MS CONTIN Tablet (2019)

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Rhodes Pharmaceuticals L.P.

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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; and RISKS FROM ...

1. Indications and Usage

MS CONTIN 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 ...

2. Dosage and Administration

2.1 Important Dosage and Administration Instructions MS CONTIN 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

MS CONTIN (morphine sulfate extended-release tablets) 15 mg: Round, blue-colored, film-coated tablets bearing the symbol PF on one side and M 15 on the other. MS CONTIN (morphine sulfate extended-release ...

4. Contraindications

MS CONTIN 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 MS CONTIN contains morphine, a Schedule II controlled substance. As an opioid, MS CONTIN exposes its 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 to rates in the clinical trials of another ...

6.2. Postmarketing Experience

The following adverse reactions have been identified during post-approval use of MS CONTIN. 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 MS CONTIN. Table 1. Clinically Significant Drug Interactions with MS CONTIN: Benzodiazepines and Other Central Nervous System (CNS) ...

8.1. Pregnancy

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

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 effectiveness in pediatric patients below the age of 18 have not been established.

8.5. Geriatric Use

The pharmacokinetics of MS CONTIN have not been studied in elderly patients. Clinical studies of MS CONTIN did not include sufficient numbers of subjects aged 65 and over to determine whether they respond ...

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 MS CONTIN and titrate slowly while monitoring ...

8.7. Renal Impairment

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

9.1. Controlled Substance

MS CONTIN contains morphine, a Schedule II controlled substance.

9.2. Abuse

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

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 MS CONTIN can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted ...

11. Description

MS CONTIN (morphine sulfate extended-release tablets) is for oral use and contains morphine sulfate, an opioid agonist. Each tablet contains the following inactive ingredients common to all strengths: ...

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 MS CONTIN is used in conjunction with alcohol, other opioids, or illicit drugs that cause central nervous system ...

12.3. Pharmacokinetics

Absorption MS CONTIN is an extended-release tablet containing morphine sulfate. Morphine is released from MS CONTIN somewhat more slowly than from immediate-release oral preparations. Following oral 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

MS CONTIN (morphine sulfate extended-release tablets) are supplied as follows: 15 mg: round, blue-colored, film-coated tablets bearing the symbol PF on one side and M 15 on the other. Bottles (opaque ...

16.2. Storage and Handling

Store at 25°C (77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Store MS CONTIN securely and dispose of properly [see Patient Counseling Information ...

17. Patient Counseling Information

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