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Hydrocodone Bitartrate and Homatropine Methylbromide 5 mg; 1.5 mg Tablet, 100-count

by Novel Laboratories, Inc. · 100 TABLET in 1 BOTTLE (40032-118-24)

NDC 40032-0118-24

🏷️ FDA NDC (as labeled) 40032-118-24 billing pads the product segment with a zero

This package

Contains100-count Pack sizes3 compare ↓

Also comes in: 30 tablets 40032-0118-03 500 tablets 40032-0118-26

Rx only Generic On market CII

🗂️ Data synced Aug 27, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm

📋 All sources & update times →

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

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

🆔 Identity & classification

FDA NDC (as labeled) 40032-118-24

Product NDC 40032-118

11-digit billing NDC 40032011824

RxCUI 992656

UNII NO70W886KK, 68JRS2HC1C

UPC 0340032118039, 0340032118244

Application # ANDA091528

SPL Set ID b203c87c-1108-4eaa-8a57-87be776d8a70

Established class (EPC) Opioid Agonist

Mechanism of action Opioid Agonists

DEA schedule CII

Marketing category ANDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2014-09-23

Route ORAL

Dosage form TABLET

Substance HYDROCODONE BITARTRATE; HOMATROPINE METHYLBROMIDE

Why two NDCs? The FDA registers this code as 40032-118-24 — 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 → 40032-0118-24. 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 Cholinergic Muscarinic Antagonist class.

Pharmacologic class Cholinergic Muscarinic Antagonist

Drug family (ATC) Anticholinergics, Belladonna alkaloids, semisynthetic, quaternary ammonium compounds

How it works Cholinergic Muscarinic 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

LabelerNovel Laboratories, Inc.

Application holderNOVEL LABORATORIES INC

FDA applicationANDA091528 (ANDA)

Labeler code40032

First marketedSep 2014

DEA scheduleCII

Product typeHuman Prescription Drug

Portfolio22 products on file

🔎 All NDCs from Novel Laboratories, Inc.

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

Where does this data come from?

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

🩺 Clinical

📖 What it is MedlinePlus · NLM

Hydrocodone is available in combination with other ingredients, and different combination products are prescribed for different uses. Some hydrocodone combination products are used to relieve severe pain. Other hydrocodone combination products are used to relieve cough. Hydrocodone is in a class of medications called opiate (narcotic) analgesics and in a class of medications called antitussives. Hydrocodone relieves pain by changing the way the brain and nervous system respond to pain. Hydrocodone relieves cough by decreasing activity in the part of the brain that causes coughing. You will tak...

Read the full MedlinePlus article ↗

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →

Where does this data come from?

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

💊 What it looks like

Color White

ShapeRound

ImprintN;350

Size8 mm

ScoringScored — splits in 2

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 L11K75P92J
A mineral salt made from calcium and phosphate. It acts as a filler and binder in tablets to add bulk and help hold the medicine together in solid form.
UNII 3SY5LH9PMK
Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
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 ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
UNII 5856J3G2A2
A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.

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

Where does this data come from?

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

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?

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

Why might an inactive ingredient be missing?

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

Can inactive ingredients matter?

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

💲 Pricing

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

Price system	Per each	Per package
Retail pharmacies payNADAC · weekly	Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo	No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly	No Part D plan price is available for this NDC in our data.

ℹ️

No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.

Try another pack size: 30 tablets 500 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

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Hydrocodone Bitartrate and Homatropine Methylbromide 5 mg/1; 1.5 mg 10702-0055-01	KVK-Tech,	100 tablets	$0.943	AA	Availability likely	—
Hydrocodone Bitartrate and Homatropine Methylbromide 5 mg/1; 1.5 mg 64950-0206-03	Genus	30 tablets	$0.943	AA	Availability likely	—
Hydrocodone Bitartrate and Homatropine Methylbromide 5 mg/1; 1.5 mg 43386-0118-01	Lupin	100 tablets	$1.020	—	FDA listed	—
Hydrocodone Bitartrate and Homatropine Methylbromide 5 mg/1; 1.5 mgthis 40032-0118-24	Novel	100 tablets	—	—	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

🏛️

2014

On the market since

Sep 2014

📍

2026

Currently FDA-listed

12 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 Hydrocodone Bitartrate and Homatropine Methylbromide — the ingredient across all brands.

Top reported reactions

Chronic Kidney Disease64

Acute Kidney Injury38

Renal Failure35

Nausea29

Fatigue28

Pneumonia21

Vomiting19

Reporter sex

Serious outcomes

Death46

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

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

Where does this data come from?

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

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
40032-0118-03	30 TABLET in 1 BOTTLE (40032-118-03)	2014-09-23	Active
40032-0118-24 You're viewing this	100 TABLET in 1 BOTTLE (40032-118-24)	2014-09-23	Active
40032-0118-26	500 TABLET in 1 BOTTLE (40032-118-26)	2014-09-23	Active

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

Pack size FAQ

What quantity is in NDC 40032-0118-24?

NDC 40032-0118-24 is a 100-count package — 100 tablet in 1 bottle.

What is the difference between NDC 40032-0118-24 and NDC 40032-0118-03?

Both are Hydrocodone Bitartrate and Homatropine Methylbromide 5 mg; 1.5 mg Tablet — the drug itself is identical. NDC 40032-0118-24 is the 100-count package, while NDC 40032-0118-03 is the 30 tablets package.

What NDC number is used to bill for this package of Hydrocodone Bitartrate and Homatropine Methylbromide 5 mg; 1.5 mg Tablet?

Bill NDC 40032-0118-24 — the 11-digit billing format is 40032011824. 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	— Not published for this NDC No photo available yet for this listing.
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	— Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
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 40032-118-24, 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: 40032-0118-24, written without dashes as 40032011824. 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 40032-0118-24, the first segment (40032) is the labeler code FDA assigned to Novel Laboratories, Inc.; the middle segment (0118) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (24) 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 Novel Laboratories, 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 (40032-0118-03), 500 tablets (40032-0118-26). 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?

