Morphine Sulfate Extended Release 100 mg/1
Morphine Sulfate · TABLET, FILM COATED, EXTENDED RELEASE · Major Pharmaceuticals
Morphine Sulfate Extended Release is a prescription opioid pain medication available as a 100 mg tablet that is designed to provide long-lasting pain relief throughout the day. It is used to treat moderate to severe pain in patients who require around-the-clock opioid treatment.
Key Facts
- Brand Name
- Morphine Sulfate Extended Release
- Generic Name
- Morphine Sulfate
- NDC Code (Product)
0904-6560- Manufacturer
- Major Pharmaceuticals
- Strength
- 100 mg/1
- Dosage Form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Marketing Status
- DEA Schedule
- Schedule II (Controlled)
- Application #
- ANDA074769
- Marketing Start
- 01/14/2011
Recall History
LUPIN SOMERSET
Failed Impurities/Degradation Specifications
LUPIN SOMERSET
Failed Impurities/Degradation Specifications
Physicians Total Care, Inc
Labeling: Label mix-up; Bottles labeled to contain Morphine Sulfate IR may contain Morphine Sulfate ER and vice-versa.
LUPIN SOMERSET
Failed Impurities/Degradation Specifications: Morphine Sulfate Extended Release Tablets are being recalled due to out of Specification Result noticed for Morphinone Sulfate impurity during 3 month stability analysis and during retain testing.
LUPIN SOMERSET
Failed Impurities/Degradation Specifications
LUPIN SOMERSET
Failed Impurities/Degradation Specifications
Dr. Reddy's Laboratories, Inc.
Failed Impurities/Degradation Specification
Bryant Ranch Prepack, Inc.
Labeling: Label Mix-up: bottles labeled as Morphine Sulfate 60 mg Extended-Release tablets contain Morphine Sulfate 30 mg Extended-Release tablets and bottles labeled as Morphine Sulfate 30 mg Extended-Release tablets may contain Morphine Sulfate 60 mg Extended-Release tablets.
SUN PHARMACEUTICAL INDUSTRIES INC
Failed Dissolution Specifications
LUPIN SOMERSET
Failed Impurities/Degradation Specifications
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Morphine sulfate extended-release tablets are 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. 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 ) Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist…
Dosage & Administration
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 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 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 ris…
Contraindications
4 CONTRAINDICATIONS Morphine sulfate extended-release tablets are 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 )
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 [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 relaxa…
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 (5.2) ] 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 Rhodes Pharmaceuticals LLC at 1-888-873-5329 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 …
Frequently Asked Questions
What is Morphine Sulfate Extended Release used for?
Morphine Sulfate Extended Release is a prescription opioid pain medication available as a 100 mg tablet that is designed to provide long-lasting pain relief throughout the day. It is used to treat moderate to severe pain in patients who require around-the-clock opioid treatment.
Is Morphine Sulfate Extended Release a controlled substance?
Yes, Morphine Sulfate Extended Release is classified as CII under the DEA Controlled Substances Act.
What is the generic name for Morphine Sulfate Extended Release?
The generic name for Morphine Sulfate Extended Release is Morphine Sulfate. There are 10 other brand versions of Morphine Sulfate.
What is the NDC code for Morphine Sulfate Extended Release 100 mg/1?
The NDC (National Drug Code) for Morphine Sulfate Extended Release 100 mg/1 is 0904-6560, listed by Major Pharmaceuticals.
Other Morphine Sulfate Extended Release Dosages
Other Morphine Brands
See all →- Morphine Sulfate20 mg/mL72162-1282
- Morphine sulfate100 mg/172162-1791
- Morphine Sulfate10 mg/5mL75826-129
- Morphine Sulfate5 mg/10574-7110
- Morphine Sulfate20 mg/10832-0226
- Morphine Sulfate60 mg/142689-008
- Morphine Sulfate15 mg/143386-540
- Morphine sulfate30 mg/10228-3090
- Morphine sulfate30 mg/163304-451
- Morphine Sulfate15 mg/10054-0235
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)