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Duramorph

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Duramorph

Indications
Dosage
How Supplied

INDICATIONS

DURAMORPH (morphine injection) is a systemic narcotic analgesic for administration by the intravenous, epidural or intrathecal routes. It is used for the management of pain not responsive to non-narcotic analgesics. DURAMORPH (morphine injection) administered epidurally or intrathecally, provides pain relief for extended periods without attendant loss of motor, sensory or sympathetic function.

Not For Use in Continuous Microinfusion Devices

DOSAGE AND ADMINISTRATION

DURAMORPH (morphine injection) is intended for intravenous, epidural or intrathecal administration.

Not For Use in Continuous Microinfusion Devices

Intravenous Administration

Dosage

The initial dose of morphine should be 2 mg to 10 mg/70 kg of body weight. No information is available regarding the use of DURAMORPH (morphine injection) in patients under the age of 18.

Geriatric Use

Administer with extreme caution. (See PRECAUTIONS.)

Epidural Administration

DURAMORPH (morphine injection) SHOULD BE ADMINISTERED EPIDURALLY BY OR UNDER THE DIRECTION OF A PHYSICIAN EXPERIENCED IN THE TECHNIQUE OF EPIDURAL ADMINISTRATION AND WHO IS THOROUGHLY FAMILIAR WITH THE LABELING. IT SHOULD BE ADMINISTERED ONLY IN SETTINGS WHERE ADEQUATE PATIENT MONITORING IS POSSIBLE. RESUSCITATIVE EQUIPMENT AND A SPECIFIC ANTAGONIST (NALOXONE INJECTION) SHOULD BE IMMEDIATELY AVAILABLE FOR THE MANAGEMENT OF RESPIRATORY DEPRESSION AS WELL AS COMPLICATIONS WHICH MIGHT RESULT FROM INADVERTENT INTRATHECAL OR INTRAVASCULAR INJECTION. (NOTE: INTRATHECAL DOSAGE IS USUALLY 1/10 THAT OF EPIDURAL DOSAGE.) PATIENT MONITORING SHOULD BE CONTINUED FOR AT LEAST 24 HOURS AFTER EACH DOSE, SINCE DELAYED RESPIRATORY DEPRESSION MAY OCCUR.

Proper placement of a needle or catheter in the epidural space should be verified before DURAMORPH (morphine injection) is injected.

Acceptable techniques for verifying proper placement include: a) aspiration to check for absence of blood or cerebrospinal fluid, or b) administration of 5 mL (3 mL in obstetric patients) of 1.5% PRESERVATIVE-FREE Lidocaine and Epinephrine (1:200,000) Injection and then observe the patient for lack of tachycardia (this indicates that vascular injection has not been made) and lack of sudden onset of segmental anesthesia (this indicates that intrathecal injection has not been made).

Epidural Adult Dosage

Initial injection of 5 mg in the lumbar region may provide satisfactory pain relief for up to 24 hours. If adequate pain relief is not achieved within one hour, careful administration of incremental doses of 1 to 2 mg at intervals sufficient to assess effectiveness may be given. No more than 10 mg/24 hr should be administered.

Thoracic administration has been shown to dramatically increase the incidence of early and late respiratory depression even at doses of 1 to 2 mg.

Geriatric Use

Administer with extreme caution. (See PRECAUTIONS.)

Epidural Pediatric Use

No information on use in pediatric patients is available. (See PRECAUTIONS.)

Intrathecal Administration

NOTE: INTRATHECAL DOSAGE IS USUALLY 1/10 THAT OF EPIDURAL DOSAGE.

