Home › NDC Lookup › Ingredients › Morphine Sulfate › 63304-0451-01

Morphine sulfate 30 mg Tablet, Film Coated, Extended Release, 100-count

by Sun Pharmaceutical Industries, Inc. · 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63304-451-01)

NDC 63304-0451-01

🏷️ FDA NDC (as labeled) 63304-451-01 billing pads the product segment with a zero

This package

Contains100-count Cost per ea$0.4555 NADAC Per package$45.55 / 100 tablets Pack sizes3 compare ↓

Also priced by: Medicaid pays $0.4708/unit · Part D plans $0.3829/unit — full pricing hub ↓

Also comes in: 10 tablets 63304-0451-03 500 tablets 63304-0451-05

Rx only Generic On market CII 🛡 REMS

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

📋 All sources & update times →

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

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

🚨

Active recall for this product.

Class II · Feb 6, 2025 — Failed Dissolution Specifications (SUN PHARMACEUTICAL INDUSTRIES INC) · FDA recall D-0249-2025

Check your lot/expiration against the official notice — look up the recall number in the FDA recall database ↗

⚠️

Other active recalls for Morphine Sulfate (different manufacturers) — 3 · tap to view

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

Class I · Aug 4, 2026 — Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL. (Fresenius Kabi USA, LLC) · FDA recall D-0788-2026

Class III · Nov 26, 2025 — Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton. (Winder Laboratories, LLC) · FDA recall D-0223-2026

Class II · Mar 12, 2024 — The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot. (Hikma Pharmaceuticals USA Inc.) · FDA recall D-0392-2024

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

🆔 Identity & classification

FDA NDC (as labeled) 63304-451-01

Product NDC 63304-451

11-digit billing NDC 63304045101

NCPDP billing unit EA — each (per item)

RxCUI 891874, 891881, 891888, 891893, 892646

UNII X3P646A2J0

UPC 0363304453010, 0363304758016, 0363304452013, 0363304450019 +1 more

Application # ANDA078761

SPL Set ID 736c9b80-682c-4cda-bf18-61b18de0bd39

Established class (EPC) Opioid Agonist

Mechanism of action Full Opioid Agonists

DEA schedule CII

Marketing category ANDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2012-05-11

Route ORAL

Dosage form TABLET, FILM COATED, EXTENDED RELEASE

Substance MORPHINE SULFATE

GPI-14 65100055100432

GPI class Morphine Sulfate ER

GCN Seq No 004096

GCN 16640

HICL code 001694

Ingredient (HICL) Morphine Sulfate

HIC1 code H

Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)

HIC2 code H3

Therapeutic class — intermediate (HIC2) Analgesics

HIC3 code H3A

Therapeutic class — specific (HIC3) Opioid Analgesics

AHFS code 28:08.08.00

AHFS class Opioid Agonists (28:08)

FDB label name MORPHINE SULF ER 30 MG TABLET

FDB brand name Morphine Sulfate Er

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 63304-451-01 — 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 → 63304-0451-01. 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 Opioid Agonist class.

Pharmacologic class Opioid Agonist

Drug family (ATC) Natural opium alkaloids

How it works Full Opioid Agonists

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

LabelerSun Pharmaceutical Industries, Inc.

Application holderSUN PHARMACEUTICAL INDUSTRIES LTD

FDA applicationANDA078761 (ANDA)

Labeler code63304

First marketedMay 2012

DEA scheduleCII

Product typeHuman Prescription Drug

Portfolio889 products on file

🔎 All NDCs from Sun Pharmaceutical Industries, 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

Label name MORPHINE SULF ER 30 MG TABLET Ingredient Morphine Sulfate

📖 What it is MedlinePlus · NLM

Morphine is used to relieve severe pain. Morphine is in a class of medications called opiate (narcotic) analgesics. It works by changing the way the brain and nervous system respond to pain.

Read the full MedlinePlus article ↗

📗 Our plain-language guide HelloPharmacist

Morphine is typically prescribed only when your pain is severe enough that other options — like non-opioid medicines or weaker opioid combinations — haven't worked or aren't expect...
Why is my doctor prescribing morphine instead of something milder?
No — and this is one of the most important rules with morphine. Alcohol combined with morphine can push your morphine blood levels to life-threatening highs. This means no wine, be...
Can I drink alcohol while taking morphine?

📖 Read our full Morphine guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

Some supplements/herbs that may interact with Morphine Sulfate — tap one for details:

Activated CharcoalMajor Coffee CharcoalModerate European MandrakeModerate GlucomannanModerate Guar GumModerate Gum ArabicModerate Slippery ElmModerate TragacanthModerate

🌿 Every supplement checked against Morphine Sulfate (172 interactions) — ranked by severity →

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 blue / purple / orange / gray / green

ShapeOval

ImprintRD74

Size14 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 2LRS185U6K
D&C Red No. 27 is a synthetic red colorant used in medicines and cosmetics. It gives tablets, capsules, or liquids their red or reddish color so products are visually identifiable.
UNII L06K8R7DQK
A synthetic blue dye approved by the FDA for use in medications and foods. It serves as a colorant to make pills and liquids visually distinct and easier to identify.
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 B697894SGQ
Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
UNII 4R4HFI6D95
Polyethylene glycol 4000 is a synthetic polymer derived from petroleum. It serves as a binder, filler, and lubricant in solid dosage forms, and helps control how quickly the medicine dissolves.
UNII FZ989GH94E
Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
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 4ELV7Z65AP
Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
UNII 7SEV7J4R1U
A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
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.

12 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 ea	Per package
Retail pharmacies payNADAC · weekly	$0.456	$45.55 / 100 tablets
Medicaid paysCMS SDUD · 12 mo	$0.4708	$47.08 / 100 tablets
Medicare drug plans payPart D · Q2 2026	$0.3829	$38.29 / 100 tablets

NADAC price history (per ea) — tap or hover for the price & month

▲ Up 36% over the last 24 months.