Novel Laboratories, 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 ~2 min read ▾

WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; MEDICATION ERRORS; CYTOCHROME P450 3A4 INTERACTION; CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; INTERACTION WITH ALCOHOL; NEONATAL OPIOID WITHDRAWAL SYNDROME (NOWS) Addiction, Abuse, and Misuse Hydrocodone Bitartrate and Homatropine Methylbromide Tablets exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Reserve Hydrocodone Bitartrate and Homatropine Methylbromide Tablets for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made.

Assess each patient's risk prior to prescribing Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, prescribe Hydrocodone Bitartrate and Homatropine Methylbromide Tablets for the shortest duration that is consistent with individual patient treatment goals , monitor all patients regularly for the development of addiction or abuse, and refill only after reevaluation of the need for continued treatment [ see Warnings and Precautions (5.1) ]. Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of Hydrocodone Bitartrate and Homatropine Methylbromide Tablets.

Monitor for respiratory depression, especially during initiation of Hydrocodone Bitartrate and Homatropine Methylbromide Tablets therapy or when used in patients at higher risk [ see Warnings and Precautions (5.2) ] . Accidental Ingestion Accidental ingestion of even one dose of Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, especially by children, can result in a fatal overdose of hydrocodone [ see Warnings and Precautions (5.2) ]. Risk of Medication Errors Ensure accuracy when prescribing, dispensing, and administering Hydrocodone Bitartrate and Homatropine Methylbromide Tablets.

Dosing errors can result in accidental overdose and death. Always use an accurate milliliter measuring device when measuring and administering Hydrocodone Bitartrate and Homatropine Methylbromide Tablets [ see Dosage and Administration (2.1) , Warnings and Precautions (5.5) ]. Cytochrome P450 3A4 Interaction The concomitant use of Hydrocodone Bitartrate and Homatropine Methylbromide Tablets with all cytochrome P450 3A4 inhibitors may result in an increase in hydrocodone plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression.

In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in hydrocodone plasma concentration. Avoid the use of Hydrocodone Bitartrate and Homatropine Methylbromide Tablets in patients taking a CYP3A4 inhibitor or inducer [ see Warnings and Precautions (5.7) , Drug Interactions (7.2 , 7.3) ]. Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death .

Avoid the use of Hydrocodone Bitartrate and Homatropine Methylbromide Tablets in patients taking benzodiazepines, other CNS depressants, or alcohol. [ see Warnings and Precautions (5.8) , Drug Interactions (7.5) ] Interaction with Alcohol Instruct patients not to consume alcoholic beverages or use prescription or non-prescription products that contain alcohol while taking Hydrocodone Bitartrate and Homatropine Methylbromide Tablets. The co-ingestion of alcohol with Hydrocodone Bitartrate and Homatropine Methylbromide Tablets may result in increased plasma levels and a potentially fatal overdose of hydrocodone [ see Warnings Precautions (5.8) and Drug Interactions (7.1) ].

Neonatal Opioid Withdrawal Syndrome (NOWS) Hydrocodone Bitartrate and Homatropine Methylbromide Tablets are no…

🎯 Indications and Usage ~1 min read ▾

1 INDICATIONS AND USAGE Hydrocodone Bitartrate and Homatropine Methylbromide Tablets are indicated for the symptomatic relief of cough in adult patients 18 years of age and older. Limitations of Use: Not indicated for pediatric patients under 18 years of age [ see Use in Specific Populations (8.4) ]. Contraindicated in pediatric patients less than 6 years of age [ see Contraindications (4) ].

Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [ see Warnings and Precautions (5.1) ] , reserve Hydrocodone Bitartrate and Homatropine Methylbromide Tablets for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made. Hydrocodone Bitartrate and Homatropine Methylbromide Tablets is a combination of hydrocodone, an opioid agonist, and homatropine, a muscarinic antagonist, indicated for the symptomatic relief of cough in adult patients 18 years of age and older.

( 1 ) Limitations of Use (1 ) Not indicated for pediatric patients under 18 years of age. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve Hydrocodone Bitartrate and Homatropine Methylbromide Tablets for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made.

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION Adults 18 years of age and older : One (1) tablet every 4 to 6 hours as needed; not to exceed six (6) tablets in 24 hours. ( 2.2 ) Do not increase the dose or dosing frequency. ( 2.1 ) Prescribe for the shortest duration consistent with treatment goals. ( 2.3 ) Reevaluate patients with unresponsive cough in 5 days or sooner for possible underlying pathology. ( 2.3 ) Reevaluate patient prior to refilling. ( 2.3 )

2.1Important Dosage and Administration Instructions Administer Hydrocodone Bitartrate and Homatropine Methylbromide Tablets by the oral route only. Advise patients not to increase the dose or dosing frequency of Hydrocodone Bitartrate and Homatropine Methylbromide Tablets because serious adverse events such as respiratory depression may occur with overdosage [ see Warnings and Precautions (5.2) , Overdosage (10) ]. The dosage of Hydrocodone Bitartrate and Homatropine Methylbromide Tablets should not be increased if cough fails to respond; an unresponsive cough should be reevaluated for possible underlying pathology [ see Dosage and Administration (2.3) , Warnings and Precautions (5.4) ].

2.2Recommended Dosage Adults 18 years of age and older : One (1) tablet every 4 to 6 hours as needed; not to exceed six (6) tablets in 24 hours.

2.3Monitoring, Maintenance, and Discontinuation of Therapy Prescribe Hydrocodone Bitartrate and Homatropine Methylbromide Tablets for the shortest duration that is consistent with individual patient treatment goals [ see Warnings and Precautions (5.1) ] . Monitor patients closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy [ see Warnings and Precautions (5.2) ] . Reevaluate patients with unresponsive cough in 5 days or sooner for possible underlying pathology, such as foreign body or lower respiratory tract disease [ see Warnings and Precautions (5.4) ].

If a patient requires a refill, reevaluate the cause of the cough and assess the need for continued treatment with Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, the relative incidence of adverse reactions, and the development of addiction, abuse, or misuse [ see Warnings and Precautions (5.1) ]. Do not abruptly discontinue Hydrocodone Bitartrate and Homatropine Methylbromide Tablets in a physically-dependent patient [ see Drug Abuse and Dependence (9.3) ]. When a patient who has been taking Hydrocodone Bitartrate and Homatropine Methylbromide Tablets regularly and may be physically dependent no longer requires therapy with Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, taper the dose gradually, by 25% to 50% every 2 to 4 days, while monitoring carefully for signs and symptoms of withdrawal.

