DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Kadian (Morphine Sulfate) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Serious adverse reactions that may be associated with KADIAN® therapy in clinical use are those observed with other opioid analgesics and include: respiratory depression, respiratory arrest, apnea, circulatory depression, cardiac arrest, hypotension, and/or shock (see OVERDOSAGE, WARNINGS).

The less severe adverse events seen on initiation of therapy with KADIAN® are also typical opioid side effects.  These events are dose dependent, and their frequency depends on the clinical setting, the patient's level of opioid tolerance, and host factors specific to the individual.  They should be expected and managed as a part of opioid analgesia.  The most frequent of these include drowsiness, dizziness, constipation and nausea.  In many cases, the frequency of these events during initiation of therapy may be minimized by careful individualization of starting dosage, slow titration, and the avoidance of large rapid swings in plasma concentrations of the opioid.  Many of these adverse events, will cease or decrease as KADIAN® therapy is continued and some degree of tolerance is developed, but others may be expected to remain troublesome throughout therapy.


Management of Excessive Drowsiness

Most patients receiving KADIAN® will experience initial drowsiness.  This usually disappears within 3-5 days and is not a cause of concern unless it is excessive, or accompanied by unsteadiness or confusion.  Dizziness and unsteadiness may be associated with postural hypotension, particularly in elderly or debilitated patients, and has been associated with syncope and falls in non-tolerant patients started on opioids.

Excessive or persistent sedation should be investigated.  Factors to be considered should include: concurrent sedative medications, the presence of hepatic or renal insufficiency, hypoxia or hypercapnia due to exacerbated respiratory failure, intolerance to the dose used (especially in older patients), disease severity and the patient's general condition.

The dosage should be adjusted according to individual needs, but additional care should be used in the selection of initial doses for the elderly patient, the cachectic or gravely ill patient, or in patients not already familiar with opioid analgesic medications to prevent excessive sedation at the onset of treatment.


Management of Nausea and Vomiting

Nausea and vomiting are common after single doses of KADIAN® or as an early undesirable effect of chronic opioid therapy.  The prescription of a suitable antiemetic should be considered, with the awareness that sedation may result (see Drug Interactions). The frequency of nausea and vomiting usually decreases within a week or so but may persist due to opioid-induced gastric stasis. Metoclopramide is often useful in such patients.


Management of Constipation

Virtually all patients suffer from constipation while taking opioids, such as KADIAN®, on a chronic basis.  Some patients, particularly elderly, debilitated or bedridden patients may become impacted.  Tolerance does not usually develop for the constipating effects of opioids.  Patients must be cautioned accordingly and laxatives, softeners and other appropriate treatments should be used prophylactically from the beginning of opioid therapy.


Adverse Events Probably Related to KADIAN® Administration

In clinical studies in patients with chronic cancer pain the most common adverse events reported by patients at least once during therapy were drowsiness (9%), constipation (9%), nausea (7%), dizziness (6%), and anxiety (6%).  Other less common side effects expected from KADIAN® or seen in less than 3% of patients in the clinical studies were:

Body as a Whole:  Asthenia, accidental injury, fever, pain, chest pain, headache, diaphoresis, chills, flu syndrome, back pain, malaise, withdrawal syndrome

Cardiovascular:  Tachycardia, atrial fibrillation, hypotension, hypertension, pallor, facial flushing, palpitations, bradycardia, syncope

Central Nervous System:  Confusion, dry mouth, anxiety, abnormal thinking, abnormal dreams, lethargy, depression, tremor, loss of concentration, insomnia, amnesia, paresthesia, agitation, vertigo, foot drop, ataxia, hypesthesia, slurred speech, hallucinations, vasodilation, euphoria, apathy, seizures, myoclonus

Endocrine:  Hyponatremia due to inappropriate ADH secretion, gynecomastia

Gastrointestinal:  Vomiting, anorexia, dysphagia, dyspepsia, diarrhea, abdominal pain, stomach atony disorder, gastro-esophageal reflux, delayed gastric emptying, biliary colic

Hemic and Lymphatic:  Anemia, leukopenia, thrombocytopenia

Metabolic and Nutritional:  Peripheral edema, hyponatremia, edema

Musculoskeletal:  Back pain, bone pain, arthralgia

Respiratory:  Hiccup, rhinitis, atelectasis, asthma, hypoxia, dyspnea, respiratory insufficiency, voice alteration, depressed cough reflex, non-cardiogenic pulmonary edema