Where does this data come from?

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

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Morphine Sulfate 30 mg 43386-0541-01	Lupin	100 tablets	$0.346	—	FDA listed	save 24%
Morphine sulfate 30 mg 00228-4271-11	Actavis	100 tablets	$0.433	AB	Discontinued	save 5%
Morphine Sulfate 30 mg 00406-8330-01	SpecGx	100 tablets	$0.455	AB	Availability likely	—
Morphine Sulfate Extended Release 30 mg 00904-6558-61	Major	1 tablet	$0.455	AB	Availability likely	—
Morphine Sulfate Extended Release 30 mg 42858-0802-01	Rhodes	100 tablets	$0.455	AB	Availability likely	—
Morphine sulfate 30 mgthis 63304-0451-01	Sun	100 tablets	$0.455	AB	Availability likely	—
Morphine Sulfate Extended Release 30 mg 68084-0158-01	American	1 tablet	$0.455	AB	Availability likely	—
MS Contin 30 mg 42858-0631-01	Rhodes	100 tablets	$8.899	AB	Availability likely	+1854%
Morphine sulfate 30 mg 63629-1088-01	Bryant	100 tablets	—	AB	Discontinued	—
Morphine Sulfate 30 mg 63629-4484-00	Bryant	40 tablets	—	AB	FDA listed	—
Morphine sulfate 30 mg 71335-0676-00	Bryant	40 tablets	—	AB	FDA listed	—
Morphine sulfate 30 mg 72162-1790-01	Bryant	100 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

🏛️

2012

On the market since

May 2012

📍

2026

Currently FDA-listed

14 years listed

🔓

Generic on the market

this product is a generic

✅This is a generic drug

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

Where does this data come from?

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

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 63304-0451-01, not the drug overall. Other pack sizes report separately.

💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.

📅 Q1 2025 – Q4 2025 · 4 quarters of data

ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.

Prescriptions last 4 qtrs

20.9K

Units reimbursed last 4 qtrs

1.2M

Gross reimbursed last 4 qtrs

$561.2K

Avg / prescription

$26.87

Avg / unit

$0.4708

Latest quarter Q4 2025

4.7KRx

Medicaid pays / ea

$0.4708

gross reimbursed

NADAC / ea

$0.4555

acquisition cost

Spread

+$0.0153

+3% vs cost

What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.

Fee-for-service vs managed care ⓘ

37% FFS 63% MCO

Fee-for-service · 7,638 Rx Managed care · 13,249 Rx

State Medicaid map

Units reimbursed · per 100k residents

90.71,128

gray = no data reported ⓘ

Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.

Tap or hover a state

…for its Medicaid breakdown

🏆 Top states by units · per 100k residents

1 Nevada 1,128 /100k

2 Hawaii 906 /100k

3 Massachusetts 864 /100k

4 Indiana 819 /100k

5 Vermont 711 /100k

6 Michigan 699 /100k

7 West Virginia 588 /100k

8 Pennsylvania 563 /100k

National units — by quarter

💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.

100 tablets this page63304-0451-01 20,887 Rx · $561,195

10 tablets63304-0451-03 No Medicaid data

500 tablets63304-0451-05 No Medicaid data

Drug total (last 4 qtrs): 20,887 Rx · 1,192,003 units · $561,195 gross reimbursed

Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Morphine Sulfate — the program that covers self-administered drugs. 9 manufacturers.

⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Morphine Sulfate. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.

Period

Total Part D spend

$3.7M

Claims incl. refills

161.4K

Beneficiaries

87.6K

Spend / beneficiary

$42.30

Spend / claim

$22.95

Trend by period

💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🛡

This drug has a REMS. A Risk Evaluation & Mitigation Strategy is an FDA-required safety program. It may require enrollment, counseling, or monitoring to manage a serious risk. See the boxed warning & full label below, and REMS@FDA ↗.

🔬 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 Morphine Sulfate — the ingredient across all brands.

Top reported reactions

Drug Dependence32,874

Overdose23,523

Pain21,685

Death17,421

Emotional Distress16,962

Drug Withdrawal Syndrome13,753

Toxicity To Various Agents11,801

Age at onset

Neonate820

Infant197

Child173

Adolescent63

Adult5,047

Elderly2,358

Reporter sex

Male · 47%

Female · 52%

Unknown · 0%

Serious outcomes

Death34,829

Hospitalization22,988

Disabling9,154

Life-threatening3,427

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	Per unit	Per pack	Marketing start	Status
63304-0451-01 You're viewing this	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63304-451-01)	$0.4555 / ea	$45.55	2012-05-11	Active
63304-0451-03	10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63304-451-03)	—	—	2012-05-11	Active
63304-0451-05	500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63304-451-05)	—	—	2012-05-11	Active

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

In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 63304-0451-01?

NDC 63304-0451-01 is a 100-count package — 100 tablet, film coated, extended release in 1 bottle.

What is the difference between NDC 63304-0451-01 and NDC 63304-0451-03?

Both are Morphine sulfate 30 mg Tablet, Film Coated, Extended Release — the drug itself is identical. NDC 63304-0451-01 is the 100-count package, while NDC 63304-0451-03 is the 10 tablets package.

What NDC number is used to bill for this package of Morphine sulfate 30 mg Tablet, Film Coated, Extended Release?

Bill NDC 63304-0451-01 — the 11-digit billing format is 63304045101. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

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

📄 Full prescribing information FDA SPL

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

🚨 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: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF MORPHINE SULFATE EXTENDED-RELEASE TABLETS WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF MORPHINE SULFATE EXTENDED-RELEASE TABLETS Addiction, Abuse, and Misuse Because the use of morphine sulfate exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient’s risk prior to prescribing and reassess all patients regularly for the development of these behaviors and conditions [see Warning and Precautions (5.1)].

Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of morphine sulfate, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of morphine sulfate are essential. Instruct patients to swallow morphine sulfate extended-release tablets whole; crushing, chewing, or dissolving morphine sulfate extended-release tablets can cause rapid release and absorption of a potentially fatal dose of morphine [see Warnings and Precautions (5.2)].

Accidental Ingestion Accidental ingestion of even one dose of morphine sulfate, especially by children, can result in a fatal overdose of morphine [see Warnings and Precautions (5.2)]. 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. Reserve concomitant prescribing of morphine sulfate and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate [see Warnings and Precautions (5.3), Drug Interactions (7)].

Neonatal Opioid Withdrawal Syndrome (NOWS) Advise pregnant women using opioids for an extended period of time of the risk of Neonatal Opioid Withdrawal Syndrome, which may be life-threatening if not recognizedand treated. Ensure that management by neonatology experts will be available at delivery [see Warnings and Precautions (5.4)]. Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) Healthcare providers are strongly encouraged to complete a REMS-compliant educationprogram, and to counsel patients and caregivers on serious risks, safe use, and theimportance of reading the Medication Guide with each prescription [see Warning andPrecautions (5.5)].

WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF MORPHINE SULFATE EXTENDED-RELEASE TABLETS See full prescribing information for complete boxed warning . Morphine sulfate exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient’s risk before prescribing and reassess regularly for these behaviors and conditions.

(5.1) Serious, life-threatening, or fatal respiratory depression may occur, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of morphine sulfate extended-release tablets are essential. Instruct patients to swallow morphine sulfate extended-release tablets whole to avoid exposure to a potentially fatal dose of morphine.

(5.2) Accidental ingestion of morphine sulfate extended-release tablets, especially by children, can result in a fatal overdose of morphine. (5.2) 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. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate.

(5.3, 7) Advise pregnant women using opioids for an extended period of time of the risk of Neonatal Opioid Withdrawal Syndrome, which may be lifethreatening if not recognized and treated. Ensure that management by neonatology experts will be available at delivery. (5.4) Healthcare provi…

🎯 Indications and Usage 220 words ▾

1 INDICATIONS AND USAGE Morphine sulfate extended-release tablets are indicated for the management of severe andpersistent pain that requires an opioid analgesic and that cannot be adequately treated withalternative options, including immediate-release opioids. Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at anydosage or duration and persist over the course of therapy [see Warnings and Precautions(5.2)] , reserve opioid analgesics, including morphine sulfate extended-release tablets, for usein patients for whom alternative treatment options are ineffective, not tolerated, or would beotherwise inadequate to provide sufficient management of pain.

Morphine sulfate extended-release tablets are not indicated as an as-needed (prn) analgesic. Morphine sulfate extended-release tablets are an opioid agonist indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. (1) Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, reserve opioid analgesics, including morphine sulfate extended release tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.

(1, 5.1) Morphine sulfate extended-release tablets are not indicated as an as-needed (prn) analgesic. (1)

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Morphine sulfate extended-release tablets should be prescribed only by healthcare providers who are knowledgeable about the use of extended-release/long-acting opioids and how to mitigate the associated risks. (2.1) Morphine sulfate extended-release 100 mg and 200 mg tablets, a single dose greater than 60 mg, or a total daily dose greater than 120 mg, are only for use in patients in whom tolerance to an opioid of comparable potency has been established. (2.1) Patients considered opioid-tolerant are those taking, for one week or longer, at least 60 mg of morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg of oral oxycodone per day, 8 mg of oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid.

(2.1) Use the lowest effective dosage for the shortest duration of time consistent with individual patient treatment goals. Reserve titration to higher doses of morphine sulfate extended-release tablets for patients in whom lower doses are insufficiently effective and in whom the expected benefits of using a higher dose opioid clearly outweigh the substantial risks. (2.1, 5) Initiate the dosing regimen for each patient individually, taking into account the patient’s underlying cause and severity of pain, prior analgesic treatment and response, and risk factors for addiction, abuse, and misuse.

(2.1, 5.1) Respiratory depression can occur at any time during opioid therapy, especially when initiating and following dosage increases with morphine sulfate extended-release tablets. Consider this risk when selecting an initial dose and when making dose adjustments. (2.1, 5.2) Instruct patients to swallow morphine sulfate extended-release tablets intact and not to cut, break, chew, crush, or dissolve morphine sulfate extended-release tablets (risk of potentially fatal dose).

(2.1, 5.1) Discuss opioid overdose reversal agents and options for acquiring them with the patient and/or caregiver, both when initiating and renewing treatment with morphine sulfate extended-release tablets, especially if the patient has additional risk factors for overdose, or close contacts at risk for exposure and overdose. (2.2, 5.1, 5.2, 5.3) Morphine sulfate extended-release tablets are administered orally once every 8 or 12 hours. (2.3) For patients who are not opioid tolerant, initiate with 15 mg tablets orally every 8 to 12 hours.

(2.3) Periodically reassess patients receiving morphine sulfate extended-release tablets to evaluate the continued need for opioid analgesics to maintain pain control, for the signs or symptoms of adverse reactions, and for the development of addiction, abuse, or misuse. (2.4) Do not rapidly reduce or abruptly discontinue morphine sulfate extended-release tablets in a physically dependent patient because rapid reduction or abrupt discontinuation of opioid analgesics has resulted in serious withdrawal symptoms, uncontrolled pain, and suicide.