If the patient develops these signs or symptoms, raise the dose to the previous level and taper more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both.

💊 Dosage Forms and Strengths 70 words ▾

3 DOSAGE FORMS AND STRENGTHS Tablet: Each tablet contains hydrocodone bitartrate 5 mg; and homatropine methylbromide 1.5 mg and supplied as white, round, scored biconvex tablet debossed with "N" on upper side of the score, "350" on the lower side of the score and plain on the other side [ see Description (11) ]. Tablets: Each tablet contains hydrocodone bitartrate 5 mg; and homatropine methylbromide 1.5 mg ( 3 )

⛔ Contraindications 172 words ▾

4 CONTRAINDICATIONS Hydrocodone Bitartrate and Homatropine Methylbromide Tablets is contraindicated for: All pediatric patients younger than 6 years of age [ see Warnings and Precautions ( 5.2 , 5.3 ) Use in Specific Populations (8.4) ]. Significant respiratory depression [ see Warnings and Precautions (5.2) ]. Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [ see Warnings and Precautions (5.4) ].

Known or suspected gastrointestinal obstruction, including paralytic ileus [ see Warnings and Precautions (5.9) ]. Hypersensitivity to hydrocodone, homatropine, or any of the inactive ingredients in Hydrocodone Bitartrate and Homatropine Methylbromide Tablets [ see Adverse Reactions (6) ]. Children younger than 6 years of age.

( 4 ) Significant respiratory depression. ( 4 ) Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment. ( 4 ) Known or suspected gastrointestinal obstruction, including paralytic ileus.

( 4 ) Hypersensitivity to hydrocodone, homatropine, or any of the inactive ingredients in Hydrocodone Bitartrate and Homatropine Methylbromide Tablets. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Life-threatening respiratory depression in patients with chronic pulmonary disease or in elderly, cachectic, or debilitated patients : Monitor closely, particularly during initiation of therapy. ( 5.4 ) Activities requiring mental alertness : Avoid engaging in hazardous tasks requiring mental alertness such as driving or operating machinery. ( 5.6 ) Risks of use in patients with head injury, impaired consciousness, increased intracranial pressure, or brain tumors : Avoid use.

May increase intracranial pressure and obscure the clinical course of head injuries. ( 5.10 ) Seizures in patients with seizure disorders : Monitor during therapy. ( 5.11 ) Severe hypotension : Monitor during initiation of therapy.

Avoid use in patients with circulatory shock. ( 5.12 ) Adrenal insufficiency : If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. ( 5.14 )

5.1Addiction, Abuse, and Misuse Hydrocodone Bitartrate and Homatropine Methylbromide Tablets contain hydrocodone, a Schedule II controlled substance. As an opioid, Hydrocodone Bitartrate and Homatropine Methylbromide Tablets exposes users to the risks of addiction, abuse, and misuse [see Drug Abuse and Dependence (9) ], which can lead to overdose and death [see Overdosage ( 10 )]. Reserve Hydrocodone Bitartrate and Homatropine Methylbromide Tablets for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made.

Assess each patient's risk prior to prescribing Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, prescribe Hydrocodone Bitartrate and Homatropine Methylbromide Tablets for the shortest duration that is consistent with individual patient treatment goals, monitor all patients regularly for the development of addiction or abuse, and refill only after reevaluation of the need for continued treatment. Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed Hydrocodone Bitartrate and Homatropine Methylbromide Tablets.

Addiction can occur at recommended dosages and if the drug is misused or abused. Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). Opioids are sought by drug abusers and people with addiction disorders and are subject to criminal diversion.

Consider these risks when prescribing or dispensing Hydrocodone Bitartrate and Homatropine Methylbromide Tablets. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on the proper disposal of unused drug. Contact local state professional licensing board or state-controlled substances authority for information on how to prevent and detect abuse or diversion of this product.

5.2Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids, including hydrocodone, one of the active ingredients in Hydrocodone Bitartrate and Homatropine Methylbromide Tablets. Hydrocodone produces dose-related respiratory depression by directly acting on the brain stem respiratory center that controls respiratory rhythm and may produce irregular and periodic breathing. Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death.

Management of respiratory depression includes discontinuation of Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, close observation, supportive measures, and use of opioid antagonists (e.g. naloxone), depending on the patient's clinical status [see Overdosage ( 10 )]. Carbon dioxide (CO2) retention from opioid-induced respiratory depression can exacerbate the sedating effects of opioids. While serious, life-threatening, or fatal respiratory d…

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in labeling: Addiction, abuse, and misuse [ see Warnings and Precautions (5.1) , Drug Abuse and Dependence (9.3) ] Life-threatening respiratory depression [ see Warnings and Precautions (5.2 , 5.3 , 5.4 , 5.8 ) and Overdosage (10) ] Accidental overdose and death due to medication errors [ see Warnings and Precautions (5.5) ] Decreased mental alertness with impaired mental and/or physical abilities [ see Warnings and Precautions (5.6) ] Interactions with benzodiazepines and other CNS depressants [ see Warnings and Precautions ( 5.8 ), and Drug Interactions (7.1) , ( 7.4) ] Paralytic ileus, gastrointestinal adverse reactions [ see Warnings and Precautions (5.9) ] Increased intracranial pressure [ see Warnings and Precautions (5.10) ] Obscured clinical course in patients with head injuries [ see Warnings and Precautions (5.10) ] Seizures [ see Warnings and Precautions (5.11) ] Severe hypotension [ see Warnings and Precautions (5.12) ] Neonatal Opioid Withdrawal Syndrome [ see Warnings and Precautions (5.13) ] Adrenal insufficiency [ see Warnings and Precautions (5.14) ] The following adverse reactions have been identified during clinical studies, in the literature, or during post-approval use of hydrocodone and/or homatropine.

Because these reactions may be reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The most common adverse reactions to Hydrocodone Bitartrate and Homatropine Methylbromide Tablets include: Sedation (somnolence, mental clouding, lethargy), impaired mental and physical performance, lightheadedness, dizziness, headache, dry mouth, nausea, vomiting, and constipation. Other reactions include: Anaphylaxis : Anaphylaxis has been reported with hydrocodone, one of the ingredients in Hydrocodone Bitartrate and Homatropine Methylbromide Tablets.

