Morphine Sulfate

MORPHINE SULFATE- morphine sulfate tablet
RedPharm Drug, Inc.

WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; AND RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS

Addiction, Abuse, and Misuse

Morphine Sulfate Tablets expose 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 Morphine Sulfate Tablets, and monitor all patients regularly for the development of these behaviors and conditions [see Warnings and Precautions (5.1)].

Life-Threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression may occur with use of Morphine Sulfate Tablets. Monitor for respiratory depression, especially during initiation of Morphine Sulfate Tablets or following a dose increase [see Warnings and Precautions (5.2)].

Accidental Ingestion

Accidental ingestion of even one dose of Morphine Sulfate Tablets, especially by children, can result in a fatal overdose of morphine [see Warnings and Precautions (5.2)].

Neonatal Opioid Withdrawal Syndrome

Prolonged use of Morphine Sulfate Tablets during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see Warnings and Precautions (5.3)].

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 [see Warnings and Precautions (5.4), Drug Interactions (7)].


Reserve concomitant prescribing of Morphine Sulfate Tablets and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.

Limit dosages and durations to the minimum required.

Follow patients for signs and symptoms of respiratory depression and sedation.

HIGHLIGHTS OF PRESCRIBING INFORMATION


These highlights do not include all the information needed to use Morphine Sulfate Tablets safely and effectively. See full prescribing information for Morphine Sulfate Tablets.
Morphine Sulfate tablets, for oral use CII
Initial U.S. Approval: 1941

WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; AND RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING.


Morphine Sulfate Tablets expose users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient’s risk before prescribing and monitor regularly for these behaviors and conditions. (5.1)

Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. (5.2)

Accidental ingestion of Morphine Sulfate Tablets, especially by children, can result in a fatal overdose of morphine. (5.2)

Prolonged use of Morphine Sulfate Tablets during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If prolonged opioid use is required in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. (5.3)

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; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation. (5.4, 7)

RECENT MAJOR CHANGES

Boxed Warning

12/2016

Indications and Usage (1)

12/2016

Dosage and Administration (2)

12/2016

Contraindications (4)

12/2016

Warnings and Precautions (5)

12/2016

INDICATIONS AND USAGE

Morphine Sulfate Tablets are an opioid agonist indicated for the management of acute and chronic pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. (1)

Limitations of Use (1)

Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve Morphine Sulfate Tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:


Have not been tolerated, or are not expected to be tolerated,

Have not provided adequate analgesia, or are not expected to provide adequate analgesia.

DOSAGE AND ADMINISTRATION


Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals. ( 2.1)

Individualize dosing based on the severity of pain, patient response, prior analgesic experience, and risk factors for addiction, abuse, and misuse. ( 2.1)

Initiate Treatment with Morphine Sulfate Tablets: 15 to 30 mg every 4 hours as needed. ( 2.2)

Do not stop Morphine Sulfate Tablets abruptly in a physically dependent patient. ( 2.4)

DOSAGE FORMS AND STRENGTHS

Tablets: 15 mg and 30 mg. (3)

CONTRAINDICATIONS


Significant respiratory depression. ( 4)

Acute or severe bronchial asthma in an unmonitored setting or in 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 PRECAUTIONS


Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients: Monitor closely, particularly during initiation and titration. ( 5.5)

Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. ( 5.7)

Severe Hypotension: Monitor during dosage initiation and titration. Avoid use of Morphine Sulfate Tablets in patients with circulatory shock. ( 5.8)

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 Tablets in patients with impaired consciousness or coma. ( 5.9)

ADVERSE REACTIONS

Most Common Adverse Reactions Seen on Initiation of Therapy are: constipation, nausea, somnolence, lightheadedness, dizziness, sedation, vomiting, and sweating. (6)

To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-800-962-8364 or FDA at 1-800-FDA-1088 or WWW.FDA.GOV/MEDWATCH.

DRUG INTERACTIONS


Serotonergic Drugs: Concomitant use may result in serotonin syndrome. Discontinue Morphine Sulfate Tablets if serotonin syndrome is suspected. ( 7)

Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics: Avoid use with Morphine Sulfate Tablets because they may reduce analgesic effect of Morphine Sulfate Tablets or precipitate withdrawal symptoms. ( 7)

USE IN SPECIFIC POPULATIONS


Pregnancy: May cause fetal harm. ( 8.1)

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 4/2017

FULL PRESCRIBING INFORMATION: CONTENTS*

WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; AND RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Important Dosage and Administration Instructions
2.2 Initial Dosage
2.3 Titration and Maintenance of Therapy
2.4 Discontinuation of Morphine Sulfate Tablets
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Addiction, Abuse, and Misuse
5.2 Life-Threatening Respiratory Depression
5.3 Neonatal Opioid Withdrawal Syndrome
5.4 Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants
5.5 Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients
5.6 Interaction with Monoamine Oxidase Inhibitors
5.7 Adrenal Insufficiency
5.8 Severe Hypotension
5.9 Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness
5.10 Risks of Use in Patients with Gastrointestinal Conditions
5.11 Increased Risk of Seizures in Patients with Seizure Disorders
5.12 Withdrawal
5.13 Risks of Driving and Operating Machinery
6 ADVERSE REACTIONS
7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.3 Females and Males of Reproductive Potential
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Hepatic Impairment
8.7 Renal Impairment
9 DRUG ABUSE AND DEPENDENCE
9.1 Controlled Substance
9.2 Abuse
9.3 Dependence
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION

*
Sections or subsections omitted from the full prescribing information are not listed.

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