DURAMORPH (morphine injection) SHOULD BE ADMINISTERED INTRATHECALLY BY OR UNDER THE DIRECTION OF A PHYSICIAN EXPERIENCED IN THE TECHNIQUE OF INTRATHECAL ADMINISTRATION AND WHO IS THOROUGHLY FAMILIAR WITH THE LABELING. IT SHOULD BE ADMINISTERED ONLY IN SETTINGS WHERE ADEQUATE PATIENT MONITORING IS POSSIBLE. RESUSCITATIVE EQUIPMENT AND A SPECIFIC

ANTAGONIST (NALOXONE INJECTION) SHOULD BE IMMEDIATELY AVAILABLE FOR THE MANAGEMENT OF RESPIRATORY DEPRESSION AS WELL AS COMPLICATIONS WHICH MIGHT RESULT FROM INADVERTENT INTRAVASCULAR INJECTION. PATIENT MONITORING SHOULD BE CONTINUED FOR AT LEAST 24 HOURS AFTER EACH DOSE, SINCE DELAYED RESPIRATORY DEPRESSION MAY OCCUR. RESPIRATORY DEPRESSION (BOTH EARLY AND LATE ONSET) HAS OCCURRED MORE FREQUENTLY FOLLOWING INTRATHECAL ADMINISTRATION THAN EPIDURAL ADMINISTRATION.

Intrathecal Adult Dosage

A single injection of 0.2 to 1 mg may provide satisfactory pain relief for up to 24 hours. (CAUTION: THIS IS ONLY 0.4 TO 2 ML OF THE 5 MG/10 ML AMPUL OR 0.2 TO 1 ML OF THE 10 MG/10 ML AMPUL OF DURAMORPH (morphine injection) ). DO NOT INJECT INTRATHECALLY MORE THAN 2 ML OF THE 5 MG/10 ML AMPUL OR 1 ML OF THE 10 MG/10 ML AMPUL. USE IN THE LUMBAR AREA ONLY IS RECOMMENDED. Repeated intrathecal injections of DURAMORPH (morphine injection) are not recommended. A constant intravenous infusion of naloxone, 0.6 mg/hr, for 24 hours after intrathecal injection may be used to reduce the incidence of potential side effects.

Geriatric Use

Administer with extreme caution. (See PRECAUTIONS.)

Repeat Dosage

If pain recurs, alternative routes of administration should be considered, since experience with repeated doses of morphine by the intrathecal route is limited.

Intrathecal Pediatric Use

No information on use in pediatric patients is available. (See PRECAUTIONS.)

Safety And Handling Instructions

DURAMORPH (morphine injection) 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 DURAMORPH (morphine injection) contains 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 diversion and abuse, it is recommended that special measures be taken to control this product within the hospital or clinic.

DURAMORPH (morphine injection) should be subject to rigid accounting, rigorous control of wastage and restricted access.

Parenteral drug products should be inspected for participate matter and discoloration prior to administration, whenever solution and container permit. DO NOT USE IF COLOR IS DARKER THAN PALE YELLOW, IF IT IS DISCOLORED IN ANY OTHER WAY OR IF IT CONTAINS A PRECIPITATE.

HOW SUPPLIED

Preservative-Free DURAMORPH (morphine sulfate injection, USP) is available in amber DOSETTE ampuls for intravenous, epidural and intrathecal administration:

5 mg/10 mL (0.5 mg/mL) packaged in 10s (NDC 60977-016-02)
10 mg/10 mL (1 mg/mL) packaged in 10s (NDC 60977-017-01)

Also available from Baxter: INFUMORPH (Preservative-free Morphine Sulfate Sterile Solution) 200 mg/20 mL (10 mg/mL) and 500 mg/20 mL (25 mg/mL) for epidural and intrathecal administration via a continuous microinfusion device.

Storage

PROTECT FROM LIGHT. Store in carton at 20°- 25°C (68°- 77°F), excursions permitted to 15°- 30°C (59°- 86°F) [see USP Controlled Room Temperature] until ready to use. DO NOT FREEZE. DURAMORPH (morphine injection) contains no preservative or antioxidant. DISCARD ANY UNUSED PORTION. DO NOT HEAT-STERILIZE.

Manufactured by: Baxter Healthcare Corporation, Deerfield, IL 60015 USA. For Product Inquiry 1 800 ANA DRUG (1-800-262-3784).

Last reviewed on RxList: 10/29/2010
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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