Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/2444
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Morphine Sulfate (Tablet)
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MORPHINE SULFATE
EXTENDED-RELEASE TABLETS ARE TO BE TAKEN WHOLE, AND ARENOT TO BE BROKEN,
CHEWED OR CRUSHED. TAKING BROKEN, CHEWED OR CRUSHED MORPHINE
SULFATE EXTENDED-RELEASE TABLETS COULD LEAD TO THE RAPID RELEASE AND
ABSORPTION OF A POTENTIALLY TOXIC DOSE OF MORPHINE. Morphine sulfate extended-release tablets are intended for use in
patients who require more than several days continuous treatment with a
potent opioid analgesic. The extended-release nature of the formulation
allows it to be administered on a more convenient schedule than
conventional immediate-release oral morphine products. (See CLINICAL
PHARMACOLOGY: Pharmacokinetics and Metabolism.) However, morphine
sulfate extended-release tablets do not release morphine continuously
over the course of a dosing interval. The administration of single doses
of morphine sulfate extended-release tablets on a ql2h 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. As with any potent opioid drug product, it is critical to adjust
the dosing regimen for each patient individually, taking into account
the patient's prior analgesic treatment experience. Although it is
clearly impossible to enumerate every consideration that is important to
the selection of initial dose and dosing interval of morphine sulfate
extended-release tablets, attention should be given to 1) the daily
dose, potency and precise characteristics of the opioid the patient has
been taking previously (e.g., whether it is a pure agonist or mixed
agonist/antagonist), 2) the reliability of the relative potency estimate
used to calculate the dose of morphine needed [N.B. potency estimates
may vary with the route of administration], 3) the degree of opioid
tolerance, if any, and 4) the general condition and medical status of the patient. The following dosing recommendations, therefore, can only be
considered suggested approaches to what is actually a series of clinical
decisions in the management of the pain of an individual
patient.<br/>Conversion from Conventional Oral Morphine to Morphine Sulfate
Extended-Release Tablets: A patient's daily morphine requirement is
established using immediate-release oral morphine (dosing every
4 to 6 hours). The patient is then converted to morphine sulfate
extended-release tablets in either of two ways: 1) by
administering one-half of the patient's 24-hour
requirement as morphine sulfate extended-release tablets on an
every 12-hour schedule; or, 2) by administering one-third of the
patient's daily requirement as morphine sulfate extended-release
tablets on an every eight hour schedule. With either method,
dose and dosing interval is then adjusted as needed (see
discussion below). The 15 mg extended-release morphine sulfate tablet should be used for initial conversion for patients whose
total daily requirement is expected to be less than 60 mg.
Morphine sulfate extended-release tablets of 30 mg strength are
recommended for patients with a daily morphine requirement of 60
to 120 mg. When the total daily dose is expected to be greater
than 120 mg, the appropriate combination of tablet strengths
should be employed.<br/>Conversion from Parenteral Morphine or Other Opioids (Parenteral
or Oral) to Morphine Sulfate Extended-Release Tablets: Morphine sulfate extended-release tablets can be
administered as the initial oral morphine drug product; in this
case, however, particular care must be exercised in the
conversion process. Because of uncertainty about, and
intersubject variation in, relative estimates of opioid potency
and cross tolerance, initial dosing regimens should be
conservative; that is, an underestimation of the 24-hour oral
morphine requirement is preferred to an overestimate. To this
end, initial individual doses of morphine sulfate
extended-release tablets should be estimated conservatively. In
patients whose daily morphine requirements are expected to be
less than or equal to 120 mg per day, morphine sulfate
extended-release tablets of 30 mg strength are recommended for
the initial titration period. Once a stable dose regimen is
reached, the patient can be converted to the 60 mg or 100 mg
tablet strength, or appropriate combination of tablet strengths,
if desired. Estimates of the
relative potency of opioids are only approximate and are
influenced by route of administration, individual patient
differences, and possibly, by an individual's medical
condition. Consequently, it is difficult to recommend any fixed
rule for converting a patient to morphine sulfate
extended-release tablets directly. The following general points
should be considered,
however. Physicians are advised to refer to published relative
potency data, keeping in mind that such ratios are only approximate.
In general, it is safer to underestimate the daily dose of morphine
sulfate extended-release tablets required and rely upon ad hoc
supplementation to deal with inadequate analgesia. (See discussion
which follows.)<br/>Use of morphine sulfate extended-release tablets as the first
opioid analgesic: There has been no systematic evaluation of morphine
sulfate extended-release tablets as an initial opioid analgesic
in the management of pain. Because it may be more difficult to titrate a patient using an extended-release morphine, it is
ordinarily advisable to begin treatment using an
immediate-release formulation.<br/>Considerations in the Adjustment of Dosing Regimens: Whatever the approach, if signs of excessive opioid
effects are observed early in a dosing interval, the next dose
should be reduced. If this adjustment leads to inadequate
analgesia, that is, "breakthrough" pain occurs late in the
dosing interval, the dosing interval may be shortened.
Alternatively, a supplemental dose of a short-acting analgesic
may be given. As experience is gained, adjustments can be made
to obtain an appropriate balance between pain relief, opioid
side effects, and the convenience of the dosing
schedule. In adjusting dosing
requirements, it is recommended that the dosing interval never
be extended beyond 12 hours because the administration of very
large single doses may lead to acute overdose. (N.B. This
product is an extended-release formulation; it does not release
morphine continuously over the dosing
interval.) For patients with low daily
morphine requirements, morphine sulfate extended-release tablets of
15 mg strength should be used.<br/>Special Instructions for Morphine Sulfate Extended-Release
Tablets, 200 mg (For use in opioid tolerant patients
only.): Morphine Sulfate Extended-Release tablets,
200 mg are for use only in opioid tolerant patients requiring
daily morphine equivalent dosages of 400 mg or more. It is
recommended that this strength be reserved for patients that
have already been titrated to a stable analgesic regimen using
lower strengths of morphine extended-release tablets or other
opioids.<br/>Conversion from morphine sulfate extended-release tablets to
parenteral opioids:: When converting a patient from morphine sulfate
extended-release tablets to parenteral opioids, it is best to
assume that the parenteral to oral potency is high. NOTE THAT
THIS IS THE CONVERSE OF THE STRATEGY USED WHEN THE DIRECTION OF
CONVERSION IS FROM THE PARENTERAL TO ORAL FORMULATIONS. IN BOTH
CASES, HOWEVER, THE AIM IS TO ESTIMATE THE NEW DOSE
CONSERVATIVELY. For example, to estimate the required 24-hour
dose of morphine for IM use, one could employ a conversion of 1
mg of morphine IM for every 6 mg of morphine as morphine sulfate
extended-release tablets. Of course, the IM 24-hour dose would
have to be divided by six and administered on a q4h regimen.
This approach is recommended because it is least likely to cause
overdose.
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Morphine Sulfate
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Morphine Sulfate (Tablet)
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Morphine sulfate extended-release tablets are indicated for the
relief of moderate to severe pain. It is intended for use in patients
who require repeated dosing with potent opioid analgesics over periods
of more than a few days. The morphine sulfate extended-release tablet, 200 mg strength is
a high dose, oral morphine formulation indicated for the relief of pain
in opioid tolerant patients only.
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Morphine Sulfate
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