(2.5, 5.14)

2.1Important Dosage and Administration Instructions Morphine sulfate extended-release tablets should be prescribed by healthcare professionals who are knowledgeable about the use of extended-release/long-acting opioids and how to mitigate the associated risks. Morphine sulfate extended-release tablets 100 mg and 200 mg tablets, a single dose greater than 60 mg, or a total daily dose greater than 120 mg, are only for use in patients in whom tolerance to an opioid of comparable potency has been established. Patients considered opioid-tolerant are those taking, for one week or longer, at least 60 mg morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone daily, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid.

Use the lowest effective dosage for the shortest duration of time consistent with individual patient treatment goals [see Warnings and Precautions (5)]. Becaus…

💊 Dosage Forms and Strengths 170 words ▾

3 DOSAGE FORMS AND STRENGTHS Morphine sulfate extended-release tablets 15 mg Round, blue-colored, film-coated tablets debossed with “ RD ” and “ 70 ” on one side and plain on the other side Morphine sulfate extended-release tablets 30 mg Round, purple-colored, film-coated tablets debossed with “ RD ” and “ 71 ” on one side and plain on the other side Morphine sulfate extended-release tablets 60 mg Round, light orange-colored, film-coated tablets debossed with “ RD ” and “ 72 ” on one side and plain on the other side Morphine sulfate extended-release tablets 100 mg* Round, gray-colored, film-coated tablets debossed with “ RD ” and “ 73 ” on one side and plain on the other side Morphine sulfate extended-release tablets 200 mg* Oval, green-colored, film-coated tablets debossed with “ RD74 ” on one side and plain on the other side *100 mg and 200 mg tablets are for use in opioid-tolerant patients only Extended-release tablets: 15 mg, 30 mg, 60 mg, 100 mg, 200 mg ( 3 )

⛔ Contraindications 140 words ▾

4 CONTRAINDICATIONS Morphine sulfate is contraindicated in patients with: • 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 (5.7)] • Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days [see Warnings and Precautions (5.8), Drug Interactions (7)]. • Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions (5.12)] • Hypersensitivity (e.g., anaphylaxis) to morphine [see Adverse Reactions (6.2)] Significant respiratory depression (4) Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment (4) Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days (4) Known or suspected gastrointestinal obstruction, including paralytic ileus (4) Hypersensitivity to morphine (4)

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Opioid-Induced Hyperalgesia and Allodynia: Opioid-Induced Hyperalgesia (OIH) occurs when an opioid analgesic paradoxically causes an increase in pain, or an increase in sensitivity to pain. If OIH is suspected, carefully consider appropriately decreasing the dose of the current opioid analgesic, or opioid rotation. (5.6) Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients : Regularly evaluate, particularly during initiation and titration.

(5.7) Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. (5.9) Severe Hypotension: Regularly evaluate during dosage initiation and titration. Avoid use in patients with circulatory shock.

(5.10) Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness: Monitor for sedation and respiratory depression. Avoid use of morphine sulfate in patients with impaired consciousness or coma. (5.11)

5.1Addiction, Abuse, and Misuse Morphine sulfate extended-release tablets contain morphine, a Schedule II controlled substance. As an opioid, morphine sulfate exposes its users to the risks of addiction, abuse, and misuse. Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed morphine sulfate.

Addiction can occur at recommended doses and if the drug is misused or abused. The risk of opioid-related overdose or overdose-related death is increased with higher opioid doses, and this risk persists over the course of therapy. In postmarketing studies, addiction, abuse, misuse, and fatal and non-fatal opioid overdose were observed in patients with long-term opioid use [see Adverse Reactions (6.2)].

Assess each patient’s risk for opioid addiction, abuse, or misuse prior to prescribing morphine sulfate, and reassess all patients receiving morphine sulfate for development of these behaviors and conditions. 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). The potential for these risks should not, however, prevent the proper management of pain in any given patient.

Patients at increased risk may be prescribed opioids such as morphine sulfate, but use in such patients necessitates intensive counseling about the risks of proper use of morphine sulfate along with frequent reevaluation for signs of addiction, abuse, and misuse. Consider recommending or prescribing an opioid overdose reversal agent [see Dosage and Administration (2.2), Warnings and Precautions (5.2)] . Abuse or misuse of morphine sulfate extended-release tablets by crushing, chewing, snorting, or injecting the dissolved product will result in the uncontrolled delivery of morphine and can result in overdose and death [see Overdosage (10)] .

Opioids are sought for nonmedical use and are subject to diversion from legitimate prescribed use. Consider these risks when prescribing or dispensing morphine sulfate. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on careful storage of the drug during the course of treatment and 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, even when used as recommended. Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death. Management of respiratory depression may include close observation, supportive measures, and use of opioid overdose reversal agent, depending on the patient’s clinical statu…

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are described, or described in greater detail, in other sections: • Addiction, Abuse, and Misuse [see Warnings and Precautions (5.1)] • Life-Threatening Respiratory Depression [see Warnings and Precautions (5.2)] • Interactions with Benzodiazepine or Other CNS Depressants [see Warnings and Precautions (5.3)] • Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.4)] • Opioid-Induced Hyperalgesia and Allodynia [see Warnings and Precautions (5.6)] • Adrenal Insufficiency [see Warnings and Precautions (5.9)] • Severe Hypotension [see Warnings and Precautions (5.10)] • Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.12)] • Seizures [see Warnings and Precautions (5.13)] • Withdrawal [see Warnings and Precautions (5.14)] Most common adverse reactions (>10%): constipation, nausea, and sedation.

( 6.1) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-818-4555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trial 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 practice. Morphine sulfate may increase the risk of serious adverse reactions such as those observed with other opioid analgesics, including respiratory depression, apnea, respiratory arrest, circulatory depression, hypotension, or shock [see Overdosage (10)] .

