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PRECAUTIONS
Morphine sulphate Cas No. 64-31-3
Morphine sulphate Tablets are a controlled-release oral formulation of
morphine sulfate indicated for the management of moderate to severe pain
when a continuous, around-the-clock analgesic is needed for an extended
period of time. Morphine sulphate does not release morphine continuously
over the course of a dosing interval. The administration of single doses of
Morphine sulphate on a q12h dosing schedule will result in higher peak and
lower trough plasma levels than those that occur when an identical daily
dose of morphine is administered using conventional oral formulations on a
q4h regimen. The clinical significance of greater fluctuations in morphine
plasma level has not been systematically evaluated.
Selection of patients for treatment with Morphine sulphate® should be
governed by the same principles that apply to the use of morphine or other
potent opioid analgesics. Specifically, the increased risks associated with
its use in the following populations should be considered: the elderly or
debilitated and those with severe impairment of hepatic, pulmonary, or renal
function; myxedema or hypothyroidism; adrenocortical insufficiency (e.g.,
Addison's Disease); CNS depression or coma; toxic psychosis; prostatic
hypertrophy or urethral stricture; acute alcoholism; delirium tremens;
kyphoscoliosis or inability to swallow.
The administration of morphine, like all opioid analgesics, may obscure the
diagnosis or clinical course in patients with acute abdominal conditions.
Morphine may aggravate convulsions in patients with convulsive disorders,
and all opioids may induce or aggravate seizures in some clinical settings.
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