuttering), hallucinations, insomnia, irritability, memory impairment, obsessive-compulsive symptoms, restlessness, somnambulism, suicidal thoughts and behavior (including suicide), tic, and tremor. NP events have been reported in adult, adolescent, and pediatric patients with and without a previous history of psychiatric disorder.

NP events have been reported mostly during montelukast sodium treatment, but some were reported after montelukast sodium discontinuation. Animal studies showed that montelukast distributes into the brain in rats [see Clinical Pharmacology (12.3)]; however, the mechanisms underlying montelukast sodium-associated NP…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS Most common adverse reactions (incidence ≥5% and greater than placebo listed in descending order of frequency): upper respiratory infection, fever, headache, pharyngitis, cough, abdominal pain, diarrhea, otitis media, influenza, rhinorrhea, sinusitis, otitis (6.1). To report SUSPECTED ADVERSE REACTIONS, contact XL Care Pharmaceuticals, Inc. at 1-866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. In the following description of clinical trials experience, adverse reactions are listed regardless of causality assessment. The most common adverse reactions (incidence ≥5% and greater than placebo; listed in descending order of frequency) in controlled clinical trials were: upper respiratory infection, fever, headache, pharyngitis, cough, abdominal pain, diarrhea, otitis media, influenza, rhinorrhea, sinusitis, otitis.

Adults and Adolescents 15 Years of Age and Older with Asthma Montelukast sodium has been evaluated for safety in approximately 2950 adult and adolescent patients 15 years of age and older in clinical trials. In placebo-controlled clinical trials, the following adverse experiences reported with montelukast sodium occurred in greater than or equal to 1% of patients and at an incidence greater than that in patients treated with placebo: Table 1: Adverse Experiences Occurring in ≥1% of Patients with an Incidence Greater than that in Patients Treated with Placebo Montelukast sodium 10 mg/day) (%) (n=1955) Placebo (%) (n=1180) Body As A Whole Pain, abdominal Asthenia/fatigue Fever 2.9 1.8 1.5 2.5 1.2

0.9Trauma Digestive System Disorders Dyspepsia 1.0 2.1 0.8

1.1Pain, dental 1.7

1.0Gastroenteritis, infectious 1.5

0.5Nervous System/Psychiatric Headache 18.4

18.1Dizziness 1.9

1.4Respiratory System Disorders Influenza 4.2

3.9Cough 2.7

2.4Congestion, nasal 1.6

1.3Skin/Skin Appendages Disorder Rash 1.6

1.2Laboratory Adverse Experiences * ALT increased 2.1

2.0AST increased 1.6

1.2Pyuria 1.0 0.9 *Number of patients tested (montelukast sodium and placebo, respectively): ALT and AST, 1935, 1170; pyuria, 1924, 1159. The frequency of less common adverse events was comparable between montelukast sodium and placebo. The safety profile of montelukast sodium, when administered as a single dose for prevention of EIB in adult and adolescent patients 15 years of age and older, was consistent with the safety profile previously described for montelukast sodium.

Cumulatively, 569 patients were treated with montelukast sodium for at least 6 months, 480 for one year, and 49 for two years in clinical trials. With prolonged treatment, the adverse experience profile did not significantly change. Adults and Adolescents 15 Years of Age and Older with Seasonal Allergic Rhinitis Montelukast sodium has been evaluated for safety in 2199 adult and adolescent patients 15 years of age and older in clinical trials.

Montelukast sodium administered once daily in the morning or in the evening had a safety profile similar to that of placebo. In placebo-controlled clinical trials, the following event was reported with montelukast sodium with a frequency ≥1% and at an incidence greater than placebo: upper respiratory infection, 1.9% of patients receiving montelukast sodium vs. 1.5% of patients receiving placebo.

In a 4-week, placebo-controlled clinical study, the safety profile was consistent with that observed in 2-week studies. The incidence of somnolence was similar to that of placebo in all studies. Adults and Adolescents 15 Years of Age and Older with Perennial Allergic Rhinitis Montelukast sodium has been evaluated for safety in 3357 adult and adolescent patients 15 years of age and older with perennial allergic rhinit…

🔄 Drug Interactions 43 words ▾

7 DRUG INTERACTIONS No dose adjustment is needed when montelukast sodium is co-administered with theophylline, prednisone, prednisolone, oral contraceptives, terfenadine, digoxin, warfarin, gemfibrozil, itraconazole, thyroid hormones, sedative hypnotics, non-steroidal anti-inflammatory agents, benzodiazepines, decongestants, and Cytochrome P450 (CYP) enzyme inducers [see Clinical Pharmacology (12.3)].