Most Frequently Observed Reactions In clinical trials, the most common adverse reactions with morphine sulfate were constipation, dizziness, sedation, nausea, vomiting, sweating, dysphoria, and euphoric mood. Some of these effects seem to be more prominent in ambulatory patients and in those not experiencing severe pain. Less Frequently Observed Reactions Cardiovascular disorders: tachycardia, bradycardia, palpitations Eye disorders: visual impairment, vision blurred, diplopia, miosis Gastrointestinal disorders: dry mouth, diarrhea, abdominal pain, constipation, dyspepsia General disorders and administration site conditions: chills, feeling abnormal, edema, edema peripheral, weakness Hepatobiliary disorders: biliary colic Metabolism and nutrition disorders: anorexia Musculoskeletal and connective tissue disorders: muscle rigidity, muscle twitching Nervous system disorders: presyncope, syncope, headache, tremor, uncoordinated muscle movements, convulsion, intracranial pressure increased, taste alteration, paresthesia, nystagmus Psychiatric disorders: agitation, mood altered, anxiety, depression, abnormal dreams, hallucination, disorientation, insomnia Renal and urinary disorders: urinary retention, urinary hesitation, antidiuretic effects Reproductive system and breast disorders: reduced libido and/or potency Respiratory, thoracic and mediastinal disorders: laryngospasm Skin and subcutaneous tissue disorders: pruritus, urticaria, rash Vascular disorders: flushing, hypotension, hypertension

6.2Post-Marketing Experience The following adverse reactions have been identified during post-approval use of morphine sulfate. Because these reactions are 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. Amenorrhea, asthenia, bronchospasm, confusional state, drug hypersensitivity, fatigue, hyperalgesia, hypertonia, ileus, increased hepatic enzymes, intestinal obstruction, lethargy, malaise, pulmonary edema, thinking disturbances, somnolence, and vertigo.

Serotonin syndrome: Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs. Adrenal insufficiency : Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one mon…

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Table 1 includes clinically significant drug interactions with morphine sulfate. Table 1: Clinically Significant Drug Interactions with morphine sulfate Benzodiazepines and Other Central Nervous System (CNS) Depressants Clinical Impact: Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death [see Warnings and Precautions (5.3)]. Intervention: Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate.

Limit dosages and durations to the minimum required. Inform patients and caregivers of this potential interaction and educate them on the signs and symptoms of respiratory depression (including sedation). If concomitant use is warranted, consider recommending or prescribing an opioid overdose reversal agent [see Dosage and Administration (2.2, 2.5), Warnings and Precautions (5.1, 5.2, 5.3)].

Examples: Benzodiazepines and other sedative hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids (gabapentin or pregabalin), other opioids, alcohol. Serotonergic Drugs Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. Intervention: If concomitant use is warranted, frequently evaluate the patient, particularly during treatment initiation and dose adjustment.

Discontinue morphine sulfate if serotonin syndrome is suspected. Examples: Selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that effect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue).

Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact: MAOI interactions with opioids may manifest as serotonin syndrome or opioid toxicity (e.g., respiratory depression, coma) [see Warnings and Precautions (5.8)]. Intervention: Do not use morphine sulfate in patients taking MAOls or within 14 days of stopping such treatment. Examples: phenelzine, tranylcypromine, linezolid Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics Clinical Impact: May reduce the analgesic effect of morphine sulfate and/or precipitate withdrawal symptoms.

Intervention: Avoid concomitant use. Examples: butorphanol, nalbuphine, pentazocine, buprenorphine Muscle Relaxants Clinical Impact: Morphine may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression. Intervention: Because respiratory depression may be greater than otherwise expected, decrease the dosage of morphine sulfate and/or the muscle relaxant as necessary.

Due to the risk of respiratory depression with concomitant use of skeletal muscle relaxants and opioids, consider recommending or prescribing an opioid overdose reversal agent [see Dosage and Administration (2.2), Warnings and Precautions (5.2, 5.3)] Examples: cyclobenzaprine, metaxalone Cimetidine Clinical Impact: The concomitant use of cimetidine can potentiate morphine effects and increase risk of hypotension, respiratory depression, profound sedation, coma, and death. Intervention: Evaluate patients for signs of respiratory depression that may be greater than otherwise expected and decrease the dosage of morphine sulfate and/or cimetidine as necessary.

Diuretics Clinical Impact: Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone. Intervention: Evaluate patients for signs of diminished diuresis and/or effects on blood press…

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy : May cause fetal harm. (8.1) Lactation : Not recommended. (8.2)

8.1Pregnancy Risk Summary Use of opioid analgesics for an extended period of time during pregnancy may cause neonatal withdrawal syndrome [see Warnings and Precautions (5.4)]. There are no available data with morphine sulfate in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. Published studies with morphine use during pregnancy have not reported a clear association with morphine and major birth defects [see Human Data].

In published animal reproduction studies, morphine administered subcutaneously during the early gestational period produced neural tube defects (i.e., exencephaly and cranioschisis) at 5 and 16 times the human daily dose of 60 mg based on body surface area (HDD) in hamsters and mice, respectively, lower fetal body weight and increased incidence of abortion at 0.4 times the HDD in the rabbit, growth retardation at 6 times the HDD in the rat, and axial skeletal fusion and cryptorchidism at 16 times the HDD in the mouse.

Administration of morphine sulfate to pregnant rats during organogenesis and through lactation resulted in cyanosis, hypothermia, decreased brain weights, pup mortality, decreased pup body weights, and adverse effects on reproductive tissues at 3 to 4 times the HDD; and long-term neurochemical changes in the brain of offspring which correlate with altered behavioral responses that persist through adulthood at exposures comparable to and less than the HDD [see Animal Data] . Based on animal data, advise pregnant women of the potential risk to a fetus.

The 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 Use of opioid analgesics for an extended period of time 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 (5.4)]. 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.

