Morphine Sulfate Extended Release

Morphine Sulfate Extended Release

Morphine Sulfate Extended Release Recall

Get an alert when a recall is issued.

Questions & Answers

Side Effects & Adverse Reactions

WARNINGS

(see CLINICAL PHARMACOLOGY)

MORPHINE SULFATE EXTENDED-RELEASE TABLETS ARE TO BE SWALLOWED WHOLE AND ARE NOT TO BE BROKEN, CHEWED, DISSOLVED, OR CRUSHED. TAKING BROKEN, CHEWED, DISSOLVED, OR CRUSHED MORPHINE SULFATE EXTENDED-RELEASE TABLETS LEADS TO RAPID RELEASE AND ABSORPTION OF A POTENTIALLY FATAL DOSE OF MORPHINE.

Morphine sulfate extended-release 100 mg AND 200 mg tablets ARE FOR USE IN OPIOID-TOLERANT PATIENTS ONLY. These tablet strengths may cause fatal respiratory depression when administered to patients not previously exposed to opioids.

Morphine sulfate extended-release 100 mg AND 200 mg tablets are for use only in opioid-tolerant patients requiring daily morphine equivalent dosages of 200 mg or more for the 100 mg tablet and 400 mg or more for the 200 mg tablet. Care should be taken in the prescribing of these tablet strengths. Patients should be instructed against use by individuals other than the patient for whom it was prescribed, as such inappropriate use may have severe medical consequences, including death.

Misuse, Abuse and Diversion of Opioids

Morphine is an opioid agonist and a Schedule II controlled substance. Such drugs are sought by drug abusers and people with addiction disorders and are subject to criminal diversion.

Morphine can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing morphine sulfate extended-release tablets in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion.

Morphine sulfate extended-release tablets can be abused by crushing, chewing, snorting or injecting the dissolved product. These practices will result in the uncontrolled delivery of the opioid and pose a significant risk to the abuser that could result in overdose and death (see WARNINGS, Drug Abuse and Addiction).

Concerns about abuse, addiction, and diversion should not prevent the proper management of pain.

Healthcare professionals should contact their State Professional Licensing Board or State Controlled Substances Authority for information on how to prevent and detect abuse or diversion of this product.

Interactions with Alcohol and Drugs of Abuse

Morphine may be expected to have additive effects when used in conjunction with alcohol, other opioids, or illicit drugs that cause central nervous system depression because respiratory depression, hypotension, and profound sedation or coma may result (see WARNINGS, Interactions with Other CNS Depressants).

Drug Abuse and Addiction

Morphine sulfate extended-release tablets are mu-agonist opioids with an abuse liability similar to other opioid agonists and is a Schedule II controlled substance. Morphine sulfate extended-release tablets and other opioids used in analgesia, can be abused and are subject to criminal diversion.

Drug addiction is characterized by compulsive use, use for non-medical purposes, and continued use despite harm or risk of harm.

Drug addiction is a treatable disease, utilizing a multi-disciplinary approach, but relapse is common.

“Drug-seeking” behavior is very common in addicts and drug abusers. Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing or referral, repeated “loss” of prescriptions, tampering with prescriptions and reluctance to provide prior medical records or contact information for other treating physician(s). “Doctor shopping” to obtain additional prescriptions is common among drug abusers and people suffering from untreated addiction.

Abuse and addiction are separate and distinct from physical dependence and tolerance. Physicians should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts. In addition, abuse of opioids can occur in the absence of true addiction and is characterized by misuse for non-medical purposes, often in combination with other psychoactive substances. Morphine sulfate extended-release tablets, like other opioids, has been diverted for non-medical use. Careful record keeping of prescribing information, including quantity, frequency, and renewal requests is strongly advised.

Proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs.

Morphine sulfate extended-release tablets are intended for oral use only as an intact tablet. Abuse of the crushed tablet poses a hazard of overdose and death. This risk is increased with concurrent abuse of alcohol and other substances. Parenteral abuse in the presence of some excipients such as talc in the tablets can be expected to result in local tissue necrosis, infection, pulmonary granulomas, and increased risk of endocarditis and valvular heart injury. Parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and HIV.

Respiratory Depression

Respiratory depression is the chief hazard of all morphine preparations. Respiratory depression occurs most frequently in the elderly and debilitated patients as well as in those suffering from conditions accompanied by hypoxia or hypercapnia when even moderate therapeutic doses may dangerously decrease pulmonary ventilation.

Morphine should be used with extreme caution in patients with chronic obstructive pulmonary disease or cor pulmonale, and in patients having a substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression. In such patients, even usual therapeutic doses of morphine may decrease respiratory drive while simultaneously increasing airway resistance to the point of apnea.

