Morphine Sulfate ER 15 mg/1

Morphine Sulfate · TABLET, FILM COATED, EXTENDED RELEASE · Bryant Ranch Prepack

No Recall HistoryCurrently in Shortage

Plain English

Morphine Sulfate ER is a tablet, film coated, extended release containing morphine sulfate at 15 mg/1, taken oral. Manufactured by Bryant Ranch Prepack.

Key Facts

Brand Name: Morphine Sulfate ER
Generic Name: Morphine Sulfate
NDC Code (Product): 63629-4483
Manufacturer: Bryant Ranch Prepack
Strength: 15 mg/1
Dosage Form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Marketing Status
DEA Schedule: Schedule II (Controlled)
Application #: ANDA074862
Marketing Start: 01/14/2011

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Morphine sulfate extended-release tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Morphine sulfate extended-release tablets are an opioid agonist indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. ( 1 ) Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve morphine sulfate extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. ( 1 ) Morphine sulfate extended-release tablets are not indicated as an as-needed (prn) analgesic. ( 1 ) Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and beca…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION To be prescribed only by healthcare providers knowledgeable in the use of potent opioids for management of chronic pain. ( 2.1 ) 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. ( 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 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 ) Instruct patients to swallow morphine sulfate extended-release tablets intact and not to cut, break, chew, crush, or dissolve morphine sulfate extended-release tablets to av…

Contraindications

4 CONTRAINDICATIONS Morphine sulfate extended-release tablets are contraindicated in patients with: Significant respiratory depression [see Warnings and Precautions (5.3) ] Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions (5.6) ] Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days [see Warnings and Precautions (5.7) , Drug Interactions (7) ] . Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions (5.11) ] 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 )

Drug Interactions

7 DRUG INTERACTIONS Table 1 includes clinically significant drug interactions with morphine sulfate extended-release tablets. Table 1: Clinically Significant Drug Interactions with Morphine Sulfate Extended-Release Tablets 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. 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. Follow patients closely for signs of respiratory depression and sedation. If concomitant use is warranted, consider prescribing naloxone for the emergency treatment of opioid overdose [see Dosage and Administration (2.2 , 2.5) , Warnings and Precautions (5.1 , 5.3 , 5.5) ] . Examples: Benzodiazepines and other sedative hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, alcohol. Serotonergic Drugs Clinical Impact: The conco…

Adverse Reactions

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 (5.3) ] Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.4) ] Interactions with Benzodiazepine or Other CNS Depressants [see Warnings and Precautions (5.5) ] Adrenal Insufficiency [see Warnings and Precautions (5.8) ] Severe Hypotension [see Warnings and Precautions (5.9) ] Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.11) ] Seizures [see Warnings and Precautions (5.12) ] Withdrawal [see Warnings and Precautions (5.13) ] Most common adverse reactions (>10%): constipation, nausea, and sedation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Rhodes Pharmaceuticals L.P. at 1-888-827-0616 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical 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 …

Frequently Asked Questions

What is Morphine Sulfate ER used for?

Morphine Sulfate ER contains Morphine Sulfate. It is a tablet, film coated, extended release taken oral. Consult your doctor for specific uses.

Is Morphine Sulfate ER a controlled substance?

Yes, Morphine Sulfate ER is classified as CII under the DEA Controlled Substances Act.

What is the generic name for Morphine Sulfate ER?

The generic name for Morphine Sulfate ER is Morphine Sulfate. There are 12 other brand versions of Morphine Sulfate.

What is the NDC code for Morphine Sulfate ER 15 mg/1?

The NDC (National Drug Code) for Morphine Sulfate ER 15 mg/1 is 63629-4483, listed by Bryant Ranch Prepack.

Product NDC

63629-4483

Package NDC

63629-4483-0

Other Morphine Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)