Morphine Sulfate

MORPHINE SULFATE — morphine sulfate injection
Meridian Medical Technologies, Inc.

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

Addiction, Abuse, and Misuse

Morphine Sulfate Injection, (Auto-Injector) 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 Morphine Sulfate Injection, (Auto-Injector), 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 Injection, (Auto-Injector). Monitor for respiratory depression, especially during initiation of Morphine Sulfate Injection, (Auto-Injector) or following a dose increase [see Warnings and Precautions (5.2)].

Neonatal Opioid Withdrawal Syndrome

Prolonged use of Morphine Sulfate Injection, (Auto-Injector) 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 Injection, (Auto-Injector) 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.

1 INDICATIONS AND USAGE

Morphine Sulfate Injection, (Auto-Injector) is indicated for the management of 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, even at recommended doses [see Warnings and Precautions (5.1)] , reserve Morphine Sulfate Injection, (Auto-Injector) 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

2 DOSAGE AND ADMINISTRATION

2.1 Important Dosage and Administration Instructions

The morphine sulfate auto-injector system was developed for use under conditions which require an automatic injection device. It carries a low risk of inadvertent intravascular injection and injection site reactions. It is preferable to deliver morphine sulfate by standard hospital techniques when conditions permit.

Monitor patients closely for respiratory depression [see Warnings and Precautions (5.2)].

2.2 Initial Dosage

Initiate treatment with a single injection of Morphine Sulfate Injection, (Auto-Injector). The morphine sulfate auto-injector delivers a fixed dose of 10 mg which will generally provide adequate analgesia for a 70 kg (154 lb) adult.

Onset of analgesia is usually within 5-20 minutes and peak analgesia will be reached in one hour. Although a single injection will usually provide appropriate relief for most individuals of normal stature, individuals who do not obtain adequate pain relief after 30 minutes may require a second dose.

The auto-injector is not intended for repeated administration, but if repeated doses must be given, the usual adult dosage for repeated administration is one injector (10 mg) every 4 hours as needed to control the pain.

2.3 Instructions for Use of the Morphine Sulfate Auto-Injector

  1. Remove red safety cap.
  2. Place purple end on patient’s outer thigh and push the unit firmly against the patient until injector functions.

Continually re-evaluate patients receiving Morphine Sulfate Injection, (Auto-Injector) to assess the maintenance of pain control and the relative incidence of adverse reactions, as well as monitoring for the development of addiction, abuse, or misuse [see Warnings and Precautions (5.1)]. Frequent communication is important among the prescriber, other members of the healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including during maintenance of therapy.

3 DOSAGE FORMS AND STRENGTHS

Morphine Sulfate Injection, USP (Auto-Injector) contains 10 mg morphine sulfate in 0.7 mL of sterile solution.

4 CONTRAINDICATIONS

Morphine Sulfate Injection, (Auto-Injector) 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 (5.5)]
  • Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days [see Warnings and Precautions (5.6)]
  • Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions (5.10)]
  • Hypersensitivity to morphine sulfate (e.g., anaphylaxis) [see Adverse Reactions (6)]

5 WARNINGS AND PRECAUTIONS

5.1 Addiction, Abuse, and Misuse

Morphine Sulfate Injection, (Auto-Injector) contains morphine sulfate, a Schedule II controlled substance. As an opioid, Morphine Sulfate Injection, (Auto-Injector) exposes users to the risks of addiction, abuse, and misuse [see Drug Abuse and Dependence (9)].

Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed Morphine Sulfate Injection, (Auto-Injector). Addiction can occur at recommended dosages and if the drug is misused or abused.

Assess each patient’s risk for opioid addiction, abuse, or misuse prior to prescribing Morphine Sulfate Injection, (Auto-Injector), and monitor all patients receiving Morphine Sulfate Injection, (Auto-Injector) for the 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 Injection, (Auto-Injector), but use in such patients necessitates intensive counseling about the risks and proper use of Morphine Sulfate Injection, (Auto-Injector) along with intensive monitoring for signs of addiction, abuse, and misuse.

Opioids are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. Consider these risks when prescribing or dispensing Morphine Sulfate Injection, (Auto-Injector). Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity. 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.

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