Body as a whole : Coma, death, fatigue, falling injuries, lethargy. Cardiovascular : Peripheral edema, increased blood pressure, decreased blood pressure, tachycardia, chest pain, palpitation, syncope, orthostatic hypotension, prolonged QT interval, hot flush. Central Nervous System : Facial dyskinesia, insomnia, migraine, increased intracranial pressure, seizure, tremor.

Dermatologic : Flushing, hyperhidrosis, pruritus, rash. Endocrine/Metabolic : Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs. Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.

Cases of androgen deficiency have occurred with chronic use of opioids. Gastrointestinal : Abdominal pain, bowel obstruction, decreased appetite, diarrhea, difficulty swallowing, dry mouth, GERD, indigestion, pancreatitis, paralytic ileus, biliary tract spasm (spasm of the sphincter of Oddi). Genitourinary : Urinary tract infection, ureteral spasm, spasm of vesicle sphincters, urinary retention.

Laboratory : Increases in serum amylase. Musculoskeletal : Arthralgia, backache, muscle spasm. Ophthalmic : Miosis (constricted pupils), visual disturbances.

Psychiatric : Agitation, anxiety, confusion, fear, dysphoria, depression. Reproductive : Hypogonadism, infertility. Respiratory : Bronchitis, cough, dyspnea, nasal congestion, nasopharyngitis, respiratory depression, sinusitis, upper respiratory tract infection.

Other : Drug abuse, drug dependence, opioid withdrawal syndrome. Common adverse reactions include: Sedation (somnolence, mental clouding, lethargy), impaired mental and physical performance, lightheadedness, dizziness, headache, dry mouth, nausea, vomiting, and constipation. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 866-403-7592 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions ~3 min read ▾

7 DRUG INTERACTIONS No specific drug interaction studies have been conducted with Hydrocodone Bitartrate and Homatropine Methylbromide Tablets. Serotonergic Drugs : Concomitant use may result in serotonin syndrome. Discontinue if serotonin syndrome is suspected.

( 7.5 ) Monoamine Oxidase Inhibitors (MAOIs) : Can potentiate the effects of hydrocodone. Avoid concomitant use in patients receiving MAOIs or within 14 days of stopping an MAOI. ( 7.6 ) Muscle Relaxants : Avoid concomitant use.

( 7.7 ) Diuretics : Hydrocodone may reduce the efficacy of diuretics. Monitor for reduced effect. ( 7.8 ) Anticholinergic drugs : Concurrent use may cause paralytic ileus.

( 5.9 , 7.9 )

7.1Alcohol Concomitant use of alcohol with Hydrocodone Bitartrate and Homatropine Methylbromide Tablets can result in an increase of hydrocodone plasma levels and potentially fatal overdose of hydrocodone. Instruct patients not to consume alcoholic beverages or use prescription or nonprescription products containing alcohol while on Hydrocodone Bitartrate and Homatropine Methylbromide Tablets therapy [ see Warnings and Precautions (5.8) and Clinical Pharmacology (12.3) ].

7.2Inhibitors of CYP3A4 and CYP2D6 The concomitant use of Hydrocodone Bitartrate and Homatropine Methylbromide Tablets and CYP3A4 inhibitors, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g. ketoconazole), or protease inhibitors (e.g., ritonavir), can increase the plasma concentration of hydrocodone, resulting in increased or prolonged opioid effects. These effects could be more pronounced with concomitant use of Hydrocodone Bitartrate and Homatropine Methylbromide Tablets and CYP2D6 and CYP3A4 inhibitors, particularly when an inhibitor is added after a stable dose of Hydrocodone Bitartrate and Homatropine Methylbromide Tablets are achieved [ see Warnings and Precautions (5.7) ].

After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, the hydrocodone plasma concentration will decrease [ see Clinical Pharmacology (12.3) ], resulting in decreased opioid efficacy or a withdrawal syndrome in patients who had developed physical dependence to hydrocodone. Avoid the use of Hydrocodone Bitartrate and Homatropine Methylbromide Tablets while taking a CYP3A4 or CYP2D6 inhibitor. If concomitant use is necessary, monitor patients for respiratory depression and sedation at frequent intervals.

7.3CYP3A4 Inducers The concomitant use of Hydrocodone Bitartrate and Homatropine Methylbromide Tablets and CYP3A4 inducers such as rifampin, carbamazepine, or phenytoin, can decrease the plasma concentration of hydrocodone [ see Clinical Pharmacology (12.3) ], resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence to hydrocodone [ see Warnings and Precautions (5.7) ]. After stopping a CYP3A4 inducer, as the effects of the inducer decline, the hydrocodone plasma concentration will increase [ see Clinical Pharmacology (12.3) ], which could increase or prolong both the therapeutic effects and adverse reactions, and may cause serious respiratory depression.

Avoid the use of Hydrocodone Bitartrate and Homatropine Methylbromide Tablets in patients who are taking CYP3A4 inducers. If concomitant use of a CYP3A4 inducer is necessary, follow the patient for reduced efficacy.

7.4Benzodiazepines, and Other CNS Depressants Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, and other opioids, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death. Avoid the use of Hydrocodone Bitartrate and Homatropine Methylbromide Tablets in patients who are taking benzodiazepines or other CNS depressants [ see Warnings and Precautions (5.8) ], and instruct patients to avoid consumption of alcohol while on Hydroc…

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy : Avoid use in pregnant women. May cause fetal harm. ( 8.1 ) Lactation : Breast-feeding not recommended. ( 8.2 ) Renal Impairment : Use with caution in patients with severe renal impairment. ( 8.6 ) Hepatic Impairment : Use with caution in patients with severe hepatic impairment. ( 8.7 )

8.1Pregnancy Risk Summary Hydrocodone Bitartrate and Homatropine Methylbromide Tablets are not recommended for use in pregnant women, including during or immediately prior to labor. Prolonged use of opioids during pregnancy may cause neonatal opioid withdrawal syndrome [ see Warnings and Precautions (5.13) , Clinical Considerations ]. There are no available data with Hydrocodone Bitartrate and Homatropine Methylbromide Tablets use in pregnant women to inform a drug-associated risk for adverse developmental outcomes.