Head Injury and Increased Intracranial Pressure

The respiratory depressant effects of morphine with carbon dioxide retention and secondary elevation of cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions, or pre-existing increase in intracranial pressure. Morphine produces effects which may obscure neurologic signs of further increases in pressure in patients with head injuries.

Hypotensive Effect

Morphine sulfate extended-release tablets, like all opioid analgesics, may cause severe hypotension in an individual whose ability to maintain his blood pressure has already been compromised by a depleted blood volume, or a concurrent administration of drugs such as phenothiazines or general anesthetics. Morphine sulfate extended-release tablets may produce orthostatic hypotension in ambulatory patients.

Morphine sulfate extended-release tablets, like all opioid analgesics, should be administered with caution to patients in circulatory shock, since vasodilation produced by the drug may further reduce cardiac output and blood pressure.

Interactions with Other CNS Depressants

Morphine sulfate extended-release tablets, like all opioid analgesics, should be used with great caution and in reduced dosage in patients who are concurrently receiving other central nervous system depressants including sedatives or hypnotics, general anesthetics, phenothiazines, other tranquilizers, and alcohol because respiratory depression, hypotension, and profound sedation or coma may result.

Other

Although extremely rare, cases of anaphylaxis have been reported.




Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

INDICATIONS AND USAGE

Morphine sulfate extended-release tablets are an extended-release oral formulation of morphine sulfate indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.

Morphine sulfate extended-release tablets are NOT intended for use as a prn analgesic.

The morphine sulfate extended-release tablets 100 mg and 200 mg strengths are high dose, extended-release, oral morphine formulations indicated for the relief of pain in opioid-tolerant patients only.

Morphine sulfate extended-release tablets are not indicated for pain in the immediate postoperative period (the first 12 to 24 hours following surgery) for patients not previously taking the drug, because its safety in this setting has not been established.

Morphine sulfate extended-release tablets are not indicated for pain in the postoperative period if the pain is mild, or not expected to persist for an extended period of time.

Morphine sulfate extended-release tablets are only indicated for postoperative use if the patient is already receiving the drug prior to surgery or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time. Physicians should individualize treatment, moving from parenteral to oral analgesics as appropriate. (See American Pain Society guidelines.)

History

There is currently no drug history available for this drug.

Other Information

DESCRIPTION

Morphine Sulfate Extended-Release Tablets are supplied in tablet form for oral administration

Morphine Sulfate Extended Release Manufacturers


  • Lake Erie Medical Dba Quality Care Products Llc
    Morphine Sulfate Extended Release (Morphine Sulfate) Tablet [Lake Erie Medical Dba Quality Care Products Llc]
  • Bryant Ranch Prepack
    Morphine Sulfate Extended Release Tablet [Bryant Ranch Prepack]
  • Lake Erie Medical Dba Quality Care Products Llc
    Morphine Sulfate Extended Release (Morphine Sulfate) Tablet [Lake Erie Medical Dba Quality Care Products Llc]
  • Lake Erie Medical Dba Quality Care Products Llc
    Morphine Sulfate Extended Release (Morphine Sulfate) Tablet, Extended Release [Lake Erie Medical Dba Quality Care Products Llc]
  • Bryant Ranch Prepack
    Morphine Sulfate Extended Release (Morphine Sulfate) Tablet, Film Coated, Extended Release [Bryant Ranch Prepack]
  • Bryant Ranch Prepack
    Morphine Sulfate Extended Release (Morphine Sulfate) Tablet, Film Coated, Extended Release [Bryant Ranch Prepack]
  • Lake Erie Medical Dba Quality Care Products Llc
    Morphine Sulfate Extended Release (Morphine Sulfate) Tablet, Film Coated, Extended Release [Lake Erie Medical Dba Quality Care Products Llc]
  • Bryant Ranch Prepack
    Morphine Sulfate Extended Release (Morphine Sulfate) Tablet, Film Coated, Extended Release [Bryant Ranch Prepack]
  • Lake Erie Medical Dba Quality Care Products Llc
    Morphine Sulfate Extended Release (Morphine Sulfate) Tablet, Film Coated, Extended Release Morphine Sulfate Extended Release (Morphine Sulfate) Tablet, Film Coated, Extended Release [Lake Erie Medical Dba Quality Care Products Llc]
  • American Health Packaging
    Morphine Sulfate Extended Release (Morphine Sulfate) Tablet, Film Coated, Extended Release [American Health Packaging]
  • Rhodes Pharmaceuticals L. P.
    Morphine Sulfate Extended Release (Morphine Sulfate) Tablet, Film Coated, Extended Release [Rhodes Pharmaceuticals L. P.]

Login To Your Free Account