Morphine sulfate may be habit forming. Overdoses may cause respiratory depression, coma, and death.
THIS PRODUCT WAS DEVELOPED FOR USE (AFTER APPROPRIATE DILUTION, IF NECESSARY) IN CONTINUOUS MICROINFUSION DEVICES FOR INTRATHECAL OR EPIDURAL INFUSION OF NARCOTICS TO CONTROL SEVERE CANCER PAIN. CHRONIC NEURAXIAL OPIOID ANALGESIA IS APPROPRIATE ONLY WHEN LESS INVASIVE MEANS OF CONTROLLING PAIN HAVE FAILED AND SHOULD ONLY BE UNDERTAKEN BY THOSE WHO ARE EXPERIENCED IN APPLYING THIS TREATMENT IN A SETTING WHERE ITS COMPLICATIONS CAN BE ADEQUATELY MANAGED.
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BECAUSE OF THE RISK OF SEVERE ADVERSE EFFECTS, PATIENTS MUST BE OBSERVED IN A FULLY EQUIPPED AND STAFFED ENVIRONMENT FOR AT LEAST 24 HOURS AFTER THE INITIAL (SINGLE) TEST DOSE AND, AS APPROPRIATE, FOR THE FIRST SEVERAL DAYS AFTER CATHETER IMPLANTATION. |
THE FACILITY MUST BE EQUIPPED TO RESUSCITATE PATIENTS WITH SEVERE OPIATE OVERDOSAGE, AND THE PERSONNEL MUST BE FAMILIAR WITH THE USE AND LIMITATIONS OF SPECIFIC NARCOTIC ANTAGONISTS (NALOXONE, NALTREXONE) IN SUCH CASES.
RESERVOIR FILLING MUST BE PERFORMED BY FULLY TRAINED AND QUALIFIED PERSONNEL, FOLLOWING THE DIRECTIONS PROVIDED BY THE DEVICE MANUFACTURER. CARE SHOULD BE TAKEN IN SELECTING THE PROPER REFILL FREQUENCY TO PREVENT DEPLETION OF THE RESERVOIR, WHICH WOULD RESULT IN EXACERBATION OF SEVERE PAIN AND/OR REFLUX OF CSF INTO SOME DEVICES. STRICT ASEPTIC TECHNIQUE IN FILLING IS REQUIRED TO AVOID BACTERIALCONTAMINATION AND SERIOUS INFECTION. EXTREME CARE MUST BE TAKEN TO ENSURE THAT THE NEEDLE IS PROPERLY IN THE FILLING PORT OF THE DEVICE BEFORE ATTEMPTING TO REFILL THE RESERVOIR. INJECTING THE SOLUTION INTO THE TISSUE AROUND THE DEVICE OR (IN THE CASE OF DEVICES THAT HAVE MORE THAN ONE PORT) ATTEMPTING TO INJECT THE REFILL DOSE INTO THE DIRECT INJECTION PORT WILL RESULT IN A LARGE, CLINICALLY SIGNIFICANT, OVERDOSAGE TO THE PATIENT.
A PERIOD OF OBSERVATION APPROPRIATE TO THE CLINICAL SITUATION SHOULD FOLLOW EACH REFILL OR MANIPULATION OF THE DRUG RESERVOIR. BEFORE DISCHARGE, THE PATIENT AND ATTENDANT(S) SHOULD RECEIVE INSTRUCTION IN THE PROPER HOME CARE OF THE DEVICE AND INSERTION SITE AND IN THE RECOGNITION AND PRACTICAL TREATMENT OF AN OVERDOSE OF NEURAXIAL MORPHINE.
INFLAMMATORY MASSES SUCH AS GRANULOMAS, SOME OF WHICH HAVE RESULTED IN SERIOUS NEUROLOGIC IMPAIRMENT INCLUDING PARALYSIS, HAVE BEEN REPORTED TO OCCUR IN PATIENTS RECEIVING CONTINUOUS INFUSION OF OPIOID ANALGESICS INCLUDING INFUMORPH VIA INDWELLING INTRATHECAL CATHETER. PATIENTS RECEIVING CONTINUOUS INFUSION OF INFUMORPH VIA INDWELLING INTRATHECAL CATHETER SHOULD BE CAREFULLY MONITORED FOR NEW NEUROLOGIC SIGNS OR SYMPTOMS. FURTHER ASSESSMENT OR INTERVENTION SHOULD BE BASED ON THE CLINICAL CONDITION OF THE INDIVIDUAL PATIENT.
PATIENTS SOMETIMES MANIFEST UNUSUAL ACCELERATION OF NEURAXIAL MORPHINE REQUIREMENTS, WHICH MAY CAUSE CONCERN REGARDING SYSTEMIC ABSORPTION AND THE HAZARDS OF LARGE DOSES; THESE PATIENTS MAY BENEFIT FROM HOSPITALIZATION AND DETOXIFICATION. TWO CASES OF MYOCLONIC-LIKE SPASM OF THE LOWER EXTREMITIES HAVE BEEN REPORTED IN PATIENTS RECEIVING MORE THAN 20 MG/DAY OF INTRATHECAL MORPHINE. AFTER DETOXIFICATION, IT MIGHT BE POSSIBLE TO RESUME TREATMENT AT LOWER DOSES, AND SOME PATIENTS HAVE BEEN SUCCESSFULLY CHANGED FROM CONTINUOUS EPIDURAL MORPHINE TO CONTINUOUS INTRATHECAL MORPHINE. REPEAT DETOXIFICATION MAY BE INDICATED AT A LATER DATE. THE UPPER DAILY DOSAGE LIMIT FOR EACH PATIENT DURING CONTINUING TREATMENT MUST BE INDIVIDUALIZED.
There is currently no manufacturer warning information available for this drug.
INFUMORPH (Preservative-free Morphine Sulfate Sterile Solution) is indicated only for intrathecal or epidural infusion in the treatment of intractable chronic pain. It was developed for use in continuous microinfusion devices and may require dilution before use as dictated by the characteristics of the device and the dosage requirements of the individual patient.
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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. |
Morphine is the most important alkaloid of opium and is a phenanthrene derivative. It is available as the sulfate salt, having the following structural formula:
7,8-Didehydro-4,5-epoxy-17-methyl-(5α,6α)-morphinan-3,6-diol sulfate (2:1) (salt), pentahydrate
(C17H19NO3)2• H2SO4• 5H2O MW is 758.83
INFUMORPH is a sterile, nonpyrogenic, isobaric, high potency solution of morphine sulfate, free of antioxidants, preservatives or other potentially neurotoxic additives. INFUMORPH is intended for use in continuous microinfusion devices for intraspinal administration in the management of pain.
Each 20 mL ampul of INFUMORPH 200 contains morphine sulfate, USP 200 mg or 10 mg/mL and sodium chloride 8 mg/mL in Water for Injection, USP. Each 20 mL ampul of INFUMORPH 500 contains morphine sulfate, USP 500 mg or 25 mg/mL and sodium chloride 6.25 mg/mL in Water for Injection, USP. If needed, sodium hydroxide and/or sulfuric acid are added for pH adjustment to 4.5. Each 20 mL ampul of INFUMORPH is intended for single use only.Discard any unused portion. DO NOT HEAT-STERILIZE.