Morphine sulfate is not recommended for use in pregnant women during or immediately prior to labor, when use of shorter-acting analgesics or other analgesic techniques are more appropriate. Opioid analgesics, including morphine sulfate, 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 opioid analgesics during labor for signs of excess sedation and respiratory depression. Data Human Data The results from a population-based prospective cohort, including 70 women exposed to morphine during the first trimester of pregnancy and 448 women exposed to morphine at any time during pregnancy, indicate no increased risk for congenital malformations. However, these studies cannot definitely es…

🤰 Pregnancy ~3 min read ▾

🧒 Pediatric Use 19 words ▾

8.4Pediatric Use The safety and effectiveness in pediatric patients below the age of 18 have not been established.

🧓 Geriatric Use 217 words ▾

8.5Geriatric Use The pharmacokinetics of morphine sulfate have not been studied in elderly patients. Clinical studies of morphine sulfate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Elderly patients (aged 65 years or older) may have increased sensitivity to morphine.

In general, use caution when selecting a dosage for an elderly patient, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy. Respiratory depression is the chief risk for elderly patients treated with opioids, and has occurred after large initial doses were administered to patients who were not opioid-tolerant or when opioids were co-administered with other agents that depress respiration.

Titrate the dosage of morphine sulfate slowly in geriatric patients and frequently reevaluate the patient for signs of central nervous system and respiratory depression [see Warnings and Precautions (5.7)]. Morphine 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, care should be taken in dose selection, and it may be useful to regularly evaluate renal function.

🆘 Overdosage ~2 min read ▾

10 OVERDOSAGE Clinical Presentation Acute overdose with morphine can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, hypotension, hypoglycemia, partial or complete airway obstruction, atypical snoring, and death. Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations [see Clinical Pharmacology (12.2)]. Toxic leukoencephalopathy has been reported after opioid overdose and can present hours, days, or weeks after apparent recovery from the initial intoxication.

Treatment of Overdose In case of overdose, priorities are the re-establishment of a patent and protected airway and institution of assisted or controlled ventilation, if needed. 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.

For clinically significant respiratory or circulatory depression secondary to opioid overdose, administer an opioid overdose reversal agent such as naloxone or nalmefene. Because the duration of reversal would be expected to be less than the duration of action of morphine in morphine sulfate, carefully monitor the patient until spontaneous respiration is reliably reestablished. Morphine sulfate will continue to release morphine and add to the morphine load for 24 to 48 hours or longer following ingestion, necessitating prolonged monitoring.

If the response to an opioid overdose reversal agent is suboptimal or only brief in nature, administer additional reversal agent as directed by the product’s prescribing information. In an individual physically dependent on opioids, administration of the recommended usual dosage of the opioid overdose reversal agent will precipitate an acute withdrawal syndrome. The severity of the withdrawal symptoms experienced will depend on the degree of physical dependence and the dose of the reversal agent administered.

If a decision is made to treat serious respiratory depression in the physically dependent patient, administration of the reversal agent should be initiated with care and by titration with smaller than usual doses of the reversal agent.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Morphine is a full opioid agonist and is relatively selective for the mu-opioid receptor, although it can bind to other opioid receptors at higher doses. The principal therapeutic action of morphine is analgesia. Like all full opioid agonists, there is no ceiling effect for analgesia with morphine.

Clinically, dosage is titrated to provide adequate analgesia and may be limited by adverse reactions, including respiratory and CNS depression. The precise mechanism of the analgesic action is unknown. However, specific CNS opioid receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and are thought to play a role in the analgesic effects of this drug.

12.2Pharmacodynamics CNS Depressant/Alcohol Interaction Additive pharmacodynamic effects may be expected when morphine sulfate is used in conjunction with alcohol, other opioids, or illicit drugs that cause central nervous system depression. Effects on the Central Nervous System Morphine produces respiratory depression by direct action on brainstem respiratory centers. The respiratory depression involves a reduction in the responsiveness of the brainstem respiratory centers to both increases in carbon dioxide tension and electrical stimulation.

Morphine causes miosis, even in total darkness. Pinpoint pupils are a sign of narcotic 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 with hypoxia in overdose situations.

Effects on the Gastrointestinal Tract and Other Smooth Muscle Morphine causes a reduction in motility associated with an increase in smooth muscle tone in the antrum of the stomach and in the 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 reduction in biliary and pancreatic secretions, spasm of the sphincter of Oddi, transient elevations in serum amylase, and opioid-induced esophageal dysfunction (OIED). Effects on the Cardiovascular System Morphine 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, 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 (6.2)]. They also stimulate prolactin, growth hormone (GH) secretion, and pancreatic secretion of insulin and glucagon. Use of opioids for an extended period of time 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 (6.2)]. 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-Efficacy Relationships The minimum effective analgesic concentration will vary widely among patients, especially among patients who have been previously treated with opioid agonists. The minimum effective analgesic concentration of morphine for any individual patient may increase over time due to an increase in pain, the development of a new p…

🧬 Mechanism of Action 114 words ▾

📦 How Supplied / Storage and Handling ~1 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Morphine sulfate extended-release tablets are supplied as follows: Morphine sulfate extended-release tablets 15 mg are round, blue-colored, film-coated tablets debossed with “RD” and “70” on one side and plain on the other side. They are supplied as follows: NDC 63304-450-03 Bottles of 10 NDC 63304-450-01 Bottles of 100 NDC 63304-450-05 Bottles of 500 Morphine sulfate extended-release tablets 30 mg are round, purple-colored, film-coated tablets debossed with “RD” and “71” on one side and plain on the other side.