Skin and Appendages:  Rash, decubitus ulcer, pruritus, skin flush

Special Senses:  Amblyopia, conjunctivitis, miosis, blurred vision, nystagmus, diplopia

Urogenital:  Urinary abnormality, amenorrhea, urinary retention, urinary hesitancy, reduced libido, reduced potency, prolonged labor


Post-marketing Adverse Events Probably Related to KADIAN®

The safety of KADIAN® has been evaluated in a randomized, prospective, open-label, 4-week treatment period, post-marketing study consisting of 1418 patients ages 18-85 with chronic, non-malignant pain (e.g., back pain, osteoarthritis, neuropathic pain).  No control arm was included in this study.  The most common adverse events reported at least once during therapy were constipation (12%), nausea (9%) and somnolence (3%).  Other less common side effects occurring in less than 3% of patients were vomiting, pruritus, dizziness, sedation, dry mouth, headache, fatigue and rash.


DRUG ABUSE AND DEPENDENCE

KADIAN ® is a mu-agonist opioid with an abuse liability similar to other opioid agonists and is a Schedule II controlled substance.  KADIAN ® and other opioids used in analgesia can be abused and are subject to criminal diversion.

KADIAN® is an opioid with no approved use in the management of addiction disorders.  Its proper usage in individuals with drug or alcohol dependence, either active or in remission, is for the management of pain requiring opioid analgesia.

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. KADIAN®, 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.

KADIAN ® is intended for oral use only.  Abuse of chewed, crushed, or dissolved capsules or pellets poses a hazard of overdose and death.  This risk is increased with concurrent abuse of alcohol and other substances. Due to the presence of talc as one of the excipients in capsules, parenteral abuse 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.



REPORTS OF SUSPECTED KADIAN SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Kadian. The information is not vetted and should not be considered as verified clinical evidence.

Possible Kadian side effects / adverse reactions in 88 year old female

Reported by a health professional (non-physician/pharmacist) from Denmark on 2011-10-03

Patient: 88 year old female

Reactions: Face Oedema

Suspect drug(s):
Ciprofloxacin
    Dosage: iv
    Indication: Product Used FOR Unknown Indication

Kadian
    Dosage: sc
    Indication: Product Used FOR Unknown Indication

Metoclopramide
    Dosage: sc
    Indication: Product Used FOR Unknown Indication

Metronidazole
    Dosage: iv
    Indication: Product Used FOR Unknown Indication

Vancomycin
    Dosage: iv
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Trospium Chloride; Polyethylene Glycol; Simvastatin; Cetirizine HCL; Amitriptyline HCL; Lidocaine; Propylthiouracil



Possible Kadian side effects / adverse reactions in 88 year old female

Reported by a health professional (non-physician/pharmacist) from Denmark on 2011-10-06

Patient: 88 year old female

Reactions: Face Oedema

Suspect drug(s):
Ciprofloxacin
    Dosage: ; iv
    Indication: Product Used FOR Unknown Indication

Kadian
    Dosage: ; sc
    Indication: Product Used FOR Unknown Indication

Metoclopramide
    Dosage: ; sc
    Indication: Product Used FOR Unknown Indication

Metronidazole
    Dosage: ; iv
    Indication: Product Used FOR Unknown Indication

Vancomycin
    Dosage: ; iv
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Polyethylene Glycol; Lidocaine; Propylthiouracil; Amiytriptyline; Simvastatin; Trospium Chloride; Cetirizine HCL



Possible Kadian side effects / adverse reactions in 45 year old female

Reported by a consumer/non-health professional from United States on 2011-11-03

Patient: 45 year old female

Reactions: Hypertensive Heart Disease, Toxicity TO Various Agents

Adverse event resulted in: death

Suspect drug(s):
Fentanyl-100
    Dosage: change every 2 - 3 days
    Indication: Pain
    End date: 2007-09-10

Kadian
    Administration route: Oral
    Indication: Pain

Other drugs received by patient: Alprazolam; Lasix; Meridia; Lamictal; Abilify; Proventil; Lyrica; Campral; Seroquel



See index of all Kadian side effect reports >>

Drug label data at the top of this Page last updated: 2013-02-08

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017