Morphine Sulfate 10 mg/mL
Morphine Sulfate · INJECTION, SOLUTION · Fresenius Kabi, USA LLC
Morphine Sulfate injection is a prescription opioid pain reliever given by intramuscular injection that is used to treat moderate to severe pain. This medication works by changing how the body senses and responds to pain.
Key Facts
- Brand Name
- Morphine Sulfate
- Generic Name
- Morphine Sulfate
- NDC Code (Product)
76045-008- Manufacturer
- Fresenius Kabi, USA LLC
- Strength
- 10 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR, INTRAVENOUS
- Marketing Status
- DEA Schedule
- Schedule II (Controlled)
- Application #
- NDA204223
- Marketing Start
- 10/30/2013
Recall History
LUPIN SOMERSET
Failed Impurities/Degradation Specifications
Pharmedium Services, LLC
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Lincare, Inc.
Lack of Assurance of Sterility: Sterility of product is not assured.
THE COMPOUNDING SHOP, INC.
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Johnson Matthey Inc.
Microbial Contamination of Non-Sterile Products: Bioburden out of specification results for Morphine Sulfate API.
SterRx, LLC
Lack of Assurance of Sterility
Pharmedium Services, LLC
Lack of sterility assurance.
Hartley Medical Center Pharmacy, Incorporated
Lack of Assurance of Sterility
Advanced Pharma Inc.
Lack of Assurance of Sterility
Akorn, Inc.
Labeling: Missing Label
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 tablets are indicated for the management of: adult and pediatric patients weighing at least 50 kg and above with acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. adults with chronic pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use: Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, [see Warnings and Precautions ( 5.1 )], 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 Morphine sulfate tablets should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate. Morphine sulfate tablets are opioid agonists indicated for the management of: adults and pediatric patients weighing 50 kg and …
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Morphine sulfate tablets should be prescribed only by healthcare professionals who are knowledgeable about the use of opioids and how to mitigate the associated risks. ( 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 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 ) Many acute pain conditions (e.g., the pain that occurs with a number of surgical procedures or acute musculoskeletal injuries) require no more than a few days of an opioid analgesic. Clinical guidelines on opioid prescribing for some acute pain conditions are available. ( 2.1 ) 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 increa…
Contraindications
4 CONTRAINDICATIONS Morphine sulfate 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) and Drug Interactions ( 7 )]. Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions ( 5.12 )]. Hypersensitivity to morphine (e.g., anaphylaxis) [see Adverse Reactions ( 6 )]. 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 )
Drug Interactions
7 DRUG INTERACTIONS Table 1 includes clinically significant drug interactions with morphine sulfate tablets. Table 1: Clinically Significant Drug Interactions with Morphine sulfate 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 prescribing naloxone for the emergency treatment of opioid overdose [see Dosage and Administration ( 2.2 ), Warnings and Precautions ( 5.1 , 5.2 , 5.3 )]. Examples: Benzodiazepines and other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antips…
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 )] The following adverse reactions associated with the use of morphine were identified in clinical studies or postmarketing reports. Because some of these reactions were 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. Serious adverse reactions associated w…
Frequently Asked Questions
What is Morphine Sulfate used for?
Morphine Sulfate injection is a prescription opioid pain reliever given by intramuscular injection that is used to treat moderate to severe pain. This medication works by changing how the body senses and responds to pain.
Is Morphine Sulfate a controlled substance?
Yes, Morphine Sulfate is classified as CII under the DEA Controlled Substances Act.
What is the generic name for Morphine Sulfate?
The generic name for Morphine Sulfate is Morphine Sulfate. There are 5 other brand versions of Morphine Sulfate.
What is the NDC code for Morphine Sulfate 10 mg/mL?
The NDC (National Drug Code) for Morphine Sulfate 10 mg/mL is 76045-008, listed by Fresenius Kabi, USA LLC.