INFUMORPH (Pres ervative-free Morphine Sulfate Sterile
Solution) is indicated only for intrathecal or epidural infus ion in the
treatment of intractable chronic pain. It was developed for us e in continuous
microinfus ion devices and may require dilution before us e as dictated by the characteris
tics of the device and the dos age requirements of the individual patient.
INFUMORPH IS NOT RECOMMENDED FOR SINGLE-DOSE INTRAVENOUS,
INTRAMUSCULAR OR SUBCUTANEOUS ADMINISTRATION DUE TO THE VERY LARGE AMOUNT OF
MORPHINE IN THE AMPUL AND THE ASSOCIATED RISK OF OVERDOSAGE.
DOSAGE AND ADMINISTRATION
INFUMORPH 200 AND 500 (10 AND 25 MG/ML, RESPECTIVELY)
SHOULD NOT BE USED FOR SINGLE-DOSE NEURAXIAL INJECTION BECAUSE LOWER DOSES CAN
BE MORE RELIABLY ADMINISTERED WITH THE STANDARD PREPARATION OF DURAMORPH (0.5 AND
CANDIDATES FOR NEURAXIAL ADMINISTRATION OF INFUMORPH IN A
CONTINUOUS MICROINFUSION DEVICE SHOULD BE HOSPITALIZED TO PROVIDE FOR ADEQUATE PATIENT
MONITORING DURING ASSESSMENT OF RESPONSE TO SINGLE DOSES OF INTRATHECAL OR
EPIDURAL MORPHINE. HOSPITALIZATION SHOULD BE MAINTAINED FOR SEVERAL DAYS AFTER
SURGERY INVOLVING THE INFUSION DEVICE FOR ADDITIONAL MONITORING AND ADJUSTMENT
OF DAILY DOSAGE. THE FACILITY MUST BE EQUIPPED WITH RESUSCITATIVE EQUIPMENT,
OXYGEN, NALOXONE INJECTION AND OTHER RESUSCITATIVE DRUGS. BECAUSE OF THE RISK
OF DELAYED RESPIRATORY DEPRESSION, PATIENTS SHOULD BE OBSERVED IN A FULLY
EQUIPPED AND STAFFED ENVIRONMENT FOR AT LEAST 24 HOURS AFTER EACH TEST DOSE
AND, AS INDICATED, FOR THE FIRST SEVERAL DAYS AFTER SURGERY.
Familiarization with the continuous microinfusion device
is essential. The desired amount of morphine should be withdrawn from the ampul
through a microfilter. To minimize risk from glass or other particles, the
product must be filtered through a 5 μ (or smaller) microfilter before
injecting into the microinfusion device. If dilution is required, 0.9%
Sodium Chloride Injection is recommended.
The starting dose must be individualized, based upon inhospital evaluation
of the response to serial single-dose intrathecal bolus injections of regular
DURAMORPH (Morphine Sulfate Injection, USP) 0.5 mg/mL or 1 mg/mL, with close
observation of the analgesic efficacy and adverse effects prior to surgery
involving the continuous microinfusion device.
The recommended initial lumbar intrathecal dose range in
patients with no tolerance to opioids is 0.2 to 1 mg/day. The published range
of doses for individuals who have some degree of opioid tolerance varies from 1
to 10 mg/day. The upper daily dosage limit for each patient must be
Limited experience with continuous intrathecal infusion
of morphine has shown that the daily doses have to be increased over time.
Although the rate of increase, over time, in the dose required to sustain analgesia
is highly variable, an estimate of the expected rate of increase is shown in
the following Figure.
Doses above 20 mg/day should be employed with caution
since they may be associated with a higher likelihood of serious side effects
(see WARNINGS concerning potential neurological hazards and ADVERSE
Administer with extreme caution. (See PRECAUTIONS.)
The starting dose must be individualized, based upon
in-hospital evaluation of the response to serial single-dose epidural bolus
injections of regular DURAMORPH (Morphine Sulfate Injection, USP) 0.5 mg/mL or
1 mg/mL, with dose observation for analgesic efficacy and adverse effects prior
to surgery involving the continuous microinfusion device.
The recommended initial epidural dose in patients who are
not tolerant to opioids ranges from 3.5 to 7.5 mg/day. The usual starting dose
for continuous epidural infusion, based upon limited data in patients who have
some degree of opioid tolerance, is 4.5 to 10 mg/day. The dose requirements may
increase significantly during treatment, frequently to 20-30 mg/day. The upper
daily limit for each patient must be individualized.
Administer with extreme caution. (See PRECAUTIONS.)
Safety And Handling Instructions
INFUMORPH is supplied in sealed ampuls. Accidental dermal
exposure should be treated by the removal of any contaminated clothing and
rinsing the affected area with water.
Each ampul of INFUMORPH contains a large amount of a
potent narcotic which has been associated with abuse and dependence among
health care providers. Due to the limited indications for this product, the
risk of overdosage and the risk of its divers ion and abuse, it is recommended
that special measures be taken to control this product within the hospital or
clinic. INFUMORPH should be subject to rigid accounting, rigorous control of
wastage and restricted access. This parenteral drug product must be ins pected
for particulate matter before opening the amber ampul and again for color after
removing contents from the ampul. Do not us e if the solution in the unopened
ampul contains a precipitate which does not disappear upon shaking. After removal,
do not use unless the solution is colorless or pale yellow.
Amber ampuls for epidural or intrathecal administration
via a continuous microinfusion device.
INFUMORPH 200 (Preservative-free Morphine Sulfate
Sterile Solution) 200 mg/20 mL (10 mg/mL) packaged individually (NDC
INFUMORPH 500 (Preservative-free Morphine Sulfate
Sterile Solution) 500 mg/20 mL (25 mg/mL) packaged individually (NDC
Also available from West-Ward: DURAMORPH (Morphine
Sulfate Injection, USP) 5 mg/10 mL (0.5 mg/mL) and 10 mg/10 mL (1 mg/mL).
Protect from light. Store at 20° - 25°C (68° - 77°F),
excursions permitted to 15°30°C
[See USP Controlled Room Temperature] until ready to us e. DO NOT FREEZE. INFUMORPH
contains no preservative or antioxidant. DISCARD ANY UNUSED PORTION. DO NOT
To report SUSPECTED ADVERSE REACTIONS, contact West-Ward
Pharmaceutical Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or
Manufactured by: WEST-WARD, PHARMACEUTICALS, Eatontown,
NJ 07724 USA. Revised: September 2011