KADIAN Capsule extended-release (2019)

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Allergan, Inc.

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BOXED WARNING SECTION

WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; INTERACTION ...

1. Indications and Usage

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. Limitations of ...

2. Dosage and Administration

2.1 Important Dosage and Administration Instructions KADIAN should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain. ...

3. Dosage Forms and Strengths

Extended-release capsules: 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, 80 mg, 100 mg, 200 mg. KADIAN contains white to off-white or tan colored polymer coated pellets, have an outer opaque capsule ...

4. Contraindications

KADIAN is contraindicated in patients with: Significant respiratory depression [see Warnings and Precautions (5.3)] Acute or severe bronchial asthma in an unmonitored setting or in the absence ...

5. Warnings and Precautions

5.1 Addiction, Abuse, and Misuse KADIAN contains morphine, a Schedule II controlled substance. As an opioid, KADIAN exposes users to the risks of addiction, abuse, and misuse. Because extended-release ...

6. Adverse Reactions

The following serious adverse reactions are described, or described in greater detail, in other sections: Addiction, Abuse, and Misuse [see Warnings and Precautions (5.1)] Life Threatening Respiratory ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of ...

6.2. Postmarketing Experience

The following adverse reactions have been identified during post approval use of morphine. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible ...

7. Drug Interactions

Table 1 includes clinically significant drug interactions with KADIAN. Table 1. Clinically Significant Drug Interactions with KADIAN: Alcohol Clinical Impact: Concomitant use of alcohol ...

8.1. Pregnancy

Risk Summary Prolonged use of opioid analgesics during pregnancy can cause neonatal opioid withdrawal syndrome [see Warnings and Precautions (5.4)]. There are no available data with KADIAN in ...

8.2. Lactation

Risk Summary Morphine is present in breast milk. Published lactation studies report variable concentrations of morphine in breast milk with administration of immediate-release morphine to nursing mothers ...

8.3. Females and Males of Reproductive Potential

Infertility Chronic use of opioids may cause reduced fertility in females and males of reproductive potential. It is not known whether these effects on fertility are reversible [see Adverse Reactions ...

8.4. Pediatric Use

The safety and efficacy of KADIAN in patients less than 18 years have not been established.

8.5. Geriatric Use

Clinical studies of KADIAN did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Elderly patients (aged 65 years or older) ...

8.6. Hepatic Impairment

Morphine pharmacokinetics have been reported to be significantly altered in patients with cirrhosis. Start these patients with a lower than usual dosage of KADIAN and titrate slowly while monitoring for ...

8.7. Renal Impairment

Morphine pharmacokinetics are altered in patients with renal failure. Start these patients with a lower than usual dosage of KADIAN and titrate slowly while monitoring for signs of respiratory depression, ...

9.1. Controlled Substance

KADIAN contains morphine, a Schedule II controlled substance.

9.2. Abuse

KADIAN contains morphine, a substance with a high potential for abuse similar to other opioids including fentanyl, hydrocodone, hydromorphone, methadone, oxycodone, oxymorphone, and tapentadol. KADIAN ...

9.3. Dependence

Both tolerance and physical dependence can develop during chronic opioid therapy. Tolerance is the need for increasing doses of opioids to maintain a defined effect such as analgesia (in the absence of ...

10. Overdosage

Clinical Presentation Acute overdosage with KADIAN can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, ...

11. Description

KADIAN (morphine sulfate) extended-release capsules, an opioid agonist, are for oral use and contain pellets of morphine sulfate. Each KADIAN extended-release capsule contains either 10 mg, 20 mg, 30 mg, ...

12.1. Mechanism of Action

Morphine is a full opioid agonist and is relatively selective for the mu-opioid receptor, although it can bind to other opioid receptors at higher doses. The principal therapeutic action of morphine is ...

12.2. Pharmacodynamics

CNS Depressant/Alcohol Interaction Additive pharmacodynamic effects may be expected when KADIAN is used in conjunction with alcohol, other opioids, or illicit drugs that cause central nervous system depression. ...

12.3. Pharmacokinetics

Absorption KADIAN capsules contain polymer coated extended-release pellets of morphine sulfate that release morphine significantly more slowly than oral morphine solution. Following the administration ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis Long-term studies in animals to evaluate the carcinogenic potential of morphine have not been conducted. Mutagenesis No formal studies to assess the mutagenic potential of morphine have ...

16.1. How Supplied

KADIAN extended-release capsules contain white to off-white or tan colored polymer coated extended-release pellets of morphine sulfate and are available in nine dose strengths.   KADIAN 10 mg KADIAN ...

16.2. Storage and Handling

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a sealed tamper-evident, childproof, light-resistant ...

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Storage and Disposal Because of the risks associated with accidental ingestion, misuse, and abuse, ...