Statex

Last updated on RxList: 3/22/2019
Statex Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 3/22/2019

Statex (morphine sulfate) is a narcotic analgesic indicated for the symptomatic relief of severe chronic pain. Statex is a Canadian brand name for morphine sulfate. Brand names for morphine sulfate in the U.S. include Avinza, Kadian, and MS Contin. Common side effects of Statex include:

Individual dosing requirements for Statex vary considerably based on each patient's age, weight, severity of pain, and medical and analgesic history. The usual initial adult dose of Statex is 10-30 mg every 4 hours around the clock. Statex may interact with alcohol, benzodiazepines or other CNS depressants (other opioids, sedatives/hypnotics, antidepressants, anxiety medications, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, phenothiazines, neuroleptics, antihistamines, antiemetics, and alcohol), beta-blockers, anticoagulants, antimuscarinics, selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitor (SNRIs). Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using Statex; it may harm a fetus. Pregnant women using opioids such as Statex should not discontinue the medication abruptly as this can cause pregnancy complications. Tapering should be slow and under medical supervision to avoid serious adverse events to the fetus. Statex passes into breast milk and can have adverse effects on nursing infants. Breastfeeding is not recommended while using Statex. Withdrawal symptoms may occur if you suddenly stop taking Statex.

Our Statex (morphine sulfate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

Back Pain: 16 Back Pain Truths and Myths See Slideshow
Statex Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Call your doctor at once if you have:

  • slow heart rate, sighing, weak or shallow breathing, breathing that stops;
  • chest pain, fast or pounding heartbeats;
  • extreme drowsiness, feeling like you might pass out;
  • serotonin syndrome--agitation, hallucinations, fever, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, diarrhea; or
  • low cortisol levels--nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.

Serious breathing problems may be more likely in older adults and people who are debilitated or have wasting syndrome or chronic breathing disorders.

Common side effects may include:

  • drowsiness, dizziness, tiredness;
  • constipation, stomach pain, nausea, vomiting;
  • sweating; or
  • feelings of extreme happiness or sadness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Statex (Morphine Sulfate Drops, Suppositories, Syrup, Tablets)

QUESTION

Medically speaking, the term "myalgia" refers to what type of pain? See Answer
Statex Professional Information

SIDE EFFECTS

Adverse Drug Reaction Overview

Adverse effects of STATEX (morphine sulfate) drops, suppositories, syrup and tablets are similar to those of other opioid analgesics, and represent an extension of pharmacological effects of the drug class. The major hazards of opioids include respiratory and central nervous system depression and to a lesser degree, circulatory depression, respiratory arrest, shock and cardiac arrest.

The most frequently observed adverse effects of STATEX are sedation, nausea and vomiting, constipation and sweating.

Sedation

Sedation is a common side effect of opioid analgesics, especially in opioid naïve individuals. Sedation may also occur partly because patients often recuperate from prolonged fatigue after the relief of persistent pain. Most patients develop tolerance to the sedative effects of opioids within three to five days and, if the sedation is not severe, will not require any treatment except reassurance. If excessive sedation persists beyond a few days, the dose of the opioid should be reduced and alternate causes investigated. Some of these are: concurrent CNS depressant medication, hepatic or renal dysfunction, brain metastases, hypercalcemia and respiratory failure. If it is necessary to reduce the dose, it can be carefully increased again after three or four days if it is obvious that the pain is not being well controlled. Dizziness and unsteadiness may be caused by postural hypotension, particularly in elderly or debilitated patients, and may be alleviated if the patient lies down.

Nausea And Vomiting

Nausea is a common side effect on initiation of therapy with opioid analgesics and is thought to occur by activation of the chemoreceptor trigger zone, stimulation of the vestibular apparatus and through delayed gastric emptying. The prevalence of nausea declines following continued treatment with opioid analgesics. When instituting therapy with an opioid for chronic pain, the routine prescription of an antiemetic should be considered. In the cancer patient, investigation of nausea should include such causes as constipation, bowel obstruction, uremia, hypercalcemia, hepatomegaly, tumor invasion of celiac plexus and concurrent use of drugs with emetogenic properties. Persistent nausea which does not respond to dosage reduction may be caused by opioid-induced gastric stasis and may be accompanied by other symptoms including anorexia, early satiety, vomiting and abdominal fullness. These symptoms respond to chronic treatment with gastrointestinal prokinetic agents.

Constipation

Practically all patients become constipated while taking opioids on a persistent basis. In some patients, particularly the elderly or bedridden, fecal impaction may result. It is essential to caution the patients in this regard and to institute an appropriate regimen of bowel management at the start of prolonged opioid therapy. Stimulant laxatives, stool softeners, and other appropriate measures should be used as required. As fecal impaction may present as overflow diarrhea, the presence of constipation should be excluded in patients on opioid therapy prior to initiating treatment for diarrhea.

The following adverse effects occur less frequently with opioid analgesics.

Less Common Adverse Drug Reactions

Cardiovascular: Supra-ventricular tachycardia, postural hypotension, palpitations, faintness and syncope.

Dermatologic: Pruritus, urticaria, other skin rashes and edema.

Endocrine: A syndrome of inappropriate antidiuretic hormone secretion characterized by hyponatremia secondary to decreased free-water excretion may be prominent (monitoring of electrolytes may be necessary).

Gastrointestinal: Dry mouth, anorexia, constipation, cramps, taste alterations and biliary tract cramps.

CNS: Euphoria, dysphoria, weakness, insomnia, dizziness, confusional symptoms and occasionally hallucinations.

Genitourinary: Urinary retention or hesitance, reduced libido or potency.

Withdrawal (Abstinence) Syndrome: Physical dependence with or without psychological dependence tend to occur on chronic administration. An abstinence syndrome may be precipitated when opioid administration is discontinued or opioid antagonists administered. The following withdrawal symptoms may be observed after opioids are discontinued: body aches, diarrhea, gooseflesh, loss of appetite, nervousness or restlessness, runny nose, sneezing, tremors or shivering, stomach cramps, nausea, trouble with sleeping, unusual increase in sweating and yawning, weakness, tachycardia and unexplained fever. With appropriate medical use of opioids and gradual withdrawal from the drug, these symptoms are usually mild.

Post-Marketing Experience

Androgen Deficiency

Chronic use of opioids may influence the hypothalamic-pituitary-gonadal axis, leading to androgen deficiency that may manifest as low libido, impotence, erectile dysfunction, amenorrhea, or infertility. The causal role of opioids in the clinical syndrome of hypogonadism is unknown because the various medical, physical, lifestyle, and psychological stressors that may influence gonadal hormone levels have not been adequately controlled for in studies conducted to date. Patients presenting with symptoms of androgen deficiency should undergo laboratory evaluation.

Read the entire FDA prescribing information for Statex (Morphine Sulfate Drops, Suppositories, Syrup, Tablets)

© Statex Patient Information is supplied by Cerner Multum, Inc. and Statex Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

Health Solutions From Our Sponsors