Controlled Substance Program

Kadian (Morphine ER) Treatment

Evidence-based Kadian extended-release morphine treatment with comprehensive medical supervision. Our specialized pain management protocols ensure safe and effective treatment for chronic pain conditions and opioid use disorder.

FDA Black Box Warning

Kadian 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 and monitor all patients regularly for the development of these behaviors and conditions.

Critical Safety Warnings:

  • Respiratory Depression: Life-threatening respiratory depression may occur, particularly during initiation or dose increases
  • Accidental Ingestion: Even one dose can be fatal in children and opioid-naive adults
  • Cytochrome P450 3A4 Interaction: Concomitant use with CYP3A4 inhibitors may result in fatal overdose
  • Neonatal Opioid Withdrawal: Prolonged use during pregnancy can result in neonatal withdrawal syndrome
  • Interaction with Alcohol: Concomitant use with alcohol or CNS depressants increases risk of respiratory depression

Kadian is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Clinical Pharmacology and Mechanism of Action

Kadian (morphine sulfate extended-release capsules) is a long-acting opioid analgesic containing morphine sulfate in a sustained-release pellet formulation. The active ingredient, morphine, is a phenanthrene derivative that acts as a full opioid receptor agonist with primary activity at the μ-opioid receptor (MOR).

Pharmacokinetic Profile

Kadian's unique sustained-release technology provides consistent plasma morphine concentrations over 24 hours, reducing peak-to-trough fluctuations associated with immediate-release formulations.

  • Onset: 1-2 hours after administration
  • Peak Plasma Levels: 8-10 hours
  • Duration: 24 hours
  • Half-life: 11-13 hours
  • Bioavailability: 20-40% (extensive first-pass metabolism)

Clinical Indications and Patient Selection

Kadian is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment in opioid-tolerant patients. Proper patient selection is critical to minimize risks while maximizing therapeutic benefits.

Appropriate Candidates

  • • Chronic severe pain requiring continuous opioid therapy
  • • Opioid-tolerant patients (≥60mg oral morphine equivalents daily)
  • • Patients with stable pain conditions
  • • Those requiring around-the-clock pain management
  • • Patients with adequate renal and hepatic function
  • • Individuals under comprehensive medical supervision

Contraindications

  • • Significant respiratory depression
  • • Acute or severe bronchial asthma
  • • Known hypersensitivity to morphine
  • • Paralytic ileus or GI obstruction
  • • Opioid-naive patients
  • • Concurrent MAO inhibitor use

Evidence-Based Treatment Protocol

Phase 1: Comprehensive Assessment

Thorough evaluation is essential before initiating Kadian therapy. Our assessment protocol follows guidelines from the American Pain Society and includes comprehensive pain evaluation, risk stratification, and baseline monitoring parameters.

Clinical Assessment Components:

  • • Detailed pain history and functional assessment
  • • Previous opioid exposure and tolerance evaluation
  • • Substance abuse risk screening (SOAPP-R, ORT)
  • • Mental health evaluation and co-occurring disorders
  • • Physical examination with neurological assessment
  • • Review of previous treatments and responses

Laboratory and Diagnostic Studies:

  • • Baseline urine drug screening
  • • Complete blood count and comprehensive metabolic panel
  • • Liver function tests and renal function assessment
  • • Relevant imaging studies for pain condition
  • • Pulmonary function tests if respiratory concerns

Phase 2: Treatment Initiation and Titration

Kadian initiation requires careful dose calculation based on previous opioid exposure and individual patient factors. The extended-release formulation allows for once-daily dosing with improved patient compliance and steady-state analgesia.

Available Strengths and Dosing

10 mg capsules
20 mg capsules
30 mg capsules
50 mg capsules
60 mg capsules
80 mg capsules
100 mg capsules
200 mg capsules

Conversion and Titration Protocol:

  • • Calculate total daily morphine equivalent dose (MED)
  • • Apply appropriate conversion factors for cross-tolerance
  • • Reduce calculated dose by 25-50% for safety margin
  • • Initiate with lowest effective dose
  • • Titrate every 2-3 days based on pain scores and side effects
  • • Maximum recommended increase: 25-50% of current dose

Critical Administration Guidelines

  • • Capsules must be swallowed whole - never crush, chew, or dissolve
  • • Can be opened and sprinkled on applesauce for patients with swallowing difficulties
  • • Administer once daily at the same time each day
  • • May be taken with or without food
  • • Store securely to prevent diversion or accidental ingestion

Phase 3: Ongoing Monitoring and Management

Continuous monitoring is essential for safe and effective Kadian therapy. Our comprehensive monitoring protocol includes regular assessment of therapeutic response, adverse effects, and signs of misuse or diversion.