Published studies with hydrocodone have reported inconsistent findings and have important methodological limitations ( see Data ). Reproductive toxicity studies have not been conducted with Hydrocodone Bitartrate and Homatropine Methylbromide Tablets; however, studies are available with individual active ingredients or related active ingredients ( see Data ). In animal reproduction studies, hydrocodone administered by the subcutaneous route to pregnant hamsters during the period of organogenesis produced a teratogenic effect at a dose approximately 45 times the maximum recommended human dose (MRHD) ( see Data ).

Based on the animal data, advise pregnant women of the potential risk to a fetus. 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 Fetal/Neonatal Adverse Reactions Prolonged use of opioid analgesics during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea and failure to gain weight.

The onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn. Observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly [ see Warnings and Precautions (5.13) ]. Labor or Delivery Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates.

An opioid antagonist, such as naloxone, must be available for reversal of opioid-induced respiratory depression in the neonate. Opioids, including Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, can prolong labor through actions which temporarily reduce the strength, duration, and frequency of uterine contractions. However, this effect is not consistent and may be offset by an increased rate of cervical dilation, which tends to shorten labor.

Monitor neonates exposed to opioids during labor for signs of excess sedation and respiratory depression. Data Human Data Hydrocodone A limited number of pregnancies have been reported in published observational studies and postmarketing reports describing hydrocodone use during pregnancy. However, these data cannot definitely establish or exclude any drug-associated risk during pregnancy.

🤰 Pregnancy ~3 min read ▾

Methodological limitations of these observational studies include small sample size and lack of details regarding dose, duration and timing of exposure. Animal Data Reproductive toxicity studies have not been conducted with Hydrocodone Bitartrate and Homatropine Methylbromide Tablets; however, studies are available with individual active ingredients or related active ingredients. Hydrocodone In an embryofetal development study in pregnant hamsters dosed on gestation day 8 during the period of organogenesis, hydrocodone induced cranioschisis, a malformation, at approximately 45 times the MRHD (on a mg/m2 basis with a matern…

🧒 Pediatric Use 126 words ▾

8.4Pediatric Use Hydrocodone Bitartrate and Homatropine Methylbromide Tablets is contraindicated in pediatric patients younger than 6 years of age because of life-threatening respiratory depression and death have occurred in pediatric patients who received hydrocodone [see Contraindications ( 4 ), Warnings and Precautions ( 5.2 )]. The safety and effectiveness of Hydrocodone Bitartrate and Homatropine Methylbromide Tablets have not been established in patients younger than 18 years of age. Hydrocodone Bitartrate and Homatropine Methylbromide Tablets is not recommended for use in patients. younger than 18 years of age because the benefits of symptomatic treatment of cough associated with allergies or the common cold do not outweigh the risks for use of hydrocodone in these patients [see Indications ( 1 ), Warnings and Precautions ( 5.3 )].

🧓 Geriatric Use 177 words ▾

8.5Geriatric Use Clinical studies have not been conducted with Hydrocodone Bitartrate and Homatropine Methylbromide Tablets in geriatric populations. Use caution when considering the use of Hydrocodone Bitartrate and Homatropine Methylbromide Tablets in patients 65 years of age or older. Elderly patients may have increased sensitivity to hydrocodone; greater frequency of decreased hepatic, renal, or cardiac function; or concomitant disease or other drug therapy [ see Warnings and Precautions (5.4) ].

Respiratory depression is the chief risk for elderly patients treated with opioids, including Hydrocodone Bitartrate and Homatropine Methylbromide Tablets. Respiratory depression has occurred after large initial doses of opioids were administered to patients who were not opioid-tolerant or when opioids were co-administered with other agents that depress respiration [ see Warnings and Precautions (5.4 , 5.8) ]. Hydrocodone is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function.

Because elderly patients are more likely to have decreased renal function, monitor these patients closely for respiratory depression, sedation, and hypotension.

🆘 Overdosage ~2 min read ▾

10 OVERDOSAGE Clinical Presentation Hydrocodone Acute overdose with hydrocodone is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, partial or complete airway obstruction, atypical snoring, hypotension, circulatory collapse, cardiac arrest, and death. Hydrocodone may cause miosis, even in total darkness.

Pinpoint pupils are a sign of opioid overdose but are not pathognomonic (e.g., pontine lesions of hemorrhagic or ischemic origin may produce similar findings). Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations [ see Clinical Pharmacology (12.2) ]. Homatropine Homatropine has broad, nonspecific anticholinergic / antimuscarinic activity that similar to, although less potent than, atropine.

Overdosage of homatropine can cause mydriasis and cycloplegia (fixed and dilated pupils), dry mouth and eyes, decreased sweating, hyperthermia, flushing, headache, visual blurring, gastrointestinal symptoms, constipation, urinary retention, tachycardia and palpitations, anxiety, restlessness, agitation, hallucinations, convulsions, cardiac arrhythmias and coma. Anticholinergic agents can also precipitate acute narrow angle glaucoma. Treatment of Overdose Treatment of overdosage is driven by the overall clinical presentation, and consists of discontinuation of Hydrocodone Bitartrate and Homatropine Methylbromide Tablets together with institution of appropriate therapy.

Give primary attention to the reestablishment of adequate respiratory exchange through provision of a patent and protected airway and the institution of assisted or controlled ventilation. Employ other supportive measures (including oxygen and vasopressors) in the management of circulatory shock and pulmonary edema as indicated. Cardiac arrest or arrhythmias will require advanced life-support measures.

Gastric emptying may be useful in removing unabsorbed drug. The opioid antagonists, naloxone and nalmefene, are specific antidotes for respiratory depression resulting from opioid overdose. For clinically significant respiratory or circulatory depression secondary to hydrocodone overdose, administer an opioid antagonist.

An antagonist should not be administered in the absence of clinically significant respiratory depression. Because the duration of opioid reversal is expected to be less than the duration of action of hydrocodone in Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, carefully monitor the patient until spontaneous respiration is reliably reestablished. If the response to an opioid antagonist is suboptimal or only brief in nature, administer additional antagonist as directed by the product's prescribing information.

