Morphine Tablets

Dosage Forms And Strengths

• Morphine sulfate extended-release tablets 15 mg
  Round, blue-colored, film-coated tablets bearing the symbol ABG on one side and 15 on the other
• Morphine sulfate extended-release tablets 30 mg
  Round, lavender-colored, film-coated tablets bearing the symbol ABG on one side and 30 on the other
• Morphine sulfate extended-release tablets 60 mg
  Round, orange-colored, film-coated tablets bearing the symbol ABG on one side and 60 on the other
• Morphine sulfate extended-release tablets 100 mg*
  Round, gray-colored, film-coated tablets bearing the symbol ABG on one side and 100 on the other
• Morphine sulfate extended-release tablets 200 mg*
  Capsule-shaped, green-colored, film-coated tablets bearing the symbol ABG on one side and 200 on the other

*100 mg and 200 mg tablets are for us e in opioid-tolerant patients only

Storage And Handling

Morphine Sulfate Extended-Release Tablets 15 mg are round, blue-colored, film-coated tablets bearing the symbol ABG on one side and 15 on the other. They are supplied as follows:

NDC 42858-801-01: opaque plastic bottles containing 100 tablets

Morphine Sulfate Extended-Release Tablets 30 mg are round, lavender-colored, film-coated tablets bearing the symbol ABG on one side and 30 on the other. They are supplied as follows:

NDC 42858-802-01: opaque plastic bottles containing 100 tablets

Morphine Sulfate Extended-Release Tablets 60 mg are round, orange-colored, film-coated tablets bearing the symbol ABG on one side and 60 on the other. They are supplied as follows:

NDC 42858-803-01: opaque plastic bottles containing 100 tablets

Morphine Sulfate Extended-Release Tablets 100 mg are round, gray-colored, film-coated tablets bearing the symbol ABG on one side and 100 on the other. They are supplied as follows:

NDC 42858-804-01: opaque plastic bottles containing 100 tablets

Morphine Sulfate Extended-Release Tablets 200 mg are capsule-shaped, green-colored, film-coated tablets bearing the symbol ABG on one side and 200 on the other. They are supplied as follows:

NDC 42858-805-01: opaque plastic bottles containing 100 tablets

Store at 25°C (77°F); excursions permitted between 15° to 30°C (59° to 86°F).

Dispense in a tight, light-resistant container.

CAUTION

DEA FORM REQUIRED

Manufactured by: Purdue Pharmaceuticals, L.P. Wilson, NC 27893. Revised: May 2015

Included as part of the "PRECAUTIONS" Section

Morphine Sulfate Extended-Release (ER) Tablets

Morphine sulfate ER tablets are:

• A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain severe enough to require daily around-the-clock, long-term treatment with an opioid, when other pain treatments such as non-opioid pain medicines or immediate-release opioid medicines do not treat your pain well enough or you cannot tolerate them.
• A long-acting (extended-release) opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death.
• Not for use to treat pain that is not around-the-clock.

Important information about morphine sulfate ER tablets:

• Get emergency help right away if you take too much morphine sulfate ER tablets (overdose). When you first start taking morphine sulfate ER tablets, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur.
• Never give anyone else your morphine sulfate ER tablets. They could die from taking it. Store morphine sulfate ER tablets away from children and in a safe place to prevent stealing or abuse. Selling or giving away morphine sulfate ER tablets is against the law.

Do not take morphine sulfate ER tablets if you have:

• severe asthma, trouble breathing, or other lung problems.
• a bowel blockage or have narrowing of the stomach or intestines.

Before taking morphine sulfate ER tablets, tell your healthcare provider if you have a history of:

• head injury, seizures
• liver, kidney, thyroid problems
• problems urinating
• pancreas or gallbladder problems
• abuse of street or prescription drugs, alcohol addiction, or mental health problems.

Tell your healthcare provider if you are:

• pregnant or planning to become pregnant. Prolonged use of morphine sulfate ER tablets during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
• breastfeeding. Morphine sulfate ER tablets pass into breast milk and may harm your baby.
• taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking morphine sulfate ER tablets with certain other medicines can cause serious side effects.