Monitoring Schedule:

Week 1-2

Daily phone contact, assess pain scores, side effects

Month 1-3

Weekly visits, UDS, pill counts, functional assessment

Ongoing

Monthly visits, quarterly comprehensive review

Key Monitoring Parameters:

  • • Pain intensity scores (0-10 numeric rating scale)
  • • Functional improvement measures (ODI, RMDQ)
  • • Respiratory rate and oxygen saturation
  • • Mental status and cognitive function
  • • Bowel function and constipation management
  • • Sleep quality and daytime sedation
  • • Signs of tolerance, dependence, or addiction
  • • Medication adherence and pill counts
  • • Random urine drug screening

Adverse Effects and Clinical Management

Understanding and managing adverse effects is crucial for successful Kadian therapy. Most side effects are dose-dependent and may improve with time or dose adjustment. Proactive management strategies can significantly improve patient tolerance and treatment outcomes.

Serious Adverse Effects

Respiratory Depression

Most serious risk, particularly in opioid-naive patients or with dose escalation. Monitor respiratory rate and oxygen saturation.

Severe Hypotension

Can occur with rapid dose increases or in volume-depleted patients. Monitor blood pressure regularly.

Adrenal Insufficiency

Rare but serious complication with chronic opioid use. Consider testing if unexplained fatigue or hypotension occurs.

Common Side Effects

Gastrointestinal >30%

Constipation (most common), nausea, vomiting. Prophylactic bowel regimen recommended.

Central Nervous System 20-30%

Drowsiness, dizziness, confusion. Usually improves with continued therapy.

Other Effects 10-20%

Dry mouth, sweating, pruritus, urinary retention. Symptomatic management often effective.

Proactive Side Effect Management

Constipation Prevention

  • • Stimulant laxative (senna) + stool softener (docusate)
  • • Adequate fluid intake (8-10 glasses daily)
  • • High-fiber diet and regular exercise
  • • Consider methylnaltrexone for refractory cases

Nausea Management

  • • Ondansetron 4-8mg every 8 hours as needed
  • • Metoclopramide 10mg before meals
  • • Small, frequent meals
  • • Usually resolves within 1-2 weeks

Drug Interactions and Safety Considerations

High-Risk Drug Interactions

CNS Depressants

Increased risk of respiratory depression, hypotension, and death.

  • • Benzodiazepines (lorazepam, alprazolam)
  • • Alcohol and ethanol-containing products
  • • Sedating antihistamines
  • • Muscle relaxants (cyclobenzaprine)
  • • General anesthetics

CYP3A4 Inhibitors

May increase morphine levels and risk of toxicity.

  • • Ketoconazole, itraconazole
  • • Erythromycin, clarithromycin
  • • Ritonavir and other protease inhibitors
  • • Grapefruit juice
  • • Cimetidine

Special Populations

Elderly Patients (≥65 years)

Increased sensitivity to opioids due to decreased clearance and increased CNS sensitivity. Start with 50% of usual adult dose and titrate slowly.

Renal Impairment

Morphine metabolites may accumulate. Consider dose reduction and extended dosing intervals in patients with creatinine clearance <30 mL/min.

Hepatic Impairment

Reduced first-pass metabolism may increase bioavailability. Start with lower doses and monitor closely for signs of toxicity.

Opioid Emergency Protocols

Recognition and immediate management of opioid overdose can be life-saving. Healthcare providers and patients should be familiar with emergency signs and response protocols.

Overdose Signs & Symptoms

  • • Respiratory depression (< 12 breaths/minute)
  • • Pinpoint pupils (miosis)
  • • Decreased level of consciousness
  • • Cyanosis (blue lips, fingernails)
  • • Cold, clammy skin
  • • Weak pulse and hypotension
  • • Gurgling or choking sounds

Emergency Response Protocol

  1. 1. Call 911 immediately
  2. 2. Administer naloxone (Narcan) if available
  3. 3. Provide rescue breathing if trained
  4. 4. Place patient in recovery position
  5. 5. Monitor vital signs continuously
  6. 6. Prepare for repeat naloxone doses
  7. 7. Transport to emergency department

Naloxone (Narcan) Administration

Intranasal Spray

  • • 4mg spray in one nostril
  • • Repeat every 2-3 minutes
  • • No assembly required
  • • Most user-friendly option

Auto-Injector

  • • 0.4mg intramuscular
  • • Press firmly against thigh
  • • Hold for 5 seconds
  • • Voice-guided instructions

Important Notes

  • • Effects last 30-90 minutes
  • • May need multiple doses
  • • Can precipitate withdrawal
  • • Always call 911

Professional Kadian Treatment Program

Our comprehensive Kadian treatment program combines evidence-based protocols, rigorous safety monitoring, and individualized care plans. We ensure optimal pain management while minimizing risks through comprehensive medical supervision and evidence-based treatment protocols.