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Available data from published prospective and retrospective cohort studies over decades with montelukast use in pregnant women have not established a drug-associated risk of major birth defects [see Data]. In animal reproduction studies, no adverse developmental effects were observed with oral administration of montelukast to pregnant rats and rabbits during organogenesis at doses approximately 100 and 110 times, respectively, the maximum recommended human daily oral dose (MRHDOD) based on AUCs [see Data].

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Poorly or moderately controlled asthma in pregnancy increases the maternal risk of perinatal adverse outcomes such as preeclampsia and infant prematurity, low birth weight, and small for gestational age. Data Human Data Published data from prospective and retrospective cohort studies have not identified an association with montelukast sodium use during pregnancy and major birth defects. Available studies have methodologic limitations, including small sample size, in some cases retrospective data collection, and inconsistent comparator groups.

Animal Data In embryo-fetal development studies, montelukast administered to pregnant rats and rabbits during organogenesis (gestation days 6 to 17 in rats and 6 to 18 in rabbits) did not cause any adverse developmental effects at maternal oral doses up to 400 and 300 mg/kg/day in rats and rabbits, respectively (approximately 100 and 110 times the AUC in humans at the MRHDOD, respectively).

8.2Lactation Risk Summary A published clinical lactation study reports the presence of montelukast in human milk. Data available on the effects of the drug on infants, either directly [see Use in Specific Populations (8.4)] or through breast milk, do not suggest a significant risk of adverse events from exposure to montelukast sodium. The effects of the drug on milk production are unknown.

The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for montelukast sodium and any potential adverse effects on the breastfed infant from montelukast sodium or from the underlying maternal condition.

8.4Pediatric Use The safety and effectiveness in pediatric patients below the age of 12 months with asthma, 6 months with perennial allergic rhinitis, and 6 years with exercise-induced bronchoconstriction have not been established.

8.5Geriatric Use Of the total number of subjects in clinical studies of montelukast, 3.5% were 65 years of age and over, and 0.4% were 75 years of age and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. The pharmacokinetic profile and the oral bioavailability of a single 10 mg oral dose of montelukast are similar in elderly and younger adults.

The plasma half-life of montelukast is slightly longer in the elderly. No dosage adjustment in the elderly is required.

8.6Hepatic Insufficiency No dosage adjustment is required in patients with mild-to-moderate hepatic insufficiency [see Clinical Pharmacology ( 12.3)].

8.7Renal Insufficiency No dosage adjustment is recommended in patients with renal insufficiency [see Clinical Pharmacology (12.3)].

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary Available data from published prospective and retrospective cohort studies over decades with montelukast use in pregnant women have not established a drug-associated risk of major birth defects [see Data]. In animal reproduction studies, no adverse developmental effects were observed with oral administration of montelukast to pregnant rats and rabbits during organogenesis at doses approximately 100 and 110 times, respectively, the maximum recommended human daily oral dose (MRHDOD) based on AUCs [see Data].

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Poorly or moderately controlled asthma in pregnancy increases the maternal risk of perinatal adverse outcomes such as preeclampsia and infant prematurity, low birth weight, and small for gestational age. Data Human Data Published data from prospective and retrospective cohort studies have not identified an association with montelukast sodium use during pregnancy and major birth defects. Available studies have methodologic limitations, including small sample size, in some cases retrospective data collection, and inconsistent comparator groups.

Animal Data In embryo-fetal development studies, montelukast administered to pregnant rats and rabbits during organogenesis (gestation days 6 to 17 in rats and 6 to 18 in rabbits) did not cause any adverse developmental effects at maternal oral doses up to 400 and 300 mg/kg/day in rats and rabbits, respectively (approximately 100 and 110 times the AUC in humans at the MRHDOD, respectively).