Hemodialysis is not routinely used to enhance the elimination of hydrocodone from the body. Physostigmine may be used parenterally for the treatment of the signs and symptoms of homatropine toxicity.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Hydrocodone Hydrocodone is an opioid agonist with relative selectivity for the mu-opioid receptor, although it can interact with other opioid receptors at higher doses. The precise mechanism of action of hydrocodone and other opiates is not known; however, hydrocodone is believed to act centrally on the cough center. In excessive doses, hydrocodone will depress respiration.

Homatropine Homatropine is an anticholinergic that inhibits activity of the muscarinic acetylcholine receptor with less potency than atropine.

12.2Pharmacodynamics Hydrocodone Effects on the Central Nervous System Hydrocodone produces respiratory depression by direct action on brain stem respiratory centers. The respiratory depression involves a reduction in the responsiveness of the brain stem respiratory centers to both increases in carbon dioxide tension and to electrical stimulation. Hydrocodone causes miosis, even in total darkness.

Pinpoint pupils are a sign of opioid overdose but are not pathognomonic (e.g., pontine lesions of hemorrhagic or ischemic origins may produce similar findings). Marked mydriasis rather than miosis may be seen due to hypoxia in overdose situations. Effects on the Gastrointestinal Tract and Other Smooth Muscle Hydrocodone causes a reduction in motility associated with an increase in smooth muscle tone in the antrum of the stomach and duodenum.

Digestion of food in the small intestine is delayed and propulsive contractions are decreased. Propulsive peristaltic waves in the colon are decreased, while tone may be increased to the point of spasm resulting in constipation. Other opioid-induced effects may include a reduction in biliary and pancreatic secretions, spasm of sphincter of Oddi, and transient elevations in serum amylase.

Effects on the Cardiovascular System Hydrocodone produces peripheral vasodilation which may result in orthostatic hypotension or syncope. Manifestations of histamine release and/or peripheral vasodilation may include pruritus, flushing, red eyes and sweating and/or orthostatic hypotension. Effects on the Endocrine System Opioids inhibit the secretion of adrenocorticotropic hormone (ACTH), cortisol, and luteinizing hormone (LH) in humans [ see Adverse Reactions (6) ].

They also stimulate prolactin, growth hormone (GH) secretion, and pancreatic secretion of insulin and glucagon. Chronic use of opioids may influence the hypothalamic-pituitary-gonadal axis, leading to androgen deficiency that may manifest as low libido, impotence, erectile dysfunction, amenorrhea, or infertility. The causal role of opioids in the clinical syndrome of hypogonadism is unknown because the various medical, physical, lifestyle, and psychological stressors that may influence gonadal hormone levels have not been adequately controlled for in studies conducted to date [ see Adverse Reactions (6) ].

Effects on the Immune System Opioids have been shown to have a variety of effects on components of the immune system in in vitro and animal models. The clinical significance of these findings is unknown. Overall, the effects of opioids appear to be modestly immunosuppressive.

Concentration–Adverse Reaction Relationships There is a relationship between increasing hydrocodone plasma concentration and increasing frequency of dose-related opioid adverse reactions such as nausea, vomiting, CNS effects, and respiratory depression. In opioid-tolerant patients, the situation may be altered by the development of tolerance to opioid-related adverse reactions. Homatropine Homatropine methylbromide has several mild but undesirable clinical properties resulting from its antisecretory effects.

These can include: dry mouth, loss of visual accommodation, photophobia, and difficulty in urination. The extent of the above actions is dictated by dose, dose escalation, therefore, results in progressively aversive symptoms in patients.

12.3 Pharmacokinetics Absorption Following a 10 mg oral dose of hydrocodone…

🧬 Mechanism of Action 77 words ▾

Homatropine Homatropine is an anticholinergic that inhibits activity of the muscarinic acetylcholine receptor with less potency than atropine.

📦 How Supplied / Storage and Handling 105 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, USP are available as a white, round, scored, biconvex tablet debossed with "N" on upper side of the score, "350" on the lower side of the score and plain on the other side containing 5 mg hydrocodone bitartrate and 1.5 mg homatropine methylbromide and is available in: Bottles of 30 NDC 40032-118-03 Bottles of 100 NDC 40032-118-24 Bottles of 500 NDC 40032-118-26 Store tablets at controlled room temperature 20ᵒC to 25ᵒC (68ᵒF to 77ᵒF). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container, as defined in the USP, with a child-resistant closure.

📋 Description 178 words ▾

11 DESCRIPTION Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, USP contains hydrocodone an opioid agonist, and homatropine a muscarinic antagonist. Each tablet of Hydrocodone Bitartrate and Homatropine Methylbromide contains 5 mg of Hydrocodone Bitartrate, USP and 1.5 mg of Homatropine Methylbromide, USP for oral administartion. Hydrocodone Bitartrate and Homatropine Methylbromide Tablets also contains the following inactive ingredients: anhydrous lactose, dicalcium phosphate anhydrous, sodium starch glycolate, colloidal silicon dioxide and magnesium stearate.

Hydrocodone Bitartrate: The chemical name for hydrocodone bitartrate is morphinan-6-one, 4,5-epoxy-3-methoxy- 17-methyl-, (5α)-, [R-(R*,R*)]-2,3-dihydroxybutanedioate (1:1), hydrate (2:5). It is also known as 4,5α-Epoxy-3-methoxy-17 methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It occurs as a fine white crystal or crystalline powder, which is derived from the opium alkaloid, thebaine.

It has a molecular weight of 494.490 and has the following chemical structure: C18H21NO3 • C4H6O6 • 21/2H2O MW 494.490 Homatropine Methylbromide The chemical name for homatropine methylbromide is 8- Azoniabicyclo[3.2.1]octane, 3-[(hydroxyphenyl-acetyl)oxy]-8, 8-dimethyl-,bromide,endo. It occurs as a white crystal or fine white crystalline powder. It has a molecular weight of 370.29 and has the following chemical structure: C17H24BrNO3 HOMATROPINE METHYLBROMIDE Image structure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Addiction, Abuse, and Misuse Inform patients that the use of Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, even when taken as recommended, can result in addiction, abuse, and misuse, which can lead to overdose and death [ see Warnings and Precautions (5.1) ] . Instruct patients not to share Hydrocodone Bitartrate and Homatropine Methylbromide Tablets with others and to take steps to protect Hydrocodone Bitartrate and Homatropine Methylbromide Tablets from theft or misuse.