They are supplied as follows: NDC 63304-451-03 Bottles of 10 NDC 63304-451-01 Bottles of 100 NDC 63304-451-05 Bottles of 500 Morphine sulfate extended-release tablets 60 mg are round, light orange-colored, film-coated tablets debossed with “RD” and “72” on one side and plain on the other side. They are supplied as follows: NDC 63304-758-03 Bottles of 10 NDC 63304-758-50 Bottles of 50 NDC 63304-758-01 Bottles of 100 NDC 63304-758-05 Bottles of 500 Morphine sulfate extended-release tablets 100 mg are round, gray-colored, film-coated tablets debossed with “RD” and “73” on one side and plain on the other side.

They are supplied as follows: NDC 63304-452-03 Bottles of 10 NDC 63304-452-01 Bottles of 100 NDC 63304-452-05 Bottles of 500 Morphine sulfate extended-release tablets 200 mg are oval, green-colored, film-coated tablets debossed with “RD74” on one side and plain on the other side. They are supplied as follows: NDC 63304-453-03 Bottles of 10 NDC 63304-453-01 Bottles of 100 NDC 63304-453-05 Bottles of 500 Store at 20° - 25° C (68° - 77° F) [See USP Controlled Room Temperature]. Store morphine sulfate extended-release tablets securely and dispose of properly [see Patient Counseling Information (17)].

Dispense in a tight, light-resistant container.

📋 Description ~1 min read ▾

11 DESCRIPTION Morphine sulfate extended-release tablets are for oral use and contains morphine sulfate, an opioid agonist. Each tablet contains the following inactive ingredients common to all strengths: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, povidone, stearic acid, talc and titanium dioxide. The tablet strengths describe the amount of morphine per tablet as the pentahydrated sulfate salt (morphine sulfate, USP).

The 15 mg tablets also contain: FD&C Blue # 2/Indigo carmine aluminum lake, ferrosoferric oxide, macrogol/PEG 4000 and macrogol/PEG 400 The 30 mg tablets also contain: D&C Red # 27/Phloxine aluminum lake, FD&C Blue # 2/Indigo carmine aluminum lake, macrogol/PEG 4000 and macrogol/PEG 400 The 60 mg tablets also contain: FD&C Yellow # 6 aluminum lake and macrogol/PEG 4000 and macrogol/PEG 400 The 100 mg tablets also contain: FD&C Blue # 2/Indigo carmine aluminum lake, ferrosoferric oxide, ferric oxide yellow, macrogol/PEG 4000 and macrogol/PEG 400 The 200 mg tablets also contain: D&C Yellow # 10 aluminum lake, FD&C Blue # 2/Indigo carmine aluminum lake, macrogol/PEG 4000 and macrogol/PEG 400 Morphine sulfate, USP are white, feathery, silky crystals, cubical masses of crystals, or white crystalline powder, soluble in water, freely soluble in hot water, slightly soluble in alcohol but more so in hot alcohol, insoluble in chloroform and in ether.

The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pKb is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its molecular weight is 758.83 and its structural formula is: spl-structure

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Storage and Disposal Because of the risks associated with accidental ingestion, misuse, and abuse, advise patients to store morphine sulfate extended-release tablets securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home. Inform patients that leaving morphine sulfate extended-release tablets unsecured can pose a deadly risk to others in the home [see Warnings and Precautions (5.1), Drug Abuse and Dependence (9.2)].

Advise patients and caregivers that when medicines are no longer needed, they should be disposed of promptly. Expired, unwanted, or unused morphine sulfate extended-release tablets should be disposed of by flushing the unused medication down the toilet if a drug take-back option is not readily available. Inform patients that they can visit www.fda.gov/drugdisposal for a complete list of medicines recommended for disposal by flushing, as well as additional information on disposal of unused medicines.

Addiction, Abuse, and Misuse Inform patients that the use of morphine sulfate extended-release 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)]. Life-Threatening Respiratory Depression Inform patients of the risk of life-threatening respiratory depression, including information that the risk is greatest when starting morphine sulfate extended-release tablets or when the dosage is increased, and that it can occur even at recommended dosages.

Educate patients and caregivers on how to recognize respiratory depression and emphasize the importance of calling 911 or getting emergency medical help right away in the event of a known or suspected overdose [see Warnings and Precautions (5.2), Overdosage (10)]. Interactions with Benzodiazepines and Other CNS Depressants Inform patients and caregivers that potentially fatal additive effects may occur if morphine sulfate extended-release tablets are used with benzodiazepines or other CNS depressants, including alcohol (e.g., non-benzodiazepine sedative/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids [gabapentin or pregabalin], and other opioids), and not to use these concomitantly unless supervised by a healthcare provider [see Warnings and Precautions (5.2), Drug Interactions (7)].

Patient Access to an Opioid Overdose Reversal Agent for the Emergency Treatment of Opioid Overdose Inform patients and caregivers about opioid overdose reversal agents (e.g., naloxone, nalmefene). Discuss the importance of having access to an opioid overdose reversal agent, especially if the patient has risk factors for overdose (e.g., concomitant use of CNS depressants, a history of opioid use disorder, or prior opioid overdose) or if there are household members (including children) or other close contacts at risk for accidental ingestion or opioid overdose.

Discuss with the patient the options for obtaining an opioid overdose reversal agent (e.g., prescription, over-the-counter, or as part of a community-based program) [see Dosage and Administration (2.2), Warnings and Precautions (5.3)]. Educate patients and caregivers on how to recognize the signs and symptoms of an overdose. Explain to patients and caregivers that effects of opioid overdose reversal agents like naloxone and nalmefene are temporary, and that they must call 911 or get emergency medical help right away in all cases of known or suspected opioid overdose, even if an opioid overdose reversal agent is administered [see Overdosage (10)].