🧒 Pediatric Use 34 words ▾

8.4Pediatric Use The safety and effectiveness in pediatric patients below the age of 12 months with asthma, 6 months with perennial allergic rhinitis, and 6 years with exercise-induced bronchoconstriction have not been established.

🧓 Geriatric Use 116 words ▾

8.5Geriatric Use Of the total number of subjects in clinical studies of montelukast, 3.5% were 65 years of age and over, and 0.4% were 75 years of age and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. The pharmacokinetic profile and the oral bioavailability of a single 10 mg oral dose of montelukast are similar in elderly and younger adults.

The plasma half-life of montelukast is slightly longer in the elderly. No dosage adjustment in the elderly is required.

🆘 Overdosage 59 words ▾

10 OVERDOSAGE No specific information is available on the treatment of overdosage with montelukast sodium. In the event of overdose, it is reasonable to employ the usual supportive measures; e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute supportive therapy, if required. It is not known whether montelukast is removed by peritoneal dialysis or hemodialysis.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The cysteinyl leukotrienes (LTC 4 , LTD 4 , LTE 4 ) are products of arachidonic acid metabolism and are released from various cells, including mast cells and eosinophils. These eicosanoids bind to cysteinyl leukotriene (CysLT) receptors. The CysLT type-1 (CysLT 1 ) receptor is found in the human airway (including airway smooth muscle cells and airway macrophages) and on other pro-inflammatory cells (including eosinophils and certain myeloid stem cells).

CysLTs have been correlated with the pathophysiology of asthma and allergic rhinitis. In asthma, leukotriene-mediated effects include airway edema, smooth muscle contraction, and altered cellular activity associated with the inflammatory process. In allergic rhinitis, CysLTs are released from the nasal mucosa after allergen exposure during both early- and late-phase reactions and are associated with symptoms of allergic rhinitis.

Montelukast is an orally active compound that binds with high affinity and selectivity to the CysLT 1 receptor (in preference to other pharmacologically important airway receptors, such as the prostanoid, cholinergic, or β-adrenergic receptor). Montelukast inhibits physiologic actions of LTD 4 at the CysLT 1 receptor without any agonist activity.

12.2Pharmacodynamics Montelukast causes inhibition of airway cysteinyl leukotriene receptors as demonstrated by the ability to inhibit bronchoconstriction due to inhaled LTD 4 in asthmatics. Doses as low as 5 mg cause substantial blockage of LTD 4 -induced bronchoconstriction. In a placebo-controlled, crossover study (n=12), montelukast sodium inhibited early- and late-phase bronchoconstriction due to antigen challenge by 75% and 57%, respectively.

The effect of montelukast sodium on eosinophils in the peripheral blood was examined in clinical trials. In patients with asthma aged 2 years and older who received montelukast sodium, a decrease in mean peripheral blood eosinophil counts ranging from 9% to 15% was noted, compared with placebo, over the double-blind treatment periods. In patients with seasonal allergic rhinitis aged 15 years and older who received montelukast sodium, a mean increase of 0.2% in peripheral blood eosinophil counts was noted, compared with a mean increase of 12.5% in placebo-treated patients, over the double-blind treatment periods; this reflects a mean difference of 12.3% in favor of montelukast sodium.

The relationship between these observations and the clinical benefits of montelukast noted in the clinical trials is not known [see Clinical Studies (14)].

12.3Pharmacokinetics Absorption Montelukast is rapidly absorbed following oral administration. After administration of the 10 mg film-coated tablet to fasted adults, the mean peak montelukast plasma concentration (C max ) is achieved in 3 to 4 hours (T max ). The mean oral bioavailability is 64%.

The oral bioavailability and C max are not influenced by a standard meal in the morning. The safety and efficacy of montelukast sodium in patients with asthma were demonstrated in clinical trials in which the 10 mg film-coated tablet formulation was administered in the evening without regard to the time of food ingestion. The safety and efficacy of montelukast sodium in patients with seasonal allergic rhinitis were demonstrated in clinical trials in which the 10 mg film-coated tablet was administered in the morning or evening without regard to the time of food ingestion.