Important Dosing and Administration Instructions Instruct patients how to measure and take the correct dose of Hydrocodone Bitartrate and Homatropine Methylbromide Tablets. Advise patients to measure Hydrocodone Bitartrate and Homatropine Methylbromide Tablets with an accurate milliliter measuring device. Patients should be informed that a household teaspoon is not an accurate measuring device and could lead to overdosage.

Advise patients to ask their pharmacist to recommend an appropriate measuring device and for instructions for measuring the correct dose [ see Dosage and Administration (2.1) , Warnings and Precautions (5.5) ]. Advise patients not to increase the dose or dosing frequency of Hydrocodone Bitartrate and Homatropine Methylbromide Tablets because serious adverse events such as respiratory depression may occur with overdosage [ see Warnings and Precautions (5.2) , Overdosage (10) ]. Life-Threatening Respiratory Depression Inform patients of the risk of life-threatening respiratory depression, including information that the risk is greatest when starting Hydrocodone Bitartrate and Homatropine Methylbromide Tablets and that it can occur even at recommended dosages [ see Warnings and Precautions (5.2) ].

Advise patients how to recognize respiratory depression and to seek medical attention if breathing difficulties develop. Accidental Ingestion Inform patients that accidental ingestion, especially by children, may result in respiratory depression or death [ see Warnings and Precautions (5.2) ]. Instruct patients to take steps to store Hydrocodone Bitartrate and Homatropine Methylbromide Tablets securely and to properly dispose of unused Hydrocodone Bitartrate and Homatropine Methylbromide Tablets in accordance with the local state guidelines and/or regulations.

Activities Requiring Mental Alertness Advise patients to avoid engaging in hazardous tasks that require mental alertness and motor coordination such as operating machinery or driving a motor vehicle as Hydrocodone Bitartrate and Homatropine Methylbromide Tablets may produce marked drowsiness [ see Warnings and Precautions (5.6) ]. Interactions with Benzodiazepines and Other Central Nervous System Depressants, Including Alcohol Inform patients and caregivers that potentially fatal additive effects may occur if Hydrocodone Bitartrate and Homatropine Methylbromide Tablets is used with benzodiazepines or other CNS depressants, including alcohol.

Advise patients to avoid concomitant use of Hydrocodone Bitartrate and Homatropine Methylbromide Tablets with benzodiazepines or other CNS depressants and instruct patients not to consume alcoholic beverages, as well as prescription and over-the-counter products that contain alcohol, during treatment with Hydrocodone Bitartrate and Homatropine Methylbromide Tablets [ see Warnings and Precautions (5.8) , Drug Interactions (7.1 , 7.4) ]. Constipation Advise patients of the potential for severe constipation [ see Warnings and Precautions (5.9) , Adverse Reactions (6) ].

Anaphylaxis Inform patients that anaphylaxis has been reported with ingredients contained in Hydrocodone Bitartrate and Homatropine Methylbromide Tablets. Advise patients how to recognize such a reaction and when to seek medical attention [ see Contraindications (4) , Adverse Reactions (6) ]. MAOI Interaction Inform patients not to take Hydrocodone Bitartrate and H…

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE Hydrocodone Bitartrate (hye'' droe koe' done bye tar' trate) and Homatropine Methylbromide (hoe mat' roe peen meth'' il broe' mide) Tablets, USP CII What is the most important information I should know about Hydrocodone Bitartrate and Homatropine Methylbromide Tablets? Hydrocodone Bitartrate and Homatropine Methylbromide Tablets is not for children under 18 years of age. Hydrocodone Bitartrate and Homatropine Methylbromide Tablets can cause serious side effects, including: Addiction, abuse and misuse.

Taking Hydrocodone Bitartrate and Homatropine Methylbromide Tablets or other medicines that contain an opioid can cause addiction, abuse and misuse, which can lead to overdose and death. This can happen even if you take Hydrocodone Bitartrate and Homatropine Methylbromide Tablets exactly as prescribed by your healthcare provider. Your risk of addiction, abuse, and misuse is increased if you or a family member has a history of drug or alcohol abuse or addiction, or mental health problems.

Do not share your Hydrocodone Bitartrate and Homatropine Methylbromide Tablets with other people. Keep Hydrocodone Bitartrate and Homatropine Methylbromide Tablets in a safe place away from children. Life-threatening breathing problems (respiratory depression) .

Hydrocodone Bitartrate and Homatropine Methylbromide Tablets can cause breathing problems (respiratory depression) that can happen at any time during treatment and can lead to death. Your risk of breathing problems is greatest when you first start taking Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, are taking other medicines that can cause breathing problems, have certain lung problems, are elderly, or have certain other health problems. Children are at higher risk for respiratory depression.

Breathing problems can happen even if you take Hydrocodone Bitartrate and Homatropine Methylbromide Tablets exactly as prescribed by your healthcare provider. Call your healthcare provider or get emergency medical help right away if anyone taking Hydrocodone Bitartrate and Homatropine Methylbromide Tablets has any of the symptoms below: increased sleepiness confusion difficulty breathing shallow breathing limpness Keep Hydrocodone Bitartrate and Homatropine Methylbromide Tablets in a safe place away from children. Accidental use of even 1 dose of Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, especially by a child, is a medical emergency and can cause breathing problems (respiratory depression) which can lead to death.

If a child accidentally takes Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, get emergency medical help right away. Overdose and death due to medicine dosing errors . Breathing problems (respiratory depression) that can lead to death and opioid withdrawal can happen if you start taking or stop taking other medicines while taking Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, including: certain antibiotics certain medicines to treat a fungal infection certain medicines to treat Human Immunodeficiency Virus (HIV)-1 infection, Acquired Immune Deficiency Syndrome (AIDS), or Hepatitis C rifampin carbamazepine phenytoin Tell your healthcare provider if you take any of these medicines.

Ask your healthcare provider or pharmacist if you are not sure if your medicine is listed above. Severe drowsiness, breathing problems (respiratory depression), coma, and death can happen in people who take Hydrocodone Bitartrate and Homatropine Methylbromide Tablets with benzodiazepines or other central nervous system depressants, including alcohol. Do not take benzodiazepines or any medicine that can cause drowsiness or sleepiness during treatment with Hydrocodone Bitartrate and Homatropine Methylbromide Tablets.

