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: cetostearyl alcohol, hydroxyethyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, talc and titanium dioxide. The tablet strengths describe the amount of morphine per tablet as the pentahydrated sulfate salt (morphine sulfate).
The 15 mg tablets also contain: FD&C Blue No. 2, lactose, polysorbate 80
The 30 mg tablets also contain: D&C Red No. 7, FD&C Blue No. 1, lactose, polysorbate 80
The 60 mg tablets also contain: D&C Red No. 30, D&C Yellow No. 10, hydroxypropyl cellulose, lactose
The 100 mg tablets also contain: black iron oxide
The 200 mg tablets also contain: D&C Yellow No. 10, FD&C Blue No. 1, hydroxypropyl cellulose
DOSAGE AND ADMINISTRATION
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. MS CONTIN 100 mg and 200 mg capsules, a single dose greater than 60 mg, or a total daily dose greater than 120 mg, are only for use in patients in whom tolerance to an opioid of comparable potency has been established. Patients considered opioid-tolerant are those taking, for one week or longer, at least 60 mg morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone daily, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid.
Initial Dosage
Use of MS CONTIN As The First Opioid Analgesic (opioid-naïve patients)
Initiate treatment with MS CONTIN with 15 mg tablets orally every 8 or 12 hours. Use Of MS CONTIN In Patients Who Are Not Opioid Tolerant (opioid non-tolerant patients). The starting dose for patients who are not opioid tolerant is MS CONTIN 15 mg orally every 12 hours. Use of higher starting doses in patients who are not opioid tolerant may cause fatal respiratory depression.
HOW SUPPLIED
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 tablets) 30 mg Round, lavender-colored, film-coated tablets bearing the symbol PF on one side and M 30 on the other
- MS CONTIN (morphine sulfate extended-release tablets) 60 mg Round, orange-colored, film-coated tablets bearing the symbol PF on one side and M 60 on the other
- MS CONTIN (morphine sulfate extended-release tablets) 100 mg Round, gray-colored, film-coated tablets bearing the symbol PF on one side and 100 on the other
- MS CONTIN (morphine sulfate extended-release tablets) 200 mg Capsule-shaped, green-colored, film-coated tablets bearing the symbol PF on one side and M 200 on the other
SIDE EFFECTS
The following serious adverse reactions are described,:
- Addiction, Abuse, and Misuse
- Life-Threatening Respiratory Depression
- Neonatal Opioid Withdrawal Syndrome
- Interactions with Benzodiazepine or Other CNS Depressants
- Adrenal Insufficiency
- Severe Hypotension
- Gastrointestinal Adverse Reactions
- Seizures
- Withdrawal