The comparative pharmacokinetics of montelukast when administered as two 5 mg chewable tablets versus one 10 mg film-coated tablet have not been evaluated. Distribution Montelukast is more than 99% bound to plasma proteins. The steady state volume of distribution of montelukast averages 8 to 11 liters.

Orally administered montelukast distributes into the brain in rats. Metabolism Montelukast is extensively metabolized. In studies with therapeutic doses, plasma concentrations of metabolites of montelukast are undetectable at…

🧬 Mechanism of Action 182 words ▾

12.1Mechanism of Action The cysteinyl leukotrienes (LTC 4 , LTD 4 , LTE 4 ) are products of arachidonic acid metabolism and are released from various cells, including mast cells and eosinophils. These eicosanoids bind to cysteinyl leukotriene (CysLT) receptors. The CysLT type-1 (CysLT 1 ) receptor is found in the human airway (including airway smooth muscle cells and airway macrophages) and on other pro-inflammatory cells (including eosinophils and certain myeloid stem cells).

CysLTs have been correlated with the pathophysiology of asthma and allergic rhinitis. In asthma, leukotriene-mediated effects include airway edema, smooth muscle contraction, and altered cellular activity associated with the inflammatory process. In allergic rhinitis, CysLTs are released from the nasal mucosa after allergen exposure during both early- and late-phase reactions and are associated with symptoms of allergic rhinitis.

Montelukast is an orally active compound that binds with high affinity and selectivity to the CysLT 1 receptor (in preference to other pharmacologically important airway receptors, such as the prostanoid, cholinergic, or β-adrenergic receptor). Montelukast inhibits physiologic actions of LTD 4 at the CysLT 1 receptor without any agonist activity.

📦 How Supplied / Storage and Handling 86 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Montelukast sodium tablets, USP 10 mg are beige, rounded square-shaped, film-coated tablets debossed with 'I' on one side and '114' on the other side. They are supplied as follows: Bottles of 30 Tablets NDC 72865-175-30 Bottles of 90 Tablets NDC 72865-175-90 Bottles of 1000 Tablets NDC 72865-175-10 Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture and light.

Store in original container. When product container is subdivided, repackage into a well-closed, light-resistance container.

📋 Description 157 words ▾

11 DESCRIPTION Montelukast sodium USP, the active ingredient in montelukast sodium tablets, USP is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene CysLT 1 receptor. Montelukast sodium USP is described chemically as [R-(E)]-1-[[[1-[3-[2-(7-chloro-2-quinolinyl)ethenyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]thio]methyl] cyclopropaneacetic acid, monosodium salt. The empirical formula is C 35 H 35 CINNaO 3 S, and its molecular weight is 608.17.

The structural formula is: Montelukast sodium USP is a hygroscopic, optically active, white or almost white powder. Montelukast sodium USP is freely soluble in water and methylene chloride, freely soluble to very soluble in alcohol. Each 10 mg film-coated montelukast sodium tablet USP contains 10.4 mg montelukast sodium USP, which is equivalent to 10 mg of montelukast, and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, mannitol and microcrystalline cellulose.

The tablets are coated with opadry yellow which contains carnauba wax, hydroxypropyl cellulose, hypromellose, red iron oxide, titanium dioxide and yellow iron oxide. Figure1.jpg

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION For the tablets, advise the patient and/or caregiver to read the FDA-approved patient labeling (Medication Guide). • Advise patients about the potential risk for serious neuropsychiatric symptoms and behavioral changes with montelukast sodium use. • Discuss the benefits and risks of montelukast sodium with patients when prescribing or continuing treatment with montelukast sodium. • Advise patients to monitor for changes in behavior or neuropsychiatric symptoms in patients taking montelukast sodium. • Instruct patients to discontinue montelukast sodium and contact a healthcare provider immediately if changes in behavior or thinking that are not typical for the patient occur, or if the patient develops suicidal ideation or suicidal behavior. • Advise patients to take montelukast sodium daily as prescribed, even when they are asymptomatic, as well as during periods of worsening asthma, and to contact their physicians if their asthma is not well controlled. • Advise Patients that oral montelukast sodium is not for the treatment of acute asthma attacks.