Advise patients and caregivers: how to treat with the opioid overdose reversal agent in the event of an opioid overdose. to tell family and friends about their opioid overdose reversal agent, and to keep it in a place where family and friends can access it in an…

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE MORPHINE (MOR feen) SULFATE EXTENDED-RELEASE TABLETS, CII Rx only Morphine sulfate extended-release tablets are: A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage severe and persistent pain that requires an extended treatment period with a daily opioid pain medicine when other do not treat your pain well enough or you cannot tolerate them. A long-acting (extended-release) opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death.

Not for use to treat pain that is not around-the-clock. Important information about morphine sulfate extended-release tablets: Get emergency help or call 911 right away if you take too much morphine sulfate extended-release tablets (overdose) . When you first start taking morphine sulfate extended-release tablets, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur.

Talk to your healthcare provider about naloxone, a medicine for the emergency treatment of an opioid overdose. Taking morphine sulfate extended-release tablets with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death. Never give anyone else your morphine sulfate extended-release tablets.

They could die from taking it. Selling or giving away morphine sulfate extended-release tablets is against the law. Store morphine sulfate extended-release tablets securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.

Do not take morphine sulfate extended-release tablets if you have: severe asthma, trouble breathing, or other lung problems. a bowel blockage or have narrowing of the stomach or intestines. Before taking morphine sulfate extended-release tablets, tell your healthcare provider if you have a history of: • head injury, seizures • liver, kidney, thyroid problems • problems urinating • pancreas or gallbladder problems • abuse of street or prescription drugs, alcohol addiction, opioid overdose, or mental health problems. Tell your healthcare provider if you are: Noticing your pain getting worse.

If your pain gets worse after you take morphine sulfate extended-release tablets, do not take more of morphine sulfate extended-release tablets without first talking to your healthcare provider. Talk to your healthcare provider if the pain that you have increases, if you feel more sensitive to pain, or if you have new pain after taking morphine sulfate extended-release tablets. Pregnant or planning to become pregnant.

Use of morphine sulfate extended-release tablets for an extended period of time during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated. Breastfeeding. Not recommended during treatment with morphine sulfate.

It may harm your baby. Living in a household where there are small children or someone who has abused street or prescription drugs. Taking prescription or over-the-counter medicines, vitamins, or herbal supplements.

Taking morphine sulfate extended-release tablets with certain other medicines can cause serious side effects. When taking morphine sulfate extended-release tablets: Do not change your dose. Take morphine sulfate extended-release tablets exactly as prescribed by your healthcare provider.

Use the lowest dose possible for the shortest duration. Take your prescribed dose every 8 to 12 hours, as directed by your healthcare provider. Do not take more than your prescribed dose.

If you miss a dose, take your next dose at the usual time. Swallow morphine sulfate extended-release tablets whole. Do not cut, break, chew, crush, dissolve, snort, or inject morphine…

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.

sedative: A substance with a calming effect that can also cause drowsiness.

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.

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

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.

apnea: A pause or temporary stop in breathing.

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

Boxed Warning: The strongest safety warning the FDA can require, set inside a bold black border because the risk it describes can be very serious.

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

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

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

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.

CNS depression: A slowing of brain and nervous-system activity that can cause drowsiness, slowed breathing, or reduced alertness.

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.

convulsion: Uncontrolled, rapid shaking of the body caused by muscles rapidly tightening and relaxing, often during a seizure.

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

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

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

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

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.

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

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

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.

extended-release: A pill or capsule made to release its medicine slowly over many hours, so it can be taken less often; often labeled ER or XR.

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.

Full Prescribing Information: The complete, detailed label for a prescription medicine that follows the summary highlights.

hallucination: Seeing, hearing, feeling, or smelling something that is not actually there.

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.

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

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

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

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.

immediate-release: A standard pill or capsule that releases all of its medicine soon after it is swallowed.

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.

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

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

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.

laryngospasm: A sudden spasm of the vocal cords that briefly closes the voice box and makes it hard to breathe or speak.

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

malaise: A general feeling of being unwell, uneasy, or low on energy, without one clear symptom.

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.

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

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.

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.

neural tube defects: Serious birth defects of a baby's brain or spine that form very early in pregnancy.

nystagmus: Rapid, involuntary back-and-forth movements of the eyes that a person cannot control.

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.

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

partial agonist: A substance that switches on a body target only part way, giving a weaker effect than a full activator would.

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

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

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

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.

PRN: Taken only as needed rather than on a fixed schedule; from the Latin phrase meaning "as the situation arises.".

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.

REMS: A special FDA-required safety program that manages a serious risk, sometimes adding extra steps for patients, pharmacists, or prescribers.

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

Rx only: A label marking meaning the medicine can be obtained only with a prescription from a licensed health professional.

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

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.

titration: Slowly adjusting a medicine's dose up or down in small steps to find the amount that works best with the fewest side effects.

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

transdermal: Delivered through the skin, usually from a patch, into the bloodstream over time.

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

trimester: One of the three roughly three-month stages that a pregnancy is divided into.

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

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

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

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

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

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

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 ↗

← 63304-0450-01 · Sun 63304-0452-01 · Sun →

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.

Morphine sulfate 30 mg Tablet, Film Coated, Extended Release, 100-count

🆔 Identity & classification

🏷️ RxNorm drug class

🏭 Manufacturer & labeler

🩺 Clinical

Patient education

Supplement & herbal interactions

💊 What it looks like

🧪 Inactive Ingredients / Excipients

Inactive ingredient FAQ

💲 Pricing

🔁 Therapeutic equivalents

⏳ Availability & generic status

🗺️ Medicaid utilization & spend

💊 Medicaid utilization by pack size

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

🔬 Reported adverse events (FAERS)

Top reported reactions

Age at onset

Reporter sex

Serious outcomes

📦 Packaging — all sizes for this product

Pack size FAQ

📄 Full prescribing information FDA SPL

12 CLINICAL PHARMACOLOGY

🔗 Related NDC lookups

💊 Related drugs in this class