Do not drink alcohol or take prescription or over-the-counter medicines that contain alcohol during treatment with Hydrocodone Bitartrate and Homatropine Methylbromide Tablets Opioid withdrawal in a newborn . Use of Hydroc…

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

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

immunosuppressive: Describes something that lowers the activity of the immune system.

in vitro: In a laboratory dish or test tube rather than in a living person or animal; results may not carry over to people.

serotonergic: Acting on serotonin, a chemical messenger involved in mood, sleep, and digestion.

abdominal pain: Pain, cramping, or discomfort felt anywhere in the belly area.

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

abuse: Using a medicine in a way it was not meant to be used, such as taking more than prescribed to feel a high.

adrenal insufficiency: A condition where the adrenal glands do not make enough of certain needed hormones, such as cortisol, a stress hormone.

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

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

agitation: A state of feeling restless and upset and being unable to relax, sometimes with pacing or fidgeting.

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

amenorrhea: The absence of monthly menstrual periods.

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

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

antagonist: A substance that blocks a target in the body so a natural signal or another medicine cannot produce its usual effect.

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

arthralgia: Joint pain.

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

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

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

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

constipation: Having bowel movements less often than usual, or passing stools that are hard, dry, and difficult to move.

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

controlled substance: A medicine regulated by law because it can be misused or lead to dependence, with special rules for prescribing and storage.

cyanosis: A bluish color of the skin, lips, or nails caused by too little oxygen in the blood.

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

CYP3A4: One of the most important liver and gut enzymes, responsible for breaking down a large share of all medicines.

cytochrome P450: A large family of enzymes, mostly in the liver, that break down many medicines so the body can remove them.

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

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

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

Drug Abuse and Dependence: A label section describing a medicine's potential to be misused and to cause the body to rely on it.

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

dyskinesia: Involuntary, uncontrolled movements of the face, arms, legs, or body.

dysphoria: A general feeling of unease, dissatisfaction, or unhappiness.

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

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

efficacy: How well a treatment works under the controlled conditions of a clinical study.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

erectile dysfunction: Trouble getting or keeping an erection.

estimated background risk: The normal chance that any pregnancy will have a birth defect or problem, even without taking any medicine.

fetal harm: Injury or damage to a developing baby while it is growing inside the womb.

flushing: Temporary redness and warmth of the skin, often on the face and neck, from widening of small blood vessels.

fungal infection: An infection caused by a fungus, such as a yeast or mold, rather than by bacteria or a virus.

GERD: Stomach acid flowing back up into the food pipe, causing heartburn and irritation.

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

hemodialysis: A treatment that uses a machine to filter waste and extra fluid from the blood when the kidneys cannot.

hepatic impairment: Reduced liver function, meaning the liver does not work as well as normal at processing substances, including medicines.

hepatitis: Inflammation of the liver, which can be caused by infections, alcohol, or certain medicines.

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

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

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

hypoxia: A condition in which the body's tissues do not get enough oxygen.

ileus: A slowdown or stop in the normal movement of the intestines, so food and waste do not pass through.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

inducer: A substance that speeds up an enzyme, which can lower the levels of drugs that enzyme breaks down.

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

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

irritability: Getting annoyed, frustrated, or angry more easily than usual.

lactation: The making and release of milk from a mother's breasts after giving birth.

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

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

Medication Guide: An FDA-approved handout written for patients that explains important safety information about certain medicines in plain language.

misuse: Using a medicine differently from how it was prescribed or directed, whether on purpose or by mistake.

mydriasis: Widening of the pupil, the dark center of the eye.

nasopharyngitis: Inflammation of the nose and throat, commonly known as the common cold.

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

neonatal: Relating to a newborn baby during its first four weeks of life.

organogenesis: The early stage of pregnancy when the developing baby's organs are first forming.

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

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

palpitations: The feeling that your heart is racing, pounding, fluttering, or skipping beats.

pancreatitis: Painful swelling of the pancreas, an organ behind the stomach that helps digest food and control blood sugar.

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

peripheral edema: Swelling, usually in the feet, ankles, or legs, caused by extra fluid building up in the tissues.

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

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

physical dependence: When the body adapts to a medicine over time, so stopping it suddenly causes uncomfortable symptoms.

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

potency: How much of a medicine is needed to produce a given effect; a more potent medicine works at a smaller dose.

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

Prescribing Information: The official, detailed document approved by the FDA that tells health professionals how to use a prescription medicine.

pruritus: Itching of the skin.

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

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

renal impairment: Reduced kidney function, meaning the kidneys do not filter waste and fluid from the blood as well as normal.

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

restlessness: An inability to stay calm or still, with a constant feeling of needing to move.

sedation: A calm, sleepy, slowed-down state caused by a medicine that relaxes the brain and body.

seizure: A sudden burst of abnormal electrical activity in the brain that can cause shaking, staring, confusion, or loss of awareness.

serotonin syndrome: A potentially dangerous reaction from too much of the brain chemical serotonin, causing agitation, fast heartbeat, sweating, and muscle twitching.

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

subcutaneous: An injection placed into the fatty layer just under the skin; often written as subcut or SC.

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

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

taper: Gradually lowering a dose in steps before stopping, rather than quitting all at once.

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

tolerance: When the body gets used to a medicine over time, so a larger dose is needed to get the same effect.

tremor: Shaking or trembling of part of the body, such as the hands, that a person cannot control.

upper respiratory tract infection: An infection of the nose, sinuses, or throat, such as the common cold.

urinary retention: Being unable to empty the bladder fully or at all.

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

vasodilation: Widening of blood vessels, which lets more blood flow through and can lower blood pressure.

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

withdrawal: Uncomfortable physical or mental symptoms that appear when a medicine the body has gotten used to is reduced or stopped.

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

← 40032-0096-60 · Novel 40032-0160-06 · Novel →

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.

Hydrocodone Bitartrate and Homatropine Methylbromide 5 mg; 1.5 mg Tablet, 100-count

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12 CLINICAL PHARMACOLOGY

12.3 Pharmacokinetics Absorption Following a 10 mg oral dose of hydrocodone…

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