They should have appropriate short-acting inhaled β-agonist medication available to treat asthma exacerbations. Patients who have exacerbations of asthma after exercise should be instructed to have available for rescue a short-acting inhaled β-agonist. Daily administration of montelukast sodium for the chronic treatment of asthma has not been established to prevent acute episodes of EIB. • Advise patients to seek medical attention if short-acting inhaled bronchodilators are needed more often than usual, or if more than the maximum number of inhalations of short-acting bronchodilator treatment prescribed for a 24-hour period are needed. • Instruct patients to continue other anti-asthma medications as prescribed unless instructed by a physician. • Instruct patients with known aspirin sensitivity to continue avoidance of aspirin or non-steroidal anti-inflammatory agents while taking montelukast sodium.

Manufactured for: XLCare Pharmaceuticals, Inc. 242 South Culver Street, Suite 202, Lawrenceville, GA 30046. Manufactured by: Evaric Pharmaceuticals Inc.

155 Commerce Drive, Hauppauge, New York 11788, United States (USA). Revised: 02/2021

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE Montelukast Sodium Tablets, USP (mon" te loo' kast soe' dee um) What is the most important information I should know about montelukast sodium tablets? Serious mental health problems have happened in people taking montelukast sodium tablets or even after treatment has stopped. This can happen in people with or without a history of mental health problems.

Stop taking montelukast sodium tablets and tell your healthcare provider right away if you or your child have any unusual changes in behavior or thinking, including any of these symptoms: • agitation, including aggressive behavior or hostility • attention problems • bad or vivid dreams • depression • disorientation (confusion) • feeling anxious • irritability • hallucinations (seeing or hearing things that are not really there) • memory problems • obsessive-compulsive symptoms • restlessness • sleep walking • stuttering • suicidal thoughts and actions (including suicide) • tremor • trouble sleeping • uncontrolled muscle movements What are montelukast sodium tablets?

Montelukast sodium tablets are a prescription medicine that blocks substances in the body called leukotrienes. This may help to improve symptoms of asthma and inflammation of the lining of the nose (allergic rhinitis). Montelukast sodium tablets do not contain a steroid.

Montelukast sodium tablets are used to: 1. Prevent asthma attacks and for the long-term treatment of asthma in adults and adolescents ages 15 years and older. Do not take montelukast sodium tablets if you need relief right away for a sudden asthma attack.

If you have an asthma attack, you should follow the instructions your healthcare provider gave you for treating asthma attacks. 2. Prevent exercise-induced asthma in people 15 years of age and older.

3. Help control the symptoms of allergic rhinitis such as sneezing, stuffy nose, runny nose, and itching of the nose. Montelukast sodium tablets are used to treat the following in people who have already taken other medicines that did not work well enough or in people who could not tolerate other medicines: • outdoor allergies that happen part of the year (seasonal allergic rhinitis) in adults and adolescents ages 15 years and older, and • indoor allergies that happen all year (perennial allergic rhinitis) in adults and adolescents ages 15 years and older.

Do not take montelukast sodium tablets if you are allergic to any of its ingredients. See the end of this Medication Guide for a complete list of the ingredients in montelukast sodium tablets. Before taking montelukast sodium tablets, tell your healthcare provider about all your medical conditions, including if you: • are allergic to aspirin • have or have had mental health problems. • are pregnant or plan to become pregnant.

Talk to your healthcare provider if you are pregnant or plan to become pregnant, montelukast sodium tablets may not be right for you. • are breastfeeding or plan to breastfeed. It is not known if montelukast sodium passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking montelukast sodium tablets.

Tell your healthcare provider about all the medicines you take, including prescription and over the counter medicines, vitamins, and herbal supplements. Some medicines may affect how montelukast sodium tablets work, or montelukast sodium tablets may affect how your other medicines work. How should I take montelukast sodium tablets?

For anyone who takes montelukast sodium tablets: • Take montelukast sodium tablets exactly as prescribed by your healthcare provider. Your healthcare provider will tell you how much montelukast sodium tablets to take, and when to take it. • Stop taking montelukast sodium tablets and tell your healthcare provider right away if you or your child have any unusual changes in behavior or thinking. • You can take montelukast sodium tablets with food or without food. • If you or your child misses a dose of montelukast sodium tablets, just tak…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 72865-0172-25 · XLCare 72865-0180-05 · XLCare →
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.