MORPHINE SULFATE tablet

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Quality Care Products LLC

INN (International Name):

MORPHINE SULFATE

Sammensætning:

MORPHINE SULFATE 15 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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

Produkt oversigt:

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.

Autorisation status:

New Drug Application

Indlægsseddel

Quality Care Products LLC
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MEDICATION GUIDE
Revised: 7/2023
Document Id: abc05e8c-34b6-4292-9d4c-27442e47d52e
34391-3
Set id: 135f85e2-f000-4ef1-98a5-9bf0ab55d2c0
Version: 3684
Effective Time: 20230725
Quality Care Products LLC

Produktets egenskaber

MORPHINE SULFATE- MORPHINE SULFATE TABLET
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 depression, toxic psychosis, acute alcoholi