When taking morphine sulfate ER tablets :

• Do not change your dose. Take morphine sulfate ER tablets exactly as prescribed by your healthcare provider.
• Take your prescribed dose every 8 to 12 hours, as directed by your healthcare provider. Do not take more than your prescribed dose. If you miss a dose, take your next dose at the usual time.
• Swallow morphine sulfate ER tablets whole. Do not cut, break, chew, crush, dissolve, snort, or inject morphine sulfate ER tablets because this may cause you to overdose and die.
• Call your healthcare provider if the dose you are taking does not control your pain.
• Do not stop taking morphine sulfate ER tablets without talking to your healthcare provider.
• After you stop taking morphine sulfate ER tablets, flush any unused tablets down the toilet.

While taking morphine sulfate ER tablets DO NOT:

• Drive or operate heavy machinery, until you know how morphine sulfate ER tablets affect you. Morphine sulfate ER tablets can make you sleepy, dizzy, or lightheaded.
• Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with morphine sulfate ER tablets may cause you to overdose and die.

The possible side effects of morphine sulfate ER tablets are:

• constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain. Call your healthcare provider if you have any of these symptoms and they are severe.
  Get emergency medical help if you have:
• trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue or throat, extreme drowsiness, light-headedness when changing positions, or you are feeling faint.

These are not all the possible side effects of morphine sulfate ER tablets. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov

The following serious adverse reactions are described elsewhere in the labeling:

• Addiction, Abuse, and Misuse [see WARNINGS AND PRECAUTIONS]
• Life-Threatening Respiratory Depression [see WARNINGS AND PRECAUTIONS]
• Neonatal Opioid Withdrawal Syndrome [see WARNINGS AND PRECAUTIONS]
• Interactions with Other CNS Depressants [see WARNINGS AND PRECAUTIONS]
• Hypotensive Effect [see WARNINGS AND PRECAUTIONS]
• Gastrointestinal Effects [see WARNINGS AND PRECAUTIONS]
• Seizures [see WARNINGS AND PRECAUTIONS]

Clinical Trial 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 drug and may not reflect the rates observed in practice.

Morphine sulfate extended-release tablets may increase the risk of serious adverse reactions such as those observed with other opioid analgesics, including respiratory depression, apnea, respiratory arrest, circulatory depression, hypotension, or shock [see OVERDOSE].

In clinical trials, the most common adverse reactions with morphine sulfate extended-release tablets were constipation, dizziness, sedation, nausea, vomiting, sweating, dysphoria, and euphoric mood.

Some of these effects seem to be more prominent in ambulatory patients and in those not experiencing severe pain.

Cardiovascular disorders: tachycardia, bradycardia, palpitations

Eye disorders: visual impairment, vision blurred, diplopia, miosis

Gastrointestinal disorders: dry mouth, diarrhea, abdominal pain, constipation, dyspepsia

General disorders and administration site conditions: chills, feeling abnormal, edema, edema peripheral, weakness

Hepatobiliary disorders: biliary colic

Metabolism and nutrition disorders: anorexia

Musculoskeletal and connective tissue disorders: muscle rigidity, muscle twitching

Nervous system disorders: presyncope, syncope, headache, tremor, uncoordinated muscle movements, convulsion, intracranial pressure increased, taste alteration, paresthesia, nystagmus

Psychiatric disorders: agitation, mood altered, anxiety, depression, abnormal dreams, hallucination, disorientation, insomnia

Renal and urinary disorders: urinary retention, urinary hesitation, antidiuretic effects

Reproductive system and breast disorders: reduced libido and/or potency

Respiratory, thoracic and mediastinal disorders: laryngospasm

Skin and subcutaneous tissue disorders: pruritus, urticaria, rash

Vascular disorders: flushing, hypotension, hypertension

Post-Marketing Experience

The following adverse reactions have been identified during postapproval use of morphine sulfate extended-release tablets: amenorrhea, asthenia, bronchospasm, confusional state, drug hypersensitivity, fatigue, hyperalgesia, hypertonia, ileus, increased hepatic enzymes, intestinal obstruction, lethargy, malaise, pulmonary edema, thinking disturbances, somnolence, and vertigo.

Anaphylaxis has been reported with ingredients contained in morphine sulfate extended-release tablets. Advise patients how to recognize such a reaction and when to seek medical attention.

Read the entire FDA prescribing information for Morphine Tablets (Morphine Sulfate Extended-release Tablets)