MORPHINE SULFATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MORPHINE SULFATE (UNII: X3P646A2J0) (MORPHINE - UNII:76I7G6D29C)

Available from:

Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC

INN (International Name):

MORPHINE SULFATE

Composition:

MORPHINE SULFATE 30 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Morphine sulfate tablets contain morphine, an opioid analgesic, indicated for the relief of moderate to severe acute and chronic pain where use of an opioid analgesic is appropriate. Morphine sulfate is contraindicated in patients with known hypersensitivity to morphine, morphine salts, or any components of the product. Morphine sulfate is contraindicated in patients with respiratory depression in the absence of resuscitative equipment. Morphine sulfate is contraindicated in patients with acute or severe bronchial asthma or hypercarbia. Morphine sulfate is contraindicated in any patient who has or is suspected of having paralytic ileus. Animal reproduction studies have not been conducted with morphine sulfate. It is also not known whether morphine sulfate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Only give morphine sulfate to a pregnant woman if clearly needed. In humans, the frequency of congenital anomalies has been reported to be no greater than expecte

Product summary:

Morphine Sulfate Tablets 15 mg Tablet: white, biconvex tablets scored on one side and product identification "54 733" debossed on the other side. Unit dose, 25 tablets per card NDC 0054-0235-24: 4 Cards Per Carton NDC 0054-0235-25: Bottle of 100 Tablets 30 mg Tablet:  white, biconvex tablets scored on one side and product identification "54 262" debossed on the other side. Unit dose, 25 tablets per card NDC 0054-0236-24: 4 Cards Per Carton NDC 0054-0236-25: Bottle of 100 Tablets Storage Store at Controlled Room Temperature, 15° to 30°C (59° to 86°F). PROTECT FROM MOISTURE. All opioids are liable to diversion and misuse both by the general public and healthcare workers and should be handled accordingly.

Authorization status:

New Drug Application

Patient Information leaflet

Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC
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MEDICATION GUIDE
Revised: 1/2021
Document Id: 5d265270-9d04-4017-9753-f2abb9130b4a
34391-3
Set id: d9a4179d-b21d-4921-be29-089ecfcb6e6a
Version: 3376
Effective Time: 20210129
Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC

Summary of Product characteristics

MORPHINE SULFATE- MORPHINE SULFATE TABLET
LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MORPHINE SULFATE TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MORPHINE SULFATE
TABLETS.
MORPHINE SULFATE TABLETS, CII
INITIAL U.S. APPROVAL: 1984
INDICATIONS AND USAGE
Morphine sulfate is an opioid analgesic indicated for the relief of
moderate to severe acute and chronic pain where an
opioid analgesic is appropriate. (1)
DOSAGE AND ADMINISTRATION
Morphine Sulfate Tablets: 15 to 30 mg every 4 hours as needed. (2.2)
DOSAGE FORMS AND STRENGTHS
Tablets: 15 mg or 30 mg. (3)
CONTRAINDICATIONS
Known hypersensitivity to morphine. (4)
Respiratory depression in the absence of resuscitative equipment. (4)
Acute or severe bronchial asthma or hypercarbia. (4)
Paralytic ileus. (4)
WARNINGS AND PRECAUTIONS
Respiratory depression: Increased risk in elderly, debilitated
patients, those suffering from conditions accompanied by
hypoxia, hypercapnia, or upper airway obstruction. (5.1)
Controlled substance: Morphine sulfate is a Schedule II controlled
substance with an abuse liability similar to other
opioids. (5.2)
CNS effects: Additive CNS depressive effects when used in conjunction
with alcohol, other opioids, or illicit drugs. (5.3)
Elevation of intracranial pressure: May be markedly exaggerated in the
presence of head injury, other intracranial
lesions. (5.4)
Hypotensive effect: Increased risk with compromised ability to
maintain blood pressure. (5.5)
Prolonged gastric obstruction: In patients with gastrointestinal
obstruction, especially paralytic ileus. (5.6)
Sphincter of Oddi spasm and diminished biliary/pancreatic secretions.
Increased risk with biliary tract disease. (5.7)
Special Risk Groups: Use with caution and in reduced dosages in
patients with severe renal or hepatic impairment,
Addison's disease, hypothyroidism, prostatic hypertrophy, or urethral
stricture, elderly, CNS dep